D
Biographical Sketches of Invited Speakers, Committee Members, and Staff

INVITED SPEAKERS

Alan Breier, M.D., was named vice president for Medical and chief medical officer for Eli Lilly and Company in August 2003. He is a member of the Lilly Research Laboratories (LRL) Policy Committee and Lilly’s Senior Management Council. He joined Lilly as an LRL research fellow in March 1997, the same year he was appointed adjunct professor of psychiatry at Indiana University School of Medicine in Indianapolis. He received a doctor of medicine degree from the University of Cincinnati School of Medicine and trained in psychiatry at Yale University School of Medicine. Dr. Breier was associate research professor of psychiatry at the University of Maryland School of Medicine and chief, Section on Clinical Studies, at the National Institute of Mental Health Intramural Research Program. In 1997 he began a career at Eli Lilly and Company, where he has focused on neuroscience drug development and led the Zyprexa Product Team. In his current role as chief medical officer, Dr. Breier leads Lilly’s medical organization, which annually conducts clinical trials in over 60 countries spanning Phase I through Phase IV studies. He has been responsible for sponsoring the Principles of Medical Research, which encompasses ethical standards for medical research, and establishing Lilly’s clinical trial registry, which is a publicly accessible web-based site for posting the initiation and results of clinical trials. He is the recipient of several awards, including the A. E. Bennett Neuropsychiatric Research Foundation Award and the Joel Elkes International Award. He is a fellow of the American College of Neuropsychopharmacolgy and has published over 225 scientific papers. He is included in Best Doctors in America.



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D Biographical Sketches of Invited Speakers, Committee Members, and Staff INVITED SPEAKERS Alan Breier, M.D., was named vice president for Medical and chief medical officer for Eli Lilly and Company in August 2003. He is a mem- ber of the Lilly Research Laboratories (LRL) Policy Committee and Lilly’s Senior Management Council. He joined Lilly as an LRL research fellow in March 1997, the same year he was appointed adjunct professor of psychiatry at Indiana University School of Medicine in Indianapolis. He received a doctor of medicine degree from the University of Cincin- nati School of Medicine and trained in psychiatry at Yale University School of Medicine. Dr. Breier was associate research professor of psy- chiatry at the University of Maryland School of Medicine and chief, Sec- tion on Clinical Studies, at the National Institute of Mental Health Intramural Research Program. In 1997 he began a career at Eli Lilly and Company, where he has focused on neuroscience drug development and led the Zyprexa Product Team. In his current role as chief medical offi- cer, Dr. Breier leads Lilly’s medical organization, which annually con- ducts clinical trials in over 60 countries spanning Phase I through Phase IV studies. He has been responsible for sponsoring the Principles of Medical Research, which encompasses ethical standards for medical re- search, and establishing Lilly’s clinical trial registry, which is a publicly accessible web-based site for posting the initiation and results of clinical trials. He is the recipient of several awards, including the A. E. Bennett Neuropsychiatric Research Foundation Award and the Joel Elkes Inter- national Award. He is a fellow of the American College of Neuropsy- chopharmacolgy and has published over 225 scientific papers. He is included in Best Doctors in America. 91

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92 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES Gavin Giovannoni, Ph.D., holds the Chair of Neurology in the Institute of Cell and Molecular Science, Queen Mary, University of London; the Department of Neurology, Barts; and The London NHS Trust, London. He did his undergraduate medical training at the University of the Wit- waterstrand, South Africa. He moved to the Institute of Neurology, Queen Square, London, in 1993 after completing his specialist training in neurology. He was awarded a Ph.D. from the University of London in 1998. His special clinical interests are multiple sclerosis (MS) and other inflammatory disorders of the central nervous system (CNS). Specific research interests include MS-related neurodegeneration and MS bio- marker discovery. He currently holds a program grant funded by the Na- tional MS Society and the MS Society of Great Britain and Northern Ireland to investigate novel neuroprotective and neurorestorative thera- pies in patients with MS. He runs an MS clinical trials unit and is chief investigator on several Phase II and III MS trials. He is particularly inter- ested in optimizing MS disease-modifying therapies. David Lewis, M.D., is UPMC Endowed Professor in Translational Neu- roscience in the Departments of Psychiatry and Neuroscience at the Uni- versity of Pittsburgh and director of the Translational Neuroscience Program at Western Psychiatric Institute and Clinic. He also serves as director of a National Institute of Mental Health (NIMH) Conte Center for the Neuroscience of Mental Disorders, which is focused on under- standing the role of prefrontal cortical dysfunction in the pathophysiol- ogy of schizophrenia. He received his medical degree from The Ohio State University, completed residencies in internal medicine and psychia- try at the University of Iowa, and received his research training at the Research Institute of the Scripps Clinic. Dr. Lewis has published over 250 scientific articles. He is currently the recipient of an NIMH MERIT Award, and he serves on the Scientific Council for NARSAD. In addi- tion, he is deputy editor of The American Journal of Psychiatry and sec- tion editor of clinical neuroscience for Neuroscience. Recognition of Dr. Lewis’s research accomplishments has included the NARSAD Lieber Prize for Schizophrenia Research, the Stanley Dean Research Award from the American College of Psychiatrists, and the American Psychiatric Association Kempf Award for Research Development. Husseini K. Manji, M.D., is chief, Laboratory of Molecular Patho- physiology, NIMH, and director of the NIMH Mood and Anxiety Disor- ders Program, the largest program of its kind in the world. He is also a

