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L; ~S~AL BIOMEDICAL SCIENC ARGE A E- EXPLORING STRATEGIES FOR FUTURE RESEARCH Committee on Large-Scale Science and Cancer Research Sharyl J. Nass and Bruce W. Stillman, Eclitors National Cancer Policy Boa rcl INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES and Division on Earth and Life Stuclies NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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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 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. Support for this project was provided by The National Cancer Institute. The views pre- sented in this report are those of the Institute of Medicine and National Research Council Committee on Large-Scale Science and Cancer Research and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data Large-scale biomedical science: exploring strategies for future research / Sharyl J. Nass and Bruce W. Stillman, editors; Committee on Large-scale Science and Cancer Research, National Cancer Policy Board and Division on Earth and Life Studies, National Research Council. p. ; cm. Includes bibliographical references. ISBN 0-309-08912-3 (pbk.) ISBN 0-309-50698-0 (PDF) 1. Medicine Research Government policy United States. 2. Cancer Research Government policy United States. 3. Federal aid to medical research United States. [DNLM: 1. Biomedical Research United States. 2. Interinstitutional Relations United States. 3. Research Design United States. 4. Resource Allocation United States. W 20.5 L322 2003] I. Nass, Sharyl J. II. Stillman, Bruce. III. National Cancer Policy Board (U.S.~. Committee on Large-scale Science and Cancer Research. IV. National Research Council (U.S.~. Division on Earth and Life Studies. R854.U5L37 2003 610'.7'2073 dc21 2003009162 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 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, aniMeditine The National Academy of Sciences is a private, nonprofit, self-perpetuating soci- ety of distinguished scholars engaged in scientific and engineering research, dedi- cated 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. Bruce M. Alberts 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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. Wm. A. Wulf 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 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 gov- ernment. Functioning in accordance with general policies determined by the Acad- emy, 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 commu- nities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www. nationa'-aca~emies.org

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COMMITTEE ON LARGE-SCALE SCIENCE AND CANCER RESEARCH JOSEPH V. SIMONE, M.D. (Chair), Simone Consulting, Dunwoody, GA BRUCE W. STILLMAN, Ph.D. (Vice Chair), Director, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY ELLEN STOVALL (Vice Chair), Executive Director, National Coalition for Cancer Survivorship, Silver Spring, MD DIANA PETITTI, M.D. (Vice Chair), Director, Research and Evaluation, Kaiser Permanente of Southern California, Pasadena, CA STILL BARGONETTI, Ph.D. Associate Professor, Hunter College, New York, NY BARRY BOZEMAN, Ph.D. Regents Professor of Public Policy, Director of the State Data and Research Center, Georgia Institute of Technology, Atlanta, GA TIM BYERS, M.D., M.P.H. Professor of Epidemiology and Associate Director, University of Colorado Cancer Center, University of Colorado School of Medicine, Denver, CO TOM CURRAN, Ph.D. Chairman of the Department of Developmental Neurobiology, St. Jude's Children's Research Hospital, Memphis, TN TIMOTHY EBERLEIN, M.D. Bixby Professor and Chairman, Washington University School of Medicine, Department of Surgery, St. Louis, MO DAVID GALAS, Ph.D. Chief Academic Officer and Norris Professor of Applied Life Sciences, Keck Graduate Institute of Applied Life Sciences, Claremont, CA KAREN HERSEY, J.D. Senior Intellectual Property Counsel, Office of Intellectual Property Counsel, Massachusetts Institute of Technology, Cambridge, MA DANIEL I. KEVLES, Ph.D. Professor, Yale University, Department of History, New Haven, CT LAUREN LINTON, Ph.D., M.B.A. President, Linton Consulting, Lincoln, MA WILLIAM W. MCGUIRE, M.D. Chairman and Chief Executive Officer, UnitedHealth Group, Minnetonka, MN COHN MENDELSOHN, M.D. President, University of Texas, M.D. Anderson Cancer Center, Houston, TX IV

