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Saturday, June 17
 

8:00am

Exhibitor Registration
Saturday June 17, 2017 8:00am - 5:00pm
TBA
 
Sunday, June 18
 

8:00am

8:00am

Exhibitor Registration
Sunday June 18, 2017 8:00am - 6:00pm
TBA

8:30am

Half Day Morning Preconference Short Courses
An additional registration fee is required for all preconference short courses. View all short courses and Register today 

Sunday June 18, 2017 8:30am - 12:00pm
TBA

8:30am

#23: Signal Detection: Identifying and Managing Safety Signals
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-17-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

Signal detection is an essential element of the overall risk management process. This short course provides a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process.  Emphasis is on practical pragmatic approaches.  Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion.  The short course also provides participants with the context to evaluate new research in the field. Back to DIA 2017  


Speakers
avatar for James Buchanan

James Buchanan

Drug Safety Consultant, Covilance LLC
Dr. Buchanan is an independent drug safety consultant. He worked in clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General Hospital before starting at Genentech where he worked for 9 years in medical information and drug safety. He then establ... Read More →


Sunday June 18, 2017 8:30am - 12:00pm
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

8:30am

#25: Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-000-17-507-L04-7; CME 3.25; IACET 3.25

The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. Since 2015, Chinese GCP guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some good clinical practices (GCP) are overturning common ways that were implemented since 2003. The CFDA is updating the drug category and IND/NDA process for the regulatory registration purpose, and enhancing inspective forces on the quality and integrity of clinical trial outcomes. The procedures of IND/NDA review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug R&D strategies in China. This course will provide insights into critical considerations impacting IND/NDA practices involving drugs development in China and current CFDA reformations of regulatory submission review and approval.

Who should attend?

This short course is designed for professionals in regulatory affairs, drug development, clinical trial management, monitoring, data management or clinical operations who have some basic knowledge of the Chinese regulatory environment and will benefit from learning updates of IND/NDA drug clinical trials.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe basic CFDA regulatory requirements for an IND/NDA process
  • Explain Chinese regulatory practice and trends for reviewing and approving submissions of drugs
  • Discuss the updated Chinese GCP guidelines for IND drug trials
  • Explain how to be compliant with Chinese GCP standards in the implementation of clinical trials
  • Complete the IND/NDA application process to the CFDA.


Sunday June 18, 2017 8:30am - 12:00pm
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Credit Type ACPE, CME, IACET
  • Tags Tutorial

8:30am

#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-17-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

Understanding best practices is critical as you design a clinical program and regulatory strategy for a drug or biologic product. Identifying and obtaining the data actually needed for a product development program is key to the success of the program. Thinking ahead to the marketing application helps a sponsor avoid many of the common mistakes that are made in overall drug development programs. Even though it may be years before an NDA/BLA/MAA submission, the marketing application is the goal of each development program and should be kept in view throughout the program to avoid pitfalls and delays in submission and product approval. This short course will cover common mistakes and solutions in the areas of drug development planning, regulatory agency interactions, and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples that illustrate approaches to adopt or to avoid.

Who should attend?

This short course is designed for professionals with basic knowledge in regulatory affairs, agency submissions, and regulatory medical writing.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify ways to increase the efficiency and success of product development programs
  • Describe key principles for successful regulatory interactions during drug development and marketing application preparation
  • Discuss best practices in developing successful clinical trial designs, statistical analysis plans, and regulatory submission documents



Speakers
avatar for Elaine Taylor

Elaine Taylor

Executive Director, Regulatory Consulting and Submissions, INC Research
Elaine B. Taylor is Global Head of Regulatory Consulting and Submissions at INC Research responsible for leading a global team of regulatory professionals providing consultation, development, and management of regulatory interactions and submissions for sponsors. With over 25 yea... Read More →


Sunday June 18, 2017 8:30am - 12:00pm
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Featured Topics Medical Writing
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

8:30am

#24: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

Payers play an important role in both national and global health care systems: their decision-making signals to manufacturers their likelihood to support the R&D required for innovative, new medicines. Only a small number of innovative medicines are approved annually. The large proportion of new drug candidates fail during the development, and the average R&D cost per approved new molecular entity is increasing. Providers and payers can be thought of as agents acting on behalf of patients and their covered beneficiaries. Payers are critical in expressing the willingness of health care systems to provide funds to support innovation. Manufacturers must understand, monitor, and anticipate the evolving payer environment to increase the likelihood of regulatory and commercial success for new products. Key tools such as pharmacoeconomic evaluation of cost-effectiveness and budget impact, as well as important processes such as health technology assessment are used in many developed countries. Understanding their varying role in different jurisdictions is critical for pricing and market access negotiations. This short course, which is hosted with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), will introduce participants to the basic economics of drug development, pricing, contracting, and market access. It will address commonly used economic concepts, such as demand, supply, willingness to pay, monopoly, intellectual property, and value. Practical observations will be made on the similarities and differences in how health care systems approach these pricing and access practices and decisions, with an emphasis on the implications for stakeholder incentives. Examples will be used to illustrate key concepts in both routine and special cases.


Who should attend?

This short course is designed for industry professionals and academics with an interest to learn more about the economic perspective on drug development, incentives for innovation, and how different countries grapple with these difficult health sector resource allocation decisions.

Learning Objectives

  • Explain what makes innovative medicines unique economic inputs into population health including how the patent system relates to the financing of global R&D
  • Discuss in what way prices for innovative medicines are established, how this differs by system, as well as the evolving impact of pharmacoeconomics and health technology assessment
  • Describe how the complex global network of public and private payers judge the value of innovative medicines



  • Speakers
    avatar for Louis Garrison

    Louis Garrison

    Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington
    Dr. Garrison is Professor in the Pharmaceutical Outcomes Research and Policy Program in the School of Pharmacy, and Adjunct Professor in the Departments of Global Health and Health Services at the University of Washington, where he joined the faculty in 2004. He also co-directs t... Read More →
    avatar for Jack Mycka

    Jack Mycka

    Global President and CEO, Medical Marketing Economics LLC (MME)
    As MME’s Global President & CEO, Jack provides critical global support for strategic marketing and pricing decisions to clients in the biotech and pharmaceutical industries. As a recognized expert consultant since 2001, he has successfully completed engagements encompassing man... Read More →


    Sunday June 18, 2017 8:30am - 12:00pm
    S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Real World Evidence
    • Credit Type CME, IACET, RN
    • Tags Tutorial

    8:30am

    #26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm
    Component Type: Tutorial
    CE: CME 3.25; IACET 3.25; RN 3.25

    Learn what regulators are looking for from sponsors and CROs as they initially assess their vendors and audit investigator sites for compliance and oversee them for compliance and quality throughout the clinical trial. As clinical trials become more complex involving additional data and vendors, why is it that companies keep using the traditional audit plan? As technology has provided the transparency and tools needed for trending, review and analytics, why is it that companies have yet to evolve to utilize them? Discuss various risk-based methodologies for audit programs and how logistical issues such as governmental travel advisories, environmental travel restrictions, resource issues (such as timing, budget) and availability of qualified individuals (auditors) may necessitate innovation to accomplish audit goals. Discuss case studies to assess risk in various remote auditing options which may provide a snapshot of compliance when travel may not be possible at that time and may assist in training auditors or providing subject matter expertise as needed from statisticians, IT professionals, etc. Learn methods for selecting what to audit and to what extent the auditing should be performed based on factors which may contribute to, or increase/decrease risk to subject safety and rights or data quality/integrity. Produce an audit plan that can be adapted for use to qualify (initial and re-qualification) and audit vendors (CROs, pharmacovigilance, eCOA vendors, etc.), study sites, and internal processes (when the department is off-site). Use the plan for auditing study site data, trial master files (TMF), databases, imaging data, etc.

    Who should attend?

    This short course is designed for:
    • Quality personnel from sponsor companies, CROs, and vendors
    • Data Managers, Clinical Operations, CRAs, Clinical Scientists, Medical Monitors and other project leaders with ideas on how and what critical to quality data should be presented to auditors
    • Representatives/ consultants of companies that provide auditing services

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Determine which data is critical to quality using risk-based methodologies
      • Explore novel methods to access documents and data.
      • Develop more comprehensive and cross functional audit plans for oversight activities of vendors and CROs
      • New methods to host/ conduct a qualification, vendor, study site, or other GCP audits


    Speakers
    avatar for Joanne Malia

    Joanne Malia

    Associate Director, Clinical Documentation Management, Regeneron Pharmaceuticals
    Joanne Malia is currently the Associate Director of Clinical Documentation Management at Regeneron, a biopharmaceutical company located in Tarrytown, NY. She has worked in clinical research at various global biotech, device, CRO and big pharma companies in the areas of quality... Read More →
    avatar for Sarah Ann Silvers

    Sarah Ann Silvers

    Director, GCP Process Control and Compliance, Ce3
    Sarah currently holds the title Director, GCP Process Control and Compliance and is charged with overseeing the Clinical Quality Program at Ce3 Inc. and its affiliate Cd3, a biometrics service provider. Among other responsibilities in this position Sarah designs, leads, and condu... Read More →


    Sunday June 18, 2017 8:30am - 12:00pm
    S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Tutorial

    8:30am

    #22: How to Prepare for an FDA Inspection
    Component Type: Tutorial
    CE: CME 3.25; IACET 3.25; RN 3.25

    This short course will provide information on how to build quality into a clinical trials program. A record number of FDA inspections, both domestic and international, and OHRP audits have resulted in an increased number of warning letters to sponsors, principal investigators, and IRBs. Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with good clinical practice expectations. Participants will also learn about the considerations for non-compliance and the types of findings in an audit that can lead to regulatory problems. This course will describe the role of the FDA and the preparation of a site for an FDA inspection. We will cover the audit from different perspectives and focus on helpful hints and procedural issues regarding what to do in case your site is chosen for an FDA inspection. There will be a discussion on how to host the audit and how best to prepare for the actual audit. The audience will be taught some of the do's and don'ts of a successful inspection. Back to DIA 2017  


    Speakers
    avatar for Michael Hamrell

    Michael Hamrell

    President, MORIAH Consultants
    Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, contract research, government and biotech industries, in domestic and international regulatory aff... Read More →


    Sunday June 18, 2017 8:30am - 12:00pm
    S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Quality-GXP
    • Credit Type CME, IACET, RN
    • Tags Tutorial

    8:30am

    #20: Leadership: How to Organize and Lead People in a Work Group
    Component Type: Tutorial
    CE: CME 3.25; PDU 3.25 PMI 2166-000197; RN 3.25

    The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This short course addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.

    Who should attend?

    This short course is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and want to learn how to exert influence on group behavior. This course will also benefit individuals to whom project managers report.

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Identify the different types of work group structures and be able to predict the quality of work the group will produce
    • Identify ways to correct dysfunctional group dynamics
    • Create and maintain cooperation among team members, including cross-functional teams



    Speakers
    avatar for Michael Laddin

    Michael Laddin

    Chief Executive Officer, LeaderPoint
    Mike Laddin is CEO of LeaderPoint. Mike has over twenty five years of senior management experience has a BS in Psychology Chemistry, MS in inPsychology and an MBA from Rockhurst University.LeaderPoint has over 700 clients including; 3M, ADP, Pfizer, Electronic Arts, LucasFilms, Z... Read More →


    Sunday June 18, 2017 8:30am - 12:00pm
    S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, PMI, RN
    • Tags Tutorial

    9:00am

    Full Day Preconference Short Courses
    An additional registration fee is required for all preconference short courses. View all short courses and Register today 

    Sunday June 18, 2017 9:00am - 5:00pm
    TBA

    9:00am

    #43: The Good Pharmacovigilance Practices in the EU: Global Applications
    Component Type: Tutorial
    CE: CME 6.50; IACET 6.50; RN 6.50

    The objective of this short course is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:
  • Overview of the latest developments in the area of pharmacovigilance in the EU including related IT systems
  • Management and reporting of adverse reactions and signal management
  • Updates of GVP Module VI •The new EU E2B(R3) ICSR implementation guide
  • New process for marketing authorization holders regarding the monitoring of medical literature and entry of relevant information into the EudraVigilance database by the EMA
  • Updates to the EudraVigilance Access Polic

    Who should attend?

    This short course is designed for professionals who work in the following areas: clinical safety and pharmacovigilance, regulatory affairs, risk management, quality and compliance.

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Describe recent developments on EU Good Pharmacovigilance Practices guidance
    • Examine principles for new literature monitoring and the revised EudraVigilance Access Policy
    • Discuss FAQs in signal management
    • Identify important aspects in preparing risk management plans and conducting - is something missing here?
    • Describe key principles for pharmacovigilance audits and inspections


  • Speakers
    avatar for Saad Shakir

    Saad Shakir

    Director, Drug Safety Research Unit
    Saad Shakir is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines. He has worked and... Read More →
    KS

    Kristina Strutt

    Senior Vice President, Global Patient Safety, Ipsen Biopharm Limited
    Kristina studied medicine at Cambridge and London Universities in the UK. She has 28 years Clinical Development and Drug Safety pharma experience in the UK, Switzerland and Germany. She lectures in pharmacovigilance on various courses in the UK, and is an examiner for the Faculty... Read More →


    Sunday June 18, 2017 9:00am - 5:00pm
    S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Tutorial

    9:00am

    #42: Analysis of Safety Data from Clinical Trials
    Component Type: Tutorial
    CE: ACPE 6.50 Knowledge UAN: 0286-0000-17-509-L04-P; CME 6.50; IACET 6.50; RN 6.50

    This short course is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

    Who should attend?

    This short course is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Discuss how to utilize guidelines and regulatory requirements for clinical trials
    • Describe ways to contribute to safety analysis plans
    • Discuss the statistical safety analysis process and pitfalls that could occur
    • Identify impact of benefit-risk assessment in safety data


    Speakers
    avatar for Jürgen Kübler

    Jürgen Kübler

    Quantitative Scientific Consultant, QSciCon
    Dr. Kübler has over 15 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from th... Read More →


    Sunday June 18, 2017 9:00am - 5:00pm
    S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Statistics
    • Credit Type ACPE, CME, IACET, RN
    • Tags Tutorial

    9:00am

    #40: Clinical Statistics for Nonstatisticians
    Component Type: Tutorial
    CE: ACPE 6.50 Knowledge UAN: 0286-0000-17-505-L04-P; CME 6.50; IACET 6.50; RN 6.50

    This short course will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the course will be on the application of statistical concepts to clinical investigation.

    Who should attend?

    This course is designed for professionals in the pharmaceutical industry involved in clinical research, medical affairs, medical writing, and other disciplines, who need to be familiar with statistical concepts.

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Discuss basic statistical concepts such as variability, confidence intervals, hypothesis testing, and p-values
    • Compare various study designs including techniques to avoid bias
    • Use statistical terminology with ease
    • Distinguish information needed for determining sample size


    Speakers
    avatar for Michael Mosier

    Michael Mosier

    Director, Biostatistics, EMB Statistical Solutions, LLC
    Michael Mosier, PhD is co-founder and Director of Biostatistics for EMB Statistical Solutions, a data management and statistical CRO. He has served on the editorial board of the Drug Information Journal and serves as instructor for the DIA Clinical Statistics for Nonstatisticians... Read More →


    Sunday June 18, 2017 9:00am - 5:00pm
    S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Statistics
    • Credit Type ACPE, CME, IACET, RN
    • Tags Tutorial

    10:30am

    Student Session
    Component Type: Session
    Level: Basic

    This session will explore the opportunities that student membership in the Drug Information Association (DIA) offers. The session will start with an overview of the DIA and its relationship to the global pharmaceutical, device, and therapeutic industries. Students will find that the information and networking opportunities that DIA provides can help shape and guide course and track selections as they proceed through their educational experiences. The session will also include an inter panel discussion on potential careers for students with a scientific and/or health care background. 10:30-10:50 Welcome and Introduction to Student Chapters Student Advisor perspective 10:50-11:00 Q &A on student chapters 11:00 -12:00 Interactive Career Panel Discussion 11:30-11:40 Panelist introductions 11:40-12:00 Discussion with audience participation

    Chair

    Raleigh E. Malik, PhD


    Speakers
    avatar for Alberto Grignolo

    Alberto Grignolo

    Corporate Vice President, PAREXEL
    Alberto Grignolo, PhD is Corporate VP, Global Strategy at PAREXEL Consulting, where he has worked for 24 years in various regulatory, drug development and management capacities. Most recently he relocated to PAREXEL's Tokyo Office for two years, establishing a new consulting unit... Read More →
    avatar for Mark Kryah

    Mark Kryah

    Senior Advisor/COO, Bio-Medicines Business Unit, Eli Lilly and Company
    Mark Kryah has been leading projects from early to late phase development for over 19 years. He has extensive international and cross-cultural experience in CMC, clinical and global development, with multiple alliance collaborations and co-development partnerships. For the past 7... Read More →
    avatar for Raleigh Malik

    Raleigh Malik

    Senior Scientific Liaison, DIA
    Dr. Raleigh Malik is a Sr. Scientist at DIA in Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to joining DIA, Dr. Malik supported med... Read More →
    avatar for Ranjini Prithviraj

    Ranjini Prithviraj

    Senior Managing Editor/Associate Director, DIA
    Dr. Ranjini Prithviraj is the Senior Managing Editor and Associate Director of Publications at DIA in Washington, D.C where she provides strategic thought leadership and delivers content that advances DIA’s mission through various media, including traditional journal publicatio... Read More →
    avatar for Margaret Richards

    Margaret Richards

    Vice President, Data Analytics and Epidemiology, RW Strategy and Analytics, Mapi
    Dr. Margaret ‘Meg’ Richards has over 25 years' experience as an epidemiologist in the public health, biopharmaceutical, and contract research sectors. Prior to joining PPD as Executive Director of Epidemiology, Dr. Richards served as a Director of Global Patient Safety & Risk... Read More →


    Sunday June 18, 2017 10:30am - 12:00pm
    Prairie Room, Hyatt McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:00pm

    DIA Drug Development and Life Sciences Career Fair: Career Fair Expo

    Join us for DIA’s Career Fair during the DIA 2017 Annual Meeting. You will have the rare chance to meet with leading employers from around the globe in the clinical and life sciences space who will be displaying available career opportunities within their organization. Following the fair, employers will have the opportunity to invite potential candidates to private, one-on-one interviews on Monday. Whether you are a recent graduate or a seasoned executive, the DIA Career Fair is the premier career advancement event for you! 

    For more information on the Career Fair, please view here

    12:00-6:00PM  Career Fair Expo

    Sunday June 18, 2017 12:00pm - 6:00pm
    Hyatt Regency McCormick Place, Regency Ballroom 2233 S. King Drive Chicago, IL 60616

    12:30pm

    1:00pm

    Half Day Afternoon Preconference Short Courses
    An additional registration fee is required for all preconference short courses. View all short courses and Register today 

    Sunday June 18, 2017 1:00pm - 4:30pm
    TBA

    1:00pm

    #32: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
    Component Type: Tutorial
    CE: ACPE 3.25 Application UAN: 0286-0000-17-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

    Risk evaluation and mitigation strategies (REMS) vary from simple to complex. Particularly for the complex Elements to Assure Safe Use (ETASU) REMS, data in the form of a REMS assessment report may greatly challenge team members as many may be new to the process. Creation of a REMS assessment report requires a high-functioning, coordinated and cooperative team (whether done all in-house or including vendors). During this short course, participants will hear about relevant FDA regulations and guidances, recent status of REMS, and experiences in leading teams to successfully create REMS assessment reports. During hands-on activities, participants will receive case studies, discuss and role play as key functional areas — data management, project writing, medical writing, pharmacovigilance, drug safety, epidemiology, and regulatory affairs, with an emphasis on providing a timely, high-quality deliverable. Time will be spent on refinement of the project plan, development of the table of contents, and how to coordinate disparate sections such as knowledge survey reports and adherence metrics. Discussion will also focus on topics such as the content of the REMS assessment as dictated by the REMS and REMS approval letter, determination of data cut-off dates, working with vendors, what to include in the report regarding survey design issues such as comprehension testing, special concerns for shared REMS, and FDA input and timing.

    Who should attend?

    This course is designed for professionals involved in clinical safety and pharmacovigilance.

    Learning Objectives

    At the conclusion of this short course, participants should be able to:
    • Describe the key milestones needed to create a REMS assessment report
    • Identify who and how to engage in the multidisciplinary team required to create the report
    • Discuss the type of sections included in various types of REMS assessment reports


    Speakers
    avatar for Mark Ammann

    Mark Ammann

    President, Catalyst Regulatory Services, LLC
    Mark A. Ammann is the owner and President of Catalyst Regulatory Services, LLC. Prior to founding Catalyst, Mark established and built a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and p... Read More →
    avatar for Catherine Sigler

    Catherine Sigler

    Executive Director, Safety, Epidemiology, Registries, and Risk Management (SERRM, UBC, An Express Scripts Company
    Dr. Catherine Sigler is a Senior Epidemiologist and Executive Director in United BioSource Corporation (subsidiary of Express Scripts Inc.) department: Surveillance, Epidemiology, Registries and Risk Management (SERRM). She provides technical expertise in pharmaceutical safety is... Read More →
    avatar for Annette Stemhagen

    Annette Stemhagen

    Senior Vice President, Safety, Epidemiology, Registries & Risk Management, UBC, An Express Scripts Company
    Dr. Stemhagen has more than 30 years of research experience, 20 yrs in safety surveillance. She has expertise in design, conduct, and analysis of peri-approval registries, LSS, actual use studies, including 35 regulatory-mandated safety studies. She has developed REMS for more th... Read More →


    Sunday June 18, 2017 1:00pm - 4:30pm
    S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type ACPE, CME, IACET, RN
    • Tags Tutorial

    1:00pm

    #35: Digital Health Technologies for Combination Products and Beyond: Development and Regulation
    Component Type: Tutorial
    CE: CME 3.25; IACET 3.25; RN 3.25

    This short course will focus on how digital health technologies are being developed and regulated in the pharmaceutical/combination products space. Although many digital health technologies follow a fairly straightforward regulatory path as devices, those that interact with drug products often encounter more regulatory uncertainty. FDA’s policy on how mobile medical apps, clinical decision support software, and wearables can be combined with pharmaceutical use is still in development, so it is often difficult to navigate the regulatory path to market for these products. This course will look at currently available FDA guidances and what they mean for digital health products that combine both a drug and device. Participants will explore how to work with FDA when developing digital health technologies that may veer outside of established regulatory pathways, and a series of case studies will examine how innovators have addressed development and regulatory hurdles.

    Learning Objectives

    Describe how digital health technologies are being regulated by FDA through a discussion of current FDA guidances and their effect on the development and approval of digital health products, some of which combine both a drug and device; Identify how to work with FDA when developing digital health technologies via established regulatory pathways and what to do when those technologies veer outside of established regulatory pathways.


    Speakers
    avatar for Wade Ackerman

    Wade Ackerman

    Partner, Covington & Burling LLP
    Wade Ackerman is a partner in Covington’s Food, Drug, and Device practice. Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions Committee where he was involved in legislative initiatives, oversight hearings, and other... Read More →


    Sunday June 18, 2017 1:00pm - 4:30pm
    S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Devices-Combination Products
    • Credit Type CME, IACET, RN
    • Tags Tutorial

    1:00pm

    #30: Preparing for a US FDA Advisory Committee Meeting
    Component Type: Tutorial
    CE: ACPE 3.25 Application UAN: 0286-0000-17-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

    What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings. What You Will Learn:
    • What an advisory committee is
    • How an advisory committee is structured
    • Critical factors for advisory committee preparation
    • How to design the most applicable preparation program for your team
    • Top ten "best practices" and "must avoids"

      Who should attend?

      This course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Identify the critical success factors in preparing for an advisory committee meeting
      • Outline those factors that are most applicable to your team
      • Design the most effective preparation strategy for your team(s)


    Speakers
    avatar for Neelu Agrawal

    Neelu Agrawal

    Principal, PharmApprove, a member of the NDA Group
    Neelu has over 20 years of strategic communication, cross-functional leadership and management consulting experience. Prior to PharmApprove, Neelu was a Partner at Rosetta, where she helped lead the company’s healthcare consulting practice. She has worked closely with clinical... Read More →
    avatar for Pete Taft

    Pete Taft

    Senior Communications Coach, PharmApprove, a member of the NDA Group
    Senior Communications Coach, Pete Taft provides strategic counsel and coaching services. He has conducted dozens of “lessons learned” sessions, videoconferences, workshops, seminars and individual coaching sessions. Pete began his career in journalism, covering crime, politic... Read More →


    Sunday June 18, 2017 1:00pm - 4:30pm
    S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Medical Writing
    • Credit Type ACPE, CME, IACET, RN
    • Tags Tutorial

    1:00pm

    #33: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
    Component Type: Tutorial
    CE: ACPE 3.25 Knowledge UAN: 0286-0000-17-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

    Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.

    Who should attend?

    This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

    Learning Objectives

    At the conclusion of this short course, participants should be able to:
    • Explain the major elements of the Japanese regulatory system
    • Describe the regulatory procedures during development, registration, and post-approval
    • Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies


    Speakers
    avatar for Alberto Grignolo

    Alberto Grignolo

    Corporate Vice President, PAREXEL
    Alberto Grignolo, PhD is Corporate VP, Global Strategy at PAREXEL Consulting, where he has worked for 24 years in various regulatory, drug development and management capacities. Most recently he relocated to PAREXEL's Tokyo Office for two years, establishing a new consulting unit... Read More →


    Sunday June 18, 2017 1:00pm - 4:30pm
    S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type ACPE, CME, IACET, RN
    • Tags Tutorial

    1:00pm

    #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
    Component Type: Tutorial
    CE: CME 3.25; IACET 3.25; RN 3.25

    The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.

    Who should attend?

    This short course is designed for professionals involved with clinical and data operations.

    Learning Objectives

    At the conclusion of this short course, participants should be able to:
    • Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology
    • Discuss the use of key tools in the RBM process
    • Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology


    Speakers
    avatar for Mary Arnould

    Mary Arnould

    Business Partner, Monitoring Excellence, Bristol-Myers Squibb
    Mary has been in the pharmaceutical industry for over 20 years. She began her career as a site monitor and monitored studies in numerous therapuetic areas. Mary managed site monitors for over 10 years. She has been supporting the implementation of Risk Based Monitoring at Bristol... Read More →
    CF

    Cecilie Freddie Lange

    RBM Specialist, Novo Nordisk A/S
    avatar for Stuart Shaw

    Stuart Shaw

    Risk Based Quality Management Project Leader, Boehringer Ingelheim Pharmaceuticals Inc.
    Stuart has over 20 years pharmaceutical experience within Biometrics and Data Management. He has contributed to many regulatory submissions and inspections during this time. Stuart has been working on the implementation of Risk Based Monitoring at Boehringer Ingelheim since 2013... Read More →


    Sunday June 18, 2017 1:00pm - 4:30pm
    S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics RBM
    • Credit Type CME, IACET, RN
    • Tags Tutorial

    1:00pm

    #31: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation
    Component Type: Tutorial
    CE: CME 3.25; RN 3.25

    This course is designed to help you understand what culture, bureaucracy and innovation really are, and the impact they can have on actual business results — in concrete, clear terms. This requires stripping away the vagueness and assumptions that so commonly surround these topics. The discussion will include three primary components:
    1. Understanding and influencing workplace culture and its impact on employee results. Culture can either disrupt people’s ability to focus on the work, or it can reinforce and support clarity of focus, but culture is created by those working, not dictated by managers.
    2. Avoiding and dealing with workplace bureaucracy, which almost always results from the creation of structure, a necessity as businesses and companies grow. Understanding and managing bureaucracy improves efficiency and economics 
    3. Understanding and encouraging workplace innovation, and the direct benefits to efficiency and profitability that innovation brings about. Managers often attempt to drive innovation formally, but these efforts usually fail due to a lack of understanding what really encourages innovation at the work level — where it matters most.

      Who should attend?

      This course is designed for managers interested in directly impacting these three areas, generating greater business results through the efforts of others. It is designed for new and experienced managers seeking to understand and address these issues with planned deliberation.

      Learning Objectives

      At the conclusion of this tutorial, participants should be able to:
      • Define ways to create focus and direction for people in work groups or project teams
      • Identify an applicable set of tools to understand, diagnose and correct dysfunctional culture, bureaucratic inefficiency, and inadequate innovation


    Speakers
    avatar for Michael Laddin

    Michael Laddin

    Chief Executive Officer, LeaderPoint
    Mike Laddin is CEO of LeaderPoint. Mike has over twenty five years of senior management experience has a BS in Psychology Chemistry, MS in inPsychology and an MBA from Rockhurst University.LeaderPoint has over 700 clients including; 3M, ADP, Pfizer, Electronic Arts, LucasFilms, Z... Read More →


    Sunday June 18, 2017 1:00pm - 4:30pm
    S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Career Development
    • Credit Type CME, RN
    • Tags Tutorial

    2:45pm

    #001: To Change or Not to Change, That is the Career Question: Knowing When it’s Time to Move On (Not, Run From)
    Component Type: Workshop
    Level: Intermediate
    CE: IACET 1.25

    Hear from your industry leaders on how they knew it was time to make a job change and how to prepare for the change. Learn techniques you can use to assess a negative performance review, being passed over for a promotion, or similar and how to avoid an emotionally based (and regretful) decision.

    Learning Objectives

    Describe the decision making process used by industry leaders when assessing a career change and the skills/thinking required to do so; Learn ways to turn negative career experiences into a positive springboard forward and gain personal insights on what it takes to make a change.

    Chair

    Kimberly Belsky, MS

    Speaker

    Panelist
    Leigh Shultz, PhD

    Panelist
    Margaret S. Richards, PhD, MPH

    Panelist
    Stephen Knowles, MD, MRCP



    Speakers
    avatar for Kimberly Belsky

    Kimberly Belsky

    Senior Director, Regulatory Affairs, Regulatory Intelligence, Mallinckrodt Pharmaceuticals
    Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceutica... Read More →
    avatar for Stephen Knowles

    Stephen Knowles

    Senior Director, Global Patient Safety, Medical and Benefit Risk Management, Eli Lilly and Company
    Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Eli Lilly in 2001 and has worked in pharmacovigilance since 2005 in various roles in both the UK and USA. In his current role, Steve has managem... Read More →
    avatar for Margaret Richards

    Margaret Richards

    Vice President, Data Analytics and Epidemiology, RW Strategy and Analytics, Mapi
    Dr. Margaret ‘Meg’ Richards has over 25 years' experience as an epidemiologist in the public health, biopharmaceutical, and contract research sectors. Prior to joining PPD as Executive Director of Epidemiology, Dr. Richards served as a Director of Global Patient Safety & Risk... Read More →
    avatar for Leigh Shultz

    Leigh Shultz

    Associate Vice President, Project Management, Merck & Co., Inc.
    Global R&D Project Management at Merck: Associate Vice President for Primary Care, ID, and Vaccines. PhD in chemistry; started at Merck in 2001 as a chemist in Pharm R&D. Joined Project Management in 2004; PMP-certified in 2007.


    Sunday June 18, 2017 2:45pm - 4:00pm
    N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Career Development,StudentProgramming
    • Credit Type IACET
    • Tags Workshop

    4:15pm

    #002: Networking Within Your Company
    Component Type: Workshop
    Level: Basic
    CE: IACET 1.25

    Even if your job rarely requires you to interact outside your company, you still need to know how to network. This is called internal networking. Internal networking is when you reach out to colleagues within your organization, even if your job doesn’t require you to do so. It’s going beyond your normal scope of job responsibilities. Networking internally means you are looking outside your immediate, day-to-day activities and thinking about how you can connect with and create value for others in your company. While many of the same principles apply for external and internal networking there is a nuance to internal networking that is unique. These differences will be explained. There will be discussion of personality types and how that impacts networking. There will also be a portion of the workshop dedicated to practicing networking.

    Learning Objectives

    Recognize the importance of networking within your company as a part of career management; differentiate personality types and identify how these preferences affect networking; Apply tools to facilitate productive working relationships and career success.

    Chair

    Chris Matheus, MBA

    Speaker

    Facilitator
    Bob Muzerall

    Facilitator
    Nadia Bracken



    Speakers
    avatar for Nadia Bracken

    Nadia Bracken

    Founder and Chief Connector, ClinOps Toolkit
    Your go-to girl for superconnecting with clinical research insiders at ClinOps Toolkit in the Facebook and LinkedIn Groups.
    avatar for Chris Matheus

    Chris Matheus

    Executive Director, Business Development, Lexitas Pharma Services
    Chris has 20 years of experience in the clinical research industry. He has focused on clinical trial technologies while working in large CROs and smaller technology companies. Chris is with Lexitas Pharma Services as Executive Director, Business Development.
    avatar for Bob Muzerall

    Bob Muzerall

    Vice President, Sales & Sales Training, AMPLEXOR Life Sciences, LLC
    Bob has held managerial and executive positions in the publishing and medical fields for over 30 years. He is currently Vice President, Sales & Sales Training at AMPLEXOR Life Sciences. AMPLEXOR Life Sciences helps the pharmaceutical, medical device and biotechnology industries l... Read More →


    Sunday June 18, 2017 4:15pm - 5:30pm
    N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Career Development,StudentProgramming
    • Credit Type IACET
    • Tags Workshop
     
    Monday, June 19
     

    6:30am

    CISCRP Medical Appreciation 5K
    Join CISCRP for the Medical Heroes Appreciation 5K Run and Walk in Chicago, IL to celebrate the study volunteers who give the gift of participation in clinical research.

    All proceeds will provide education and outreach about clinical research participation to patients and their families in minority and under-served communities.

    PrintPLUS The Greater Gift Initiative is teaming up with CISCRP again to offer a vaccine to a child in need on behalf of every registrant!

    Prizes for top runners, top fundraisers, the team with the most spirit and more!

    For more information and to learn about sponsorship opportunities, please email Ellyn at ellyngetz@ciscrp.org

    Monday June 19, 2017 6:30am - 8:00am
    TBA

    7:00am

    Attendee, Speaker, and Exhibitor Registration
    Monday June 19, 2017 7:00am - 6:00pm
    TBA

    7:30am

    Annual Meeting Orientation
    Monday June 19, 2017 7:30am - 8:15am
    TBA

    7:30am

    Coffee and Light Refreshments
    Monday June 19, 2017 7:30am - 8:30am
    TBA

    8:30am

    #101: Drug Repurposing: Where Will it Take Us?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-562-L04-P; CME 1.50; IACET 1.50; RN 1.50

    Drug repurposing includes approved drug indication expansion, drug-like compound repositioning, and drug reformulation strategies to help get medicines to patients faster. Because repositioning leverages sunk costs for compounds that have failed to reach market, and approved drugs can be reformulated or repurposed to treat a different disorder, the cost often times to get the new therapy to market is reduced. Will “repurposing" disrupt the current market? How can academia, industry, and health authorities collaborate to advance drug repurposing efforts? What is needed to overcome economic, patent, and regulatory hurdles to get repurposed drugs to patients faster? These questions and others will be addressed during this DIAmond session by an esteemed panel of representatives from NIH NCATS, Cures Within Reach, industry, and academia.

    Learning Objectives

    Define the concept of drug repurposing; Discuss opportunities and challenges for academia, industry, and health authorities to collaborate to advance drug repurposing efforts; Review the economic, patent, and regulatory hurdles that exist to get repurposed drugs to patients faster.

    Chair

    Bruce E Bloom, DDS, JD

    Speaker

    Funder Perspective
    Christine Colvis, PhD

    Using Human Genetic Variation to Repurpose Existing Medications for New Diseases
    Jill Pulley, MBA

    Industry Perspective
    Pamela Hill, MS, PMP

    Industry Perspective
    K. Gary Barnette, PhD



    Speakers
    avatar for K. Gary Barnette

    K. Gary Barnette

    Senior Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services, LLC
    With more than 20 years of industry experience, Dr. K. Gary Barnette brings to Camargo a wealth of knowledge of FDA regulations. At Camargo, Barnette is responsible for propelling the growth of the company and establishing excellent customer service practices by utilizing his sub... Read More →
    avatar for Bruce Bloom

    Bruce Bloom

    President and Chief Science Officer, Cures Within Reach
    Dr. Bruce Bloom is President and Chief Science Officer of Cures Within Reach, a non-profit saving lives using its CureAccelerator™ platform repurposing approved drugs/devices to quickly deliver safe and affordable treatments for unsolved diseases. He is an Ashoka Fellow, Patien... Read More →
    avatar for Christine Colvis

    Christine Colvis

    Director, Drug Development Partnership Programs, National Center for Advancing Translational Sciences (NCATS)
    Christine Colvis joined NCATS in June 2012 as the Center’s director of drug development partnership programs. Her team is best known for leading the Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program, which supports pre-clinical and clinical... Read More →
    avatar for Pamela Hill

    Pamela Hill

    Open Innovation Program Director, Principal Scientist, Emerging Innovations Unit, AstraZeneca
    With more than 15 years of experience in the biopharmaceutical industry, Pam Hill has worked in the discovery phase supporting multiple therapy areas and brought mulitple drugs into clincial studies. Hill is currently leading the Open Innovation program at AstraZeneca which has r... Read More →
    avatar for Jill Pulley

    Jill Pulley

    Executive Director, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center
    Jill Pulley has focused her career on providing disease-neutral, large-scale infrastructure so that researchers can initiate and conduct high quality translational science in a compliant, efficient, and cost effective manner. She is Executive Director of the Vanderbilt Institute... Read More →


    Monday June 19, 2017 8:30am - 10:00am
    S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Academic Clinical Researcher,Public Policy,Rare Disease,StudentProgramming
    • Credit Type ACPE, CME, IACET, RN
    • Tags Forum

    8:30am

    #102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-565-L04-P; CME 1.50; IACET 1.50; RN 1.50

    Though the Randomized Controlled Trial (RCT) has been the trusted standard for generating high-quality evidence of medical product safety and efficacy, the need for more rapid and cost effective understanding of product effectiveness and safety in the real-world has given rise to the vision that draws on real-world evidence as well as that derived from more traditional clinical research applications.

