Therapeutic Leader, Psychiatry, Janssen Pharmaceutical Companies

Larry Alphs received his M.D. and Ph.D. from the University of Chicago Pritzker School of Medicine with a doctorate in neuropharmacology. In addition, he completed 2 years as a PRAT fellow at NIH and a residency in psychiatry at the University of Chicago Hospitals and Clinics. He worked for 10 years in academia as a researcher/clinician specializing in clinical research with persons with serious psychiatric disorders. His interests focused on nosology and treatment of schizophrenia and drug-induced movement disorders. For the past 15 years he has worked as a clinical scientist in the pharmaceutical industry where he has done Phase I-IV work in a variety of CNS disorders, including schizophrenia, bipolar disorder, suicidality, anxiety, depression, epilepsy, neuropathic pain, and traumatic brain injury. He currently is Therapeutic Leader, Psychiatry for Janssen Scientific Affairs in Titusville, NJ and serves as the Past-President for the International Society for CNS Clinical Trials and Methodology.  Larry was also recipient of the Johnson and Johnson 2011 Volunteer of the Year award recognizing his service to the ISCTM.

Deputy Head of Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM)

Dr. Broich is professionally trained and board certified in Neurology, Psychiatry, Behavioral Psychotherapy. He completed a research fellowship at the Department of Nuclear Medicine at Hospital of the University of Pennsylvania. Dr. Broich was Vice Head in the Department of Psychiatry and Psychotherapy at the Hospital of the Martin Luther University in Halle Wittenberg. Dr. Broich held the position of Head of the Section Neurology Psychiatry at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, and since 2005 has operated as department head for that group. He is also the German alternate member of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA).

Dr. Broich is currently engaged in research in the areas of: Neuropharmacology, Neurodegenerative Disorders, Neuroimaging, Biomarkers in drug development, Clinical trial design.

Dr. Broich maintains membership in the following learned societies: German Society of Psychiatry; Psychotherapy and Neurosciences; German Society of Gerontopsychiatry; German Society of Biological Psychiatry; German Society of Neuropsychopharmacology; European College of Neuropsychopharmacology; International Psycho]geriatric Association; American Society for Experimental Neurotherapeutics (ASENT); World Federation of Biological Psychiatry.

Dr. Broich is the author and co-author of more than 90 Publications (peer reviewed articles, reviews, book sections).

Research Associate Professor of Clinical Psychology in Psychiatry, Penn Medicine Neuroscience Center

Dr. Brown provides clinical training for clinicians in suicide assessment and risk management, cognitive behavior therapy for depression and suicide prevention.

Dr. Brown’s research has focused on developing, evaluating, and disseminating targeted, psychotherapy interventions for individuals who are indicated as being at high risk for suicide. Currently, he is investigating the effectiveness of cognitive therapy for adult patients who recently attempted suicide and for suicidal older men. Recently, he has worked on developing and implementing brief intervention strategies (safety planning) for suicide prevention in civilian and VA emergency departments as well as for psychiatric inpatient settings in the military.

Vice President, Client Services, Bracket Global

Mr. Butler works with Bracket, a division of UBC/Medco, which specializes in endpoint reliability services for clinical trials. Mr. Butler is responsible for all client activities at Bracket, and is focused on development and support of new services for rater training and certification, ratings reliability and monitoring services, and computerized cognitive testing. Along with Bracket’s senior scientific staff, Mr. Butler supports all of Bracket’s research and publication efforts.

Mr. Butler has 7 years of experience working in the CNS pharmaceutical services industry. In his prior position as Associate Vice President, Creative Services, Mr. Butler led a group responsible for development of training materials for UBC’s clinician and patient training and education programs. He led a team of clinicians, multimedia developers, producers, and filmmakers with experience in clinical and documentary video production. Under Mr. Butler’s leadership, Bracket has created thousands of hours of clinical training and education video, translated into more than 50 languages.

Vice President for Global Health Policy, Government Affairs and Policy, Johnson & Johnson

Ms. Buto has responsibility for providing policy analysis and developing positions on a wide range of U.S. and international issues, including the Medicare drug benefit, government reimbursement, coverage of new technologies, and regulatory requirements. In addition to reviewing how federal, state, and international government policies affect Johnson & Johnson products and customers, she is responsible for helping to identify areas of opportunity for J&J to take leadership in shaping health care policy.

Prior to joining J&J, Kathy was a senior health adviser at the Congressional Budget Office, helping to develop the cost models for the Medicare drug benefit. Before that, she spent more than 18 years in senior positions at the Health Care Financing Administration, including Deputy Director, Center for Health Plans and Providers, and Associate Administrator for Policy. In these positions, she headed the policy, reimbursement, research, and coverage functions for the agency, as well as managing Medicare’s fee-for-service and managed care operations. 

Kathy received her Bachelor of Arts from Douglass College and her Masters in Public Administration from Harvard University.

Director, Office of Behavioral Safety Research, NHTSA

Richard P. Compton, Ph.D., is the Director of the Office of Behavioral Safety Research, Research and Program Development, Traffic Injury Control, at the National Highway Traffic Safety Administration, U.S. Department of Transportation.  He joined NHTSA over 30 years ago as a Research Psychologist in the Office of Research and Development.  Over the years he has directed and authored numerous research studies in the areas of alcohol and drug impaired driving, occupant protection, young drivers, older drivers, and speeding and other unsafe driving actions, especially the evaluation of new technology, sanctions, enforcement and public information and education.  He has conducted evaluations of national, state and local traffic safety programs to determine their effectiveness.

He received his Ph.D. degree in experimental psychology from the University of Nebraska in 1977 and has taught a variety of courses at the University level.  He is a member of the American Psychological Association and the Human Factors Society.  He is on the Executive Board of the International Council on Alcohol, Drugs and Traffic Safety.  He is also a member of the Transportation Research Board’s Committee on Alcohol, Other Drugs and Transportation, Committee on Operator Education and Regulation, and the Subcommittee on Young Drivers, Strategic Highway Research Program Safety Technical Coordinating Committee, as well as the Executive Board of the National Safety Council’s Committee on Alcohol and Other Drugs.  

He is currently responsible for directing NHTSA’s behavioral safety research program that encompasses such topics as alcohol and drug impaired driving, occupant protection (seat belt use and child passenger protection), speeding, older drivers, young drivers, driver licensing and driver education, motorcycle safety, pedestrian and bicycle safety, school bus safety, emergency medical services, drowsy and distracted driving, and international programs.

Dr. Coric is currently Group Director at Bristol-Myers Squibb in Neuroscience Global Clinical Research and Associate Clinical Professor of Psychiatry at the Yale School of Medicine. Since joining Bristol-Myers Squibb in 2007, Dr. Coric has worked on a number of neuroscience clinical programs at Bristol-Myers Squibb including the Phase 2 Gamma Secretase Inhibitor studies in Alzheimer’s disease, CRF1 receptor antagonist program, CGRP antagonist program and aripiprazole studies. 

Professor of Psychiatry, Department of Psychiatry, Sheba Medical Center, Israel

Michael Davidson, MD is a graduate of the State University of Milan Medical School (1976). He trained in cardiology and medicine (Tel Aviv Medical Center) and psychiatry (Metropolitan Hospital and Mount Sinai School of Medicine, NY) between 1976 and 1984, and was Unit Director, Division Director in Old Age Psychiatry at Mount Sinai, and Associate Clinical Director, Pilgrim Psychiatric Hospital (NY), before moving to the Psychiatric Services and Memory Clinic, Sheba Medical Center (Israel) in 1995. Currently he is Director of the department of psychiatry at the Chaim Sheba Medical Center, Tel Aviv, he is Board Certified in Psychiatry in Israel and the United States.

