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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary D Biographical Sketches of Invited Speakers Charles M. Beasley, Jr., M.D., F.F.P.M., is a distinguished Lilly Scholar and the chief scientific officer, Global Patient Safety, Lilly Research Laboratories, Eli Lilly and Company. Dr. Beasley’s internship was in the Department of Psychiatry, Yale University, and he completed his training in psychiatry at the University of Cincinnati in 1987. He immediately joined Eli Lilly and Company in the area of clinical development of psychiatric medications. He was responsible for Prozac from the time of its U.S. launch through 1991, working extensively on the topic of the potential for SSRI medications to induce suicidality. During that period he was also responsible for the development program for atomoxetine as an antidepressant (program terminated). At that time he developed a particular interest in placebo response and trial design. From 1991 through 2001 he was responsible for the development of Zyprexa as a treatment for schizophrenia. From 2001 through 2002 he served as medical director for Cialis. Since 2003 he has served as a consultant across all therapeutic areas in both experimental design and safety, initially from a position in the neuroscience area and since 2004 in Global Patient Safety. He has a particular interest in three areas of safety: suicide, hepatic dysfunction, and delay in cardiac ventricular repolarization and the design of “Thorough QT Studies.” He was first author of the first meta-analysis of the adult, major depression, controlled, fluoxetine database analyzing the
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary emergence of suicidal ideation and suicidal behavior. His interest in ventricular repolarization derives from work with academic collaborators on the characterization of multiple cardiac ion channel blockade by antipsychotics beginning in 1995 and the design of one of the first “Thorough QT Studies” required for regulatory approval of Cialis in 2000. During his 21 years in industry with Lilly, he has authored over 80 peer-reviewed publications. He is an inventor on eight patents of Lilly products. He has extensive experience interacting with multiple divisions of the FDA, European regulatory authorities, and Japanese regulatory authorities. He is a member of the American Osteopathic Association, the American Psychiatric Association, the American Society for Clinical Psychopharmacology, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the American Federation for Clinical Research. He is also a fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom and member of the American Academy of Pharmaceutical Physicians. David Brent, M.D., was born in Rochester, New York, and grew up in the Philadelphia area. He received his undergraduate education at Pennsylvania State University and graduated from Jefferson Medical College of Thomas Jefferson University. Dr. Brent trained in pediatrics at the University of Colorado and in general and child psychiatry at Western Psychiatric Institute and Clinic and completed a master’s degree in psychiatric epidemiology at the University of Pittsburgh School of Public Health. He is currently academic chief, child and adolescent psychiatry, at Western Psychiatric Institute and Clinic and professor of psychiatry, pediatrics and epidemiology, University of Pittsburgh School Medical Center. He cofounded and now directs Services for Teens at Risk (STAR), a commonwealth of Pennsylvania–funded program for suicide prevention, education of professionals, and the treatment of at-risk youth and their families. His work in the area of suicide has focused on the epidemiology of adolescent suicide and has helped to identify the role of firearms, substance abuse, and affective disorders as risk factors for youth suicide. Consequently, he and colleagues at Western Psychiatric Institute and Clinic have helped to establish the role of cognitive therapy as a treatment for depressed adolescents in an NIMH-funded clinical trial. Dr. Brent has also focused on the familial and genetic aspects of suicide, having found that suicidal behavior clusters in families, and is currently, along with colleagues at New York State Psychiatric Institute, studying how suicidal behavior may be transmitted from parent to child. His work has been funded by the William T. Grant Foundation and the National
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary Institute of Mental Health, and he currently directs an NIMH-funded Advanced Center for Interventions and Services Research for Early-Onset Mood and Anxiety Disorders devoted to improving the life course of youth with mood and anxiety disorders and consequently at high risk for suicide. Gregory Brown, Ph.D., is a research associate professor of clinical psychology in psychiatry at the University of Pennsylvania and serves as co-principal investigator of the NIMH-funded Center for the Treatment and Prevention of Suicide. His research has focused on targeted psychotherapy interventions for individuals who are at highest risk for suicide, and he has worked on developing suicide assessment and brief intervention strategies for suicide prevention in emergency departments. He is currently investigating the effectiveness of cognitive therapy for adult patients who recently attempted suicide and for suicidal older men. He is the winner of the 2007 Edwin Shneidman Award for outstanding contributions in suicide research from the American Association of Suicidology. He serves on the American Foundation for Suicide Prevention Scientific Advisory Board and Research Grants Committee. ShaAvhrée Buckman, M.D., Ph.D., FAAP, is currently the director (acting) of the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. OTS comprises the Office of Biostatistics, Office of Clinical Pharmacology, and provides oversight to CDER research involving human subjects as well as CDER regulatory science research. OTS is responsible for providing coordination for Critical Path Initiatives across CDER in partnership with individual CDER offices. Prior to joining OTS, Dr. Buckman served as a medical team leader in the Division of Pediatric Drug Development, Office of Counter Terrorism and Pediatric Drug Development, CDER. She received her M.D. and Ph.D. degrees with an emphasis on molecular cell biology from Washington University School of Medicine. She completed pediatric specialty training at Baylor College of Medicine. Robert Gibbons, Ph.D., is the director of the Center for Health Statistics at the University of Illinois at Chicago (UIC) and professor of biostatistics and psychiatry, University of Illinois at Chicago. He is a fellow of the American Statistical Association and a member of the Institute of Medicine of the National Academy of Sciences. He is a recipient of the Youden Prize for Statistical Contributions to Chemistry and the Harvard Award for contributions to psychiatric epidemiology and biostatistics.
