ATMP

ATMP

Purpose
This interest group is focused on the unique challenges faced in the development and commercialization of cell and gene therapy products. The need for collaboration is essential, given the nature of these products, the evolving science, and the need for clarity in the application of the GMPs. Considering the strongly academic base of knowledge for these products, PDA has a unique opportunity to provide collaborative guidance that will benefit the patient community as the participants steward their products toward commercialization. The group will share insights on: new, advanced manufacturing techniques, experimental approaches to address the challenges of lifecycle management, scientific thinking related to standards and standardization, and commercialization efforts of maturing companies within the space.
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Interest Group Leaders
Rebecca Jordan
BMS
Takehiro Okumura
Takeda Pharmaceutical Company Ltd
Peter (Sascha) Kitschmann