Acumen Pharmaceuticals Welcomes Dr. Amy Schacterle as Chief Regulatory Officer & Head of Quality

Acumen Pharmaceuticals, Inc., a biopharma company advancing innovative treatments for Alzheimer’s disease by targeting soluble amyloid beta oligomers (AβOs), has appointed Dr. Amy Schacterle as its new Chief Regulatory Officer & Head of Quality. In her new role, Dr. Schacterle will report directly to Jim Doherty, Acumen's President & Chief Development Officer.

Dr. Amy Schacterle joins Acumen with a robust background spanning over three decades in regulatory affairs, quality assurance, and the development of therapies, particularly for central nervous system disorders. Most recently, as Senior Vice President of R&D Strategy and Business Management at Sage Therapeutics, she played a pivotal role in shaping the company’s portfolio strategy, optimizing resources, and providing regulatory guidance.

Dan O’Connell, Chief Executive Officer of Acumen, said in a statement, “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. 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.”

Mr. O’Connell further added, “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.”

In her earlier role at Sage, Dr. Schacterle was instrumental in establishing and leading the Regulatory and Quality teams, driving efforts that led to the historic approval of the first treatment specifically for postpartum depression. Her prior experience also includes serving as Vice President of Regulatory Affairs at Sunovion Pharmaceuticals (formerly Sepracor), where she oversaw development and regulatory operations at the Marlborough location. Dr. Schacterle earned her Ph.D. and M.S. in biomedical engineering from the University of Virginia, following a B.S. in the same field from Rensselaer Polytechnic Institute.

Dr. Schacterle, commented, “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.”