Speakers

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Gopi Shanker
Director, Head of Psychiatry
Novartis Institutes for Biomedical Research

Gopi Shanker has spent over 19 years working in the area of neuroscience drug discovery and has led preclinical and clinical drug discovery programs in the areas of neuropsychiatry, neurodegeneration and pain/migraine. Gopi completed his doctoral work in neuroendocrinology at the Indian Institute of Science, Bangalore (India) and his post-doctoral work in sensory neurobiology at the Mt. Sinai School of Medicine, New York. He started his research in drug discovery at Regeneron Pharmaceuticals and developed a deeper focus on discovering neuroscience therapies at Amgen thereafter. He joined the Neuroscience disease area at Novartis in 2013. At Novartis, Gopi is responsible for setting the strategy and leading the neuropsychiatry unit as well as initiating and establishing drug discovery programs focused on neuropsychiatric and neurodevelopmental disorders and advancing them into the clinic.

Day One

Wednesday 11 November 2020

9:10 am | Kick-off Panel Discussion: What is Preventing Experts from Redefining the Field & Developing Transformative Drugs for Psychiatric Patients in Need?

9:00 am | Chair's Opening Remarks

Seth Lederman
Co-Founder
CEO & Chairman Tonix Pharmaceuticals

Seth Lederman is founder and CEO of Tonix.  Prior to founding Tonix, Dr. Lederman founded Vela, Targent, and Validus Pharmaceuticals.  Targent was acquired by Spectrum Pharmaceuticals, which marketed Targent’s levoleucovorin as Fusilev® for advanced colorectal cancer. Dr. Lederman was on the faculty of Columbia University medical school from 1985 – 2017 (Asst. Prof 1988 – 1996 and then Assoc. Prof with tenure.)  Dr. Lederman earned an AB from Princeton in Chemistry cum laude in 1979 and an MD from Columbia University's College of Physicians and Surgeons in 1983. Dr. Lederman trained in internal medicine and rheumatology at Columbia's Presbyterian Hospital.

Day Two

Thursday 12 November 2020

12:20 pm | Live Q&A

11:55 am | Developing a PTSD Therapeutic - Phase 3 Clinical Development

Steve Paul
CEO and Chairman
Karuna Therapeutics, Inc

Steve Paul, M.D., is an expert in central nervous system (CNS) drug discovery and development. He spent 17 years at Eli Lilly and Company (NYSE: LLY), during which time he held several key leadership roles, including Executive Vice President for Science and Technology and President of the Lilly Research Laboratories. At Lilly he was responsible for the company’s overall research and development efforts and helped to oversee the development of CNS drugs such as Zyprexa® and Cymbalta® as well as the development of xanomeline where its antipsychotic and procognitive properties were initially demonstrated. Prior to Lilly, Steve spent 18 years at the National Institute of Health (NIH) and served as the Scientific Director of the National Institute of Mental Health (NIMH). Dr. Paul is a co-founder and board member of Sage Therapeutics (NASDAQ: SAGE), a co-founder of Voyager Therapeutics (NASDAQ: VYGR) where he served as President, Chief Executive Officer, and member of the board of directors, and a member of the board of directors at Alnylam Pharmaceuticals (NASDAQ: ALNY). Dr. Paul is the former director of the Appel Alzheimer Disease Research Institute at Weill Cornell Medical College and is currently a Professor of Psychiatry at Washington University School of Medicine in St. Louis. Dr. Paul has authored or co-authored more than 550 papers and book chapters. He is an elected fellow of the American Association for the Advancement of Science and a member of the National Academy of Medicine (NAM) of the National Academy of Sciences (NAS). He is also an elected Fellow Emeritus of the American College of Neuropsychopharmacology (ACNP) and served as ACNP President (1999). Dr. Paul is the Chairman of the Board of the Foundation for the NIH (FNIH) and previously served on the Science Board of the U.S. Food and Drug Administration (FDA) in addition to serving on many other advisory committees and receiving many awards and honors for his scientific research.  

Day Two

Thursday 12 November 2020

3:20 pm | Live Q&A

2:05 pm | Emergence of the Next Generation of Anti-Psychotics

Kurt Rasmussen
Director, Division of Therapeutics & Medical Consequences
The National Institute on Drug Abuse (NIDA)

Dr. Rasmussen is an internationally recognized neuroscientist, who specializes in basic addiction research and drug development.  Dr. Rasmussen has extensive knowledge of neuropsychiatric and neurological therapeutics and is known for his expertise in pharmaceutical discovery research from hypothesis generation to clinical candidate evaluation.  As Director of the Division of Therapeutics and Medical Consequences, Dr. Rasmussen directs NIDA’s Medications Development Program, evaluating the safety and efficacy of pharmacotherapies, behavioral therapies, and devices to treat substance use disorders through peer reviewed grants, contracts, and interagency agreements.  Previous experience includes 28 years at Eli Lilly. He joined NIDA in April 2018.

