Apple Tree Pharmaceuticals

Susan B. Stewart, FRAPS, RAC, Regulatory Affairs Advisor
Sue has more than twenty years of regulatory affairs and quality assurance experience. She has led regulatory strategy and agency interaction in the development and commercialization of a broad range of drugs, biologics and devices. In addition to her role at Apple Tree Pharmaceuticals, she currently serves as Senior Vice President, Regulatory, Quality and Compliance for Tokai Pharmaceuticals, with its prostate cancer drug currently in Phase 2. Prior to joining Tokai, she was Vice President of Regulatory Affairs at TransMolecular, Inc., a role that also included strategic planning and IP management for oncology programs. From 1993-2006, Sue served as Vice President of Regulatory Affairs for Genzyme Corporation, during which time she also served as a Director for MG Biotherapeutics, a Genzyme joint venture with Medtronic Inc. In addition to conducting due diligence for new acquisitions, she was the regulatory lead on Genzyme's drug and cell therapy collaborations with Diacrin, Inc., Cambridge Antibody Technologies, Dyax, Inc. and Geltex. Her commercial product experience includes global registration and life-cycle management of Renagel®, Synvisc®, Carticel® and Thyrogen®. From 1990-1993, she served as Quality Assurance Supervisor for Abbott Laboratories.

A Fellow of the Regulatory Affairs Professionals Society, and both US and EU RAC certified, Sue holds a B.A. from Annhurst College.