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary His research interests span many areas, including analysis of longitudinal data, environmental statistics, and statistical applications in health services research, mental health, fMRI, molecular genetics, chemistry, and organ transplantation. Joel Greenhouse, Ph.D., is professor of statistics at Carnegie Mellon University and adjunct professor of psychiatry and epidemiology at the University of Pittsburgh. He is an elected fellow of the American Statistical Association, and the American Association for the Advancement of Science and an elected member of the International Statistical Institute. Professor Greenhouse is a recipient of Carnegie Mellon University’s Ryan Teaching Award and the College of Humanities and Social Sciences’ E. Dunlop Smith Award for distinguished teaching and educational service. He has been the director of an NIMH-funded training program in psychiatric statistics for pre and postdoctoral fellows; has served on data monitoring and safety boards and scientific advisory committees for a number of NIH and Veterans Administration studies; and has served on several National Academy of Sciences committees, including the Committee on National Statistics and the Institute of Medicine’s Committee on the Assessment of Family Violence Interventions. He is an editor of Statistics in Medicine and is a past editor of the Institute of Mathematical Statistics’ Lecture Notes and Monograph Series. His research interests include methods for the analysis of data from longitudinal and observational studies, including methods for clinical trials and meta-analysis. Professor Greenhouse is also interested in issues related to the use of research synthesis in practice, especially as it is used to synthesize evidence for making policy and for scientific discovery. Gail Griffith worked for the campaign to ban landmines, which won the Nobel Peace Prize in 1997. As part of her efforts on behalf of the landmine campaign, she assembled renowned musical artists and produced concerts throughout the United States, Canada, and Europe to lobby for a landmine ban. She helped to craft rehabilitation programs on behalf of the Vietnam Veterans of America Foundation to address the needs of civilian victims of war in Southeast Asia and Africa and ran foreign policy-making and executive training programs for international leaders for Georgetown University’s School of Foreign Service for over 15 years. Since her adolescent son’s near-lethal suicide attempt in 2001, Ms. Griffith has devoted herself to advocacy on behalf of people with mental illness and to writing about teen depression. She is a member of the Na-
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary tional Alliance on Mental Illness, Mental Health America, the International Association of Suicide Prevention and SPAN and served as a board member of the American Foundation for Suicide Prevention from 2005 to 2008, where she helped produce two instructional films on teen suicide prevention. In 2004 she was appointed to serve as the patient representative to the U.S. Food and Drug Administration’s scientific advisory committee charged with investigating the possible link between antidepressant medication and suicidal thinking in young people. In 2005 she was invited to review the proposed research models on suicide and treatment options for the National Institute of Mental Health, and in 2007 she was named as the consumer representative to the FDA’s Pharmacological Drugs Advisory Committee for a four-year term. In November 2008 she was invited to speak at the Institute of Medicine’s Values in Health Care summit, and in January, 2010, she was a presenter at the Columbia University International Capstone Meeting on Suicidality. Ms. Griffith is listed in the 2005–2006 National Register of Who’s Who in administrative and executive leaders. Ms. Griffith is a graduate of the University of California at Berkeley and holds a graduate degree from Georgetown University. She lives in Washington, DC, with her husband, architect Jack Brady. She is the author of Will’s Choice: A Suicidal Teen, a Desperate Mother and a Chronicle of Recovery, published by HarperCollins in May 2005. Will’s Choice was a finalist for the 2005 Suze Orman First Book, “2005 Books for a Better Life Award.” In June 2006 Ms. Griffith received the Tipper Gore: Remember the Children Award, bestowed by Mental Health America (formerly the National Mental Health Association). Thomas Laughren, M.D., is currently division director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at the FDA. Prior to coming to the FDA in September 1983, Dr. Laughren was affiliated with the VA Medical Center in Providence, Rhode Island, and was on the faculty of the Brown University Program in Medicine. He received his medical degree from the University of Wisconsin–Madison, 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, he oversees 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 or coauthored 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
