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.
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.
Who Should Attend?
- VP/Director/Manager of Research and Development
- VP/Director/Manager of Product Development
- VP/Director/Manager of Technical Operations
- VP/Director/Manager of CMC Operations
- Anyone involved in the decision-making process for analytical chemistry
Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the Pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.
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