Dr. Davidson’s early work focused on the development of clinical methodologies to measure amine concentrations, which was believed to reflect central DA activity and hence could help understand psychosis. When developments in molecular biology brought the direct examination of the brain tissue to the fore in psychiatric research, he saw that a brain bank with ante-mortem phenomenological assessment was needed. He established what is now the largest brain bank with ante-mortem assessment, from which researchers around the world may obtain tissue and, possibly, correlate their biological findings with detailed clinical phenomenological data. He has also described schizophrenia in old age and demonstrated that, for the most part, psychotic symptoms do not burn out as previously believed, and cognitive impairment is the major determinant of these patients’ symptoms and level of functioning. As a corollary to this work, he investigated the process of institutionalization and de-institutionalization, and other social aspects of the illness.

His focus, in investigating dementia, particularly Alzheimer’s disease, was to show that manipulation of the cholinergic activity might benefit AD patients. Aware that Ache is only one of several neurotransmitters deficient in AD, he took part in studies combining cholinergic and adrenergic augmenting drugs in AD, such as clonidine and yohimbine, as well as non-specific augmentation, such as aminopyridine. He also investigated if non-pharmacological strategies might help delay cognitive decline in the elderly and demonstrated that non-specific intellectual activity has a mild effect in this direction. Currently he is involved in investigating the role of cardiovascular risk factors in dementia. His latest publication in the field is Beeri M, Goldbourt U, Silverman JM, Noy S, Schmeidler J, Ravona R, Sverdlick A, Davidson M “Diabetes mellitus in midlife and the risk of dementia three decades later”, Neurology 63: 1902-1907 2004.

He is the recipient of many awards and grants, has published or edited more than 200 scientific articles and/or books. He co-chaired IPA’s Jerusalem Congress (1997) and was elected to the Board of Directors in 2000. Other professional affiliations include ACNP, ECNP, the World Psychiatric Association, Section on Biological Psychiatry. He is a reviewer for NIMH, and the Israeli Chief Scientist Committee and for journals such as AJP, Arch Gen Psychiatry to Alzheimer’s disease and Associated Disorders to name only a few. He has recently received the prestigious ECNP Neuropharmacology award. Over the last 2 years he has been the chair of the IPA publication committee. He has served on IPA’s Board of Directors since 2000.

Director, Pfizer, Inc. Assistant Clinical Professor, University of Connecticut School of Medicine

Editor-in-Chief, Health Affairs Journal

Susan Dentzer is the editor-in-chief of Health Affairs, the nation’s leading peer-reviewed journal focused on the intersection of health, health care and health policy in the United States and internationally.  One of the nation’s most respected health and health policy journalists, she is an on-air analyst on health issues with the PBS NewsHour, and a frequent guest and commentator on such National Public Radio shows as This American Life and The Diane Rehm Show.
Dentzer is an elected member of the Institute of Medicine, the health arm of the National Academy of Sciences, and of the Council on Foreign Relations, the independent, nonpartisan membership organization and think tank dedicated to exploring the foreign policy choices facing the United States and other countries.
At Health Affairs, Dentzer oversees the journal’s team of nearly 30 editors and other staff in producing the monthly publication and web site.   Health Affairs has been described by the Washington Post as the “Bible” of health policy.  Its articles and their authors are frequently cited in the Congressional Record and in congressional testimony as well as in the news media.  The Health Affairs web site recorded 50 million page views in 2010.
Before joining Health Affairs in May 2008, Dentzer was on-air Health Correspondent at the PBS NewsHour. From 1998 to 2008, she led the show’s unit providing in-depth coverage of health care and health policy. Prior to joining the PBS NewsHour, she was chief economics correspondent and economics columnist for U.S. News & World Report, and previously was a senior writer at Newsweek.
Dentzer’s other work in television has included appearances as a regular analyst or commentator on CNN and The McLaughlin Group. Her writing has also earned her several fellowships, including a Nieman Fellowship at Harvard University, where she studied health economics and policy, and a U.S.-Japan Leadership Program Fellowship, during which she researched the effects of the rapidly aging Japanese population.
Dentzer is an elected member of the National Academy of Social Insurance, a nonprofit, nonpartisan organization made up of the nation’s leading experts on social insurance, is a fellow of the Hastings Center, a nonpartisan research institution dedicated to bioethics and the public interest.
Dentzer is a member of the Board of Directors of Research!America, the nation’s largest not-for-profit public education and advocacy alliance committed to making research to improve health a higher national priority. She is also a member of the Board of Overseers of the International Rescue Committee, a humanitarian organization providing relief to refugees and displaced persons around the world. She chairs the IRC board’s Program Committee, which oversees the organization’s activities in resettling refugees in the United States and in dealing with refugees and displaced persons in roughly 25 countries.  Formerly, Dentzer served on the Board of Directors of the Global Health Council and was its chair from 2008-2010.
A graduate of Dartmouth and holder of an honorary master of arts from the institution, Ms. Dentzer is a Dartmouth trustee emerita and chaired the Dartmouth Board of Trustees from 2001 to 2004. She serves on the Board of Overseers of Dartmouth Medical School.
Dentzer, her husband and their three children live in the Washington, DC area.

Director, Clinical Statistics, Pfizer, Inc.

Sarah DuBrava, MS, has 10 years of experience in clinical trials.  She joined Pfizer in 2007 and is currently in the Primary Care Business Unit supporting Lyrica and Chantix.  She is a member of the ISCTM Working Group addressing suicidal ideation and behavior, Alzheimer’s Association Suicidal Ideation and Behavior Task Force, a cross-industry Suicidal Ideation and Behavior working group of statisticians, and has been involved in developing and revising the Pfizer internal guidance on suicidal ideation and behavior monitoring.

Lead Medical Officer, Division of Neurology Products, CDER, FDA

CNS Medical Affairs, Janssen Pharmaceutical Companies

Before coming to J&J, Dr. Ferziger was the physician leader of behavioral health disease management for CareGroup, a network of academic medical centers and community hospitals in the Boston, Massachusetts region, and a member of the Department of Psychiatry at Beth Israel Deaconess Medical Center and Harvard Medical School. He received his undergraduate degree from Brown University and his medical degree from Albany Medical College in New York. He completed residency training in psychiatry at the New York Hospital – Cornell Payne Whitney Clinic and fellowships in psychopharmacology, at the Harvard Medical School Clinical Research Training Program, and in Medical Informatics, at the HMS Center for Clinical Computing.

Global Head Neuroscience, F. Hoffmann LaRoche

George Garibaldi, M.D. is Global Head of Neuroscience and Clinical Development for F. Hoffmann La Roche. As well as serving now as Past President of the ISCTM, Dr. Garibaldi serves on the Executive Committees for the International College for Geriatric Psychoneuropharmacology (ICGP), the American Academy of Child and Adolescent Psychiatry (AACAP), and the Collegium Internationale Neuropsychopharmacologicum.

Director, Nathan S. Kline Institute for Psychiatric Research, Vice Chair for Research, Psychiatry Department, NYU Langone Medical Center 

Dr. Goff earned his medical degree at the University of California School of Medicine, Los Angeles, and completed his internship in Internal Medicine at Cedars-Sinai Medical Center in Los Angeles and his residency in Psychiatry at Massachusetts General Hospital in Boston. His research fellowship in Psychopharmacology was completed at Tufts-New England Medical Center in Boston.  Following training, he established the Schizophrenia Clinical and Research Program at the Massachusetts General Hospital of which he was Director for 25 years, until his move to NYU Medical Center and the Nathan Kline Institute in February, 2012.

Dr. Goff has published over 200 articles concerning schizophrenia and related topics. At the MGH he developed a translational clinical research program integrating pharmacology, cognitive behavioral therapy, neuroimaging, and genetics to enhance our understanding of the pathophysiology of schizophrenia and to develop new treatments.  He is now Director of the Nathan Kline Institute and Vice Chair of Psychiatry at NYU Medical Center where he is continuing his research directed at developing novel treatments for schizophrenia.
Dr. Goff is the recipient of the Kempf Award for Mentorship in Biological Psychiatry from the American Psychiatric Association; the Wayne Fenton, MD, Award for Exceptional Clinical Care; and the Stanley Dean Award for Research in Schizophrenia from the American College of Psychiatrists.  