Day One

Wednesday 11 November 2020

6:50 pm | Live Q&A

5:35 pm | Addressing the Opioid Crisis & Driving a Change

Patricio O’Donnell
Executive Medical Director and Head, Neurocircuitry Biomarkers
Takeda Pharmaceuticals

Patricio O’Donnell combines an outstanding academic career in Neuroscience with experience in drug discovery and development for neuropsychiatric indications. He is an Executive Medical Director in the Neuroscience Translational Medicine group at Takeda. Dr. O’Donnell grew up in Buenos Aires, Argentina and earned his M.D. and Ph.D. degrees from the University of Buenos Aires. Dr. O’Donnell worked as a postdoctoral fellow with Anthony Grace at the University of Pittsburgh, where he pioneered studies on the physiological properties of the nucleus accumbens, and then moved on to establishing his own research program at Albany Medical College. In 2006 he was recruited by the University of Maryland, and in 2013 he moved to Pfizer. He is the recipient of numerous awards including the 2010 National Alliance for Schizophrenia and Depression Distinguished Investigator Award. Dr. O’Donnell is a fellow in the American College of Neuropsychopharmacology (ACNP), chaired several conferences including the 2009 Gordon Conference on Catecholamines and the Winter Conference on Brain Research in 2012 and 2013. Dr. O’Donnell has authored over 100 scientific papers, served or serves on the Editorial Boards of the Journal of Neuroscience, Neuropsychopharmacology, The International Journal of Neuropsychopharmacology, Schizophrenia Bulletin, and the Journal of Pharmacology & Experimental Therapeutics, among others, and sat on advisory committees of the National Institutes of Health. He serves on the scientific advisory board of several private foundations and has advised major pharmaceutical and biotech companies. Before joining Takeda, Dr. O’Donnell led discovery efforts for Psychiatry and Pfizer and prior to that he was a Professor of Anatomy & Neurobiology and Psychiatry at the University of Maryland School of Medicine.

Day One

Wednesday 11 November 2020

10:30 am | Live Q&A

9:40 am | Advancing Neurophysiology & Cognition Translational Biomarkers to Drive Drug Development for Neuropsychiatric Disorders

9:10 am | Kick-off Panel Discussion: What is Preventing Experts from Redefining the Field & Developing Transformative Drugs for Psychiatric Patients in Need?

Errol De Souza
Executive Chairman
Bionomics

Dr De Souza is a leader in the development of therapeutics for treatment of central nervous system (CNS) disorders. He has substantial experience as an executive in the biopharmaceutical industry, having founded companies (Neurocrine Sciences Inc.) and served as President and CEO of several public (Biodel Inc; Synaptic Pharmaceutical) and private (Archemix Corp. and Neuropore Therapies Inc.) biotech companies.  Over Dr. De Souza's career, he has served in a number of high-ranking R&D roles, including SVP and U.S. head of Aventis (1998-2002), co-founder and EVP of R&D at Neurocrine (1992-1998) and Head of CNS at DuPont Merck (1990-1992). He has edited 6 books and is an author or co-author of approximately 300 original articles, chapters or reviews and 300 abstracts.  His research has focused on the receptor mechanisms involved in coordinating brain-endocrine-immune responses to stress.  He is the recipient of numerous national and international awards including the 1990 Joseph Cochin Young Investigator Award of the Committee on Problems of Drug Dependence, the 1991 Jordi Folch-Pi Memorial Award of the American Society for Neurochemistry, the 1994 Curt Richter Award and the 2005 Service Award of the International Society of Psychoneuroendocrinology, the 1997 Daniel H. Efron Award of the American College of Neuropsychopharmacology and the 2005 Ernst & Young Entrepreneur of the Year (New England Biotech category).  Dr. De Souza has served on the faculty of several universities including The Johns Hopkins University School of Medicine, University of Pennsylvania School of Medicine, University of California at San Diego and Rutgers University

Day Two

Thursday 12 November 2020

11:30 am | BNC210: A Negative Allosteric Modulator of Alpha7 Nicotinic Acetylcholine Receptor in Development for the Treatment of Anxiety, Depression & Post Traumatic Stress Disorder

