Jeonghoon Han

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