Meet Our 2026 Featured Speakers

Tiffany Farchione, M.D. received her medical degree from Wayne State University in Detroit, Michigan, and completed adult residency and child & adolescent fellowship training at the University of Pittsburgh's Western Psychiatric Institute and Clinic. Dr. Farchione is board certified in both general and child & adolescent psychiatry. Prior to joining FDA in 2010, Dr. Farchione was affiliated with the University of Pittsburgh Medical Center and was on the faculty of the University of Pittsburgh. As the Director of the Division of Psychiatry at FDA, Dr. Farchione is involved in the oversight of new drug review for all psychiatric drug development activities conducted under investigational new drug applications, and the review of all new drug applications and supplements for new psychiatric drug claims. 

Bernard Fischer, M.D. is a psychiatrist and the acting Deputy Director of the Office of Neuroscience in the Office of New Drugs at the U.S. Food and Drug Administration (FDA).  He provides regulatory oversight of development and marketing approval of drugs for psychiatric and neurologic disorders, addiction, anesthesia, and pain under investigational new drug applications (INDs) and new drug applications (NDAs). Prior to the FDA, he spent more than 10 years in academic medicine at the Maryland Psychiatric Research Center (MPRC) and the Department of Veterans Affairs.  Dr. Fischer earned his medical degree from the Medical College of Virginia.  He completed a 5-year research/clinical residency in psychiatry at the University of Maryland/Sheppard Pratt followed by a post-doctoral fellowship in mental illness research at the MPRC.  He holds a master’s degree in biomedical ethics and has been board certified in both psychiatry and addiction medicine.  He has authored or co-authored more than 50 scientific publications. 

Qi Liu, Ph.D., M.Stat., FCP is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA. She is a co-chair of CDER's AI Council and the lead of CDER AI Review Rapid Response Team. She is a member of the FDA-Wide AI Policy Coordination and Planning Council. She is also on the executive board of CDER’s Quantitative Medicine Center of Excellence. She helped establishing and has been directing the OCP Innovative Data Analytics Program (focusing on AI, Real-world data and digital health) and AI review team. She had the experience leading Physiological Based Pharmacokinetic Modeling and Simulation Oversight Board and co-leading Biologics Oversight Board. During her career at the FDA, she also contributed to over 200 NDA/sNDA/BLA/sBLA reviews, and numerous IND reviews. She was on many working groups developing FDA guidance documents and Manual of Policies & Procedures. 

Valentina Mantua, M.D., Ph.D., is Associate Director for Regulatory Science in the Office of Neuroscience at FDA’s Center for Drug Evaluation and Research (CDER). She leads initiatives to advance innovative methods and tools in clinical trials and represents the Agency in pre-competitive collaborations with partners including NIH and FNIH. Before joining FDA in 2019, Dr. Mantua served as a delegate of the Italian Medicines Agency (AIFA) to several committees and working parties of the European Medicines Agency (EMA) and practiced as a board-certified psychiatrist in the UK at South London and Maudsley NHS Foundation Trust. She is an active committee member of the American Society of Clinical Psychopharmacology (ASCP). Dr. Mantua received her M.D. and psychiatry residency training from Sapienza University of Rome and a Ph.D. in Neurobiology of Affective Disorders from the University of Pisa. 

Roberta Rasetti, M.D.,Ph.D. joined the FDA in late 2020 as a physician in the Division of Psychiatry. She received her MD and PhD from the University of Turin, Italy, and completed an adult residency at the University of Pennsylvania, Department of Psychiatry. Prior to joining the FDA in 2020, Dr. Rasetti was affiliated with the Georgetown University School of Medicine and was on the faculty of Georgetown University and a Clinical Fellow at the National Institute of Mental Health, where she focused on schizophrenia research. As a medical reviewer in the Division of Psychiatry at the FDA, Dr. Rasetti is involved in the review of new drug applications and supplements for new psychiatric drugs. 

Lori Davis, MD is Senior Research Psychiatrist at the Birmingham VA Health Care System and Adjunct Professor of Psychiatry in the Department of Psychiatry, University of Alabama Heersink School of Medicine, in Birmingham, AL. She received her undergraduate degree from Duke University and her medical degree from the University of North Carolina at Chapel Hill. She completed a psychiatry residency at the University of Alabama at Birmingham.  Dr. Davis has been designing and conducting clinical trials in mental health disorders for over 30 years under continuous peer-reviewed funding, resulting in over 130 publications. Her research aims to better understand the effects of pharmacotherapy, psychotherapy, vocational rehabilitation, mindfulness meditation, and other novel treatments for posttraumatic stress disorder (PTSD), depression, and substance use disorders. 