12:20 pm | Live Q&A

Phil Skolnick
Chief Scientific Officer
Opiant

Phil Skolnick has held leadership positions in industry, government and academia. Prior to joining Opiant, Dr. Skolnick served as the Director, Division of Therapeutics and Medical Consequences at the National Institute on Drug Abuse (2010-2017). He was Chief Scientific Officer (2001-2009) and President (2007-2009) of DOV Pharmaceutical, and a Lilly Research Fellow at Lilly Research Laboratories (1997-2000).  He served as Senior Investigator and Chief,  of the Laboratory of Neuroscience, NIH from 1986-1997. Dr. Skolnick has co-authored more than 550 publications in the fields of molecular and clinical neuropsychopharmacology. Dr. Skolnick received a BS from Long Island University (summa cum laude) and a PhD from the Department of Pharmacology, George Washington University School of Medicine. Among his awards and honors are an Anna Monika Prize, a Lifetime Achievement Award from the American Society of Clinical Psychopharmacology, and DSc (honoris causa) degrees from Long Island University and the University of Wisconsin-Milwaukee.

Day One

Wednesday 11 November 2020

6:50 pm | Live Q&A

6:00 pm | Fighting Fire with Fire: Development of Intranasal Nalmefene to Treat Synthetic Opioid Overdose

Jill Harkavy Friedman
Vice President of Research
American Foundation for Suicide Prevention

Dr. Jill Harkavy-Friedman leads the American Foundation for Suicide Prevention’s growing research grant program. She works with over 200 scientific advisors to evaluate progress in the field and chart the next areas of inquiry to yield impactful insights and strategies for suicide prevention. She serves as liaison to other national organizations and together they work to facilitate innovative and impactful research with a goal translating research into the prevention of suicide. In her more than 30 years of experience as both a clinician and a researcher, she has always been passionate about translating research into practice. Harkavy-Friedman has published over 100 articles, and she works closely with AFSP’s Education, Communication, and Public Policy and Advocacy teams to develop programs and messages to ensure they follow best practices in suicide prevention and reflect the latest findings in research. Dr. Harkavy-Friedman earned her bachelor’s degree in Psychology at the University of Pennsylvania and her master’s degree and doctorate in Clinical Psychology at the University of Florida. In 1984, after her internship at Yale-New Haven Hospital, she joined Montefiore Medical Center/Albert Einstein College of Medicine as an assistant professor where she established the Adolescent Depression and Suicide Program. In 1989, Harkavy-Friedman moved to Columbia University/New York State Psychiatric Institute, first as an assistant professor and currently as an associate professor of clinical psychology in psychiatry. As a licensed psychologist, she maintains a clinical practice in Manhattan.

Day One

Wednesday 11 November 2020

3:25 pm | Live Q&A

2:35 pm | Exploring Why it is Pivotal to Include Suicidal Patients in Neuropsychiatric Clinical Studies

Nassir Ghaemi
Translational Medicine, Neuroscience
Novartis Institutes for Biomedical Research

Nassir Ghaemi MD MPH is a psychiatrist and researcher specializing in depression and bipolar illness. He is a Director at Novartis Institutes of Biomedical Research in Cambridge MA, where he leads clinical psychiatry research on discovery and early development of new drugs. He also is Professor of Psychiatry at Tufts Medical Center in Boston and also Lecturer on Psychiatry at Harvard Medical School. He has published over 200 scientific articles, over 50 scientific book chapters, and he has written or edited over half a dozen books. He is an Associate Editor of Acta Psychiatrica Scandinavica, and is a Distinguished Fellow of the American Psychiatric Association.

Day One

Wednesday 11 November 2020

12:55 pm | Live Q&A

11:30 am | Core Clinical Trial Design Issues that Prevent us From Developing Effective & Transformative Drugs

Gerard Sanacora
Director Yale Depression Research Program
Yale University School of Medicine

Dr. Sanacora completed his Ph.D. in Physiology and Biophysics and his M.D. at Stony Brook University. He moved to Yale University to complete the Clinical Neuroscientist Training Program Residency and a Neuroimaging Fellowship. He is currently the George and Esther Gross Professor of Psychiatry at the Yale, the Director of the Yale Depression Research Program and the co-Director of the Yale-New Haven Hospital Interventional Psychiatry Service.  Dr. Sanacora’s career has focused largely on elucidating the pathophysiological mechanisms associated with mood and other neuropsychiatric disorders and using this information to inform the development of novel treatment strategies. His work spans the spectrum from rodent models of neuropsychiatric disorders to large phase 3 clinical trials. He has received the Anna-Monkia Stiftung international award for the investigation of the biological substrate and functional disturbances of depression, the Joel Elkes Research Award for Outstanding contributions to Psychopharmacology from the American College of Neuropsychopharmacology.

