OVERVIEW
FOCUS AREAS
Committed to agile development of life sciences technologies through informed regulatory approach, risk management, and commercialization strategies since 2015.
– Regulatory submissions and meetings with US FDA
– Cell and gene therapy product design and manufacturing
– Drug product specifications and analytical assays
– Post-approval changes
– Comparability studies
– Potency assay development
– Product facility inspections
Dr. Tiffany Lucas applies her FDA expertise in cell and gene therapies and her background as an investment analyst to deliver strategic chemistry, manufacturing, and controls (CMC) guidance. She enhances regulatory submissions across all phases of product development, from pre-IND to post-commercialization.
Dr. Lucas possesses over six years of regulatory experience as a reviewer at the U.S. Food and Drug Administration (FDA), where she led the review of cell and gene therapy products within the Center for Biologics Evaluation and Research (CBER). During her tenure at the FDA, she oversaw an extensive portfolio of cell and gene therapy products, spanning from pre-IND stages through license approval and post-licensure changes. She chaired a Biologics License Application (BLA) for an approved product, lead Pre-License Inspection (PLI) activities for the product office, and she served as a CMC reviewer for multiple BLAs.
Her CMC cell and gene therapy experience covers 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 for products, 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 understands that each product is unique, and she provides customized advice tailored to each program.
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EDUCATION:
- Postdoctoral Fellowship in Immunology and Infectious Disease, Washington University School of Medicine St. Louis
- Doctorate of Philosophy (PhD) in Molecular Microbiology and Immunology Program, University of Missouri School of Medicine
- Master of Science (MS) in Entomology, University of Arizona
- Bachelor of Science (BS) in Biology with Honors, Truman State University
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- US Food and Drug Administration, CBER, Office of Gene Therapy
Senior Reviewer for Chemistry, Manufacturing, and Controls (2018-2025)
- Areas of CMC expertise: cell and gene therapy product design and manufacturing, preIND, IND, BLA, and post-licensure changes, comparability studies, product labeling and product information, out-of-specification products and deviations, manufacturing scale-up and scale-out, release specifications, analytical assays including potency assays, retroviral and lentiviral vector design and manufacturing, cell bank testing, and human- and animal-derived reagents, product information in the package insert.
- Diverse product experience: CAR T cells, CD34+/hematopoetic stem cell products, directly administered viral vectors, NK cells, allogeneic and autologous cellular products, gene editing modalities (CRISPR, TALEN), mRNA therapeutics, neoantigen-based products, and bioinformatics- and genetics-informed approaches to product design.
- Regulatory Agency interactions: meeting packages for all meeting types (INTERACT, preIND, IND, EOP, Meetings A, C, D, preBLA, BLA), special designation requests (Breakthrough, Regenerative Medicine Advanced Therapy [RMAT], etc).
- BioGenerator, Investment Arm of BioSTL
Investment Analyst (2017-2018)
Experienced investment analyst with experience performing due diligence on biotech companies, including scientific, IP, regulatory, unmet need, and market potential; drafting and pitching recommendations on scientific experiments and company research data to advance technology; and managing contracted support personnel for regulatory, legal, and key opinion leader projects.
- US Food and Drug Administration, CBER, Office of Gene Therapy
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