DIA 2017 Annual Meeting: Full Schedule

11:00am CDT

#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

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 multiple... Read More →

Speakers

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 serves... Read More →

Marie Manley

Partner and Head of the Regulatory Practice, Bristows LLP

Maria Isabel, Partner & Head of the Regulatory Department at Bristows LLP, specialises in European & UK regulatory and competition law in the bio-pharmaceutical and medical devices sectors. Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise... Read More →

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

08: StratPlan-Exec-Partnershps, Session

Level Intermediate
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Credit Type CME, IACET, PMI, RN
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9:30am CDT

#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

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 President... Read More →

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

15:Engage-Exchange, Session | 08: StratPlan-Exec-Partnershps, Session | 09: TranslSci-Preclin-Clin-ProdDev, Session

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Featured Topics Clinical Operations
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10:30am CDT

#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

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 →

Speakers

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 cell... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
S501abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Forum

Level Basic
Featured Topics Career Development
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Featured Topics Career Development,StudentProgramming
Credit Type CME, IACET, PMI, RN
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10:30am CDT

#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

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 strategy... Read More →

Speakers

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 demonstrates... Read More →

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

08: StratPlan-Exec-Partnershps, Session

Level Intermediate
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Credit Type CME, IACET, PMI, RN
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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.

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

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2:00pm CDT

#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

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 graduated... Read More →

Tuesday June 20, 2017 2:00pm - 3:00pm CDT
Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

15:Engage-Exchange, Session | 08: StratPlan-Exec-Partnershps, Session

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2:00pm CDT

#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

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 Vanderbilt... Read More →

Karla Childers

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

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-Founder... Read More →

Walter Straus

Vice President, Safety and PV, Moderna, United States

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 epidemiologist... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session

Level Advanced
Featured Topics Clinical Operations, Academic Clinical Researcher, Patient Centric
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Featured Topics Clinical Operations,Academic Clinical Researcher,Patient Centric
Credit Type ACPE, CME, IACET, PMI, RN
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2:00pm CDT

#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

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, Anti-Infectives... Read More →

Speakers

Janice Chang

Chief Executive Officer, TransCelerate Biopharma Inc., United States

Janice Chang is the Chief Executive Officer at TransCelerate BioPharma Inc. She has been involved with the organization since its inception. In her current position, Janice works closely with the Board of Directors to shape the long-term strategic vision and priorities for the organization... Read More →

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 BCM... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session

Level Intermediate
Featured Topics Public Policy
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Featured Topics Public Policy
Credit Type CME, IACET, PMI, RN
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4:00pm CDT

#283: The Impact of Industry Consortia on Creating Collaborative Solutions to Drug Development Challenges: What Does the Future Hold?

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000199; RN 1.25

It takes $2.6 billion in capitalized costs to develop a new drug. Only one in 10 new drug applications is approved, and cycle times are not faster compared to the mid-90s. Many companies continue to spend time and energy on addressing challenges that do not bring competitive differentiation. The Avoca Quality Consortium along with other industry consortia have enabled sponsors, CROs, and specialty providers to leapfrog solution development through common, collaboration platforms. In this forum, we will discuss the process for driving change through industry collaborations, and we will explore the challenges and opportunities for making a meaningful impact in an industry that is slow to change. Two case studies, one involving workforce development and one involving oversight, will be covered.

Learning Objectives

Discuss how consortia and industry collaboratives can provide benefits in drug development.