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KATHLEEN H. MOONEY, Ph.D. Professor and Peery Presidential Endowed Chair in Nursing Research, University of Utah College of Nursing, Salt Lake City, UT NANCY MUELLER, Sc.D. Professor of Epidemiology, Harvard School of Public Health, Department of Epidemiology, Boston, MA PATRICIA A. NOLAN, M.D., M.P.H. Director, Rhode Island Department of Health, Providence, RI CECIL B. PICKETT, Ph.D. Executive Vice President, Discovery Research, Schering Plough Institute, Kenilworth, Nr STEPHEN PRESCOTT, M.D. Executive Director H.A. and Edna Benning Presidential Chair in Human Molecular Biology and Genetics, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT LOUISE B. RUSSELL, Ph.D. Research Professor of Economics, Institute for Health, Rutgers University, New Brunswick, Nr THOMAS I. SMITH, M.D., F.A.C.P. Professor, Medical College of Virginia at Virginia Commonwealth University, Division of Hematology, Richmond, VA SUSAN WEINER, Ph.D. President, The Children's Cause, Silver Spring, MD ROBERT C. YOUNG, M.D. President, American Cancer Society and the Fox Chase Cancer Center, Philadelphia, PA STUDY STAFF SHARYL I. NASS, Ph.D. Study Director ROGER HEADMAN, M.D. Director, National Cancer Policy Board MARY}OY BALLANTYNE Research Associate NICCI DOWD Administrative Assistant (through January 2003) NAKIA JOHNSON Project Assistant (from February 2003) *Members of the National Cancer Policy Board, Institute of Medicine, The National Academies. V

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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 pro- cedures 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 integ- rity of the deliberative process. We wish to thank the following individu- als for their review of this report: Mina l. Bissell, Ph.D. Distinguished Scientist, Life Sciences Division, Lawrence Berkeley National Laboratory Marvin Cassman, Ph.D. Director, QB3 at University of California, San Francisco Mildred Cho, Ph.D. Senior Research Scholar and Acting Co-director, Stanford Center for Biomedical Ethics Carol Dahl, Ph.D. Biospect, Inc. Chi Dang, M.D., Ph.D. Professor, Division of Hematology, Johns Hopkins University Department of Medicine Alfred G. Oilman, M.D., Ph.D. Regental Professor and Chairman, Department of Pharmocology, University of Texas Southwestern Medical Center Allen S. Lichter, M.D. Newman Family Professor of Radiation Oncology, Dean, University of Michigan Medical School Candace Swimmer, Ph.D. Research Fellow, Department of Genome Biochemistry, Exelixis, Inc. Shirley M. Tilghman, Ph.D. President, Princeton University Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the con- clusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Enriqueta C. Bond, Ph.D., President, Burroughs Wellcome Fund and Charles E. Phelps, Ph.D., Provost University of Rochester. Appointed by the Na- tional Research Council and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all re- view comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. Al

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Acknowledgments The committee gratefully acknowledges the contributions of many individuals who provided invaluable information and data for the study, either through formal presentations or through informal contacts with the study staff: Herman Alvarado, Bi Ade, Lee Babiss, Wendy Baldwin, Tohn Carney, Robert Cook-Deegan, Carol Dahl, lames Deatherage, Toseph DeRisi, Marie Freire, lack Gibbons, Tohn Gohagan, Eric Green, Judith Greenberg, Ed- ward Hackett, Edward Harlow, Nathaniel Heintz, David Hirsh, Nancy Hopkins, lames Jensen, Marvin Kalt, Richard Klausner, William Koster, Rolph Leming, loan Leonard, Arnold Levine, David Livingston, Rochelle Long, David Longfellow, Michael Lorenz, Richard Lyttle, Pamela Marino, Richard Nelson, Emanuel Petricoin, Michael Rogers, Jacques Rossouw, Walter Schaefer, William Schraeder, Stuart Schreiber, Edward Scolnick, Scott Somers, Paula Stephan, Marcus Stoffel, Robert Strausberg, Daniel Sullivan, Roy Vagelos, Craig Venter, LeRoy Walters, Barbara Weber, Michael Wigler, Robert Wittes. . . v''

