SVP, Regulatory Affairs
Sears Therapeutics, Inc
James R. Weston
Senior Vice President, Regulatory Affairs
Seres Therapeutics, Inc.
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 currently heads the regulatory function at Seres Therapeutics, Inc. a company leading the development of microbiome therapeutics. He has previously held regulatory leadership positions at Oxyrane Ltd, Shire HGT (now Takeda), BioBridges LLC, Talaris Advisors. Alseres Pharmaceuticals, Cato Research Ltd and others. 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.
Tuesday, September 24
1:00 PM – 1:55 PM