Chair

Patricia Leuchten

Speaker

Industry Consortia are Propelling Collaborative, Creative Solutions in Drug Development: How Have we Enabled Partnering Between Sponsors, CROs, and Other Industry Stakeholder Groups to Foster Change and Create Streamlined Solutions?
Steven B. Whittaker

Change Management Requires Processes, Technology, AND PEOPLE: A New Paradigm in Innovative Workforce Development Through Previously Unused Forms of Collaboration
James Kremidas

Industry-Based GCP, GLP, GMP, and Nonregulated Outsourcing Oversight Maturity Model: Partnering on Solutions to Reduce the Gap Between Sponsors and CROs
Barbara Kristina Beck, MS

Moderators

Patricia Leuchten

President and Chief Executive Officer, The Avoca Group

Patricia Leuchten is Founder and CEO of The Avoca Group, a consulting and research firm focused in clinical outsourcing and the first company to measure the health of sponsor-CRO relationships. In 2012, Ms. Leuchten founded the Avoca Quality Consortium, a division of Avoca that provides... Read More →

Speakers

Barbara Beck

Director, Written Standards and Governance, Third Party Resourcing, GlaxoSmithKline

Barbara Beck is currently with GlaxoSmithKline (GSK), and in her role she is helping to support outsourcing activities within GSK Pharma R&D. One particular area of interest is in building internal capability in the oversight space. This desire led to the collaboration with the AQC... Read More →

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)

Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing... Read More →

Steven Whittaker

Executive Director, Quality Consortium, The Avoca Group

Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution... Read More →

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Forum

Level Intermediate
Featured Topics Academic Clinical Researcher, Quality-GXP
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Featured Topics Academic Clinical Researcher,Quality-GXP
Credit Type CME, IACET, PMI, RN
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9:30am CDT

#304: Mergers and Acquisitions: First, Do No Harm

Component Type: Session
Level: Intermediate

Mergers and acquisitions (M&A) are increasingly common in our industry. Managers gaining new employees and employees entering new structures and systems - and often entirely new workplace cultures - may struggle to adapt, sometimes with disastrous consequences. Even with careful planning and thoughtful communication, stress and anxiety levels can remain high in the period of time before and after the event. In this session, we will discuss the factors that impact emotional well-being in an M&A, from both the manager’s and the employee’s perspectives. We will walk through two M&A scenarios in which the manager or the employee has become disenchanted or disengaged, and we will discuss ways in which to ‘hit the reset button’ in order to mitigate the harm. Participants will engage in role play, and will be given a guide to healthy M&A communication to take back to their workplace.

Learning Objectives

Describe how a mergerand acquisition can impact both a manager’s and an employee’s emotional well-being; Develop a communication plan to reduce levels of stress and anxiety; Recognize when the level of anxiety is high, and employ corrective action to mitigate that anxiety.

Chair

Margaret S. Richards, PhD, MPH

Speakers

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 →

Wednesday June 21, 2017 9:30am - 10:30am CDT
Aisle 300/400 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

15:Engage-Exchange, Session | 14: ProfDevelopment, Session | 08: StratPlan-Exec-Partnershps, Session | 09: TranslSci-Preclin-Clin-ProdDev, Session | 03: MedAffairs-SciComm, Session

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10:30am CDT

#323: Effective Collaborations: Navigating the Grey Space

Component Type: Forum
Level: Advanced
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000200; RN 1.25

Research and development (R&D) partnership models are a common arrangement that can be found in small and large companies alike. While legal agreements provide the guardrails for those engagements, the success of a partnership can hinge on how well the alliance managers and relevant team members manage the grey spaces not explicitly covered in the pre-arranged contract. In this forum, we will talk through some areas that often fall into this grey space such as data ownership, firewalls, and governance committees.

Learning Objectives

Identify areas that may not be commonly covered in collaboration agreements and learn how to effectively negotiate those spaces while maximizing the health of the collaboration.

Chair

Andrew Townshend

Speaker

Outside the Contract: Best Practices for Alliance Relationship Maintenance
Andrew Townshend

Navigating Governance in a Partnership: Are the Players Really Equal? How to Navigate the Potential Imbalance
Stephane Marzabal, PhD

Making the Most of Your Collaboration: What to do When the Contract is Silent
Matthew J Meitzner, MS

Moderators

Andrew Townshend

Senior Vice President, Alliance Development, INC Research

Vice President of Business Development at INC Research. Mr. Townshend has responsibility for developing strategic accounts within the Pharma and biotech industries focused on novel and innovative engagement and alliance models. Prior to this, Mr. Townshend was Vice President Outsourcing... Read More →

Speakers

Stephane Marzabal

Co Founder, SYNOV Solutions LLC

Stephane Marzabal has 20 years experience in the pharmaceutical industry. He started in Clinical Operations & in 2006, moved to Program Leadership managing assets in partnerships, across all phases of development. He successfully led teams to the launch of 2 drugs. In parallel, he... Read More →

Matthew Meitzner

Associate Director, Project Management, Merck & Co., Inc.

