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L;
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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-
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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
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and research, and recognizes the superior achievements of engineers. Dr. Wm. A.
Wulf is president of the National Academy of Engineering.
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The National Research Council was organized by the National Academy of Sci-
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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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