Professor of Psychiatry, Research Professor of Biostatistics, University of North Carolina School of Medicine

Robert M. Hamer, Ph.D. received his Ph.D. degree from the University of North Carolina at Chapel Hill in Quantitative Psychology (Behavioral Statistics) in 1979. After a postdoctoral fellowship in Bayesian Statistics at the University of Iowa, with Melvin Novick, Ph.D., he joined the faculty of Virginia Commonwealth University (Medical College of Virginia), with joint appointments in Psychiatry and Biostatistics, in December, 1979 as an Assistant Professor. He was promoted to Associate Professor with tenure in 1985.

In 1991, while on educational leave from VCU he became Visiting Associate Professor in the Department of Statistics, Rutgers University. In 1994, he joined the faculty in the Department of Psychiatry, Robert Wood Johnson Medical School, in Piscataway NJ.

In 2001, he joined the faculty at the University of North Carolina, with appointments in the School of Medicine (Psychiatry) and the School of Public Health (Biostatistics).

He served one term on the US FDA Psychopharmacology Drugs Advisory Committee, from 1988 to 1992, and is served a second term from 1999 to 2002 on the same advisory committee. He has served on many NIH study sections, and currently serves on an NIMH standing study section, ITMA (formerly ITV). He consults for the FDA, multiple pharmaceutical companies, and SAS Institute. He is experienced in serving on NIH-funded and industry-sponsored DSMB / IDMCs.

Currently, most of his time is spent designing, planning, and working on psychopharmacology clinical trials, performing psychiatric research in collaboration with other psychiatry faculty, occasional medical research in other fields with faculty members in other fields, performing research on clinical trials methodology and statistics, and teaching.

Professor of Psychiatry, University of Miami Miller School of Medicine 

Philip D. Harvey, PhD is Professor of Psychiatry and director of the Division of Psychology at the University of Miami Miller School of Medicine.  He was formerly professor of Psychiatry at Emory University School of Medicine and Mt. Sinai School of Medicine and Chief Psychologist at Mt. Sinai Hospital. He has received a number of awards, including the Inaugural Schizophrenia International Research Society (SIRS) Clinical Scientist Distinguished Contributions award. His research has focused for years on cognition and functioning and he has written extensively on aging in schizophrenia, functional impairments in severe mental illness, the cognitive effects of typical and atypical antipsychotics, as well as studying the effects of cognitive enhancing agents in various conditions, including schizophrenia, dementia, affective disorders, and traumatic brain injury.  He directs an annual conference on cognition that is an official satellite of the International Congress on Schizophrenia Research and the Schizophrenia International Research Society.  

Principal Research Scientist, Global Health Outcomes, LBM

Dr. Haynes received her PhD and master’s degree in statistics and master’s degree in mathematics from Baylor University. She has fourteen years of clinical research experience in the pharmaceutical industry, primarily with Eli Lilly and Company (Lilly). In her first role at Lilly as a statistician, Dr. Haynes collaborated on several successful FDA submissions in schizophrenia, and was a research partner in bipolar disorder, Alzheimer’s disease, and Parkinson’s disease. She also gained extensive experience designing positive Phase IIIB and IV clinical trials in ADHD. At i3 Global, she served as a strategic statistical and scientific consultant for internal i3 scientists, external sponsors, and key opinion leaders in the CNS Medical and Scientific Affairs group.

Dr. Haynes rejoined Lilly in 2011 as a Principal Research Scientist in the Global Health Outcomes division developing research for products in Lilly Biomedicines. Her special areas of interest include ADHD and schizophrenia. Throughout her career she has continued to actively publish and present at US and international CNS meetings. She serves in the International Society for CNS Clinical Trials and Methodology as a member of the executive and scientific committees and chairs the adaptive design working group. 

Senior Vice President, Public Policy and Practice Improvement, National Council for Behavioral Healthcare

Mr. Ingoglia is the Senior Vice President of Public Policy & Practice Improvement for the National Council for Community Behavioral Healthcare where he directs Federal and state affairs, policy, and technical assistance to the National Council’s more than 1,900 member organizations nationwide. He plays a major role in Federal and State policy advocacy and analyses on myriad issues relevant to behavioral health financing and health reform. Mr. Ingoglia is also an adjunct faculty member of The George Washington University Graduate School of Political Management, where he teaches Mental Health Policy and Congress and The Politics of Non-Profits.

He holds a Master of Social Work and a Bachelor of Arts in Social Work, both from The Catholic University of America.

Director, Division of Neurology Product, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Dr. Katz joined the FDA as a medical officer in 1983, where he is currently the Director of the Division of Neurology Products (previously called the Division of Neuropharmacological Drug Products). He has lectured extensively on various aspects of neurologic drug development as well as written numerous articles on the same issues. He received his BA in mathematics from Queens College in New York City and his medical degree from Albert Einstein College of Medicine in New York City. He completed his residency in neurology in 1982 at the Einstein-affiliated hospitals in New York.

Professor, Departments of Psychiatry and Behavioral Sciences and Psychology, Duke University Medical Center
President, Neurocog Trials, Inc.

Dr. Keefe’s research is primarily devoted to understanding cognitive dysfunction in patients with schizophrenia and related disorders, including those at high risk for schizophrenia. He has a specific interest in the treatment of cognitive deficits in schizophrenia and designing methods to assess cognitive change.

Dr. Keefe has led the development of the battery of tests for several multi-site studies of cognitive dysfunction treatment-response, including the National Institute of Mental Health (NIMH) Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and the Brief Assessment of Cognition in Schizophrenia (BACS), a battery of tests that can be used in clinical trials or clinical settings to assess cognitive deficit treatment response. He is a member of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Neurocognition Committee and Director of the Chief Neuropsychologists for the NIMH Treatment Units for Research on Neurocognition and Schizophrenia (TURNS) project, which aims to find new medications for improving cognition in patients with schizophrenia.

In addition to more than 120 scientific papers on schizophrenia, Dr. Keefe has authored Understanding Schizophrenia (1994) and On the Sweet Spot: Stalking the Effortless Present (2003). He has also edited two books, The Assessment of Negative Symptom and Cognitive Deficit Treatment Response (2000) and Improving Cognitive Function in Schizophrenia, 2nd ed. (2004). He serves on the Editorial Boards of Schizophrenia Research, Schizophrenia Bulletin, and Psychiatry. He is on the Scientific Board of NARSAD.

Dr. Keefe received his BA from Princeton University and his Ph.D. in clinical psychology from New York University.

Clinical Indication Leader, Neuroscience, Novartis Pharmaceuticals

Dr. Kenney is a board certified neurologist who spent the last 10 years caring for Parkinson disease patients and conducting clinical research in order to improve treatment options for those suffering from a variety of movement disorders.

Dr. Kenney’s core medical and neurology training took place at Boston University School of Medicine and the University of California, San Diego.  A combined clinical and research fellowship was completed at the Baylor College of Medicine.  Faculty positions were held at UCSD, Baylor and, most recently, Boston University.  He has published over 50 manuscripts, abstracts and book chapters focused on Parkinson’s disease, hyperkinetic movement disorders, essential tremor, and deep brain stimulation.

A transition from academia to industry five years ago led Dr. Kenney to two positions within clinical development.  The first involved working at Merck Serono as a medical director with the goal of completing phase III development of safinamide for Parkinson disease.  The current position is as a Clinical Indication Leader overseeing the phase II development of AFQ056/mavoglurant for Parkinson disease levodopa-induced dyskinesia.

