“CMC was not usually a core part of the planning — it was more of an afterthought. Now that funding has tightened, that is changing.”

Siddhartha Jain, President of Shoolin Management Company, has spent two decades in biologics CMC across Novartis, Regeneron, Sanofi, and other major companies, contributing to the development and manufacturing of over 10 clinical and commercial molecules.

In this episode of the PharmaSource podcast, Sid shares why raw material variability remains one of the industry’s most underestimated risks, what separates a technically proficient CDMO from one that is merely experienced, and why digital CMC transformation fails when it ignores people and process.

Read the full article.