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Well Characterized Biologics & Biological Assays
November 1-3, 2022
College Park Marriott Hotel & Conference CenterHyattsville, Maryland, USA

Tiffany Lucas
CMC Gene Therapy Product Reviewer at FDA


Dr. Tiffany Lucas is a Gene Therapy Product Reviewer in the Division of Cellular and Gene Therapies at FDA’s Center for Biologics Evaluation. She reviews pre-IND, IND, and BLA submissions for gene therapy products, as well as development of materials for internal training, international regulatory discussion, and inter-agency consultations.

Previously, Tiffany worked in early-stage biotech development as an Investment Analyst and a Technology Transfer fellow at Washington University’s Office of Technology Management. She completed postdoctoral research on neurotropic viruses and immunology at Washington University Medical School and earned her PhD at University Missouri researching retrovirus assembly and cellular factors.

Agenda Sessions

  • FDA Address: Walk through of the CMC Section of a Gene Therapy IND

  • Regulatory Town Hall


Speakers at this event