Minsung Choy
Director of Regulatory Affairs, Cell Therapy Legend Biotech
I am a Director of Regulatory Affairs at Legend Biotech, where I lead global regulatory strategy for cell and gene therapy programs. I have experience advancing research-stage assets to IND submission, including regulatory planning, health authority interactions, and IND submissions.
Prior to joining Legend, I served as a Global Regulatory Strategist at Bayer, where I supported development programs across multiple therapeutic areas, including oncology and rare diseases, and contributed to the regulatory strategy and development of companion diagnostics (CDx).
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