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary topics. Dr. Laughren has received numerous awards from FDA for his regulatory accomplishments. Husseini K. Manji, M.D., is global head, neuroscience at Johnson & Johnson Pharmaceutical Research and Development LLC. He was previously chief, Laboratory of Molecular Pathophysiology & Experimental Therapeutics, NIMH, and director of the NIMH Mood and Anxiety Disorders Program, the largest program of its kind. He is also a visiting professor in the Department of Psychiatry at Duke University. Dr. Manji received his B.S. (biochemistry) and M.D. from the University of British Columbia. Following psychiatry residency training, he completed fellowship training in psychopharmacology at the NIMH and obtained extensive additional training in cellular and molecular biology at the National Institute of Diabetes and Digestive and Kidney Diseseas. The major focus of his ongoing research is the investigation of disease- and treatment-induced changes in gene and protein expression profiles that regulate synaptic and neural plasticity in mood disorders. His work has helped to conceptualize these illnesses as genetically influenced disorders of synaptic and neural plasticity and has led to the investigation of novel therapeutics for refractory mood disorders. Additionally, he has worked extensively on the development of diagnostic and treatment response biomarkers. Dr. Manji is a recipient of numerous research awards, including the A. E. Bennett Award for Neuropsychiatric Research, the Ziskind-Somerfeld Award for Neuropsychiatric Research, the NARSAD Mood Disorders Prize (Falcone Prize), the Mogens Schou Distinguished Research Award, the American College of Neuropsycho-pharmacology’s (ACNP’s) Joel Elkes Award for Distinguished Research, the Canadian Association of Professors in Psychiatry Award, the Henry and Page Laughlin Distinguished Teacher Award, the Brown University School of Medicine Distinguished Researcher Award, the Depression and Bipolar Support Alliance Klerman Senior Distinguished Researcher Award, the NIMH Award for Excellence in Clinical Care and Research, and the NIMH Director’s Career Research Award for significant scientific achievement. In addition to his research endeavors, Dr. Manji is actively involved in medical and neuroscience education endeavors and has served as a member of the National Board of Medical Examiners (NBME) Behavioral Science Test Committee, the Howard Hughes Medical Institute Research Scholars Program Selection and Advisory Committee, and numerous national curriculum committees. He developed and codirects the NIH Foundation for the Advanced Education in the Sciences Graduate
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary Course in the Neurobiology of Mental Illness and has received both the NIMH Mentor of the Year and NIMH Supervisor of the Year awards. He has published extensively on the molecular and cellular neurobiology of severe mood disorders and their treatments, is editor of Neuropsycho-pharmacology Reviews: The Next Generation of Progress, deputy editor of Biological Psychiatry, associate editor of Bipolar Disorders, and a member of the editorial board of numerous journals. He is a councilor of the ACNP, chairs the ACNP’s Task Force on New Medication Development, and is president of the Society of Biological Psychiatry. J. John Mann, M.D., is The Paul Janssen Professor of Translational Neuroscience (in psychiatry and in radiology) at Columbia University and chief of the Department of Neuroscience at the New York State Psychiatric Institute. Dr. Mann is trained in Psychiatry and Internal Medicine and has also obtained a doctorate in neurochemistry. His research uses functional brain imaging, neurochemistry, and molecular genetics to probe the causes of depression and suicide. Dr. Mann is the director of the NIMH Conte Center for the Neuroscience of Mental Disorders, director of the Stanley Center for Applied Neuroscience of Bipolar Disorders, and president of the International Academy of Suicide Research. He has published 401 papers and edited 10 books on the subjects of the biology and treatment of mood disorders, suicidal behavior, and other psychiatric disorders. In private practice he specializes in the treatment of mood disorders. David Michelson, M.D., received his B.A. in English from Wesleyan University. Following a period of service as a teacher in the Peace Corps, he received his M.D. from the Albert Einstein College of Medicine in New York. He completed his internship and residency in psychiatry at Yale University, where he was also a chief resident and faculty member prior to moving to the National Institute of Mental Health as a member of the Clinical Neuroendocrinology Branch. During his tenure at the National Institute of Mental Health, Dr. Michelson’s research focused on the HPA axis, including development of investigative methodologies for assessing HPA axis regulation and elucidating the pathophysiology and clinical sequelae of HPA axis activation in depression and multiple sclerosis. His work in this area has been published in the New England Journal of Medicine and in the Journal of Clinical Endocrinology & Metabolism. Dr. Michelson joined Eli Lilly and Company as a clinical research physician in 1996. In 1999 he became the medical director and later senior medical director for the atomoxetine product team (Strattera, a com-
