Bryan Choi
Professor INHA University
He graduated from the Department of Molecular Biology at Seoul National University, where he earned his BS, MS, and Ph.D. degrees in Korea. His Ph.D. research focused on the regulation of gene transcription. During his post-doctoral career, he studied chemical biology at the Institute of Chemistry and Cell Biology at Harvard Medical School in Boston. He worked on target validation for drug screening at LG Biomedical Institute in San Diego. He is currently a professor at Inha University College of Medicine. His research primarily focuses on cell therapies for treating various conditions, including spinal cord injury, diabetes, cartilage defects, and osteoarthritis. He is also one of the co-founders of ATEMs Inc., a biotech company in Korea developing tissue-engineering products to treat articular cartilage defects. He served as Vice-Director of the Strategic Center for Regenerative Medicine (SCRM) from November 2001 to April 2021, collaborating with government agencies, companies, and international partners to advance the regenerative medicine industry from both domestic and global perspectives. He also served as the Asia Regional Vice-President of the International Society for Cell and Gene Therapy (ISCT) for two years until May 2023 and as Secretary General of the Council for Advanced Regenerative Medicine (CARM), a company association in Korea, for four years until January 2024.
Seminars
With Curocell’s Phase III cell therapy now market-approved in South Korea, the race is on to further advance more
innovative treatment options. These must meet both regional and global regulatory criteria for CMC and clinical
data packages, especially as more complex products enter development such as in vivo CAR-T, gene editing,
autologous, and allogeneic approaches.
This workshop will gather experts to discuss:
- Understanding regulatory guidance on developing cell and gene therapies through pre-clinical model toxicity
- profile, safety study design patient recruitment and endpoints
- Reviewing phase-appropriate interactions with regulators for effective characterization of cell and gene therapies
- including identify, purity and control assays
- Addressing the common pitfalls when benchmarking quality attributes to regulatory standards and what data
- packages are required for South Korea, USA and across the globe