Matt Meitzner is an experienced project manager in the pharmaceutical and medical device industries.

Wednesday June 21, 2017 10:30am - 11:45am CDT
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Forum

Level Advanced
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Credit Type CME, IACET, PMI, RN
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10:30am CDT

#324: Keys to Effective Product Launch Preparation

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000204; RN 1.25

Given the small number of products that often make it successfully through development, not many people have the chance to launch a product. This session will describe a framework for effective launch preparation and how different functions should begin preparing and planning for a successful launch.

Learning Objectives

Describe a launch development model; Discuss examples of global launch successes and failures.

Chair

Stephanie F. Brown, MA

Speaker

Preparation and Partnership: The ‘Secret Sauce’ in Launch Readiness
Stephanie F. Brown, MA

Everything You Wanted to Know About Launching a Drug but Were Afraid to Ask!
Matthew Steven Curin, PharmD

Moderators

Stephanie Brown

Senior Director, Medical Affairs Launch Readiness, Eli Lilly and Company

Stephanie Brown, Sr. Director, Med Affairs Solutions & Launch Readiness at Eli Lilly and Company, has held leadership roles in various Med Affairs functions such as medical writing, med info, med ed, project management, MSL strategy, and eCapabilities. Because of these experiences... Read More →

Speakers

Matthew Curin

Executive Director, Program Management, Epizyme

Matt has been working in the pharmaceutical industry for almost 20 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →

Matthew Curin

Director, Project and Process Excellence, Astellas Pharma US, Inc.

Earned a Doctor of Pharmacy from the University of Michigan. Spent 8 years in clinical manufacturing before moving into project management. Since 2007, has provided project management support for clinical development, medical affairs, and commercial. Previously worked at Pharmacia... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
N426c McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session

Level Intermediate
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Credit Type CME, IACET, PMI, RN
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10:30am CDT

#325: Leading in the Midst of Ambiguity

Component Type: Workshop
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000208; RN 1.25

While projects are often well-defined, project leaders may sometimes find themselves in situations where a project or initiative does not have many clear guardrails or defined outcomes. Being effective in this type of situation requires the confidence and ability to take prudent risks and navigate teams through uncertainty. Participants in this workshop will work through case studies and practice skills needed to be successful in these situations.

Learning Objectives

Discuss leadership skills that can be applied to the effective management of ambiguous or uncertain situations.

Chair

Nicky Rousseau, CPA, MBA

Speaker

Making Sense Out of Chaos: Leading in the Midst of Ambiguity
Nicky Rousseau, CPA, MBA

Facilitator
Jennifer Cubino, MA

Moderators

Nicky Rousseau

Senior Director, Sales Organization Development, QuintilesIMS

Nicky helps leaders and teams solve business challenges through experiential learning, coaching and leadership development programs. Participants accelerate their adaptability and growth through enhanced generative conversations, complex problem-solving, and clear aspiration. Nicky... Read More →

Speakers

Jennifer Cubino

Delivery Head, Senior Director, Customer Operations, QuintilesIMS

Innovative team leader and problem solver specializing in iterative design processes to build transformative solutions for pharma customers, site research partners and above all else, patients. Demonstrated ability to successfully lead multi-disciplinary teams integrating technology... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Workshop

Level Intermediate
Featured Topics Career Development
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Featured Topics Career Development,StudentProgramming
Credit Type CME, IACET, PMI, RN
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4:00pm CDT

#379: The Art of Negotiation: Preparing Yourself and Your Team for Their Seat at the Table

Component Type: Workshop
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000205; RN 1.25

The ability to facilitate rapid decision making is a key skill for a project manager; however, sometimes speed can come at the expense of one of your stakeholder groups. How can you improve your influence and negotiation skills in order to help those critical conversations be more well rounded and focused on collective goals rather than personal agendas?

