CHAIRPERSON

Mr. Hayden is an accomplished biopharmaceutical executive and board member, having served earlier in his career at the highest levels in big pharma and thereafter as Chairman or Director of numerous biotechnology companies. During his 25-year career at Bristol-Myers Squibb, he held a series of key leadership roles including President of Global Pharmaceuticals. Mr. Hayden has served as Board Chairman at a wide range of companies, including REGENXBIO, Amicus Therapeutics, Insmed, Vitae Pharmaceuticals, Gloucester Pharmaceuticals, and WindMIL Therapeutics. He continues to serve as Chairman of Otsuka America Pharmaceuticals Incorporated and as a Director at Theseus Pharmaceuticals.

Mr. Hayden received an M.B.A. from Indiana University and his undergraduate degree from Harvard University.

DIRECTOR

Dr. Goldstein s a Cell Biologist, Geneticist and Neuroscientist recognized for his work on molecular motors and the role of molecular transport pathways in neurodegenerative disease. Dr. Goldstein joined the faculty in Cell and Developmental Biology at Harvard University in 1984 where he was promoted to Full Professor with tenure in 1990. He is currently a Professor Emeritus of Cellular and Molecular Medicine and Neuroscience at UC San Diego and is also the Scientific Director of the Sanford Consortium for Regenerative Medicine. Dr. Goldstein co-founded the public biotech company Cytokinetics, which has developed drugs that are close to licensing. In collaboration with faculty and administrative colleagues he launched the UC San Diego Stem Cell program, the Sanford Consortium for Regenerative Medicine and the Sanford Stem Cell Clinical Center. He has received the Public Service Award from the American Society for Cell Biology and has had a Public Policy Fellowship named for him by the International Society for Stem Cell Research. Dr. Goldstein is a member of the American Academy of Arts and Sciences and the National Academy of Sciences.

He holds a PhD in Genetics from the University of Washington.

CHIEF EXECUTIVE OFFICER, FOUNDER & DIRECTOR

Dr. Lapuerta has 25 years of experience in the biotech industry and a track record of successful drug approvals including Xermelo, Inpefa, Abilify, and Avalide. He was previously Chief Medical Officer at Lexicon Therapeutics and Vice President of Clinical Development at Bristol-Myers Squibb. His work has been published in leading scientific journals including the New England Journal of Medicine.

Dr. Lapuerta holds an MD from Harvard Medical School and a Bachelor’s degree in Biology from Harvard College where he graduated Summa Cum Laude.

Dr. Cutler is a Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University and Chief Medical Officer of the Neuroscience Education Institute. 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.

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. 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.

After receiving his medical degree from the University of Padova School of Medicine, 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.

Dr. Fava obtained his medical degree from the University of Padova School of Medicine and completed residency training in endocrinology at the same university.

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.

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. 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.

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. Nierenberg is the Director of the Dauten Family Center for Bipolar Treatment Innovation Massachusetts General Hospital and Professor of Psychiatry, Harvard Medical School. In addition to directing the Dauten Center, Dr. Nierenberg is the co-director of Mass General’s Center for Clinical Research Education and associate director of the Depression Clinical and Research Program. He also holds the Thomas P. Hackett, MD, Endowed Chair in Psychiatry at Mass General.

After completing his residency in psychiatry at New York University/Bellevue Hospital, he studied clinical epidemiology at Yale University as a Robert Wood Johnson Clinical Scholar. Dr. Nierenberg then joined the faculty at Harvard Medical School, first at McLean Hospital in Belmont, MA and then at Massachusetts General Hospital. He is also an Honorary Professor in the School of Medicine, Faculty of Health at Deakin University, Geelong, Australia, and an Honorary Skou Professor at Aarhus University in Denmark.

Dr. Nierenberg focuses on clinical trials for bipolar disorder and depression, with over 590 published papers and a Google Scholar h-index of 125. He has been listed among The Best Doctors or Top Doctors in America for the treatment of mood and anxiety disorders yearly since 1994. He has been honored with the International Society for Bipolar Disorders Mogens Schou Award for Research and the Brain and Behavior Research Foundation’s Colvin Prize. Dr. Nierenberg is currently the PI of the Sequential Multiple Assignment of Treatment study for bipolar depression (SMART-BD) and the Bipolar Disorder Learning Health Network.

Dr. Nierenberg graduated from the Albert Einstein College of Medicine of Yeshiva University, Bronx, NY.

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. 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.

After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH.

