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Wednesday, June 30 • 10:00am - 11:00am
#319 L: The FDA's Clinical Trial Diversity Initiative in the Setting of the Ongoing COVID-19 Pandemic

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-609-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA’s commitment to Clinical Trial (CT) diversity is integral to the agency’s mission. Recognizing that COVID-19 affects certain populations differently, FDA’s session will explore solutions and stakeholder collaborations in support of CT diversity.

Learning Objectives

Recognize how the COVID-19 pandemic underscores the need for clinical trial diversity; Identify ways to increase underrepresented populations in clinical trials in accordance with FDA policy guidance; Evaluate the effectiveness of current FDA policy initiatives aimed at increasing historically underrepresented populations in clinical trials.

Chair

Wambui Chege, MD, FACP

Speaker

Panelist
Richardae Araojo, PharmD, MS

Panelist
John Concato, MD, MPH, MS

Panelist
Peter Basseches, PhD

Panelist
Anu Osinusi, MD, MPH

Panelist
Richard Knight, MBA

Panelist
John Whyte, DrMed, MD, MPH


Speakers
PB

Peter Basseches

Distinguished Scientist, Global Regulatory Affairs and Clinical Safety, Merck & Co., Inc, United States
avatar for Richardae Araojo

Richardae Araojo

Associate Commissioner for Minority Health, Director, Office of Minority Health, FDA, United States
RDML Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration. In this role she provides leadership, oversight, and direction on minority health, health disparity... Read More →
WC

Wambui Chege

Physician Policy Advisor, DMPD, OMP, CDER, FDA, United States
LCDR Wambui Chege is a Physician Policy Advisor in the Division of Medical Policy Development, in the Office of Medical Policy’s Office of Medical Policy Initiatives within the FDA’s Center for Drug Evaluation and Research. She has previously served as Medical Officer, Team Lead... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency... Read More →
RK

Richard Knight

President, American Association of Kidney Patients , United States
Mr. Knight has a background in public policy and Congressional operations based on both his professional experience on Capitol Hill, where he served in various roles including communications, policy, and Legislative Director as well his advocacy work as a kidney transplant patient... Read More →
AO

Anu Osinusi

Vice President, Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences, Inc., United States
Vice President, leading the Viral Hepatitis (hepatitis B, C and D), Respiratory and Emerging (COVID-19, Ebola, others) Viruses group at Gilead Sciences, Inc. Anu is a clinician-researcher with over 15 years of experience in infectious diseases, liver diseases, global health and drug... Read More →
avatar for John Whyte

John Whyte

Chief Medical Officer, WebMD, United States
Dr. John Whyte is a popular physician, executive, policymaker and writer who has been communicating to the public on important health issues for the past 20 twenty years. He is currently the Chief Medical Officer of WebMD where he helps lead the editorial and strategic direction... Read More →

Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum