6 CMC Strategies Are Transforming Biologics Drug Development

If you're still treating CMC as something to figure out after the science is proven, Siddhartha Jain would tell you that's exactly the kind of thinking that's burning through capital. With two decades spanning Novartis, Regeneron, and Sanofi, and contributions to over 10 clinical and commercial molecules, Sid brings hard-won perspective to six strategies that are reshaping how biologics programs actually get to the clinic.

The funding environment has forced a reckoning. When capital was cheap, detailed CMC planning was optional. Now it isn't. As Sid puts it, CMC costs are the highest costs in getting to the IND, and early-stage companies can no longer afford to treat them as a rounding error. His guidance: resist the urge to build physical infrastructure early. Use CROs and CDMOs to preserve runway, then build internal capability incrementally.

On CDMO selection, Sid draws a distinction that's easy to miss: experience and technical proficiency are not the same thing. Scientific culture, not headcount or client history, is what separates a partner that can solve your specific problems from one that's merely done similar work before.

Raw material variability and digital CMC transformation also get a more critical look than they typically receive. Listen now to stress-test your current CMC strategy against one of the field's most experienced practitioners.