Acumen Pharmaceuticals Appoints Dr. Amy Schacterle as Chief Regulatory Officer & Head of Quality
Acumen Pharmaceuticals (NASDAQ: ABOS) has appointed Dr. Amy Schacterle as Chief Regulatory Officer & Head of Quality. Dr. Schacterle brings over 30 years of experience in regulatory affairs and quality assurance, with expertise in central nervous system diseases. She previously served as Senior VP of R&D Strategy at Sage Therapeutics, where she led regulatory efforts for the first postpartum depression treatment approval. She joins as the company advances its Alzheimer's disease therapeutic candidate, sabirnetug, which is currently in Phase 2 clinical trials across five countries. Dr. Schacterle replaces Dr. Janice Hitchcock, who is retiring after successfully leading the regulatory strategy for the Phase 1 INTERCEPT-AD study and Phase 2 ALTITUDE-AD study.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha nominato Dr. Amy Schachterle come Chief Regulatory Officer e Responsabile della Qualità. La Dott.ssa Schachterle porta con sé oltre 30 anni di esperienza nel settore degli affari regolatori e dell'assicurazione della qualità, con specializzazione nelle malattie del sistema nervoso centrale. In precedenza ha ricoperto il ruolo di Vicepresidente Senior della Strategia R&S presso Sage Therapeutics, dove ha guidato gli sforzi regolatori per l'approvazione del primo trattamento per la depressione postpartum. Si unisce all'azienda mentre avanza la candidatura terapeutica per il morbo di Alzheimer, sabirnetug, attualmente in fase di sperimentazione clinica di Fase 2 in cinque paesi. La Dott.ssa Schachterle sostituisce la Dott.ssa Janice Hitchcock, che si ritira dopo aver guidato con successo la strategia regolatoria per lo studio INTERCEPT-AD di Fase 1 e lo studio ALTITUDE-AD di Fase 2.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha nombrado a Dr. Amy Schachterle como Directora Reguladora y Jefa de Calidad. La Dra. Schachterle aporta más de 30 años de experiencia en asuntos regulatorios y garantía de calidad, con especialización en enfermedades del sistema nervioso central. Anteriormente se desempeñó como Vicepresidenta Senior de Estrategia de I+D en Sage Therapeutics, donde lideró los esfuerzos regulatorios para la primera aprobación de un tratamiento para la depresión posparto. Se une a la empresa mientras avanza su candidato terapéutico para la enfermedad de Alzheimer, sabirnetug, que actualmente está en ensayos clínicos de Fase 2 en cinco países. La Dra. Schachterle reemplaza a la Dra. Janice Hitchcock, quien se retira después de liderar con éxito la estrategia regulatoria para el estudio INTERCEPT-AD de Fase 1 y el estudio ALTITUDE-AD de Fase 2.
아큐멘 제약 (NASDAQ: ABOS)는 Dr. Amy Schachterle를 최고 규제 책임자 및 품질 책임자로 임명했습니다. Schachterle 박사는 중앙신경계 질환에 대한 전문성과 함께 규제 업무 및 품질 보증 분야에서 30년 이상의 경력을 가지고 있습니다. 그녀는 이전에 Sage Therapeutics에서 R&D 전략의 수석 부사장으로 재직하며 첫 번째 산후 우울증 치료 승인을 위한 규제 노력을 주도했습니다. Schachterle 박사는 현재 5개국에서 2상 임상 시험 중인 알츠하이머 질환 치료 후보물질 sabirnetug의 개발을 진전시키는 가운데 회사에 합류하게 되었습니다. Schachterle 박사는 1상 INTERCEPT-AD 연구 및 2상 ALTITUDE-AD 연구를 위한 규제 전략을 성공적으로 이끌었던 Janice Hitchcock 박사를 대체합니다.
Acumen Pharmaceuticals (NASDAQ: ABOS) a nommé Dr. Amy Schachterle au poste de Directrice des affaires réglementaires et Responsable de la qualité. Dr. Schachterle apporte plus de 30 ans d'expérience dans les affaires réglementaires et l'assurance qualité, avec une expertise dans les maladies du système nerveux central. Auparavant, elle a été Vice-présidente senior de la stratégie R&D chez Sage Therapeutics, où elle a dirigé les efforts réglementaires pour la première approbation d'un traitement contre la dépression postpartum. Elle rejoint l'entreprise alors que celle-ci avance son candidat thérapeutique pour la maladie d'Alzheimer, sabirnetug, qui est actuellement en essais cliniques de phase 2 dans cinq pays. Dr. Schachterle remplace Dr. Janice Hitchcock, qui prend sa retraite après avoir dirigé avec succès la stratégie réglementaire pour l'étude INTERCEPT-AD de phase 1 et l'étude ALTITUDE-AD de phase 2.
Acumen Pharmaceuticals (NASDAQ: ABOS) hat Dr. Amy Schachterle zur Chief Regulatory Officer und Leiterin der Qualität ernannt. Dr. Schachterle bringt über 30 Jahre Erfahrung im Bereich der regulatorischen Angelegenheiten und der Qualitätssicherung mit, mit Fachkenntnissen in Erkrankungen des zentralen Nervensystems. Zuvor war sie Senior VP für F&E-Strategie bei Sage Therapeutics, wo sie die regulatorischen Bemühungen für die Genehmigung der ersten Behandlung von postpartum Depressionen leitete. Sie kommt zu dem Unternehmen, während dieses seinen therapeutischen Kandidaten für Alzheimer, sabirnetug, vorantreibt, der sich derzeit in der Phase-2-Studie in fünf Ländern befindet. Dr. Schachterle ersetzt Dr. Janice Hitchcock, die sich zurückzieht, nachdem sie erfolgreich die regulatorische Strategie für die Phase-1-Studie INTERCEPT-AD und die Phase-2-Studie ALTITUDE-AD geleitet hat.
- Company strengthens leadership with experienced regulatory executive having 30+ years of expertise
- New CRO has successful track record in drug approvals, including first-ever postpartum depression treatment
- Phase 2 clinical trials for sabirnetug are actively ongoing in five countries
- None.
NEWTON, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), announced today the appointment of Amy Schacterle, Ph.D., 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.”
“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,” Dr. Schacterle said. “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.”
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.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential and potential clinical efficacy of Acumen’s product candidate, sabirnetug (ACU193), and development plans for sabirnetug. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.
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