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James Weston, MBA
Senior Vice President of Regulatory Affairs at Seres Therapeutics

Profile

Jim Weston is a veteran regulatory affairs and quality executive with a demonstrated ability to spearhead the drug development process by crafting effective regulatory and clinical strategies world-wide, including the US, Canada, Europe (centralized and member states), Australia and Japan. His knowledge of domestic and international regulatory requirements and his close interactions with regulatory authorities has resulted in successful and timely implementation of clinical trial programs and integrated regulatory submissions, including investigational and marketing applications that resulted in the approval of more than 11 drugs/biologics worldwide. Jim is passionate about drug development and has extensive experience in structuring and coaching high-performance drug development teams. He is able to act decisively to meet key regulatory objectives and to instill creative energy and motivation to all involved in the drug development process to achieve success. Jim currently heads the regulatory function at Seres Therapeutics, Inc. a company leading the development of microbiome therapeutics. Jim previously headed the Regulatory function for Oxyrane Ltd., a company focused on enzyme replacement therapies. Prior that he lead the CMC Regulatory group at Shire HGT where he was instrumental in the expansion of their marketed products into new markets and development of investigational products. Previously, he was a senior consultant at BioBridges LLC and Talaris Advisors where he provided strategic regulatory expertise to many small and mid-sized development companies. He was also the Senior Vice President of Regulatory Affairs and Quality for Alseres Pharmaceuticals, directing the regulatory strategies for candidates in Parkinson’s disease, Dementia and Spinal Cord Injury. Before Alseres, Jim was Vice President Corporate and Regulatory Strategy and Managing Director of Cato Research, Boston. He also held Senior Regulatory Affairs and Government Relations management positions with Biopure and Regulatory, Clinical Research, Quality Assurance and Quality Control management positions at DuPont Pharmaceuticals. Jim has a BA in Biological Sciences degree from Rutgers College and an MBA from Northeastern University. He is a member of and frequent presenter for many professional organizations, including the Regulatory Affairs Professionals Society, Drug Information Association, Parenteral Drug Association, and the Special Operations Medical Association and formerly was the co-chair of the Quality and Regulatory Committee of the Massachusetts Biotechnology Council.

James Weston, MBA's Network

Agenda Sessions

  • The Legal and IP side of manufacturing and production The Regulatory Challenge for Approving Microbiome Products to meet the unmet medical needs of patients

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