    In this DIAmond session, prominent thinkers on scientific evidence for support of biomedical decision-making will discuss our readiness to tap Real World Evidence (RWE) for safety and efficacy questions and then consider its uses for regulatory purposes. The benefits and challenges of using RWE to generate evidence of sufficient quality for decision making, following the concept of using fit-for-purpose research tools, will be examined.

    This DIAmond session will stimulate new insights on our readiness for the next steps in the evolution of evidence generation using RWE.

    Learning Objectives

    Discuss current uses of RWE in the medical product life cycle; Describe potential uses of RWE to improve the speed and cost effectiveness determining safety and effectiveness of medical products in real world use; Compare and contrast the strengths of RCT and RWE data as evidence for medical and regulatory decision making.

    Chair

    Iris Loew-Friedrich, DrMed

    Speaker

    Panelist
    Nancy A. Dreyer, PhD, MPH

    Panelist
    Robert J. Temple, MD

    Panelist
    Alison Cave, PhD

    Panelist
    Brian D. Bradbury, PhD, MA

    Panelist
    Stephanie Devaney, PhD



    Speakers
    avatar for Brian Bradbury

    Brian Bradbury

    Executive Director & Head, Data and Analytics, Center for Observational Research, Amgen, Inc.
    Dr Bradbury works in the Center for Observational Research at Amgen conducting epidemiologic research across the development lifecycle. Brian is an Adjunct Assistant Professor of Epidemiology at the UCLA School of Public Health. He received his DSc in Epidemiology from Boston Uni... Read More →
    avatar for Alison Cave

    Alison Cave

    Principal Scientific Administrator, European Medicines Agency (EMA)
    Alison Cave is a Principal Scientific Administrator at the European Medicines Agency within the Pharmacovigilance and Epidemiology Department. She has over 20 years of academic research experience in the cardiovascular field gained in the US and UK. Prior to joining the EMA she w... Read More →
    SD

    Stephanie Devaney

    Deputy Director of the All of Us Research Program, National Institutes of Health (NIH)
    Stephanie Devaney is the Deputy Director of the All of Us Research Program at NIH. Prior to this she led the coordination of the Precision Medicine Initiative from the Office of the Chief of Staff at the White House. In this role she coordinated the many components of the Initiat... Read More →
    avatar for Nancy Dreyer

    Nancy Dreyer

    Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation, QuintilesIMS
    Nancy Dreyer is the Global Chief of Scientific Affairs for QuintilesIMS Real-World Insights, and heads the Center for Advanced Evidence Generation. She leads an international team conducting research on the safety, effectiveness, and value of medical treatments using secondary an... Read More →
    avatar for Iris Loew-Friedrich

    Iris Loew-Friedrich

    Chief Medical Officer, Executive VP and Head, Development and Medical Practices, UCB, Inc.
    Iris is Chief Medical Officer at UCB, member of the Exec Committee and Head of the Development & Medical Practices. She provides strategic leadership for global Clin Dev, Medical & Regulatory Affairs, External Engagement and Patient Affairs. She is a physician, board-certified in... Read More →
    avatar for Robert Temple

    Robert Temple

    Deputy Center Director for Clinical Science, Office of the Center Director, CDER, FDA
    Dr. Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is Acting Deputy Director of the Office of Drug Evaluation I, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug... Read More →


    Monday June 19, 2017 8:30am - 10:00am
    S100a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Real World Evidence,Patient Centric ,Public Policy,StudentProgramming
    • Credit Type ACPE, CME, IACET, RN
    • Tags Session

    8:30am

    #103: The Future of Patient Engagement: Measuring What Matters
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-568-L04-P; CME 1.50; IACET 1.50; RN 1.50

    As awareness and theory around patient engagement in the medical product life cycle have matured, stakeholders are now focusing on best practices and implementation of patient centric strategies. In this session, patient, industry, and regulatory stakeholders will share their perspectives on today’s meaning of effective engagement and what the future state of patient engagement will look like. Panelists will discuss what they believe should be the outcomes of their investments of effort and how we can engage patients to identify the outcomes that matter most. The idea of “return on engagement” will be explored: how do we measure what matters? How do we turn insights into regulatory utilities? And how do we capture the return – to drug and device development – on this investment in patient engagement?

    Join Patient Engagement Community for a follow up Round Table discussion at 12:30pm in the Community Corner.

    Learning Objectives

    Describe the meaning of effective patient engagement and where it should take place during the medical product life cycle; Discuss approaches to involving patients in the determination of meaningful outcomes throughout the life cycle of medical therapies; Identify potential measures that could demonstrate the return on meaningful engagement for patient, regulatory, and industry stakeholders. Explore patient engagement in today’s policy environment and in the context of global harmonization.

    Chair

    Debra Lappin, JD

    Speaker

    Panelist
    Anne C. Beal, MD, MPH

    Panelist
    Juan Garcia-Burgos, MD

    Panelist
    K. Kimberly McCleary

    Panelist
    Paul Kluetz, MD

    Panelist
    Ronald Joseph Bartek, MA



    Speakers
    avatar for Ronald Bartek

    Ronald Bartek

    Co-Founder/Founding President, Friedreich's Ataxia Research Alliance (FARA)
    Co-founder/President, FARA, Board of Directors, NORD; NIH/NINDS National Advisory Council; partner/president, government affairs firm; 20 yrs federal service in defense, foreign policy & intelligence; U.S. Delegation to Intermediate-Range Nuclear Forces (INF) Treaty talks, Geneva... Read More →
    avatar for Anne Beal

    Anne Beal

    Senior VP, Chief Patient Officer and Global Head of Patient Centricity, Sanofi
    Dr. Anne C. Beal, is the Chief Patient Officer at Sanofi. She is responsible for integrating the patient voice and priorities into all aspects of Sanofi’s work to facilitate development of healthcare solutions that truly meet patients’ needs. Dr. Beal joined Sanofi from PCORI... Read More →
    avatar for Juan Garcia-Burgos

    Juan Garcia-Burgos

    Head of Public Engagement Department, European Medicines Agency, European Union
    Juan Garcia Burgos is Head of Public Engagement Department and Co-chair of the EMA patients’ & healthcare professionals’ working parties. He is a Medical Doctor specialised in urology. In 2002 he joined the EMA to coordinate the preparation of EU clinical guidelines for drug... Read More →
    avatar for Paul Kluetz

    Paul Kluetz

    Associate Director for Patient Outcomes (Acting), OCE, FDA
    Paul G. Kluetz, M.D., is a medical oncologist and the Acting Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. He is interested in defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval a... Read More →
    avatar for Debra Lappin

    Debra Lappin

    Head, Health Biosciences Practice, FaegreBD Consulting
    Debra Lappin serves as a principal with Faegre Baker Daniels Consulting, where she leads the health and biosciences team, and as counsel with Faegre Baker Daniels. She consults with public, private and nonprofit entities across the life science sector and is a creative force in f... Read More →
    avatar for K. Kimberly McCleary

    K. Kimberly McCleary

    Managing Director, FasterCures, A Center of the Milken Institute
    Kim leads the Patients Count: Science of Patient Input program through which FasterCures aims to improve health by expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. She has been involved in... Read More →


    Monday June 19, 2017 8:30am - 10:00am
    S100c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Patient Centric ,Clinical Operations,Wearables-Mobile Health,StudentProgramming
    • Credit Type ACPE, CME, IACET, RN
    • Tags Session

    10:00am

    Coffee Break
    Exhibit Hall

    Monday June 19, 2017 10:00am - 11:00am
    TBA

    10:00am

    Exhibit Hall Open
    Monday June 19, 2017 10:00am - 6:00pm
    TBA

    10:15am

    #104: Cenduit LLC Innovation Theater: High-Profile Early Onset Alzheimer’s Disease Study in an Academic Setting Requiring Highly Configurable IRT System for Complex Study Design.
    Component Type: Session



    Chair

    Cenduit LLC


    Speakers

    Monday June 19, 2017 10:15am - 10:45am
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:15am

    #105: DBMS Consulting Innovation Theater: Replacing dsNavigator with Oracle TMS as a centralized coding solution
    Component Type: Session

    Many organizations are in the process of replacing dsNavigator and/or trying to have one centralized coding platform to preserve existing coding and global synonyms. DBMS Consulting presents methods of conversion to use Oracle's industry leading solution of Oracle TMS in combination with DBMS Consulting's TMS Integration Layer (TMSINT), to provide maximum integration and reuse of existing coding from dsNavigator and also to integrate with SAS, Medidata Rave and Oracle Inform.

    Chair

    DBMS Consulting


    Speakers

    Monday June 19, 2017 10:15am - 10:45am
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #130: Career Opportunities in Transitions in Life Science
    Component Type: Session

    Shifting careers can be hard to explain. How do you repurpose skills learned during your career lifecycle? When do you know it’s time to move on? Visit the Content Hub’s inaugural session, “Career Opportunities – Transitions in Life Science,” for an informal discussion, facilitated by two senior life science professionals, on their career transitions and the strategies they employed to get there.

    Chair

    Linda F. Bowen

    Speaker

    Career Opportunities in Transitions in Life Science
    Linda F. Bowen

    Career Opportunities in Transitions in Life Science
    Bev Hudson, MBA



    Speakers
    avatar for Linda Bowen

    Linda Bowen

    Senior Director, Global Regulatory Science and Policy, Sanofi
    Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →
    BH

    Bev Hudson

    Vice President Life Sciences, AMPLEXOR Life Sciences


    Monday June 19, 2017 11:00am - 11:30am
    S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #106: Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research From Sponsor, Vendor and National Health System Perspective: Case Studies
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    In this session, you will hear case studies in leveraging big data/real-world data in clinical development. The case studies include an industry perspective on how one biopharmaceutical company generated significant incremental value out of the data investments the company has already made in other areas, with appropriate data governance, a leading vendor’s perspective on an end-to-end value proposition of using real world data from clinical strategy to product launch, and best practices, challenges, and opportunities of leveraging claims and EHR data from the perspective of a non-profit organization affiliated with a national health ministry.

    Learning Objectives

    Describe the full potential of existing datasets within the organization with appropriate data governance; Discuss opportunities and challenges with leveraging big data/ real world data for clinical trial design, optimizing planning and recruitment, mitigating against avoidable delays and costs, and segmenting for market launches.

    Chair

    Crystal Ancona, MS

    Speaker

    Big Data: Unleashing the Full Potential of Big Data to Make the Buzzword Tangible
    Crystal Ancona, MS

    From Trial to Launch: Closing the Innovation Loop and Designing Smarter Trials with Real World Evidence
    Andrew Cassel

    Big Data Utilization Experience in Clinical Trial Feasibility
    Kelly Han



    Moderators
    avatar for Crystal Ancona

    Crystal Ancona

    Operational Data Analyst, AbbVie, Inc.
    Crystal joined AbbVie in 2013 as a project manager for clinical trial technology development after holding a prior role as a Quality Systems Analyst with Stryker Neurovascular. Crystal moved into her Operations Data Analyst role in December of 2015 and shortly after started worki... Read More →

    Speakers
    avatar for Crystal Ancona

    Crystal Ancona

    Operational Data Analyst, AbbVie, Inc.
    Crystal joined AbbVie in 2013 as a project manager for clinical trial technology development after holding a prior role as a Quality Systems Analyst with Stryker Neurovascular. Crystal moved into her Operations Data Analyst role in December of 2015 and shortly after started worki... Read More →
    AC

    Andrew Cassel

    Managing Director, Analytics, Medidata Solutions
    Mr. Cassel manages Medidata's Analytics business, overseeing the organization's strategy, product development, and sales and marketing activities. Prior to joining Medidata in 2011 he spent 8 years with Accenture's Pharmaceutical R&D consulting practice working with customers on... Read More →
    KH

    Kelly Han

    Business Development & Global Cooperation Manager, KoNECT
    Kelly is the BD & Global Cooperation Manager for Korea National Enterprise for Clinical Trials(KoNECT). KoNECT is a government affiliation, funded by Ministry of Health and Welfare. Kelly has joined KoNECT in 2016, Prior to joining KoNECT, She worked for Samsung C&T & Korean Foun... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #107: Leveraging Wearables and Sensors in Clinical Trials and mHealth
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    ue to the increased miniaturization of sensors and circuitry, the health and wellness industry is seeing rapid proliferation in the number and diversity of wearables and sensors to provide personal wellness applications. This provides opportunity to collect greater and richer data during clinical trials and post-marketing studies, and also to develop beyond-the-pill strategies to support the launch or marketing of products. This session explores the implementation of wearables and sensors within clinical trials and mHealth programs. Reporting work of the C-PATH ePRO Consortium, we identify suitable evidence that could be considered to support the selection of wearable devices and the validity of endpoints derived from wearables data in clinical trials. We explore practical considerations for wearable and sensor use in beyond-the-pill mHealth programs. Finally, we examine the experience of one pharmaceutical company in transitioning wearables from pilot evaluations to implementation in trials and mHealth programs. Join Study Endpoints Community for a follow up Round Table discussion at 10:30am Tuesday June 20th in the Community Corner.

    Learning Objectives

    Describe factors influencing wearable device selection and identify possible evidence needed to support their use to provide trial endpoint data; Identify practical considerations for wearable device use within mHealth programs; Identify how pharma is leveraging wearables from pilot studies to implementation in trials and mHealth programs.

    Chair

    Bill Byrom, PhD

    Speaker

    Selection of Wearable Devices and Validation of Health Outcome Assessments Derived from Wearables Data
    Bill Byrom, PhD

    Transitioning Wearables From Pilot Evaluations to Trials and mHealth Programs
    Daragh Ryan

    Challenges of Using Consumer Wearables in Beyond the Pill Programs: A Pharma and Patient Perspective
    Chris Watson, PhD



    Moderators
    avatar for Bill Byrom

    Bill Byrom

    Senior Director of Product Innovation, and Vice Director of ePRO Consortium, ICON, plc.
    Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Ou... Read More →

    Speakers
    avatar for Bill Byrom

    Bill Byrom

    Senior Director of Product Innovation, and Vice Director of ePRO Consortium, ICON, plc.
    Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Ou... Read More →
    avatar for Daragh Ryan

    Daragh Ryan

    eClinical and mHealth Consultant, Actelion
    Daragh Ryan is a Clinical Trials Technology Consultant with 20 years of global experience in mobile and wireless technologies, software development and clinical trials. He has a passion for technology and its successful implementation in business. More recently, his focus has bee... Read More →
    avatar for Chris Watson

    Chris Watson

    Director of Product Strategy, ERT
    Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 18 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 9 years, Chris has been tra... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S501abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #108: Artificial Intelligence/Machine Learning
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    What are the ways in which artificial intelligence (AI) can impact clinical decision making and how we design and run clinical trials? How effective or robust is AI in these areas? What parts of clinical research and care will AI take over? What are the barriers to full deployment of AI in clinical care and research? What are the privacy and policy implications of learning software that continuously builds on patient experience to better deliver to the next patient?

    Learning Objectives

    Discuss how artificial intelligence can impact product development, research, and clinical care; Identify potential benefits and barriers to use of artificial intelligence.

    Chair

    Badri Rengarajan, MD

    Speaker

    AI for Beginners: Impact of Artificial Intelligence on eClinical Technology
    Vladimir Pyagay

    Deep Learning for Data-Driven Predictions Based on Medical Images, Videos, and Data
    Andrea Cherubini, PhD

    Intelligent Automation and Robotics in Clinical Development: A Case Study
    Aman Thukral, DrSc, MBA, MPharm



    Moderators
    avatar for Badri Rengarajan

    Badri Rengarajan

    Medical Affairs Lead, ASPIRE Unit, Actelion
    Serves as Medical Affairs Lead for ASPIRE unit at Actelion Pharmaceuticals, US. 15 years’ experience across medical affairs, product development, BD, regulatory, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senio... Read More →

    Speakers
    avatar for Andrea Cherubini

    Andrea Cherubini

    Chief Technical Advisor, Linkverse
    Andrea Cherubini is Professor of Physics at Magna Graecia University and Chief Technical Advisor at Linkverse Srl. His research interests include Medical Imaging and Machine Learning with application to Computer Aided Diagnosis. He has published over 100 articles in international... Read More →
    avatar for Vladimir Pyagay

    Vladimir Pyagay

    Product Manager, TransPerfect
    Vladimir has spent over seven years in clinical technology and services industry.He consults with pharmaceutical, biotechnology, medical device, and CRO companies to determine how to most efficiently use the Trial Interactive platform to streamline clinical development processes... Read More →
    avatar for Badri Rengarajan

    Badri Rengarajan

    Medical Affairs Lead, ASPIRE Unit, Actelion
    Serves as Medical Affairs Lead for ASPIRE unit at Actelion Pharmaceuticals, US. 15 years’ experience across medical affairs, product development, BD, regulatory, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senio... Read More →
    avatar for Aman Thukral

    Aman Thukral

    Assistant Director, AbbVie, Inc.
    Aman Thukral is an Assistant Director, Strategy & Innovation in Development Operations at AbbVie. He has over ten years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eClinical strategy, pilot... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S502ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #109: Submission Dossiers: Communications Excellence to Drive Speed and Quality
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Pharmaceutical companies are driving the 'time to submission' paradigm in today's market pressured by submitting dossiers to multiple markets in the same time period, as quickly as possible following last database lock of pivotal studies. In turn cross-functional teams are looking for strategies/approaches to realize a quicker yet just as effective submissions. This session will explore optimal authoring approaches to plan, execute, and deliver marketing applications to time and quality. Case studies will provide cross-disciplinary views to highlight successful approaches and best communications practice.

    Join Medical Writing Community for a follow up Round Table discussion at 1:45pm in the Community Corner.

    Learning Objectives

    Define communications strategy linked to draft label; Discuss authoring strategies to maximize time to submission and approval from LSLV (last subject, last visit.)

    Chair

    Frank Hubbard, PhD

    Speaker

    Agreeing Submission Document Timelines 6 Months in Advance and Sticking to Them: Fairy Tale or Reality?
    Steve Sibley, MS

    It Is a Complex Team Sport to Prepare Global Simultaneous Submissions in an Alliance Project Team
    Lei C Chuang, MSc

    Regulatory Medical Writing Strategies for Accelerating Submissions
    Kent Cochran, III, MS



    Moderators
    avatar for Frank Hubbard

    Frank Hubbard

    President, Global Regulatory Writing Solutions, Inc.
    Following a 14-year career in the Medical Communications Science group at AstraZeneca, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my pr... Read More →

    Speakers
    LC

    Lei Chuang

    Advisory Consultant, Global Drug Development Consulting
    Lei is an experienced Project Management Professional (PMP) with 20+ years of global drug development project and program management experience for small, large, and hybrid (bio)pharmaceutical companies. With a track record of employing integrative project management practice and... Read More →
    KC

    Kent Cochran

    Director, Janssen Pharmaceutical Companies of Johnson & Johnson
    A medical writer and manager for 20+ years, Kent has worked in multiple therapeutic areas (mainly Oncology) in small and large global companies, including Wyeth, Centocor, and Johnson & Johnson. He has successfully managed the writing activities for multiple global submissions. H... Read More →
    avatar for Frank Hubbard

    Frank Hubbard

    President, Global Regulatory Writing Solutions, Inc.
    Following a 14-year career in the Medical Communications Science group at AstraZeneca, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my pr... Read More →
    SS

    Steve Sibley

    Vice President, Global Submissions and Submissions Leadership, Synchrogenix, a Certara Company
    With a career spanning more than 25 years in the pharmaceutical industry, Mr. Sibley has extensive regulatory writing experience across Modules 1-5, with project and team leadership roles on more than 50 submissions. His experience is truly global, having worked in project teams... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S503ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #110: Globalization of Medical Affairs Departments
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Traditionally, medical affairs departments have focused most on domestic operations but more and more companies are broadening their reach to international operations, especially in the EU, Pacific Rim, and emerging markets. These new markets vary considerably from the US and from country to country, requiring new knowledge and skill development. The forum will share perspectives from medical affairs professionals across the globe who will discuss the necessary skills and best practices for working globally and cross functionally.

    Learning Objectives

    Discuss the necessary skills and best practices for medical affairs professionals to work globally and cross functionally.

    Chair

    Rebecca A. Vermeulen, RPh

    Speaker

    Solutions Developed to Improve Customer Experiences Globally
    Anja Schaefer, DrSc

    Panelist
    Jay F Mouser

    Advancing Patient Care with Digital Health
    Mike Baker, MSc



    Moderators
    avatar for Rebecca Vermeulen

    Rebecca Vermeulen

    Head, Customer Strategy Global Medical Affairs, Hoffmann-La Roche Ltd.
    Rebecca brings a variety of experiences and capabilities to her role as Global Customer Strategy for Global Medical Affairs at Roche. She has spent 25 years in the pharmaceutical industry leading teams across Medical Affairs including Medical Communications and MSLs. Rebecca has... Read More →

    Speakers
    MB

    Mike Baker

    Group Leader, Digital Health, F. Hoffmann-La Roche Ltd.
    Mike Baker is the Group Leader for Digital Health in Global Medical Affairs at Roche. Mike leads a team that identifies Digital Health opportunities across the portfolio and supports generating new data & interventions that improve patient care and outcomes.
    avatar for Jay Mouser

    Jay Mouser

    Principal, Medical Science Liaison, Janssen Scientific Affairs, LLC
    Jay Mouser was recently the Medical Lead for Diabetes at AstraZeneca – Switzerland. He was responsible for development and implementation of medical plans, advisory boards, congress planning, investigator initiated trials, MSL activities, KOL engagement, etc. Prior to joining A... Read More →
    avatar for Anja Schaefer

    Anja Schaefer

    Chief Executive Officer, TaRes GmbH
    Anja Schaefer has since 2014 been CEO of a strategy consultancy company TaRes GmbH, Germany. She has more than 25 years experience in the health care industry including international leadership roles for pharmaceutical and medical device companies in various medical affairs funct... Read More →
    avatar for Rebecca Vermeulen

    Rebecca Vermeulen

    Head, Customer Strategy Global Medical Affairs, Hoffmann-La Roche Ltd.
    Rebecca brings a variety of experiences and capabilities to her role as Global Customer Strategy for Global Medical Affairs at Roche. She has spent 25 years in the pharmaceutical industry leading teams across Medical Affairs including Medical Communications and MSLs. Rebecca has... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S504abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #111: Patient Engagement: 4 W's and an H
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-520-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Patient engagement is a hot topic across the industry and has potential touchpoints throughout the life cycle of a product or portfolio. Because it's a new idea in product development, we want to hear from those who've used patient engagement techniques while planning and executing development programs, as well as during and post approval. We are seeking clear examples on why, what, when, who, and how these engagement tactics were used and the value they added. Ideally, this session will include an update from the TUFTS/ DIA working group on Patient Engagement and provide some benchmarking data about what's happening across industry. When these tactics were used, what changed in the planning and execution of programs? And what surprises arose, both in the process of engagement and in the outcomes?

    Learning Objectives

    Provide data on patient engagement practices across industry; Prepare 'map' of potential points of engagement across product life cycle; Discuss case studies about patient engagement tactics and what was learned, applied based on the outcomes.

    Chair

    Jane E. Myles, MS

    Speaker

    Driving Engagement in All Phases of Alzheimer’s Disease: Creating Lasting Engagement and Achieving Trial Success
    Barbara Bernik Zupancic, MBA, MSc

    From Design to Dissemination: How iConquerMS Engages People With MS Throughout the Research Continuum
    Hollie Schmidt, MS



    Moderators
    avatar for Jane Myles

    Jane Myles

    Head, Operational Intelligence and Innovation, Genentech, A Member of the Roche Group
    Jane is the Head, Operational Intelligence and Innovation for Roche, working at Genentech. She's worked at Genentech for 14 years in many roles, including line manager and a operational program manager. In prior lives she held various roles in global trial management at QLT, Sano... Read More →

    Speakers
    avatar for Hollie Schmidt

    Hollie Schmidt

    Vice President of Scientific Operations, Accelerated Cure Project
    Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder commun... Read More →
    avatar for Barbara Zupancic

    Barbara Zupancic

    Director, Patient Recruitment, Worldwide Clinical Trials
    Barbara Zupancic is currently the Director, Patient Recruitment and Retention at Worldwide Clinical Trials. Barbara has over 15 year experience in clinical research, specifically focused on patient recruitment and feasibility. Connecting with patients and their families is at the... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #112: Data Sharing: 2017 and Beyond
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-523-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Society is increasingly expecting data transparency in many aspects of life, including clinical data. The European Medicines Agency (EMA) has set a timeframe for lay summaries of trials to be published, while FDA has expressed concerns about inappropriate promotional practices if data are shared with the trial patients prior to FDA review/approval. No clear guidelines or processes established on how to share results back to the trial patients themselves. At the same time, some ethics review boards are expecting individual data results back to the patient, which is a whole different level of data specificity.

    Learning Objectives

    Discuss the legislations changes that are expected and the impact if there are differences between regulatory agencies; Discuss the mechanisms or barriers for dissemination of individual research results and/or clinical trial lay summaries.

    Chair

    Rebecca Li, PhD

    Speaker

    Data Sharing and Transparency: A Global Neutral Platform
    Rebecca Li, PhD

    Patient Engagement: Meaningful Approaches to Sharing the Data Patients Want and Deserve
    Jill McNair, MBA

    Plain Language Summaries: Questions, Challenges, and New Developments
    Susannah Chang, PhD



    Moderators
    avatar for Rebecca Li

    Rebecca Li

    Executive Director, Harvard MRCT Clinical Trials Center, Brigham and Women's Hospital
    Rebecca Li, PhD, has over 17 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. Dr. Li has served as the Executive Director of the Multi-regional Clinical Trial Center at Harvard since 2012. She is also a co-F... Read More →

    Speakers
    avatar for Susannah Chang

    Susannah Chang

    Manager, Oncology Regulatory Medical Writing, Janssen Pharmaceutical Companies of Johnson & Johnson
    Susannah is a member of the TransCelerate subteam on Layperson Summaries and has been developing a layperson template for use at Janssen. She received her PhD in neurobiology from UC San Diego, completed postdoctoral research in Germany, and was a research assistant professor at... Read More →
    avatar for Rebecca Li

    Rebecca Li

    Executive Director, Harvard MRCT Clinical Trials Center, Brigham and Women's Hospital
    Rebecca Li, PhD, has over 17 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. Dr. Li has served as the Executive Director of the Multi-regional Clinical Trial Center at Harvard since 2012. She is also a co-F... Read More →
    avatar for Jill McNair

    Jill McNair

    Senior Director, Patient Engagement, CISCRP
    Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at CISCRP. In this role, she oversees a team dedicated to helping sponsor companies provide trial results summaries in plain language to study volunteers. She is passionate... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #113: We Can't Forget the Children in This Process
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-528-L04-P; CME 1.25; IACET 1.25; RN 1.25

    We can't forget the children in this process. The trend of the regulators is that it will become mandatory to involve a Young Person’s Advisory Group (YPAG) in the process of approving the design of clinical studies and being integrated in all related developmental processes. Towards this spirit, this session will bring examples of how Young Person’s Advisory Groups can be incorporated into the clinical development process. One example is our panel will include a representative from AbbVie and he will provide a first-hand perspective on partnering with a youth group for external protocol review and the impact on clinical protocol development timelines. He will also present how they overcame legal and compliance barriers due to engaging a youth population and incorporating their feedback into their pediatric trial.

    Learning Objectives

    Demonstrate how to increase the input and influence of children and their families/caregivers into the development of clinical research.

    Chair

    Lisa Palladino Kim, MS

    Speaker

    Tales From a Sponsor: Youth Engagement in Research
    Mary A Short, MSN, RN

    Virtual/Global Engagement of the Caregiver/Patient Community in Research Study Design
    Korey Capozza, MPH

    Tales from the Front: A Young Adult Recounts Her Own Clinical Trial Experiences and the Efforts of iCAN to Improve the Experiences of Others
    Katie Palermo



    Moderators
    avatar for Lisa Kim

    Lisa Kim

    Director of Capstone / Lecturer, Rutgers School of Health Professions
    Lisa Palladino Kim has 15 years of pharmaceutical expertise, with a concentration in Clinical Operations, which allowed her to gain experience leading career, policy, and process development initiatives. She is the Director of Capstone/Lecturer for Rutgers School of Health Profes... Read More →

    Speakers
    avatar for Korey Capozza

    Korey Capozza

    Director, Global Parents For Eczema Research
    Korey Capozza, MPH, has worked for over a decade on patient-focused technology innovations in health care and patient engagement initiatives. She is director of Global Parents for Eczema Research (GPER), an international coalition of parents and caregivers united to improve treat... Read More →
    avatar for Lisa Kim

    Lisa Kim

    Director of Capstone / Lecturer, Rutgers School of Health Professions
    Lisa Palladino Kim has 15 years of pharmaceutical expertise, with a concentration in Clinical Operations, which allowed her to gain experience leading career, policy, and process development initiatives. She is the Director of Capstone/Lecturer for Rutgers School of Health Profes... Read More →
    avatar for Katie Palermo

    Katie Palermo

    Member, Ann and Robert H. Luie Childrens' Hospital Kids Advisory Board
    Member, Ann and Robert H. Lurie Children’s Hospital Kids Advisory Board. Katie is a recent graduate of Lyons Township High School in La Grange, Illinois and will be attending University of Illinois in the Fall studying Health in Communications. Katie is a two time survivor of A... Read More →
    avatar for Mary Short

    Mary Short

    Research Advisor, Clinical, MDU, Medical Pediatric Capabilities, Eli Lilly and Company
    Mary Short is a Research Advisor for Pediatric Capabilities and co-chair of the Pediatric Steering Committee at Eli Lilly and Company. Mary supported multiple clinical trials including pediatric sepsis and pulmonary hypertension. She is a RN, a Perinatal Clinical Nurse Specialist... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N426c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Development and approval timelines for drugs and therapeutic biologic products affect us all. This will be the first reauthorization occurring in parallel with a new Congress and a new administration. This session will focus on how PDUFA has affected both the regulator and regulated industry and what we can expect in the sixth iteration of the agreement.

    Learning Objectives

    Discuss a historical review of PDUFA from expediting approvals to expediting development; Identify what's new in PDUFA VI and the impact on sponsor and regulator.

    Chair

    Kim M. Quaintance-Lunn

    Speaker

    Panelist
    Theresa M. Mullin, PhD

    FDA Perspective
    Patrick Frey

    Industry Perspective
    Sandra A. Milligan, JD, MD

    Panelist
    Lucy Vereshchagina, PhD



    Moderators
    avatar for Kim Quaintance-Lunn

    Kim Quaintance-Lunn

    Vice President and Head, US Regulatory Policy, Bayer
    Kim Quaintance-Lunn serves as the Vice President and Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the develop... Read More →

    Speakers
    avatar for Patrick Frey

    Patrick Frey

    Chief of Staff, Office of New Drugs, CDER, FDA
    Patrick Frey is the Chief of Staff in CDER's Office of New Drugs. He has played leadership roles in the reauthorization of PDUFA V and VI as well as BSUFA II. He was also the CDER lead in developing and implementing CDER's structured framework for benefit-risk assessment. Patrick... Read More →
    avatar for Sandra Milligan

    Sandra Milligan

    Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories
    Sandra Milligan, MD, JD, is Senior Vice President ande Head of Global Regulatory Affairs and Clinical Safety, consisting of the global regulatory, safety and CMC functions of Merck Research Laboratories. In addition to serving on the board of directors and past president of the D... Read More →
    avatar for Theresa Mullin

    Theresa Mullin

    Director, Office of Strategic Programs, CDER, FDA
    Dr. Theresa Mullin plays a lead role in a number of CDER’s strategic initiatives including the human drugs international program, drug user fee negotiation and implementation, regulatory informatics, and major program evaluations and other initiatives. She is currently serving... Read More →
    avatar for Kim Quaintance-Lunn

    Kim Quaintance-Lunn

    Vice President and Head, US Regulatory Policy, Bayer
    Kim Quaintance-Lunn serves as the Vice President and Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the develop... Read More →
    LV

    Lucy Vereshchagina

    Deputy Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
    Dr. Vereshchagina is a Deputy Vice President at the Pharmaceutical Research and Manufacturers of America or PhRMA. She leads the Regulatory Advocacy team with the focus on the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), as well as other regulatory... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #117: Postmarketing Safety Studies: Approaches and Regulatory Insights
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-533-L04-P; CME 1.25; IACET 1.25; RN 1.25

    We are seeing an increase globally in the number of postmarketing safety studies requested by regulatory agencies. This session will discuss approaches to planning and conducting observational postmarketing studies, regulatory perspectives on such studies and a case example.

    Learning Objectives

    Discuss approaches to postmarketing safety studies and the ways in which they can have impact and provide value.

    Chair

    Elsie Grace, PhD, MS

    Speaker

    Take-Home Learnings on Do’s and Dont’s on the Planning and Conduct of a PASS
    Javier Cid, DrPH, MD, MBA, MSc

    How to Maximize the Impact of Postmarketing Research: Considerations for Effective Execution and Compliance
    Aarthi B. Iyer, JD, MPH

    An Innovative Patient-Centric Approach to Conducting Postmarketing Safety Studies
    Deborah Covington, DrPH



    Moderators
    EG

    Elsie Grace

    Epidemiologist, Global Patient Safety, Eli Lilly and Company
    Elsie Grace is a Senior Research Scientist at Eli Lilly and Company. Her work as a pharmacoepidemiologist within the Global Patient Safety organization focuses on providing epidemiologic expertise to the development, submission, and launch of products within the autoimmune therap... Read More →

    Speakers
    JC

    Javier Cid

    Research Scientist, Evidera
    Javier Cid, MD, DrPH, is Research Scientist and Epidemiologist at Evidera. He has over 20 years of experience, across academia, pharma companies and consulting, mainly in pharmacoepidemiology and drug safety, especially in neurosciences, oncology, diabetes, chronic kidney disease... Read More →
    DC

    Deborah Covington

    Senior Research Scientist, Evidera
    Deborah Covington, DrPH, is a senior research scientist at Evidera and part-time faculty at the University of North Carolina, Wilmington. She received her doctorate from the University of North Carolina, Chapel Hill and has 30+ years of epidemiological research experience focusin... Read More →
    EG

    Elsie Grace

    Epidemiologist, Global Patient Safety, Eli Lilly and Company
    Elsie Grace is a Senior Research Scientist at Eli Lilly and Company. Her work as a pharmacoepidemiologist within the Global Patient Safety organization focuses on providing epidemiologic expertise to the development, submission, and launch of products within the autoimmune therap... Read More →
    avatar for Aarthi Iyer

    Aarthi Iyer

    Regulatory Attorney, Kinetiq, a Division of Quorum IRB
    Aarthi B. Iyer is a Regulatory Attorney for Kinetiq, a consulting and technology division of Quorum Review IRB. Aarthi provides guidance and regulatory analysis on issues related to human subjects research including informed consent, privacy, data use, and compliance with federal... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #118: Counting on Safety
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-536-L04-P; CME 1.25; IACET 1.25; RN 1.25

    The regulatory landscape for safety monitoring is evolving, particularly in emerging regulation/guidance from the US FDA and EMA. This maturing regulatory landscape calls for a systematic and proactive process, multi-disciplinary collaboration, quantitative framework/methods/tools, built on a solid safety data architecture. This session will feature presentations on global safety monitoring regulations and the relevant clinical and statistical considerations. The FDA IND safety reporting final rule will be reviewed (FDA speaker invited). The design consideration to align with the recent guidance of the FDA IND safety reporting final rule will be shared by an industry representative.

    Learning Objectives

    Discuss the latest regulatory landscape for safety monitoring.

    Chair

    William Wang, PhD

    Speaker

    IND Safety Reporting
    Stephanie Shapley, MBA

    Safety Assessment Committees: More Than One Way to Navigate the Pharmacovigilance Seas
    Barbara A. Hendrickson, DrMed, MD

    Systems Theoretic Process Analysis : A New Way to Strengthen Pharmacovigilance Processes - A Case Study
    Alan M. Hochberg



    Moderators
    avatar for William Wang

    William Wang

    Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
    Bill has over 23 years of experience in the pharmaceutical industry. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). He was a recipient of the DIA... Read More →

    Speakers
    BH

    Barbara Hendrickson

    Senior Medical Director, AbbVie, Inc.
    Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety and Co-lead of the Safety Statistics Excellence program at AbbVie. She is a physician with 13 years of pharmaceutical industry experience and 15 years in academic research with sub... Read More →
    avatar for Alan Hochberg

    Alan Hochberg

    Scientific Enablement Leader, F. Hoffmann-La Roche Ltd.
    Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engin... Read More →
    SS

    Stephanie Shapley

    Associate Director for Regulatory Affairs, OMPI, OMP, CDER, FDA
    Stephanie Shapley is the Associate Director for Regulatory Affairs in the Office of Medical Policy Initiatives, within the Office of Medical Policy in FDA's Center for Drug Evaluation and Research.
    avatar for William Wang

    William Wang

    Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
    Bill has over 23 years of experience in the pharmaceutical industry. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). He was a recipient of the DIA... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #119: Designing and Implementing a Robust Pharmacovigilance System for Vaccines
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-539-L04-P; CME 1.25; IACET 1.25; RN 1.25

    This session will provide insights into the distinct challenges in vaccine pharmacovigilance. Vaccine postmarketing surveillance is critical to mitigating risks, aiding in a response to vaccine safety concerns, and building public trust. The session will present the common need around the globe to manage public concerns about events related to vaccine safety. It will also discuss the differences in safety reporting requirements in vaccines in the US versus EU and the specific points to be taken into account in safety management and signal evaluation of vaccines both from the US and EU perspective.