Learning Objectives

Identify tools and tips for effective negotiations.

Chair

Jennifer A. Emerson, PhD, PMP

Speaker

The Art of Negotiation: Strategies for Success and Leadership at the Bargaining Table
Jennifer A. Emerson, PhD, PMP

Stakeholder Engagement and Effective Governance Decision Making
Nathan R. Kreischer, MS, PMP

Moderators

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 international... Read More →

Speakers

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co. Inc., United States

Nathan is a Director within Global Project & Alliance Management at Merck. He has over 14 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Workshop

Level Basic
Featured Topics Career Development
format json
Featured Topics Career Development,StudentProgramming
Credit Type CME, IACET, PMI, RN
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4:00pm CDT

#380: Effective Portfolio Management and How to Ensure You Get the Value Out of the Decisions Made

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000209; RN 1.25

Making timely portfolio decisions is critical to ensure organizations achieve the value of the exercise. This session will discuss how those decisions can be made and communicated effectively. Speakers will also address how to ensure timely closeout once a decision to discontinue or deprioritize has been made.

Learning Objectives

Discuss basic concepts of portfolio management decision making; Identify best practices for ensuring timely close-out of a project.

Chair

Kemi Yusuf, MBA, PMP

Speaker

The Art and Science of Effective Portfolio Management: How to Make the Right Portfolio Decisions and Make Them Stick
Kemi Yusuf, MBA, PMP

Defining and Obtaining Value as a Result of Portfolio Management: Considerations for Pharma and Biotech Companies
Dan Tierno, MA, MBA

When It’s Time to Call it Quits: Close Out of Late-Stage Clinical Programs
Larissa Wilsie, MS, PMP

Moderators

Kemi Yusuf

Head, International PV Strategy and Office of the Product Safety Team, AbbVie, Inc.

Kemi Yusuf leads International Pharmacovigilance (PV) Strategy and Office of the Product Safety Team within AbbVie. She has over 15 years of experience in developing and implementing global transformational strategies to elevate business performance, expand capabilities, strengthen... Read More →

Speakers

Dan Tierno

Associate Director, Global Clinical Data Sciences and Analytics, Bayer

Mr. Dan Tierno has over 20 years of experience in the pharmaceutical and biotech industry, specializing in drug development, data sciences and analytics for clinical trials, and commercialization of novel small molecule and cell based therapeutics. Mr. Tierno has spoken on training... Read More →

Larissa Wilsie

Associate Director, Project Management, Merck & Co., Inc.

A cell biologist by training, Larissa joined Merck in 2004 as a Discovery scientist. She moved into project management in 2013 and has worked across therapeutic areas, supporting programs from early stage development through post-approval activities. She is a staff manager and mentor... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session

Level Basic
Featured Topics Clinical Operations
format json
Featured Topics Clinical Operations,StudentProgramming
Credit Type CME, IACET, PMI, RN
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4:00pm CDT

#381: Maximizing Success in Partner Collaborations

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000210; RN 1.25

Clinical research is an inherently collaborative enterprise, but competing objectives and priorities between stakeholders (e.g., CROs, government sponsors, pharmaceutical companies, research sites) can hinder innovation and progress within the industry. Being responsive to stakeholder’s needs is critical to research success, but how do we make progress when priorities seem to conflict with each other? Careful planning and strategic focus are imperative to successfully negotiate the needs of all stakeholders. This session will explore how this can be achieved using case studies from three different types of organizations.

Learning Objectives

Identify the perspectives and priorities of different clinical research entities, including CROs, government sponsors, voluntary health organizations, and pharmaceutical companies; Describe challenges resulting from these differences and identify potential solutions; Discuss success factors for implementing solutions to collaboration challenges across different clinical research entities.