Day One

Wednesday 11 November 2020

12:55 pm | Live Q&A

12:30 pm | Pushing the Envelope: Discovering Consequential Trial Design

Sharon Mates
Chairman, President & CEO
Intra-Cellular Therapies, Inc.

Dr. Mates leads Intra-Cellular Therapies, a biopharmaceutical company founded on Nobel prize-winning research that broadens the way scientists understand how therapeutics affect the intra-cellular signaling of neurons and other cells. The company leverages this intra-cellular approach to develop and commercialize innovative treatments. Dr. Mates has more than 25 years of experience leading companies with a commitment to cutting-edge science and research to discover innovative approaches to treating disease. Prior to co-founding ITCI in 2002, she was President and board member of North American Vaccine Inc. and its predecessor companies for almost a decade. Throughout her career, she has held numerous advisory and board positions including a current board appointment to Biotechnology Innovation Organization Emerging Company Section. Dr. Mates received her B.S from The Ohio State University and her Ph.D. from the University of Washington. She completed her postdoctoral fellowships at the Massachusetts General Hospital and Harvard Medical School.

Day One

Wednesday 11 November 2020

5:20 pm | Live Q&A

4:30 pm | Bipolar Depression: Unmet Needs Continue to Exist

Day Two

Thursday 12 November 2020

3:20 pm | Live Q&A

2:30 pm | Schizophrenia, A New Treatment Option for Patients

Srikanth Gottipati
Associate Director, Think Team
Otsuka Pharmaceuticals

Day One

Wednesday 11 November 2020

12:55 pm | Live Q&A

12:05 pm | Data Driven Analysis to Drive our Understanding of Placebo Responses in Neuropsychiatric Drug Development

David Donabedian
CEO
Axial Biotherapeutics

Dr. Donabedian is an accomplished business development and strategy executive with extensive leadership experience. Dr. Donabedian has a track record of building companies, most recently as a Venture Partner at Longwood Fund. Prior to joining Longwood, Dr. Donabedian has held various leadership roles at biopharmaceutical companies including AbbVie and GSK. At AbbVie, Dr. Donabedian served as Vice President & Global Head of Ventures and Early Stage Collaborations where he led a global team that completed significant transactions across multiple therapeutic areas and stages of development. Prior to AbbVie, Dr. Donabedian served as Vice President Global New Deal Strategy and Development at GlaxoSmithKline, and Senior Manager at Accenture’s Strategic Services Consulting Group. He holds a BA in Chemistry from St. Anselm College, a Ph.D. in Polymer Chemistry from the University of Massachusetts Lowell, and an MBA from the University of North Carolina. He currently serves on the Board of Alcyone Life Sciences, a privately held CNS company which he co-founded.

Gary K. Zammit
President & CEO
Clinilabs Drug Development Corporation

Gary Zammit, PhD, is the President & CEO of Clinilabs, a full-service CRO that provides clinical drug development to industry, focusing on CNS therapeutics.  He also is an Associate Clinical Professor of Psychiatry, Icahn School of Medicine at Mount Sinai (New York, NY).  Dr. Zammit earned a Ph.D. degree in clinical psychology from the University of Toledo (Toledo, OH), where he won both the Turin Service Award and the Leckie Scholar Award.  He completed an internship and clinical research fellowship in the Department of Psychiatry at the New York Hospital - Cornell University Medical College (White Plains, NY), where he won the Alumni Award for Excellence.  Dr. Zammit is widely sought for his expertise in neuropsychiatric drug development, particularly in the field of sleep medicine.  He has authored two books and over 230  articles and abstracts that have appeared in medical journals.

Day One

Wednesday 11 November 2020

10:30 am | Live Q&A

10:05 am | The Role of the CRO in Patient-Centric CNS Clinical Trials

Rick Doblin
Executive Director
Multidisciplinary Association for Psychedelic Studies (MAPS)

Rick Doblin, Ph.D., is the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). He received his doctorate in Public Policy from Harvard's Kennedy School of Government, where he wrote his dissertation on the regulation of the medical uses of psychedelics and marijuana and his Master's thesis on a survey of oncologists about smoked marijuana vs. the oral THC pill in nausea control for cancer patients. His undergraduate thesis at New College of Florida was a 25-year follow-up to the classic Good Friday Experiment, which evaluated the potential of psychedelic drugs to catalyze religious experiences. He also conducted a thirty-four year follow-up study to Timothy Leary's Concord Prison Experiment. Rick studied with Dr. Stanislav Grof and was among the first to be certified as a Holotropic Breathwork practitioner. His professional goal is to help develop legal contexts for the beneficial uses of psychedelics and marijuana, primarily as prescription medicines but also for personal growth for otherwise healthy people, and eventually to become a legally licensed psychedelic therapist. He founded MAPS in 1986, and currently resides in Boston with his wife, dog, and empty rooms from three children, one of whom is in college and two have graduated.

