University of Wisconsin–Madison

The Critical Role of CMC in Your IND Submission – Optimizing the CMC Process

When: September 7, 2017 11:00am CST

Drug development programs are rightfully targeted toward initiation of clinical trials. Based on this goal, emphasis is typically placed upon toxicological and pharmacological studies, sometimes at the expense of Chemistry, Manufacturing and Control (CMC). CMC is critical to IND approval and requires careful planning in order to meet all FDA requirements. This discussion will focus on the primary CMC requirements for a biopharmaceutical IND submission. The risk/reward criteria for determining the level and degree of method validation, reference standard characterization and formulation will be discussed in terms of streamlining the entire development process. In addition, possible pitfalls in the development process will be identified and addressed.

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