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary pound for ADHD) and led its clinical development and regulatory submissions in the United States and globally. In 2003 he became the executive medical director of the Neuroscience Therapeutic Area, with overall responsibility for overseeing Lilly’s early-phase neuroscience clinical development program, including compounds with psychiatric, neurologic, and pain/migraine indications. He also was a member of Eli Lilly’s corporate governance team, managing the company’s early-phase portfolio. In 2006 Dr. Michelson joined Merck in his current position as the vice president for neuroscience and ophthalmology clinical research. Matthew K. Nock, Ph.D., is the John L. Loeb Associate Professor of the Social Sciences in the Department of Psychology at Harvard University. He received his M.S. (2000), M.Phil. (2001), and Ph.D. (2003) in psychology from Yale University. He completed his clinical internship at the NYU–Child Study Center and Bellevue Hospital Center (2003) and joined the faculty of the Department of Psychology at Harvard University the same year. His research interests focus primarily on the etiology, assessment, and treatment of self-injurious and aggressive behaviors, particularly among children and adolescents. Current projects include the development and evaluation of laboratory and ecological assessment methods for evaluating processes associated with self-injurious and aggressive behaviors. A related line of his research focuses on the evaluation of treatments for impulsive, aggressive, and self-injurious behaviors and on factors that mediate and moderate clinical change. Kelly Posner, Ph.D., is the founder and principal investigator of the Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute and an associate clinical professor at Columbia University College of Physicians and Surgeons. Her expertise lies in the areas of suicidality and medication effects. Amidst the controversy over the relationship between antidepressants and suicidality, the FDA commissioned a study led by Dr. Posner as part of its antidepressant safety analyses to develop methods of suicidality assessment and foster interpretability of data. This methodology to better identify and categorize suicidal occurrences, the Columbia Classification Algorithm of Suicide Assessment (C-CASA), was subsequently mandated to clinical trials of numerous non-psychotropic drug classes and centrally acting agents, including anticonvulsants, Singulair, and cannabinoid 1 receptor (CB1R) inverse agonists and provided data for all FDA-mandated analyses. The FDA has characterized this work as “setting a standard in the field.” The Columbia Suicide Severity Rating Scale (C-SSRS) is the prospective ver-
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary sion of the C-CASA and is being used broadly across the field of medicine in many clinical and research domains. It is frequently mandated or recommended by various international agencies such as the FDA and European Medicines Agency. The C-SSRS is used for the assessment of suicidality across a wide range of settings: NIMH- and foundation-supported research trials, emergency rooms, hospitals, clinical practice, surveillance efforts, VAs, and programs for college campuses. Dr. Posner continues to work with the FDA, CDC, NIMH, VA, and other agencies on suicide assessment, surveillance, and prevention and publishes and speaks internationally on the risks, benefits, and public health implications encompassed by recent drug safety controversies. New York magazine named Dr. Posner and her colleagues among New York’s most influential people for their work on the safety of antidepressants, and in 2007 she was recognized as the Most Distinguished Alumni of Yeshiva University in the past 50 years. Most recently, Dr. Posner gave the invited presentation on tackling depression and suicide at the first European Union high-level conference on mental health. William Z. Potter, M.D., Ph.D., is vice president, Franchise Integrator Neuroscience at Merck Research Laboratories, Inc. Prior to joining Merck he served as the executive director and Lilly clinical research fellow of the Neuroscience Therapeutic Area at Lilly Research Laboratories. He developed a Lilly/Indiana University fellowship early in 1996 and was named professor of psychiatry at Indiana University Medical Center. Before being associated with Lilly Research Laboratories, he held the position of chief, Section on Clinical Pharmacology, Intramural Research Program, at the National Institute of Mental Health in Bethesda, Maryland. He had been with the Public Health Service and the National Institutes of Health since 1971. He has authored more than 200 publications in the field of preclinical and clinical pharmacology, mostly focused on drugs used in affective illnesses and methods for evaluating drug effects in humans. He has received many honors during his career, including the 1975–1977 Falk Fellow, American Psychiatric Association; 1986 Meritorious Service Medal, U.S. Public Health Service; and, in 1990, St. Elizabeth’s Residency Program Alumnus of the Year Award. Marc Stone, M.D., is a senior medical reviewer specializing in safety issues in the Division of Psychiatry Products at the U.S. Food and Drug Administration. Dr. Stone is board certified in internal medicine and has had fellowship training in general internal medicine and clinical epide-