    Learning Objectives

    Discuss differences in safety reporting requirements in vaccines in the US versus EU; Recognize special considerations in safety management and signal evaluation of vaccines.

    Chair

    Sanjeev Miglani, MD

    Speaker

    Special Safety Considerations in Vaccines: US Perspective
    Sanjeev Miglani, MD

    Active Vaccine Safety Surveillance in Low- and Middle-Income Countries
    Walter Straus

    GVP Module for Vaccine Pharmacovigilance
    Seema Jaitly, DrMed



    Moderators
    avatar for Sanjeev Miglani

    Sanjeev Miglani

    Vice President-PV and Clinical Safety North America and Global Medical Affairs, APCER Life Sciences
    Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities fo... Read More →

    Speakers
    avatar for Seema Jaitly

    Seema Jaitly

    Managing Director, Essjay Solutions Ltd
    Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in general medicine and psychiatry for four years. She has worked in the pharmaceutical industry for over 20 years at CROs, large and small companies spanning clinical resea... Read More →
    avatar for Sanjeev Miglani

    Sanjeev Miglani

    Vice President-PV and Clinical Safety North America and Global Medical Affairs, APCER Life Sciences
    Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities fo... Read More →
    avatar for Walter Straus

    Walter Straus

    Associate Vice President, Therapeutic Area Head, Clinical Safety and Risk Mgmt, Merck & Co., Inc.
    Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologis... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #120: FDA Rare Disease Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-541-L04-P; CME 1.25; IACET 1.25; RN 1.25

    This forum will address the unique regulatory complexities and challenges specific to orphan drug development. It will provide key information about programs available to expedite the development of orphan products and will include audience Q&A.

    Learning Objectives

    Identify unique regulatory complexities and challenges specific to orphan drug development; Describe FDA programs available to expedite the development of orphan products.

    Chair

    James E. Valentine, JD, MHS

    Speaker

    Panelist
    Gayatri R. Rao, JD, MD

    Panelist
    Jonathan C. Goldsmith, MD, FACP

    Panelist
    Ilan Irony, MD

    Panelist
    Michael Pacanowski, PharmD, MPH



    Moderators
    avatar for James Valentine

    James Valentine

    Attorney, Hyman, Phelps & McNamara, PC
    James Valentine is an associate at Hyman, Phelps & McNamara, P.C., a law firm in Washington, D.C. There he assists medical product industry clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Prior to joining the firm, h... Read More →

    Speakers
    avatar for Jonathan Goldsmith

    Jonathan Goldsmith

    Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
    Dr. Goldsmith is Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to federal service, he was a tenured professor in academia and focused on clinical drug development in regulated industry, at NHLBI/NIH and at orphan disease foundations. He earned hi... Read More →
    II

    Ilan Irony

    Deputy Director, DCEPT, OTAT, CBER, FDA
    After training at UCSF and NIH and years of practice in Internal Medicine and Endocrinology, Dr. Irony joined FDA CBER in 2000 as a clinical reviewer. He also worked in the Endocrine Division in CDER as a reviewer and team leader. In 2011, he returned to CBER as the branch chief... Read More →
    MP

    Michael Pacanowski

    Associate Director for Genomics and Targeted Therapy, OCP, CDER, FDA
    Dr. Pacanowski is the Associate Director for Genomics and Targeted Therapy in the Office of Clinical Pharmacology at FDA. His team of translational scientists works to advance the use of pharmacogenomics and other biomarker innovations in drug development through review of invest... Read More →
    avatar for Gayatri Rao

    Gayatri Rao

    Director, Office of Orphan Products Development, Office of the Commissioner, FDA
    Gayatri R. Rao is the Director for the Office of Orphan Products Development (OOPD) at FDA. The Office’s mission is to advance the development of promising drugs, biologics, devices, and medical foods for rare diseases. Dr. Rao oversees several programs that promote product dev... Read More →
    avatar for James Valentine

    James Valentine

    Attorney, Hyman, Phelps & McNamara, PC
    James Valentine is an associate at Hyman, Phelps & McNamara, P.C., a law firm in Washington, D.C. There he assists medical product industry clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Prior to joining the firm, h... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #121: Effective Life Cycle Management
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000198; RN 1.25

    During development of a novel pharmaceutical candidate, the focus is often on near term and immediate success as costs and attrition need to balance across a portfolio of candidates. However, subsequent to regulatory approval, commercial asset teams are obliged to address several important life cycle expectations. How do organizations manage this space and allocate resources to support? What work/planning can or should be completed pre-approval that would set the program up for success? This forum will give an overview of typical life cycle management activities and walk through some case studies that highlight different approaches (e.g., serial planning, parallel planning).

    Learning Objectives

    Discuss activities and resources needed to effectively manage product life cycle.

    Chair

    Keith Ruark, MBA

    Speaker

    The State of Life Cycle Management Planning Today: Observations and Lessons Learned
    Keith Ruark, MBA

    From Lab to Launch: Optimizing Intellectual Property Rights in Life Cycle Management Strategy
    Maria Isabel Manley, LLM

    US Legal Framework and Core Regulatory Intellectual Property Rights
    Kellie B. Combs, JD



    Moderators
    avatar for Keith Ruark

    Keith Ruark

    Executive Director, Strategy Consulting, INC Research
    Keith Ruark is a practice lead for Commercial & Medical Strategy Consulting within INC Research. He has 20+ years of experience in the healthcare industry, spending much of his career in roles and functions at the interface of research & development and commercial. He has led mul... Read More →

    Speakers
    avatar for Kellie Combs

    Kellie Combs

    Partner, Ropes & Gray LLP
    Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She... Read More →
    avatar for Maria Manley

    Maria Manley

    Partner, Head of the Regulatory Legal Group, Bristows LLP
    Marie Manley is a Partner at Bristows & heads the Regulatory Practice. She specialises in bio/pharmaceutical products & medical devices within the UK/EU regulatory & competition fields. She represents leading pharmaceutical companies before the UK/EU courts & institutions, includ... Read More →
    avatar for Keith Ruark

    Keith Ruark

    Executive Director, Strategy Consulting, INC Research
    Keith Ruark is a practice lead for Commercial & Medical Strategy Consulting within INC Research. He has 20+ years of experience in the healthcare industry, spending much of his career in roles and functions at the interface of research & development and commercial. He has led mul... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S505ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #122: GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-572-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Glioblastoma (GBM), is the most common of adult brain tumors; and with 50% of patients dying in the first year post diagnosis and a 5 year survival of 5%, it remains among the most lethal of all cancers. Large numbers of GBM clinical trials have been performed on nearly all classes of potential therapies. However, with one exception, a single cytotoxic, temozolomide, have failed to produce meaningful increases in survival. Therefore, the treatment of GBM has not changed significantly for decades. Ironically, due to projects like The Caner Genome Atlas, GBM is one of the most comprehensively molecularly characterized tumors to date. GBM AGILE is the product of an unprecedented global collaboration of over 130 leaders from across the neur-oncology communities that seeks to change this dismal reality.

    This session will discuss GBM AGILE, a transformative, Bayesian statistics driven global platform trial where successful agents will proceed seamlessly vial algorithm through two seamless stages. In its essence, GBM AGILE’s two stages combines classic phase 2 screening and registration trials, and in doing so, makes the best use of limited patient resources and offers unprecedented opportunities to increase the efficiency of drug/biologics development.

    Learning Objectives

    Discuss the overall statistical design, unique features and patient advantages of GBM AGILE; Describe aspects of GBM AGILE that are potentially transformative for therapeutics development.

    Chair

    Donald A Berry, PhD

    Speaker

    Panelist
    Mustafa Khasraw, MD

    Panelist
    Amy Heimberger, MD

    Panelist
    Brian Alexander, MD, MPH



    Speakers
    BA

    Brian Alexander

    Associate Professor of Radiation Oncology, Harvard Medical School, Dana-Farber Cancer Institute
    Brian Alexander is an Associate Professor of Radiation Oncology at Harvard Medical School. He leads the Program for Innovations in Therapeutic and Biomarker Development at the Dana-Farber Cancer Institute and is the Deputy Director for Regulatory Science at the Harvard/MIT Center... Read More →
    DB

    Donald Berry

    Professor, Department of Biostatistics, M.D. Anderson Cancer Center
    Donald Berry is a professor in the Department of Biostatistics of the University of Texas M.D. Anderson Cancer Center. He has held endowed faculty positions at Duke University and at M.D. Anderson. Dr. Berry has authored over 400 publications. He is listed by ScienceWatch.com as... Read More →
    AH

    Amy Heimberger

    Professor in the Department of Neurosurgery, University of Texas MD Anderson Cancer Center
    avatar for Mustafa Khasraw

    Mustafa Khasraw

    Associate Professor, University of Sydney
    Senior Research Fellow/ Clinical Lead at the National Health and Medical Research Council Clinical Trials Centre, University of Sydney and medical oncologist at Royal North Shore Hospital (RNSH) where he originally completed his medical oncology training in Sydney and subsequentl... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Statistics
    • Credit Type ACPE, CME, IACET, RN
    • Tags Session

    11:00am

    #123: Calling All Angels to the Valley of Death
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    The Valley of Death refers to the obstacles that are keeping innovative medical research discoveries from becoming new therapies or even making it to clinical trials.  Funding is necessary to bridge the gap.  This session will provide insight into strategies used by translational research scientists and funding agencies to expedite the transformation of basic research into break through clinical applications.

    Learning Objectives

    Describe strategies used to expedite the transformation of basic research into breakthrough clinical applications.

    Chair

    David Vulcano, MBA

    Speaker

    What Angel Investors Think About Medical Product Investing
    David Vulcano, MBA

    NCATS Small Business Opportunities
    Christine Colvis, PhD

    Panelist
    Ginger A Spitzer, MA



    Moderators
    avatar for David Vulcano

    David Vulcano

    Assistant Vice President and Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)
    David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA, the largest private healthcare provider in the United States, as the AVP and Responsible Executive for Clinica... Read More →

    Speakers
    avatar for Christine Colvis

    Christine Colvis

    Director, Drug Development Partnership Programs, National Center for Advancing Translational Sciences (NCATS)
    Christine Colvis joined NCATS in June 2012 as the Center’s director of drug development partnership programs. Her team is best known for leading the Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program, which supports pre-clinical and clinical... Read More →
    GS

    Ginger Spitzer

    Executive Director, Foundation of Sarcoidosis Research
    Virginia "Ginger" Spitzer leads the strategic plan to support the FSR mission and to build resources. With a strong background in non-profit management, Ginger holds expertise in organizational growth, operations, and funder relations. With over 25 years of experience in the fiel... Read More →
    avatar for David Vulcano

    David Vulcano

    Assistant Vice President and Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)
    David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA, the largest private healthcare provider in the United States, as the AVP and Responsible Executive for Clinica... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    The session explores sophisticated PK/PD modelling in NDA enabling studies such as in hepatic and renal studies conducted for labelling requirements or provides an exploration of PK/PD for early proof of concept (POC) studies which may help to progress development more quickly. Specific therapeutic areas of PK/PD models in patients may be explored. Examples of a topic may include antiviral drugs revealing a drop in viral load associated with exposure to the drug.

    Learning Objectives

    Discuss how sophisticated studies help in early clinical research to determine if you have a winning drug; Describe how PK/PD in patients give you better information for POC decision making.

    Chair

    Galina Bernstein, PhD

    Speaker

    Proof of Concept in Early Phase Studies Through PK/PD Modeling: Clinical CRO Perspective
    Galina Bernstein, PhD

    Role of Late Phase PK/PD in Regulatory Decisions
    Justin C Earp, PhD

    Drug-Disease Modeling Applied to Drug Development and Regulatory Decision Making
    Stephan Schmidt, PhD



    Moderators
    avatar for Galina Bernstein

    Galina Bernstein

    Director of Pharmacometrics, Early Phase, INC Research
    Dr Galina Bernstein received PhD in Biochemistry from Moscow State University, postdoctoral training from College of Pharmacy, U of Michigan, and pharmacokinetics training at Pfizer GRD PDM department. She has 15+ years’ experience in analytics, PK and PK/PD modeling for IVD, s... Read More →

    Speakers
    avatar for Galina Bernstein

    Galina Bernstein

    Director of Pharmacometrics, Early Phase, INC Research
    Dr Galina Bernstein received PhD in Biochemistry from Moscow State University, postdoctoral training from College of Pharmacy, U of Michigan, and pharmacokinetics training at Pfizer GRD PDM department. She has 15+ years’ experience in analytics, PK and PK/PD modeling for IVD, s... Read More →
    JE

    Justin Earp

    Pharmacometric Reviewer, OCP, OTS, CDER, FDA
    Dr. Earp received his BS in Biochemistry from the University of Arizona, Tucson in May 2002. In 2008, Dr. Earp received his doctorate in pharmaceutical sciences from SUNY at Buffalo and then joined the Division of Pharmacometrics in the Office of Clinical Pharmacology, US FDA whe... Read More →
    SS

    Stephan Schmidt

    Associate Director, Center for Pharmacometrics and Systems Pharmacology, University of Florida
    Dr. Schmidt is an Assistant Professor & Associate Director of the Center for Pharmacometrics and Systems Pharmacology in Lake Nona (Orlando). Dr. Schmidt serves as the Chair of the Special Interest Groups on Systems Pharmacology of the International Pharmaceutical Federation (FIP... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #125: Hybrid Study Designs: An Innovative Approach to Obtaining Valuable Information by Combining Existing Data with New Data Length
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Speakers will share innovative approaches to obtaining valuable information by combining existing data with new data.

    Learning Objectives

    Define what constitutes a hybrid study design; Explain why hybrid designs are more cost efficient than traditional study designs; Describe at least one example of a hybrid study design.

    Chair

    Margaret S. Richards, PhD, MPH

    Speaker

    Leveraging Real-World Data to Plan and Execute Hybrid Studies for Peri- and Postapproval Drug and Device Research
    Hady Khoury, MD

    Why Choose a Hybrid Design? Insights from a Study with Duchenne Muscular Dystrophy Patients and Caregivers
    William C. Maier, PhD, MPH

    Feedback from a Hybrid Study in Oncology: Benefits of Combining Prospective Data and Existing Retrospective Data in One Place
    Bertrand Le Bourgeois, MSc



    Speakers
    avatar for Bertrand Le Bourgeois

    Bertrand Le Bourgeois

    Sales and Marketing Director, Medsharing
    Bertrand Le Bourgeois graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He has spent his career in IT Consulting, with the last 15 years in the healthcare and pharma industries. Now Bertand acts as sales and marketin... Read More →
    avatar for Hady Khoury

    Hady Khoury

    Vice President, Global Head, Research Services, Commercialization and Outcomes, ICON, plc.
    Hady Khoury, VP and Global Head of Research Services, is a Medicine graduate with over 21 years of clinical research experience in the pharmaceutical industry. Hady has been instrumental in harmonizing and integrating operating models, using centralized site management, global hu... Read More →
    avatar for William Maier

    William Maier

    Chief Scientific Officer, Head, Patient-Centered Sciences, Mapi
    Chief Scientific Officer (www.mapigroup.com) and Head of Patient-Centered Sciences. Dr Maier has over 20 years of experience in drug development and commercialization at global pharmaceutical companies. Currently, he works with pharmaceutical companies throughout the world to pro... Read More →
    avatar for Margaret Richards

    Margaret Richards

    Vice President, Data Analytics and Epidemiology, RW Strategy and Analytics, Mapi
    Dr. Margaret ‘Meg’ Richards has over 25 years' experience as an epidemiologist in the public health, biopharmaceutical, and contract research sectors. Prior to joining PPD as Executive Director of Epidemiology, Dr. Richards served as a Director of Global Patient Safety & Risk... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Session

    11:00am

    #126: Breaking Down the Wall for FDA to Leverage Real World Data
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This forum will explore the use of real world evidence/big data in drug and device development, regulatory decision making under PDUFA VI and MDUFA IV, and transactional data sources.

    Learning Objectives

    Discuss FDA's plans for implementing the RWE provisions once PDUFA VI begins in October 2017; Describe potential methodologies for gathering and analyzing RWE; Explain perspectives from those who have conducted RWE/pragmatic clinical trial pilots or demonstrations; Discuss prospects for use of RWE to help inform efficacy not only in the postmarket space but also premarket for original NDAs.

    Chair

    Sophie Janssens

    Speaker

    A Study on the Use of Real World Evidence in Clinical Research and Postmarketing Safety Monitoring
    Mary Jo Lamberti, PhD, MA

    FDA Perspective
    Jonathan P. Jarow, MD, PhD

    How Are Innovators Bringing Real World Data to the Table?
    John Reites



    Moderators
    avatar for Sophie Janssens

    Sophie Janssens

    Global Director Pricing and Market Access, UCB Pharma, Inc
    Sophie has 20+ years of working experience; in the Pharmaceutical Industry, as Management Consultant for the pharma & public sector and as political advisor for the public sector. As Global Head of RWE at UCB Pharma, she has the responsibility to drive life cycle RWE strategy & t... Read More →

    Speakers
    avatar for Sophie Janssens

    Sophie Janssens

    Global Director Pricing and Market Access, UCB Pharma, Inc
    Sophie has 20+ years of working experience; in the Pharmaceutical Industry, as Management Consultant for the pharma & public sector and as political advisor for the public sector. As Global Head of RWE at UCB Pharma, she has the responsibility to drive life cycle RWE strategy & t... Read More →
    avatar for Jonathan Jarow

    Jonathan Jarow

    Senior Medical Advisor, FDA
    Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Onco... Read More →
    avatar for Mary Jo Lamberti

    Mary Jo Lamberti

    Senior Research Fellow, Tufts University
    Mary Jo Lamberti manages multi-sponsored and grant funded research projects at the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. She has extensive experience conducting research on biopharmaceutical industry practices and trends within CRO... Read More →
    avatar for John Reites

    John Reites

    Chief Product Officer, Partner, THREAD
    Executive intrapreneur turned digital health entrepreneur, John’s career includes over 14 years leading global drug development and healthcare innovation. Named one of the Top 100 Influencers in Digital Health, John provides expertise and execution experience in digital health... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This panel will use a case study format and present the risk-based approach used to select sites for inspection and discuss the role of FDA’s international offices in facilitating inspections and engaging with regulatory counterparts in country. The forum will review violations that called into question the accuracy of data, and discuss the impact to drug applications.

    Learning Objectives

    Identify the risk-based approach for selecting firms for inspection and define the role of FDA’s international offices in inspections; Describe inspectional findings of a bioequivalence/bioanalytical firm in India that demonstrated significant violations impacting data quality; Discuss the process for considering regulatory impact of inspectional findings and implementing follow up actions.

    Chair

    Leslie Ball, MD

    Speaker

    Panelist
    Sean Y. Kassim, PhD

    Panelist
    Mathew T. Thomas, MD

    Panelist
    Arindam Dasgupta, PhD



    Speakers
    avatar for Leslie Ball

    Leslie Ball

    Assistant Commissioner and Deputy Director, OIP, OC, FDA
    Since September 2012, she has served as Assistant Commissioner and Deputy Director of the FDA’s Office of International Programs (OIP). OIP leads FDA’s international activities and oversees the operation of FDA’s eleven regional and country offices. Prior to this position... Read More →
    avatar for Arindam Dasgupta

    Arindam Dasgupta

    Deputy Director, Division of New Drug Bioequivalence, OSIS, OTS, CDER, FDA
    Arindam received his M.S. in Biophysics and Molecular Biology from the University of Calcutta (1994) and Ph.D in Molecular Biology from Jadavpur University, Kolkata. After finishing his Ph.D., he was a postdoctoral researcher at UVA and NIH (1999-2008). He joined CDER as a Pharma... Read More →
    avatar for Sean Kassim

    Sean Kassim

    Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA
    Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →
    avatar for Mathew Thomas

    Mathew Thomas

    Country Director, India Office, Office of International Programs, OC, FDA
    Dr. Mathew T. Thomas serves as the Acting Director for the FDA India Office from February 23, 2015. Prior to this posting Mathew was the Director of the Division of Enforcement and Postmarket Safety (DEPS), in CDER’s Office of Scientific Investigations (OSI) within the Office o... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:00am

    #128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Two and one half years after stand-up, FDA’s Office of Pharmaceutical Quality is firmly established in it’s primary mission of assuring the quality and availability of safe and effective medicines to the public. The progression in organizational maturation allows a growing focus on innovative approaches to regulatory review and inspection in the agency’s ongoing efforts at continuous improvement and utilization of emerging technologies. This session will outline ongoing initiatives underway in OPQ and will provide the audience with access to selected OPQ senior leadership.

    Learning Objectives

    Describe initiatives and implementation strategies related to the Product Quality Benefit/Risk Framework; Explain OPQ’s current view on science and risk-based policies and standards related to drug product quality; Discuss how FDA facilitates the adoption of emerging technology into pharmaceutical manufacturing.

    Chair

    Patrick Ricucci, PMP

    Speaker

    A Regulatory Perspective on Science and Risk-Based Policies and Standards Related to Product Quality
    Laurie Graham

    Panelist
    Wendy Wilson-Lee, PhD

    OPQ's Innovative Approaches For Facilitating the Adoption of Emerging Technology
    Lucinda F. Buhse, PhD



    Speakers
    avatar for Lucinda Buhse

    Lucinda Buhse

    Director, Office of Testing, OPQ, CDER, FDA
    Dr. Buhse joined OTR in 2001 as Deputy Director of Division of Pharmaceutical Analysis. She was promoted to Division Director in 2004 and has been Director of Office of Testing and Research since 2013. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Ph... Read More →
    LG

    Laurie Graham

    Acting Director, DIPAP, OPPQ, OPQ, CDER, FDA
    Ms. Graham is the Acting Directorof the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.
    avatar for Patrick Ricucci

    Patrick Ricucci

    Associate Director of Regulatory Affairs (Acting), ONDP, OPQ, CDER, FDA
    Patrick is the acting Associate Director of Regulatory Affairs in the Office of New Drug Products (ONDP) within FDA’s Office of Pharmaceutical Quality. He’s also a certified Project Management Professional (PMP). Patrick is intricately involved in ONDP efforts such as strateg... Read More →
    avatar for Wendy Wilson-Lee

    Wendy Wilson-Lee

    Acting Branch Chief, Office of New Drug Products, OPQ, CDER, FDA
    Wendy is an acting Branch Chief in the Office of New Drug Products, bringing 10 years of review experience to the position. She has a B.S. in Chemical Engineering as well as a B.S. in Chemistry from North Carolina A&T State University. She earned her Ph.D. in Pharmaceutical Scien... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Forum

    11:00am

    #129: Engage and Exchange Student Forum
    Component Type: Session
    Level: Basic

    This session will explore three areas of interest to advanced students in pharmacy, pharmaceutics, life sciences, and related programs:
    1) The uses and abuses of business cards.
    2) Opportunities in the pharmaceutical industry for recent graduates.
    3) What recruiters want and how to help them advance your career.

    Learning Objectives

    Define due diligence (DD) in an M&A and describe what due diligence includes; Construct key questions to ask in the DD process to inform go/no-go decisions.

    Chair

    Danny Benau, PhD

    Speaker

    Facilitator
    Sameer Thapar, PharmD, RPh

    Facilitator
    Emily Cox



    Speakers
    avatar for Danny Benau

    Danny Benau

    Director, Biomedical Writing Programs, University of the Sciences
    BA, Boston University, 1975; PhD, Boston University, 1984; MSOD, University of Pennsylvania; Wyeth Ayerst Research 1991 - 2001; Principal Scientific Writer; Freelance; Writing Consultant; Currently Associate Professor of Biomedical Writing University of the Sciences in Philadelph... Read More →
    EC

    Emily Cox

    Staffing Manager, Synchrogenix, a Certara company
    avatar for Sameer Thapar

    Sameer Thapar

    Global Pharmacovigilance Director, Oracle
    Dr. Sameer Thapar is Oracle Health Science Consulting’s Director of Global Pharmacovigilance and concurrently Assistant Professor, Drug safety and Pharmacovigilance, Masters in Clinical Trial Sciences program at Rutgers University. As a subject matter expert in pharmacovigilanc... Read More →


    Monday June 19, 2017 11:00am - 12:15pm
    Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics StudentProgramming
    • Tags Session

    11:00am

    #115: Update from the CFDA
    Component Type: Session
    Level: Intermediate
    CE: CME 1.50; IACET 1.50; RN 1.50

    In August 2015, China’s State Council issued an document entitled "The Opinions on Reforming Review and Approval Process for Drugs and Medical Devices", unveiling a long-awaited major regulatory reform plan, with five main goals: to improve regulatory review and approval quality, address the drug application backlog, upgrade quality of generic drugs, promote innovative drug research and development, and to enhance regulatory transparency. Since then, many reform measures have been implemented. In this session, members from various organizations in the China Food and Drug Administration (CFDA) in will discuss the major initiatives and progress, as well as the future directions of the regulatory reform in China.

    Learning Objectives

    Identify and understand the latest CFDA’s activities and initiatives in regulatory reform as well their impacts on Chinese pharmaceutical regulation and enforcement; Recognize China’s evolving regulatory environment and future development.

    Chair

    Ling Su, PhD

    Speaker

    CDE Reform Measures
    Zhimin Yang, MD

    Strengthen Regulatory Enforcement on Clinical Trial Integrity and Data Quality
    Rong Zhang, MS

    ADR Monitoring in China
    Duo Dong

    Panelist
    Xiaoling Qin



    Speakers
    DD

    Duo Dong

    Deputy Division Director, National Center for ADA Monitoring, China Food and Drug Administration (CFDA)
    DD

    Duo Dong

    Deputy Division Director, National Center for ADA Monitoring, China Food and Drug Administration (CFDA)
    XQ

    Xiaoling Qin

    Deputy Director General, Department of International Cooperation, China Food and Drug Adminsitration (CFDA)
    ZY

    Zhimin Yang

    Division Director, Center for Drug Evaluation, China Food and Drug Administration (CFDA)
    RZ

    Rong Zhang

    Deputy Chief Technician, Center For Food and Drug Inspection, China Food and Drug Administration (CFDA)
    Zhang Rong, Deputy Chief Technician, have been working for Center for Food and Drug Inspection for 20 years in the field of Medcial Devices inspection, GCP inspection.


    Monday June 19, 2017 11:00am - 12:30pm
    S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Clinical Operations,Global Regulatory
    • Credit Type CME, IACET, RN
    • Tags Session

    11:45am

    #131: A Day in the Life of A....
    Component Type: Session

    A day in the Life of a VP of Sales. Never dull and a lot of fun- talking to clients about translation projects, managing people, working through a contract, what do we need for a tradeshow? Please join us!

    Chair

    Bev Hudson, MBA


    Speakers
    BH

    Bev Hudson

    Vice President Life Sciences, AMPLEXOR Life Sciences


    Monday June 19, 2017 11:45am - 12:15pm
    S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:00pm

    Luncheon
    Exhibit Hall

    Monday June 19, 2017 12:00pm - 2:45pm
    TBA

    12:30pm

    #132: QuintilesIMS Innovation Theater: The Next Generation of Clinical Development is Here
    Component Type: Session
    Level: Intermediate

    Imagine a new type of clinical trial. Where you start with a clear picture of the relevant patients, physicians, unmet needs, and treatment patterns around the world. Where protocol amendments are rare, and hitting timelines is the norm. QuintilesIMS brings a new approach to clinical development that puts both precision and predictability within reach.

    Chair

    QuintilesIMS


    Speakers
    PJ

    Patrick Jordan

    Enterprise Head, Next Gen, QuintilesIMS
    Has held a variety of leadership positions in the biopharmaceutical industry spanning corporate development, operations, product development and partnership management. He is currently Head of Operations and Account Development for Quintiles’ Customer Solutions Business.
    CV

    Cynthia Verst

    President, Clinical Operations, QuintilesIMS


    Monday June 19, 2017 12:30pm - 1:00pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:30pm

    #133: Tata Consultancy Services Innovation Theater: Global Regulatory Information Portal (GRIP) – A Regulatory Information Strategic Effectiveness Portal
    Component Type: Session

    With a rapidly changing business environment and increased scrutiny from regulatory agencies, Life Sciences companies have greater focus on productivity across all functions. Historically seen as an area of operational efficiency, Regulatory Information Management is now becoming a strategic component of business and a single source of truth supported by global business processes. GRIP is one such portal which would help answer some of the questions that are arising on truth of data available in the current systems.

    Chair

    Tata Consultancy Services


    Speakers
    AG

    Abhinav Gupta

    Ast General Manager Client Relations, TCS
    DL

    Dominique Lagrave

    Director, Global Regulatory Affairs and Safety Operations, Amgen
    Dominique has over 20 years of international regulatory affairs experience with the last 15 years spent in global regulatory operations management. Since 2015, Dominique is a Director at Amgen where he is leading the global regulatory operations organization with responsibility f... Read More →


    Monday June 19, 2017 12:30pm - 1:00pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:30pm

    DIA Patient Engagement Community Round Table Discussion: The Future of Patient Engagement: Measuring What Matters
    Component Type: Session

    Join DIA PE Community for a round table discussion tied to session #103 The Future of Patient Engagement: Measuring What Matters (Monday, June 19th)

    Chair

    Mary Stober Murray, MBA


    Speakers
    avatar for Mary Murray

    Mary Murray

    Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb
    Mary Stober Murray is responsible for establishing industry - advocacy collaborations to introduce patient-inspired changes that differentiate clinical research and ultimately the therapies available to protect or restore patients’ health.


    Monday June 19, 2017 12:30pm - 1:30pm
    Community Corner McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:30pm

    #134: Student Poster Session and Oral Presentations 1A
    Component Type: Poster Presentation




    Monday June 19, 2017 12:30pm - 2:45pm
    Exh Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:30pm

    Student Poster Session
    Component Type: Poster Presentation




    Speakers
    AA

    Akhil Agarwal

    Student, Sinhagad Institute
    EB

    Eliane Barras

    Regulatory Affairs Candidate, Humber College
    CB

    Célia Bouharati

    Pharmacy student, Université Claude Bernard - Institut De Pharmacie Industrielle De Lyon
    AC

    Ashnik Chauhan

    Seth GS Medical College & KEM Hospital
    I am a 3rd year MBBS (undergraduate) student with keen interest in scientific research and medicine. I aspire to achieve excellence in my role as a clinician and a researcher, which can be directed towards helping others and progress of science.
    DD

    Deena D'Souza

    B. Pharm Student, Bombay College Of Pharmacy
    Final Year Student of Bachelor of Pharmacy with a keen interest in Neurological disorders and Medicinal Chemistry. Other Posts: President of ISPOR student's chapter of Bombay college of pharmacy.
    AD

    Anh Duong

    Pharm D Student Summer Intern at FDA, Touro University
    SG

    Susann Grill

    University of Bremen
    AG

    Aurélien Grolleau

    MSc Student, Université Claude Bernard - Institut De Pharmacie Industrielle De Lyon
    NH

    Noreen Hussain

    Touro College of Pharmacy
    Noreen Hussain is currently a student at the Touro College of Pharmacy. She anticipates completing her PharmD in 2019.
    GK

    Gian King

    Ernest Mario School of Pharmacy
    Entering my second professional year of pharmacy school at the Ernest Mario School of Pharmacy at Rutgers University.
    ML

    Meng Li

    Master Student, University of Macau
    I am the first year master student of medicinal administration in the University of Macau, my current research interests include the development of maternal and child health care and the multiple criteria decision analysis for health technology assessment.
    YP

    Yen Ping Lim

    Student, National University of Singapore
    KM

    Kirolous Makarious

    PharmD Candidate, Touro College of Pharmacy
    MN

    Mona Nili

    Student, St. John's University
    MS

    Mio Saito

    Keio University
    MA

    Muntazir Ali Sayed

    RCSM Government Medical College & CPR General Hospital, India
    I am a Medical Student from India. I will soon be a doctor. I feel myself to be efficient, productive, committed, enthusiastic and hard-working in whatever I do. In short the word 'Sedulous' fits best to describe my personality. Apart from academic excellence, I have always been... Read More →
    AS

    Anne Shah

    PhD candidate, Virginia Commonwealth University
    SS

    Seema Singh

    Student, Sasoon Hospital
    PS

    Priyal Soni

    Student, Rutgers, The State University of New Jersey
    TW

    Taylor Walsh

    Pharmacy Student, South Carolina College of Pharmacy


    Monday June 19, 2017 12:30pm - 6:00pm
    Poster Area Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:00pm

    DIA Drug Development and Life Sciences Career Fair: Private Interviews

    Available only to candidates who have preregistered for the event and have been invited to interview by an employer. For more information on how to register, please contact Dinorah.Martinez@DIAglobal.org.

    For more information on the Career Fair, please view here 


    Monday June 19, 2017 1:00pm - 5:00pm
    Hyatt Regency McCormick Place, Regency Ballroom 2233 S. King Drive Chicago, IL 60616

    1:15pm

    #135: PAREXEL International Innovation Theater: Developing Drugs in the New Era of Personalized Medicines
    Component Type: Session

    Over the next five years, personalized medicines in development are expected to increase to nearly 70%, according to the Tufts Center for the Study of Drug Development (TCSDD), potentially improving drug safety and efficacy and also the likelihood of approval. Genomic-guided or supported drug development is a new paradigm requiring companies to think beyond traditional drug development models. This presentation focuses on critical skills to successfully make this transformation.

    Chair

    PAREXEL International


    Speakers
    AN

    Anita Nelsen

    Senior Director, CRS, EP GENOMIC MEDICINE, PAREXEL
    SP

    Sy Pretorius

    Senior Vice President and Chief Scientific Officer, PAREXEL


    Monday June 19, 2017 1:15pm - 1:45pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:15pm

    #136: Covance Innovation Theater: Lessons Learned From Deploying Clinical Data Review: Ensuring Patient Safety, Increasing Operational Efficiency and Creating New Insights
    Component Type: Session
    Level: Intermediate

    Periodic review of clinical data from a patient safety and medical practice perspective is an essential component of clinical study conduct. It is important in driving an effective risk-based monitoring strategy, following the FDA guidance for a greater role of central monitoring in the clinical oversight process. Hear how Xcellerate Medical Review has been successfully employed in numerous studies and has proven to meaningfully improve the quality, time & cost of the clinical oversight process.

    Chair

    Covance Inc.


    Speakers
    avatar for Dimitris Agrafiotis

    Dimitris Agrafiotis

    Chief Data Officer and Head of Technology Products, Covance Inc.
    Dimitris Agrafiotis, PhD, FRSC, is Chief Data Officer and Head of Technology Products at Covance. He has over 25 years of experience in pharmaceutical R&D that spans venture-funded biotech, large pharma and the CRO industry, and is an internationally recognized thought leader wit... Read More →
    CI

    Covance Inc.

    Covance Inc.


    Monday June 19, 2017 1:15pm - 1:45pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:15pm

    #138: Day in the Life of A…Part 2
    Component Type: Session

    A Day in the Life of a Contracts Manager - a review of the high level experiences and expectations. During this informal conversation we will discuss some of the expectations around the work performed, what a contracts manager does and why each of us is responsible for knowing what’s in the contract.

    Chair

    Kelly L Smith


    Speakers
    avatar for Kelly Smith

    Kelly Smith

    Contracts and Budgets, Receptos/Celgene
    Kelly Smith has been a legal professional for twenty years, of which, ten of those years specializing in the pharmaceutical arena. After graduating from The University of California at Berkeley, Mr. Smith worked in both the buy and sell side of the pharmaceutical industry at such... Read More →


    Monday June 19, 2017 1:15pm - 1:45pm
    S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:15pm

    #137: The Worst Coworker on the Block: Can YOU Work with Difficult People? Yes, You Can!
    Component Type: Session
    Level: Intermediate

    The life science industry is dominated by teams. High-performing teams create a dynamic where innovation and productivity flourish. They respect and amplify the talents of the individual. Put simply: they get more done. However, even the most motivated teams can have challenging team members and, possibly, be derailed by those individuals. With candor (and humor), this session will outline specific extreme team member personalities (archetypes) that can disrupt a project or process. Small groups will focus on strategies for keeping cool, obtaining information, and maintaining team rapport with their challenging team member. Attendees will be encouraged to share their examples and solutions within their small group and then the larger audience. This will be an interactive session for attendees at all levels.

    Learning Objectives

    Discuss the challenges of working in a group dynamic; Detail strategies for handling challenging team members; Strategize how to create a better rapport.

