Regulatory CMC in cell and gene therapy: navigating an evolving space

Lawrence C. Starke is currently head of Regulatory CMC Policy and Intelligence at Novartis Pharmaceuticals Corporation in East Hanover, NJ. Prior to assuming his currently role, Dr Starke was RA-CMC Unit Head for Cell and Gene Therapy Products at Novartis and held positions of increasing responsibility within the biologic RA-CMC roles at Eli Lilly and Company and at Merck. Dr Starke received his PhD in Cell and Molecular Biology at Duke University in Durham, North Carolina and was a research associate at Baylor College of Medicine in Houston, Texas prior to his career in the pharmaceutical industry.

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