After a brief look at the current European Guidelines for Advanced Therapy Medicinal Products (ATMPs), this presentation will go through the nonclinical development plan for ATMPs and how to ease its translation to the clinical setting, focusing on the nonclinical considerations and approaches. Because ATMPs products have specific clinical target(s) and that any manufacturing process change could easily affect their intrinsic properties, the optimal nonclinical development plan should consists of an integrated approach involving CMC / NC and Clinical expertise and use of Target Product Profile, which, if they are critical for any pharmaceutical product, appear even more crucial for ATMPs development.
Cécile F. Rousseau, Director
With 10+ years in nonclinical and translational research and histotechnology, Cécile F. Rousseau has considerable expertise in medical devices, engineered cellular therapies and companion diagnostics. Within VCLS, the main projects in which she is involved concern the nonclinical and clinical areas, including but not limited to medical devices, cellular therapy, gene therapy, and in vitro diagnostics.