    Chair

    Robin Whitsell


    Speakers
    avatar for Robin Whitsell

    Robin Whitsell

    President, Whitsell Innovations, Inc.
    Ms. Whitsell has 20 years of industry experience. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical & clinical development at Inspire Pharmaceuticals, a team lead at GlaxoWellcome (now GlaxoSmithKline), and a CRA at Parexel International CRO. She was na... Read More →


    Monday June 19, 2017 1:15pm - 2:15pm
    Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:45pm

    DIA Medical Writing Community Round Table Discussion: Submission Dossiers: Communications Excellence to Drive Speed and Quality
    Component Type: Session

    Join DIA MW Community for a round table discussion tied to session #109 Submission Dossiers: Communications Excellence to Drive Speed and Quality (Monday, June 19th)

    Chair

    David B. Clemow, PhD


    Speakers
    avatar for David Clemow

    David Clemow

    Advisor, Scientific Communications Information Strategy, Eli Lilly and Company
    David is an Advisor Scientific Communications Information Strategy supporting the Alzheimer’s Platform at Eli Lilly with over 17 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document... Read More →


    Monday June 19, 2017 1:45pm - 2:45pm
    Community Corner McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #139: Deloitte Consulting Innovation Theater: 21st Century Cures and Person-Centered Research: A Recipe for Innovation
    Component Type: Session
    Level: Intermediate

    The 21st Century Cures Act allocates $6.3 billion to advance medical research and allow for innovation and flexibility for product regulation at the FDA. Life sciences companies risk being competitively disadvantaged if they aren't pursuing the newer breakthrough, priority, or accelerated pathway included in Cures and recent initiatives at the FDA. As the industry aims to meet the evolving needs of stakeholders this regulatory flexibility will be imperative in driving both approval and access.

    Chair

    Deloitte Consulting LLP


    Speakers
    AD

    Asif Dhar

    Principal, Deloitte Consulting
    Asif was an original architect of ConvergeHEALTH by Deloitte and was also the former managing director of Deloitte Health Informatics, LLC. He is also a Chief Medical Informatics Officer for Deloitte Consulting and helps drive our Therapeutic Area Transformation Integrated offeri... Read More →


    Monday June 19, 2017 2:00pm - 2:30pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #140: SAS Institute Inc. Innovation Theater: Clinical Analytics Workflow Optimization
    Component Type: Session

    Managing a clinical trial analytics exercise is filled with opportunity to optimize workflow. Join SAS to learn how you can manage all analytics tasks in parallel. See the advantages of a connected repository and analytics environment as well as scalability for any size of analytics tasks--from simulations to computation on big data. See how to minimize the effort required to create compliant datasets. Share our vision for the clinical trial analytics environment of the future–ready today.

    Chair

    SAS Institute Inc.


    Speakers
    avatar for Matt Becker

    Matt Becker

    Principal Industry Consultant, SAS Institute Inc.
    Matt Becker has been a Principal Industry Consultant at SAS since 2013. Prior to joining SAS, he had been using SAS in the life science industry since 1988 with his focus areas being clinical programming, clinical data management and clinical visualizations. Matt has presented nu... Read More →
    avatar for Mike Henderson

    Mike Henderson

    Sr Manager, Pre-Sales Support, SAS Institute Inc.
    A lifetime learner with a background in statistics that is passionate about accurately quantifying the patient experience in healthcare through better drug/device evaluation in research, development, clinical, and market settings. Mike holds degrees in mathematics (BS) and statis... Read More →
    SI

    SAS Institute Inc.

    SAS Institute Inc


    Monday June 19, 2017 2:00pm - 2:30pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    3:00pm

    #142: Opening Remarks and Keynote Address
    Component Type: Session

    Join us for the DIA 2017 Keynote Address.

    Alexander Tsiarias of StoryMD tells the personal stories of diseases and the power of patient data and interactive experiences to drive greater patient engagement. He’ll share stories of empowered patients and how they along with enlightened researchers drove these insights into action. For more information about Alexander, please visit http://www.diaglobal.org/en/flagship/dia-2017/program/keynote-speaker.

    Chair

    Barbara Lopez Kunz, MSc

    Speaker

    Keynote Speaker
    Alexander Tsiaras



    Speakers
    avatar for Alexander Tsiaras

    Alexander Tsiaras

    Founder & CEO, StoryMD
    Alexander Tsiaras is the Founder, CEO and Editor-in-Chief of TheVisualMD.com. Mr. Tsiaras grew TheVisualMD.com out of his already well established journalism enterprise.


    Monday June 19, 2017 3:00pm - 4:30pm
    Arie Crown Theater McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:30pm

    Opening Reception
    Exhibit Hall

    Monday June 19, 2017 4:30pm - 6:00pm
    TBA

    4:45pm

    #143: Advanced Clinical Innovation Theater: Avoid Systems Overload: Connecting and Operationalizing Disparate Technology Systems Supporting Clinical Trials
    Component Type: Session

    Learn to maximize visibility, improve decision-making and uphold compliance with the latest regulatory requirements by implementing these best practices for connecting disparate data sources across your clinical trial.

    Chair

    Advanced Clinical


    Speakers
    SA

    Stacey Arrambide

    Vice President, Biometrics, Advanced Clinical
    AC

    Advanced Clinical

    Associate Director, Marketing, NA
    avatar for Cheryle Evans

    Cheryle Evans

    Senior Vice President, Clinical and Medical Operations, Advanced Clinical


    Monday June 19, 2017 4:45pm - 5:15pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:45pm

    #145: Educational Measures Innovation Theater: EM Array™ Live Meeting Technology
    Component Type: Session
    Level: Intermediate

    EM Array™ second screen technology takes ordinary meetings and turns them into dynamic experiences. Live meeting data and analytics drive actionable insight and continual improvement. You increase audience engagement by up to 20X, surprise attendees with more than 25 interactive capabilities and continually improve meeting impact with data driven insight. Proven with more than 6,000 events and 1,000,000 participants, EM brings excellent reliability.

    Chair

    Educational Measures


    Speakers
    RM

    Ryan Mazon

    Senior Vice President, Business Development, Educational Measures


    Monday June 19, 2017 4:45pm - 5:15pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:45pm

    #146: Student Poster Session and Oral Presentations 1B
    Component Type: Poster Presentation




    Monday June 19, 2017 4:45pm - 5:30pm
    Exh Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    5:30pm

    #147: Appian Innovation Theater: Product Lifecycle Management In The Digital Era
    Component Type: Session

    To maintain quality, accelerate time to market, and add value to the patient, companies must digitally transform across the product life-cycle. Appian is designed to enable mobility, low-code development, and rapid deployment through digital transformation. With Appian, innovate ways to leverage proven technology while enhancing processes and delivering greater efficiency.

    Chair

    Appian


    Speakers
    avatar for Evjatar Cohen

    Evjatar Cohen

    Vice President, Global Pharmaceuticals & Life Sciences, Appian Corporation
    Please check out my LinkedIn profile https://www.linkedin.com/in/evicohen/


    Monday June 19, 2017 5:30pm - 6:00pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    5:30pm

    #148: DBMS Consulting Innovation Theater: Manage Customized SMQs/MedDRA Queries and Customized SDGs/Drug Groupings and Facilitate Risk Profiling and Safety Analysis with OpenCQT
    Component Type: Session
    Level: Intermediate

    Many organizations have created Customized SMQs/MedDRA Queries and Customized SDGs/Drug Groupings, but do not have a way of managing these custom SMQs/custom SDGs which may be unique to specific products/indications/protocols except in disparate spreadsheets. Additionally, they have proven to be vitally important in safety analysis and signal detection. DBMS Consulting presents OpenCQT as a software solution to manage custom SMQs/SDGs and facilitates risk profile analysis using custom SMQs/SDGs.

    Chair

    DBMS Consulting


    Monday June 19, 2017 5:30pm - 6:00pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
     
    Tuesday, June 20
     

    7:00am

    Coffee and Light Refreshments
    Tuesday June 20, 2017 7:00am - 8:00am
    TBA

    7:00am

    Attendee, Speaker, and Exhibitor Registration
    Tuesday June 20, 2017 7:00am - 5:15pm
    TBA

    8:00am

    #201: Paying for Value in Biopharmaceuticals: Trends in the United States
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-563-L04-P; CME 1.50; IACET 1.50; RN 1.50

    Recent political and media attention has focused on the cost of medicines, with U.S. politicians and some consumer organizations demanding lower prices, as well as more transparency around pricing that all too frequently seems opaque. At the same time, U.S. health care is transitioning to focus more on paying for the value of care provided, rather than on the volume of goods and services, including for drugs. This DIAmond session will provide context on how drug pricing, reimbursement, and purchasing decisions are evolving in the US. Topics to be explored include how U.S. biopharmaceutical prices are determined in contrast to other countries; the roles of different players, such as pharmacy benefit managers, in the system; and how payers and manufacturers are embracing new value-based arrangements to make more efficient and effective use of the dollars spent on biopharmaceuticals.

    Learning Objectives

    Discuss the decision making process for drug pricing, reimbursement, and access to medicines; Define value and its impact on health care spending

    Chair

    Sudip Parikh, PhD

    Speaker

    Panelist
    Sloane Salzburg, MS

    Panelist
    Shawn Davis

    Panelist
    Joel Beetsch, PhD

    Panelist
    Phillip J. Lerner, MD, MPH



    Speakers
    avatar for Joel Beetsch

    Joel Beetsch

    Vice President, Patient Advocacy Group, Celgene Corporation
    Dr. Beetsch, VP of Patient Advocacy in Celgene’s Corporate Affairs Dept., leads the global development & execution of a coordinated patient-focused Advocacy strategy working w/multiple patient, provider, payer, & policy organizations to foster safe & effective solutions to heal... Read More →
    avatar for Shawn Davis

    Shawn Davis

    Senior Director, Formulary Solutions, Express Scripts
    Shawn helps Express Scripts’ clients improve patient’s health while reducing costs by developing solutions to deliver complex, life-saving medications at sustainable prices. His responsibilities include: Chairing the Value Assessment Committee to develop the Express Scripts... Read More →
    avatar for Phillip Lerner

    Phillip Lerner

    Vice President and National Medical Director, Aetna, Inc.
    Dr. Phil Lerner is Vice President and National Medical Director at Aetna. He is the Head of Condition Analysis and leads multiple clinical teams that analyze claims data and develop strategies to help Aetna members receive evidence based cost effective health care. He also leads... Read More →
    avatar for Sudip Parikh

    Sudip Parikh

    Senior Vice President and Managing Director, DIA Americas, DIA
    avatar for Sloane Salzburg

    Sloane Salzburg

    Executive Director, Prescriptions For A Healthy America
    Sloane Salzburg is Vice President for the Council for Affordable Health Coverage (CAHC) and Executive Director of CAHC's 50-organization campaign, called Prescriptions for a Healthy America (P4HA). P4HA works to raise awareness of the growing challenges posed by medication nonadh... Read More →



    Tuesday June 20, 2017 8:00am - 9:30am
    S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Real World Evidence,Public Policy,StudentProgramming
    • Credit Type ACPE, CME, IACET, RN
    • Tags Session

    8:00am

    #202: People Will Talk: Gathering Insights from Digital Listening
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-566-L04-P; CME 1.50; IACET 1.50; RN 1.50

    There is growing interest from global stakeholders — biopharma, regulators, and patients — to analyze digital health information either posted online by patients or captured by pharma through patient/HCP requests. This information represents a large repository of safety and patient experience insights that could supplement data from existing sources. Panelists in this DIAmond session will address how digital health information can be analyzed to support medical affairs, pharmacovigilance and commercialization efforts. Topics addressed include an overview of techniques, use cases, compliance with regulatory guidelines, and patient privacy.

    Learning Objectives

    Describe the challenges of using social media data to supplement postmarketing safety data; Discuss the impact of social media data on compliance with regulatory guidelines.

    Chair

    Lorrie Schifano, PharmD

    Speaker

    Current Techniques for Analyzing Text That Can be Used in Medical Affairs, Benefit-Risk Assessment, and the Voice of the Customer
    Jeffery Lanier Painter, JR, JD, MS

    Digital Listening Throughout a Product's Life Cycle
    Chi Bahk, MS

    Current Parameters for Collecting/Utilizing This Data Compliantly
    Phil Tregunno

    Panelist
    Gerald J. Dal Pan



    Moderators
    avatar for Lorrie Schifano

    Lorrie Schifano

    Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline
    Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill... Read More →

    Speakers
    avatar for Chi Bahk

    Chi Bahk

    Business Operations Lead, Epidemico, Booz Allen Hamilton
    Chi is a public health professional with expertise in utilizing non-traditional data sources such as online news and social media for health vigilance, especially in the areas of disease monitoring and patient understanding. She's worked as part of academia, tech start-up, and la... Read More →
    avatar for Gerald Dal&nbspPan

    Gerald Dal Pan

    Director, Office of Surveillance and Epidemiology, CDER, FDA
    Dr. Dal Pan is the Director of the Office of Surveillance and Epidemiology in FDA’s CDER, where he is responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is involved in both t... Read More →
    avatar for Jeffery Painter

    Jeffery Painter

    Chief Executive Officer/Founder, Jivecast
    Jeffery Painter is the CEO and founder of JiveCast, a firm specializing in building analytics tools for a broad range of industries. While at GSK, Jeff was Director of Analytics in Medical Affairs where he led a data science team using text analytics to better understand the voic... Read More →
    avatar for Phil Tregunno

    Phil Tregunno

    Signal Management Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
    Phil is a Unit Manager within MHRA's Vigilance Intelligence and Research Group (VIRG) and has over thirteen years of experience working in pharmacovigilance. For the past eight years he has been responsible for leading and developing the Signal Management function, including syst... Read More →


    Tuesday June 20, 2017 8:00am - 9:30am
    S100c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Clinical Operations,Statistics,Quality-GXP,Patient Centric ,Global Regulatory,Data Management,Real World Evidence,StudentProgramming
    • Credit Type ACPE, CME, IACET, RN
    • Tags Forum

    8:00am

    #203: Radical Technologies: Changing the Future of Biopharmaceuticals
    Component Type: Session
    Level: Intermediate
    CE: CME 1.50; IACET 1.50; RN 1.50

    In this DIAmond session, innovative thinkers project the impact of some of the most radical emerging technologies on the future of biomedical research. From real-time patient monitoring through mHealth technology to digitally enabled precision medicine to “research as a care option” supported by advanced analytics, the expert panel will explore radical changes that will improve the biopharmaceutical development process of the future and the radical technologies that will make them possible.

    Learning Objectives

    Discuss the potential impact of one or more emerging new technologies on the development process and outcomes for biopharmaceutical products; Describe ways in which today's biopharmaceutical development process will be different in five years and what the impact will be for industry as well as the patient/consumer.

    Chair

    Craig H. Lipset, MBA

    Speaker

    Panelist
    Jeffry G. James, MBA

    Panelist
    Alicia Staley, MBA, MS

    Panelist
    Julian M. Jenkins



    Speakers
    avatar for Jeffry James

    Jeffry James

    Chief Executive Officer, Wilmington Health, PLLC
    Jeff James is currently the CEO of Wilmington Health in Wilmington, NC. Wilmington Health is a multispecialty group practice with 161 providers covering 37 specialties in 22 locations. He is responsible for the strategic vision and its deployment as well as all financial and oper... Read More →
    JJ

    Julian Jenkins

    Vice President, Innovation Performance and Technology, GlaxoSmithKline
    Dr. Julian Jenkins is VP ad head of Innovation, Performance and Technology at GSK R&D, which involves maintaining a state of the art clinical technology infrastructure and the innovation agenda for clinical research. He is also GSK’s representative on the TransCelerate oversigh... Read More →
    avatar for Craig Lipset

    Craig Lipset

    Head of Clinical Innovation, Global Product Development, Pfizer Inc.
    Craig’s is responsible for impacting clinical research through digital tools, patient engagement, and novel collaborations. He serves on the Board for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, the Operations Committee for TransCelerate... Read More →
    avatar for Alicia Staley

    Alicia Staley

    Patient Advocate, Independent Patient Advocate
    Alicia Staley is the Patient Advocate at Cure Forward. She is a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore at Syracuse University. After 15 years in software design and information systems management, Alicia began applying her engineering... Read More →


    Tuesday June 20, 2017 8:00am - 9:30am
    S100a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Real World Evidence,Wearables-Mobile Health,Devices-Combination Products,StudentProgramming
    • Credit Type CME, IACET, RN
    • Tags Session

    9:30am

    Coffee Break
    Exhibit Hall

    Tuesday June 20, 2017 9:30am - 10:30am
    TBA

    9:30am

    #204: Effective Team Management in Global Trials
    Component Type: Session
    Level: Intermediate

    Global drug development has long been an accepted practice and expectation for clinical research success. Despite the proliferation of technology and other industry innovations, success or failure still depends on a high performing team. Teams are increasingly spread out across the globe and in many cases working remotely which further challenges communication and direct collaboration. Still other challenges emerge when project teams are potentially comprised of representatives from the sponsor, contract research organizations (CROs) and independent contractors. This session will examine the role of the study start-up process, how to spot the early warning signs of dysfunction and practical strategies for how to best align and engage the global team.

    Learning Objectives

    Discuss how to design a successful project kick-off meeting; Discuss getting the most out of study start-up; Recognizing the signs of a team in trouble; Strategies to align objectives across multiple cultures and diverse backgrounds.

    Chair

    Peter A. DiBiaso, MHA


    Speakers
    avatar for Peter DiBiaso

    Peter DiBiaso

    Global Vice President, Managing Director, QuintilesIMS
    Peter us a clinical development professional with a strategic focus in leading global operations that support the optimization of bio-pharmaceutical research and investigator relationships. In a series of progressive roles for Quintiles, he currently serve as the Global Vice Pres... Read More →


    Tuesday June 20, 2017 9:30am - 10:30am
    Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Clinical Operations
    • Tags Session

    9:30am

    #205: Professional Poster Session 2A
    Component Type: Poster Presentation




    Tuesday June 20, 2017 9:30am - 10:30am
    Exh Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    9:30am

    Exhibit Hall Opens
    Tuesday June 20, 2017 9:30am - 5:00pm
    TBA

    9:30am

    Professional Poster Session 1
    Component Type: Poster Presentation




    Speakers
    avatar for Basirat Adeyemi

    Basirat Adeyemi

    Global Regulatory Affairs Post-Doctoral Fellow, Rutgers, The State University of New Jersey
    Basirat Adeyemi is a pharmacist completing a Global Regulatory Affairs (GRA) post-doctoral fellowship at Merck & Co. Inc. partnered with the Rutgers Pharmaceutical Industry Fellowship (RPIF). She earned a Doctor of Pharmacy degree from Touro College of Pharmacy and a B.S. in Biol... Read More →
    avatar for Alexandra Atkins

    Alexandra Atkins

    Senior Scientific Director, NeuroCog Trials
    avatar for Catherine De Castro

    Catherine De Castro

    Associate Director, QuintilesIMS
    Catherine de Castro is a member of QuintilesIMS' Project Management Center of Excellence, which focuses on the continuous evolution of QI Project Leaders. Her expertise is in process improvement and strategic initiatives. In her current role she focuses on embedding project manag... Read More →
    avatar for Yen-Ming Chan

    Yen-Ming Chan

    Postdoctoral Fellow, Office of New Drugs, Center for Drug Evaluation and Research, FDA
    I received my Ph.D. from the University of Toronto. During my graduate school training, I gained in-depth experience in designing and conducting clinical trials to investigate the efficacy and safety of a wide range of dietary supplements. I am currently a postdoctoral fellow a... Read More →
    avatar for Tina Chhabra

    Tina Chhabra

    Post-PharmD Regulatory Affairs Fellow, Biogen; MCPHS University
    Tina Chhabra is a Post-Doctoral fellow in Regulatory Affairs and Safety & Benefit-Risk Management with the Biogen-MCPHS University post-graduate fellowship program. She received her Bachelor's in Political Science and PharmD from Virginia Commonwealth University.
    DC

    Deborah Covington

    Senior Research Scientist, Evidera
    Deborah Covington, DrPH, is a senior research scientist at Evidera and part-time faculty at the University of North Carolina, Wilmington. She received her doctorate from the University of North Carolina, Chapel Hill and has 30+ years of epidemiological research experience focusin... Read More →
    AC

    Amy Curry

    Safety Evaluation and Risk Management Scientist, GlaxoSmithKline
    avatar for Nadeeka Dias

    Nadeeka Dias

    Scientific Advisor, ERT
    Nadeeka Dias is a clinical neuroscientist with 8 years of in-depth experience in the design and management of human clinical research. She has extensive expertise in psychiatry and neuropharmacology, as well as proficiency with clinical outcome assessments and rater training in a... Read More →
    avatar for Meghan Donahue

    Meghan Donahue

    Solution Design Studio Manager, QuintilesIMS
    Meghan Donahue is the Solution Design Studio Manager at QuintilesIMS. In this role, she leads collaborative workshops utilizing user-centric methodologies, markets the Design Studio's capabilities, actively networks to establish strategic relationships, and evaluates emerging tec... Read More →
    avatar for Jennifer Emerson

    Jennifer Emerson

    Owner, Emerson Consulting & Clinical Research Services
    Dr. Emerson is an Epidemiologist and Registered Nurse with 15 years' industry experience. She worked in Oncology Clinical Research as both a CRA and Project Manager before moving over to the Quality Management side of the business. Dr. Emerson is now the owner of ECCRS, an intern... Read More →
    avatar for Harry Gewanter

    Harry Gewanter

    Chairman, Alliance for Safe Biologic Medicines
    Dr. Gewanter is a pediatric rheumatologist and current chair of ASBM. A graduate of Duke University and Wayne State University School of Medicine, he received his pediatric and rheumatology training at the University of Rochester/Strong Memorial Hospital. He has practiced in Rich... Read More →
    KH

    Kit Howard

    Director of Education, CDISC
    Kit Howard, principal at Kestrel, provides data standards and quality consulting & education to biopharma, medical device and academic organizations. Kit is a CDISC Registered Service Provider, a member of CDASH & co-leads the Medical Devices team. She is an SCDM Certified Clinic... Read More →
    YT

    Yi Tzu Hsu

    Project Manager, TFDA/Center For Drug Evaluation
    avatar for Candice Hughes

    Candice Hughes

    CEO/Founder, Hughes BioPharma Advisers LLC
    Candice M Hughes, PhD, MBA, is a strategy and management consultant for pharmaceutical/biotech firms via Hughes BioPharma Advisers and a serial entrepreneur who founded digital health startup, AdapTac Games. She has worked with a third of the top 25 global pharma and leading biot... Read More →
    avatar for Maori Ito

    Maori Ito

    Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
    Ms. Maori Ito is currently working as a safety evaluator at the Office of Medical Informatics and Epidemiology of Pharmaceuticals and Medical Devices Agency (PMDA). Having graduated from the master course of Computational Biology at Tokyo University, she joined the National Insti... Read More →
    avatar for Dayna Lesueur

    Dayna Lesueur

    Regulatory Affairs Post-PharmD Fellow, Alnylam Pharmaceuticals, Inc.
    Dayna graduated with her PharmD in May of 2016 and is currently completing a 2-year Fellowship in Regulatory Strategy at Alnylam Pharmaceuticals, a pre-commercial biotechnology company developing RNA interference (RNAi) in the rare disease space. Dayna's focus at Alnylam so far h... Read More →
    avatar for Lawrence Liberti

    Lawrence Liberti

    Executive Director, Centre For Innovation In Regulatory Science (CIRS)
    For the past 37 years, Mr Liberti has worked in the fields of regulatory affairs and clinical R&D. Since 2009 he has served as the Executive Director of CIRS (formerly the CMR International Institute for Regulatory Science), an independent, division of Clarivate Analytics. He is... Read More →
    JL

    Jenny Ly

    Clinical Science Advisor, ERT
    avatar for Melissa Mielcarz

    Melissa Mielcarz

    AD, Clinical Operations, QuintilesIMS
    avatar for Vineeth Nair

    Vineeth Nair

    Post-Doctoral Fellow, Rutgers, The State University of New Jersey
    I am a second year Medical Affairs post-doctoral fellow within the Rutgers Institute for Pharmaceutical Industry Fellowships in partnership with Pfizer Consumer Healthcare. I am a pharmacist by training and I am interested in Medical Affairs, Medical Information, and Outcomes Res... Read More →
    avatar for Daina Nanchanatt

    Daina Nanchanatt

    Post-Doctoral Fellow, Rutgers, The State University of New Jersey
    Daina Nanchanatt joined the Rutgers University Pharmaceutical Industry Fellowship Program in partnership with Bayer Consumer Health in 2016. She is currently completing a two year fellowship with the Innovation and Development Category Leadership team at Bayer. Daina earned her P... Read More →
    FP

    Fatima Paruk

    Chief Medical Officer, Allscripts Analytics
    KP

    Katelyn Patterson

    Leidos Biomedical Research, Inc
    avatar for Vincent Philiponis

    Vincent Philiponis

    Medical Director, Medical Affairs, ICON, plc.
    More then 18 years Clinical Trials experience, trained in family medicine, doctural degree in Pharmacology and Molecular Biology, NIH Fellowships in cancer and aging.
    avatar for Srinivas Pai Raikar

    Srinivas Pai Raikar

    Director, QuintilesIMS
    Srinivas is currently leading the initiatives focused on building site relationships and partnerships through a team of Alliance managers working closely with Quintiles preferred sites besides leading the CTE/NE offering in Asia Pac. He has 25 years of combined global biopharmace... Read More →
    avatar for Masooma Razvi

    Masooma Razvi

    Regulatory Affairs Postdoctoral Fellow, GlaxoSmithKline, University of North Carolina-GlaxoSmithKline
    Masooma Razvi received her Doctor of Pharmacy degree from the University of Illinois at Chicago and completed a PGY1 general practice pharmacy residency at Wheaton Franciscan Healthcare in Milwaukee, Wisconsin. She is currently finishing up the second year of her Regulatory Affai... Read More →
    CR

    Chi-Tun Ruan

    Reviewer, TFDA
    avatar for Jui Shah

    Jui Shah

    Health Scientist Administrator, NIAID, Clinical Research Resources Branch, National Institutes of Health (NIH)
    Dr. Shah is a Regulatory Affairs professional with over 18 years of experience ranging from basic research through product development. Dr. Shah's experience as the Regulatory lead is varied and includes clinical trials for drugs and biologics in various therapeutic areas from di... Read More →
    avatar for Jennifer Shing

    Jennifer Shing

    Postdoctoral Fellow, Office of New Drugs, CDER, FDA
    Jennifer Shing received her Ph.D. in Molecular Pharmacology and Experimental Therapeutics from Mayo Clinic Graduate School of Biomedical Sciences. She is currently an Oak Ridge for Science and Education Fellow at the U.S. Food and Drug Administration (FDA), where she performs sci... Read More →
    avatar for Scott Snyder

    Scott Snyder

    Senior Safety Data Scientist, AbbVie, Inc.
    Scott earned his PharmD at Midwestern University’s Chicago College of Pharmacy. He has worked in pharmaceutical industry at AbbVie within Pharmacovigilance and Patient Safety, Global Medical Information, and Regulatory Affairs. Scott currently works as a Senior Safety Data Scie... Read More →
    avatar for Judith Thompson

    Judith Thompson

    UCB, Inc.
    Judith Thompson was born and raised in Atlanta, GA. She studied pharmacy at Xavier University of Louisiana College of Pharmacy and proceeded to work in a fast-paced environment, assuring positive patient impact in retail and clinical pharmacy settings. Passionate about patients... Read More →
    PV

    Priscilla Velentgas

    Senior Director, Epidemiology, QuintilesIMS
    avatar for Rod Walker

    Rod Walker

    Operations Lead, Quintiles Precision Enrollment, QuintilesIMS
    avatar for Kevin White

    Kevin White

    Director REMS Technology, Celgene Corporation
    avatar for Rinah Yamamoto

    Rinah Yamamoto

    Clinical Science Advisor, ERT
    Dr. Yamamoto holds a PhD in Experimental Psychology from Tufts University. She has experience in pre-clinical and clinical research in mood and anxiety disorders, substance use disorders, incentive salience, interactions of nutrition and behavior, and functional and pharmacologic... Read More →
    avatar for Rinah Yamamoto

    Rinah Yamamoto

    Clinical Science Advisor, ERT
    Dr. Yamamoto holds a PhD in Experimental Psychology from Tufts University. She has experience in pre-clinical and clinical research in mood and anxiety disorders, substance use disorders, incentive salience, interactions of nutrition and behavior, and functional and pharmacologic... Read More →
    avatar for Zhongwei Zhou

    Zhongwei Zhou

    Director, Data Optimization, Pfizer Inc.
    Zhongwei has worked more than 23 years in different major pharmaceutical companies across both Rx and OTC fields, and has become a "world-class" SAS programmer in clinical trial.


    Tuesday June 20, 2017 9:30am - 5:00pm
    Poster Area Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    9:45am

    #206: Covance Innovation Theater: Overcoming Study Complexity Through Data-Driven Design
    Component Type: Session
    Level: Intermediate

    New data streams and regulations are making clinical trials more complex, driving increased and longer duration of drug development. Protocol design complexity and amendments are major factors in these delays. Design bloat negatively impacts an investigator’s ability to be successful. Covance data-driven trial design solutions leverage our proprietary database of over 16,000 protocols and Xcellerate investigator performance data to analyze and quantify the impact of protocol design decisions.

    Chair

    Covance Inc.


    Speakers
    avatar for Bill Hanlon

    Bill Hanlon

    Chief Development Officer and Head of Global Regulatory Affairs, Covance Inc.
    Dr. William Hanlon, PhD, is the chief development officer and head of global regulatory affairs for Covance. He has been with Covance for four and a half years, after spending 25 years in pharma in the discovery and the development side of developing drugs for global commercializ... Read More →
    CI

    Covance Inc.

    Covance Inc.


    Tuesday June 20, 2017 9:45am - 10:15am
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    9:45am

    #207: Veeva Systems, Inc. Innovation Theater: 2017 Unified Clinical Operations Survey
    Component Type: Session

    The Veeva 2017 Unified Clinical Operations Survey examines the life sciences industry’s progress in reducing system and process complexity to improve study execution. The goal of the research is to understand the drivers, benefits, and barriers of a unified clinical operating model.

    Chair

    Veeva Systems, Inc.


    Speakers
    MB

    Michael Burton

    Director, Value Engineering, Veeva Systems
    VS

    Veeva Systems, Inc.

    NA
    Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →


    Tuesday June 20, 2017 9:45am - 10:15am
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #231: A Risk-Based Approach to Quality Management for RWE Studies
    Component Type: Session

    Real World Evidence (RWE) has emerged as an area of great interest and opportunity, especially with ever-increasing capabilities for data mining. RWE has established value in informing prescriber and payer decision-making and interest in RWE generation and use continues to grow with discussions turning to possibilities of its value in supporting new indications and label claims. While broadly the quality objectives of “human research subject protection/patient safety” and “data reliability” apply to RWE, there is no definitive quality regulation or even guidance for the research that generates RWE as there is for interventional, well-controlled clinical trials. In this discussion, we will explore the expectations for quality and compliance in the rapidly expanding RWE ecosystem and how they can be achieved using pragmatic – and perhaps even unconventional – approaches.

    Chair

    David William Fryrear, MSc


    Speakers
    avatar for David Fryrear

    David Fryrear

    Senior Director, R&D Quality Assurance, AbbVie, Inc.
    David Fryrear is a Senior Director in R&D Quality Assurance at AbbVie.  In this role, he is the global head of clinical and pharmacovigilance quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management.  Prior to joining AbbVie in J... Read More →


    Tuesday June 20, 2017 10:30am - 11:00am
    S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #217: Update from CBER: Advancing the Development of Complex Biologic Products
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.00; IACET 1.00; RN 1.00

    This session will provide an overview of how the Center for Biologics Evaluation and Research (CBER) works to advance the development of complex biological products such as vaccines, live biotherapeutics, and cellular and gene therapies. The session will include a discussion of how the Center is working to implement relevant provision of the 21st Century Cure Act aimed at further expediting the development of important medical products.

    Learning Objectives

    Identify regulatory work recently completed or in progress and communicate Center priorities for the coming years.

    Chair

    Peter W. Marks, MD, PhD


    Speakers
    avatar for Peter Marks

    Peter Marks

    Director, Center for Biologics Evaluation and Research, FDA
    Served as Clinical Director of Hematology at Brigham and Women's Hospital, worked in the pharmaceutical industry on the clinical development of hematology and oncology products, led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He join... Read More →


    Tuesday June 20, 2017 10:30am - 11:30am
    S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • Level Intermediate
    • format json
    • Featured Topics StudentProgramming,Global Regulatory
    • Credit Type CME, IACET, RN
    • Tags Forum

    10:30am

    #218: ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-17-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

    The Department of Health and Human Services issued a final rule (42 CFR Part 11), with an April 18, 2017 compliance date, clarifying existing requirements and establishing new requirements for registering and submitting summary results of clinical trials to ClinicalTrials.gov. The 21st Century Cures Act became law in December 2016 and includes provisions related to ClinicalTrials.gov reporting, including stakeholder outreach, reporting of compliance activities, and manufacturer obligations for making available policies about expanded access and linking to ClinicalTrials.gov. This session aims to help clinical trial sponsors understand their legal obligations for submitting registration and results information to ClinicalTrials.gov and the steps taken by NIH under the Cures Act.

    Learning Objectives

    Describe the requirements in 42 CFR Part 11 for the submission of registration and results information by trial sponsors and investigators to ClinicalTrials.gov, including information on expanded access; Discuss potential consequences of noncompliance with 42 CFR Part 11; Describe NIH obligations under the 21st Century Cures Act related to ClinicalTrials.gov.

    Chair

    Rebecca J. Williams, PharmD, MPH

    Speaker

    Perspective From ClinicalTrials.gov
    Rebecca J. Williams, PharmD, MPH



    Speakers
    avatar for Rebecca Williams

    Rebecca Williams

    Assistant Director, ClinicalTrials.gov, NCBI, National Library of Medicine, NIH
    As the Assistant Director of ClinicalTrials.gov, Dr.Williams is responsible for the results submission process, outreach and education, policy and regulation development and implementation, and research related to evaluating and improving the reporting of clinical research.


    Tuesday June 20, 2017 10:30am - 11:30am
    S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Public Policy,Clinical Operations
    • Credit Type ACPE, CME, IACET, RN
    • Tags Session

    10:30am

    #220: Cardiac Safety
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.00; IACET 1.00; RN 1.00

    In December 2015, the ICH E 14 guidance was updated to reflect an expanded role for Concentration-Response modeling of QTc data accepting it as an alternative to the traditional by-time-point analysis as the primary basis for decisions to classify the risk of QT prolongation of a drug. Careful ECG evaluation in early phase studies using Exposure-response analysis can thus serve as a potential alternative to the E14 “thorough QT” study. This adds to protocol complexity in early phase studies. Stakeholder impressions and expectations of the revision in the guidance as well as potential challenges and opportunities including newer approaches to assessment of cardiac safety will be discussed. This session will describe with case studies how TQT grade ECG data can be collected in phase I studies. As the guidance indicates that a separate positive control may not be necessary, alternative approaches for protection against false negatives will be considered.

    Learning Objectives

    Describe how cardiac safety assessment is evolving and changing; Discuss key aspects of QT assessment in phase I studies to support TQT waivers; Identify how ECG core lab processes influence data quality and assessment of QTc in phase 1 studies.

    Chair

    Snehal N Kothari

    Speaker

    Evaluating Attitudes and Experiences with Evolving Cardiac Safety Assessment Solutions
    Kenneth A. Getz, MBA

    The Power of Phase1 Studies to Detect Clinical Relevant QTc Prolongation
    Jörg Täubel, MD, FFPM



    Moderators
    avatar for Snehal Kothari

    Snehal Kothari

    Chief Medical & Scientific Officer, QuintilesIMS
    Dr Kothari is Chief Medical & Scientific Officer for Quintiles IMS Cardiac Safety.He provides advice on all aspects of cardiac safety & directs the ECG core lab with an experience of over 15 years and spanning hundreds of studies. Trained in Mumbai & Paris, he is a Fellow of Amer... Read More →

    Speakers
    avatar for Kenneth Getz

    Kenneth Getz

    Director of Sponsored Research Programs and Associate Professor, Center For the Study of Drug Development, Tufts University School of Medicine
    Mr. Getz is an internationally recognized expert on drug development management practices and trends. His research on protocol design complexity, clinical research efficiency, and on outsourcing and site management practices -- conducted over the past three decades -- are widely... Read More →
    avatar for Snehal Kothari

    Snehal Kothari

    Chief Medical & Scientific Officer, QuintilesIMS
    Dr Kothari is Chief Medical & Scientific Officer for Quintiles IMS Cardiac Safety.He provides advice on all aspects of cardiac safety & directs the ECG core lab with an experience of over 15 years and spanning hundreds of studies. Trained in Mumbai & Paris, he is a Fellow of Amer... Read More →
    avatar for Jörg Täubel

    Jörg Täubel

    Chief Executive Officer, Richmond Pharmacology Ltd.
    Jörg Täubel is a medical practitioner and CEO of Richmond Pharmacology. He has worked in clinical pharmacology for 24 years. He is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians (UK) and the Institute of Directors. He is a member of the B... Read More →


    Tuesday June 20, 2017 10:30am - 11:30am
    S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    DIA Study Endpoints Community Round Table Discussion: Leveraging Wearables and Sensors in the Clinical Trials and mHealth
    Component Type: Session

    Join DIA SE Community for a round table discussion tied to session #107 Leveraging Wearables and Sensors in the Clinical Trials and mHealth (Monday, June 19th)

    Chair

    Emuella Flood


    Speakers
    avatar for Emuella Flood

    Emuella Flood

    Senior Director, Patient-Reported Outcomes, ICON, plc.


    Tuesday June 20, 2017 10:30am - 11:30am
    Community Corner McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #208: Big Data: Regulatory Information
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This forum will explain leveraging information assets to show correlations and relationships and discuss effective management of regulatory information. This forum will cover all aspects of big data, RWD/RWE, etc.. as it pertains to the regulatory environment. From data standards to analytics, the forum will explore the potential benefits and challenges from a regulatory perspective.

    Learning Objectives

    Discuss effective management of regulatory information.

