DIA 2017 Annual Meeting: Full Schedule

11:00am CDT

#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

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 →

Bev Hudson

Vice President Life Sciences, AMPLEXOR Life Sciences

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

14: ProfDevelopment, Session | 17: ContentHub, Session

format json
Tags Session

11:45am CDT

#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

Bev Hudson

Vice President Life Sciences, AMPLEXOR Life Sciences

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

17: ContentHub, Session

format json
Tags Session

1:15pm CDT

#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

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 CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

17: ContentHub, Session

format json
Tags Session

10:30am CDT

#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

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 January... Read More →

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

11: Quality, Session | 17: ContentHub, Session

format json
Tags Session

1:15pm CDT

#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

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States

Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

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 previously... Read More →

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 discovery... Read More →

Leigh Shultz

Head, Commercial Trade Channels, Merck & Co., Inc.

Elizabeth Somers

Executive Director, Global Project and Alliance Management, Merck Sharp & Dohme LLC, United States

Liz is an Executive Director in Global Project and Alliance Management at Merck focusing on Discovery PM. She manages a team focused on Discovery projects including complex collaborations which leverages her experience managing complex cross functional drug development programs and... Read More →

Tuesday June 20, 2017 1:15pm - 1:45pm CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session | 05: Regulatory, Session | 17: ContentHub, Session

format json
Tags Session

2:45pm CDT

#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

Emuella Flood

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

Tuesday June 20, 2017 2:45pm - 3:15pm CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

04: PatientEngagement, Session | 17: ContentHub, Session

format json
Tags Session

4:00pm CDT

#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

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. Mitchel... Read More →

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

01: Data-BigData-eHealth, Session | 11: Quality, Session | 17: ContentHub, Session

format json
Tags Session

4:45pm CDT

#293: Conversations That Matter: How do Regulatory Affairs Professionals Wish to Engage with Statisticians and Vice Versa?

Component Type: Session
Level: Basic

DIA is an important cross-functional organization for those professions like Regulatory Affairs and Statistics. Both professions are involved from early to late stage development and post-marketing. How can we help each other be more effective in our respective roles? What would both professions like to see discussed in sessions at the Annual Meeting? Statisticians turn data into knowledge. How can we be more effectively included in the Annual Meeting? Join the Statistics Community in this brainstorming discussion.

Learning Objectives

Discuss how the Regulatory Affairs and Statistics Communities might benefit from each other's community support.

Chair

Susan P. Duke, MSc

Speakers

Susan Duke

Consultant, Drug Safety Counts LLC

Susan has been active industry-wide in topics relating to quantifying patient safety since 2011 when she joined GSK's pharmacovigilance department's benefit-risk initiative. She is currently co-lead of a cross-functional initiative on safety monitoring. She has authored several publications... Read More →

Tuesday June 20, 2017 4:45pm - 5:15pm CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

05: Regulatory, Session | 06: Safety-PV, Session | 17: ContentHub, Session

format json
Featured Topics Statistics
Tags Session

10:30am CDT

#331: Conversations that Matter: How do Pharmacovigilance Professionals wish to Engage with Statisticians and Vice Versa?

Component Type: Session

DIA is an important cross-functional organization for those professions like Pharmacovigilance and Statistics. Both professions are involved from early to late stage development and post-marketing. How can we help each other be more effective in our respective roles? What would both professions like to see discussed in sessions at the Annual Meeting? Statisticians turn data into knowledge. How can we be more effectively included in the Annual Meeting? Join the Statistics Community in this brainstorming discussion.

Chair

Joan Buenconsejo, PhD, MPH

Speakers

Joan Buenconsejo

Senior Director, Biostatistics, AstraZeneca

Joan Buenconsejo is Senior Director, Biostatistics supporting late stage cardiovascular, renal and metabolic therapeutic areas within biopharmaceutical R&D at AstraZeneca. Prior to AZ, she was a statistics team lead at CDER, FDA. Dr. Buenconsejo is chair of the DIA Statistics Community... Read More →

Wednesday June 21, 2017 10:30am - 11:00am CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

06: Safety-PV, Session | 05: Regulatory, Session | 17: ContentHub, Session

format json
Featured Topics Statistics
Tags Session

11:15am CDT

#333: Information Quality in EHR Computer Systems

Component Type: Session
Level: Intermediate

The hospitals and clinics are implementing these computer systems. Pharma companies would lke to use the data in these systems in their studies, but they are not regulated by FDA and therefore there are some questions about the use of the information in these systems.

Learning Objectives

Identify the difference between EMR and EHR and to begin to think about the considerations for EHR info quality.

Chair

Anu Virkar, MA, MS

Speakers

Calvin Kim

Senior GxP IT Auditor, Bayer

Calvin is a seasoned IT auditor with over 20 years of experience in various sectors of GxP regulated industries. As a core member of a global QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technologies used in... Read More →

Anu Virkar

Vice President, Quality and Compliance, eClinical, IBM Watson Health

Anu Virkar, MS, MA, PMP is the VP of Q&C. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and Med device industry for over 15 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She... Read More →

Wednesday June 21, 2017 11:15am - 11:45am CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

11: Quality, Session | 17: ContentHub, Session

format json
Featured Topics Real World Evidence,Clinical Operations
Tags Session

2:45pm CDT

#361: Online Health Communities: A New Frontier in Health Research

Component Type: Session

Patients are the most valuable sources of information when seeking to learn about people’s experiences living with a specific condition, and which medical approaches have or have not worked. Online communities are a direct access point to an immense amount of valuable data that can be gathered quickly and inexpensively by posing questions to the communities, fielding online surveys, or applying social listening techniques to organic conversations. This session will engage the audience in a lively discussion focusing on new ideas for gathering information from online communities as ways to advance health research, particularly clinical trials, product development and acceptance testing.

Chair

Sara Hayes, MPH

Speakers

Sara Hayes

Director, Community Development, Health Union, LLC

Sara Hayes, MPH, is Director of Community Development at Health Union where she uses her experience in health care and patient engagement to support Health Union’s communities. With a Master’s degree in Public Health and experience across a variety of healthcare settings, Sara... Read More →

Wednesday June 21, 2017 2:45pm - 3:15pm CDT
S400 Concourse McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

04: PatientEngagement, Session | 17: ContentHub, Session

format json
Tags Session