Tiffany Lucas, Ph.D.

Regulatory Affairs Practice – U.S.

OVERVIEW

FOCUS AREAS

Committed to agile development of life sciences technologies through informed regulatory approach, risk management, and commercialization strategies since 2015.

Regulatory CMC submissions and meetings with US FDA
Cell and gene therapy product design and manufacturing
Post-approval changes
Comparability studies
Potency assay development
Drug product specifications and analytical assays
Product facility inspections

As a Principal Consultant in ELIQUENT Life Sciences, Dr. Tiffany Lucas leverages her extensive FDA expertise with cell and gene therapy products, along with her experience as an investment analyst, to benefit ELIQUENT’s clients. She offers strategic chemistry, manufacturing, and control (CMC) guidance to improve regulatory submissions across all stages of product development, from pre-IND through post-commercialization.

Dr. Lucas holds over 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 cell and gene therapy products from preIND through license approval and post-licensure changes. Additionally, she has chaired a BLA for an approved product, including leading PLI inspections for the product office, and has served in the CMC review of multiple BLAs.

Dr. Lucas possesses over six years of regulatory experience as a reviewer at the U.S. Food and Drug Administration (FDA), specializing in cell and gene therapy 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 modifications. She chaired a Biologics License Application (BLA) for an approved product, leading 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, 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.

: 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
: 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.