Mark Lee, PhD FDA

Dr. Lee joined FDA in 2008 and has served in his main role as a primary product reviewer for the innovative products submitted to the Office of Cellular, Tissue and Gene Therapies (OCTGT) of CBER. He has experience with reviewing submissions for over 100 products through various approval pathways (e.g. IND-BLA, IDE-PMA/HDE/510(k)) at all stages of development and has served as product quality specialist for pre- and post-license inspections. An area of expertise for Dr. Lee is the emerging area of combination products which incorporate biologics such as live cells with other components such as delivery devices and scaffolds/matrices. This included serving as chair of the first cell-device combination product license approval at CBER in 2012. Some of Dr. Lee’s other roles for CBER/FDA include serving as liaisons and chairs for Intra-Agency and international efforts involving Emerging Technologies such as ISO TC 150/SC7 and TC 194/SC1 for which he has served as part of the US delegation.

Dr. Lee’s educational background includes Ph.D. and B.S.E. degrees in Bioengineering from the University of Pennsylvania, M.S. in Polymer Science from the University of Connecticut and post-doctoral training in Cellular Biology from the Institute of Medicine and Engineering /School of Medicine at Penn.