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Bethesda North Marriott Hotel and Conference Center

Sep 17, 2015 7:15 AM - Sep 18, 2015 4:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products

Engage with patients, industry, and regulators to address the challenges of when and how to include patient perspectives in benefit-risk assessment of medical products.

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Session 1: Medical Product Development, Benefit-Risk Assessment, & Patient Engagement: Concepts and Context

Session Chair(s)

Patricia Furlong, BSN

Patricia Furlong, BSN

Founding President and Chief Executive Officer

Parent Project Muscular Dystrophy, United States

Marilyn A. Metcalf, PhD

Marilyn A. Metcalf, PhD

Senior Director, Patient Focused Development, Global Medical

GlaxoSmithKline, United States

The purpose of this session is to discuss foundational concepts with all stakeholders together to establish the context of benefit-risk and patient engagement in medical product development and to agree to common terminology for the duration of the conference. The importance of benefit-risk assessment and key times it takes place in the product cycle, its meaning in the context of patient need, stakeholders to be involved, and the importance of patient partner engagement will be discussed. The foundations and meaning of many types of patient engagement will be an important focus of this session.

Speaker(s)

K. Kimberly McCleary

Environmental Context - Why is This Important Now?

K. Kimberly McCleary

The Kith Collective, LLC, United States

Founder and Chief Executive Officer

Andrea Stern Ferris, MBA

Patient Perspective

Andrea Stern Ferris, MBA

LUNGevity Foundation, United States

President and CEO

Tarek Hammad, MD, PhD, MS, MSc, FISPE

Overview of Medical Product Development and Benefit-Risk Assessment

Tarek Hammad, MD, PhD, MS, MSc, FISPE

Takeda, United States

Vice President, Head of Medical Safety, Marketed Products

Richard Forshee, PhD

Setting the Baseline on Benefit-Risk Assessment

Richard Forshee, PhD

FDA, United States

Deputy Director, OBPV CBER

Marilyn A. Metcalf, PhD

Patient Engagement in the Context of Drug Development & Benefit-Risk Assessment

Marilyn A. Metcalf, PhD

GlaxoSmithKline, United States

Senior Director, Patient Focused Development, Global Medical

Q&A Discussion/Feedback between Conference Participants & Panel

Panel Discussion

United States

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