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93 APPENDIX D visiting professor in the Departments of Psychiatry at Columbia Univer- sity and Duke University. Dr. Manji received his B.S. (biochemistry) and M.D. from the University of British Columbia. Following psychiatry residency training, he subsequently completed fellowship training in psychopharmacology at NIMH and obtained extensive additional train- ing in cellular and molecular biology at the National Institute of Diabetes and Digestive and Kidney Diseases. The major focus of his ongoing re- search is the investigation of disease- and treatment-induced changes in gene and protein expression profiles that regulate cellular plasticity and resilience in mood disorders. In broad terms, his laboratories’ scientific goals are to capitalize upon recent insights into our understanding of the signaling pathways mediating the effects of mood stabilizers, to under- stand the pathophysiology of severe mood disorders, and to develop im- proved therapeutics. He has received ongoing research funding for his work on signaling pathways, plasticity, and new medication development for severe mood disorders. Bruce Rosen, M.D., Ph.D., is professor of radiology at the Harvard Medical School in Boston and director of the Athinoula A. Martinos Center for Biomedical Imaging at Massachusetts General Hospital, Mas- sachusetts Institute of Technology (MIT), and the Harvard Medical School. He received a doctorate in medical physics from MIT and an M.D. from the Hahnemann Medical College in Philadelphia and is cur- rently board certified in medicine and radiology. Dr. Rosen is an interna- tional leader in the development and utilization of physiological and functional nuclear magnetic resonance (NMR) techniques. His current research in NMR technique development includes the measurement of the physiological and metabolic changes associated with brain activation and cerebrovascular insult and how functional imaging tools can be applied to solve specific biological and clinical problems. Dr. Rosen is author or coauthor of more than 125 peer-reviewed articles, book chap- ters, and reviews. He is the associate editor of Human Brain Mapping and is a member of the editorial boards of several scientific journals. Allen D. Roses, M.D., FRCP (Hon), was appointed as senior vice presi- dent, Pharmacogenetics for GlaxoSmithKline (GSK), in July 2006. Pre- viously, he held the position of senior vice president, Genetics Research for GSK. In 1997, Dr. Roses joined Glaxo Wellcome and was charged with organizing genetic strategies for susceptibility gene discovery, pharmacogenetics strategy and implementation, and integration of genet-

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94 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES ics into medicine discovery and development. In the GSK research and development (R&D) structure, genetics, genomics, proteomics, and bio- informatics are part of Genetics Research and support the entire R&D pipeline. Roses’s group recently published the proof of principle experi- ments for using linkage disequilibrium mapping to identify susceptibility loci for drug adverse events. In 1997 when he left Duke University Medical Center, Dr. Roses was the Jefferson Pilot Professor of Neurobi- ology and Neurology, director of the Joseph and Kathleen Bryan Alz- heimer’s Disease Research Center, chief of the Division of Neurology, and director of the Center for Human Genetics. Dr. Roses was one of the first clinical neurologists to apply molecular genetic strategies to neuro- logical diseases. His laboratory at Duke reported the chromosomal loca- tion for more than 15 diseases, including several muscular dystrophies and Lou Gehrig’s disease. He led the team that identified APOE as a ma- jor, widely confirmed susceptibility gene in common late-onset Alz- heimer’s disease. Translation of these findings to pathway analyses, drug discovery, and development has continued at GSK. Howard Schulman, Ph.D., is vice president at PPD Biomarker Discov- ery Sciences, a position he has held since stepping down as head of neu- robiology at Stanford University. In his current capacity he has worked with pharmaceutical and biotechnology company leaders to develop bio- marker discovery programs that facilitate their drug discovery and vali- dation as well as clinical development. Dr. Schulman received his B.S. in chemistry from UCLA in 1971 and his Ph.D. in biological chemistry at Harvard University in 1976 studying phospholipid metabolism with Eugene P. Kennedy. Subsequently he undertook postdoctoral research in neuropharmacology in the Department of Pharmacology at Yale Univer- sity under the supervision of Nobel Laureate Paul Greengard. In 1978 he joined the faculty at Stanford University as an assistant professor in the Department of Pharmacology and subsequently in the Department of Neurobiology. He was most recently the chair of the Department of Neu- robiology and cofounder and codirector of the Stanford Brain Research Center. He joined SurroMed in 2000 as vice president, a company whose biomarker assets were acquired by PPD in 2005 and where he now heads the biomarker discovery unit. As a scientist he has been a major contributor to progress in the field of molecular pharmacology research for more than 20 years, with over 100 primary articles. Dr. Schulman discovered one of the key protein kinases responsible for transmitting information from calcium-linked hormones, neurotransmitters, and cyto-

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95 APPENDIX D kines in heart, brain, and endocrine systems. He initiated two programs in pharmaceutical companies that are developing CaM kinase-based therapeutics in CNS (Roche) and cardiovascular (Scios—J&J) arenas. He was recently elected a fellow of the American Association for the Advancement of Science. Ira Shoulson, M.D., is the Louis C. Lasagna Professor of Experimental Therapeutics and professor of Neurology, Pharmacology, and Medicine at the University of Rochester School of Medicine in Rochester, New York. He received his M.D. (1971) and postdoctoral training in medicine (1971–1973) and neurology (1975–1977) at the University of Rochester and in experimental therapeutics at the National Institutes of Health (NIH) (1973–1975). He founded the Parkinson Study Group (1985) and the Huntington Study Group (1994), international academic consortia devoted to research and development of treatments for Parkinson’s disease, Huntington’s disease, and related neurodegenerative and neuro- genetic disorders. He has served as principal investigator of the NIH- sponsored trials Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP), the Prospective Huntington At Risk Obser- vational Study (PHAROS), and more than 25 other multicenter con- trolled trials. He is the director of the Experimental Therapeutics Program at the University of Rochester Department of Neurology, the chair of the executive committee of the Huntington Study Group, a con- sultant for the Food and Drug Administration, former member of the Na- tional Institute of Neurological Disorders and Stroke Council, associate editor of Archives of Neurology, and past president of the American So- ciety for Experimental NeuroTherapeutics (ASENT). He has authored more than 230 scientific reports. Paul A. Sieving, M.D., Ph.D., became director of the National Eye Insti- tute, NIH, in 2001. He came from the University of Michigan Medical School, where he was the Paul R. Lichter Professor of Ophthalmic Ge- netics and was the founding director of the Center for Retinal and Macu- lar Degeneration in the Department of Ophthalmology and Visual Sciences. He served as vice chair for clinical research for the Foundation Fighting Blindness from 1996 to 2001. He is on the Bressler Vision Award Committee and serves on the jury for the annual $1 million Award for Vision Research of the Champalimaud Foundation, Portugal. He was elected to membership in the American Ophthalmological Society in 1993 and the Academia Ophthalmologica Internationalis in

