Cell and Gene Therapy Roundtable June 5, 2025

Forum | Virtual

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• Date: June 5, 2025
• Time: 9:00 a.m. - 12:00 p.m. ET

Webcase Recording: FDA Roundtable on Cell and Gene Therapy

Media Inquiries: HHS Press Office.

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FDA Cell and Gene Therapy Roundtable
June 5, 2025
Roundtable Participants

 

Jeff Allen, PhD
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, MD
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, MD, PhD
Founder and Managing Partner
Newpath Partners

Andrew M. Cameron MD, PhD
Director
Department of Surgery
The Johns Hopkins University School of Medicine

Paula Cannon, PhD
Distinguished Professor of Microbiology and Immunology
Keck School of Medicine
University of Southern California

Terence R. Flotte, MD
Professor, Provost, Dean of UMass Chan Medical School
President, American Society of Gene and Cell Therapy

Charles A. Gersbach, PhD
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, JD
Chief Executive Officer
Alliance for Regenerative Medicine

Carl H. June, MD
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, MD
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, PhD
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 MD, MPH
Vice President, Medical Development Xenotransplantation
United Therapeutics

Crystal Mackall, MD
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, PhD
Founder and CEO
Neurogene

Sean J. Morrison, PhD
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, MD, MPH 
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Michelle Rengarajan, MD, PhD
Physician-Scientist and Attending Endocrinologist
Massachusetts General Hospital
Instructor in Medicine
Harvard Medical School

Shengdar Q. Tsai, PhD 
Associate Member, Department of Hematology, St. Jude Children's Research Hospital
Co-chair, Steering Committee of NIH Somatic Cell Genome Editing Consortium

Fyodor Urnov, PhD
Professor of Molecular Therapeutics at University of California, Berkeley
Scientific Director at Innovative Genomics Institute

Nicole Verdun, MD
Super Office Director
Office of Therapeutic Products
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration