Amy Schacterle, PhD
Chief Regulatory Officer & Head of Quality
Dr. Schacterle brings over 30 years of experience in regulatory affairs, quality assurance, and therapeutic development to Acumen, with a focus on diseases of the central nervous system. Most recently, she served as Senior Vice President of R&D Strategy and Business Management at Sage Therapeutics, where she was instrumental in portfolio strategy, resource prioritization, and regulatory leadership. Prior to this role, she was responsible for building and leading the Regulatory and Quality organizations at Sage, leading the efforts for the groundbreaking approval of the first-ever treatment specific for postpartum depression. As Vice President, Regulatory Affairs at Sunovion Pharmaceuticals (previously Sepracor) she led the development and commercial regulatory activities for all products at the company’s Marlborough campus. In her prior roles, she was responsible for regulatory strategy and oversight for a variety of drug, biologic and medical device products.
Dr. Schacterle holds a Ph.D. and M.S. in biomedical engineering from the University of Virginia, and a B.S. in biomedical engineering from Rensselaer Polytechnic Institute.