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Acronyms AAAS - American Association for the Advancement of Science AEC - Atomic Energy Commission (forerunner of DOE) AFCS - Alliance for Cellular Signaling AIP - American Institute of Physics AUTM - Association of University Technology Managers BAA - Broad Agency Announcement CDC - Centers for Disease Control and Prevention CEPH - Centre d'Etude du Polymorphisme Humaine CERN - Conseil European Pour La Rechierche Nucleaire CES - Cooperative Extension Services CGAP - Cancer Genome Anatomy Project COSEPUP - Committee on Science, Engineering, and Public Policy CRADA - Cooperative Research and Development Agreement CSR- Center for Scientific Review DARPA - The Defense Advanced Research Projects Agency DHHS - Department of Health and Human Services DOD - Department of Defense DOE - Department of Energy DIP - Developmental Therapeutics Program EDRN - The Early Detection Research Network EPA - Environmental Protection Agency EST - Expressed Sequence Tag IX

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x FDA - Food and Drug Administration GPRA - Government Performance and Results Act HOP - Human Genome Project HHMI - Howard Hughes Medical Institute HRT - Hormone Replacement Therapy HUGO - Human Genome Organization HUPO - Human Proteome Organization INS - Immigration and Naturalization Service IRG - Integrated Review Groups IUPAP - International Union of Pure and Applied Physics rCSG - Joint Center for Structure Genomics MBL - Marine Biology Laboratory MMHCC - Mouse Models of Human Cancers Consortium MOU - Memoranda of Understanding ACRONYMS NACA - National Advisory Committee for Aeronautics NAS - National Academy of Sciences NASA - National Aeronautics and Space Administration NCAB - National Cancer Advisory Board NCI - National Cancer Institute NDRC - National Defense Research Committee NHGRI - National Human Genome Research Institute NHLBI - National Heart Lung and Blood Institute NIAID - National Institute of Allergy and Infectious Diseases NIEHS - National Institute of Environmental Health Science NIGMS - National Institute of General Medical Sciences NIH - National Institutes of Health NOAA - National Oceanic and Atmospheric Administration NOARL - Naval Oceanographic and Atmospheric Research Laboratory NRAC - Naval Research Advisory Committee NRC - National Research Council NRSA - National Research Service Awards NSF - National Science Foundation NTP - National Toxicology Program OES - Office of Experiment Stations OMB - Office of Management and Budget ONR- Office of Naval Research

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ACRONYMS OSHA - Occupational Safety and Health Administration OSTP - Office of Science and Technology Policy OTA - Office of Technology Assessment OTIR- Office of Technology and Industrial Relations PA - Program Announcement PDB - Protein Data Bank PFGRC - Pathogen Functional Genomics Resource Center PSAC - Presidents Science Advisory Committee PSI - Protein Structure Initiative RAID - Rapid Access to Intervention Development RFA - Request for Applications RTLA - Reach Through License Agreements SBIR - Small Business Innovation Research SDI - Strategic Defense Initiative SEP - Special Emphasis Panels SNP - Single Nucleotide Polymorphisms SPORE - Specialized Programs of Research Excellence SSC - Superconducting Super Collider STC - Science and Technology Centers STTR - Small Business Technology Transfer TIGR - The Institute for Genomic Research UIP - Unconventional Innovations Program URA - Universities Research Association USDA - United States Department of Agriculture VA - Department of Veterans Affairs VRC - Vaccine Research Center WHI - Women's Health Initiative Xl i

