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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS
NEUROSCIENCE BIOMARKERS AND BIOSIGNATURES
Converging Technologies, Emerging Partnerships
WORKSHOP SUMMARY
Miriam Davis, Sarah Hanson, Bruce Altevogt, Rapporteurs
Forum on Neuroscience and Nervous System Disorders
Board on Health Sciences Policy
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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 Governing 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 Sciences and the Alzheimer’s Association; Amgen, Inc.; AstraZeneca Pharmaceuticals, 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 National 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 support 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 almost all cultures and religions since the beginning of recorded history. The serpent 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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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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 responsibility 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 National 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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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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.
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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 purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following 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 constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Dr. Theodore R. Marmor, Yale University School of Management, 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 committee and the institution.
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships, Workshop Summary
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
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