CNS Clinical and Regulatory Advisory Board
Maurizio Fava, M.D.
Dr. Maurizio Fava is acknowledged as a world-renowned expert in depressive disorders and psychopharmacology. Dr. Fava is currently Director of the Division of Clinical Research of the Massachusetts General Hospital (MGH) Research Institute, Executive Vice Chair, Department of Psychiatry at MGH, and Executive Director of the MGH Clinical Trials Network and Institute (CTNI), as well as Slater Family Professor of Psychiatry at Harvard Medical School. He has authored or co-authored more than 600 original articles published in medical journals with international circulation. The citation impact of his work is extremely high, as his articles have been cited more than 40,000 times in the literature. He has edited eight books, published more than 50 chapters and 600 abstracts, and has given more than 350 presentations at national and international meetings. Dr. Fava is the recipient of several awards and is on the editorial board of five international medical journals.
Thomas Laughren M.D.
Dr. Thomas Laughren, currently a consultant in psychiatric drug development, is recently retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Prior to joining the FDA in September 1983, he was affiliated with the VA Medical Center in Providence, RI, and was on the faculty of the Brown University Program in Medicine. He received his medical degree from the University of Wisconsin in Madison, Wisconsin, and also completed residency training in psychiatry at the University of Wisconsin. He is board certified in general psychiatry. As Division Director for the Division of Psychiatry Products, he oversaw the review of all psychiatric drug development activities conducted under Investigation New Drug (IND) and New Drug Applications (NDA) and supplements for new psychiatric drug claims. He has authored and co-authored many papers and book chapters on regulatory and methodological issues pertaining to the development of psychiatric drugs, and is a frequent speaker at professional meetings on these same topics. Dr. Laughren has received numerous awards for his regulatory accomplishments.
Sanjay Mathew, M.D.
Dr. Sanjay Mathew is a leading expert in the psychopharmacological management of adult patients with difficult-to-treat depressive and anxiety disorders and is currently an Associate Professor of Psychiatry and Behavioral Sciences at Baylor College of Medicine in Houston, Texas. Dr. Mathew is the Johnson Family Chair for Research in Psychiatry, Associate Professor with Tenure in the Menninger Department of Psychiatry and Behavioral Sciences, and director of the Mood & Anxiety Disorders Research Program. His research program is the recipient of federal grants and contracts from the National Institute of Mental Health (NIMH) and the Department of Veterans Affairs to develop novel therapies for patients with treatment-resistant depression and post-traumatic stress disorder (PTSD). His translational research program focuses on testing of experimental therapies for depression and anxiety, and discovering illness and treatment-related biomarkers. Dr. Mathew’s group has overseen and collaborated in numerous early phase investigations of glutamate-modulating agents which act as rapidly-acting antidepressants.
Gerard Sanacora, M.D., Ph.D.
Dr. Gerard Sanacora is a Professor of Psychiatry at Yale University, the Director of the Yale Depression Research Program, and the Scientific Director of the Yale-New Haven Hospital Interventional Psychiatry Service. Dr. Sanacora is recognized as a leading translational neuroscientist in the area of mood disorders research. His work is concentrated largely on elucidating the pathophysiological mechanisms associated with mood and other neuropsychiatric disorders. Much of his recent research has focused on studies of the amino acid neurotransmitter systems (GABA and Glutamate) and their contributions to the neurobiology of mood disorders and the mechanism of rapid antidepressant action. His basic science laboratory employs a variety of rodent models to explore the effects of chronic stress on cellular and molecular biology, and to study the mechanisms of drug action. His clinical laboratory employs novel magnetic resonance spectroscopy methodologies and pharmacological challenge paradigms to study the amino acid neurotransmitter systems in individuals suffering from various neuropsychiatric disorders. In addition, Dr. Sanacora has recently led several clinical trials studying novel antidepressant drugs.