NOVEMBER 29 & 30, 2023

To share comments related to the topics addressed during the workshop, please post your comments to the FDA public docket by January 29, 2024.

Virtual Public Meeting Resources:

Full two-day agenda

Download full two-day PowerPoint slide set

Speaker and Panelist Biographies

Virtual Public Meeting Recordings:

Watch Day 1:

Watch Day 2:

*ASL interpretation and Closed Captioning (CC) is available on both videos.

Virtual Public Meeting Speakers, Moderators & Panelists:

Day 1 (in order of appearance):

• Karen Hicks, Deputy Director, Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA) 
• Patrizia Cavazzoni, Director, CDER, FDA
• Richardae Araojo, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, FDA
• Lola Fashoyin-Aje, Deputy Division Director & Associate Director, Oncology Center for Excellence (OCE), FDA
• Eldrin Lewis, Simon H. Stertzer Professor of Cardiovascular Medicine, Stanford Medicine
• Laura Mauri, Senior Vice President (VP), Chief Scientific, Medical and Regulatory Officer, Medtronic
• Allison Cuff Shimooka, Chief Operating Officer (COO), TransCelerate BioPharma, Inc.
• Ricki Fairley, Chief Executive Officer (CEO), Touch, the Black Breast Cancer Alliance
• Dionne Price, Deputy Director, Office of Biostatistics, CDER, FDA
• Scott Halpern, John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania
• Dooti Roy, Director, Global Biostatistics & Data Sciences, Boehringer Ingelheim Inc
• Bobbi Bogaev Chapman, Vice President (VP), Heart Failure, Abiomed
• Tom Fleming, Professor of Statistics and Biostatistics, University of Washington
• Michel Reid, Senior Director and Head, Global Demographics and Diversity, GlaxoSmithKline
• Larissa Aviles-Santa, Director, Division of Clinical and Health Services Research, National Institute on Minority Health and Health Disparity (NIMHD), National Institutes of Health (NIH)
• Rose Blackburne, VP, Global Therapeutic Area Head, General Medicine & Women’s Health, Medical Science & Strategy (MSS), PPD, Thermo Fisher Scientific Company
• Anne Lyerly, Professor of Social Medicine, The University of North Carolina at Chapel Hill
• Michele Kipke, Professor of Pediatrics, Associate Vice President for Strategic Health Initiatives, Keck School of Medicine, University of Southern California
• Jennifer Jones-McMeans, Divisional VP of Global Clinical Affairs, Abbott
• Dawn Corbett, Inclusion Policy Officer, Office of Extramural Research, NIH
• David Resnik, Bioethicist, National Institute of Environmental Health Sciences, NIH
• Willyanne Decormier Plosky, Program Director, Multi-Regional Clinical Trials Center, Harvard University
• Kellie Malloy Foerter, VP, Global Trial Management, Immunology, Cardiovascular and Neuroscience, Bristol Myers Squibb
• Ari Ne’eman, PhD Candidate, Harvard University
• Alison Barkoff, Performing the duties of the ACL Administrator and Assistant Secretary for Aging
• Sally Okun, Executive Director, Clinical Trials Transformation Initiative (CTTI)

Day 2 (in order of appearance):

• Mathilda Fienkeng, Director, Division of Medical Policy Development, OMP, CDER, FDA
• Paul Appelbaum, Professor of Psychiatry, Medicine & Law, Columbia University
• Patricia Areán, Director, Division of Services and Intervention Research, National Institute of Mental Health, NIH
• Allissa Torres, Director of Mental Health Equity, Mental Health America
• Scott Kim, Senior Investigator, Department of Bioethics, NIH Clinical Center
• Eric Lenze, Professor and Head, Department of Psychiatry, Washington University School of Medicine
• Craig Tendler, VP, Oncology Clinical Development, Diagnostics & Global Medical Affairs, Janssen, Pharmaceutical Companies of Johnson and Johnson
• Craig Lipset, Co-Founder and Co-Chair, Decentralized Trials and Research Alliance
• Laura Esserman, Professor of Surgery & Radiology, School of Medicine, University of California, San Francisco
• Luther T. Clark, Deputy Chief Patient Officer, Merck
• Alanna Morris, Associate Professor, Department of Medicine, Emory University School of Medicine
• Ivor Horn, Director of Health Equity and Product Inclusion, Google
• James Hildreth, President and CEO, Meharry Medical College
• Paula Boyles, External Clinical Trial Data Sharing Program Lead, Pfizer
• Cynthia Chauhan, Heart Failure Collaborative
• Tarek Hammad, VP, Head of Medical Safety, Marketed Products, Global Patient Safety Evaluation, Takeda
• Barbara Bierer, Professor of Medicine, Center for Bioethics, Harvard Medical School
• Tesheia Johnson, Deputy Director and COO, Yale Center for Clinical Investigation
• Ileana Pina, Professor of Medicine, Thomas Jefferson University
• Angeloe Burch, Sr, African American Community Collaborative, Inc
• Reed Tuckson, Managing Director, Tuckson Health Connections, LLC
• Perla Nunes, Perla Nunes, Consulting
• Billy Caceres, Assistant Professor, Columbia University School of Nursing
• Kali Zhou, Assistant Professor of Clinical Medicine, Keck School of Medicine, University of Southern California
• Nakela Cook, Executive Director, Patient-Centered Outcomes Research Institute
• Peter Marks, Director, Center for Biologics Evaluation and Research, FDA
• Jeff Shuren, Director, Center for Devices and Radiological Health, FDA
• Peter Stein, Director, Office of New Drugs, CDER, FDA
• Marc Theoret, Deputy Director, OCE, FDA
• Meghan McKenzie, Principal, Patient Inclusion and Health Equity, Chief Diversity Office, Genentech
• Karen Hicks, Deputy Director, OMP, CDER, FDA

Additional Resources:

CTTI Diversity Project Page

Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies