Approaches To CMC Involvement Across Drug Development

In Q42017, ISR interviewed fifteen tenured CMC professionals at top 50 Pharma companies to learn when during the drug development cycle CMC has its greatest involvement and influence.  Two alternate approaches were relayed to ISR by research participants—in the first approach CMC’s greatest influence is early on and decreases as the compound matures. In the second approach, influence starts low and increases with each phase of development.