Acumen Pharmaceuticals has appointed Amy Schacterle, PhD, as Chief Regulatory Officer & Head of Quality, reporting to Jim Doherty, President & Chief Development Officer at Acumen.

“Dr. Schacterle is a highly regarded leader who has successfully led global regulatory and quality activities across multiple neurologic and psychiatric therapeutic areas and all stages of development,” said Dan O’Connell, Chief Executive Officer of Acumen.

“She joins Acumen as we are making considerable clinical progress with our therapeutic candidate, sabirnetug, and continue to evolve our development strategy in advance of key clinical data. We are delighted to have someone with Amy’s deep expertise and experience in global regulatory and development strategy join our team in our quest to bring next-generation treatments to the Alzheimer’s patient community,” said O’Connell.

“I also want to express our sincere gratitude to Janice Hitchcock, Ph.D., Vice President of Regulatory Affairs, who is retiring at the end of the year. Dr. Hitchcock has led our regulatory function and has been instrumental in bringing sabirnetug from IND to Phase 2. She developed the regulatory strategy supporting our successful Phase 1 INTERCEPT-AD study, and led our FDA and EMA interactions regarding the design of our Phase 2 ALTITUDE-AD study for sabirnetug that is now ongoing in five countries,” Mr. O’Connell added.

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 at the company’s Marlborough campus.

“I am excited to be joining Acumen at this pivotal time in the company’s history and look forward to leading global regulatory interactions and quality oversight to support the company’s mission of improving the lives of patients with early Alzheimer’s disease. I am thrilled to be a part of the talented team at Acumen and build on the excellent work done to date as the company moves toward late-stage development of a potential next-generation treatment for Alzheimer’s,” said Dr. Schacterle.

Dr. Schacterle holds a PhD and MS in biomedical engineering from the University of Virginia, and a B.S. in biomedical engineering from Rensselaer Polytechnic Institute.