    Chair

    Vada A. Perkins, BSN, MS, MSc, RN

    Speaker

    FDA Perspective
    David Martin, MD, MPH

    Health Canada Perspective
    Vikesh Srivastava

    Panelist
    Thomas Senderovitz, DrMed, MD



    Moderators
    avatar for Vada Perkins

    Vada Perkins

    Identifica, LLC, Identifica, LLC
    Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards t... Read More →

    Speakers
    avatar for David Martin

    David Martin

    Liaison to the Reagan-Udall Foundation IMEDS Program, OMP, CDER, FDA
    David Martin is involved in opening Sentinel resources to the public, developing real world evidence policy, and engaging patients in evidence generation. He is the principal investigator for the first effort to capture patient-provided data through a mobile device application, s... Read More →
    avatar for Vada Perkins

    Vada Perkins

    Identifica, LLC, Identifica, LLC
    Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards t... Read More →
    TS

    Thomas Senderovitz

    Director General, Danish Medicines Agency
    Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at t... Read More →
    VS

    Vikesh Srivastava

    Associate Director, Business Informatics Division, HPFB, Health Canada
    Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #209: Evolving Data Standards and Regulations
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session will describe the current state and evolution of data standards.

    Learning Objectives

    Discuss the status of required study data standards, as well as other data standards initiatives; Summarize FDA's efforts to develop, test, and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives.

    Chair

    Ron D. Fitzmartin, PhD, MBA

    Speaker

    Impact of the Binding Guidance for Standardized Study Data Internally at the FDA
    Vaishali Popat, MD, MPH

    CDASH v2.0: Whats New and What Does it Mean for Me?
    Dawn Marie Kaminski

    CDISC Standards for Regulatory Submissions
    Lauren Becnel

    Metadata Driven Data Operations: What is it and How Can it Transform Traditional Clinical Data Management/Analysis/Reporting
    Michael Goedde



    Speakers
    avatar for Lauren Becnel

    Lauren Becnel

    Vice President, Strategy and Innovation, Clinical Data Intechange Standards Consortium (CDISC)
    Lauren Becnel leads strategy development, technologic and innovative programs at CDISC. Her projects include, for example, the SHARE metadata repository, which houses all CDISC standards; projects related to the CDISC, HL7 and ISO standard BRIDG translational research domain info... Read More →
    avatar for Benedikt Egersdoerfer

    Benedikt Egersdoerfer

    Vice President, Global Data Operations, PAREXEL International
    With over 20 years of experience in clinical research and the pharmaceutical industry, Dr. Egersdörfer has been instrumental in founding and leading departments responsible for the acquisition, integration, analysis, and reporting of data used in the Drug Development and Drug Sa... Read More →
    avatar for Ron Fitzmartin

    Ron Fitzmartin

    Senior Advisor, Office of Strategic Programs, CDER, FDA
    Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at D... Read More →
    avatar for Michael Goedde

    Michael Goedde

    Vice President, Clinical Data Management and Database Programming, PAREXEL
    Michael Goedde is a Certified Clinical Data Manager with more than 26 years of experience in the pharmaceutical and biotechnology industry. In his career he led CDM and programming groups at Aventis, Kos Pharma, HGS, Medimmune and PAREXEL. Michael serves on the Board of Trustees... Read More →
    avatar for Dawn Kaminski

    Dawn Kaminski

    Director, Clinical Data Strategies, Accenture Accelerated R&D Services
    Dawn Kaminski has over 20 years of experience. With Accenture, Ms. Kaminski has provided consultation to organizations in the adoption of CDISC standards, served as a primary architect for an EDC system and consulted on clinical trial best practices. Dawn is a member of the CDASH... Read More →
    avatar for Vaishali Popat

    Vaishali Popat

    Associate Director of Biomedical Informatics and Reg Review Science, OND, CDER, FDA
    Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing d... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #210: The New Business Reality for the Medical Science Liaison Community
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    The medical liaison role has experienced a dramatic transformation in the new era of industry growth and consolidation. Indeed, the explosion of small biopharmaceutical companies—coupled with their subsequent acquisition by more established, global pharmaceutical corporations—has resulted in the emergence of new business challenges facing medical liaisons requiring novel skill sets. This forum is designed to examine the medical liaison role given the internal/external business environment and to provide insight into how the role may evolve in the context of organizational growth and acquisition.

    Learning Objectives

    Describe the business challenges facing medical liaisons from the perspective of both smaller biopharmaceutical companies and larger, global organizations; Identify common core medical liaison activities and how they may evolve and change within the context of organizational growth and acquisition; Discuss novel skill sets required to successfully address these issues across entities of various sizes and structure in the current market landscape.

    Chair

    Kevin Charles Henderson, PharmD, MBA

    Speaker

    Small Start-Up, Single Pipeline Molecule
    Dipam Doshi, PharmD

    Panelist
    Paul James, PharmD, MBA

    Panelist
    Kimberly Johnson, PharmD



    Moderators
    avatar for Kevin Henderson

    Kevin Henderson

    MSL Field Operations and Resources Manager, Genentech, A Member of the Roche Group
    Kevin is currently a Field Operations and Resources Manager but has held a variety of roles in both US Commercial and Medical areas at Genentech. His experience includes strategic roles in oncology NME launches and line extensions. His relevant education includes a Pharm.D. and a... Read More →

    Speakers
    DD

    Dipam Doshi

    Senior Medical Science Liaison, ZS Pharma
    Dipam Doshi graduated with his PharmD from University of the Pacific in 2010. After graduating he completed a one year fellowship at Daiichi Sankyo within the Rutgers Pharmaceutical Industry Fellowship program. From 2011-2015, Dipam Doshi has been a Medical Science Liaison with D... Read More →
    avatar for Kevin Henderson

    Kevin Henderson

    MSL Field Operations and Resources Manager, Genentech, A Member of the Roche Group
    Kevin is currently a Field Operations and Resources Manager but has held a variety of roles in both US Commercial and Medical areas at Genentech. His experience includes strategic roles in oncology NME launches and line extensions. His relevant education includes a Pharm.D. and a... Read More →
    PJ

    Paul James

    Associate Director, Medical Science Liaisons, Genentech, A Member of the Roche Group
    Paul James, PharmD, MBA – Paul has been an employee of Genentech for 10 years. During his 20-years in industry, he has assisted with training international MSLs, developed strategies to engage medical organizations, and aided the development of a customer relationship managemen... Read More →
    avatar for Kimberly Johnson

    Kimberly Johnson

    Field Medical Advisor, Eli Lilly and Company
    Kimberly Johnson, PharmD. – Kim has been an employee of Eli Lilly and Company for 21 Years. She has held various positions: Global Health Economics, US Health Outcomes Research Liaison, and US Medical Human Resource Representative. Kim eventually returned to her home state of M... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #211: Sharing the Burden
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-521-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Many in industry are interested in identifying new and innovative technologies to engage with patients throughout and after a clinical trial. The industry is enamored with multimedia eConsent platforms, but do they really help speed clinical trials to completion and reduce regulatory burden? When patients receive patient diaries, digital data capture tools, or even digital patient stipends does the learning curve and maintenance of use really benefit the patient? When sites have to log into multiple platforms to obtain study related information, it might require a new password for each platform. A more connected world enabled by digital technology can potentially help open up conversations in the area of clinical research, but it can also create more burden for investigator sites and patients when it is not streamlined or integrated. This session will explore how these innovations are being implemented without adding burden to the sites and patient users. Speakers will discuss how they are innovative but also reducing the added burden onto the site or patient.

    Learning Objectives

    Recognize how to anticipate site and patient burden due to the increased trend of introducing new technology processes; Describe ways to address site and patient burden.

    Chair

    Deborah Howe

    Speaker

    How Appropriate use of Technology can Share and Reduce the Burden of Modern Clinical Trials
    Paul O'Donohoe, MSc

    Patient Perspective
    Deborah E. Collyar



    Speakers
    DC

    Deborah Collyar

    President, Patient Advocates In Research (PAIR)
    Deborah Collyar is a leader in health advocacy, utilizing successful business, leadership and IT skills to bridge gaps between science, research, medicine and patients. Her advocacy work encompasses diseases, programs and policies at grassroots, national and international levels... Read More →
    avatar for Deborah Howe

    Deborah Howe

    Associate Director, Vendor Alliance Lead, Bristol-Myers Squibb
    Deborah Howe is an Associate Director in Vendor Alliance Management in Global Clinical Operations at Bristol-Myers Squibb. Deborah joined Bristol-Myers Squibb in 2005 and has held positions of increasing responsibility in the area of clinical trial enrollment and engagement. Debo... Read More →
    avatar for Paul O'Donohoe

    Paul O'Donohoe

    Director, Health Outcomes, CRF Health
    Paul O’Donohoe is Director of Health Outcomes at CRF Health and is based in their London office. He is responsible for developing the company’s internal scientific expertise and supporting the scientific consulting being offered to clients. Previously Paul worked as a researc... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #212: Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What Have We Learned?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-524-L04-P; CME 1.25; IACET 1.25; RN 1.25

    This forum will focus on the practical side of patient engagement ensuring that attendees get a real life view of the topic. Participants/panelists who have a passion for patient engagement and play key roles in their organizations to make patient engagement happen will be invited to participate – again providing a realistic insight into their approaches, initiatives, challenges, and successes. They will also provide a wealth and diversity of experience to drive a dynamic and interactive discussion that will encourage all attendees to participate.

    Join Patient Engagement Community for a follow up Round Table discussion at 1:00pm in the Community Corner.

    Learning Objectives

    Discuss various approaches to patient engagement; Describe some initiatives for patient engagement along with challenges and success stories.

    Chair

    Marc M. Boutin, JD

    Speaker

    EMA Perspective
    Juan Garcia-Burgos, MD

    FDA Perspective
    Theresa M. Mullin, PhD

    Patient Perspective
    Jan Geissler, MBA

    Industry Perspective
    Anton Hoos, MD, PhD, MBA



    Moderators
    avatar for Marc Boutin

    Marc Boutin

    Chief Executive Officer, National Health Council (NHC)
    the CEO of the National Health Council.Boutin has been a leading voice for greater patient involvement, starting with the development of new drugs to regulatory oversight of health care delivery. Under his leadership, the NHC has convened a broad range of stakeholders to effectiv... Read More →

    Speakers
    avatar for Juan Garcia-Burgos

    Juan Garcia-Burgos

    Head of Public Engagement Department, European Medicines Agency, European Union
    Juan Garcia Burgos is Head of Public Engagement Department and Co-chair of the EMA patients’ & healthcare professionals’ working parties. He is a Medical Doctor specialised in urology. In 2002 he joined the EMA to coordinate the preparation of EU clinical guidelines for drug... Read More →
    JG

    Jan Geissler

    Patient Representative, EUPATI
    Founder and Managing Director of Patvocates. Former Director of the European Patients' Academy (EUPATI). Cancer survivor and co-founder of the CML Advocates Network, the Leukemia Patient Advocates Foundation, LeukaNET, Leukämie-Online and the European Cancer Patient Coalition.
    avatar for Anton Hoos

    Anton Hoos

    Vice President and Medical Director, Europe, Amgen GmbH
    Tony Hoos currently serves as the Chief of Medical for Amgen in Europe, which includes all therapeutic areas as well as all medical departments in Europe. Tony has been passionate about patient involvement in the development and life cycle of medicines for many years. He has work... Read More →
    avatar for Theresa Mullin

    Theresa Mullin

    Director, Office of Strategic Programs, CDER, FDA
    Dr. Theresa Mullin plays a lead role in a number of CDER’s strategic initiatives including the human drugs international program, drug user fee negotiation and implementation, regulatory informatics, and major program evaluations and other initiatives. She is currently serving... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #213: Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This forum will provide an overview of the regulatory context for the coming surge of disruptive innovation. We will discuss the challenges involved and explore how FDA and others could collaborate to develop new approaches to facilitate this innovation. We will describe the steps FDA has already begun taking to prepare, as well as lay out where the agency could go further.

    Learning Objectives

    Explain how disruptive innovations will challenge regulatory frameworks; describe how FDA, companies and patients may approach collaborating to facilitate disruptive innovations such as gene therapy, combination products and microbiome exploration; Explain how regulatory approaches may change in order to accommodate this innovation

    Chair

    Nancy Bradish Myers, JD

    Speaker

    Panelist
    Richard Moscicki, MD

    Gene Therapy Cures: How Will They Break the Mold?
    Anne-Virginie L. Eggimann, MS

    Panelist
    Tal Zaks, MD, PhD



    Moderators
    avatar for Nancy Myers

    Nancy Myers

    President, Catalyst Healthcare Consulting, Inc
    Nancy Bradish Myers, JD is President of Catalyst Healthcare Consulting. Catalyst is a regulatory strategy and policy firm focusing on innovative technologies. Ms. Myers served as Senior Strategic Advisor in FDA’s Office of the Commissioner and has held senior positions at PhRMA... Read More →

    Speakers
    avatar for Anne-Virginie Eggimann

    Anne-Virginie Eggimann

    Vice President, Regulatory Science, Bluebird Bio
    Anne-Virginie joined bluebird bio in 2011 to lead global regulatory strategy and create innovative pathways to accelerate the development of bluebird bio’s gene therapy products. Previously, AV was an Executive Director at Voisin Consulting, leading rare diseases, oncology, and... Read More →
    avatar for Richard Moscicki

    Richard Moscicki

    Deputy Center Director for Science Operations, OCD, CDER, FDA
    Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., joined the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), as Deputy Center Director for Science Operations. A nationally recognized expert in clinical research and development, Dr. Moscick... Read More →
    avatar for Tal Zaks

    Tal Zaks

    Chief Medical Officer, Moderna Therapeutics
    As chief medical officer, Dr. Tal Zaks oversees preclinical development, clinical development and regulatory affairs across Moderna and its ventures. Prior to joining Moderna, Dr. Zaks was senior vice president and head of Global Oncology at Sanofi, where he was responsible for a... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #214: Recent Trends in Asian Regulations for Drug Development: What is Coming Next?
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Needless to say, Asia is one of the most important and emerging regions in the world and its significance in global drug development is increasing. This session is aiming to give an update on the recent regulatory trends in East Asian countries. Regulatory agencies from major East Asian countries including Japan, Singapore, and Taiwan, together with the industry representation, will give an overview of the recent regulatory environment changes in each country. We will also hear about their effort to promote harmonization of regulations for drug development in this region and discuss actual examples of Asian drug development utilizing multiregional clinical trials in Asian countries.

    Learning Objectives

    Discuss the most updated regulations for drug development in each Asian country; Discuss how Asia is contributing to worldwide drug development; Describe activities in the Asian region with respect to modernization and harmonization of regulations.

    Chair

    Akio Uemura, PhD

    Speaker

    Successful Regional Collaborative Experience in Global New Drug Development: TFDA Perspective
    Chao-Yi Joyce Wang, MSc

    RecentTrend in Drug Development Regulations of China and Other Asian Countries
    Vicky (Fengyun) Han, Esq

    The Latest Japanese RegulatorySituations to Promote Drug Development and Advance Regulatory Science
    Yoshiaki Uyama, PhD



    Speakers
    avatar for Vicky (Fengyun) Han

    Vicky (Fengyun) Han

    Senior Director, Regulatory Policy Group Lead for Asia Pacific, Janssen Pharmaceutical Companies of Johnson & Johnson
    Vicky Han is Senior Director at Janssen Pharmaceuticals in charge of Asia Pacific Regulatory Policy since 2016. Her experiences spans in Asia & Europe, she dedicated 18 years in GSK, wherein 12 years in GSK China for leading regulatory affairs. In 2008, she moved to Belgium for d... Read More →
    avatar for Akio Uemura

    Akio Uemura

    Executive Director, Head of Japan Development, Allergan Japan K.K.
    1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Jap... Read More →
    avatar for Yoshiaki Uyama

    Yoshiaki Uyama

    Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
    Yoshiaki Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety m... Read More →
    avatar for Chao-Yi Wang

    Chao-Yi Wang

    Director, Division of Medicinal Products, TFDA
    Ms. Chao-Yi (Joyce) Wang was appointed as the Director of Division of Medicinal Products, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare on January 7, 2016. She is responsible for management of pharmaceutical policies and regulations, including premark... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #215: The Evolving Model of Using Artificial Intelligence to Deliver Actionable Regulatory Intelligence
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    The breadth and scope of a regulatory intelligence function is often dependent on the knowledge of its employees, the tools they can access or the consultants they employ. What if we were able to employ machine learning and cognitive computing to help deliver actionable intelligence? This session will look at evolving models for Artificial Intelligence and the challenges in developing and validating these systems.

    Join RA Community, Regulatory Intelligence Working Group for a follow up Round Table discussion at 1:00pm, Wednesday June 21st in the Community Corner.

    Learning Objectives

    Discuss artificial intelligence concepts, tools, and case studies in the development of actionable regulatory intelligence.

    Chair

    Linda F. Bowen

    Speaker

    Advances in Regulatory Intelligence Through Artificial Intelligence: Industry Perspective
    Patrick K Brady, PharmD

    Enigma Variations: The Use of Artificial Intelligence in Regulatory Decision Making
    Tom Macfarlane, RAC



    Moderators
    avatar for Linda Bowen

    Linda Bowen

    Senior Director, Global Regulatory Science and Policy, Sanofi
    Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →

    Speakers
    avatar for Linda Bowen

    Linda Bowen

    Senior Director, Global Regulatory Science and Policy, Sanofi
    Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →
    avatar for Patrick Brady

    Patrick Brady

    Regulatory Policy and Intelligence, Bayer
    Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and re... Read More →
    avatar for Tom Macfarlane

    Tom Macfarlane

    Director, Life Sciences, Accenture Accelerated R&D Services
    A Neuroscientist by training, Tom has worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also works with emergent technologies... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #216: International Collaboration in Times of Public Health Crisis
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    International collaboration amongst regulators is important from the industry aspiration that it should suffice to develop one global dossier. In the wake of the Ebola crisis, and again during the current Zika event, regulators have and are demonstrating a willingness to find new and pragmatic ways of working together with industry with the ultimate goal of providing health care solutions which are in demand by society. Are there lessons learned that can be shared and discussed? Can the envelope be pushed even further?

    Learning Objectives

    Describe the current state of cooperation amongst regulators during Public Health Emergencies; Identify the challenges faced by the stakeholders, Discuss lessons learned in addressing the challenges.

    Chair

    Ian Hudson

    Speaker

    Crisis Management in the Face of a Global Health Pandemic: How Can We Leverage International Efforts?
    Jarbas Barbosa

    Update From the FDA
    Carmen T. Maher

    Update from the EMA
    Agnès Saint-Raymond, MD



    Moderators
    avatar for Ian Hudson

    Ian Hudson

    Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)
    Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Divi... Read More →

    Speakers
    avatar for Jarbas Barbosa

    Jarbas Barbosa

    ICMRA Project Lead; Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
    Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health syste... Read More →
    avatar for Ian Hudson

    Ian Hudson

    Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)
    Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Divi... Read More →
    avatar for Carmen Maher

    Carmen Maher

    Acting Assistant Commissioner for Counterterrorism Policy, OCS, OC, FDA
    RADM Carmen Maher, MA, BSN, RN, RAC, is a nurse officer in the U.S. Public Health Service Commissioned Corps. She is an Assistant Surgeon General and Acting Assistant Commissioner for Counterterrorism Policy and Acting Director of the Office of Counterterrorism and Emerging Threa... Read More →
    avatar for Agnès Saint-Raymond

    Agnès Saint-Raymond

    Head of International Affairs (ad interim), Head of Portfolio Board, European Medicines Agency, European Union
    MD and qualified Paediatrician. Chef de Clinique in Paed. in Necker-Enfants-Malades Hospital (Paris, 1985-1990). Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medici... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #219: Safety Evaluation: Transforming Information into Evidence
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-534-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Safety evaluation is a continuous process taking place throughout the life cycle of a medical product. Safety concerns have often been the primary driver in stopping or delaying development for many drug candidates. The lack of necessary safety data can compromise the regulatory acceptance of a program or a decision on a drug reimbursement. What are the different sources of safety data? How can one gather the necessary safety information without adding too much to drug development cost and without delaying the process of taking the effective medicine to a patient? In this session, presenters will review different sources of safety data and present medical considerations and statistical strategies of looking at pre-marketing stage of drug development, post-marketing safety surveillance, and other sources of real world data, and discuss how to use the totality of information to generate evidence for regulators, payers, physicians, and patients.

    Learning Objectives

    Identify different sources of safety data; Discuss how to use the totality of information to generate evidence.

    Chair

    Olga V Marchenko, PhD, MS

    Speaker

    Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
    Richard C. Zink, PhD

    Traditional Sources of Pharmacovigilance Data and How Social Media Listening Has Been Used as a Complementary Data Source
    Lorrie Schifano, PharmD

    Transforming Data into Evidence
    Olga V Marchenko, PhD, MS



    Moderators
    avatar for Olga Marchenko

    Olga Marchenko

    Vice President, Advisory Analytics, QuintilesIMS
    Olga Marchenko is Vice President at QuintilesIMS. She is a head of Advisory Analytics at QuintilesIMS Consulting Unit. A leading expert working on adaptive designs and safety, she provides strategic leadership for design and analysis of clinical trials. Dr. Marchenko received her... Read More →

    Speakers
    avatar for Olga Marchenko

    Olga Marchenko

    Vice President, Advisory Analytics, QuintilesIMS
    Olga Marchenko is Vice President at QuintilesIMS. She is a head of Advisory Analytics at QuintilesIMS Consulting Unit. A leading expert working on adaptive designs and safety, she provides strategic leadership for design and analysis of clinical trials. Dr. Marchenko received her... Read More →
    avatar for Lorrie Schifano

    Lorrie Schifano

    Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline
    Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill... Read More →
    avatar for Richard Zink

    Richard Zink

    Principal Research Statistician Developer, JMP Life Sciences Division, SAS Institute Inc., JMP Division
    Richard C. Zink is Principal Research Statistician Developer in the JMP Life Sciences division at SAS Institute, following eight years in the pharmaceutical industry. Richard is Statistics Section Editor for "Therapeutic Innovation & Regulatory Science", and holds a PhD in Biosta... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #221: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session will provide an overview of current focus areas, trends, and hot topics of pharmacovigilance (PV) inspectors. Presenters will discuss approaches for evaluating your own organizations's PV system and proactively address opportunities for advancement.

    Join Clinical Safety & Pharmacovigilance Community for a follow up Round Tables discussion at 2:00pm in the Community Corner.

    Learning Objectives

    Describe current focus areas, trends, and hot topics of PV inspectors.

    Speaker

    MHRA Perspective
    Rory Littlebury

    Industry Perspective
    Carolyn Winter, RN



    Speakers
    MB

    Michael Bean

    Senior Director, Regulatory Compliance R&D, Janssen Pharmaceutical Companies of Johnson & Johnson
    Currently Senior Director at Janssen pharma working in Complince with previous experince as an Inspector at the MHRA and compliance funtions in various Pharma/CRO organsaitions
    RL

    Rory Littlebury

    Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
    Rory has ten years experience working at the MHRA, including working within Licensing and Pharmacovigilance Divisions prior to taking on a Pharmacovigilance Inspector role. Rory’s experience includes engagement as a regulator with a variety of stakeholders, from multi-national... Read More →
    CW

    Carolyn Winter

    Director, PV & RA Quality Assurance, AbbVie, Inc.
    Carolyn has been leading the global Pharmacovigilance (PV) Quality Assurance function at AbbVie since August 2010. In 2016, the Regulatory Affairs audit team also joined her group. Previously, Carolyn worked as Deputy Director for Vigilex Ltd, a PV consultancy, having previously... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Session

    10:30am

    #222: Serving the Patient Who Needs Early Access to Treatments and Achieving Meaningful Outcomes
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-545-L04-P; CME 1.25; IACET 1.25; RN 1.25

    As most rare diseases have no approved therapies, these patient populations are frequently desperate for any kind of treatment. As a result, they request earlier and more extensive access to investigational drugs before many of the safety and dosing questions have been addressed. This could result in erroneously high adverse event profiles or subjective benefits that skew the development program. How do we better define how to broaden access while simultaneously maintaining rigid control of the data?

    Learning Objectives

    Discuss the importance of collaboration between key stakeholders in the for profit and non-profit sectors in the development of Early Access therapeutic approaches for rare disease.

    Chair

    Stella C.F. Blackburn

    Speaker

    So Near Yet So Far: How Do We Get Early Access for Patients with Unmet Medical Needs and Life-limiting Diseases?
    Stella C.F. Blackburn

    Aligning Objectives of Drug Development and Patient Access
    Richard Scheyer, MD

    Reagan-Udall Foundation for the FDA Expanded Access Navigator
    June S. Wasser, MA



    Moderators
    avatar for Stella Blackburn

    Stella Blackburn

    Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
    Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society o... Read More →

    Speakers
    avatar for Stella Blackburn

    Stella Blackburn

    Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
    Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society o... Read More →
    avatar for Richard Scheyer

    Richard Scheyer

    Vice President, Medical Affairs, Medpace
    Dr. Richard Scheyer is VP Medical Affairs at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD f... Read More →
    avatar for June Wasser

    June Wasser

    Executive Director, Reagan-Udall Foundation For the FDA
    June Wasser is the Executive Director of the Reagan-Udall Foundation for the FDA and is responsible for building strategic relationships throughout the public-private sector with the goal of developing a portfolio of unique programs that complement and enhance the priorities and... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S505ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #223: Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol Development, and Operations Perspective
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session is planned to provide a basic overview of studies in rare diseases and how they differ from most other therapeutic areas. Brief overview of the challenges will be presented with special emphasis on statistical challenges, protocol design realities, operational changes required and recruiting perspectives.

    Learning Objectives

    Identify a better understanding of the differences in special population studies and some possible solutions.

    Chair

    William B. Smith, MD

    Speaker

    FDA Perspective
    Yeh-Fong Chen, PhD

    Industry Perspective
    Robert P. Homolka, MBA, MS

    Panelist
    Gil Price, MD



    Moderators
    avatar for William Smith

    William Smith

    President, New Orleans Center for Clinical Research
    William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →

    Speakers
    avatar for Yeh-Fong Chen

    Yeh-Fong Chen

    Mathematical Statistician, Office of Translational Sciences, CDER, FDA
    Dr. Yeh-Fong Chen is the statistical team leader supporting the Division of Gastroenterology and Inborn Errors Products at the Division of Biometrics III at US Food and Drug Association. She joined FDA in 2000 immediately after graduation with a PhD degree in Statistics from the... Read More →
    RH

    Robert Homolka

    Clinical Pharmacology Group Lead, Shire
    Mr. Robert Homolka is the Director of Clinical Pharmacology Operations at Shire. For the last 20 years, Mr. Homolka has worked at AstraZeneca followed by Shire in Clinical Pharmacology. He has participated in, managed, and/ or overseen more than 200 studies while part of Clinical... Read More →
    avatar for Gil Price

    Gil Price

    Chief Medical Officer, Propharma Group
    Over the past 25 years, Dr. Price has worked in various capacities including professional communications, clinical development, and pharmacovigilance in differing therapeutic areas including vaccines, oncology, and infectious disease. He is considered by many to be a KOL in pharm... Read More →
    avatar for William Smith

    William Smith

    President, New Orleans Center for Clinical Research
    William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S503ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #224: Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with Biomarkers
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-553-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Central nervous system (CNS) drug development is plagued with challenges. First, getting a CNS therapeutic to the appropriate pharmacodynamic compartment most often requires crossing the blood-brain-barrier for target engagement. Determining the appropriate dose, understanding PK-PD relationships and the use of predominantly subjective clinical outcome measures all contribute to the high attrition rate for CNS therapeutics. To get new therapeutics to market for this area of high unmet medical need, we can turn to biomarkers to establish target engagement, verify mechanism of action, and detect a signal of efficacy. This session will discuss the role of biomarkers in early clinical research to help de-risk drug development programs.

    Learning Objectives

    Identify how biomarkers can be used to help de-risk CNS drug development programs.

    Chair

    Bruce Morimoto, PhD

    Speaker

    Public / Private Partnerships in Alzheimer’s Biomarkers
    Keith Fargo, PhD

    Small Clinical Trials: Alternative Design and Analysis
    Michael Gold, MD



    Moderators
    avatar for Nita Ichhpurani

    Nita Ichhpurani

    Senior Director, Global Clinical Development, Celerion
    24 yrs of pharma experience. At Pharmacia, Nita was a Chemist and PM in Clinical Pharmacology in oncology and CNS research. At MDS, she managed Global Central lab teams and later become the Latin American Lab Manager. At Celerion, she managed drug development programs from discov... Read More →

    Speakers
    avatar for Keith Fargo

    Keith Fargo

    Director of Medical and Scientific Relations, Alzheimer's Association
    At the Alzheimer's Association, Dr. Fargo is responsible for coordinating the scientific programming for the Alzheimer's Association International Conference (AAIC), the largest scientific dementia conference in the world. In addition, Dr. Fargo oversees the International Society... Read More →
    MG

    Michael Gold

    Head of Neuroscience, AbbVie, Inc.
    Dr. Gold obtained his BS, MS and MD degrees from the University of Miami. He completed a residency in Neurology at the Albert Einstein College of Medicine in NYC and a fellowship in Behavioral Neurology at the University of Florida. Dr. Gold has nearly 20 years of industry experi... Read More →
    avatar for Bruce Morimoto

    Bruce Morimoto

    Vice President, Scientific Affairs, Celerion
    Bruce is the Vice President, Scientific Affairs, a key leadership position at Celerion and is directly responsible for developing and deploying scientific, regulatory and medical expertise and advice to various biotech and emerging pharmaceutical companies. Prior to joining Celer... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S504abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #225: So You Say You're an Extrovert: Being an Effective Leader when All You Really Want Is a Stage
    Component Type: Forum
    Level: Basic
    CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000202; RN 1.25

    Some might argue that extroverts make natural leaders given their love of people and engagement. But not all extroverts are effective leaders. Their need for interaction and attention can sometimes hinder their ability to allow space for others and hear the positions of their peers and direct reports. In this forum, we'll hear from individuals who have worked at overcoming being extroverted as well as introverts who have effectively collaborated with extroverts and learned how to engage others to create a collaborative, equitable environment in which a variety of personalities can thrive.

    Learning Objectives

    Describe the pros and cons of being an extroverted leader; Identify effective strategies for collaborating with both extroverts and introverts.

    Chair

    Alice Ford-Hutchinson, PhD, PMP

    Speaker

    A Path Towards High Performance Teams: Sharing the Stage as an Extroverted Leader
    Alice Ford-Hutchinson, PhD, PMP

    One Ambivert’s Tale of Two Personalities
    Cathie Snyder



    Moderators
    avatar for Alice Ford-Hutchinson

    Alice Ford-Hutchinson

    Director, Global Project and Alliance Management, Merck & Co., Inc.
    Alice Ford-Hutchinson, PhD, PMP, is currently a Director of Global Project and Alliance Management at Merck focused in Oncology. She joined Merck in 2009 where she has provided leadership as a project manager within a variety of therapeutic areas and development stages. She previ... Read More →

    Speakers
    avatar for Alice Ford-Hutchinson

    Alice Ford-Hutchinson

    Director, Global Project and Alliance Management, Merck & Co., Inc.
    Alice Ford-Hutchinson, PhD, PMP, is currently a Director of Global Project and Alliance Management at Merck focused in Oncology. She joined Merck in 2009 where she has provided leadership as a project manager within a variety of therapeutic areas and development stages. She previ... Read More →
    avatar for Cathie Snyder

    Cathie Snyder

    Senior Director, Operations, Rho, Inc.
    Cathie Snyder, Sr. Director of Operations at Rho, has 20 years of pharmaceutical industry experience. Since joining Rho in 2005, she has been responsible for all aspects of clinical research, from protocol development to manuscript submission, with primary experience in sickle ce... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S501abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • Level Basic
    • Featured Topics Career Development
    • format json
    • Featured Topics Career Development,StudentProgramming
    • Credit Type CME, IACET, PMI, RN
    • Tags Forum

    10:30am

    #226: Accelerating Drug Development Through Innovation
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000206; RN 1.25

    There has been a lot of discussion recently around accelerating drug development via innovative trial design. This can lead to shortened timelines and bringing products to patients more quickly. There are a variety of stakeholders involved in the successful execution of these innovative plans. In this session, participants will be given a case study in which they have to create a solution leveraging innovative ideas that will have been highlighted by subject matter experts.

    Learning Objectives

    Describe the application of innovative drug development methodologies.

    Chair

    John Reites

    Speaker

    5 Ways to Move Digital Health Innovation from Pilot to Platform
    John Reites

    Moving Digital Health in Clinical Trials Beyond the Concept
    Hassan Kadhim, MSc



    Moderators
    avatar for John Reites

    John Reites

    Chief Product Officer, Partner, THREAD
    Executive intrapreneur turned digital health entrepreneur, John’s career includes over 14 years leading global drug development and healthcare innovation. Named one of the Top 100 Influencers in Digital Health, John provides expertise and execution experience in digital health... Read More →

    Speakers
    HK

    Hassan Kadhim

    Business Consultant, IS BP R&DM, Boehringer Ingelheim Pharmaceuticals, Inc.
    Hassan Kadhim possesses 10+ years’ experience with informatics in the pharmaceutical / biotechnology industry. With degrees in bioinformatics and clinical drug development, he has a good mix of pharmaceutical industry, informatics and digital health experience. Hassan demonstra... Read More →
    avatar for John Reites

    John Reites

    Chief Product Officer, Partner, THREAD
    Executive intrapreneur turned digital health entrepreneur, John’s career includes over 14 years leading global drug development and healthcare innovation. Named one of the Top 100 Influencers in Digital Health, John provides expertise and execution experience in digital health... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S502ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #227: At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session will cover aspects of design, implementation, and data analysis related to wearable devices. Case studies are strongly encouraged.

    Learning Objectives

    Discuss the regulatory framework, development and validation of instruments/devices, and analysis issues; Describe examples of use in clinical trials.

    Chair

    Leonard Sacks, MD

    Speaker

    FDA Perspective
    Nikunj B. Patel, PharmD

    Industry Perspective
    Robert A. DiCicco, PharmD

    Academia Perspective
    E. Ray Dorsey, MD, MBA



    Speakers
    avatar for Robert DiCicco

    Robert DiCicco

    Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
    Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has ove... Read More →
    avatar for E. Ray Dorsey

    E. Ray Dorsey

    David M. Levy Professor of Neurology and Director of the CHET, University of Rochester Medical Center
    Dr. Dorsey is helping investigate new treatments for movement disorders and improve the way care is delivered for individuals with Parkinson disease and other neurological disorders. Using simple web-based video conferencing, he and his colleagues are seeking to provide care to i... Read More →
    avatar for Nikunj Patel

    Nikunj Patel

    Clinical Outcome Assessments Reviewer, OND, CDER, FDA
    Nikunj Patel is a clinical outcome assessment (COA) reviewer in the Office of New Drugs. Dr. Patel advises OND review divisions on COA-based endpoint development and implementation under the IND/NDA/BLA pathway. Additionally, he reviews qualification submissions under the COA typ... Read More →
    LS

    Leonard Sacks

    Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA
    Dr. Sacks is the associate director for clinical methodology in the Office of Medical Policy at FDA. He is an infectious disease doctor by training with previous clinical experience in local and foreign hospitals. Since joining FDA in 1998, he has occupied various positions, as a... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #228: Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development
    Component Type: Session
    Level: Advanced
    CE: CME 1.25; IACET 1.25; RN 1.25

    Master ("umbrella") protocols that have multiple treatment options are being used to optimize enrollment and expedite drug development based on biomarkers/specific disease traits. This session will discuss this approach and the benefits and challenges of these multi-company collaborations.

    Learning Objectives

    Describe the Umbrella concept; Discuss key considerations.

    Chair

    Theresa Crofts Ashton, PhD

    Speaker

    The Use of Statistical Innovation to Increase Efficiency in Difficult-to-Enroll Clinical Trials
    Kert Viele, PhD

    Combined Adaptive Early Phase Trials: From First-Time-in-Human to Proof of Concept in One Protocol
    Ulrike Lorch, MD, FFPM

    Beat AML: Practicalities and Lessons Learned From the Construct of a 10-Study Leukemia Umbrella Trial
    Amy Burd, PhD

    Panelist
    Nicholas Kenny, PhD



    Moderators
    avatar for Theresa Ashton

    Theresa Ashton

    Senior Director, Clinical Statistics, GlaxoSmithKline
    Teri Ashton received her PhD in Biostatistics from Medical College of Virginia and has been working in the Pharmaceutical Industry for 15 years. She has worked primarily in Oncology and Infectious Diseases, leading innovative clinical trial design discussions across all phases of... Read More →

    Speakers
    avatar for Theresa Ashton

    Theresa Ashton

    Senior Director, Clinical Statistics, GlaxoSmithKline
    Teri Ashton received her PhD in Biostatistics from Medical College of Virginia and has been working in the Pharmaceutical Industry for 15 years. She has worked primarily in Oncology and Infectious Diseases, leading innovative clinical trial design discussions across all phases of... Read More →
    AB

    Amy Burd

    Vice President, Research Strategy, Leukemia & Lymphoma Society
    Amy Burd, Ph.D., is vice president of research strategy for The Leukemia & Lymphoma Society. Dr. Burd first began working with LLS in 2009 as senior director of LLS’s Therapy Acceleration Program. In her current role, Dr. Burd provides strategic planning and oversight for missi... Read More →
    avatar for Nicholas Kenny

    Nicholas Kenny

    Executive Vice President, Oncology and Hematology, INC Research
    Dr Nick Kenny leads the Oncology division (~900 oncology clinical research professionals) at INC Research, a full service global CRO headquartered in Raleigh NC, USA. Nick has over 25 years of basic and clinical research and development experience. His immediate past twelve years... Read More →
    avatar for Ulrike Lorch

    Ulrike Lorch

    Medical Director, Richmond Pharmacology Ltd.
    Dr Lorch is Medical Director of Richmond Pharmacology in London (UK). She is a Fellow of the Royal College of Anaesthetists and a Fellow of the Faculty of Pharmaceutical Medicine, holding its specialist accreditation. She has special expertise in early phase integrated, adaptive... Read More →
    KV

    Kert Viele

    Director and Senior Statistical Scientist, Berry Consultants
    Kert Viele is a Director and Senior Statistical Scientist with Berry Consultants, specializing in the design of Bayesian and adaptive clinical trials. He joined Berry Consultants in 2010 after serving as a faculty member in Statistics at the University of Kentucky. He is a former... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #229: Outcomes Standardization: An Imperative to Value Assessments
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Data from both premarket and postmarketing clinical trials and formal registries of medical products can be used to assess safety and effectiveness across the medical product life cycle. Sources outside of clinical trials, such as EHRs, can provide evidence of continued effectiveness when used in larger populations in the postmarketing setting. However, the lack of consistent outcome assessments is a potential barrier to evaluating safety and efficacy across the continuum of the product life cycle.