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96 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES 2005. He received an honorary doctor of science from Valparaiso Uni- versity in 2003 and was named as one of The Best Doctors in America in 1998, 2001, and 2005. Dr. Sieving has received a number of awards, in- cluding the RPB Senior Scientific Investigator Award, 1998; the Alcon Award, Alcon Research Institute, 2000; and the 2005 Pisart Vision Award from the New York Lighthouse International for the Blind. In 2006 he was elected to the Institute of Medicine of the National Acad- emy of Sciences, one of the highest honors in the fields of medicine and health. Steven Warach, M.D., Ph.D., received his B.S., M.A., and Ph.D. de- grees from Michigan State University and his M.D. degree from Harvard Medical School. After receiving his Ph.D. in neuroscience and psychol- ogy for studies of cerebrovascular effects of cognitive tasks and gender, he did his postdoctoral work at the University of Pennsylvania in Dr. Martin Reivich’s Cerebrovascular Research Center. Upon completion of his M.D., he did his neurology residency in the Harvard-Longwood Neu- rology Training Program. In conjunction with his residency, Dr. Warach completed an MRI fellowship with Dr. Robert Edelman at Beth Israel Hospital in Boston, Massachusetts. During this fellowship he began his work developing and using diffusion-perfusion MRI methods for the clinical diagnosis, management, and investigation of acute stroke. In 1993 he joined the faculty of the Neurology Department at Beth Israel Hospital, and in 1994 he was appointed chief of the Division of Cere- brovascular Diseases. Dr. Warach joined the National Institute of Neuro- logical Disorders and Stroke in 1999 as chief of the newly formed Section on Stroke Diagnostics and Therapeutics. His section will be identifying promising experimental stroke therapies through the use of imaging surrogate markers. Meg Winberg, Ph.D., received her Ph.D. from the Massachusetts Insti- tute of Technology in 1994. She then pursued postdoctoral studies in ge- netics and neurobiology with Dr. Corey Goodman at the University of California, Berkeley, defining the role of plexins and semaphorins in mo- torneuron guidance in a model genetic system. In 1999 she joined Ex- elixis, Inc., where she managed several efforts including genetics technology development for the company’s proprietary discovery plat- form, and target identification and validation in support of a major corpo- rate alliance. Since 2005, She has served as director of research for the Spinal Muscular Atrophy Foundation, where she is responsible for exe-

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97 APPENDIX D cuting the foundation’s scientific plan, via sponsored research and col- laborations with academic and industry investigators. Janet Woodcock, M.D., is deputy commissioner and chief medical offi- cer, Food and Drug Administration (FDA). She is responsible for over- seeing agency operations and cross-cutting regulatory and scientific processes at FDA. Dr. Woodcock served as director, Center for Drug Evaluation and Research at FDA (1994–2005). She previously served in other positions at FDA including director, Office of Therapeutics Re- search and Review, and acting deputy director, Center for Biologics Evaluation and Research. She received her M.D. from Northwestern Medical School and completed further training and held teaching ap- pointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986. COMMITTEE MEMBERS Alan I. Leshner, Ph.D. (Chair), is Chief Executive Officer of the American Association for the Advancement of Science (AAAS) and Executive Publisher of its journal, Science. Previously Dr. Leshner had been Director of the National Institute on Drug Abuse at NIH, and Dep- uty Director and Acting Director of NIMH. Before that, he held a variety of senior positions at the National Science Foundation. Dr. Leshner began his career at Bucknell University, where he was Professor of Psy- chology. Dr. Leshner is an elected member of the Institute of Medicine of the National Academies of Science, and a fellow of AAAS, the National Academy of Public Administration, and the American Academy of Arts and Sciences. He was appointed by the U.S. President to the National Science Board and is a member of the Advisory Committee to the Director of NIH. He received an A.B. in Psychology from Franklin and Marshall College and M.S. and Ph.D. degrees in Physiological Psychology from Rutgers University. Dr. Leshner also holds honorary Doctor of Science degrees from Franklin and Marshall College and the Pavlov Medical University in St. Petersburg, Russia. Huda Akil, Ph.D., is the Gardner Quarton Distinguished University Pro- fessor of Neuroscience and Psychiatry at the University of Michigan, and the co-director of the Molecular and Behavioral Neuroscience Institute. Dr. Akil has made seminal contributions to the understanding of the neu-

