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James WarrenVice President, Pharmaceutical Development at Ultragenyx Gene Therapy
Profile
Dr. Warren has 28 years of experience in the development, manufacturing, and commercialization of gene therapy viral vectors and live viral vaccines, with applied focus on bioprocess development and CMC Development Strategy. At Ultragenyx, he leads a team of 86 scientists and engineers, responsible for all early- and late-stage Process and Analytical Development of AAV portfolio products as well as Pilot Scale Manufacturing. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, Shire, and Merck & Co, where he led process development and manufacturing teams responsible for development of several clinical vector and vaccine candidates and the licensure of RotaTeq®, Varivax®, ProQuad®, and Zostavax®. Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a PhD in Molecular and Cellular Biology from Lehigh University
Agenda Sessions
Bioprocess Engineering Strategies to Enhance Productivity and Yield of the Pinnacle ™ Producer Cell Line Platform, Enabling High Productivity at 2000L Scale
, 8:50amView Session