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary miology. For the past 20 years he has applied economic and epidemiologic techniques to the evaluation of medical practices and technologies, the critique of research design, and the assessment and synthesis of research data. Before coming to FDA, Dr. Stone worked for the Centers for Medicare and Medicaid Services, the Agency for Health Care Policy and Research, the Institute of Medicine, and the U.S. Agency for International Development. Madhukar Trivedi, M.D., is currently a professor and chief of the Division of Mood Disorders in the Department of Psychiatry at the University of Texas Southwestern Medical Center at Dallas. He holds the Betty Jo Hay Distinguished Chair in Mental Health. Dr. Trivedi is an established efficacy and effectiveness researcher in the treatment of depression. He has focused his research on pharmacological, psychosocial, and other nonpharmacological treatments for depression. Dr. Trivedi has been a principal investigator in multiple clinical trials funded through NIMH and the Texas Department of Mental Health. He has been involved with evidence-based depression guideline development since 1990, when he joined the Depression Guideline Panel of the Agency for Health Care Policy and Research (AHCPR). He has been the director of the Depression Algorithm for Texas Medication Algorithm Project since its inception. He has served as the chair of the Depression Work Group of the International Psychopharmacology Algorithm Project and as the scientific content expert for the San Antonio Cochrane Center’s evidence-based, AHCPR-funded efforts to update the Depression Guidelines. He spearheaded the rollout of best practices for the treatment of major depressive disorder in various mental health and mental retardation centers across the state of Texas. He is also studying the effectiveness of treatments of depression in primary care. Dr. Trivedi is the principal investigator of the Depression Trials Network Combining Medications to Enhance Depression Outcomes (CO-MED) trial, which focuses on the use of specific antidepressant combinations to increase remission rates by treating a broader spectrum of depressed patients and by capitalizing on additive pharmacological effects. He is also principal investigator of three current NIMH grants entitled “CBASP Augmentation for Treatment of Chronic Depression (REVAMP),” “Treatment with Exercise Augmentation for Depression (TREAD),” and “Computerized Decision Support System for Depression (CDSS-D).” Dr. Trivedi is also the co-principal investigator of the Texas Node of the NIDA-funded Clinical Trials Network and was the co-principal investigator of the NIMH-
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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary funded project entitled “Sequenced Treatment Alternatives to Relieve Depression (STAR*D).” Dr. Trivedi has mentored many psychopharmacology postdoctoral fellows and research–track residents over the past many years in Mood and Anxiety Disorders and is the principal investigator of an NIMH-funded postdoctoral T32 training program. He has received numerous awards including the Gerald L. Klerman Award from the National Depressive and Manic-Depressive Association Scientific Advisory Board—NDMDA and the Psychiatric Excellence Award from the Texas Society of Psychiatric Physicians—TSPP. He is or has been a member of several institutional review groups of the NIMH. Dr. Trivedi has published over 286 articles and chapters related to the diagnosis and treatment of mood disorders. Robert Valuck, Ph.D., is a professor in the Department of Clinical Pharmacy at the University of Colorado Denver School of Pharmacy. His training and education include a B.S. in pharmacy from the University of Colorado and an M.S. and a Ph.D. in pharmacy (with an emphasis in pharmacy administration) from the University of Illinois at Chicago. His clinical research interests are pharmacoepidemiology (emphasis on psychotropic medications); health services research (HSR); evaluation of drug-related policy; development, implementation, and evaluation of computerized decision support systems (DSS) for optimization of prescribed pharmacotherapy; drug utilization review (DUR); and drug formularies. Dr. Valuck has received numerous honors and awards, including the Distinguished Investigator Award from the American Foundation for Suicide Prevention in 2007.
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