Director, Controlled Substance Staff, U.S. Food and Drug Administration

Professor of Psychiatry and Neuroscience, Baylor College of Medicine

Thomas R. Kosten, MD, is the JH Waggoner Professor of Psychiatry, Pharmacology and Neuroscience, vice-Chair for Psychiatry and Co-director of the Institute for Clinical and Translational Research at Baylor College of Medicine. His other key appointments are Distinguished Professor of Psychiatry at Peking University Medical School and Professor of Epidemiology and of Behavioral Health at MD Anderson Cancer Prevention Center. He is a former Professor at Yale University School of Medicine, the founding Vice Chair for Addiction Psychiatry of the American Board of Psychiatry and Neurology, and Past President of both the American Academy of Addiction Psychiatry and the College on Problems of Drug Dependence. He is a Distinguished Fellow in the American Psychiatric Association and a Fellow of the American College of Neuropsychopharmacology. He has served as a Congressional Fellow in the US House of Representatives and is a long-standing member of various substance abuse commissions for the National Academy of Sciences. Since 2001, he has retained the ongoing distinction as a “Top Doc” in the field of addictions; an annual ranking by U.S. News and World Report. He is on the board of several notable journals in substance abuse. He has also published over 550 papers, books, and reviews describing his medication contributions including vaccines for cocaine, opiates and methamphetamine, and disulfiram as a pharmacogenetic treatment for cocaine dependence.

Professor, Department of Psychiatry, New York University
Director, Statistical Sciences and Epidemiology Division, Nathan S. Kline Institute for Psychiatric Research
Director, WHO Collaborating Center for Research and Training in Mental Health Program Management

Eugene Laska, Ph.D. is Professor of Psychiatry in the Department of Psychiatry at New York University Langone School of Medicine. He received a Ph.D. in Mathematics from the Courant Institute of New York University, and completed a PHS Postdoctoral Fellowship at the Department of Statistics at Stanford University.   Dr. Laska is the Director of the Statistical Sciences Division of the Nathan Kline Institute for Psychiatric Research and was the Director of the World Health Organization Collaborating Center for Research and Training in Mental Health Program Management for the past twenty years. In that capacity he was involved in study design and statistical analysis involving research centers around the world. He was the principle investigator on seven NIH-funded grants, has authored more than 140 peer reviewed publications and has edited three books. He is a fellow of the American Association for the Advancement of Science and the American Statistical Association. He has served as a consultant to many large and small pharmaceutical companies in the areas of biostatistics and clinical trial design.  

Division Director, Division of Psychiatry Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Retired

Dr. Laughren is recently retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA. Prior to coming to FDA in September, 1983, Dr. Laughren 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 he also completed residency training in psychiatry at the University of Wisconsin. Dr. Laughren is board certified in general psychiatry. As Division Director for the Division of Psychiatry Products, Dr. Laughren oversaw the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. He has authored and co-authored many papers 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.

Executive Vice President, Chief Medical Officer, Pfizer, Inc.

Freda Lewis-Hall is the chief medical officer of Pfizer Inc. Trained as a psychiatrist, she has held leadership roles in academia, medical research, front-line patient care, and at global biopharmaceutical companies including Vertex, Bristol-Myers Squibb and Eli Lilly. Prior to her work in industry, she led research projects for the National Institutes of Health and was vice chairperson of the Department of Psychiatry at Howard University College of Medicine.

In 2010, Dr. Lewis-Hall was appointed by the Obama Administration to the inaugural Board of Governors for the Patient-Centered Outcomes Research Institute (PCORI), and in 2012 she was appointed chair of the Cures Acceleration Network Review Board and a member of the National Center for Advancing Translational Sciences (NCATS) Advisory Council of the National Institutes of Health. She also serves on the Executive Committee of the Clinical Trials Transformation Initiative and on numerous other boards, including those of Harvard Medical School, The Institute of Medicine’s Forum on Drug Discovery, Development, and Translation, and Save the Children.
Dr. Lewis-Hall has been named as one of Savoy’s Top Influential Women in Corporate America in 2012 and was selected as the Healthcare Businesswomen’s Association 2011 “Woman of the Year.” A passionate advocate for empowering patients through health information, Dr. Lewis-Hall speaks frequently in venues from TEDMED to the Essence Music Festival and appears regularly on the Emmy-winning daytime syndicated show, The Doctors.

Director of Clinical Sciences, CNS Products, Takeda Global Research and Development

Dr. Macek is a graduate of the University of Michigan – Ann Arbor (PharmD) and Emory University (PhD, Molecular Therapeutics and Toxicology). Prior to joining Takeda in 2007, he was a Director of Clinical Neurosciences at Pfizer. His clinical research experience over the last ten years has spanned multiple therapeutic areas, but currently is in the global clinical development of CNS agents, particularly in the area of psychiatry. He is also a clinical adjunct assistant professor at the University of Michigan – Ann Arbor and Wayne State University Eugene Appelbaum Colleges of Pharmacy.

Director of Psychiatry Research, Zucker Hillside Hospital

Dr. Malhotra is the Director of Psychiatry Research at the Zucker Hillside Hospital in Glen Oaks, NY, Professor of Psychiatry and Behavioral Sciences at the Albert Einstein College of Medicine (AECOM) in the Bronx, NY, and an Investigator at the Feinstein institute for Medical Research in Manhasset, NY. Dr. Malhotra’s research group currently focuses on identifying the biological underpinnings of schizophrenia and the mechanism of action of antipsychotic drugs. His group has identified a number of genes associated with increased risk for the disorder, determined their relationship with important clinical manifestations of illness, including cognitive impairment, and examined the role of genetic factors in predicting individual responses to pharmacological treatment. His group published the first genome-wide association study (GWAS) of schizophrenia, using new technology assessing hundreds of thousands of markers across the genome, as well as developed a new analytic strategy to assess the data. Moreover, a recent project provides new evidence for a role of specific genetic factors in vulnerability to antipsychotic drug-induced weight gain, a common yet potentially serious side effect of treatment.

Dr. Malhotra is principal investigator of grants from the National Institute of Mental Health (NIMH), NARSAD, and industry. He is a frequent speaker at international and national meetings, as well as giving numerous Grand Rounds presentations at academic institutions across the U.S. He is a member of the Editorial Boards of seven medical and scientific journals, participates in NIH study sections, and serves as the program chair for the only annual meeting dedicated to pharmacogenetics in psychiatry.

Executive Director, National Association of County Behavioral Health and Developmental Disability Directors

Ron Manderscheid, Ph.D., serves as the Executive Director of the National Association of County Behavioral Health and Developmental Disability Directors. The Association represents county and local authorities in Washington, D.C., and provides a national program of technical assistance and support. Concurrently, he is Adjunct Professor at the Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, and President of ACMHA—The College for Behavioral Health Leadership. Dr. Manderscheid serves on the boards of the Employee Assistance Research Foundation, the Danya Institute, the FrameWorks Institute, the Council on Quality and Leadership, and the International Credentialing and Reciprocity Consortium. Previously, he served as the Director of Mental Health and Substance Use Programs at the Global Health Sector of SRA International and in several federal leadership roles in the U.S. Department of Health and Human Services. Throughout his career, he has emphasized and promoted peer and family concerns.

Dr. Manderscheid is a former Member of the Secretary of Health and Human Services Advisory Committee on Healthy People 2020, Past President of the Federal Executive Institute Alumni Association (FEIAA) Foundation, Past President of FEIAA, and past Chair of the American Public Health Association (APHA) Mental Health Section and a past member of the APHA Governing Council. He has also served as the Chairperson of the Sociological Practice Section of the American Sociological Association, and as President of the Washington Academy of Sciences and the District of Columbia Sociological Society.

Earlier, Dr. Manderscheid served as Branch Chief, Survey and Analysis Branch, for the Federal Center for Mental Health Services (CMHS), SAMHSA.

During the Clinton National Health Care Reform debate, Dr. Manderscheid served as Senior Policy Advisor on National Health Care Reform in the Office of the Assistant Secretary for Health at the U.S. Department of Health and Human Services. At that time, Dr. Manderscheid was also a member of the Mental Health and Substance Abuse Work Group of the President’s Task Force on Health Care Reform. He has continued this work in support of the implementation of the Affordable Care Act of 2010.