    Learning Objectives

    Discuss the gaps and challenges in the current environment resulting from a lack of outcomes standardization.

    Chair

    Richard Gliklich, MD

    Speaker

    Standardizing Outcomes for Patient Registries: Early Results From the Outcome Measures Framework Pilot Test
    Elise Berliner, PhD

    Panelist
    Paul Stang, PhD, FISPE

    Panelist
    John H. Powers, III, MD, FACP



    Moderators
    avatar for Richard Gliklich

    Richard Gliklich

    Chief Executive Officer, OM1
    Dr. Richard Gliklich is the CEO of OM1, Inc., a company focused on outcomes measurement and personalization of big data for health care. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale University... Read More →

    Speakers
    EB

    Elise Berliner

    Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
    Elise Berliner, Ph.D., is the Director of the Technology Assessment Program at AHRQ which provides technology assessments to Medicare to inform coverage decisions and other policy issues. Prior to joining AHRQ, Dr. Berliner worked as a consultant on cost-effectiveness and outcome... Read More →
    avatar for Richard Gliklich

    Richard Gliklich

    Chief Executive Officer, OM1
    Dr. Richard Gliklich is the CEO of OM1, Inc., a company focused on outcomes measurement and personalization of big data for health care. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale University... Read More →
    avatar for John Powers

    John Powers

    Professor of Clinical Medicine, George Washington University School of Medicine
    Dr. Powers is a physician/investigator and an internist and specialist in infectious diseases. Dr Powers has particular expertise in the design, conduct and analysis of clinical trials and has published numerous articles and book chapters in this area.
    avatar for Paul Stang

    Paul Stang

    Vice President: Global Epidemiology, Janssen Research & Development, LLC
    Currently VP Global Epidemiology at J&J; formerly VP Cerner Corporation, which he joined after co-founding and serving as CSO Galt Associates. Worked at Glaxo and SmithKline Beecham as well as clinical appointments in Neurology and Neurosurgery. Published widely in epidemiology wit... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    N426c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    10:30am

    #230: Global Harmonization: Mutual Recognition
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Despite efforts to harmonize regulatory requirements, the proliferation of divergent expectations continues to unnecessarily complicate management of product supply chains. While divergent regulatory requirements are largely the result of local economic drivers, the impact on regulatory approvals, inspections, change management and inventory limits continuous improvement and optimization of manufacturing and is ultimately challenging for industry and regulatory authorities globally.

    Learning Objectives

    Discuss the challenges of global harmonization on the management of the product supply chain

    Chair

    Roger Nosal

    Speaker

    EU-FDA Mutual Recognition Agreement for GMP Inspections
    Niraj Mehta, PhD

    Industry Perspective
    Chi-Wan Chen, PhD

    Postapproval Change Management Protocols: Future Opportunities
    Terrance Ocheltree



    Speakers
    CC

    Chi-Wan Chen

    Executive Director, Global CMC, Pfizer Inc.
    Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on Asia Pacific. She has made numerous presentations on regulatory and CMC in or on AP. Prior to joining Pfizer in 2008, She had served in US FDA for over... Read More →
    avatar for Niraj Mehta

    Niraj Mehta

    Associate Director for Global Regulatory Policy, GO, OC, FDA
    Niraj Mehta, Ph.D., is the Associate Director for Global Regulatory Policy in the Office of Global Regulatory Operations and Policy at the U.S. Food and Drug Administration. Dr. Mehta was a key member of team that negotiated the amended Pharmaceutical Annex to the 1998 US-EU Mutu... Read More →
    avatar for Roger Nosal

    Roger Nosal

    Vice President and Head, Global CMC, Pfizer Inc.
    Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical c... Read More →
    avatar for Terrance Ocheltree

    Terrance Ocheltree

    Senior Director Regulatory Policy and Intelligence, AbbVie, Inc.
    Terry is a Sr. Director in Regulatory Policy and Intelligence at AbbVie. He has a BA in Business and BS in Pharmacy, a PhD in Pharmaceutics. Having worked in retail and hospital pharmacy prior to joining the industry, Terry has over 30 years of pharmacy and pharmaceutical experie... Read More →


    Tuesday June 20, 2017 10:30am - 11:45am
    S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Session

    10:45am

    #232: Healthy CRO/Sponsor Relations: “Sole” Mate or Flavor of the Month
    Component Type: Session
    Level: Intermediate

    This interactive session will analyze a CRO/sponsor relationship that has been in effect for many years. In groups, participants will discuss the strengths and weaknesses of this case study and what might be their “Secret Sauce” and/or if people or process have allowed them to continue as partners for many years. As participants reflect on their analysis of the case study they will compare with their own experiences and determine what is the recipe for a healthy long lasting CRO/Sponsor relationship. The groups will then reveal their findings to all participants for feedback, discussion, and/or actions they may take to their organizations.

    Learning Objectives

    Describe the common pitfalls of CRO/Sponsor relations; Identify various strategies and best practices for maintaining healthy and long lasting CRO/Sponsor relationships.

    Chair

    David Burnham

    Speaker

    Facilitator
    Sondra Smyrnios, MSc



    Speakers
    avatar for David Burnham

    David Burnham

    Senior Vice President Strategic Alliance, INC Research
    David Burnham serves as Vice President, Strategic Alliances at INC Research, where he is responsible for developing and nurturing relationships between customers and the CRO. Throughout his 20 years in the industry running programs from IND to product approval he understands that... Read More →
    avatar for Sondra Smyrnios

    Sondra Smyrnios

    Vice President, Clinical Development Operations, Alkermes


    Tuesday June 20, 2017 10:45am - 11:45am
    Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    11:30am

    Luncheon
    Exhibit Hall

    Tuesday June 20, 2017 11:30am - 2:00pm
    TBA

    12:00pm

    #234: QuintilesIMS Innovation Theater: Changing Trials Through Analytics: How it Works
    Component Type: Session
    Level: Intermediate

    What is the difference between traditional clinical development and the next generation approach? This session shows how real-world insights replace assumptions to bring new levels of precision and predictability to your trials. Case studies show how data is used to pinpoint specific patient populations and speed timelines.

    Chair

    QuintilesIMS


    Tuesday June 20, 2017 12:00pm - 12:45pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:00pm

    #235: Amplexor Innovation Theater: Reduce Complexity – Increase Compliance – Decrease TCO’s: Regulatory Vendor Promises - Innovations or Buzzwords?
    Component Type: Session

    The magic of Multitenancy. Continuous Publishing. Bringing the industry to the Cloud. Single source of Truth. Artificial Intelligence. Next Generation of RIM. Integral by design. This session will discuss the dependency between Complexity and Compliance and their correlation to known software and service vendor promises.

    Chair

    AMPLEXOR


    Tuesday June 20, 2017 12:00pm - 12:45pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:00pm

    DIA Communities Luncheon
    Component Type: Session

    Join DIA Communities for the Annual Communities Luncheon. Open to all DIA Community members and interested attendees. Your opportunity to meet and network with fellow Community members at the Community Luncheon. Not a member? Take this exciting opportunity to learn more about DIA’s Communities and new ways to volunteer at the Community Luncheon.

    Chair

    Tshaka Cunningham, PhD


    Speakers
    TC

    Tshaka Cunningham

    Associate Director, Scientific Collaboration, DIA


    Tuesday June 20, 2017 12:00pm - 1:00pm
    N427bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:00pm

    #236: Professional Poster Session and Oral Presentions 2B
    Component Type: Poster Presentation

    Oral presentations of select abstracts will occur from 12:00 – 1:45 pm. Poster presenters will also be available at their assigned poster boards to answer questions.  






    Tuesday June 20, 2017 12:00pm - 1:45pm
    Exh Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:45pm

    PowerUp!
    Component Type: Session

    Hear from your fellow attendees as they share their personal and professional stories of how they used their insights to drive action in their field of work.

    Chair

    Larry A. Blankstein, PhD

    Speaker

    Mixing Science, Policy, and Politics Without Getting Sick
    Sudip Parikh, PhD

    Continuous Improvement
    Angela van der Salm, DrSc, PhD

    Smart(er) Choices
    Nancy Pire Smerkanich, DrSc, MS

    Grumpy Butt
    Kimberly Belsky, MS

    Why it is Worth it to Look Beyond Your own Back Yard
    Holger G. Adelmann



    Speakers
    avatar for Holger Adelmann

    Holger Adelmann

    Senior Vice President and Managing Director, DIA EMEA
    Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Ass... Read More →
    avatar for Kimberly Belsky

    Kimberly Belsky

    Senior Director, Regulatory Affairs, Regulatory Intelligence, Mallinckrodt Pharmaceuticals
    Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceutica... Read More →
    avatar for Larry Blankstein

    Larry Blankstein

    Consultant, Clinical Development, Blankstein Consulting Group
    Dr. Larry Blankstein is an independent Senior Consultant to the Pharmaceutical and Biotechnology industry. He has over 22 years' experience in drug development strategy, clinical operations and mergers and acquisitions. He received his Ph.D. degree in Biology from Wesleyan Univer... Read More →
    avatar for Sudip Parikh

    Sudip Parikh

    Senior Vice President and Managing Director, DIA Americas, DIA
    avatar for Angela van der Salm

    Angela van der Salm

    Director Pharmacovigilance, DADA Consultancy
    PhD education level with accompanying communication skills, 10 years of experience in PV and 6 years of experience functioning as a QPPV, underwent and conducted 20 audits; fluid intelligence, quick thinking, helicopter view and focus for ensuring actions are set out and conducte... Read More →
    avatar for Nancy Smerkanich

    Nancy Smerkanich

    Assistant Professor, Clinical Pharmacy; Educational Liaison & Instructor, ICRS, University of Southern California
    Dr. Smerkanich recently completed her doctorate in Regulatory Science on the Implementation of Benefit-Risk Frameworks in Industry. She leads the clinical regulatory courses while continuing to provide regulatory guidance to her academic and industry peers. In her new role at USC... Read More →


    Tuesday June 20, 2017 12:45pm - 1:30pm
    N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    12:45pm

    #237: Strategies for Communicating with FDA
    Component Type: Session
    Level: Intermediate

    Do you ever wonder how your peers manage their interactions with FDA?  Do you wonder why your peers get a response when you do not?  What challenges, and what successes, have you had?  Join us for an interactive session to discuss best practices and strategies for communicating with FDA.  You will work in groups to evaluate a communication scenario, develop a set of options for your approach to communicating, and develop strategies, best practices, tips, etc. based on your experience and general knowledge.  This is not an overview of meeting types or timelines; this is an opportunity to brainstorm ideas and share strategic best practices around communication.

    Learning Objectives

    Explore various strategies for communication with FDA; Discover best practices for communication from your peers.

    Chair

    Leah Christl, PhD

    Speaker

    Session Co-Chair
    Kim M. Quaintance-Lunn



    Speakers
    avatar for Leah Christl

    Leah Christl

    Associate Director for Therapeutic Biologics, TBBS, OND, CDER, FDA
    Dr. Christl is the Associate Director for Therapeutic Biologics in the Office of New Drugs at FDA, leading the Therapeutic Biologics and Biosimilars Staff (TBBS) in OND. TBBS ensures consistency in the scientific and regulatory approach regarding development programs for proposed... Read More →
    avatar for Kim Quaintance-Lunn

    Kim Quaintance-Lunn

    Vice President and Head, US Regulatory Policy, Bayer
    Kim Quaintance-Lunn serves as the Vice President and Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the develop... Read More →


    Tuesday June 20, 2017 12:45pm - 1:45pm
    Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:00pm

    #238: Veeva Systems, Inc. Innovation Theater: Tomorrow's Clinical Trial, Powered by Modern EDC
    Component Type: Session

    What does it look like to run clinical trials in a world where study builds take weeks, not months? Where there’s no downtime when executing amendments. And no need to manually transcribe data. While the scientific landscape has transformed over the past decade, EDC has been left behind. Today, there’s a new way of executing trials that simplifies the complexity, while enabling better clinical development.

    Join us to learn what’s next for EDC.

    Chair

    Veeva Systems, Inc.


    Speakers
    DG

    Drew Garty

    Product Management, Vault EDC, Veeva
    As a leader of Veeva Systems’s expanded clinical data management solutions, Drew is passionate about developing and implementing technology solutions to solve the life sciences industry’s greatest challenges. His focus is on building Veeva Vault EDC and Veeva Vault eSource ap... Read More →
    VS

    Veeva Systems, Inc.

    NA
    Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →
    RY

    Richard Young

    Vice President, Veeva Systems
    As vice president for Veeva Vault EDC, Richard is responsible for establishing Veeva Vault EDC as the best in class solution for all data acquisition, management and reporting purposes. With almost 25 years of experience in life sciences, Richard is known for his executive vision... Read More →


    Tuesday June 20, 2017 1:00pm - 1:45pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:00pm

    #239A: BioClinica Innovation Theater: Case Studies: How Companies Are Finally Reaping the Benefits of Risk-Based Monitoring.
    Component Type: Session

    Bioclinica will demonstrate how companies are beginning to reap the promised benefits of risk-based monitoring by implementing a holistic, cloud-based technology solution that encompasses and manages clinical and operational trial risk. This unique quality management software allows organizes organizations to easily leverage existing trial data, systems, and processes using machine learning and advanced statistical algorithms to predict, identify, and correct risk throughout the trial lifecycle – delivering improved patient safety, data quality, and resourcing.

    Chair

    BioClinica


    Speakers

    Tuesday June 20, 2017 1:00pm - 1:45pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:00pm

    DIA Patient Engagement Community Round Table Discussion: Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What Have We Learned?
    Component Type: Session

    Join DIA PE Community for a round table discussion tied to session #212 Walking the Walk in the Patient Focused Medicines Development: From Theory to Practice What Have We Learned? (Tuesday, June 20th)

    Chair

    Mary Stober Murray, MBA


    Speakers
    avatar for Mary Murray

    Mary Murray

    Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb
    Mary Stober Murray is responsible for establishing industry - advocacy collaborations to introduce patient-inspired changes that differentiate clinical research and ultimately the therapies available to protect or restore patients’ health.


    Tuesday June 20, 2017 1:00pm - 1:45pm
    Community Corner McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:15pm

    #239B: Strategies for Managing Difficult Stakeholders
    Component Type: Session

    The ability to flex one’s style or approach to work with a variety of stakeholders or to find solutions to new problems continues to be a key capability for career success. Building off of the Tuesday session on leading as an extrovert, members of the PM Community will discuss and take questions on different strategies and styles they have found successful in managing difficult stakeholders on the job.

    Chair

    Leigh Shultz, PhD


    Speakers
    avatar for Karla Childers

    Karla Childers

    Senior Director, Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson
    Karla Childers is a Senior Director of Strategic Projects in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibilities are the Clinical Trial Data Transparency Initiative and the Johnson & Johnson Bioethics Committee.
    avatar for Alice Ford-Hutchinson

    Alice Ford-Hutchinson

    Director, Global Project and Alliance Management, Merck & Co., Inc.
    Alice Ford-Hutchinson, PhD, PMP, is currently a Director of Global Project and Alliance Management at Merck focused in Oncology. She joined Merck in 2009 where she has provided leadership as a project manager within a variety of therapeutic areas and development stages. She previ... Read More →
    avatar for Nita Ichhpurani

    Nita Ichhpurani

    Senior Director, Global Clinical Development, Celerion
    24 yrs of pharma experience. At Pharmacia, Nita was a Chemist and PM in Clinical Pharmacology in oncology and CNS research. At MDS, she managed Global Central lab teams and later become the Latin American Lab Manager. At Celerion, she managed drug development programs from discov... Read More →
    avatar for Leigh Shultz

    Leigh Shultz

    Associate Vice President, Project Management, Merck & Co., Inc.
    Global R&D Project Management at Merck: Associate Vice President for Primary Care, ID, and Vaccines. PhD in chemistry; started at Merck in 2001 as a chemist in Pharm R&D. Joined Project Management in 2004; PMP-certified in 2007.
    avatar for Elizabeth Somers

    Elizabeth Somers

    Director of Project Management, Global Project and Alliance Management, Merck & Co., Inc.
    Liz is a Director of Project Management in the Global Project and Alliance Management group at Merck. She manages a group focused on Discovery collaborations which leverages her experience managing complex cross functional drug development programs and her extensive experience as... Read More →


    Tuesday June 20, 2017 1:15pm - 1:45pm
    S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    1:30pm

    Exhibit Guest Passes
    Present your business card at the Exhibitor registration desk

    Tuesday June 20, 2017 1:30pm - 3:30pm
    TBA

    2:00pm

    #243: Data and Privacy Protection
    Component Type: Session
    Level: Intermediate
    CE: CME 1.00; IACET 1.00; RN 1.00

    In 2018, EU General Data Privacy Requirements (GDPR) will extend scope of EU data protection law to all foreign companies processing data of EU residents. For pharma companies, CROs, and others involved in the clinical development process, violations of the new regulation can result in fines up to $10 million Euros or 2% of the organization's worldwide revenue. The US and the EU have entered into a vexed relationship regarding data protection and privacy, Privacy Shield. The panel will discuss current privacy regulations in the US and how the GDPR relates to US privacy initiatives, including HIPAA and ONC regulations and proposed legislation in the US Congress.

    Learning Objectives

    Discuss EU GDPR; Describe the US government privacy and data protection requirements; Discuss issues related to these two frameworks for protecting PII.

    Chair

    Peter S. Alterman, PhD

    Speaker

    The €10 Million Penalty: Are You Ready for EU's New PII Regulation?
    Peter S. Alterman, PhD

    Data Protections, Data Directives, and Clinical Trial Data: How Can I Collect and Use My Global Clinical Trial Data?
    Jonathan Andrus, MS

    Emerging Technologies Coupled With the Ever Increasing Globalization of Data and Information Demand New Ways to Discuss and Protect Personal Information
    Debra N. Diener, JD, MA



    Speakers
    avatar for Peter Alterman

    Peter Alterman

    Chief Operating Officer, SAFE-BioPharma Association
    Dr. Alterman serves on numerous government and industry electronic identity management committees and workgroups. Peter has received numerous government and private sector awards for leadership in federated identity management.
    avatar for Jonathan Andrus

    Jonathan Andrus

    Chief Operations & Data Officer, Clinical Ink
    As Chief Operating Officer, Jonathan Andrus leads Clinical Ink’s global data management and quality & compliance teams to help drug sponsors better leverage eSource data. With 20+ years of experience, Mr. Andrus brings extensive expertise developing eClinical services that inte... Read More →
    avatar for Debra Diener

    Debra Diener

    Consultant, Privacy and Identity Management
    Over 30 years in senior managerial, legal, policy and legislative positions in all three branches of the Federal Government. Served as the Senior Advisor and Director of Privacy Policy for the Dept of Homeland Security; served on US delegations to international bodies including t... Read More →


    Tuesday June 20, 2017 2:00pm - 3:00pm
    N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #260: Comparative Effectiveness: State of the Art and Stakeholder Perspectives
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-17-510-L04-P; CME 1.00; IACET 1.00; RN 1.00

    In this session, we will think through the designs and endpoints for comparative effectiveness and safety. This work is typically performed by NIH and PCORI in the US but has been proposed to CDER and CBER.

    Learning Objectives

    Review key areas where multiple stakeholders are converging around real world evidence for effectiveness, safety and value; Discuss the importance of patient-relevant endpoints in effectiveness and safety from PCORI's perspective; Describe how changing regulations may impact health technology assessment.

    Chair

    Robert W DuBois, MD, PhD

    Speaker

    Mind the ‘Efficacy-Effectiveness’ Gap: Will Changes in Regulations on Real-World Research Revolutionize Health Technology Assessment?
    David Thompson, PhD

    Update From PCORI
    Jean Slutsky, MPH



    Moderators
    avatar for Robert DuBois

    Robert DuBois

    Executive Vice President and Chief Science Officer, National Pharmaceutical Council
    Robert W. Dubois, MD, PhD, is the chief science officer and executive vice president of the National Pharmaceutical Council (NPC). Dr. Dubois, who is board certified in internal medicine, brings more than 25 years of experience in health care research. Dr. Dubois received his AB... Read More →

    Speakers
    avatar for Robert DuBois

    Robert DuBois

    Executive Vice President and Chief Science Officer, National Pharmaceutical Council
    Robert W. Dubois, MD, PhD, is the chief science officer and executive vice president of the National Pharmaceutical Council (NPC). Dr. Dubois, who is board certified in internal medicine, brings more than 25 years of experience in health care research. Dr. Dubois received his AB... Read More →
    avatar for Jean Slutsky

    Jean Slutsky

    Chief Engagement and Dissemination Officer, Patient-Centered Outcomes Research Institute (PCORI)
    Jean Slutsky is PCORI’s Chief Engagement and Dissemination Officer leading engagement activities and dissemination and implementation efforts. Before joining PCORI, Slutsky directed the Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality, where sh... Read More →
    avatar for David Thompson

    David Thompson

    Senior Vice President, Real World Evidence Consulting, Inventiv Health
    David Thompson, PhD is Senior Vice President, Real World Evidence & Insights, for InVentiv Health. Dr. Thompson is a health economist with 25+ years of experience in the real-world research arena. Prior to joining inVentiv Health, he held leadership positions at Quintiles (2012-2... Read More →


    Tuesday June 20, 2017 2:00pm - 3:00pm
    S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #263: Mergers and Acquisitions: Due Diligence Considerations
    Component Type: Session
    Level: Intermediate

    Mergers and acquisitions (M&A) are increasingly common in our industry. The due diligence (DD) necessary to drive the best course of action requires careful planning and forethought by key stakeholders. In this session, we will walk through an M&A scenario to brainstorm on pivotal questions to ask in pursuit of the go/no-go decision. Participants will actively engage in group brainstorming to synthesize key DD questions in finance, operations, commercial, legal, HR, IT, facilities, and other corporate functions, and will be provided with key considerations to take back to their workplace.

    Learning Objectives

    Define due diligence (DD) in an M&A and describe what due diligence includes; Construct key questions to ask in the DD process to inform go/no-go decisions.

    Chair

    Donny Chen, MBA


    Speakers
    avatar for Donny Chen

    Donny Chen

    Senior Director, Medical Affairs Research Operations, PPD
    Donny Chen, senior director of medical affairs research operations at PPD, has spent the last 18 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen gra... Read More →


    Tuesday June 20, 2017 2:00pm - 3:00pm
    Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches
    Component Type: Session

    Join DIA CSP Community for a round table discussion tied to session #221 Pharmacovigilance Inspections: Hot Topics and Proactive Approaches (Tuesday, June 20th)

    Chair

    Catherine Baldridge, MS


    Speakers
    avatar for Catherine Baldridge

    Catherine Baldridge

    Clinical Safety and Pharmacovigilance, PV Compliance, Indivior


    Tuesday June 20, 2017 2:00pm - 3:00pm
    Community Corner McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #240: Mobile Health: Participatory Research
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This forum will discuss the use of social media, crowdsourced research, personal health records, and commercial genomics.

    Learning Objectives

    Discuss the use of mobile health and social media to increase Participatory Health Research (PHR) and other innovative approaches to data collection, analysis, and use.

    Chair

    Wayne Amchin, MA, MPA, RAC

    Speaker

    FDA in the Mobile App Space: It's not your Flip-phone FDA Anymore!
    Wayne Amchin, MA, MPA, RAC

    Conducting Clinical Trials in Digital Health: What Could Go Possibly Wrong?
    Mintu P Turakhia, MD, MS

    Digital in the Age of People-Centered Research: An Industry Perspective
    Craig H. Lipset, MBA



    Speakers
    avatar for Wayne Amchin

    Wayne Amchin

    Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER, FDA
    Wayne manages the pulmonary arterial hypertension (PAH) portfolio, which includes many drug-device combination products, along with other therapeutic areas. He is the winner of the FDA’s Innovation Lab 1st Prototype Challenge for Mobile Apps, and he is developing the first mobi... Read More →
    avatar for Craig Lipset

    Craig Lipset

    Head of Clinical Innovation, Global Product Development, Pfizer Inc.
    Craig’s is responsible for impacting clinical research through digital tools, patient engagement, and novel collaborations. He serves on the Board for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, the Operations Committee for TransCelerate... Read More →
    avatar for Mintu Turakhia

    Mintu Turakhia

    Senior Director, Center for Digital Health; Chief of EP, Palo Alto VA, Stanford University
    Mintu Turakhia M.D. M.A.S. is a cardiac electrophysiologist, outcomes researcher, and Associate Professor of Medicine at Stanford University. He is Director of Cardiac Electrophysiology at the VA Palo Alto Health Care System and Senior Director of the Stanford Center for Digital... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    N426c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #241: FDA Session: Electronic Submissions and Data
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Study Data Standards are required in clinical and nonclinical studies that start after December 17, 2016. Technical rejection criteria will be added to the existing eCTD validation criteria to enforce the deadlines. This session will provide an update on these topics and others focused on eCTD and standardized study data.

    Learning Objectives

    Discuss the status of electronic submissions, standardized data requirements, and data validation at FDA.

    Chair

    Ron D. Fitzmartin, PhD, MBA

    Speaker

    Moving Forward: Statistical Review of CDISC ADaM Standardized Data at CDER
    Weiya Zhang, PhD

    Results from the CDISC-SEND Fit for Use Pilot: A Structured Assessment of Nonclinical Pilot Submissions to FDA
    Elaine Thompson, PhD

    CDER Perspective
    Colleen Ratliffe, MS, PMP

    CBER Perspective
    Virginia Hussong



    Speakers
    avatar for Ron Fitzmartin

    Ron Fitzmartin

    Senior Advisor, Office of Strategic Programs, CDER, FDA
    Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at D... Read More →
    avatar for Virginia Hussong

    Virginia Hussong

    Data Standards Program Manager, OD, BSS, CBER, FDA
    Virginia Hussong is Program Manager for Data Standards in the Center for Biologics Evaluation and Research, U.S. FDA, and has been with FDA for 13 years, overseeing implementation of data standards and electronic submissions. Her current focus is data standards strategy, developm... Read More →
    avatar for Colleen Ratliffe

    Colleen Ratliffe

    Project Management Officer, Office of Strategic Programs, CDER, FDA
    Colleen Ratliffe is a project management officer on the Data Standards team within the Office of Strategic Programs, CDER. The data standards team’s core functions include coordinating and leading projects that support and promote the development of data standards and policy an... Read More →
    avatar for Elaine Thompson

    Elaine Thompson

    Senior Staff Fellow, OTS, OCS, CDER, FDA
    Dr. Thompson is focused on enhancing FDA review of nonclinical CDISC-SEND submissions by expanding and improving the SEND standard with CDISC and PhUSE, leading the KickStart reviewer service, and developing software to visualize SEND data. Before joining CDER, she completed a FD... Read More →
    WZ

    Weiya Zhang

    Mathematical Statistician, OB, Office of Translational Science, CDER, FDA
    Weiya Zhang received her Ph.D. in Statistics from the University of Illinois at Chicago in 2007. She joint US Food and Drug Administration (FDA) in 2014 working as a Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research (CDER). Before that... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #242: Big Data: Current and Emerging Technologies
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session will cover scalable and expandable big data infrastructures; cloud, outsourcing, and remote monitoring.

    Learning Objectives

    Discuss how big data and new technology can be used to enhance patient experience, manage outcomes, and enhance research.

    Chair

    David Kiger

    Speaker

    Obtaining Better Outcomes with Unstructured/Structured Data; How to Improve Clinical, Regulatory, and Commercial Convergence
    David Kiger

    Generating Meaningful Clinical Evidence from Electronic Health Record Data: Oncology as a Case Study
    Amy Abernethy, MD, PhD

    Shouldn’t Patient Registries Be Attractive to Patients? Implementing Thoughtful Technology for Richer Data
    Mildred Menos, MA



    Moderators
    avatar for David Kiger

    David Kiger

    Vice President, Product Strategy, PAREXEL
    David is currently VP Product Strategy and Marketing Business Partner at PAREXEL International. He defines GTM (Go-To-Market) approaches and launches for company in the areas of patient, clinical, and regulatory technologies. David lives in the San Francisco Bay Area and brings a... Read More →

    Speakers
    avatar for Amy Abernethy

    Amy Abernethy

    Chief Medical Officer and Senior Vice President Oncology, Flatiron Health
    Amy P. Abernethy, MD PhD is the Chief Medical Officer and Chief Scientific Officer at Flatiron Health, a healthcare technology company focused on organizing the world's cancer data and making it actionable for providers, patients, researchers and life sciences. She is a hematolog... Read More →
    avatar for David Kiger

    David Kiger

    Vice President, Product Strategy, PAREXEL
    David is currently VP Product Strategy and Marketing Business Partner at PAREXEL International. He defines GTM (Go-To-Market) approaches and launches for company in the areas of patient, clinical, and regulatory technologies. David lives in the San Francisco Bay Area and brings a... Read More →
    avatar for Mildred Menos

    Mildred Menos

    Director of Project Management, The Life Raft Group
    Mildred has been with the Life Raft Group- a patient organization devoted to a rare cancer, Gastrointestinal Stromal Tumor (GIST)- since 2014. In her current role as Director of Project Management, she is overseeing the development and roll out of the organization’s new health da... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #244: New Trial Design Approaches: Including New Endpoints
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Can better endpoint structures be developed that capture disease status and medical product performance, yet still allow interpretability? Can we employ trial designs that are not ‘one size fits all’ and generate better data more efficiently?

    Learning Objectives

    Discuss how the clinical trial enterprise may be enhanced with novel designs.

    Chair

    John Reites

    Speaker

    Happy 2nd Birthday ResearchKit: New Opportunities and Limitations Using ResearchKit in Your Mobile Health Studies
    John Reites

    Digital Biomarkers From Real World Mobile Sensor Data in Clinical Trials: How Relevant are They?
    Christian Gossens

    Generating Novel Endpoints Through Mobile Technology: A Promising and Realistic New Approach to Trial Design
    Robert A. DiCicco, PharmD



    Moderators
    avatar for John Reites

    John Reites

    Chief Product Officer, Partner, THREAD
    Executive intrapreneur turned digital health entrepreneur, John’s career includes over 14 years leading global drug development and healthcare innovation. Named one of the Top 100 Influencers in Digital Health, John provides expertise and execution experience in digital health... Read More →

    Speakers
    avatar for Robert DiCicco

    Robert DiCicco

    Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
    Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has ove... Read More →
    avatar for Christian Gossens

    Christian Gossens

    Global Head, Early Development Workflows, F. Hoffmann-La Roche Ltd.
    Christian is leading the Early Development Workflow team in Roche’s Research and Early Development Informatics (pREDi) organization. He is driving technology innovation into clinical trials - focusing currently on the adoption of mobile sensors for digital biomarker development... Read More →
    avatar for John Reites

    John Reites

    Chief Product Officer, Partner, THREAD
    Executive intrapreneur turned digital health entrepreneur, John’s career includes over 14 years leading global drug development and healthcare innovation. Named one of the Top 100 Influencers in Digital Health, John provides expertise and execution experience in digital health... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S501abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #245: Leveraging Wearables and Sensors in Clinical Trials: Case Studies
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Due to the increased miniaturization of sensors and circuitry, the health and wellness industry is seeing rapid proliferation in the number and diversity of wearables and sensors to provide personal wellness applications. This provides opportunity to collect greater and richer data during clinical trials and post-marketing studies, and also to develop beyond the pill strategies to support launching or marketing products.

    This session explores the impact of wearables and sensors on clinical trial conduct and participation. We also consider how to ensure the validity and acceptability of health outcomes that are derived from wearables data. Finally, we consider how pharma is levering wearables and sensors to deliver beyond the pill strategies to support patients and physicians in the effective use of their treatments.

    Learning Objectives

    Describe the impact of wearables and sensors on clinical trial conduct and participation; Identify how pharma is leveraging wearables; Discuss the importance of validity and acceptability of the data from wearables.

    Chair

    Michael Phinney, MBA

    Speaker

    How Can Wearables Improve Patient Care and Enhance Research in Autoimmune Diseases?
    Michael Phinney, MBA

    Mobile Accelerometry in Clinical Trials: Towards Regulatory Decision Making
    Martin Daumer, PhD

    Novel Technology for Continuous Arrhythmia Monitoring: The Role in Assessing CV Arrhythmic Safety
    Richard Clark



    Moderators
    avatar for Michael Phinney

    Michael Phinney

    Engagement Leader, QuintilesIMS
    Michael has dedicated the last twelve years of his professional life to improving clients’ probability of success. As a consulting business partner, Michael has worked with various departments of major biopharmaceutical companies providing strategic and transformational solutio... Read More →

    Speakers
    avatar for Richard Clark

    Richard Clark

    Consultant, Clark Life Science Consulting LLC
    Richard Clark worked for Medtronic as Sr. Director of Business Development. He has 25+ years’ experience in biopharma and medical device industry. In his role at Medtronic Richard collaborated to integrate novel arrhythmia monitoring technology into clinical research and co-aut... Read More →
    avatar for Martin Daumer

    Martin Daumer

    Scientific Director, Sylvia Lawry Centre For Multiple Sclerosis Research - The Human Motion Institute
    Dr Martin Daumer: Director of the SLCMSR e.v. - The Human Motion Institute in Munich and managing director of the IT company, Trium Analysis Online GmbH. He is also visiting lecturer for Telemedicine and Clinical Applications of Computational Medicine at the Technical University... Read More →
    avatar for Michael Phinney

    Michael Phinney

    Engagement Leader, QuintilesIMS
    Michael has dedicated the last twelve years of his professional life to improving clients’ probability of success. As a consulting business partner, Michael has worked with various departments of major biopharmaceutical companies providing strategic and transformational solutio... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S502ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #246: Medical Information and the Patient: Effective Communication and Handling of Requests
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-516-L04-P; CME 1.25; IACET 1.25; RN 1.25

    This session will share ideas for how to better engage patients who contact us for medical information, including information that is outside the product label. We will explore the rules and regulations surrounding the provision of “consistent-with” label information to consumers and review the global patient demand for medical information and novel approaches or new methods for engaging patients. The session will feature how one company has been engaging patients in Latin America via phone, email, and various apps as well as another company's experience with creating and fulfilling patient questions with standard documents that were developed specifically for them – the information used, the approval process, and the feedback that has been provided regarding such documents.

    Learning Objectives

    Discuss ways to better meet patient medical information needs; Define off label; Recognize gaps in using the product label to determine appropriateness of content to be disseminated; Identify methods to bridge the gaps to optimize the customer experience; List some key considerations around providing written medical information responses to patients and caregivers.

    Chair

    Sara Doshi, PharmD

    Speaker

    Engaging Patients
    Debbie Tennant, PharmD, RPh

    Driving New Experiences Forward: Implementing Consumer Response Documents
    Brandi Fannon Gregg, PharmD

    Tailoring Medical Information to Patients: Answering Questions Effectively and Efficiently
    Hanady Elhadidy, PharmD



    Moderators
    avatar for Sara Doshi

    Sara Doshi

    Director, Medical Information Strategy and Capabilities, GMI, Eli Lilly and Company
    Sara graduated with her PharmD from Butler University and then completed the Purdue University/Eli Lilly and Company Drug Information Residency. She then accepted a role with Global Medical Information (GMI) at Lilly. Sara spent several years supporting numerous products/therapeu... Read More →

    Speakers
    avatar for Sara Doshi

    Sara Doshi

    Director, Medical Information Strategy and Capabilities, GMI, Eli Lilly and Company
    Sara graduated with her PharmD from Butler University and then completed the Purdue University/Eli Lilly and Company Drug Information Residency. She then accepted a role with Global Medical Information (GMI) at Lilly. Sara spent several years supporting numerous products/therapeu... Read More →
    avatar for Hanady Elhadidy

    Hanady Elhadidy

    Associate Director, Medical Information, Bristol-Myers Squibb
    Hanady is the Medical Contact Lead for Latin America, Pacific Rim, and Middle East Africa at Bristol-Myers Squibb and is responsible for operational excellence in providing Medical Information to Patients and HCPs via the Medical Contact Centers. Hanady has served in a variety of... Read More →
    avatar for Brandi Gregg

    Brandi Gregg

    HCP Associate, UCBCares, UCB, Inc.
    Brandi Gregg is a pharmacist at UCB, Inc. in their patient-inspired solution center, UCBCares®. She received her Pharm.D. in 2010 from Mercer University College of Pharmacy. Her previous professional experience includes pharmacy management in a corporate retail setting and pharm... Read More →
    DT

    Debbie Tennant

    Director, Medical Information, Pfizer Inc.
    Debbie currently leads the North America Anti-Infective, Biosimilars, and Injectables therapeutic team for Pfizer Medical Information. Prior to joining Pfizer, Debbie worked in Medical Information at Hospira. She also has experience in hospital pharmacy, serving in various roles... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S503ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #247: Best Practice for Advisory Committee Meeting Preparation
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Often times, FDA requests pharmaceutical sponsors participate in an Advisory Committee meeting during the review of a NDA/sNDA. Understanding the best practices for preparation of an advisory committee meeting (slide deck, briefing book, review of FDA's advisory committee brief) is crucial and critical to its success.

