Resources Archives

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