Joseph Goldberg, M.D. is Clinical Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai in New York City, and is the immediate-past president of ASCP.  He is also deputy editor-in-chief of the Journal of Clinical Psychiatry.  He attended college at the University of Chicago, graduate school in neuroscience at the University of Illinois, medical school at Northwestern University, and completed his psychiatry residency and fellowship at the Payne Whitney Clinical of New York Hospital where he founded the bipolar disorders research clinic before moving to the Icahn School of Medicine at Mount Sinai.  Dr. Goldberg has published over 250 peer reviewed publications and five books on topics related to clinical psychopharmacology in mood and psychotic disorders and is an active clinical investigator and educator in the treatment and outcome of major psychiatric disorders. 

John M. Kane, M.D. served as chair of psychiatry for 34 years at the Zucker Hillside Hospital and is currently the Co-Director of the Institute of Behavioral Research at the Feinstein Institutes for Medical Research. He also served as the inaugural chair of Psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell for 12 years.   He is the recipient of many awards, including the Lieber Prize, the APA’s Kempf Award and Foundations Prize, the New York State Office of Mental Health Lifetime Achievement Award, The Dean Award from the American College of Psychiatrists, and the ASCP’s Donald Klein Lifetime Achievement Award. He has served as President of the American Society of Clinical Psychopharmacology, the Psychiatry Research Society and the Schizophrenia International Research Society.  Dr. Kane has been the principal investigator on 24 U.S. National Institutes of Health grants focusing on schizophrenia, psychobiology and treatment, recovery, and improving the quality and cost of care. He is the author of over 950 peer-reviewed papers and serves on the editorial boards of numerous journals.

Andrew A. Nierenberg, M.D. is the Director of the Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital, holds the Thomas P. Hackett, MD Endowed Chair at MGH, and is a Professor of Psychiatry at Harvard Medical School. In addition to directing the Dauten Center, Dr. Nierenberg serves as the co-director of the MGH Center for Clinical Research Education. Dr. Nierenberg focuses on clinical trials for bipolar disorder and depression, with over 625 published papers and a Google Scholar h-index of over 130. 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, the Brain and Behavior Research Foundation’s Colvin Prize, and the NAMI Scientific Research Award.  Dr. Nierenberg is currently the PI of the Sequential Multiple Assignment of Treatment study for bipolar depression (SMART-BD) (that compares treatments for bipolar depression) funded by the Patient Centered Outcomes Research Institute (PCORI). He also leads the Bipolar Action Network, a Learning Health Network comprising multiple healthcare systems, which breaks down the barriers between clinical, research, and quality improvement activities to achieve better outcomes. Dr. Nierenberg has an active clinical practice, supervises and teaches residents, serves on multiple nonprofit advocacy boards, is a member of multiple journal editorial boards, and is the editor-in-chief of Psychiatric Annals. 

Lori Davis, MD is Senior Research Psychiatrist at the Birmingham VA Health Care System and Adjunct Professor of Psychiatry in the Department of Psychiatry, University of Alabama Heersink School of Medicine, in Birmingham, AL. She received her undergraduate degree from Duke University and her medical degree from the University of North Carolina at Chapel Hill. She completed a psychiatry residency at the University of Alabama at Birmingham.  Dr. Davis has been designing and conducting clinical trials in mental health disorders for over 30 years under continuous peer-reviewed funding, resulting in over 130 publications. Her research aims to better understand the effects of pharmacotherapy, psychotherapy, vocational rehabilitation, mindfulness meditation, and other novel treatments for posttraumatic stress disorder (PTSD), depression, and substance use disorders. 

Daniel Falk, Ph.D. is the Branch Chief of the Medications Development Branch (MDB) within the Division of Treatment and Recovery (DTR) at the National Institute on Alcohol Abuse and Alcoholism (NIAAA). At NIAAA, he directs research on pharmacotherapy for alcohol use disorder (AUD) and novel methods for clinical trials, including the evaluation of new endpoints. Dr. Falk co-leads the NIAAA Alcohol Pharmacotherapy Evaluation Program (APEP) - a contract program which evaluates the efficacy and safety of novel and repurposed compounds to treat AUD in laboratory and randomized clinical trials. Dr. Falk is also the Coordinator of the NIAAA Data Archive, a large data repository over 775 NIAAA funded studies involving human subjects. Dr. Falk has authored over 50 publications and presentations on a diverse set of alcohol-related topics, including pharmacotherapy to treat AUD, statistical methods and outcomes for alcohol clinical trials, psychiatric comorbidity of AUD, and correlates of alcohol use. 

