NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES

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Miriam Davis, Sarah Hanson, Bruce Altevogt, Rapporteurs Forum on Neuroscience and Nervous System Disorders Board on Health Sciences Policy

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, N.W. • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Gov- erning Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This project was supported by contracts between the National Academy of Sci- ences and the Alzheimer’s Association; Amgen, Inc.; AstraZeneca Pharmaceuti- cals, Inc.; the Department of Health and Human Services’ National Institutes of Health (Contract No. N01-OD-4-213) through the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Aging (NIA), the National Institute on Drug Abuse (NIDA), the National Eye Institute (NEI), the NIH Blueprint for Neuroscience Research, the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS); Eli Lilly and Company; GE Healthcare, Inc.; GlaxoSmithKline, Inc.; Johnson & Johnson Pharmaceutical Research and Development, LLC; Merck Research Laboratories, Inc.; the National Multiple Sclerosis Society; the Na- tional Science Foundation (Contract No. OIA-0647541); Pfizer Global Research and Development, Inc.; and the Society for Neuroscience. The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the view of the organizations or agencies that provided sup- port for this project. International Standard Book Number-13:978-0-309-10889-8 International Standard Book Number-10:0-309-10889-6 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624- 6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: Institute of Medicine. 2008. Neuroscience biomarkers and biosignatures: Converging technologies, emerging partnerships, workshop summary. Washington, DC: The National Academies Press. The serpent has been a symbol of long life, healing, and knowledge among al- most all cultures and religions since the beginning of recorded history. The ser- pent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the re- sponsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the Na- tional Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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BIOMARKERS PLANNING COMMITTEE ALAN LESHNER (Chair), American Association for the Advancement of Science, Washington, D.C. MARC BARLOW, GE Healthcare, Inc., Bucks, United Kingdom DENNIS CHOI, Emory University, Atlanta, Georgia TIMOTHY COETZEE, National Multiple Sclerosis Society, New York THOMAS INSEL, National Institute of Mental Health, Bethesda, Maryland KATHIE OLSEN, National Science Foundation, Arlington, Virginia WILLIAM POTTER, Merck Research Laboratories, Inc., North Wales, Pennsylvania WILLIAM THIES, Alzheimer’s Association, Chicago, Illinois ROY TWYMAN, Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, New Jersey IOM Staff BRUCE ALTEVOGT, Project Director SARAH HANSON, Senior Program Associate LORA TAYLOR, Senior Project Assistant JAMES MCGUINESS, Summer Intern v

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FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS ALAN LESHNER (Chair), American Association for the Advancement of Science, Washington, D.C. HUDA AKIL, University of Michigan, Ann Arbor MARC BARLOW, GE Healthcare, Inc., Bucks, United Kingdom DANIEL BURCH, CeNeRx Biopharma, Research Triangle Park, North Carolina DENNIS CHOI, Emory University, Atlanta, Georgia TIMOTHY COETZEE, National Multiple Sclerosis Society, New York DAVID COHEN, Columbia University, Society for Neuroscience representative, New York RICHARD FRANK, GE Healthcare, Inc., Princeton, New Jersey RICHARD HODES, National Institute on Aging, Bethesda, Maryland STEVEN HYMAN, Harvard University, Cambridge, Massachusetts JUDY ILLES, University of British Columbia, Vancouver, Canada THOMAS INSEL, National Institute of Mental Health, Bethesda, Maryland STORY LANDIS, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland TING-KAI LI, National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland MICHAL OBERDORFER, NIH Blueprint for Neuroscience Research, Bethesda, Maryland KATHIE OLSEN, National Science Foundation, Arlington, Virginia ATUL PANDE, GlaxoSmithKline, Inc., Research Triangle Park, North Carolina STEVEN PAUL, Eli Lilly and Company, Indianapolis, Indiana WILLIAM POTTER, Merck Research Laboratories, Inc., North Wales, Pennsylvania PAUL SIEVING, National Eye Institute, Bethesda, Maryland RAE SILVER, Columbia University, New York WILLIAM THIES, Alzheimer’s Association, Chicago, Illinois ROY TWYMAN, Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, New Jersey NORA VOLKOW, National Institute on Drug Abuse, Bethesda, Maryland FRANK YOCCA, AstraZeneca Pharmaceuticals, Wilmington, Delaware CHRISTIAN ZIMMERMAN, Neuroscience Associates, Boise, Idaho vi

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STEVIN ZORN, Pfizer Global Research and Development, Ann Arbor, Michigan IOM Staff BRUCE ALTEVOGT, Project Director SARAH HANSON, Senior Program Associate LORA TAYLOR, Senior Project Assistant JAMES MCGUINESS, Summer Intern IOM Anniversary Fellow LISA BARCELLOS, University of California, Berkeley vii

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BOARD ON HEALTH SCIENCES POLICY* FRED H. GAGE (Chair), The Salk Institute for Biological Studies, La Jolla, California C. THOMAS CASKEY, University of Texas, Houston Health Science Center GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, Indiana JAMES F. CHILDRESS, University of Virginia, Charlottesville ELLEN WRIGHT CLAYTON, Vanderbilt University Medical School, Nashville, Tennessee LINDA C. GIUDICE, University of California, San Francisco LYNN R. GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland LAWRENCE O. GOSTIN, Georgetown University Law Center, Washington, D.C. MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, Maryland DAVID KORN, Association of American Medical Colleges, Washington, D.C. ALAN LESHNER, American Association for the Advancement of Science, Washington, D.C. JONATHAN D. MORENO, University of Pennsylvania, Philadelphia E. ALBERT REECE, University of Maryland School of Medicine, Baltimore LINDA ROSENSTOCK, University of California, Los Angeles MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, Missouri OWEN N. WITTE, University of California, Los Angeles IOM Staff ANDREW M. POPE, Director AMY HAAS, Board Assistant DONNA RANDALL, Financial Officer *IOM Boards do not review or approve workshop summaries. The responsibility for the content of the summary rests with the rapporteurs and the institution. viii

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The pur- pose of this independent review is to provide candid and critical com- ments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional stan- dards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to pro- tect the integrity of the deliberative process. We wish to thank the fol- lowing individuals for their review of this report: Joseph T. Coyle, Harvard Medical School Allen D. Roses, GlaxoSmithKline Ira Shoulson, Department of Neurology, Pharmacology and Medicine, School of Medicine, University of Rochester Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was over- seen by Dr. Theodore R. Marmor, Yale University School of Manage- ment, Professor Emeritus. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring com- mittee and the institution. ix

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Contents SUMMARY 1 INTRODUCTION 9 1 BIOMARKER AND BIOSIGNATURE PRINCIPLES 15 2 POTENTIAL TOOLS FOR BIOMARKER AND BIOSIGNATURE DEVELOPMENT 27 3 PSYCHIATRIC AND DRUG ADDICTION DISORDERS 39 4 NEUROLOGICAL AND EYE DISEASES 55 APPENDIXES A References 71 B Public Workshop on Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships 81 C Workshop Attendees 87 D Biographical Sketches of Invited Speakers, Committee Members, and Staff 91 xi

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