Early CMC Work Impacts Regulatory Submissions

How important is early CMC work in the grand scheme of what will ultimately become a submitted CMC package? In this segment of the Bioprocess Online Live event Data-Driven CMC For PD Speed, Regulatory Efficiency, CMC experts Brian Kirk, Ph.D. (Merck, Minerva, Takeda) and Blair McNeill, Ph.D. (Amgen, Bayer, Alkermes, Roivant) answer that question and address common challenges in CMC data package preparation.

View the full presentation here.