SCIENTIFIC FOUNDER, CHAIR OF SCIENTIFIC ADVISORY BOARD

Dr. Tsai is the Director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology, a Picower Professor of Neuroscience, and an Associate Member of the Broad Institute. Dr. Tsai became an Assistant Professor of Pathology at Harvard Medical School and was promoted to Professor in 2002. She then relocated to the Massachusetts Institute of Technology in 2006. She was an Investigator of the Howard Hughes Medical Institute from 1997 to 2013. Dr. Tsai is also a Fellow of the American Association for the Advancement of Science, a member of the National Academy of Medicine, and an Academician of the Academia Sinica in Taiwan.

She obtained her Ph.D. from University of Texas Southwestern Medical Center in Dallas and completed postdoctoral training at Cold Spring Harbor Laboratories and Massachusetts General Hospital.

Dr. Ewing is a senior medicinal chemist experienced in leading teams to deliver development candidates, running academic collaborations and leading scientific assessments for business development opportunities. Dr. Ewing has held the position of Vice President, Head of Drug Discovery at the Barer Institute, a discovery phase oncology biotech, and served as a senior director in Discovery Chemistry at Bristol Myers Squibb where he led medicinal chemistry teams in the therapeutic areas of cardiovascular, diabetes, obesity, and heart failure.

Over his career, Dr. Ewing led medicinal chemistry teams to deliver over 15 development candidates. He has 74 patents, and 73 peer reviewed publications. In 2021, he was awarded the American Chemical Society (ACS) Fellow for his scientific achievements and contributions to the Society, and in 2018 received the Ondetti-Cushman award for leadership of the FXIa team that discovered Milvexian. Prior to Bristol Myers, he spent 12 years at Rhone-Poulenc Rorer (now part of Sanofi).

He received his Ph.D. in Organic Chemistry from the University of Pennsylvania, and his B.S. in Chemistry West Chester University of Pennsylvania.

Dr. Main currently serves as Executive Vice President of Innovation & Chemical Sciences at Lexicon Pharmaceuticals. He previously served in a series of manufacturing and scientific leadership positions at Lexicon that led to 9 compounds entering human clinical trials, with two products, Xermelo and Zynquista, achieving market approval. Dr. Main was Chief Executive Officer & President of Coelacanth Corporation, a leader in proprietary chemistry technologies to rapidly discover new chemical entities for drug development. Coelacanth was acquired by Lexicon in 2001. Dr. Main was formerly Senior Vice President of U.S Research at Novartis, where he worked for 20 years before joining Coelacanth.

He holds a PhD in synthetic organic chemistry from the University of Liverpool, England and completed postdoctoral studies with the Nobel Laureate, Robert B. Woodward at the Woodward Research Institute in Basel, Switzerland.

Dr. Pitts has over 30 years of experience in medicinal chemistry, including the development of kinase inhibitors. He was previously Senior Principal Scientist at Bristol-Myers Squibb where he was responsible for both scientific leadership and management of medicinal chemistry efforts (internal/external) on current and past immunology/inflammation targets (e.g. TYK2, IRAK4, JAK1/3,JAK2, S1P1, IKK2, PDE7, PDE4, MMP-13 etc.). His additional responsibilities directed at sustaining/expanding the immunology portfolio. Dr. Pitts specializes in structure-based drug design, immunology, inflammation, and heterocyclic chemistry.

He holds a PhD in Chemistry from the University of Virginia as well as a Bachelor’s degree in Pharmacy and a Masters degree in Chemistry from St. John’s University.

Dr. Vasdev is the Director and Chief Radiochemist of the Centre for Addiction and Mental Health (CAMH) Brain Health Imaging Centre, and the Director of the Azrieli Centre for Neuro-Radiochemistry at CAMH. He is also the endowed Azrieli Chair in Brain and Behaviour, and a Tier 1 Canada Research Chair in Radiochemistry and Nuclear Medicine. In addition, he is a full Professor in the Department of Psychiatry at the University of Toronto. Dr. Vasdev’s research focuses on developing novel radiochemical methods, primarily with 11 C and 18 F, and translating new PET imaging agents to use in various brain health illnesses. Current targets under investigation are tau protein, which is implicated in Alzheimer’s disease and related dementias; traumatic brain injuries; brain inflammation in mental illnesses; and cell signaling pathways involved in neuropsychiatric conditions and neuro-oncology. He is a Fellow of the American Chemical Society, Royal Society of Chemistry, and the Society of Nuclear Medicine and Molecular Imaging.

Dr. Vasdev received his Bachelor degrees in Chemistry and Psychology and his PhD in Chemistry from McMaster University.