The Critical Role of CMC in Your IND Submission

Early stage drug developers generally have their sights firmly set on the initiation of clinical trials, focusing on toxicological and pharmacological studies. Often, the importance of Chemistry, Manufacturing and Control (CMC) data is underestimated. But the CMC package is critical to IND approval, and meeting all FDA requirements demands careful planning and sound execution.

This discussion will focus on the primary CMC requirements for a biopharmaceutical IND submission. It will cover the risk/reward criteria for determining the level and degree of method validation, reference standard characterization and formulation; as well as potential pitfalls and ways to streamline the entire development process.

Speaker

Glenn E. Petrie, Ph.D., Senior Scientific Advisor, ABC Laboratories

Dr. Glenn Petrie has over 20 years of experience in the drug development arena with a focus on bioPharmaceuticals. Prior to joining ABC, he served as a director at a major CRO and as team leader in the development, Chemistry Manufacture and Control (CMC) design and IND submissions for a wide variety of bioPharmaceuticals (monoclonal antibodies, drug conjugates, peptides, etc.). Dr. Petrie is a subject matter expert in the analysis of proteins including HPLC, mass spectroscopy, ELISAs and electrophoresis. He received his B.A. in Biochemistry at Rice University and his doctorate in Biochemistry at the University of Illinois Urbana-Champaign.

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