Pre-Conference Day

Cell and gene therapy development is advancing toward commercialization faster than most manufacturing, process development, analytical, and CMC teams can keep pace. This is especially evident as South Korea’s first CAR‑T therapy enters the market.

Amid ongoing regulatory uncertainty, the primary challenge lies not in clinical performance but in supply chain and process readiness, making now a critical window to build robust, scalable, and compliant manufacturing strategies.

Join this workshop to gain key insights on:

• Systemic Agility: Mitigating material complexities and supply network volatility
• Clinical development of chimeric antigen receptor T-cell therapy manufacturing, formulation and administration
• Ensuring safety and cost efficiency in the scaled manufacturing of cell therapy products

This networking session is your opportunity to get face-to-face with many of the brightest minds working in the mRNA, cell and gene fields and establish meaningful business relationships ahead of the main conference days

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