4M Therapeutics Announces Formation of Clinical Advisory Board

SKILLMAN, N.J.–(BUSINESS WIRE)–4M Therapeutics Inc., an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative conditions, today announced the formation of its Clinical Advisory Board comprised of five physician scientists and leaders in the treatment and research of a variety of neuropsychiatric and neurodegenerative conditions. This group of experts join Dr. Maurizio Fava, the company’s clinical consultant, in providing invaluable guidance and insights to the 4M Therapeutics management team.

“Our newly formed Clinical Advisory Board brings together pioneers from top institutions across the country dedicated to treating central nervous system disorders,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “We continue to build a robust team that we believe will enable us to capitalize on the potential of our novel drugs to better address a growing need for safer and more effective therapies for the brain. I would like to welcome each new member to 4M Therapeutics, and we look forward to leveraging their expertise and decades of experience to advance our promising pipeline of compounds into the clinic.”

Andrew J. Cutler, M.D.

Dr. Cutler is a Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University and Chief Medical Officer of the Neuroscience Education Institute. He holds a BS in Biology from Haverford College, and obtained his medical degree from the University of Virginia School of Medicine, where he was elected into the Alpha Omega Alpha (AOA) honor medical society. Dr Cutler completed his medical internship and residencies in both Internal Medicine and Psychiatry at the University of Virginia Health Sciences Center, where he also did research training in dopamine receptor pharmacology. He is board certified in Internal Medicine by the American Board of Internal Medicine and in Psychiatry by the American Board of Psychiatry and Neurology. He is also a Certified Physician Investigator (CPI) from the Association of Clinical Research Professionals (ACRP).

Dr. Cutler has been conducting clinical research since 1993 and has been a Principal Investigator on over 400 clinical trials in a variety of CNS and medical indications, focusing on ADHD, bipolar disorder, depression and schizophrenia in children, adolescents and adults. He was an Assistant Professor of Psychiatry at the University of Chicago before moving to Florida and founding Florida Clinical Research Center (FCRC) in 1998. He sold FCRC to Meridien Research in 2016. He retired from Meridien as Executive Vice President and Chief Medical Officer in 2019. He has authored more than 150 peer-reviewed scientific articles and has presented more than 300 abstracts and posters at scientific meetings around the world. He is a peer reviewer for several prominent medical journals and has served on several editorial boards. He has chaired or attended over 250 medical and scientific advisory boards, delivered more than 3,000 national and international pharmaceutical promotional talks, and over 300 continuing medical education (CME) and Grand rounds presentations. He has participated in more than 50 national satellite TV medical education broadcasts and led 200-plus national medical web conferences. Dr. Cutler consults with pharmaceutical and biotechnology companies and serves on the board of the Neuroscience Education Institute.

Dr. Cutler is a member of the American Psychiatric Association (APA), the Florida Psychiatric Society (FPS) and the American Medical Association (AMA). He is honored to be a Fellow of both the APA and the Academy of Psychosomatic Medicine. He has received numerous professional honors and awards, including the Merck Award for outstanding medical scholarship, the University of Virginia Pride Award for outstanding patient care, the William Sorum Award from the APA, the Outstanding Congressional Fellow Award from the 103rd US Congress, a citation from Florida Hospital for outstanding patient care, and the Distinguished Clinical Professional Award from the Central Florida Mental Health Association.

Dr. Maurizio Fava, M.D.

Dr. Fava is Chair of the Department of Psychiatry/Psychiatrist-in-Chief of the Massachusetts General Hospital (MGH), executive director of the Clinical Trials Network and Institute at MGH, and serves as the associate dean for clinical and translational research and the Slater Family Professor of Psychiatry at Harvard Medical School. Dr. Fava is a world leader in the field of depression and clinical psychopharmacology. He has edited eight books and authored or co-authored more than 900 original articles published in medical journals with international circulation which have been cited more than 100,000 times and with an h index greater than 150 on Google Scholar.

Dr. Fava obtained his medical degree from the University of Padova School of Medicine and completed residency training in endocrinology at the same university. He then moved to the United States and completed residency training in psychiatry at MGH. He founded and was director of the hospital’s Depression Clinical and Research Program from 1990 until 2014. Under Dr. Fava’s direction, the Depression Clinical and Research Program became one of the most highly regarded depression programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research work. In 2007, he also founded and is now the executive director of the MGH Psychiatry Clinical Trials Network and Institute, the first academic CRO specialized in the coordination of multi-center clinical trials in psychiatry.

Dr. Fava has been successful in obtaining funding as principal or co-principal investigator from both the National Institutes of Health and other sources for a total of more than $150 million. Dr. Fava’s prominence in the field is reflected in his role as the co-principal investigator of STAR*D, the largest research study ever conducted in the area of depression, of the RAPID Network, the NIMH-funded series of studies of novel, rapidly-acting antidepressant therapies, and of the Clinical Coordinating Center of EPPIC-Net, the NINDS-funded network conducting proof-of-concept trials in pain. Dr. Fava is a well-known national and international lecturer, having given more than 300 presentations at national and international meetings. He is the former President of the American Society of Clinical Psychopharmacology and, in 2023, Dr. Fava was elected to the National Academy of Medicine.

Paul E. Keck, M.D.

Dr. Keck is Craig and Frances Lindner Professor of Psychiatry and Neuroscience at the University of Cincinnati (UC) College of Medicine. He is also President-CEO of the Lindner Center of HOPE, a state-of-the-science, UC-affiliated comprehensive mental health center in Mason, Ohio. He has been in the top 20 of the most cited scientists in the world, publishing in the fields of psychology and psychiatry, since 1996.

He is the author of over 375 scientific papers in leading medical journals. He has also contributed over 175 reviews and chapters to major psychiatric textbooks. Dr. Keck is the editor or author of 6 scientific books.

Dr. Keck is the recipient of numerous honors, including the Gerald Klerman Young Investigator Award from the National Depressive and Manic-Depressive Association (NDMDA); the Gerald Klerman Senior Investigator Award from the Depression & Bipolar Support Alliance (DBSA); the Exemplary Psychiatrist Award from the National Alliance of the Mentally Ill (NAMI); the Philip Isenberg Teaching Award from Harvard Medical School; two Communicator Awards for Continuing Medical Education; and two Golden Apple Teaching Awards from the University of Cincinnati College of Medicine. He is listed as one of the Best Doctors in Cincinnati by Cincinnati Magazine, The Best Doctors in America, & Top Psychiatrists In America, & The World’s Most Influential Scientific Minds by ScienceWatch.

A magna cum laude and Phi Beta Kappa graduate of Dartmouth College, Dr. Keck received his MD with honors from the Mount Sinai School of Medicine, New York, NY. He served his internship in Internal Medicine at the Beth Israel Medical Center in New York and completed his residency training in Psychiatry at Harvard Medical School and McLean Hospital, Belmont, MA. Dr. Keck remained on faculty at McLean and Harvard before joining the Department of Psychiatry at the University of Cincinnati in 1991.

Jonathan Meyer, M.D.

Dr. Meyer is a Voluntary Clinical Professor of Psychiatry at University of California, San Diego, and a Distinguished Life Fellow of the American Psychiatric Association. He is a graduate of Stanford University and Harvard Medical School, finished his adult psychiatry residency at LA County-USC Medical Center and completed fellowships there in Consultation/Liaison Psychiatry and Psychopharmacology Research. Dr. Meyer has teaching duties at UC San Diego and the Balboa Naval Medical Center in San Diego, and is a psychopharmacology consultant to the first episode psychosis program at Balboa Naval Medical Center in San Diego. Dr. Meyer has lectured and published extensively on psychopharmacology, and is the sole author of the chapter on the Pharmacotherapy of Psychosis and Mania for the last 3 editions of Goodman & Gilman’s The Pharmacological Basis of Therapeutics. Along with Dr. Stephen Stahl, he is co-author of the Clozapine Handbook published in 2019, The Clinical Use of Antipsychotic Plasma Levels released in 2021, and The Lithium Handbook published in 2023, all three by Cambridge University Press.

Andrew Nierenberg, M.D.

Dr. Nierenberg is the Director of the Dauten Family Center for Bipolar Treatment Innovation, the Associate Director of the Depression Clinical and Research Program, and the Co-Director of the Center for Clinical Research Education at Massachusetts General Hospital. He developed an online research infrastructure called MoodNetwork to bring together patients, caregivers, and other stakeholders affected by mood disorders to better collect and understand patient data. Dr. Nierenberg has published over 450 papers and has been listed in The Best Doctors in America for the treatment of mood and anxiety disorders in every edition since 1994. He attended medical school at the Albert Einstein College of Medicine and completed his residency at NYU/Bellevue Hospital Center.

Gary Sachs, M.D.

Dr. Sachs is an internationally recognized expert clinician and clinical trialist with extensive experience in rater training and clinical trial methodologies for mood and anxiety disorder research. As Principal Investigator of the National Institute of Mental Health (NIHM) Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), Dr. Sachs led the largest treatment study ever conducted for bipolar disorder. He has been instrumental in developing practice guidelines and technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials.

Dr. Sachs is Clinical Vice President of Signant Health. He founded Concordant Rater Systems which was acquired by Signant Health in 2010. Dr. Sachs was also the founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is Associate Clinical Professor of Psychiatry at the Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include clinical trial methodology, placebo response mitigation, psychopharmacology, patient centric outcome measures, bipolar mood disorder, and development of measure-based practice guidelines. Dr. Sachs served on the board of directors for the Depression and Bipolar Support Alliance. Dr Sachs was president of the International Society for CNS Clinical Trial Methodology (ISCTM) 2022-2024. He has authored over 200 peer reviewed articles.

About 4M Therapeutics Inc.

4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative diseases. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.