How Can CMC Keep Up With The Rush To The Clinic?

In an effort to support fast-track clinical programs and the otherwise rush to the clinic, CMC (chemistry, manufacturing, and controls) professionals in early-stage biotechs find themselves behind the eight ball. Start-ups habitually overestimate their understanding of the scope, complexity, and impact of CMC. They then unrealistically rely on CDMOs to assist with arbitrarily decided clinical start dates.