OCTOBER 18 & 19, 2023
Virtual Public Meeting Resources:
Final Meeting Report and Summary
Full two-day agenda
Download full two-day PowerPoint slide set
Speaker and Panelist Biographies
Guidances and Additional Resources
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):
- Jacqueline Corrigan-Curay, Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
- Janet Woodcock, Principal Deputy Commissioner, FDA
- John Farley , CDER, FDA
- Anina Adelfio, Chief Operating Officer, Association of Clinical Research Organizations (ACRO)
- David Borasky, Vice President, Compliance Review Solutions, WCG
- Janice Chang, Chief Executive Officer, TransCelerate
- Karla Childers, Head, Bioethics-based Science & Technology Policy, Office of the Chief Medical Officer, Johnson & Johnson
- Janet Vessotskie, Deputy Vice President of Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
- Captain Julienne Vaillancourt, Center for Biologics Evaluation and Research (CBER), FDA
- Karin Hoelzer, Director of Policy and Regulatory Affairs, National Organization for Rare Disorders (NORD)
- Valen Keefer, Patient Advocate, Educator, Consultant, Thermo Fisher Scientific and Otsuka America Pharmaceutical
- Neena Nizar, Executive Director, Founder, Jansen's Foundation
- Harpreet Singh , CDER, FDA
- Lisa Bennett, Principal Quality Lead, Roche
- Kenneth Getz, Executive Director, Tufts Center for the Study of Drug Development; Professor, Tufts University School of Medicine
- Chris Labaki, Post-doctoral Research Fellow, Dana-Farber Cancer Institute (DFCI), Broad Institute of MIT, Harvard
- Vinod (Vinny) Parthasarathy, Senior Clinical Monitoring Director, Medtronic
- Joanne (Jo) Spallone, Clinical Quality Consultant (JS GCP Clinical Consulting Services, LLC); Retired from Novartis Pharmaceuticals
- Sally Okun, Executive Director, Clinical Trials Transformation Initiative (CTTI)
Day 2 (in order of appearance):
- Celia Witten, Deputy Center Director, CBER, FDA
- Bray Patrick-Lake, Center for Devices and Radiological Health (CDRH), FDA
- John Beigel, Associate Director for Clinical Research, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH)
- Margaret Mooney, Associate Director, Chief, Clinical Investigations Branch (CIB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI)
- Salina Waddy, Associate Director, CTSA Program Clinical Affairs, Chief, CTSA Program Clinical Affairs Branch, Division of Clinical Innovation, Clinical Affairs Branch, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)
- Paul Kluetz, Deputy Director, Oncology Center for Excellence (OCE), FDA
- John H. Alexander, Professor of Medicine/Cardiology, Duke Clinical Research Institute, Duke University; Co-Chair, CTTI
- Jeffrey Blank, Adult Patient with Cystic Fibrosis
- Marianne Chase, Senior Director of Clinical Trial Operations, Neurological Clinical Research Institute/ Healey & AMG Center for ALS at Mass General Hospital
- Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, Bristol-Myers Squibb
- Nina Movsesyan, Manager, Clinical Research Programs, Metabolic Disorders Division, CHOC Children’s Hospital Orange County
- Veronica Suarez, Global Product Leader, Vaccines Innovation Unit, CSL
- Kassa Ayalew , CDER, FDA
- Cindy Geoghegan, Patient Advocate, Advisor, and Activist
- Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare
- Patrick Naldony, Global Head, Clinical Data Management, Clinical Sciences & Operations, Sanofi
- Pamela Tenaerts, Chief Scientific Officer, Medable
- Ramya Thota, Investigator, Intermountain Health
- Marion Wolfs, Head, Risk Management and Central Monitoring Oncology, Johnson & Johnson Innovative Medicine
- M. Khair ElZarrad, Director, Office of Medical Policy, CDER, FDA
Additional Resources:
Virtual Public Workshop to Enhance Clinical Study Diversity
