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Cell & Gene Therapy International
See you next year! September 15-18, 2025
Hynes Convention CenterBoston, MA

Jin Sung Hong
Biologist, OTP, OCTHT, CBER at FDA
Speaker

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

    2:30pm