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98 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES robiology of emotions, including pain, anxiety, depression, and substance abuse. Early on, she focused on the role of the endorphins and their re- ceptors in pain and stress responsiveness. Her scientific contributions have been recognized with numerous honors and awards. These include the Pacesetter Award from the National Institute on Drug Abuse (NIDA) in 1993 and, with Dr. Stanley Watson, the Pasarow Award for Neurosci- ence Research in 1994. In 1998 she received the Sachar Award from Co- lumbia University and the Bristol Myers Squibb Unrestricted Research Funds Award. She is past president of the American College of Neuro- psychopharmacology (1998) and past president of the Society for Neuro- science (2004), the largest neuroscience organization in the world, with over 35,000 members. She was elected a fellow of AAAS in 2000. In 1994 she was elected to the Institute of Medicine of the National Acad- emy of Sciences and is currently a member of its council. More recently (2004), she was elected to the American Academy of Arts and Sciences. Marc Barlow joined the Strategic Marketing group at GE Healthcare as leader of the neuroscience area in 2005. In this role he is responsible for the development and delivery of disease area strategies for CNS. Before joining GE Mr. Barlow was the marketing director of Sanofi-Aventis in the United Kingdom. Prior to this he held a number of senior sales and marketing positions within the pharmaceutical industry both domesti- cally in the United Kingdom and internationally based out of the United States and Switzerland. A large amount of Mr. Barlow’s experience has been gained in the neuroscience area, particularly in epilepsy, Alz- heimer’s disease, and stroke. Mr. Barlow graduated from the University of Wolverhampton in 1983 with a focus in biological sciences and the Chartered Institute of Marketing with a diploma in Marketing Studies in 1987. Daniel J. Burch, M.D., is executive vice president of research and de- velopment and chief medical officer of CeNeRx Biopharma. Dr. Burch holds an M.D. from Vanderbilt University and an M.B.A. from the Wharton School, University of Pennsylvania. He completed a residency in internal medicine at Vanderbilt University School of Medi- cine and a fellowship in infectious diseases at Washington University School of Medicine. He has worked in the pharmaceutical industry for a total of 15 years at Abbott Laboratories, SmithKlineBeecham, and GlaxoSmithKline (GSK). His most recent post at GSK was senior vice

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99 APPENDIX D president, Neurosciences Medicines Development Centre. He was ap- pointed to his current position in 2007. Dennis W. Choi, M.D., Ph.D., graduated from Harvard College in 1974 and received M.D. and Ph.D. degrees in 1978 (the latter in pharmacol- ogy) from Harvard University and the Harvard-MIT Program in Health Sciences and Technology. After completing residency and fellowship training in neurology at Harvard, Dr. Choi joined the faculty at Stanford University and began research into the mechanisms underlying patho- logical neuronal death. In 1991 he joined Washington University Medi- cal School as head of the Neurology Department; there he also established the Center for the Study of Nervous System Injury and di- rected the McDonnell Center for Cellular and Molecular Neurobiology. From 2001 until 2006 he was executive vice president for neuroscience at Merck Research Labs. He is currently executive director of Emory University’s Strategic Neurosciences Initiative and director of the Com- prehensive Neuroscience Center in the Woodruff Health Sciences Center at Emory University. He is a fellow of the AAAS and a member of the IOM, the Executive Committee of the Dana Alliance for Brain Research, and the College of Physicians of Philadelphia. He has served as president of the Society for Neuroscience, vice president of the American Neuro- logical Association, and chairman of the U.S./Canada Regional Commit- tee of the International Brain Research Organization. He has also served on the National Academy of Sciences Board on Life Sciences and coun- cils for the National Institute of Neurological Disorders and Stroke, the Society for Neuroscience, the Winter Conference for Brain Research, the International Society for Cerebral Blood Flow and Metabolism, and the Neurotrauma Society. He has been a member of advisory boards for the Christopher Reeve Paralysis Foundation, the Grass Foundation, the Hereditary Disease Foundation, the Spinal Muscular Atrophy Founda- tion, the Harvard-MIT Program in Health Sciences and Technology, the Queen’s Neuroscience Institute in Honolulu, the Max-Planck Institute in Heidelberg, the Korea Institute for Advanced Study in Seoul, and the FDA, as well as for several university-based research consortia, biotech- nology companies, and pharmaceutical companies. Timothy Coetzee, Ph.D., is the National Multiple Sclerosis Society’s vice president for discovery partnerships. In this capacity, Dr. Coetzee is responsible for the Society’s strategic funding of biotechnology and pharmaceutical companies as well as partnerships with the financial and

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100 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES business communities. He received his Ph.D. in molecular biology from Albany Medical College in 1993 and has been involved with MS re- search since then. He was a research fellow in the laboratory of society grantee Dr. Brian Popko at the University of North Carolina at Chapel Hill and was also the recipient of one of the Society’s Advanced Post- doctoral Fellowship Awards. After completing his training with Dr. Popko, Dr. Coetzee joined the faculty of the Department of Neuroscience at the University of Connecticut School of Medicine, where he con- ducted research that applied new technologies to understand how myelin is formed in the nervous system. He is the author of a number of research publications on the structure and function of myelin. He joined the Soci- ety Home Office staff in the fall of 2000. David H. Cohen, Ph.D., is professor of psychiatry and biological sci- ences at Columbia University, where he served as vice president and dean of the Faculty of Arts and Sciences from 1995 to 2003. Prior to joining Columbia, Dr. Cohen served as vice president for research and dean of the graduate school and subsequently as provost at Northwestern University. He has held professorships in physiology and/or neurosci- ence at Northwestern, SUNY Stony Brook, the University of Virginia School of Medicine, and Case Western University School of Medicine. Dr. Cohen has held various elected offices in national and international organizations, including president of the Society for Neuroscience and chairman of the Association of American Medical Colleges. He has served on varied boards including Argonne National Laboratory, the Fermi National Accelerator Laboratory, Zenith Electronics, and Colum- bia University Press. He has also served on numerous advisory commit- tees for various organizations, including NIH, the National Science Foundation (NSF), the Department of Defense, and the National Acad- emy of Sciences. Dr. Cohen received his B.A. from Harvard University and his Ph.D. from the University of California, Berkeley and was an NSF postdoctoral fellow at UCLA. Richard Frank, M.D., Ph.D., is vice president of clinical and medical strategy at GE Healthcare, Princeton, New Jersey. He has two decades of experience designing and implementing clinical trials in the pharmaceu- tical industry and built the Experimental Medicine Department at Phar- macia before joining GE Heatlhcare in 2005. Dr. Frank earned M.D. and Ph.D. (pharmacology) degrees concurrently and joined the pharmaceuti- cal industry upon completion of his clinical training in 1985. He is past

