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October 25-28, 2021
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Tiffany Lucas
Gene Therapy CMC Product Reviewer, Biologist at FDA

Profile

Gene Therapies Branch CMC reviewers conduct scientific review, interpretation, and documentation of product manufacturing data to evaluate the safety and quality of gene therapy products in regulatory submissions, regulatory reviews of regulatory submissions, guidance and policy development activities in gene therapy and genetic editing. The Gene Therapies Branch in Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies, is located within the Center for Biologics Evaluation and Research (CBER). Experienced laboratory scientist in virology, retroviral and lentiviral gene therapy vectors, immunology, medical entomology, tissue imaging, infectious disease, and insect model systems.

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