He served as principal editor for eight editions of Mental Health, United States. He has also authored numerous scientific and professional publications on services to persons with mental illnesses. Each month, he prepares a commentary, the Manderscheid Report, for Behavioral Healthcare.

He is the recipient of both federal and professional awards, including the 1995 National Sociological Practice Award; Substance Abuse and Mental Health Services Administration (SAMHSA) Administrator’s Award for Meritorious Achievement, 1995; SAMHSA Administrator’s Award for Meritorious Achievement (Group Award to Branch) 1995; 1st Annual Going to Bat Award, National Association for Rural Mental Health, 1996; Friends of Case Management Award, National Association of Case Management, 1996; Quality of Work Life SAMHSA Partnership Award, 1997; SAMHSA Outstanding Teamwork Award, 1997; Loras College Distinguished Alumni Award, 1998; Federal Executive Institute Alumni Association’s Meritorious Service Award, 1999; HHS Secretary’s Distinguished Service Award, 1999, 2004, 2005, 2006, and 2008; American Public Health Association’s Mental Health Section Award, 2000; Mental Health Statistics Improvement Program’s National Leadership Award, 2001; American Association for Psychosocial Rehabilitation’s Irving T. Blumberg Humanitarian Award, 2002; American College of Mental Health Administration’s Saul Feldman Lifetime Achievement Award, 2003, and Distinguished Service Award, 2006; National Association of State Mental Health Program Directors Career Distinguished Service Award, 2006; National Council of Community Behavioral Healthcare Distinguished Public Service Award, 2006; the 50th Anniversary Award, Southern Regional Conference on Mental Health Statistics, 2008; the Knee-Witman National Distinguished Award in Health and Mental Health Policy, 2009; the New Jersey Association of Mental Health and Addiction Agencies Gold Standard Award for Outstanding Leadership in Healthcare Reform, 2011; and the District of Columbia Sociological Society Stuart A. Rice Award for Career Achievement, 2011.

Dr. Manderscheid also worked in a variety of positions with the National Institute of Mental Health (NIMH). While there, he served as NIMH’s Chief, Statistical Research Branch, where he provided strong leadership in implementing the National Reporting System (NRP) and the Mental Health Statistics Improvement Program (MHSIP).

Dr. Manderscheid received a B.A. degree (with highest honors) in Sociology from Loras College; a M.A. degree in Sociology-Anthropology from Marquette University; and a Ph.D. in Sociology, with a specialization in Social Psychology and Statistics from the University of Maryland. He is also a graduate of the Federal Executive Institute.

Director, Department of Veterans Affairs, VISN 22 Mental Ilness Research, Education and Clinical Center
Professor, Psychiatry, David Geffen School of Medicine, UCLA

Dr. Marder’s research has focused on improving the long-term treatment of individuals with schizophrenia through pharmacological and psychosocial strategies. He was the Principal Investigator for the NIMH MATRICS initiative to improve neurocognition in schizophrenia as well as the leader of a trials network to study candidate drugs for enhancing cognition.

Dr. Marder has received the Exemplary Psychiatrist Award from the National Alliance for the Mentally Ill, the Stanley Dean Research Award of the American College of Psychiatry, the Alexander Gralnick Award for Schizophrenia Research from the American Psychiatric Association, and the APIRE/Kempf Fund Award for Research Development is Psychobiological Psychiatry He is listed in The Best Doctors in America and America’s Top Doctors.

Chief of the Section of Hospital Medicine, Director of the Center for Health and Social Sciences, Associate Professor, Department of Medicine and Associate Faculty Member, Harris School and the Department of Economics, University of Chicago

David O. Meltzer M.D., Ph.D. is Chief of the Section of Hospital Medicine, Director of the Center for Health and the Social Sciences, and Chair of the Committee on Clinical and Translational Science at The University of Chicago, where he is Associate Professor in the Department of Medicine, Department of Economics and the Harris School of Public Policy Studies.  Meltzer’s research explores problems in health economics and public policy with a focus on the theoretical foundations of medical cost-effectiveness analysis and the cost and quality of hospital care. Meltzer has performed randomized trials comparing the use of doctors who specialize in inpatient care (“hospitalists”) with traditional physicians and directed the AHRQ-funded Hospital Medicine and Economics Center for Education and Research in Therapeutics (CERT) at the University of Chicago. He  is currently leading a CTSA-funded collaboration of Chicago-Area academic medical centers to work with University HealthSystem Consortium to develop infrastructure to support hospital-based comparative effectiveness research and a Centers for Medicaid and Medicare Innovation Innovation Challenge award to study the effects of improved continuity in the doctor patient relationship between the inpatient and outpatient setting on the costs and outcomes of care for frequently hospitalized Medicare patients.

Meltzer received his MD and PhD in economics from the University of Chicago and completed his residency in internal medicine at Brigham and Women’s Hospital in Boston. Meltzer is the recipient of numerous awards, including the Lee Lusted Prize of the Society for Medical Decision Making, the Health Care Research Award of the National Institute for Health Care Management, and the Eugene Garfield Award from Research America. Meltzer is a research associate of the National Bureau of Economic Research, elected member of the American Society for Clinical Investigation, and past president of the Society for Medical Decision Making. He has served on several IOM panels, include one examining U.S. organ allocation policy and the recent panel on the Learning Health Care System that produced Best Care at Lower Cost.  He also has served on the DHHS Secretary’s Advisory Committee on Healthy People 2020, the Patient Centered Outcomes Research Institute (PCORI) Methodology Committee, as a Council Member of the National Institute for General Medical Studies, and as a health economics advisor for the Congressional Budget Office.  

Vice President of Clinical Development, Optinose

John joined Optinose in 2010 as lead for the clinical teams in the development and implementation of all clinical programs, as well as for regulatory submissions and interactions with regulatory agencies.

Prior to joining OptiNose, John served as Vice President of Clinical Operations and Strategic Planning at at Cephalon, Inc where he was a leader in the development, planning and execution of all company clinical programs, which included oncology, CNS, pain and respiratory therapeutic areas. While at Cephalon he also led the clinical development programs for analgesic products through NDA submissions and product launch. Additionally, John has worked at Purdue Pharma L.P., Novartis Pharmaceuticals Corp. and Sandoz Pharmaceutical Corp. He has conducted clinical trials in all phases of development. Throughout his career John has served as a clinical lead for multiple NDA submissions and product launches and he has published extensively within the fields of analgesia and CNS clinical research.

John earned a Doctor of Pharmacy Degree from Purdue University in West Lafayette, Indiana. He also completed an Industrial Clinical Pharmacy Fellowship at Rutgers University in New Brunswick, New Jersey.

Professor of Psychiatry, Pennsylvania State Hershey Medical Center

Dr. Roger Meyer is a 1962 graduate of Harvard Medical School, completed an internship in medicine with Dr. Robert Petersdorf at the University of Washington and King County Hospital (Seattle, WA), and a residency in psychiatry at the Massachusetts Mental Health Center at Harvard.
Dr. Meyer has a very distinguished record of service as a professor at Boston University, Harvard University, the University of Connecticut, and George Washington, as an NIH-funded researcher and research center director (BU, Harvard, and UConn), as a department head and Executive Dean (UConn), and as VP Medical Affairs and CEO of the Medical Center at GW. In his research career, Dr. Meyer focused on factors that lead to the development of addictive disorders and the elements that can modify those behaviors in patients and laboratory animals. He is one of the world’s leading clinical research authorities on addictive disorders and alcoholism. His distinction, as a researcher and as an academic leader, has been highlighted by his election as President of both the American College of Neuropsychopharmacology and the American Association of Chairmen of Departments of Psychiatry. He has authored 170 papers and six books and is currently Professor of Psychiatry at Penn State Hershey Medical Center and Clinical Professor of Psychiatry at Georgetown and at Virginia Commonwealth University
In addition to his research, Dr. Meyer has had a very distinguished career as a consultant to federal agencies and the Association of American Medical Colleges (AAMC). He has served as consultant to the White House drug abuse offices during the Nixon, Reagan, and Bush (I) administrations, to the Department of Veterans Affairs, the NIH and the FDA. For industry, he has served on Scientific Advisory Boards for Bristol Myers Squibb and Johnson and Johnson; and, as a consultant to many companies on a range of issues related to methodological and regulatory affairs. At the AAMC, he served as Senior Consultant on Clinical Research, assisting the Association in its efforts to strengthen clinical research infrastructure at its member colleges. From 1997-2012, Dr. Meyer served as President and CEO of Best Practice Project Management, Inc. (a consulting and project management company), which he founded with four other scientific colleagues. He served part time in his role at Best Practice from 1997-2001 and from 2010-2012. In the intervening years, he directed Best Practice full time.