Christopher Missling
President & CEO
Anavex

Day Two

Thursday 12 November 2020

10:25 am | Live Q&A

9:10 am | Exploring Mechanistic Approaches to Treating Neuropsychiatric Disorders such as Depression, Autism & Cognitive Impairment

Angel Angelov
VP Medical Affairs
Neurocrine

Day One

Wednesday 11 November 2020

3:25 pm | Live Q&A

2:10 pm | Spearheading Innovation in Clinical Development & Approval for New Neuropsychiatric Drugs

Sheldon Preskorn
Professor, Department of Psychiatry & Behavioral Sciences
University of Kansas School of Medicine (UKSM)

Dr. Preskorn has worked over 139 pharmaceutical, biotechnology, diagnostic and device companies including every major company in the United States, most in Europe, and several in Japan in the various ways listed below.  This experience has been particularly focused on CNS therapeutic agents but has extended to other therapeutic areas.  Within the CNS, the experience has focused on Major Depression, Senile Dementia of the Alzheimer’s type, Schizophrenia, anxiety disorders, and various forms of cognitive impairment.  During a 25-year period, Dr. Preskorn served as a principal investigator on clinical trials for every antidepressant and antipsychotic marketed in the United States.

Stephen Hurst
Co-founder, Executive Chair & Co-CEO
Mind Medicine

Day One

Wednesday 11 November 2020

6:50 pm | Live Q&A

6:25 pm | Trailblazing Non-Hallucinogenic & Hallucinogenic Solutions to Psychiatric Disorders

Jonathan Javitt
Founder & CEO
NeuroRx, Inc.

Day One

Wednesday 11 November 2020

5:20 pm | Live Q&A

4:55 pm | Unique Mechanism of Action Associated with NMDA Antagonists for Treating Suicidal Bipolar Depression

Giulio Maria Pasinetti
Saunders Family Chair & Professor of Neurology, Psychiatry & Neuroscience,Geriatrics & Adult Development
Icahn School of Medicine, Mount Sinai

Day Two

Thursday 12 November 2020

3:20 pm | Live Q&A

2:55 pm | Linking Innate Immunity, Neuroinflammation & the Gut Brain Axis to the Development of Psychiatric Disorders

Vaibhav Narayan
Vice President, Data Science, Neuroscience Therapeutic Area
Janssen R&D

Day Two

Thursday 12 November 2020

10:25 am | Live Q&A

9:35 am | Leveraging Informatics & Digital Technologies for Precision & Predictive Neuropsychiatric Diseases

Alberto Cruz-Martin
Assistant Professor of Biology
Boston University

Day Two

Thursday 12 November 2020

3:20 pm | Live Q&A

1:40 pm | Investigating How Altered C4 Expression Contributes Directly to Schizophrenia Pathogenesis

Carol Tamminga
Lou & Ellen McGinley Distinguished Chair, McKenzie Chair in Psychiatry, Translational Neuroscience Division in Schizophrenia
UT Southwestern

Day One

Wednesday 11 November 2020

3:25 pm | Live Q&A

3:00 pm | Using Biotypes to Propose Rational Targets & Enrich Study Population

Christian Thomsen
Global Head, CNS Business Development & Licensing
Boehringer Ingelheim

Day Two

Thursday 12 November 2020

10:25 am | Live Q&A

10:00 am | Exploring Boehringer-Ingelheim’s Commitment to Bringing First-inClass Medicines to Neuropsychiatric Patients

Massimiliano Bianchi
President & CEO
Ulysses Neuroscience

Day One

Wednesday 11 November 2020

11:55 am | Translational Clinical & Preclinical Approaches to Advance Drug Discovery in Neuropsychiatric & Neurodevelopmental Disorders

12:55 pm | Live Q&A

9:10 am | Kick-off Panel Discussion: What is Preventing Experts from Redefining the Field & Developing Transformative Drugs for Psychiatric Patients in Need?