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Monday, June 27 • 8:30am - 9:45am
#114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-604-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are the experts in their disease and its impact, and across the research enterprise, stakeholders are working to identify how to best leverage this expertise to enhance trial design, conduct, and overall relevance to patients. This session will provide patient, regulator, and industry perspectives on how this goal can be achieved. Speakers will review key FDA, Clinical Trials Transformation Initiative, and sponsor initiatives designed to bring the patient into the conversation as trials are designed, implemented, and their results reviewed. Presenters will discuss challenges faced and offer ideas on how these challenges may be proactively addressed.

Learning Objectives

Discuss key FDA initiatives related to patient engagement and how these may better incorporate the patient perspective into all stages of drug development; State a patient perspective on how patients could be better engaged in trial design and recruitment and learn about a project to facilitate patient engagement and recruitment.

Chair

Jonca C. Bull, MD

Speaker

Patient Perspective
Jane Perlmutter

Patient Centric Trial Design: It's More Than Just the Trial
Joseph Kim

FDA Perspective
Elektra Johanna Papadopoulos



Chair
avatar for Jonca Bull

Jonca Bull

Assistant Commissioner for Minority Health, Office of the Commissioner, FDA
Dr. Bull worked at the FDA from 1994 to 2006. She served as Director of clinical regulatory policy at Genentech and as Vice President for US Regulatory Policy at Novartis, returning to FDA in 2012 to serve in the Office of the Commissioner as Assistant Commissioner for Minority Health,

Speakers
avatar for Joseph Kim

Joseph Kim

Senior Advisor, Clinical Innovation, Eli Lilly and Company
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on innovative patient engagement solutions. He has spent over 17 years in the Pharma industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. He holds a BS in Molecular Biology and an MBA. He can be reached at kim_joseph_p@lilly.com and... Read More →
EP

Elektra Papadopoulos

Acting Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Elektra has been a medical officer at the FDA since 2001 and she currently serves as the Acting Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in CDER. The Staff provides internal consultation regarding clinical outcome assessment development and implementation across different therapeutic areas. The Staff also participates in guidance and policy development with regard to use of clinical outcome... Read More →
avatar for Jane Perlmutter

Jane Perlmutter

Founder and President, Gemini Group
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of research questions, design of trial protocols, and encouraging innovation to increase the speed of developing new treatments. She is also involved in health research... Read More →


Monday June 27, 2016 8:30am - 9:45am
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA