Appointees Andrew J. Cutler, M.D., Paul E.
Keck, M.D., Jonathan Meyer, M.D., Andrew Nierenberg, M.D., and Gary
Sachs, M.D. join clinical consultant, Maurizio Fava, M.D.
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.
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