Head, Clinical Research, Mitsubishi Tanabe Pharma Development America

During his career Dr. Palumbo has held senior leadership roles in academic research, hospital administration, biotech, European pharma, US-based big pharma, and global Japanese research and development. He has played a central role in driving trial methodology strategies, implementation, and measurement in many areas of research, including stimulant addiction, alcoholism and substance abuse, nicotine dependence, neurology and neuro-degeneration, chronic medical disease, sleep disorders, psychiatry and behavioral medicine, cognition, orphan conditions, quality of life, and subjective endpoint assessment.

He is a strong proponent of “end-to-end” development processes which focus on precise translational research and a thoughtful approach to proof of principle. He has provided industry-based viewpoints to “pre-competitive” consortia, including the Alcohol Clinical Trials Initiative (ACTIVE Group), and has advocated for the treatment of addictions and psychiatric disorders in support of One Mind for Research.

Dr. Palumbo is a graduate of the University of Pennsylvania, the George Washington University School of Medicine, and the Clinical Neuroscience Training Program at the Yale University School of Medicine, where he holds an adjunct appointment in the Department of Psychiatry. Dr. Palumbo is now Co-Chair, along with Thomas Kosten, MD, of the ISCTM Working Group on Stimulant Dependence and Use Disorders.

Senior Vice President, GlaxoSmithKline

Atul Pande, M.D., is Senior Vice President and Senior Advisor, Pharmaceutical R&D at GlaxoSmithKline. In this role he works closely with drug development teams to develop and/or refine clinical and regulatory strategies with a special focus on major regulatory filings. Previously he was the Head of the Neurosciences Medicines Development Center at GlaxoSmithKline and held accountability for delivering the Neurosciences late-stage pipeline from proof of concept to registration, launch and lifecycle management.

Atul joined GSK in 2007 prior to which he was the Chief Medical Officer for Cenerx Biopharma, a privately held company. In the past Atul has also served as the Vice President, Global Project Management, and then as Vice President, Neurosciences Development for Pfizer Global Research and Development. Atul’s drug development and regulatory experience spans across the areas of anxiety, depression, epilepsy, neuropathic pain, schizophrenia, traumatic brain injury, and Alzheimer’s and Parkinson’s disease.

Atul is a psychiatrist and a Fellow of the Royal College of Physicians of Canada. He began his career as a faculty member at the University of Michigan Medical School where his research focused on mood disorders. He joined Lilly Research Laboratories in 1992 and since then has held various positions at other companies, including Parke-Davis Research and Pfizer.

Atul is a fellow of several scientific societies including the American Psychiatric Asociation, the Canadian College of Neuropsychopharmacology, the Collegium Internationale NeuroPsychopharmacologicum, and a member of the Society of Biological Psychiatry. He has published over 50 peer-reviewed scientific papers and over 100 abstracts, book chapters, and book reviews.

Chairman, Department of Psychiatry, Rush University Medical Center

Dr. Mark Pollack is The Grainger Professor and Chairman of the Department of Psychiatry at Rush University Medical Center. He received his M.D. in 1982 from New Jersey Medical School and completed residency and fellowship training in psychiatry at Massachusetts General Hospital  where he served as Director of the Center for Anxiety and Traumatic Stress Disorders and Professor of Psychiatry at Harvard Medical School until 2011.

His areas of clinical and research interest include the acute and long-term course, pathophysiology and treatment of patients with anxiety disorders  including panic disorder, social anxiety disorder, PTSD and generalized anxiety disorder and associated comorbidities, development of novel pharmacologic agents for mood and anxiety disorders, uses of combined cognitive-behavioral and pharmacologic therapies for treatment refractory patients, presentation and treatment of anxiety in the medical setting, and the pathophysiology and treatment of substance abuse.

 Dr Pollack has received federal funding from the National Institute of Mental Health (NIMH) and National Institute of Drug Abuse (NIDA) to study the longitudinal course of panic disorder, the application of cognitive-behavioral interventions for the reduction of illicit drug use in drug abusers, the impact of terrorist attacks on the development of PTSD and course of disorder in bipolar patients, changes in brain function as assessed by MR Spectroscopy and neuropsychological testing in patients on methadone maintenance, treatment response and pharmacogenetics in refractory social anxiety disorder, treatment of sleep and examination of biomarkers in PTSD and the and use of d-cycloserine to enhance the treatment efficacy of cognitive-behavioral therapy in social anxiety and panic disorder.   He has published over 300 articles, reviews and chapters, and is co-editor of the books “Challenges in Clinical Practice: Pharmacologic and Psychosocial Strategies”, “Panic Disorder and Its Treatment,” and “Social Phobia: Research and Practice” and “Ten Minute CBT”.  Dr. Pollack lectures widely in national and international forum and serves on numerous editorial and advisory boards. He is President-Elect of the Anxiety and Depression Association of America, past Chairman of its Scientific Advisory Board, and serves on its Board of Directors.

Senior Director, Research and Development, Primary Care Business Unit, Pfizer, Inc.

 Holly Posner is a trained Neurologist and Internist. She completed a Fellowship in Aging and Dementia, Cognition and Behavior at the Sergievsky Center, part of Columbia University in Manhattan. Concurrently she completed a Masters in Epidemiology. She has a long-standing interest in Measurement. When an opportunity arose to better understand the measurement properties underpinning the ADAS-cog, she put together a group of co-collaborators including, among others, Mike Weiner, Paul Aisen, Ron Petersen, Yaakov Stern, Ola Selnes, Jeremy Hobart, and Stefan Cano, and identified non-profit monies to do the analyses in a non-proprietary dataset, the cognitive outcomes in ADNI. Current collaborators and interested parties also include representatives of a number of pharmaceutical companies, the Alzheimer’s Association, and the Critical Path Institute.

Dr. Posner also works full time for Pfizer where she designs and runs clinical trials as the Clinical Program Lead in Adult Adjunctive Epilepsy, specifically Lyrica. Pfizer knows she is also working on cognitive assessment in Alzheimer’s, but is not directly supporting it. They elected to become one of a number of funders of that project which is being funded by the Foundation for the NIH. Dr. Posner is involved in a number of similar, non-overlapping initiatives. Dr. Posner is not working on Alzheimer’s at Pfizer.

Robert R. Sprague Endowed Chair in Brain Imaging; Professor of Psychiatry and Human Behavior at the University of California, Irvine; Director of Clinical Psychiatric Research

Dr. Potkin received his medical degree from Washington University in St. Louis. Trained as a psychiatrist at Duke University, Dr. Potkin spent nine years at the National Institute of Mental Health (NIMH) as a clinical research psychiatrist before coming to UCI in 1984. Dr. Potkin’s career has been devoted to understanding the causes of, and development of new treatments for, schizophrenia, bipolar disorder, Alzheimer’s disease, and other neuropsychiatric diseases.

Dr. Potkin is the author of more than 260 peer reviewed scientific articles and book chapters. He serves on several editorial boards and is a member of numerous neuropsychiatric organizations, including the Collegium Internationale Neuropsychoparmacologicum (CINP), the largest international neuropsychopharmacology organization, as well as the American College of Neuropsychopharmacology (ACNP), and is a Distinguished Life Fellow of the American Psychiatric Association (APA). From 1981 to 1983, he was the first US exchange scientist on the bilateral exchange of science and technology between the People’s Republic of China and the United States.

