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FDA Cell and Gene Therapy Roundtable (June 2025)

    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

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