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101 APPENDIX D president and founding director of the Society of Non-invasive Imaging in Drug Development and a fellow of the Faculty of Pharmaceutical Medicine, Royal College of Physicians. He serves on the scientific re- view board for the Institute for the Study of Aging and is a member of the editorial board of Molecular Imaging and Biology. Richard Hodes, M.D., is the Director of the National Institute on Aging at NIH. He is a diplomat of the American Board of Internal Medicine. In 1995 Dr. Hodes was elected as a member of The Dana Alliance for Brain Initiatives; in 1997 he was elected as a Fellow of the AAAS; and in 1999 he was elected to membership in the IOM of the NAS. He also maintains an active involvement in research on the NIH campus in Bethesda, Mary- land, through his direction of the Immune Regulation Section, a labora- tory devoted to studying regulation of the immune system focused on cellular and molecular events that activate the immune response. In the past Dr. Hodes acted as a clinical investigator in the National Cancer In- stitute, then as the deputy chief and acting chief of the Cancer Institute’s Immunology Branch. Since 1982 he has served as program coordinator for the U.S.-Japan Cooperative Cancer Research Program and since 1992 on the scientific advisory board of the Cancer Research Institute. Dr. Hodes received his M.D. degree from the Harvard Medical School and completed a research fellowship at the Karolinska Institute in Stock- holm and clinical training in internal medicine at Massachusetts General Hospital. Steven E. Hyman, M.D., is provost of Harvard University and professor of neurobiology at Harvard Medical School. From 1996 to 2001, Dr. Hyman served as director of NIMH. Before that, he was professor of psychiatry at Harvard Medical School, director of psychiatry research at Massachusetts General Hospital, and the first faculty director of Harvard University’s Mind, Brain, and Behavior Initiative. In the laboratory, he studied the regulation of gene expression by neurotransmitters, especially dopamine, and by drugs that influence dopamine systems. This research was aimed at understanding addiction and the action of therapeutic psy- chotropic drugs. Dr. Hyman is a member of the IOM of the NAS, a fel- low of the American Academy of Arts and Sciences, and a fellow of the American College of Neuropsychopharmacology. He is editor in chief of the Annual Review of Neuroscience. He has received awards for public service from the U.S. government and from patient advocacy groups such as the National Alliance for the Mentally Ill and the National Men-

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106 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES genetic mechanisms underlying development and expression of behavior was supported by NIH. Her awards include the NSF Director’s Superior Accomplishment Award; the International Behavioral Neuroscience So- ciety Award; the Society for Behavioral Neuroendocrinology Award for outstanding contributions in research and education; the Barry M. Gold- water Educator Award from the American Institute of Aeronautics and Astronautics—National Capital Section; the Barnard Medal of Distinc- tion, which is the college’s most significant recognition of individuals for demonstrated excellence in conduct of their lives and careers; and NASA’s Outstanding Leadership Medal. She has also received honorary degrees from Chatham College, Clarkson University, and the University of South Carolina. Atul Pande, M.D., is senior vice president, Neurosciences Medicines Development Center at GlaxoSmithKline. Dr. Pande received his medi- cal training in India and trained in psychiatry in India and subsequently at the University of Western Ontario in London, Canada. Following a mood disorders research fellowship at the University of Michigan Medi- cal School, he served on the Department of Psychiatry faculty. In 1992 he joined the Lilly Research Laboratories in Indianapolis. Since then he has continued his career in pharmaceutical research and has held posi- tions at Parke-Davis Pharmaceutical Research (now part of Pfizer), Pfizer Global R&D and Cenerx Biopharma. Dr. Pande has drug devel- opment and regulatory submission experience in a broad range of psy- chiatric and neurological disorders. He has over 50 peer-reviewed publications, six patents, and numerous book chapters, abstracts, and sci- entific presentations to his credit. He is a member of the Society of Bio- logical Psychiatry and a fellow of the Royal College of Physicians and Surgeons of Canada, the American Psychiatric Association, the Canadian College of Neuropsychopharmacology, and the Collegium Internationale Neuro-Psychopharmacologicum. Steven Marc Paul, M.D., is executive vice president of science and technology and president of the LRL of Eli Lilly and Company. Dr. Paul joined Lilly in April 1993, initially as a vice president of the LRL re- sponsible for CNS Discovery and Decision Phase Medical Research. In 1996 he was appointed vice president (and in 1998 group vice president) of Therapeutic Area Discovery Research and Clinical Investigation. In this position his responsibilities included all therapeutic area discovery research, medicinal chemistry, toxicology/drug disposition, and decision