Dr. Potkin is the recipient of numerous awards, including the A.E. Bennett Award from the Society of Biological Psychiatry for psychiatric research; the Michtell Balter Award; the Outstanding Psychiatrist Award from the California Alliance for the Mentally Ill; and the Riley Public Service Award from the Mental Health Association of Orange County, a rare distinction for a research psychiatrist. Dr. Potkin has twice been awarded the Exemplary Psychiatrist Award by the National Alliance for the Mentally Ill (NAMI), the most influential family based organization advocating for the mentally ill, in recognition of the outstanding clinical care he has provided to individuals suffering from mental illness and, most specifically, to those with schizophrenia.

Dr. Potkin has approached decreasing stigma for those suffering from mental illness in a variety of ways. His brain imaging, biological and genetic studies provide evidence that schizophrenia and bipolar disorder are brain illnesses. Dr. Potkin directs two interdisciplinary research consortia. The Biomedical Imaging Research Network (BIRN) is a national consortium of computer scientists, physicists, cognitive scientists and physicians developing tools and the associated infrastructure needed for multi‐site neuroimaging studies. He also directs the Transdisciplinary Imaging Genetics Center (TIGC) that develops new methods for combining imaging and genetic data to leverage the power of these disciplines as a gene discovery tool for neuropsychiatric illness. These discoveries include microRNA 137 and TNIK for schizophrenia and TOMM40 for Alzheimer’s disease.

Senior Vice President, Medical and Scientific Affairs at Worldwide Clinical Trials, Inc.

Dr. Riordan has been involved in the assessment, treatment and investigation of various CNS disorders in both industry and academia for the past 15 years and was one of the original WCT team members in 1998. He is currently responsible for the scientific conduct and service delivery of all clinical research initiatives undertaken by WCT. Dr. Riordan has been the primary author of more than 50 protocols in various analgesic, neurologic and psychiatric indications across all phases of development. He has been involved in several clinical development programs across a number of indications, as well as numerous advisory boards and regulatory interactions. With advanced training in neuroimaging procedures, quantitative methods, experimental and neuropsychology, Dr. Riordan is a licensed psychologist and has published numerous peer-reviewed abstracts, articles, book chapters and books. Prior to joining WCT, he was senior vice president of clinical research at CEDRA Corporation, WCT’s early phase development unit, where he was responsible for helping to establish their specialized patient study unit. Prior, he served as vice president/global head of medical and scientific affairs for another large CRO. He also spent several years in the departments of psychiatry and neurology at Thomas Jefferson, Dartmouth, University of Pennsylvania and Stony Brook Medical Schools. 

Director of Research, Sleep Disorders and Research Center at Henry Ford Health System, Henry Ford Hospital Sleep Center

* B.A., Psychology, City University of New York Hunter College, New York, NY 1966
* Ph.D., Experimental Psych, University of Cincinnati, Cincinnati, OH 1970

Significant Achievments

* Lifetime Achievement Award, National Sleep Foundation, April 2002
* Key Note Lecture, Hellenic Sleep Research Society, Athens, Greece, 1999
* Nathaniel Kleitman Award of the American Sleep Disorders Association, 1990
* Rush Bronze Award, American Psychiatric Association Meeting, Toronto, May 1977. Scientific Exhibit, “Evaluation of Hypnotics in Various Patient Populations.”
* Consultant Member, Orphan Products Development IRG, Food & Drug Administration, 1984-Present
* Chairman, Special Study Section, NIH (Review of Sleep Research Proposals), 1985-86, 1988
* Member Special Study Section, NIH (Review of Sleep Research Proposals), 1983-84

Published 275 Articles, 12 Edited Volumes, 109 Chapters, and 382 Abstracts

Executive Director, Patient-Centered Outcomes Research Institute (PCORI)

A family physician, clinical epidemiologist and health services researcher, Dr. Selby has more than 35 years of experience in patient care, research and administration. He is responsible for identifying strategic issues and opportunities for PCORI and implementing and administering programs authorized by the PCORI Board of Governors.

Dr. Selby joined PCORI from Kaiser Permanente, Northern California, where he was Director of the Division of Research for 13 years and oversaw a department of more than 50 investigators and 500 research staff working on more than 250 ongoing studies. He was with Kaiser Permanente for 27 years. An accomplished researcher, Dr. Selby has authored more than 200 peer-reviewed articles and continues to conduct research, primarily in the areas of diabetes outcomes and quality improvement. His publications cover a spectrum of topics, including effectiveness studies of colorectal cancer screening strategies; treatment effectiveness, population management and disparities in diabetes mellitus; primary care delivery and quality measurement.

Dr. Selby was elected to membership in the Institute of Medicine in 2009 and was a member of the Agency for Healthcare Research and Quality study section for Health Care Quality and Effectiveness from 1999-2003. A native of Fulton, Missouri, Dr. Selby received his medical degree from Northwestern University and his master’s in public health from the University of California, Berkeley. He was a commissioned officer in the Public Health Service from 1976-1983 and received the Commissioned Officer’s Award in 1981.

He serves as Lecturer in the Department of Epidemiology and Biostatistics, University of California, San Francisco School of Medicine, and as a Consulting Professor, Health Research and Policy, Stanford University School of Medicine.

Director, Center of Excellence for Abuse Liability , Grunenthal USA 

Dr. Marta Sokolowska has extensive experience in pre-clinical, clinical and epidemiological assessments of drug abuse liability.  Since 2009 she has been the Head of Center of Excellence for Abuse Liability at Grünenthal USA. Her responsibilities focus on scientific and regulatory direction for multifarious abuse liability related projects pre and post marketing approval.

Prior to joining Grünenthal Marta served as a Research Scientist in the Clinical Pharmacology department of Kendle which was formerly DecisionLine Clinical Research Corporation and Ventana Clinical Research Corporation. She started her career with Kendle in 2005. Her key responsibilities were research studies involving assessment of central nervous system acting drugs including abuse liability, ethanol-drug and drug-drug interaction, single and multiple dose escalation, pharmacokinetic and pharmacodynamics studies.

Dr. Sokolowska completed her PhD in experimental psychology at McMaster University, Canada, evaluating pre-clinical models of abuse potential assessment. During her post-doctoral fellowship, she was involved in examination of neurocognitive changes associated with mood disorders. Dr. Sokolowska has presented at numerous scientific meetings with the FDA, industry, and academia on methodology of abuse liability assessments.  

Director, Pfizer, Inc.

Michelle Stewart, Ph.D., joined Pfizer’s Outcomes Research group in 2002 and is currently the Outcomes Research therapeutic area lead for Specialty Care Neurosciences working on marketed and late development assets. She has worked in a variety of therapeutic areas with a major focus on schizophrenia and bipolar disorder.

She was one of Pfizer’s representatives on the MATRICS-CT industry-academic partnership subcommittee that has been working to validate an intermediate functional measure for cognition in schizophrenia. She is co-chair (with Adam Butler) of the International Society for CNS Clinical Trials and Methodology (ISCTM) Working Group addressing suicidal ideation and behavior and has been involved in revising Pfizer’s internal guidance on suicidality monitoring. Prior to joining Pfizer, Michelle conducted federally funded research at the University of Arizona focusing on psychosocial interventions for persons with serious mental illness in the Arizona public mental health system. Michelle received her Ph.D. in psychology from the University of Arizona and a M.A. in clinical psychology from the University of Colorado at Colorado Springs.

Deputy Director for Clinical Science, US Food and Drug Administration

Vice President, Global Development, Bristol Myers Squibb

Dr Tiller received her medical degree from Glasgow University, her executive MBA from Drexel University and her MPhil in Organizational Dynamics from the University of Pennsylvania. She was elected to Fellowship of the Royal College of Psychiatrists, UK in 2006.
 