    Learning Objectives

    Discuss how to generate a quality briefing book; Recognize considerations for preparing for the Advisory Committee meeting such as expectation and FDA information needs.

    Chair

    Chris Miller, MS

    Speaker

    Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
    Jeffrey M. Dayno

    Effective Preparation for an FDA Advisory Committee Meeting: Applying Lessons from Abuse-Deterrent Opioids
    John Markman, MD

    FDA Advisory Committee Slide Preparation: Doing More with Less
    Michael Bourque, MS



    Moderators
    avatar for Chris Miller

    Chris Miller

    Biostatistician, Communications Strategist, Medical Writer, 3D Communications
    Chris Miller is a biostatistician with broad experience in the design, analysis, and interpretation of clinical trials. He guides teams to present data effectively for regulatory submissions and FDA advisory committee meetings. Prior to joining 3D, Chris was a senior biostatistic... Read More →

    Speakers
    avatar for Michael Bourque

    Michael Bourque

    Associate Director, Principal Regulatory Writer, Synchrogenix, a Certara Company
    Michael Bourque has over 17 years of medical writing and clinical research experience across a wide range of therapeutic areas including infectious diseases, vaccines, pain, oncology, and pediatric medicine. He is currently Associate Director at Synchrogenix. In addition to servi... Read More →
    avatar for Jeffrey Dayno

    Jeffrey Dayno

    Chief Medical Officer, Egalet Corporation
    avatar for John Markman

    John Markman

    Professor of Neurosurgery and Neurology, University of Rochester
    John Markman founded and directs the University of Rochester’s Neuromedicine Pain Management Center and Translational Pain Research Program, a leading academic research site for the clinical study of chronic pain. John, a Professor of Neurosurgery and Neurology, has chaired the... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S504abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #248: Building the Medical Strategy and Tactics
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session will focus on how to develop a comprehensive medical plan for your medical affairs unit. Speakers will discuss key considerations, such as effective collaboration and value add to clinical development, research and development, and commercialization groups.

    Learning Objectives

    Discuss key considerations and strategies for medical manager/directors when developing medical plans.

    Chair

    Anny Chen, PharmD

    Speaker

    How to Build Medical Strategy from the Perspective of a Biotech Company
    Chung H. (Lou) Lu, PharmD

    Scientific Communications Planning
    Bhakti Kshatriya, PharmD

    Developing Medical Strategy and Tactics With a Focus on Data Generation
    Fabrizio Tondolo, MD



    Speakers
    AC

    Anny Chen

    Senior Director, Global Scientific Communications, Novartis Pharmaceuticals Corporation
    avatar for Bhakti Kshatriya

    Bhakti Kshatriya

    Founder, Publication Practice Counsel, Truposha, LLC
    Dr. Kshatriya is author, speaker & medical communications expert with over 20 yrs industry experience, incl. prelaunch, launch & end of product lifecycle Rx-to-OTC switch. She recently published book Recoding Scientific Publishing: Raising the Bar in an Era of Transformation, pro... Read More →
    avatar for Chung H. (Lou) Lu

    Chung H. (Lou) Lu

    Senior Director - Medical Affairs and Medical Information, Otonomy, Inc
    Lou is Sr. Director of Medical Affairs at Otonomy, a biopharmaceutical company focused on novel ear disorder therapies. Prior to Otonomy, Lou was Director of Medical Affairs at Cadence Pharmaceuticals launching OFIRMEV, intravenous acetaminophen. Before Cadence, Lou spent 6 years... Read More →
    LL

    Lou Lu

    Senior Director - Medical Affairs and Medical Information, Otonomy, Inc
    A Senior Medical Affairs Professional with a 10-year track record of taking pharmaceutical products from Phase 3 to launch and through the post-marketing lifecycle. A strong work ethic and instinctive focus on detail with extensive pharma/biotech Medical Affairs knowledge. A self... Read More →
    avatar for Fabrizio Tondolo

    Fabrizio Tondolo

    Global Medical Affairs Lead, Infectious Disease, Merck & Co., Inc.
    Fabrizio is Associate Vice President Hospital & Specialty in US Medical Affairs in Merck. He received his MD degree at the University of Bologna (Italy) and, after two years of medical practice, joined Merck in 1995. Through his career in Merck, he has lived in Italy, Switzerland... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #249: Not Your Grandma's Patient Advocacy Group Anymore
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-522-L04-P; CME 1.25; IACET 1.25; RN 1.25

    This forum, subtitled The Growth of Relational, Regulatory and Research Equity in Modern Patient Advocacy Groups, will share end-to-end stories of how advocates are gaining influence with researchers, policy makers, and regulators to drive the approvals of new therapies. The panelists will tell their stories from the point of view of the advocates who have organized resources differently to increase the volume and speed of research in their disease, and to address gaps in the environment in order to speed review and approvals.   Panelists will offer practical advice on how to build a coalition of patients, researchers, and family care physicians to navigate promising new therapies through the regulatory process and ultimately to patients. 

    Learning Objectives

    Discuss how to work with patient advocacy groups to develop, assess, and approve new medicines.

    Chair

    Laura Kolaczkowski

    Speaker

    Panelist
    Upal Basu Roy, PhD, MPH

    Panelist
    Melissa Hogan, Esq, JD

    Panelist
    K. Kimberly McCleary



    Moderators
    avatar for Mary Murray

    Mary Murray

    Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb
    Mary Stober Murray is responsible for establishing industry - advocacy collaborations to introduce patient-inspired changes that differentiate clinical research and ultimately the therapies available to protect or restore patients’ health.

    Speakers
    avatar for Melissa Hogan

    Melissa Hogan

    Founder/President, Project Alive
    Melissa Hogan is the President of Project Alive, the leading research and advocacy foundation for the rare disease Hunter Syndrome (MPS II). She also serves as a Patient Representative to the FDA and on the boards of several rare disease organizations. Prior to her son’s diagno... Read More →
    avatar for Melissa Hogan

    Melissa Hogan

    Founder/President, Project Alive
    Melissa Hogan is the President of Project Alive, the leading research and advocacy foundation for the rare disease Hunter Syndrome (MPS II). She also serves as a Patient Representative to the FDA and on the boards of several rare disease organizations. Prior to her son’s diagno... Read More →
    avatar for Laura Kolaczkowski

    Laura Kolaczkowski

    Lead Patient Representative, Co-Principal Investigator, Iconquerms PPRN, Pcornet
    Laura is an advocate, patient and researcher in the multiple sclerosis community. She is the co-principal investigator for iConquerMS, a PCORI funded Patient Powered Research Network. Experienced in patient centric research, she has been a stakeholder reviewer for PCORI and the D... Read More →
    avatar for K. Kimberly McCleary

    K. Kimberly McCleary

    Managing Director, FasterCures, A Center of the Milken Institute
    Kim leads the Patients Count: Science of Patient Input program through which FasterCures aims to improve health by expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. She has been involved in... Read More →
    UB

    Upal Basu Roy

    Director of Translational Research Program/Director of Patient FoRCe, LUNGevity Foundation
    As Director of Translational Research Program, Upal implements LUNGevity’s research awards program. He is also in charge of monitoring and evaluating the research program. Upal is also Director of LUNGevity’s Patient-Focused Research Center (Patient FoRCe). He conducts resear... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #250: If You See Something (About a Clinical Trial), Do You Say Something (to Your Doctor?)
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-525-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Patient enrollment and participation in clinical trials is a necessary part of bringing safe and effective medicines to the patients who need them, yet it presents a continuing challenge in drug development. Efforts to increase patient and provider participation in research often start with clinical trial awareness and education initiatives. This session features the latest generation of clinical trial awareness efforts (for example, the crowdsourcing Ideathon organized by INC Research and CISCRP), to campaigns led by patient advocacy groups as well as the industry coalition TransCelerate. The session will explore how these efforts are designed to bring new participants into the system, both patients and providers. Speakers will discuss measurable design elements of campaigns, such as calls to action that can help us trace awareness to enrollment.

    Learning Objectives

    Describe elements of content creation, media planning and execution; Develop a metrics pathway and reports illuminating awareness to enrollment.

    Chair

    Tyler Ludlow, MBA

    Speaker

    The Role of Shared Decision Making in Clinical Trial Enrollment: A Pilot Intervention
    Tyler Ludlow, MBA

    How TransCelerate Is Expanding Clinical Research Awareness
    Candice E Junge, PhD

    Leverage EHR Data and the Physician-Patient Relationship to Raise Patient Awareness of Trials and Accelerate Recruitment
    Greg Sweatt



    Moderators
    avatar for Tyler Ludlow

    Tyler Ludlow

    Senior Decision Scientist, Eli Lilly and Company
    As a decision scientist, Tyler helps people (1) shift their view of decisions as a burden, to opportunities for growth, and (2) make better decisions. After a decade of helping leaders and organizations, he turned his focus to individual and personal contexts. Professionally, he... Read More →

    Speakers
    avatar for Candice Junge

    Candice Junge

    Development Design Director, Amgen Inc.
    Candice Junge is a Director in Amgen's Development Design Center working across therapeutic areas to develop novel program and clinical study design strategies. The Design Center team brings broad clinical development expertise, data modeling and analytics, and operational insigh... Read More →
    avatar for Tyler Ludlow

    Tyler Ludlow

    Senior Decision Scientist, Eli Lilly and Company
    As a decision scientist, Tyler helps people (1) shift their view of decisions as a burden, to opportunities for growth, and (2) make better decisions. After a decade of helping leaders and organizations, he turned his focus to individual and personal contexts. Professionally, he... Read More →
    avatar for Greg Sweatt

    Greg Sweatt

    Vice President Life Sciences, ePatientFinder
    Greg has 20+ years of experience in organizing sales teams, designing marketing messages and managing growth in technology markets. A veteran of Applied Materials, Greg managed multibillion dollar accounts determining their needs and delivering cutting-edge capital equipment solu... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #251: Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-529-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Presenters will discuss how patient input and real world evidence can be used to meet the "adequate and well-controlled studies" standard. The panel will discuss the meaning of the science of patient input, and provide examples of successfully using patient input (e.g., in making trial endpoint decisions; weighing benefit/risk; modifying study protocols based on patient input, etc.) within the regulatory context to enhance drug development and approval by incorporating the patient voice. Gaps and challenges with suggested solutions will be discussed, and differences among US and non-US regulatory agencies may be considered.

    Learning Objectives

    Define the science of patient input; Describe the challenges and solutions to successfully incorporating the patient voice into drug development.

    Chair

    Bennett Levitan, MD, PhD

    Speaker

    The Voice of the Patient: Setting the Therapeutic Context for Regulatory Decision Making
    James E. Valentine, JD, MHS

    Incorporating Patient Preferences in Benefit-Risk Assessments: Interpreting ICH M4E (R2)
    Lesley Wise, PhD, MSc

    Advancing the Science of Patient Inputs in the Regulatory Setting
    Telba Irony, PhD



    Moderators
    avatar for Bennett Levitan

    Bennett Levitan

    Senior Director, Benefit-Risk Assessment, Department of Epidemiology, Janssen Research & Development, LLC
    Bennett Levitan, MD-PhD is Senior Director, Dept of Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and has led numerous teams in preparation of benefit-risk assessments. He co-led development of the PhRMA BRAT Framew... Read More →

    Speakers
    avatar for Telba Irony

    Telba Irony

    Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
    Telba Irony is Deputy Director of the Office of Biostatistics and Epidemiology at CBER, FDA. She joined FDA to implement Bayesian statistics in medical device clinical trials and led patient preference studies at CDRH. Telba received the 2014 FDA Excellence in Analytical Science... Read More →
    avatar for James Valentine

    James Valentine

    Attorney, Hyman, Phelps & McNamara, PC
    James Valentine is an associate at Hyman, Phelps & McNamara, P.C., a law firm in Washington, D.C. There he assists medical product industry clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Prior to joining the firm, h... Read More →
    avatar for Lesley Wise

    Lesley Wise

    Managing Director, Wise Pharmacovigilance and Risk Management Ltd
    Lesley Wise has more than 15 years of experience in pharmacovigilance both in medicines regulation at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology where she worked closely with coll... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #252: What’s New in Devices: European Medical Device Regulations and MDUFA IV
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    With the new medical device and IVD regulations in the EU, plus the renewal of MDUFA in the USA, the year 2017 is a pivotal and disruptive period for medical device and diagnostic regulations. This session explores notable developments in global device regulation

    Learning Objectives

    Summarize recent global device regulatory changes; Describe potential approaches for development and lifecycle management strategies to ensure future compliance.

    Chair

    Angela Stokes, MS

    Speaker

    Are You Ready for the Medical Devices Regulation? What Should Manufacturers be Considering Now
    Angela Stokes, MS

    The EU Medical Device Regulations: The Notified Body View
    Theresa Jeary

    US Perspective
    LeeAnn L Chambers, MS



    Moderators
    avatar for Angela Stokes

    Angela Stokes

    Senior Director, Global Regulatory Consulting, INC Research
    Angela Stokes has over 27 years experience in the pharmaceutical and medical device industry in a variety of Regulatory Affairs based roles, most recently as Senior Director Global Regulatory Consulting at INC Research. She is experienced in medicinal product and medical device d... Read More →

    Speakers
    LC

    LeeAnn Chambers

    Principal Research Scientist, Global Regulatory Affairs, CMC - Devices, Eli Lilly and Company
    LeeAnn Chambers has been a Regulatory Affairs professional at Eli Lilly and Company for 20 years. She assists teams in developing global registration strategies for medical devices and drug / device combination products. She has guided the preparation of device content in US IND... Read More →
    avatar for Theresa Jeary

    Theresa Jeary

    Technical Manager, Lloyds Register Quality Assurance
    Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory department... Read More →
    avatar for Angela Stokes

    Angela Stokes

    Senior Director, Global Regulatory Consulting, INC Research
    Angela Stokes has over 27 years experience in the pharmaceutical and medical device industry in a variety of Regulatory Affairs based roles, most recently as Senior Director Global Regulatory Consulting at INC Research. She is experienced in medicinal product and medical device d... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #253: Regulatory Challenges with Next Generation Sequencing
    Component Type: Session
    Level: Intermediate
    CE: CME 1.00; IACET 1.00; RN 1.00

    The high interest and rapid uptake of next-generation sequencing in the clinic speaks to the promise of this technology as a valuable adjunct for optimizing therapeutic treatment, yet much of this promise remains untapped. The challenge associated with establishing a regulatory framework stems from the lack of available standards to help establish the safety and effectiveness of this technology, and from the lack of high quality, public databases with data curated from validated methods for use in clinical decision making

    Learning Objectives

    Explain recent efforts by regulatory bodies, academia, and regulated industry to curate data from this technology and use it for regulatory decision making.

    Chair

    Kim Tyrrell-Knott, JD

    Speaker

    What's Next for Next Gen Sequencing
    Kim Tyrrell-Knott, JD

    FDA Perspective
    Laura Koontz, PhD

    Panelist
    Ingo Chakravarty

    Panelist
    Kelli Lynn Tanzella, PhD, MS



    Moderators
    avatar for Kim Tyrrell-Knott

    Kim Tyrrell-Knott

    Partner, Epstein Becker & Green, P.C.
    KIM TYRRELL-KNOTT* is a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego and Washington, DC, and serves on the firm's National Health Care and Life Sciences Steering Committee. She has significant experience advising investors and companies on... Read More →

    Speakers
    avatar for Ingo Chakravarty

    Ingo Chakravarty

    President and Chief Executive Officer, NAVICAN, An Intermountain Healthcare Company
    Ingo Chakravarty, President and CEO of NAVICAN, joined Intermountain Healthcare in June 2016, spinning off NAVICAN in October 2016. He previously served in senior roles at Genmark Diagnostics, Gen-Probe, Roche Diagnostics, and Ventana Medical Systems here in the United States and... Read More →
    LK

    Laura Koontz

    Office of InVitro Diagnostics and Radiological Health (OIR), CDRH, FDA
    Laura M. Koontz, PhD, is a member of the Personalized Medicine Staff at the Food and Drug Administration in the Center for Devices and Radiological Health. Prior to joining the FDA, she was the Director of Policy for the Ovarian Cancer National Alliance. She also was an ASHG-NHGR... Read More →
    avatar for Kelli Tanzella

    Kelli Tanzella

    Senior Director, Regulatory Affair, Clinical and Compliance Life Sciences Soluti, Thermo Fisher Scientific
    Kelli Tanzella, Sr. Director Global Regulatory Affairs, Clinical, & Compliance in the Life Sciences Group at Thermo Fisher Scientific has over 25 years’ experience in the pharmaceutical and medical device industries. She is responsible for development and implementation of regu... Read More →
    avatar for Kim Tyrrell-Knott

    Kim Tyrrell-Knott

    Partner, Epstein Becker & Green, P.C.
    KIM TYRRELL-KNOTT* is a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego and Washington, DC, and serves on the firm's National Health Care and Life Sciences Steering Committee. She has significant experience advising investors and companies on... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #254: New Considerations in Benefit-Risk Management
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Benefit-risk management continues to evolve as noted changes have been seen with ICH's M4E (R2) -Guideline on Enhancing the Format and Structure of Benefit-Risk Information along with the proposed changes to the EMA's Module V - Risk Management Systems and the FDA's draft Guidance on FDA's Application of Statutory Factors in Determining When a REMS is Necessary. This session will focus on proposed changes and the impact on MAHs. Best practices and change management efforts will be discussed.

    Learning Objectives

    Describe how the updates and proposed revisions will impact one's pharmacovigilance organization.

    Chair

    Meredith Y. Smith, PhD, MPA

    Speaker

    Implementing Benefit-Risk Management More Effectively
    Steve Mayall, PhD

    The Revised ICH M4E Benefit-Risk Assessment Guidance: Update and Practical Implications
    Tarek Hammad, MD, PhD, MS, MSc, FISPE

    Regulatory Perspective on the New ICH Guidance and the Evolving Nature of Benefit-Risk Assessment
    Patrick Frey



    Moderators
    avatar for Meredith Smith

    Meredith Smith

    Global Risk Management Officer, Global Patient Safety, Amgen Inc.
    Dr. Meredith Smith is Global Risk Management Officer in the Global Patient Safety department at Amgen. She is a social and behavioral scientist by training and has worked in the industry for approximately 15 years. She served on the CIOMS IX Working Group on Risk Minimization Too... Read More →

    Speakers
    avatar for Patrick Frey

    Patrick Frey

    Chief of Staff, Office of New Drugs, CDER, FDA
    Patrick Frey is the Chief of Staff in CDER's Office of New Drugs. He has played leadership roles in the reauthorization of PDUFA V and VI as well as BSUFA II. He was also the CDER lead in developing and implementing CDER's structured framework for benefit-risk assessment. Patrick... Read More →
    avatar for Tarek Hammad

    Tarek Hammad

    Executive Director, Pharmacoepidemology, Merck Research Laboratories
    Dr. Tarek Hammad joined Merck in 2013 as an Executive Director in the department of Pharmacoepidemiology. Prior to that, he has had a distinguished career with the FDA, most recently as Deputy Director of the Division of Epidemiology, CDER. He is nationally and internationally re... Read More →
    avatar for Steve Mayall

    Steve Mayall

    Principal Consultant, Pope Woodhead & Associates Ltd
    Steve Mayall is a Principal Consultant in Pope Woodhead’s Development Consulting Practice. He has advised a wide variety of global pharmaceutical and biotech companies on benefit-risk management during the past 15 years. Key areas have included developing risk management plans... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #255: Integrating the Patient's Voice Across the Development Program of Rare Diseases: Translation Into Meaningful Outcomes
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-542-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Patients living with a rare disease have a direct stake in the end-benefit, and as a result should have their perspective included in the process of developing drugs. The development of clinically meaningful “patient focused” outcome measures has advanced substantially in recent decades. However, several challenges remain when designing and implementing meaningful outcome measures, including heterogeneity of outcomes, availability of suitable, reliable and valid measures, recruitment, and selection of appropriate data collection methods. This session will discuss how the inclusion of the patient's knowledge and experience, the Patient’s Voice, throughout the investigational continuum can help address the many drug development challenges, yield better clinically meaningful outcomes, and get therapies to patient's faster.

    Learning Objectives

    Discuss the various ways of collecting data and various types of patient perspective data and how such data can be used to create patient-centered alignment on regulatory decisions regarding safety and effectiveness; Describe potential benefits and risks of integrating the patient voice throughout clinical development; Discuss examples of how patient engagement at various stages of clinical development has positively impacted clinical trials.

    Chair

    David H. Schubert

    Speaker

    The Importance of Meaningful Endpoints for Rare Disease Clinicians and Patients
    Lisa Marie Dilworth, MS

    Developing the PKU-QOL: A Long Journey to Integrate the Patients’ Voice into Phenylketonuria Drug Development Programs
    Benoit Arnould, PhD, MSc

    Rare Disease Drug Development: Incorporating Patients' Perspective Through the Use of Patient Exit Interviews
    Lili Garrard, PhD



    Moderators
    avatar for David Schubert

    David Schubert

    Vice President of Regulatory and Quality, Stealth BioTherapeutics
    David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of... Read More →

    Speakers
    avatar for Benoit Arnould

    Benoit Arnould

    Senior Director, Global, Patient-Centered Outcomes, Patient Centered Sciences, Mapi
    Benoit Arnould PhD is Senior Director Global, Patient-Centered Outcomes at Mapi, and has conducted studies to develop and validate Patient-reported outcome (PRO) instruments for more than 15 years. His primary interests are Endpoint Strategy and the application of Mixed Methods R... Read More →
    avatar for Lisa Dilworth

    Lisa Dilworth

    Director of Therapeutic Expertise, Scientific Affairs, Rare Diseases, PRA Health Sciences
    Ms. Dilworth is dedicated to Rare Diseases with over 16 years of experience. She consults with clients to develop global therapeutic product strategies. Ms. Dilworth supports clinical operations with regard to patient recruitment, investigator relations, global feasibility, and s... Read More →
    LG

    Lili Garrard

    Mathematical Statistician, Office of Biostatistics, CDER, FDA
    Lili Garrard is a statistical reviewer in the FDA-CDER Office of Biostatistics. She recently joined the FDA from the University of Kansas Medical Center where she received her Ph.D. in Biostatistics. Dr. Garrard previously worked for the National Database of Nursing Quality Indic... Read More →
    avatar for David Schubert

    David Schubert

    Vice President of Regulatory and Quality, Stealth BioTherapeutics
    David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S505ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #256: Post-Trial Access: Ensuring Patient Access Across the Development Spectrum
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-555-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000203; RN 1.25

    Clinical trials are an important way many patients gain access to life saving treatment they might not otherwise be able to obtain. Once the trial ends for an individual patient, what happens during the time treatment stops and the investigational agent becomes approved? Sponsors of clinical trials for life threatening diseases need to plan proactively for the management of this transition and engage with downstream stakeholders to ensure continued access to beneficial treatments.

    Learning Objectives

    Define what is meant by post-trial access; Discuss the bioethical principles behind providing post-trial access; Describe the planning that should be undertaken in advance of initiating a trial for a life threatening disease.

    Chair

    Karla Childers, MS

    Speaker

    Development of a Common Ethical Framework for Post Trial Responsibilities
    Rebecca Li, PhD

    Post-Trial Access: Terminology and Ethical Concepts Matter
    Luann E Van Campen, PhD, MA, MS

    Panelist
    Walter Straus



    Speakers
    avatar for Luann Van Campen

    Luann Van Campen

    Senior Advisor and Head of Bioethics, Eli Lilly and Company
    Since 2008, Luann Van Campen, PhD, has been the head of Lilly Bioethics, and has served on external work groups. Prior to this role, she developed publications for neuroscience drugs and established Lilly publication policy. Before Lilly, she worked in hearing science at Vanderbi... Read More →
    avatar for Karla Childers

    Karla Childers

    Senior Director, Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson
    Karla Childers is a Senior Director of Strategic Projects in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibilities are the Clinical Trial Data Transparency Initiative and the Johnson & Johnson Bioethics Committee.
    avatar for Rebecca Li

    Rebecca Li

    Executive Director, Harvard MRCT Clinical Trials Center, Brigham and Women's Hospital
    Rebecca Li, PhD, has over 17 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. Dr. Li has served as the Executive Director of the Multi-regional Clinical Trial Center at Harvard since 2012. She is also a co-F... Read More →
    avatar for Walter Straus

    Walter Straus

    Associate Vice President, Therapeutic Area Head, Clinical Safety and Risk Mgmt, Merck & Co., Inc.
    Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologis... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #257: Strategic Planning Across Research Organizations
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000207; RN 1.25

    Leveraging innovative technologies, cutting edge research, and unique capabilities are the hallmarks of robust drug discovery and development. Government organizations approach these activities differently and regional variation can also play a role in how research is conducted. Understanding these perspectives can lead to more effective collaborations. This session will give the audience insights on strategic planning and implementation of partnerships using examples from Canada, the US and the Pharma industry.

    Learning Objectives

    Discuss how clinical research is conducted in Canada; Identify key differences that can be leveraged in executing effective collaborations.

    Chair

    Shurjeel Choudhri

    Speaker

    Initiatives for Enhancing the Canadian Clinical Research Environment: A Showcase of Cross-Sectoral Collaborations
    Shurjeel Choudhri

    Innovative Approaches to Getting Products to Market: The Experience in an Academic Medical Center
    Bambi Grilley, RPh, RAC

    Industry Perspective for Strategic Collaboration
    Janice Chang



    Moderators
    avatar for Shurjeel Choudhri

    Shurjeel Choudhri

    Senior Vice President and Head, Medical and Scientific Affairs, Bayer
    Dr. Choudhri is the Head of Medical and Scientific Affairs (M&SA) for Bayer Inc. and the current chair of the Canadian Clinical Trials Coordinating Centre executive committee. Before assuming his current role as Head of M&SA in Canada, Dr. Choudhri was a Global Clinical Leader, A... Read More →

    Speakers
    avatar for Janice Chang

    Janice Chang

    Senior Vice President, Global Operations, TransCelerate Biopharma Inc.
    Ms. Chang oversees TransCelerate’s (TCB) growing global operations, including strategic engagements with industry groups and regulators, and TCB's portfolio across clinical, preclinical and PV. She spearheads engagements with other industry consortia, patient groups, sites, CRO... Read More →
    avatar for Shurjeel Choudhri

    Shurjeel Choudhri

    Senior Vice President and Head, Medical and Scientific Affairs, Bayer
    Dr. Choudhri is the Head of Medical and Scientific Affairs (M&SA) for Bayer Inc. and the current chair of the Canadian Clinical Trials Coordinating Centre executive committee. Before assuming his current role as Head of M&SA in Canada, Dr. Choudhri was a Global Clinical Leader, A... Read More →
    avatar for Bambi Grilley

    Bambi Grilley

    Director, Clinical Research & Early Product Dev., Center for Cell & Gene Therapy, Baylor College of Medicine
    Ms. Grilley has 30 years of experience in research with expertise in investigational drugs, IRB review, regulatory affairs and study conduct. She is currently responsible for coordinating the development, implementation, and conduct of all clinical research protocols for CAGT at... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #258: Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-556-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Patient-reported outcomes (PROs)are not new. The FDA released a final guidance on this topic in 2009, and there have been many presentations and discussions on the evidence and measurement principles used to guide development of fit-for-purpose PRO assessments. This session will move the conversation from basic PRO development to discuss the latest hot topics regarding PROs in drug development. Hot topics might include (but are not limited to): FDA's flexibility in implementing principles in the guidance; methods to evaluate meaningful change on PRO assessments; strategies for incorporating PRO endpoints into multiplicity-adjusted endpoint hierarchy with traditional endpoints; novel methods to validate new PRO tools).

    Learning Objectives

    Summarize practical insights and methods that can be used to facilitate the development and use of PROs in clinical trials.

    Chair

    Selena Daniels, PharmD, MS

    Speaker

    Capturing the Patient's Voice in Evaluating Safety and Tolerability: Industry Perspective
    Arnold Degboe, MD, PhD, MBA

    Capturing the Patients’ Voice in the Evaluation of Safety and Tolerability: FDA Perspective
    Paul Kluetz, MD

    Capturing the Patients’ Voice in the Evaluation of Safety and Tolerability: FDA Perspective
    Ann Marie Trentacosti, MD



    Speakers
    avatar for Selena Daniels

    Selena Daniels

    COA Staff Team Leader, Office of New Drugs, CDER, FDA
    Selena Daniels is a Team Leader on the Clinical Outcome Assessments (COA) Staff at FDA. Selena leads a team of expert analysts who evaluate COA endpoint issues related to the evaluation of clinical benefit in clinical trials to support labeling claims. Prior to the FDA, she was a... Read More →
    avatar for Arnold Degboe

    Arnold Degboe

    Director, Patient Science-Oncology, Patient Centricity, Global Medical Affairs, AstraZeneca
    Arnold is a physician by training and a health economics & outcomes researcher with over 16 years of combined experience in clinical practice, outcomes research and pharma. He holds a medical degree from Ghana, and a dual-titled Ph.D. in Health Policy & Demography from Penn State... Read More →
    avatar for Paul Kluetz

    Paul Kluetz

    Associate Director for Patient Outcomes (Acting), OCE, FDA
    Paul G. Kluetz, M.D., is a medical oncologist and the Acting Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. He is interested in defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval a... Read More →
    avatar for Ann Marie Trentacosti

    Ann Marie Trentacosti

    Medical Officer, Labeling Development Team, OND, CDER, FDA
    Dr. Ann Marie Trentacosti is the Medical Lead for the Labeling Development Team (LDT) in the Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). LDT ensures that the prescribing information is a useful communication... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #259: Novel Techniques for Improving Clinical Trial Subject Retention
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-557-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Speakers are invited to share proven techniques and approaches to reduce the number of subjects lost to follow up in a clinical trial and discuss the statistical impact of reducing loss to follow up on the validity of clinical trial results.

    Learning Objectives

    Describe approaches and techniques for decreasing the number of subjects lost-to-follow-up to reduce the impact on study validity.

    Chair

    Karen M Hauda, JD, MS

    Speaker

    Lost to Follow Up No More: Lessons Learned From Increasing Patient Retention in Diabetes Trials
    Francine Wormley Williams, MPH

    Using Innovative Technology to Improve Subject Retention in Clinical Trials
    Jill Platko, PhD

    One Size Does Not Fit All: Retention Methods Custom-Designed for Your Specific Patient Population
    Valerie Powell, MS



    Speakers
    avatar for Karen Hauda

    Karen Hauda

    Senior Director, Regulatory Policy, Novo Nordisk A/S
    Karen Hauda is the Senior Director for Regulatory Policy in the Clinical Development, Medical and Regulatory Affairs Division at Novo Nordisk. In this role, she supervises regulatory advocacy and develops filing strategies to positively influence the regulatory environment in the... Read More →
    avatar for Jill Platko

    Jill Platko

    Senior Scientific Advisor, CRF Health
    At CRF Health, Dr. Jill Platko provides scientific guidance in both the presales process and for projects. This includes the review of clinical trial protocols, to determine ePRO data collection design. Her role is to ensure that CRF’s technology meets the scientific requiremen... Read More →
    avatar for Valerie Powell

    Valerie Powell

    Director, Patient Insights and Engagement, Mapi
    Valerie Powell has over 25 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She collaborates with behavioral scientists in a number of specialties, conducting qualitative research using a range of methodologies an... Read More →
    avatar for Francine Williams

    Francine Williams

    Associate Director, Project Management, Trials, Novo Nordisk A/S
    Francine Williams had over 23 years of pharmaceutical industry experience including over 17 years of clinical trial program management leadership with cross-functional internal teams, and external vendors in Phases 1-IV. She has effectively build/develop teams, manages and mentor... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    2:00pm

    #261: Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in Support of Marketing Applications of New Drug Products to EMA and FDA
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    EMA and FDA collaborative inspections of clinical investigators, sponsors and CROs of clinical trials submitted in support of marketing applications of new drug products have the same objectives of data verification and human subject protection. The goals of the EMA-FDA collaborative initiative are to conduct periodic information exchanges on GCP-related information streamline sharing of GCP inspection planning information, communicate on inspection outcomes effectively and in a timely manner, conduct collaborative GCP inspections by sharing information, experience and inspection procedures, co-operating in the conduct of inspections and sharing knowledge of best practice; share information on the interpretation of GCP, by keeping each other informed of GCP-related legislation, regulatory guidance and related documents and to identify and act together to benefit the clinical research process. Since the EMA-FDA collaborative initiative began in 2009, approximately 48 entities have been inspected by both EMA and FDA for shared applications. This session will characterize and compare the EMA and FDA GCP findings from the 48 entities inspected by both agencies; and provide insight about the extent of the similarities and differences of these common inspections.

    Learning Objectives

    Identify the shared pre-market applications with common inspections by both EMA and FDA; Compare the inspectional findings of the common inspections; Summarize the similarities and differences of the common inspections by EMA and FDA.

    Chair

    Sandra L. Kweder

    Speaker

    An Overview of EMA-FDA Good Clinical Practice (GCP) Collaboration: Focus on Comparison of Inspection Findings Project
    Kassa Ayalew, MD, MPH

    EMA Perspectives
    Anabela Marcal, PharmD

    Preliminary GCP Inspection Findings from Common Marketing Applications: Differences and Similarities
    Jenn W. Sellers, MD

    Comments from Industry Perspectives
    Ann Meeker-O'Connell, MS



    Speakers
    avatar for Kassa Ayalew

    Kassa Ayalew

    Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER, FDA
    Kassa Ayalew, M.D., M.P.H. is a Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a pediatric Infectious Disease spe... Read More →
    avatar for Sandra Kweder

    Sandra Kweder

    Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
    Dr. Kweder has been in her position in 2016, and previously held a number of leadership positions in CDER. Her work there focused on improving review processes to build a high performing organization that values scientific rigor, open discourse and high quality decision making. T... Read More →
    avatar for Anabela Marcal

    Anabela Marcal

    Head of Compliance and Inspections Department, European Medicines Agency, European Union
    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.
    avatar for Ann Meeker-O'Connell

    Ann Meeker-O'Connell

    Senior Director/ Head, BioResearch Quality and Compliance, Consumer Products, Johnson & Johnson
    Ann Meeker-O’Connell heads Bioresearch Quality and Compliance for the Johnson & Johnson Consumer Sector. In this role, Ann oversees a global program for GCP, GLP, and Safety Vigilance oversight. Prior to J&J, Ann served as Director of the Division of Good Clinical Practice Comp... Read More →
    avatar for Jenn Sellers

    Jenn Sellers

    Medical Officer, OSI, OC, CDER, FDA
    Dr. Sellers is a board certified pediatrician working as a senior medical officer for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. She... Read More →


    Tuesday June 20, 2017 2:00pm - 3:15pm
    N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Session

    2:00pm

    #262: Clinical Relevant Specifications: Leveraging Principles of QbD
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Quality specifications are established to confirm and demonstrate that all product critical quality attributes are in control, reliably deliver consistent product and guarantee appropriate safety and efficacy for the patient. However, current in vitro methods for evaluating product quality are not always biorelevant or predictive of product performance. The challenge is how to effectively develop product specifications that provide appropriate relationships to in vivo product performance. Suggested topics for presentation and discussion include: biopharmaceuticals assays that demonstrate predictive product performance, using clinical study results to support quality specifications , the regulatory acceptance of in silico methods to establish in vivo/in vitro relationships and ICH M9 BCS-based biowaivers .

    Learning Objectives

    Discuss industry and regulatory (Office of Pharmaceutical Quality) perspectives on clinical relevance; Describe approaches, for both small molecule and biotechnology products, to establishing clinically relevant specifications, including leveraging quality by design; Discuss case studies that demonstrate the establishment of or challenges associated with clinically relevant specifications.

    Chair

    Laurie Graham

    Speaker

    FDA Perspective
    Sarah Pope Miksinski, PhD

    Using QbD Principles to Establish Launch Program Specifications
    John Joly, PhD



    Speakers
    LG

    Laurie Graham

    Acting Director, DIPAP, OPPQ, OPQ, CDER, FDA
    Ms. Graham is the Acting Directorof the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.
    JJ

    John Joly

    Senior Director Analytical Development and Quality Control, Genentech, A Member of the Roche Group
    John Joly is the head of Analytical Development & QC at Genentech within the Pharma Technical Development organization. John has been at Genentech for 24 years and led the Early Stage Cell Culture department for 10 years. John was the Technical Development Team Leader for Lucenti... Read More →
    avatar for Sarah Pope Miksinski

    Sarah Pope Miksinski

    Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance, OPQ, CDER, FDA
    Dr. Miksinski received her B.A. from Earlham College (1994) and her Ph.D. from Oklahoma State University (1999). She served as an NIH postdoctoral fellow from 2000-2002, and began as a CMC reviewer at the FDA in 2002. She is now the Acting Director of ONDQA/DNDQA 2.