Fuad Issa, M.D. has been the Psychological Health Research Portfolio Manager at Research & Engineering Directorate, Defense Health Agency (DHA) since January 2022. Prior to that Dr. Issa served as Chief of Clinical Care at DHA Psychological Health Center of Excellence since 2016. He has worked in the civilian, military and veteran mental health arenas both in clinical and research capacities. Dr. Issa has published in peer-reviewed journals, presented at national and international conferences, and authored book chapters. Dr. Issa earned his medical degree from Aleppo University, Syria, and trained in Psychiatry at Case Western Reserve University; later he was senior research fellow in clinical psychopharmacology at the National Institute of Mental Health, conducting clinical and basic science research on serious mental illnesses. He continued his involvement in research at Washington Research and George Washington University until he joined DHA. Dr. Issa is board certified in Psychiatry, distinguished life fellow of the American Psychiatric Association, member of Society of Biological Psychiatry and American Medical Association. He is a Clinical Professor of Psychiatry and Behavioral Sciences at George Washington University. 

Iván D. Montoya, M.D., M.P.H.is the Director of the Division of Therapeutics and Medical Consequences (DTMC) at the National Institute on Drug Abuse (NIDA), NIH, where he provides scientific and administrative leadership for a national and international research portfolio focused on medications, biologics, behavioral interventions, devices, and digital therapeutics for substance use disorders (SUDs), as well as research on their medical consequences. He has extensive expertise in translational addiction science, multi-site clinical trials, pharmacotherapy and biologics development, and ethical oversight of complex clinical research, and has authored multiple peer-reviewed publications and edited major reference works in addiction medicine. 

Matthew Rudorfer, M.D. is the Chief of the Psychopharmacology, Somatic, and Integrated Treatments Research Program in the National Institute of Mental Health (NIMH) Division of Services and Intervention Research (DSIR) Treatment and Preventive Interventions Research Branch. In this position Dr. Rudorfer provides programmatic support for confirmatory efficacy and effectiveness clinical trials and related research focused on studies of optimized and personalized treatment across a range of disorders, mainly in adults, using a variety of medication, device-based, and behavioral interventions, often in sequence or combination. He also helps coordinate ethics research for the Institute. He has served as a member and chair of the FDA Psychiatric Drugs Advisory Committee.

Dr. Rudorfer began his NIMH career in the intramural research program, where for several years he conducted research on novel and existing pharmacologic and neuromodulation treatments for complex mood disorders, establishing an ECT clinical and research service. Moving on to the extramural program, he served as program director of the annual NCDEU treatment research meeting – eventually co-chairing with ASCP – and editor-in-chief of the Psychopharmacology Bulletin before assuming his present position. Board-certified in Psychiatry and Clinical Pharmacology, Dr. Rudorfer received his medical degree from the State University of New York – Downstate Medical Center and trained in psychiatry at Washington University in St. Louis before coming to NIH. At present he maintains a small private practice of psychiatry and psychopharmacology and serves as chair of the Continuing Medical Education (CME) Committee of the Washington Psychiatric Society.

Tracy Yu-Ping Wang, MD, MHS, MSc  Chief, is a cardiologist and clinical researcher with expertise in observational research, implementation science and pragmatic randomized clinical trials.   Wang leads PCORI’s comparative clinical effectiveness research (CER) portfolio focused on increasing the evidence base for existing interventions and emerging innovations to improve health care and health outcomes through multidisciplinary research. She provides strategic guidance and oversight of ongoing programs and new initiatives designed to enhance and accelerate patient-centered CER.   Prior to her current role, Wang was a professor of medicine at Duke University and led several large studies at the Duke Clinical Research Institute that have focused on comparative effectiveness and safety, care quality assessment and quality improvement. To date, she has published over 350 peer-reviewed manuscripts, lectured widely on pragmatic trials and the use of data to guide initiatives aimed at reducing gaps in healthcare access and outcomes. Additionally, she has evolved the platform for research to enrich representative site and patient recruitment, innovate longitudinal patient follow-up, facilitate the collection of patient-reported outcomes and pragmatically adjudicate clinical events of interest. She previously served as Assistant Dean of Continuing Medical Education and Director of Health Services and Outcomes Research at Duke.   Wang has served on numerous volunteer committees, tasks forces and writing groups for the American Heart Association (AHA), American College of Cardiology and American College of Physicians. She previously chaired the AHA Council Operations Committee (2020-22) and AHA’s Quality of Care and Outcomes Research (QCOR) Council (2017-19). She is an associate editor of the JAMA Internal Medicine journal and serves on the editorial boards of several other high-impact journals. In 2022, she was awarded the AHA QCOR Outstanding Lifetime Achievement Award and has received multiple awards recognizing her excellence in research mentorship and leadership.   A graduate of Yale University, Wang received her medical degree from Harvard Medical School, Master of Science degree in molecular biochemistry and biophysics from Yale University, and Master of Health Science degree in clinical research from Duke University.