Acting Gene Therapy Branch Chief, Division of Cell and Gene Therapy
Center for Biologics Evaluation and Research (CBER), FDA

Dr. Denise Gavin,
Team Lead, Gene Therapy Branch,
Office of Cellular Tissue and Gene Therapies (OCTGT), US Food and Drug Administration (FDA)

Denise Gavin received her Ph.D. in Immunology/Microbiology with a focus on Molecular Virology from Rush University School of Medicine in Chicago IL. She conducted a post-doctoral fellowship in the Gene Therapy Center at the University of North Carolina-Chapel Hill, and in the Laboratory of Molecular Biology, at the National Institute of Neurological Disease and Stroke. Her research focused on the molecular biology of Adeno-associated virus (AAV) and gene transfer studies for neural degenerative diseases and stroke.

Dr. Gavin is a Team Leader in the Gene Therapy Branch which reviews the chemistry, manufacturing and controls information for Gene Therapy products. In addition, she represents the FDA on the NIH Recombinant DNA Advisory Committee and on the International Pharmaceutical Regulators Forum Gene Therapy Working Group. Dr. Gavin also provides outreach to GT stakeholders and serves on the organizing committee for the annual Bioassay Workshop sponsored by CASSS.

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