    Tuesday June 20, 2017 2:00pm - 3:15pm
    S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Credit Type CME, IACET, RN
    • Tags Session

    2:45pm

    #265: Patient Engagement in Study Endpoints: Will the Rising Tide Lift All Boats?
    Component Type: Session

    It is clear that patients should be involved in the identification of relevant study endpoints, and the appropriate measurement of those endpoints. Less clear is how to ensure that patient-centric endpoints are driven through the different stakeholder environments, integrated into routine clinical care, and communicated in relevant forums. The content hub will comprise a facilitated discussion between a member of the Patient Engagement community and a member of the Study Endpoints community. Each will respond to some pre-prepared questions (e.g. how do you define patient endpoint involvement; does it make a difference with the different stakeholders) and then take questions from the floor.

    Chair

    Emuella Flood


    Speakers
    avatar for Emuella Flood

    Emuella Flood

    Senior Director, Patient-Reported Outcomes, ICON, plc.


    Tuesday June 20, 2017 2:45pm - 3:15pm
    S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    3:00pm

    Refreshment Break
    Exhibit Hall

    Tuesday June 20, 2017 3:00pm - 4:00pm
    TBA

    3:25pm

    #266: BBK Worldwide Innovation Theater: Building a Patient-Centric Mindset through Theatrical Contemplation
    Component Type: Session
    Level: Intermediate

    True Innovation “Theater”, at last! This presentation will draw upon the inherent awe of the arts to discuss creative thinking and its role in creating empathy for people suffering from myriad conditions and the need for science to find a cure. Actor, screenwriter, and director Ron Fassler, who has made his career in the arts while also raising a son who was diagnosed with Autism Spectrum Disorder (ASD), will share his theatrical and personal perspectives into theatrical arts that deal with social anxiety and ASD. He will be interviewed by Maria Scaros-Mercado, the executive director of a memory-care assisted living facility and board president of a dramatic program for patients and caretakers living with dementia.

    Chair

    BBK Worldwide


    Speakers
    avatar for Ron Fassler

    Ron Fassler

    Author and Actor, BBK Worldwide
    Author of Up in the Cheap Seats: A Historical Memoir of Broadway, Ron is an actor, writer and director with 38 years of professional credits to his name. Mainly known for his role on the sci-fi cult series Alien Nation, he has guest-starred on nearly a hundred television shows an... Read More →
    BW

    BBK Worldwide

    BBK Worldwide


    Tuesday June 20, 2017 3:25pm - 3:55pm
    Theater #2 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    3:25pm

    #267: Veeva Systems, Inc. Innovation Theater: Unified RIM: End-to-end Submissions Development—from Planning Through Archival
    Component Type: Session

    Companies should be able to plan and develop submissions within a single system—not five, ten, or >100 if you're really big.

    Chair

    Veeva Systems, Inc.


    Speakers
    avatar for Marc Gabriel

    Marc Gabriel

    Senior Director of Product Strategy, Veeva Systems
    Marc Gabriel is a Senior Director of Product Strategy at Veeva Systems, where he is responsible for defining the enterprise market approach for the Vault Regulatory suite of products. Prior to joining Veeva in June 2017, he served as client partner and RIM consulting lead at Kina... Read More →
    VS

    Veeva Systems, Inc.

    NA
    Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →
    avatar for Jim Reilly

    Jim Reilly

    Senior Director, Vault RIM, Veeva Systems
    Jim Reilly is a Director of Product Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Regulatory suite of products. For the last 15 years, he has held a variety of senior positions in Regulatory publishing, software delivery, consul... Read More →


    Tuesday June 20, 2017 3:25pm - 3:55pm
    Theater #1 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #292: How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies
    Component Type: Session

    In the not too distant future, we as an industry will execute, manage and monitor clinical trials the same way we execute, manage and monitor banking transactions online, quickly and without the need to maintain paper records. However, as we bring new and innovative technology solutions to the market, we must assess and address the concerns of all of the stakeholders within the clinical trial enterprise. We need to assure patients, clinical research sites, pharmaceutical and device companies, as well as regulators, that there will be improved efficiencies, improved data quality and integrity, improved patient safety, reduced fraud and an overall better experience during the clinical trial process. Topics to be addressed include clinical site acceptance, regulatory concerns, software validation, risk assessments, change management within companies, and a comprehensive assessments of the risks and rewards.

    Chair

    Jules T Mitchel, PhD, MBA


    Speakers
    avatar for Jules Mitchel

    Jules Mitchel

    President, Target Health, Inc.
    Dr. Mitchel is President and co-founder of Target Health Inc., a New York City-based full service eCRO dedicated to all aspects of Drug and Device Development. He also leads the team at Target Health developing software tools to enable the “Paperless Clinical Trial.” Dr. Mitc... Read More →


    Tuesday June 20, 2017 4:00pm - 4:30pm
    S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #268: FDA Session: Health IT at FDA
    Component Type: Session
    Level: Intermediate
    CE: CME 1.00; IACET 1.00; RN 1.00

    This session will focus on the status of health informatics at the FDA. Topics will include data standards for health care and clinical research, as well as use of EDC and EHRs in clinical research.

    Learning Objectives

    Explain the Health IT activities at the FDA; Discuss the use of Health IT systems in clinical research; Discuss the results of one of the FDA-led initiatives focusing on the use of EHRs and other types of eSource in clinical investigations.

    Chair

    Mitra Rocca, MSc

    Speaker

    Health Information Technology at FDA
    Mitra Rocca, MSc

    Structured Sourcing of Clinical Data from EHRs
    Adam L Asare, PhD



    Speakers
    avatar for Adam Asare

    Adam Asare

    Chief Data Officer, Quantum Leap Healthcare Collaborative
    Adam Asare has over 15 years’ experience in academic and industry developing clinical and research information systems. He recently joined Quantum Leap Healthcare Collaborative where he oversees efforts for process re-engineering for quality improvement of clinical trials and r... Read More →
    avatar for Mitra Rocca

    Mitra Rocca

    Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA
    Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to join... Read More →


    Tuesday June 20, 2017 4:00pm - 5:00pm
    N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #272: Microbiome: Innovative Therapeutics, Challenges, and Opportunities
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.00; IACET 1.00; RN 1.00

    Emerging research points to the significant role of microbiome in contributing to disease and how promoting maintenance of a “healthy microbiome” across a wide variety of disease states can maintain health, prevent, intercept, and treat disease states. How do we handle the complexity of the microbiome in conducting clinical research and monitoring? Does addressing the microbiome impact how we view disease and clinical practice? Do we need new regulatory and medical approaches to manage?

    Learning Objectives

    Describe the complexity of the microbiome in both health and disease management; Identify how addressing the microbiome can fundamentally change our approach to medicine.

    Chair

    Caroline B. Kurtz, PhD

    Speaker

    Overview of the Microbiome and Approaches to Therapeutic Development
    Caroline B. Kurtz, PhD

    Regulatory Aspects of Microbiome Product Development
    James R. Weston, MBA

    Clinical Development Challenges for Microbiome Drug Development
    Paul K. Plumb



    Moderators
    avatar for Caroline Kurtz

    Caroline Kurtz

    Head of Translational Science and Product Development, Synlogic
    Dr. Caroline Kurtz is Head of Translational Sciences at Synlogic. Previously, Caroline was a Vice President at Ironwood Pharmaceuticals, where she led the development of linaclotide (LINZESS®). Prior to her role at Ironwood, Caroline served as Director of Infectious Diseases at... Read More →

    Speakers
    avatar for Caroline Kurtz

    Caroline Kurtz

    Head of Translational Science and Product Development, Synlogic
    Dr. Caroline Kurtz is Head of Translational Sciences at Synlogic. Previously, Caroline was a Vice President at Ironwood Pharmaceuticals, where she led the development of linaclotide (LINZESS®). Prior to her role at Ironwood, Caroline served as Director of Infectious Diseases at... Read More →
    PP

    Paul Plumb

    Head of Clinical Operations, Rebiotix, Inc.
    Paul K. Plumb is the Head of Clinical Operations at Rebiotix, a clinical-stage microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Paul has over 30 years of medical technology and healthcare delivery e... Read More →
    JW

    James Weston

    Vice President, Regulatory Affairs, Seres Therapeutics, Inc.
    Jim Weston is a veteran regulatory affairs and quality executive with a demonstrated ability to spearhead the drug development process by crafting effective regulatory and clinical strategies world-wide, including the US, Canada, Europe (centralized and member states), Australia... Read More →


    Tuesday June 20, 2017 4:00pm - 5:00pm
    S502ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #286: Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In...
    Component Type: Session
    Level: Intermediate
    CE: CME 1.00; IACET 1.00; RN 1.00

    Sponsors, investigator sites, regulators and CRO organizations are invited to share the results of audits and inspections in which risk-based monitoring studies have been assessed.

    Learning Objectives

    Discuss the implementation of the risk-based monitoring approach as judged by auditors and inspectors.

    Chair

    John Hicks, MBA, MSc

    Speaker

    Evaluation of Risk-Based Monitoring From the Perspective of the Sponsor’s GCP Auditor
    John Hicks, MBA, MSc

    Results from Five Years of Risk-Based Monitoring Studies: Experience with Health Authorities and Internal Auditors
    Esther M. Huffman, MA

    Industry Perspective
    Maryrose Petrizzo, MS



    Moderators
    avatar for John Hicks

    John Hicks

    Global Quality Auditing Manager, Eli Lilly and Company
    Over 20 years experience in management and auditing clinical study activity ensuring and evaluating compliance to Good Clinical Practices, and applicable regulatory regulations. Provided project and clinical trial management expertise for global research in multiple phases and th... Read More →

    Speakers
    avatar for John Hicks

    John Hicks

    Global Quality Auditing Manager, Eli Lilly and Company
    Over 20 years experience in management and auditing clinical study activity ensuring and evaluating compliance to Good Clinical Practices, and applicable regulatory regulations. Provided project and clinical trial management expertise for global research in multiple phases and th... Read More →
    EH

    Esther Huffman

    Associate Director, Monitoring Excellence, Bristol-Myers Squibb
    Esther is an Associate Director in the Monitoring Excellence Group at Bristol-Myers Squibb, where she has spent the past several years developing and operationalizing the Risk-Based Monitoring methodology. In her current role, Esther facilitates the changes in technology, process... Read More →
    avatar for Maryrose Petrizzo

    Maryrose Petrizzo

    President and Principal Consultant, Clinical Quality Assured, LLC
    Maryrose has over 20years of GCP experience in Clinical QA and Quality Systems for the pharmaceutical, biologics and medical device industries including: site and process auditing, inspection readiness, due diligence, acquisition integrations, and clinical vendor management. Alwa... Read More →


    Tuesday June 20, 2017 4:00pm - 5:00pm
    S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #291: Combination Products
    Component Type: Session
    Level: Intermediate

    A workshop to explore the world of combination product safety. Discuss the real-world, least burdensome approach to Postmarket Safety Reporting (PMSR) for US Combination Products, in light of the final rule. Help the audience appreciate the complexity of implementing PMSR in a global organization. Participants will work in teams to work through mock case(s) of combination products approved as drug application type with a device constituent part. We will have interactive discussion about key challenges including global impact and highlight industry best practices.

    Learning Objectives

    Describe the basic requirements as highlighted in the final rule; Identify simple solutions to comply with the regulation.

    Chair

    Khaudeja Bano, MD, MS


    Speakers
    avatar for Khaudeja Bano

    Khaudeja Bano

    Senior Medical Director, Medical Affairs, Diagnostics, Abbott Laboratories
    Khaudeja is a Physician with Masters in Clinical Research, Pharmaceutical Engineering Certification, a DBA, and a certified Project Management Professional. She is an avid Toastmaster and a certified coach. Khaudeja has 25 years of professional experience, including clinical prac... Read More →


    Tuesday June 20, 2017 4:00pm - 5:00pm
    Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Devices-Combination Products
    • Tags Session

    4:00pm

    #269: Big Data: Genomics and Personalized Medicine
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-511-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Using big data to identify correlations and determinants of disease or to predict response to therapy.

    Learning Objectives

    Describe challenges and opportunities of using big data to achieve more precise modeling of complex diseases.

    Chair

    Arpit Dave, MS

    Speaker

    Conundrum of Analytics in R&D: How to Drive Science by Leveraging Data
    Arpit Dave, MS

    The Path from Big Data to Precision Medicine: Leveraging Population Analytics to Prevent, Intercept, and Cure Complex Disease
    Bevan Emma Huang, PhD

    Connected Health Ecosystem: Practice Application of Precision Medicine
    Michael Mentesana, MA



    Moderators
    avatar for Arpit Dave

    Arpit Dave

    Executive Director and Head of Enterprise Information Management Solutions, Bristol-Myers Squibb
    Arpit Davé joined BMS in 2011 and is Executive Director and head of Enterprise Information Management Solutions. He is responsible for the development of global information management strategy to enable an agile, data-driven business. Arpit is strategic and pragmatic leader focu... Read More →

    Speakers
    avatar for Arpit Dave

    Arpit Dave

    Executive Director and Head of Enterprise Information Management Solutions, Bristol-Myers Squibb
    Arpit Davé joined BMS in 2011 and is Executive Director and head of Enterprise Information Management Solutions. He is responsible for the development of global information management strategy to enable an agile, data-driven business. Arpit is strategic and pragmatic leader focu... Read More →
    avatar for Bevan Huang

    Bevan Huang

    Associate Scientific Director, Janssen Research & Development, LLC
    Emma Huang is an Associate Scientific Director at Janssen R&D, leading the Population Analytics team, which helps develop and support cross-enterprise precision medicine and real world evidence initiatives through analysis of large-scale population data. She is a statistical gene... Read More →
    MM

    Michael Mentesana

    Partner, Global Pharmaceutical and Life Sciences R&D, Advisory Services Leader, PriceWaterhouseCoopers LLP
    Michael is a dynamic consulting executive with more than twenty years of experience assisting organizations improve business performance. Michael is the Pharmaceutical & Life Sciences R&D Advisory Services Leader for PricewaterhouseCoopers’ and is based in NYC. Michael is prima... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #270: Data Quality
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session will discuss data quality in the light of risk-based methodologies: data fit for purpose, appropriate risk treatment, and quality by design.

    Learning Objectives

    Discuss if and how the approach to data quality has evolved with the adoption of risk-based methodologies.

    Chair

    Teresa Ancukiewicz, MA

    Speaker

    A Quality by Design Approach to Data Quality
    Erik Doffagne, MS

    Going Beyond Data Collection to Ensure Data Quality
    Kenneth Stoltzfus

    Model Data Management Plan
    Scott Brand, PhD



    Moderators
    avatar for Teresa Ancukiewicz

    Teresa Ancukiewicz

    Senior Manager, Clinical Data Management, Boston Scientific Corporation
    Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the D... Read More →

    Speakers
    avatar for Teresa Ancukiewicz

    Teresa Ancukiewicz

    Senior Manager, Clinical Data Management, Boston Scientific Corporation
    Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the D... Read More →
    avatar for Scott Brand

    Scott Brand

    Principal Scientist Data and BioInformatics, FEFA, LLC
    Scott Brand is Principal Scientist Global Data and BioInformatics for FEFA LLC. He has 40 years experience in science and the pharmaceutical industry. Scott has a PhD in biology and carried out research in quantitative biology. He then had two postdocs at Harvard and Yale Medical... Read More →
    avatar for Erik Doffagne

    Erik Doffagne

    Product Manager, CluePoints
    Erik holds a bachelor degree in Computer Science and a master degree in Biostatistics. He has more than 10 years of experience in the life science industry. Erik has spent the last 5 years at developing methodology and technology for central statistical monitoring. Erik has co-au... Read More →
    KS

    Kenneth Stoltzfus

    Clinical Data Strategies, Accelerated R&D Life Sciences, Accenture Accelerated R&D Services
    Ken Stoltzfus has 26 years of broad experience in the pharmaceutical industry that ranges from data management to SAS programming to standards governance. Ken has led assessments, designs and implementations of CDISC data standards, along with the recommended strategies to achiev... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #271: Next Generation Patient Recruitment: Part 1 of 2
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session explores how we might leverage artificial intelligence (AI) approaches to assist patient recruitment. We will provide a conceptual overview of key AI methodologies including machine learning, natural language processing and network mapping, and explore how these operate in the context of structured and unstructured data such as the data found in electronic health records. We will review case studies to illustrate AI in action in aiding patient matching and selection for clinical trials, including recent experience using IBM Explorys. We will conclude with an interactive panel discussion.

    Learning Objectives

    Describe how new techniques for formulation and product manufacturing will modernize the delivery of products to patients.

    Chair

    Bill Byrom, PhD

    Speaker

    AI and Technology Disruptions in Clinical Operations and Patient Recruitment
    Manish Khatri, MS

    Can Artificial Intelligence Transform Patient Recruitment?
    Wout Brusselaers, MA

    Next Generation Patient Recruitment: Clinical Trial Matching
    Gretchen Goller, MA



    Speakers
    avatar for Wout Brusselaers

    Wout Brusselaers

    Chief Executive Officer, Deep 6 AI
    Wout Brusselaers is CEO and co-founder of Deep 6 AI. Wout started his career as a diplomat in the Middle East before joining McKinsey’s South-East Asia offices serving governments, local and global MNCs and startups across many industries. His entrepreneurial streak led him to... Read More →
    avatar for Bill Byrom

    Bill Byrom

    Senior Director of Product Innovation, and Vice Director of ePRO Consortium, ICON, plc.
    Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Ou... Read More →
    GG

    Gretchen Goller

    Global Head of Patient Recruitment Services, ICON, plc.
    Gretchen leads the Patient Recruitment Services group at ICON working with a team of strategists to implement recruitment and retention programs on all pertinent ICON studies. Most recently Gretchen was the Senior Director leading the Patient Access and Retention Services group a... Read More →
    avatar for Manish Khatri

    Manish Khatri

    Consulting Manager, Clinical SME - R&D Advisory Services, Ernst and Young
    Manish has focused his career to contribute his bit in getting medicines to patients - safer, faster and cheaper. He has expertise in bridging analytics, technology and clinical operations. His career spans CRO industry and in advising several different biopharma companies both i... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S501abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #273: Creating Adaptive Contents for a Multichannel World
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    This session will discuss the importance of creating structurally rich, discoverable, adaptable content to meet the high demands of our multichannel world. Includes a discussion on component authoring and how to transition from traditional content creation and the importance of developing a content strategy for content reuse.

    Learning Objectives

    Describe an approach to transforming medical information content for multiple channels.

    Chair

    Cecil Lee, RPh

    Speaker

    Becoming the Next Content Super Model: Introducing Content Modeling - A Key Skill to Develop Reusable Adaptive Contents
    Cecil Lee, RPh

    Creating Adaptive Contents for a Multichannel World
    Samuel Rosen



    Moderators
    avatar for Cecil Lee

    Cecil Lee

    Knowledge Management Advisor, Global Customer Information, Eli Lilly and Company
    The Knowledge Management advisor role has a mission to develop and execute content strategies which continuously drive innovation in knowledge management. Such work enhances efficiencies on content optimization and its reuse for our global function. I have been in Global Medical... Read More →

    Speakers
    avatar for Cecil Lee

    Cecil Lee

    Knowledge Management Advisor, Global Customer Information, Eli Lilly and Company
    The Knowledge Management advisor role has a mission to develop and execute content strategies which continuously drive innovation in knowledge management. Such work enhances efficiencies on content optimization and its reuse for our global function. I have been in Global Medical... Read More →
    avatar for Samuel Rosen

    Samuel Rosen

    Technical Architect, Mavens
    Sam Rosen is a Lead Technical Architect at Mavens, a Chicago-based consulting firm with an exclusive focus in the pharmaceutical and life science industries. Sam’s vast experience delivering cloud-based technology solutions that improve business processes and his expertise in m... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S503ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #274: Effective Collaboration Between Sponsors and Medical Writing Vendors
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    With pharmaceutical companies outsourcing more medical/regulatory writing activities, the need for medical writing service providers is growing. The ultimate goal of outsourcing should be to build a productive, long-term relationship with a core team of writers who are an integral part of a clinical team. This session is of relevance to both medical writing departments and outsourcing departments in order to discuss and find ways sponsors can be more effective at bringing vendor medical writers’ particular skill sets to bear and help clinical teams prepare their regulatory documentation more efficiently.

    Learning Objectives

    Discuss what success looks likes and the benefits of a strategic partnership; Describe the role of the vendor medical writer and project manager in partnership with a pharmaceutical sponsor.

    Chair

    Tammy Franklin, MSc

    Speaker

    Strategic Partnerships for Medical Writing: The Sponsor’s Perspective
    Tammy Franklin, MSc

    Keys to a Successful Specialized Medical Writing Partnership: The Vendor’s Perspective
    Timothy D. Garver, PhD

    Medical Writing Vendor Infrastructure Supports Strategic and Collaborative Partnerships: A Project Manager’s Perspective
    Nancy Pultorak



    Moderators
    avatar for Tammy Franklin

    Tammy Franklin

    Senior Director, Global Medical Writing, UCB, Inc.
    Tammy Franklin is the Senior Director of Global Medical Writing at UCB and is responsible for the leadership and management of the medical writing organization. She has over 15 years of experience in regulatory writing, including extensive knowledge of submission planning and con... Read More →

    Speakers
    avatar for Tammy Franklin

    Tammy Franklin

    Senior Director, Global Medical Writing, UCB, Inc.
    Tammy Franklin is the Senior Director of Global Medical Writing at UCB and is responsible for the leadership and management of the medical writing organization. She has over 15 years of experience in regulatory writing, including extensive knowledge of submission planning and con... Read More →
    TG

    Timothy Garver

    Chief Operating Officer and Executive Vice President, Impact Pharmaceutical Services
    Tim Garver, PhD, is the Executive VP and COO of Impact Pharmaceutical Services, Inc., a consulting and contract research organization. Tim has over 20 years of medical writing experience for both drugs and biologics, during which time he has played a key role in over 25 marketing... Read More →
    avatar for Nancy Pultorak

    Nancy Pultorak

    Project Manager, Audubon PM Associates
    Ms. Pultorak is a results driven research professional with 26 years of experience in pharmaceutical & academic health organizations with leadership expertise and a proven track record in building successful units and management of cross-disciplinary initiatives. She has particul... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #275: Partnering with Patients: Virtual and Traditional Communities - When for What
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Communities - we're all part of them as humans. This forum will discuss how to engage with or create communities for patient engagement and which are most effective to achieve your business and patient-centric objectives. How does one work through the process of selecting which community to work with, or to build one from the ground up? Is it more effective to work with virtual or traditional communities?

    Learning Objectives

    Recognize decision-making and logistics planning to use virtual / traditional communities; Describe which traditional communities are best fit for program objectives; Discuss the benefits and challenges of working with both types of communities.

    Chair

    Kevin Ray Campbell, DrMed, FACC

    Speaker

    The Effective Use of Social Media In Medicine: Engaging Patients and Improving Outcomes
    Kevin Ray Campbell, DrMed, FACC

    Create and Engage the Organically Developed Patient Network
    T.J. Sharpe

    Using Mobile Technologies to Improve Patient Care
    David Albert, MD

    Insight Into Traditional Communities to Engage With Patients
    Kristin Nicole Voorhees, MA



    Moderators
    avatar for Kevin Campbell

    Kevin Campbell

    Cardiologist and CEO, K-Roc Consulting
    Dr Kevin Campbell is an internationally recognized cardiologist and on air television medical, health and wellness expert. He appears regularly on Fox, CBS and other national outlets. A pioneer of the use of social media and digital technologies in healthcare, Dr Campbell is also... Read More →

    Speakers
    avatar for David Albert

    David Albert

    Founder and Chief Medical Officer, AliveCor, Inc.
    David Albert is a physician, inventor & serial entrepreneur who has developed life-saving products over the last 30 years, turning those innovations into startups. Today, he is a Founder & Chief Medical Officer of AliveCor. His latest invention, the Kardia ECG, became a global se... Read More →
    avatar for Kevin Campbell

    Kevin Campbell

    Cardiologist and CEO, K-Roc Consulting
    Dr Kevin Campbell is an internationally recognized cardiologist and on air television medical, health and wellness expert. He appears regularly on Fox, CBS and other national outlets. A pioneer of the use of social media and digital technologies in healthcare, Dr Campbell is also... Read More →
    avatar for T.J. Sharpe

    T.J. Sharpe

    Patient #1 blog on Philly.com, www.Philly.com
    T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog on www.philly.com/patient1.  Diagnosed in August 2012 with tumors in multiple organs, his second clinical trial, for the anti-PD-1 drug, is producing optimistic results. He wr... Read More →
    avatar for Kristin Voorhees

    Kristin Voorhees

    Senior Manager, Advocacy Relations, Continuum Clinical
    Kristin recently joined Continuum Clinical as Senior Manager, Advocacy Relations to partner with PAGs and professional medical societies to increase awareness of clients, their programs and their clinical trials. Previously, she led patient-centered programs in partnership with p... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #276: Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-526-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Presenters will discuss how patient input and real world evidence can be used to meet the "adequate and well-controlled studies" standard. The panel will discuss the meaning of the science of patient input, and provide examples of successfully using patient input (e.g., in making trial endpoint decisions; weighing benefit/risk; modifying study protocols based on patient input, etc.) within the regulatory context to enhance drug development and approval by incorporating the patient voice. Gaps and challenges with suggested solutions will be discussed, and differences among US and non-US regulatory agencies may be considered.

    Learning Objectives

    Define the science of patient input; Describe the challenges and solutions to successfully incorporating the patient voice into drug development.

    Chair

    Roslyn F Schneider

    Speaker

    Evolving Methods of Including Patients' Input in Drug Development
    Roslyn F Schneider

    Incorporating Patient Preferences in Drug Development and Approval
    Kevin Marsh, PhD, MSc

    Incorporating the Patient Perspective into a Target Product Profile for Intercepting Alzheimer’s Disease
    Bennett Levitan, MD, PhD



    Moderators
    avatar for Roslyn Schneider

    Roslyn Schneider

    Global Patient Affairs Lead, Pfizer Inc.
    Roslyn Schneider, Global Patient Affairs Lead at Pfizer drives more systematic patient centricity throughout the medicine development lifecycle. She held other roles in Medical Affairs, Medical Strategy and Development at Pfizer since 2006. Roz is an Internist, Pulmonologist, Int... Read More →

    Speakers
    avatar for Bennett Levitan

    Bennett Levitan

    Senior Director, Benefit-Risk Assessment, Department of Epidemiology, Janssen Research & Development, LLC
    Bennett Levitan, MD-PhD is Senior Director, Dept of Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and has led numerous teams in preparation of benefit-risk assessments. He co-led development of the PhRMA BRAT Framew... Read More →
    avatar for Kevin Marsh

    Kevin Marsh

    Executive Director, Evidera
    Kevin Marsh is Executive Director of Outcomes Research for Evidera. His research interests include using MCDA and quantitative preference data to inform health decisions, including pipeline optimisation, authorisation, reimbursement, and prescription decisions. He actively contri... Read More →
    avatar for Roslyn Schneider

    Roslyn Schneider

    Global Patient Affairs Lead, Pfizer Inc.
    Roslyn Schneider, Global Patient Affairs Lead at Pfizer drives more systematic patient centricity throughout the medicine development lifecycle. She held other roles in Medical Affairs, Medical Strategy and Development at Pfizer since 2006. Roz is an Internist, Pulmonologist, Int... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #277: The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    FDA and industry have taken lessons learned from the first four years of the biosimilar user fee agreement (BsUFA) and applied them to this first reauthorization of the program. This session will focus on changes to the program and their affect on both industry and the agency.

    Learning Objectives

    Discuss what's new in BsUFA II and the impact on sponsors and regulators.

    Chair

    Juliana Marguerite Reed, MS

    Speaker

    Biosimilar User Fee Act (BsUFA II) Reauthorization: Proposed Agreements
    Leah Christl, PhD

    Panelist
    Hillel Cohen, PhD

    Panelist
    Kimberly Greco

    Panelist
    John Pakulski, RPh



    Moderators
    avatar for Juliana Reed

    Juliana Reed

    Vice President, Government Affairs, Coherus BioSciences
    Extensive experience in the development of biosimilars policy around the globe. Prior to joining Coherus Biosciences, Juliana was at Hospira Inc, for over 10 years working to advance biosimilars in multiple global regions. Juliana is one of the founders of the Biosimilars Forum... Read More →

    Speakers
    avatar for Leah Christl

    Leah Christl

    Associate Director for Therapeutic Biologics, TBBS, OND, CDER, FDA
    Dr. Christl is the Associate Director for Therapeutic Biologics in the Office of New Drugs at FDA, leading the Therapeutic Biologics and Biosimilars Staff (TBBS) in OND. TBBS ensures consistency in the scientific and regulatory approach regarding development programs for proposed... Read More →
    avatar for Hillel Cohen

    Hillel Cohen

    Executive Director, Scientific Affairs, Sandoz Inc.
    Hillel Cohen is Executive Director at Sandoz, helping explain biosimilar policies to the healthcare community, public, & health authorities. He led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee. Recently he participated in BsUFA2 neg... Read More →
    avatar for Kimberly Greco

    Kimberly Greco

    Director, Research and Development Policy, Amgen Inc.
    JP

    John Pakulski

    Head, Regulatory Science, Biologics, Mylan Inc.
    avatar for Juliana Reed

    Juliana Reed

    Vice President, Government Affairs, Coherus BioSciences
    Extensive experience in the development of biosimilars policy around the globe. Prior to joining Coherus Biosciences, Juliana was at Hospira Inc, for over 10 years working to advance biosimilars in multiple global regions. Juliana is one of the founders of the Biosimilars Forum... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #278: PMDA Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    In this forum, members of PMDA’s executive staff will discuss progress made towards achieving the goals outlined in its “PMDA International Strategic Plan 2015”, as well as other initiatives currently underway. The presenters will also introduce new initiatives aiming to further PMDA’s contributions to global health, and will answer questions from the floor directly.

    Learning Objectives

    Identify the latest PMDA’s activities and direction on Japanese pharmaceutical regulation; Recognize the PMDA’s initiatives under the international regulatory environment.

    Chair

    Toshiyoshi Tominaga, PhD

    Speaker

    Panelist
    Tatsuya Kondo

    Panelist
    Shinobu Uzu, MPharm

    Panelist
    Kazuhiko Mori, MSc



    Moderators
    avatar for Toshiyoshi Tominaga

    Toshiyoshi Tominaga

    Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
    Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, h... Read More →

    Speakers
    avatar for Tatsuya Kondo

    Tatsuya Kondo

    Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
    Dr. Tatsuya Kondo is the Chief Executive of Pharmaceuticals and Medical Devices Agency since 2008. Before taking the current position, he spent most of his career as a neurosurgeon after he graduated from the University of Tokyo in 1968. He also has wide-ranging experience overse... Read More →
    avatar for Kazuhiko Mori

    Kazuhiko Mori

    Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)
    Kazuhiko Mori, MSc., is currently Councilor for Pharmaceutical Affairs, Minister’s Secretariat of the Ministry Health, Lobour and Welfare (MHLW). Mr. Mori has led many of MHLW/PMDA’s drug initiatives. He contributed to introduce new approaches to drug safety regulation includ... Read More →
    avatar for Toshiyoshi Tominaga

    Toshiyoshi Tominaga

    Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
    Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, h... Read More →
    avatar for Shinobu Uzu

    Shinobu Uzu

    Chief Safety Officer, Pharmaceuticals and Medical Devices Agency (PMDA)
    Mr. Shinobu Uzu is Chief Safety Officer, PMDA. He is responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law. Mr. Uzu took Master degree of Pharmacy from graduate school of the University... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #279: Brexit: Where Are We Now?
    Component Type: Forum
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    Brexit will impact on the established European Regulatory environment over the next decade. It may create potential new opportunities for deeper integration of the operational processes of the EU Regulatory Network, however, and may also create potential risks for regulatory business continuity that could be harmful to patients. This session will provide an overview of the current state of play of the political process from a UK as well as an EU perspective. It will seek views from important healthcare stakeholder groups, such as industry, regulators and patients on the longer term impact as well as practical aspects that need to be considered to avoid unintended consequences for EU and UK citizens while fully respecting the political decisions. Multiple stakeholder perspectives will look at the post Brexit scenario from a UK, EU and global regulatory environment view. Key stakeholders will discuss in a panel debate the impact of the expected changes on their organization and how they will capitalize on potential opportunities or mitigate potential risks to the regulatory business.

    Learning Objectives

    Discuss the impacted changes on an organization; Describe how an organization can capitalize on potential opportunities or mitigate risks to their regulatory business.

    Chair

    Sandra L. Kweder

    Speaker

    Panelist
    Virginia Lee Acha, PhD, MSc

    Panelist
    Jonathan Mogford

    Panelist
    Agnès Saint-Raymond, MD



    Speakers
    avatar for Virginia Acha

    Virginia Acha

    Executive Director, Research, Medical and Innovation, Association of the British Pharmaceutical Industry (ABPI)
    Virginia (Ginny) has worked in private sector and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined ABPI in 2015 to lead policy for research, medical and innovation to deliver bett... Read More →
    avatar for Sandra Kweder

    Sandra Kweder

    Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
    Dr. Kweder has been in her position in 2016, and previously held a number of leadership positions in CDER. Her work there focused on improving review processes to build a high performing organization that values scientific rigor, open discourse and high quality decision making. T... Read More →
    avatar for Jonathan Mogford

    Jonathan Mogford

    Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),
    avatar for Agnès Saint-Raymond

    Agnès Saint-Raymond

    Head of International Affairs (ad interim), Head of Portfolio Board, European Medicines Agency, European Union
    MD and qualified Paediatrician. Chef de Clinique in Paed. in Necker-Enfants-Malades Hospital (Paris, 1985-1990). Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medici... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
    • format json
    • Featured Topics Global Regulatory,Public Policy
    • Credit Type CME, IACET, RN
    • Tags Forum

    4:00pm

    #280: Developing Pharmacovigilance Policy Based on Impact
    Component Type: Session
    Level: Intermediate
    CE: CME 1.25; IACET 1.25; RN 1.25

    A trend is emerging to consider that pharmacovigilance regulations need to be justified in terms of their impact on patient safety, rather than simply being reactions to past concerns. If this idea catches on, it has huge implications for industry and regulators. This session will explore the implications of justifying pharmacovigilance regulations based on their impact on patient safety.

    Learning Objectives

    Describe the implications of justifying pharmacovigilance regulations based on their impact on patient safety.

    Chair

    Alan M. Hochberg

    Speaker

    Future Regulatory Goals of the Periodic Benefit-Risk Evaluation Reports (PBRER ): Are They Being Achieved?
    Shelley Gandhi, MS

    Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions
    Gerald J. Dal Pan



    Moderators
    avatar for Alan Hochberg

    Alan Hochberg

    Scientific Enablement Leader, F. Hoffmann-La Roche Ltd.
    Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engin... Read More →

    Speakers
    avatar for Gerald Dal&nbspPan

    Gerald Dal Pan

    Director, Office of Surveillance and Epidemiology, CDER, FDA
    Dr. Dal Pan is the Director of the Office of Surveillance and Epidemiology in FDA’s CDER, where he is responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is involved in both t... Read More →
    avatar for Shelley Gandhi

    Shelley Gandhi

    Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
    Shelley Gandhi brings a wealth of experience in the pharmacovigilance arena after being with the MHRA (UK Regulatory Authority) for 19 years and 2 years with the NDA group working with industry. She has extensive knowledge of all European regulatory processes related to monitorin... Read More →
    avatar for Alan Hochberg

    Alan Hochberg

    Scientific Enablement Leader, F. Hoffmann-La Roche Ltd.
    Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engin... Read More →


    Tuesday June 20, 2017 4:00pm - 5:15pm
    S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

    4:00pm

    #281: Integrating the Patient's Voice Across the Development Program of Rare Diseases: At the Table - Where to Sit?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-546-L04-P; CME 1.25; IACET 1.25; RN 1.25

    Patient advocacy groups are increasingly recognized as partners in drug development for the various important roles they can play in improving the clinical trial enterprise. With the renewed and heightened commitment to incorporating the patient voice into drug development and regulatory decision making under the 21st Century Cures Act and PDUFA VI, there is a significant opportunity to enhance participation by patient groups in the work of drug developers and the FDA review process. This session will discuss how as a result, there is value in all stakeholders understanding these opportunities and emerging models for incorporating the voice of the patient, from providing drug developers and regulators a unified understanding of the patient experience with the rare disease, to helping ensure that patient-centered information about outcomes in clinical trials are collected, such as through patient-reported outcomes measures.

    Learning Objectives

    Discuss the regulatory advantages of understanding the patient experience with a rare disease, including new opportunities under the 21st Century Cures Act and PDUFA VI; Describe how the patient’s perspective profoundly affects all dimensions of orphan drug development; Identify how engagement with a small patient population can aid in study endpoint selection that reflects outcomes meaningful to patients.

    Chair

    David H. Schubert

    Speaker

    The Importance of the Patient Voice and Patient-Industry Partnerships in Rare Disease
    Christine McSherry, RN

    The Rare Disease Patient Voice: Not One-Size-Fits-All
    James E. Valentine, JD, MHS

    Mobile App for Pulmonary Arterial Hypertension
    Wayne Amchin, MA, MPA, RAC



    Moderators
    avatar for David Schubert

    David Schubert

    Vice President of Regulatory and Quality, Stealth BioTherapeutics
    David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of... Read More →

    Speakers
    avatar for Wayne Amchin

    Wayne Amchin

    Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER, FDA
    Wayne manages the pulmonary arterial hypertension (PAH) portfolio, which includes many drug-device combination products, along with other therapeutic areas. He is the winner of the FDA’s Innovation Lab 1st Prototype Challenge for Mobile Apps, and he is developing the first mobi... Read More →
    avatar for Christine McSherry

    Christine McSherry

    Executive Director, The Jett Foundation