Chair

Shann Williams, PMP

Speaker

Competing or Complementary Demands? How Seemingly Opposing Needs From Government and Pharmaceutical Clients Created Cohesion.
Shann Williams, PMP

Beat AML: A Ground Breaking Master Trial Run by a Consortium of AROs, Global Drug Companies, CRO, and eClinical Vendors
Len Rosenberg, PhD, RPh

The Execution Evolution: Exploring the Untapped Value in Medical Device CRO Partnerships
Charles Raymond, MBA

Moderators

Shann Williams

Senior Director, Operations, Rho, Inc.

Shann Williams, PMP, Sr. Director, Operations has over 10 years of experience managing clinical trials. She is currently a Director of Operations for the Statistical and Clinical Coordinating Center at Rho, Inc. funded out of the NIH-NIAID Division of Asthma, Immunology, and Transplantation... Read More →

Speakers

Charles Raymond

Manager, Commercial Affairs, ICON, plc.

Life Science Finance Professional with 10 plus years of industry experience spanning across Clinical and Device service providers with a recent focus on driving partnerships through Commercial and Operational excellence. Secured preferred provider status over the past 18 months with... Read More →

Len Rosenberg

Head, Clin Ops, Leukemia & Lymphoma Society

Dr. Rosenberg is Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society and also Managing Partner of eP2Consulting, Inc. since 2001. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session

Level Intermediate
Featured Topics Academic Clinical Researcher, Clinical Operations, Outsourcing, Devices-Combination Products
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Featured Topics Academic Clinical Researcher,Clinical Operations,Devices-Combination Products
Credit Type CME, IACET, PMI, RN
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10:45am CDT

#408: Flexing Your Project Management Muscles Outside of Traditional Roles

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000201; RN 1.25

Typically the expectations for a Project Manager on a drug development team are very clear and defined. However, there are opportunities to leverage project management (PM) skills and experience in areas of organizations that may not have a formal PM function or might call the role something different. In this forum, hear from different project managers about their experience in flexing their PM muscles in different ways.

Learning Objectives

Describe the various roles and responsibilities of project managers either in non-drug development projects or in junior roles.

Chair

Gina Maria Johns, PMP

Speaker

Getting Out of Your Comfort Zone: A Drug Development Project Manager on a Patient-Centered Initiative
Carrie Furin

From Bench Chemist to Business Owner: How a Career in Nontraditional Project Management Roles Created Career Opportunity
Gina Maria Johns, PMP

Associate Project Manager, Coordinator, Planner: PM Roles and Their Link to Departmental Structure and Vision
Juan Castano, MBA, PMP

Moderators

Gina Johns

Founder/ Project Manager, Ocean Consulting Solutions LLC

Gina Johns is a project management consultant with 20+ years of experience in the pharmaceutical industry, working in all segments of drug discovery and development (from programs in target validation through early and late development, and registration and approval). As a consultant... Read More →

Speakers

Juan Castano

Associate Director, Asset Planner, Pfizer Inc

Juan Castano is an Associate Director, Asset Planner within the Portfolio & Project Management group at Pfizer. He has over 15 years of experience in pharma drug development. He began his career as a Process Chemist at Merck where he later joined the Project Management group. Juan... Read More →

Carrie Furin

Manager, Clinical Trial Management, Eli Lilly and Company

Carrie is a Manager with Eli Lilly and Company overseeing Clinical Trial Managers on Oncology trials. She has over 10 years of drug development experience in clinical operations and project management. Carrie has led teams across multiple therapeutic areas and phases, which has provided... Read More →

Thursday June 22, 2017 10:45am - 12:00pm CDT
S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616

08: StratPlan-Exec-Partnershps, Session

Level Basic
Featured Topics Clinical Operations, Academic Clinical Researcher, Patient Centric
format json
Featured Topics Clinical Operations,Academic Clinical Researcher,StudentProgramming,Patient Centric
Credit Type CME, IACET, PMI, RN
Tags Session