Denise Gavin


Denise is the Chief of the Gene Therapy Branch (GTB), at the United States Food and Drug Administration (FDA), Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologic Evaluation and Research (CBER). In this role, she oversees the manufacturing, testing and controls (CMC) evaluations for gene therapy products under Investigational New Drug and Biological License Applications. The GTB oversees a wide variety of products including viral and non-viral vectors, ex vivo genetically modified cells and products that involve genome editing. The GTB is also responsible for developing policy related to regulation of cell and gene therapy products; and we perform outreach to gene therapy stakeholders. Denise has been on the Bioassay Steering Committee since 2010.

Prior to joining the FDA, she was a fellow at the NIH, National Institute of Neurological Disease and Stroke, Laboratory of Molecular Biology (LMB), Bethesda, MD. The LMB was studying the molecular mechanisms involved in neurodegeneration and CNS development. Denise was also a fellow at the University of North Carolina-Chapel Hill, Gene Therapy Center in NC, where she studied the molecular mechanism of AAV replication and integration. Denise has a PhD. in molecular virology from Rush University School of Medicine in Chicago, Illinois.