Shibani Mitra-Kaushik

Company: Takeda Pharmaceutical Co. Ltd.

Job title: Head, Product Control Analytics, Cell Therapies

Seminars:

Industry Leader’s Fireside Chat: Cell Therapy Potency Assays 9:10 am

• What progress have we made since the potency assays produced for the first commercialized cell therapy products?  • What challenges are we still experiencing?  • What do we think about the current regulatory guidance, and how do we interpret it?Read more

day: Conference Day One AM

Adopting a Phase-Appropriate, Time & Cost-Effective Strategy for Method Validation for Potency Assays 1:00 pm

• Identifying the best analytical methods to define potency assays reflective of the  mechanism of action  • Implementing validated potency assays for release, stability, and comparability • Bridging challenges between early and late phase potency indicating methodsRead more

day: Conference Day Two - PM