Dr Tiller specialized in acute adult psychiatry, training at St Bartholomew’s Hospital and the Maudsley Hospital and Institute of Psychiatry in London, England.  She spent two years at Duke, NC performing research behavioral genetics and obesity/diabetes.

Dr Tiller practiced academic psychiatry for 17 years before joining industry. Dr Tiller was a Consultant Adult Psychiatrist at the Maudsley Hospital and was responsible for clinical teams providing inpatient, outpatient and day hospital care. She established a highly regarded Crisis Resolution and Treatment team to provide 24 hour home based care to patients with psychosis, this team reduced inpatient admissions by 25%. In 1999 Dr Tiller was appointed Clinical Director at the Maudsley Hospital and subsequently the South London and Maudsley NHS Trust (SLAM). In this role she managed adult psychiatric services across several major teaching hospitals with responsibility for clinical governance and pharmacy budgets.

In 2004, Dr Tiller joined Cephalon Inc. where Dr Tiller held positions of increasing responsibility latterly as Vice President of CNS/Pain. Dr Tiller supervised global clinical development programs across multiple neuroscience phase I-IV indications including; anxiety disorders, ADHD, disorders of excessive sleepiness, schizophrenia, bipolar depression and cognition as well as pain. In 2011 Dr Tiller joined BMS as Full Development Lead for BMS’ Alzheimer ’s disease development program.

Assistant Professor, Utrecht University

Dr. Joris Verster is Assistant Professor of Psychopharmacology at Utrecht University, The Netherlands. Verster has extensive experience with conducting and managing clinical trials related to driving and traffic safety, drug abuse and addiction, and sleep and sleep disorders. Verster is editor of several books including Drugs, Driving and Traffic Safety, and Editor-in-Chief of Current Drug Abuse Reviews and The Open Addiction Journal. Verster is executive board member of The International Council on Alcohol, Drugs and Traffic Safety (ICADTS) and founder of the Alcohol Hangover Research Group. Verster is (co)-author of over 100 articles and book chapters. 

Head, Translational Imaging-Genetics Research, Centre for Addiction and Mental Health

Dr. Aristotle Voineskos is a psychiatrist and scientist at the Centre for Addiction and Mental Health (CAMH). At CAMH he treats patients within the Geriatric Mental Health and Schizophrenia Programs, and conducts his research within the new Research Imaging Centre and Neuroscience Program. He is the Koerner New Scientist, and is Head of the new Translational Imaging-Genetics Research Program at CAMH. He is Assistant Professor in the Department of Psychiatry, Faculty of Medicine at the University of Toronto.

Dr. Voineskos’s work combines multi-modal neuroimaging and genetics approaches to map gene effects in the brain with a view to discovering vulnerability pathways for severe mental illness. This will aid in early identification of at-risk individuals and disease prevention. Currently, his neuroimaging approaches include MRI techniques known as diffusion tensor imaging and cortical thickness mapping. Disease populations currently under study include schizophrenia, bipolar disorder and Alzheimer’s disease, as well as studying healthy individuals and healthy aging.
Another area of Dr. Voineskos’s work includes understanding genetic and structural brain determinants of brain function by combining the approaches described above with transcranial magnetic stimulation (TMS).

Chief Executive and Clinical Officer, Collaborative Neuroscience Network, Inc.

Previously, Dr. Walling was Vice President of Clinical Services at Psychiatric Management Resources & Stadt Solutions Pharmacy Corporation. Dr. Walling was also an Assistant Professor and Research Scientist in Psychiatry and Behavioral Sciences at the University of Texas Medical Branch at Galveston. Dr. Walling has clinical experience as a licensed psychologist and marriage, family, and child counselor.

Throughout his career, Dr. Walling has been a lead or co-investigator for more than 90 clinical studies, with many focusing on schizophrenia and/or schizoaffective disorder. He has published numerous articles in leading medical journals including the American Journal of Psychiatry, American Journal of Psychotherapy, and Journal of Nervous and Mental Disease. Dr. Walling has also authored numerous book chapters and has served as a reviewer for leading publications including Psychiatric Services, Psychiatry Research, and the American Journal of Clinical Hypnosis.

Dr. Walling has presented at leading medical meetings including the annual meetings of the American Psychological Association (of which he is a member), the American Psychiatric Association, and the International Congress on Schizophrenia Research.

Dr. Walling received his doctorate in counseling psychology from the University of Southern California. He received his master’s degree in counseling from California State University, where he also received his bachelor’s degree. He completed his internship at the University of Texas Medical Branch at Galveston.

Chief ad interim, Section of Neuropsychology, Associate Professor, Department of Neuro-Oncology, M. D. Anderson Cancer Center

Dr. Wefel is an Associate Professor and ad interim Neuropsychology Section Chief in the Department of Neuro-Oncology at M. D. Anderson Cancer Center.  He maintains an active consultation-liaison service where he conducts comprehensive neuropsychological assessments performs presurgical fMRI of higher order cognitive function for neurosurgical planning and offers interventions to cancer patients suffering from central nervous system effects of cancer, cancer treatment, or other illnesses.  He provides clinical and research mentoring as a Program Supervisor within the Neuropsychology Postdoctoral Fellowship program and holds an appointment as an Adjunct Clinical Assistant Professor in the Clinical Psychology graduate program at the University of Houston where he is involved in the training of Neuropsychology graduate students.  Dr. Wefel’s research activities seek to characterize the prevalence, pattern, course, risks, and biologic and neural substrates for the development of neurocognitive dysfunction associated with cancer and cancer therapies.  Ultimately, this will lead to identification and testing of interventions to prevent and/or minimize cognitive dysfunction.    He is the neurocognitive study chair on numerous cooperative group, industry sponsored and investigator initiated trials involving patients with high grade brain tumor, brain metastasis and breast cancer. 

Professor of Psychology and Psychiatry, University of North Carolina at Chapel Hill
Associate Director, Center of Excellence for Research and treatment of Bipolar Disorder

Dr. Youngstrom is the first recipient of the Early Career Award from the Division of Child and Adolescent Clinical Psychology, and has also been an American College of Neuropsychopharmacology Travel Fellow. He has served as the Director of the Data Management and Statistical Analysis Unit and Research Methods Core of the Center for Research in Bipolar Disorder across the Life Cycle. He earned his doctorate in clinical psychology at the University of Delaware, and he completed his predoctoral internship training at Western Psychiatric Institute and Clinic before joining the faculty at Case Western Reserve University. Dr. Youngstrom is a licensed psychologist who specializes in the relationship of emotions and psychopathology, and the clinical assessment of children and families. He teaches courses on assessment and therapy, developmental psychopathology, research design, and multivariate statistics, and has earned the Carl F. Wittke, Glennan Fellowship, and the Northeastern Ohio Teaching Awards. He also actively investigates ways of improving the use of clinical assessment instruments for making better differential diagnoses, predictions about future functioning, or monitoring of treatment progress – particularly with regard to bipolar disorder across the lifespan. Dr. Youngstrom has spoken on the topic of pediatric bipolar disorder at scientific meetings in Canada, Europe, South America, and Asia, as well as around the United States. Dr. Youngstrom has published more than 100 peer reviewed publications on the topics of clinical assessment and emotion, and he has served as an ad hoc reviewer on more than thirty prominent psychology and psychiatry journals as well as being on the editorial boards of the Journal of the American Academy of Child and Adolescent Psychiatry, the Journal of Clinical Child and Adolescent Psychology, the Journal of Child and Adolescent Psychopharmacology, and Psychological Assessment. Dr. Youngstrom is the principal investigator on a five year grant from the National Institute of Mental Health (R01 MH066647) and co-investigator of a second, multi-site R01, both designed to improve the assessment of bipolar disorder in diverse community samples. He has received grants from the NIMH, the Ohio Department of Mental Health, Cuyahoga County, and the Schubert Center for Child Development, and has been principal or co-investigator on more than $14 million in funded projects.