Tiffany Lucas

Dr. Tiffany Lucas leverages over ten years in biotechnology development and six years of regulatory experience as a reviewer at the US FDA in cell and gene therapy within the Center for Biologics Evaluation and Research (CBER). At the FDA, she managed a wide range of products from preIND through BLA and post-licensure changes. Her CMC cell and gene therapy experience covers US FDA regulatory meetings, submissions, comparability studies, manufacturing scale-up/out, analytical assays and validations, potency assays, non-conforming product and manufacturing deviation issues, pre-licensure inspections, commercial release specifications, viral vector and cell manufacturing, and rare disease product development challenges. Dr. Lucas' background as an investment analyst and in technology licensing, patents, and risk assessment enhances her understanding of program and product development strategies. She recognizes that each product is unique, and she tailors advice to each program. She earned her PhD for her work on retroviral vector engineering and design as a Life Sciences Fellow at the University of Missouri School of Medicine and completed a postdoctoral fellowship in immunology and infectious disease at Washington University School of Medicine St. Louis.