Lauren Kokai

Lauren Kokai, Ph.D., is a CMC Reviewer and Staff Fellow within the FDA's Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products, Division of Cell Therapy 2, Tissue Engineering Branch. In this capacity, she conducts comprehensive, science-based regulatory reviews across the full product lifecycle for complex cell and gene therapy submissions, including BLAs, PMAs, INDs, and IDEs. She recently served as a Subject Matter Expert for the FDA's Standards Recognition Program and contributed to the "Leveraging Data for CGTs" working group. Dr. Kokai brings a uniquely integrated perspective to the assessment of prior knowledge in ATMP development, drawing on over 20 years of experience spanning federal regulatory review, academic translational research, and industry R&D. Prior to joining the FDA, she served as a tenure-track Assistant Professor of Plastic Surgery and Bioengineering at the University of Pittsburgh, with a focus on cell therapies, tissue-engineered products, and drug-device combination products. Her earlier industry experience at Allergan, Inc. (now Abbvie) further informs her understanding of platform technology development and manufacturing control strategies. Dr. Kokai holds a Ph.D. in Bioengineering from the University of Pittsburgh and has authored 46 peer-reviewed publications, five textbook chapters and served as Editor for the textbook, "Scientific Principles of Adipose Stem Cells".