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107 APPENDIX D phase (Phase I/II) medical research. He and his leadership team were responsible for meeting the pipeline performance objectives of LRL and improving R&D productivity, especially in discovery and the early phases of clinical development. In 2003 Dr. Paul was named executive vice president of Lilly and president of LRL with responsibility for all research and development at Lilly. In 2005 he was named chief scientific officer of the Year as one of the Annual Pharmaceutical Achievement Awards. Prior to assuming his position at Lilly, Dr. Paul served as scien- tific director of NIMH/NIH in Bethesda, Maryland. He received his B.A. degree magna cum laude with honors in biology and psychology from Tulane University in 1972. He received his M.S. degree in anatomy (neu- roanatomy) and his M.D. degree, both in 1975, from the Tulane Univer- sity School of Medicine. Following an internship in neurology at Charity Hospital in New Orleans, he served as a resident in psychiatry and an instructor in the Department of Psychiatry at the University of Chicago, Pritzker School of Medicine. In 1976 he was awarded a research fellow- ship in the Pharmacology Research Associate Training Program of the National Institute of General Medical Science to work with Nobel laure- ate Dr. Julius Axelrod in the Laboratory of Clinical Science, IRP, of NIMH. In June 1978 he became a clinical associate in the Clinical Psy- chobiology Branch of NIMH and served in that position for 2 years. In 1982, he was appointed chief of the Clinical Neuroscience Branch as well as chief of the Section on Preclinical Studies, IRP, NIMH. Dr. Paul also served as medical director in the Commissioned Corps of the United States Public Health Service and maintained a private practice in psy- chiatry and psychopharmacology. He is board certified by the American Board of Psychiatry and Neurology and has been elected a fellow in the American College of Neuropsychopharmacology (ACNP), served on the ACNP Council, and was elected president of the ACNP (1999). He is currently licensed to practice medicine in the state of Maryland. He also serves on the executive board of PhRMA’s Science and Regulatory Committee and is incoming chair. Dr. Paul served as a member of the National Advisory General Medical Sciences Council, NIH (1996– 1999), and was appointed by the secretary of health and human services to serve as a member of the advisory committee to the director of NIH (2001–2006). William Z. Potter, M.D., Ph.D., is vice president, Franchise Integra- tor Neuroscience, at Merck Research Laboratories. Prior to joining Merck he served as the executive director and Lilly Clinical Research

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108 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES Fellow of the Neuroscience Therapeutic Area at LRL. He developed a Lilly/IU fellowship early in 1996 and was named professor of psychiatry at IUMC. Before being associated with LRL, he held the position of chief, Section on Clinical Pharmacology, Intramural Research Program at NIMH in Bethesda, Maryland. He had been with the Public Health Service and NIH 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. Some of those include the 1975–1977 Falk Fellow, American Psychiatric Asso- ciation; the 1986 Meritorious Service Medal, United States Public Health Service; and, in 1990, St. Elizabeth’s Residency Program Alumnus of the Year Award. Paul A. Sieving, M.D., Ph.D. (biography in Invited Speakers). Rae Silver, Ph.D., is Helene L. and Mark N. Kaplan Professor of Natu- ral and Physical Sciences and holds joint appointments at Barnard Col- lege and Columbia University. Dr. Silver is a fellow of the American Academy of Arts and Sciences. She has participated extensively in scien- tific and educational activities, including serving as chair for NASA’s Research Maximization and Prioritization Committee reviewing Scien- tific Priorities for the International Space Station; Society for Neurosci- ence Program Committee (Theme E—Autonomic and Limbic System); chair, External Advisory Committee, NSF Center for the Study of Bio- logical Rhythms at the University of Virginia; search committees for journal editors, department chairs, and provost at various institutions. She has been a panel member of a number of committees, including NASA: International Space Station Cost and Management Evaluation Task Force; NSF Center for Behavioral Neuroscience External Advisory Board member Georgia State, Emory, and other colleges; Society for Neuroscience Education Committee Ford Foundation Minority Fellow- ship Review panel. She was also president, Society Research in Biologi- cal Rhythms. As senior adviser at NSF, she worked with NSF staffers in all the scientific directorates to create a series of workshops to examine opportunities for the next decade in making advances in neuroscience through the joint efforts of biologists, chemists, educators, mathemati- cians, physicists, psychologists, and statisticians. Silver’s studies of the biological clock in the suprachiasmatic nucleus of the brain were the first to conclusively demonstrate that this brain tissue can be readily trans-

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109 APPENDIX D planted and restore function at a very high success rate in an animal model. The laboratory is renowned for analysis of the input, output, and intraneuronal circuits underlying the function of the brain’s master clock. A second line of research entails the study of mast cells (renowned for their role in producing allergic reactions) in modulating brain function and as a major source of brain histamine. The research has been sup- ported without interruption by NIH and NSF, among other sources. Dr. Silver is deeply committed to educating undergraduate and graduate stu- dents, both at the national and institutional level and in the hands-on con- text of the laboratory. Consistent with this interest, she created the undergraduate program in Quantitative Reasoning at Barnard College and published, with colleagues, studies of mathematical learning. She initiated the undergraduate major in neuroscience, serving as its first program director. She also served as director of the graduate program in psychology at Columbia University. William H. Thies, Ph.D., is vice president for medical and scientific relations at the Alzheimer’s Association, where he oversees the world’s largest private, nonprofit Alzheimer’s disease research grants program. Under his direction, the organization’s annual grant budget has doubled, and the program has designated special focus areas targeting the relation- ship between cardiovascular risk factors and Alzheimer’s disease, care- giving and care systems, and research involving diverse populations. He played a key role in launching Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, and in establishing the Research Round- table, a consortium of senior scientists from industry, academia, and gov- ernment who convene regularly to explore common barriers to drug discovery. In previous work at the American Heart Association (AHA) from 1988 to 1998, Dr. Thies formed a new stroke division that recently became the American Stroke Association. He also built the Emergency Cardiac Care Program, a continuing medical education program that trains over 3 million professionals annually. He has worked with NINDS to form the Brain Attack Coalition. Prior to joining AHA, he held faculty positions at Indiana University in Bloomington and the University of Pittsburgh. Dr. Thies earned a B.A. in biology from Lake Forest College, Lake Forest, Illinois, and a Ph.D. in pharmacology from the University of Pittsburgh School of Medicine. Roy E. Twyman, M.D., is vice president, Franchise Development in the Central Nervous System/Pain Area of Johnson & Johnson Pharmaceuti-

