Jin Sung HongBiologist, OTP, OCTHT, CBER at FDASpeaker
Profile
Jin Sung Hong is currently a CMC reviewer in Office of Cell Therapy and Human Tissue (OCTHT), Office of Therapeutic Products (OTP) in CBER. From 2021, he has served as a primary CMC reviewer in INTERACT, pre-IND, IND, IDE, and BLA submissions for cell therapy products, tissue-engineered products, combination products, and devices. Before joining CBER, he conducted regulatory related research and development on biomanufacturing of various products in CDER/FDA and VRC/NIAID/NIH. He received his Ph.D. in Bioengineering from Georgia Institute of Technology and did his postdoctoral training at NHLBI/NIH.
Agenda Sessions
Current Status and Challenges for Development of Cell Therapy and Tissue Engineered Products- CMC perspectives
, 2:30pmView Session