Join Thermo Fisher Scientific for an overview of how we approach the transition from bench to clinic and help our clients overcome these hurdles by developing robust plans for their assets. The CMC (Chemistry, Manufacturing, and Control) section of an investigational new drug (IND) application describes what and how your drug substance will be delivered to a potential patient.  The clinical requirements drive the nonclinical study designs that drive drug substance and product development strategies. We will explore tactics for moving from the lab bench to GMP supplies as part of an integrated development strategy.
 

Kevin more than 25 years of experience in chemical synthesis and drug delivery for early- and late-stage  pharmaceutical products. He has supported various active pharmaceutical ingredient (API) synthesis and formulation manufacturing programs, with a focus on solubilization and other drug delivery methods for APIs, and the application of adaptive clinical trials to enable drug product optimization.