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110 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES cal Research and Development. In this position, he oversees licensing and acquisition efforts for neurology, psychiatry, and pain franchises while coordinating strategic activities for CNS discovery optimization, early human studies and proof of concept, new technologies, and cross- company projects. Additional oversight includes the pharmacogenomics and neuroimaging teams that support broad-based pharma R&D across all therapeutic areas. Before his work at Johnson & Johnson, Dr. Twyman was on the faculty of the University of Utah and the University of Michigan. He received his B.S. degree from Purdue University in electrical engineering. He earned his M.D. from the University of Ken- tucky and completed a neurology residency at the University of Michi- gan. Nora D. Volkow, M.D., became director of the National Institute on Drug Abuse in May 2003. Dr. Volkow came to NIDA from Brookhaven National Laboratory (BNL), where she held concurrent positions includ- ing associate director for life sciences, director of nuclear medicine, and director of the NIDA-Department of Energy Regional Neuroimaging Center. In addition, she was a professor in the Department of Psychiatry and associate dean of the medical school at the State University of New York (SUNY), Stony Brook. Dr. Volkow brings to NIDA a long record of accomplishment in drug addiction research. She is a recognized expert on the brain’s dopamine system, with her research focusing on the brains of addicted, obese, and aging individuals. Her studies have documented changes in the dopamine system affecting the actions of frontal brain regions involved with motivation, drive, and pleasure and the decline of brain dopamine function with age. Her work includes more than 350 peer-reviewed publications, three edited books, and more than 50 book chapters and non-peer-reviewed manuscripts. The recipient of multiple awards, she was elected to membership in the IOM of the NAS and was named “Innovator of the Year” in 2000 by U.S. News & World Report. Dr. Volkow received her B.A. from Modern American School, Mexico City; her M.D. from the National University of Mexico, Mexico City; and her postdoctoral training in psychiatry at New York University. In addition to BNL and SUNY Stony Brook, she has worked at the Univer- sity of Texas Medical School and Sainte Anne Psychiatric Hospital in Paris. Frank D. Yocca, Ph.D., is currently vice president and head of CNS and Pain Drug Discovery for AstraZeneca at the Wilmington, Delaware, fa-

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111 APPENDIX D cility. His research focus is on new treatments for psychiatric diseases. Dr. Yocca received his Ph.D. in pharmacology from St. John’s Univer- sity in New York City. His work focused on the effect of antidepressants on circadian rhythms. Subsequently he was a postdoctoral fellow at Mt. Sinai Department of Pharmacology. Prior to joining AstraZeneca, he was executive director at the Bristol Myers Squibb Pharmaceutical Research Institute. He originally joined the Bristol Myers Company in 1984 as a postdoctoral fellow in CNS research. Utilizing techniques he learned from his academic postdoctoral position, Dr. Yocca helped to elucidate the mechanism of action of the anxiolytic drug Buspar. He then joined Bristol Myers as an employee and made significant advances in under- standing the physiological role of the 5-HT1A receptor and its role in psychiatric disease states. During the 21 years spent with Bristol-Myers and then Bristol Myers Squibb, he supported a number of psychiatric discovery programs, helping to discover and develop the antidepressant Serzone. Throughout his tenure, he continued to work in the field of serotonin and advanced a number of agents to clinical trials including several antimigraine agents (avitriptan) as well as antipsychotics and anxiolytics. In the latter stages of his career at BMS, he also became involved in externalization and development. He contributed to the in-licensing and development of the novel antipsychotic agent Abilify. Additionally, Dr. Yocca was part of the externalization team that in- licensed to BMS the recently approved antidepressant agent Emsam, the first antidepressant to be administered through a patch. In development, he was early development project leader for CRF antagonists and was also involved in Phase IV clinical studies with Abilify. Dr. Yocca is a member of numerous scientific societies, including SFN and ACNP. Christian G. Zimmerman, M.D., FACS, M.B.A., is chairman and founder of the Idaho Neurological Institute (INI), adjunct professor of psychology at Boise State University, and past chief executive officer of Neuroscience Associates. He also served as a board member for the Idaho State Board of Health and Welfare. Dr. Zimmerman established the INI research facility to focus on nervous system injury, repair, and neuroplasticity; leads its various interdisciplinary research teams; and is co-professor for biology and cognitive neuroscience research students trained at the facility. Research projects include a 20-year longitudinal study of traumatic brain injury; investigations of spinal injury, stroke, aneurysms, arterial thrombolytic therapy intervention, neuropathology, CNS tumors, sleep disorders, deep brain stimulation, and movement dis-

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112 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES orders; and five TATRC telemedicine grants. In his role as INI chairman, he has facilitated numerous symposia and workshops to provide educa- tional opportunities for medical professionals and the general public. Additionally, he chairs prevention programs for Idaho’s youth such as Think First. Dr. Zimmerman is diplomate of the American Board of Neu- rological Surgery and Pain Management and a fellow of the American College of Surgeons and Physician Executives. He received his M.B.A. from Auburn University. Stevin H. Zorn, Ph.D., is vice president and head of Central Nervous System Disorders Research at Pfizer Global Research and Development and also coleads Pfizer’s CNS Therapeutic Area Leadership Team. He received a B.S. degree in chemistry from Lafayette College, Easton, Pennsylvania, and M.S. and Ph.D. degrees in biomedical sciences with an emphasis on toxicology and neuropharmacology, respectively. Dr. Zorn conducted postdoctoral research studies in Paul Greengard’s Labo- ratory of Molecular and Cellular Neuroscience at Rockefeller Univer- sity before joining Pfizer in 1989. He has coauthored numerous scientific research communications and patents and has contributed to the ad- vancement of a wide variety of drug candidates, some of which are now helping to improve the lives of patients suffering from CNS-related ill- ness. IOM STAFF Bruce M. Altevogt, Ph.D., is a senior program officer in the Board on Health Sciences Policy at the IOM. His primary interests focus on policy issues related to basic research and preparedness for catastrophic events. He received his doctoral thesis from Harvard University’s Program in Neuroscience. Following over 10 years of research, Dr. Altevogt joined The National Academies as a science and technology policy fellow with the Christine Mirzayan Science & Technology Policy Graduate Fellow- ship Program. Since joining the Board on Health Sciences Policy, he has been a program officer on multiple IOM studies, including Sleep Disor- ders and Sleep Deprivation: An Unmet Public Health Problem, The Na- tional Academies’ Guidelines for Human Embryonic Stem Cell Research: 2007 Amendments, and Assessment of the NIOSH Head-and- Face Anthropometric Survey of U.S. Respirator Users. He is currently serving as the director of the Forum on Neuroscience and Nervous Sys-

