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The Impact of the FDA on Product Development - It is Never too Early to Formulate a Regulatory Strategy
March 25, 2022, 12 - 1 p.m.
Edwin Moore, PhD
Ed Moore brings 40 years of biopharmaceutical, pharmaceutical, and clinical diagnostic industry experience from global companies, Baxter Healthcare Corp, and Abbott Laboratories, in R&D product development. During his career, he has held various roles in CMC pre-clinical product development for recombinant therapeutic proteins and for IV parenteral small molecule products in Analytical Method Development, Stability Testing, Formulation, as well as leading overall pre-clinical product development for a recombinant therapeutic protein product. He has held positions from bench scientist, R&D Product Development, to Sr. Director, Global Analytical Method Development and Validation.
Robin Geller, PhD
Robin has over 25 years of corporate and academic experience. Her business experience includes extensive work in pharmacovigilance, regulatory strategy, and regulatory intelligence. She has held a number of positions at Baxter in the R&D, Quality, Regulatory and Pharmacovigilance organizations including Director of Pharmacovigilance Intelligence and Safety Writing. Her research expertise is in cell biology, genetics, and immunology. She has led research teams in T cell signaling and tumor vaccine development.