FDA Roundtable on Cell and Gene Therapy

WASHINGTON, DC—June 4, 2025—Media and the public are invited to listen to the FDA’s Center for Biologics Evaluation and Research (CBER) Cell and Gene Therapy (CGT) Roundtable. This event will gather world-renowned experts from industry and academia, and stakeholders from patient organizations to discuss approaches supporting CGT research and development.

Moderators:

• Vinay Prasad, M.D., M.P.H. — Director, CBER
• Nicole Verdun, M.D. — Super Office Director, Office of Therapeutic Products, CBER

Panelists:

• Jeff Allen, Ph.D. — Present and CEO, Friends of Cancer Research
• Ron Bartek — Co-founder and President, Friedreich's Ataxia Research Alliance
• Allyson Berent, DVM, DACVIM — Chief Scientific Officer, Foundation for Angelman Syndrome Therapeutics; Co-Director, Angelman Syndrome Biomarker and Outcome Measure
• Catherine Bollard, MBChB, M.D. — Senior Vice President and Chief Research Officer; Director, Center for Cancer and Immunology Research; Professor of Pediatrics and Immunology, Children's National and The George Washington University
• Thomas Cahill, M.D., Ph.D. — Founder and Managing Partner, Newpath Partners
• Andrew M. Cameron MD, Ph.D. — Director, Department of Surgery, The Johns Hopkins University School of Medicine
• Paula Cannon, Ph.D. — Distinguished Professor of Microbiology and Immunology, Keck School of Medicine, University of Southern California
• Terence R. Flotte, M.D. — Professor, Provost, Dean of UMass Chan Medical School; President, American Society of Gene and Cell Therapy
• Charles A. Gersbach, Ph.D. — John W. Strohbehn Distinguished Professor, Department of Biomedical Engineering; Director, Center for Advanced Genomic Technologies, Duke University
• Bambi Grilley, RPh, CCRC, CCRP, CIP, RAC — Director, Clinical Research and Early Product Development, Center for Cell and Gene Therapy; Professor, Pediatrics, Baylor College of Medicine; Chief Regulatory Officer, International Society for Cell & Gene Therapy
• Timothy Hunt, J.D. — Chief Executive Officer, Alliance for Regenerative Medicine
• Carl H. June, M.D. — Richard W. Vague Professor in Immunotherapy, Department of Pathology and Laboratory Medicine, Director Center for Cellular Immunotherapies; Director, Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Smilow Center for Translational Research
• Donald B. Kohn, M.D. — Distinguished Professor: Microbiology, Immunology and Molecular Genetics; Pediatrics, Hematology/Oncology; Molecular and Medical Pharmacology (University of California, Los Angeles)
• Brett Kopelan, MA — Executive Director, The Dystrophic Epidermolysis Bullosa Research Association of America
• David Liu, Ph.D. — Richard Merkin Professor and Director of the Merkin Institute for Transformative Technologies in Healthcare; Director of the Chemical Biology and Therapeutic Sciences Program; Core Institute Member and Vice-Chair of the Faculty, Broad Institute; Investigator, Howard Hughes Medical Institute; Thomas Dudley Cabot Professor of the Natural Sciences and Professor of Chemistry & Chemical Biology, Harvard University
• Jayme Locke M.D., MPH — Vice President, Medical Development, Xenotransplantation, United Therapeutics
• Crystal Mackall, M.D. — Ernest and Amelia Gallo Family Professor of Pediatrics and Medicine; Founding Director, Stanford Center for Cancer Cell Therapy; Director of the Parker Institute for Cancer Immunotherapy

Stanford University

• Rachel McMinn, Ph.D. — Founder and CEO, Neurogene
• Sean J. Morrison, Ph.D. — Investigator, Howard Hughes Medical Institute; Director, Children's Research Institute at UT Southwestern

University of Texas Southwestern Medical Center, Dallas, Texas; Chair of Public Policy Committee, International Society for Stem Cell Research

• Terry Pirovolakis — CEO & Founder, Elpida Therapeutics
• Vinayak Prasad, M.D., MPH — Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
• Michelle Rengarajan, M.D., Ph.D. — Physician-Scientist and Attending Endocrinologist, Massachusetts General Hospital; Instructor in Medicine, Harvard Medical School
• Shengdar Q. Tsai, Ph.D. — Associate Member, Department of Hematology, St. Jude Children's Research Hospital; Co-chair, Steering Committee of NIH Somatic Cell Genome Editing Consortium
• Fyodor Urnov, Ph.D. — Professor of Molecular Therapeutics at University of California, Berkeley; Scientific Director at Innovative Genomics Institute
• Nicole Verdun, M.D. — Super Office Director, Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration