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Evolution of Translational Omics: Lessons Learned and the Path Forward This PDF is available from The National Academies Press at http://www.nap.edu/catalog.php?record_id=13297 Evolution of Translational Omics: Lessons Learned and the Path Forward ISBN Christine M. Micheel, Sharyl J. Nass, and Gilbert S. Omenn, Editors; 978-0-309-22418-5 Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials; Board on Health Care Services; Board on 354 pages Health Sciences Policy; Institute of Medicine 6 x 9 PAPERBACK (2012) Visit the National Academies Press online and register for... Instant access to free PDF downloads of titles from the NATIONAL ACADEMY OF SCIENCES NATIONAL ACADEMY OF ENGINEERING INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL 10% off print titles Custom notification of new releases in your field of interest Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Request reprint permission for this book Copyright © National Academy of Sciences. All rights reserved. Evolution of Translational Omics: Lessons Learned and the Path Forward EVOLUTION OF TRANSLATIONAL OMICS Lessons Learned and the Path Forward Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials Board on Health Care Services Board on Health Sciences Policy Christine M. Micheel, Sharyl J. Nass, and Gilbert S. Omenn, Editors Copyright © National Academy of Sciences. All rights reserved. Evolution of Translational Omics: Lessons Learned and the Path Forward THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW 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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract Nos. HHSN261200900003C (National Cancer Insti- tute); HHSF223201010692P and HHSF22301018T (Food and Drug Administration); and 200-2011-38807 and 200-2005-13434 (Centers for Disease Control and Prevention). This study was also supported by the U.S. Department of Veterans Affairs, the American Society for Clinical Pathology, and the College of American Pathologists. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number 13: 978-0-309-22418-5 International Standard Book Number 10: 0-309-22418-7 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http:// www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www. iom.edu. Copyright 2012 by the National Academy of Sciences. All rights reserved. Printed in the United States of America 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. Suggested citation: IOM (Institute of Medicine). 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. Copyright © National Academy of Sciences. All rights reserved. Evolution of Translational Omics: Lessons Learned and the Path Forward “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health. Copyright © National Academy of Sciences. All rights reserved. Evolution of Translational Omics: Lessons Learned and the Path Forward 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 Acad- emy 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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 Sci- ences 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 Copyright © National Academy of Sciences. All rights reserved. Evolution of Translational Omics: Lessons Learned and the Path Forward COMMITTEE ON THE REVIEW OF OMICS-BASED TESTS FOR PREDICTING PATIENT OUTCOMES IN CLINICAL TRIALS GILBERT S. OMENN (Chair), Professor of Internal Medicine, Human Genetics and Public Health; Director, University of Michigan Center for Computational Medicine and Bioinformatics, University of Michigan Medical School, Ann Arbor CATHERINE D. DEANGELIS, Professor of Pediatrics, Johns Hopkins School of Medicine, Professor of Health Policy and Management, Johns Hopkins School of Public Health, and Editor-in-Chief Emerita, Journal of the American Medical Association, Baltimore, MD DAVID L. DEMETS, Professor of Statistics and Biostatistics, University of Wisconsin, Madison THOMAS R. FLEMING, Professor of Biostatistics, Statistics, University of Washington, Seattle GAIL GELLER, Professor of Medicine, Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD JOE GRAY, Gordon Moore Endowed Chair, Department of Biomedical Engineering, Center for Spatial Systems Biomedicine, Oregon Health & Science University Knight Cancer Institute, Portland DANIEL F. HAYES, Clinical Director of the Breast Oncology Program, and Stuart B. Padnos Professor of Breast Cancer Research, University of Michigan Comprehensive Cancer Center, Ann Arbor I. CRAIG HENDERSON, Adjunct Professor of Medicine, University of California, San Francisco and Helen Diller Family Comprehensive Cancer Center LARRY KESSLER, Professor and Chair, Department of Health Services, University of Washington School of Public Health, Seattle STANLEY LAPIDUS, Founder, President, and CEO, SynapDx Corporation, Southborough, MA DEBRA G. B. LEONARD, Professor and Vice Chair for Laboratory Medicine, and Director of the Clinical Laboratories, Weill Medical College of Cornell University, New York, NY HAROLD L. MOSES, Director Emeritus, Hortense B. Ingram Professor of Molecular Oncology, and Professor of Cancer Biology, Medicine, and Pathology, Vanderbilt-Ingram Cancer Center, Nashville, TN WILLIAM PAO, Associate Professor of Medicine, Cancer Biology, and Pathology, Microbiology, Immunology, Ingram Associate Professor of Cancer Research, Director of the Division of Hematology/Oncology, and Director of Personalized Cancer Medicine, Vanderbilt University School of Medicine, Nashville, TN v Copyright © National Academy of Sciences. All rights reserved. Evolution of Translational Omics: Lessons Learned and the Path Forward REBECCA D. PENTZ, Professor of Hematology and Oncology in Research Ethics, Emory School of Medicine, Atlanta, GA NATHAN D. PRICE, Associate Professor, Institute for Systems Biology, Seattle, WA JOHN QUACKENBUSH, Professor of Computational Biology and Bioinformatics, Dana-Farber Cancer Institute, Boston, MA ELDA RAILEY, Cofounder, Research Advocacy Network, Plano, TX DAVID RANSOHOFF, Professor of Medicine, Clinical Professor of Epidemiology, University of North
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