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Contents EXECUTIVE SUMMARY 1 INTRODUCTION The National Cancer Policy Board, 15 2 DEFINING "LARGE-SCALE SCIENCE" IN BIOMEDICAL RESEARCH Examples of potential large-scale biomedical research projects, 20 Genomics, 21 Structural Biology and Proteomics, 22 Bioinformatics, 23 Diagnostics and Biomarker Research, 23 Patient Databases and Specimen Banks, 24 Potential obstacles to undertaking large-scale biomedical research projects, 24 Determining Appropriate Funding Mechanisms and Allocation of Funds, 24 Organization and Management, 25 Personnel Issues, 26 Information Sharing and Intellectual Property Concerns, 27 Summary, 28 3 MODELS OF LARGE-SCALE SCIENCE The Human Genome Project, 31 Past examples of large-scale projects funded by NCI, 40 Cancer Chemotherapy Program, 41 x''' 1 12 17 29

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XIV Chemical Carcinogenesis Program, 43 Cancer Virus Program, 44 Recently developed large-scale projects at NCI, 45 The Cancer Genome Anatomy Project, 45 Early Detection Research Network, 47 Unconventional Innovations Program, 48 Mouse Models of Human Cancers Consortium, 50 Specialized Programs of Research Excellence, 52 The Molecular Targets Laboratory, 53 Recent examples from other branches of NIH, 54 NIGMS Glue Grants, 54 NIGMS Protein Structure Initiative, 57 The Pathogen Functional Genomics Resource Center, 61 The Women's Health Initiative, 62 Vaccine research, 64 National Science Foundation's Science and Technology Centers Program, 65 The SNP Consortium, 67 Human Proteome Organization, 70 Howard Hughes Medical Institute, 71 Synchrotron resources at the National Laboratories, 73 Defense Advanced Research Projects Agency, 74 Summary, 77 4 FUNDING FOR LARGE-SCALE SCIENCE History of federal support for scientific research, 82 Allocation of federal funds for scientific research, 83 NIH funding, 94 Congressional Appropriations to NIH, 95 NIH Peer Review of Funding Applications, 105 Funding Mechanisms for Extramural Research and Solicitation of NIH Grant Applications, 109 Nonfederal funding of large-scale biomedical research projects, 115 Industry Funding of Large-Scale Biomedical Research, 116 Nonprofit Funding of Large-Scale Biomedical Research, 123 Issues associated with international collaborations, 125 Summary, 126 5 ORGANIZATION AND MANAGEMENT OF LARGE- SCALE BIOMEDICAL RESEARCH PROJECTS Examples of management assessment for large-scale projects, 131 CONTENTS 80 130

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CONTENTS Assessment of Federally Funded Laboratories, 131 Evaluation of the National Science Foundation's Science and Technology Centers Program, 132 Special considerations for the management of large-scale biomedical research projects, 133 The industry model of project management: comparison with academia, 136 Summary, 138 6 TRAINING AND CAREER STRUCTURES IN BIOMEDICAL RESEARCH The traditional academic training and career structure in biomedical science, 143 Overview of trends in the bioscience workforce, 148 Ph.D. Scientists, 148 M.D. Scientists, 155 Potential impact of large-scale research on biomedical training and career structures, 157 Summary, 160 7 INTELLECTUAL PROPERTY AND ACCESS TO RESEARCH TOOLS AND DATA Nonexclusive and exclusive licensing, 167 Reach-through license agreements, 169 Research exemptions, 170 Patent pools, 172 University policies and technology transfer offices, 174 Examples of intellectual property and data sharing issues associated with large-scale projects, 176 Genomics and DNA Patents, 176 Protein Patents, 181 Databases, 182 Patient confidentiality and consent, 183 Effects of intellectual property claims on the sharing of data and research tools, 184 Summary, 190 8 FINDINGS AND RECOMMENDATIONS REFERENCES APPENDIX INDEX xv 140 162 192 202 213 269

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