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113 APPENDIX D tem Disorders and a co-study director on the National Academy of Sci- ences Human Embryonic Stem Cells Research Advisory Committee. He received his B.A. from the University of Virginia in Charlottesville, where he majored in biology and minored in South Asian studies. Andrew Pope, Ph.D., is director of the Board on Health Sciences Policy and the Board on Neuroscience and Behavioral Health at IOM. With a Ph.D. in physiology and biochemistry, his primary interests focus on en- vironmental and occupational influences on human health. Dr. Pope’s previous research activities focused on the neuroendocrine and reproduc- tive effects of various environmental substances in food-producing ani- mals. During his tenure at the National Academies and since 1989 at IOM, Dr. Pope has directed numerous studies; topics include injury con- trol, disability prevention, biological markers, neurotoxicology, indoor allergens, and the enhancement of environmental and occupational health content in medical and nursing school curricula. Most recently, Dr. Pope directed studies on NIH priority-setting processes, organ procurement and transplantation policy, and the role of science and technology in countering terrorism. Sarah L. Hanson is a senior program associate in the Board on Health Sciences Policy at IOM. Ms. Hanson previously worked for the Commit- tee on Sleep Medicine and Research. She is currently the senior program associate for the Forum on Neuroscience and Nervous System Disorders. Prior to joining IOM, she served as research and program assistant at the National Research Center for Women & Families. Ms. Hanson has a B.A. from the University of Kansas with a double major in political sci- ence and international studies. She is currently taking pre-med courses at the University of Maryland and hopes to attend medical school in the future. Lora K. Taylor is a senior project assistant in the Board on Health Sci- ences Policy at IOM. She has 15 years of experience working at the NAS and, prior to joining IOM, served as the administrative associate for the Report Review Committee and the Division on Life Sciences’ Ocean Studies Board. Ms. Taylor has a B.A. from Georgetown University with a double major in psychology and fine arts. James McGuiness is a College of William and Mary student currently interning at the Institute of Medicine and aiding the Forum on Neurosci-

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114 NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES ence and Nervous System Disorders staff. In his third year now, he plans to major in neuroscience and pursue a career in the research or medical fields. At school he is active in many clubs and organizations and is planning on researching with one of his professors this fall. IOM Fellow Lisa F. Barcellos, Ph.D., is currently employed as Assistant Professor of Epidemiology in the School of Public Health at the University of Cali- fornia, Berkeley. Dr. Barcellos obtained her Ph.D. in Immunology from the School of Public Health, University of California Berkeley in 1996. She was awarded a National Multiple Sclerosis Society postdoctoral fel- lowship in 1997, and completed three years of postdoctoral training in Genetic Epidemiology in the Department of Neurology, University of California, San Francisco in 2001. While at University of California, San Francisco, she was also the recipient of a NIH/K12 clinical research and training award as part of the prestigious NIH-funded “Building Interdis- ciplinary Research Careers in Women’s Health” program for two years (2002–2004). Dr. Barcellos currently holds faculty appointments in the Department of Neurology, University of California, San Francisco and Kaiser Perma- nente Division of Research Oakland. She serves as a co-investigator for the United States Multiple Sclerosis Genetics Group and the Multiple Sclerosis International Genetics Consortium. She is also a member of the Kaiser Permanente Autoimmune Disease Research Group and the Na- tional Multiple Sclerosis Society Task Force on Prospective Studies of Risk Factors in Multiple Sclerosis. Dr. Barcellos has significant expertise and training in areas of human genetics, genetic epidemiology, molecular genetics and statistical analysis of complex genetic diseases. She has ac- tively participated in the design, implementation, analysis and interpreta- tion of human genetic disease studies for the last ten years, including numerous investigations of candidate disease genes and genomic regions, as well as autoimmune phenotype characterization and the identification of genotype-phenotype correlations in studies of autoimmune disease. In collaboration with colleagues at University of California, San Fran- cisco and Kaiser Permanente Division of Research, Dr. Barcellos has established a strong NIH-funded research program with a primary focus

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115 APPENDIX D on the identification of genetic, social and environmental risk factors for particular autoimmune diseases including multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis and other conditions. Her cur- rent projects are comprised of large family-based and population-based studies, and include the application of novel analytical approaches to characterize gene-gene, gene-environment, parent-of-origin and mater- nal-child histocompatibility relationships underlying susceptibility to these diseases. Her research program also includes the application of state-of-the-art high throughput single nucleotide polymorphism (or SNP) genotyping methodologies. A major emphasis of her work is the comprehensive investigation of the major histocompatibility compex re- gion genes on chromosome 6p21 in autoimmunity. Dr Barcellos has co- authored more than 35 publications in the scientific literature and is a member of the American Society of Human Genetics and International Genetic Epidemiology Society. She currently serves as a genetic epide- miology consultant to Celera Diagnostics in Alameda, CA, the March of Dimes California Birth Defects Monitoring Program in Berkeley, CA, and the Kaiser Permanente Program in Genes, Environment and Health in Oakland, CA. In addition to her autoimmune disease research pro- gram, Dr. Barcellos has also successfully developed and established graduate level curriculum in areas of human genetics, molecular and ge- netic epidemiology in the University of California, Berkeley, School of Public Health.

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