How To Avoid Last Minute CMC Roadblocks To Approval

R. Wayne Wiley, Vice President, Regulatory Affairs and Pharmacovigilance, and Richard Sidwell, Vice President, Chief Scientific Officer, Societal™ CDMO

It’s tempting to minimize or defer CMC activities while preparing for clinical milestones. Are you making decisions that may delay — rather than accelerate — development?

Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. Unfortunately, as time passes, there is an increased risk of CMC issues becoming more complicated, time consuming, and expensive to fix.

This article provides a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.