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Tuesday, June 29 • 4:00pm - 5:00pm
#257 SL: Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-588-L04-P; CME 1.00; IACET 1.00; RN 1.00

With combined experience running studies and drafting FDA rules, this panel will show why guidance on trial diversity has not produced results. Audience polling will help illuminate how incentives can translate guidance into thoughtful action.

Learning Objectives

Characterize obstacles that rendered FDA guidance on clinical trial diversity ineffective thus far; Identify federal initiatives, such as the Orphan Drug Act, that have successfully galvanized industry in other contexts; Define incentives that might invigorate industry-led minority enrollment programs; Evaluate an audience ranking of proposed incentives using real-time digital polling.

Chair

Stephen Keith, MD, MPH

Speaker

Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?
Peter J. Pitts

Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?
David H Strauss, MD

Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?
Kimberly Y. Smith, MD, MPH


Speakers
avatar for Stephen Keith

Stephen Keith

Senior Medical Director, Medical and Scientific Management, Clinical Solutions, Syneos Health, United States
Dr. Stephen Keith has over 25 years of experience in biopharma. He joined Syneos Health in 2018 as Medical Director. Previously, he held C-level positions at 3 biotech companies, as well as a senior position at Merck. Prior to entering the industry, he served as Health Policy Advisor... Read More →
avatar for Peter Pitts

Peter Pitts

President, Center for Medicine in the Public Interest (CMPI), United States
Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. Peter was FDA’s Associate Commissioner for External Relations, serving as senior... Read More →
avatar for Kimberly Smith

Kimberly Smith

Senior Vice President, Head of Research and Development, ViiV Healthcare, United States
A pioneering woman of color, Dr. Smith is one of the first to lead research and development for a multi-national pharmaceutical company. As head of R&D for ViiV Healthcare, the only company 100% dedicated to HIV medicines, she leads the industry in developing new drugs that have the... Read More →
avatar for David Strauss

David Strauss

Special Lecturer, Columbia University , United States
Dr. Strauss’s expertise involves the ethics and regulation of clinical research. He is currently Special Lecturer in the Department of Psychiatry at Columbia University and serves as Senior Advisor to the Multi-Regional Clinical Trials Center (MRCT) at Brigham & Women's Hospital... Read More →

Tuesday June 29, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum