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Committee on Large-Scale Science and Cancer Research
Sharyl J. Nass and Bruce W. Stillman,
Editors
National Cancer Policy Board
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
and
Division on Earth and Life Studies
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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2003 National Academy of Sciences. All rights reserved.
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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
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Copyright 2003 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
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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.
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of the National Academy of Sciences, as a parallel organization of outstanding
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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.
The Institute of Medicine was established in 1970 by the National Academy of
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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.
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iv
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
*JILL 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 J. 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
*JOHN MENDELSOHN, M.D. President, University of Texas, M.D.
Anderson Cancer Center, Houston, TX
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2003 National Academy of Sciences. All rights reserved.
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v
*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, NJ
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, NJ
*THOMAS J. 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 J. NASS, Ph.D. Study Director
ROGER HERDMAN, M.D. Director, National Cancer Policy Board
MARYJOY 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.
Copyright ©
2003 National Academy of Sciences. All rights reserved.
Unless otherwise indicated, all materials in this PDF File provided by the National Academies Press (www.nap.edu) for research
purposes are copyrighted by the National Academy of Sciences. Distribution, posting, or copying is strictly prohibited without
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vi
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 J. 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. Gilman, 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.
Copyright ©
2003 National Academy of Sciences. All rights reserved.
Unless otherwise indicated, all materials in this PDF File provided by the National Academies Press (www.nap.edu) for research
purposes are copyrighted by the National Academy of Sciences. Distribution, posting, or copying is strictly prohibited without
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vii
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, John Carney,
Robert Cook-Deegan, Carol Dahl, James Deatherage, Joseph DeRisi, Marie
Freire, Jack Gibbons, John Gohagan, Eric Green, Judith Greenberg, Ed-
ward Hackett, Edward Harlow, Nathaniel Heintz, David Hirsh, Nancy
Hopkins, James Jensen, Marvin Kalt, Richard Klausner, William Koster,
Rolph Leming, Joan 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.
Acknowledgments
Copyright ©
2003 National Academy of Sciences. All rights reserved.
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2003 National Academy of Sciences. All rights reserved.
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ix
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
DTP – Developmental Therapeutics Program
EDRN – The Early Detection Research Network
EPA – Environmental Protection Agency
EST – Expressed Sequence Tag
Acronyms
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2003 National Academy of Sciences. All rights reserved.
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x ACRONYMS
FDA – Food and Drug Administration
GPRA – Government Performance and Results Act
HGP – 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
JCSG – Joint Center for Structure Genomics
MBL – Marine Biology Laboratory
MMHCC – Mouse Models of Human Cancers Consortium
MOU – Memoranda of Understanding
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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[...]... 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 LARGESCALE BIOMEDICAL RESEARCH PROJECTS Examples of management assessment for large-scale projects, 131 80 130 Copyright... as research tools may offer the greatest challenge in this regard because it is difficult to predict the future applications and value of a particular tool, and because a number of different tools may be needed for a single research project Since many large-scale projects in the biosciences aim to produce data and other tools for future research, this subject is especially salient for large-scale research. .. field of biomedical research is adapting to the inclusion of large-scale projects • Identify obstacles to the implementation of large-scale projects in cancer research • Provide policy recommendations for improving the process for conducting large-scale projects in cancer research should they be undertaken in the future This report is organized as follows Chapter 2 develops a working definition of large-scale. .. Associated with Large-Scale Projects Potential Paths to Solutions No systematic method for assessing large-scale biomedical research opportunities exists Develop an NIH-wide mechanism for soliciting and reviewing proposals for large-scale projects, with input from all relevant sectors of biomedical science Carefully planning and orchestrating the launch as well as the phase out of a large-scale project... staff for large-scale projects, and for recognizing and rewarding scientific collaborations and team-building efforts • Funding agencies should develop appropriate career paths for individuals who serve as program managers for the large-scale projects they fund • Academic institutions should develop appropriate career paths, including suitable criteria for performance evaluation and promotion, for those... 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. .. accomplished through a large-scale science venture in biology But is this the best or only way to take on future large-scale biomedical research? There are other strategies for funding and organizing such projects, some of which have never been used in biology but have worked well in other scientific fields Because the concept of large-scale science is relatively new to the field of biomedical research, and... large-scale science” with respect to cancer research; (2) identify examples of ongoing large-scale projects to determine the current state of the field; (3) identify obstacles to the implementation of largescale projects in biomedical research; and (4) make recommendations for improving the process for conducting large-scale biomedical science projects, should such projects be undertaken in the future. .. initiation and phase-out of a large-scale project Careful assessment of past and current large-scale projects to identify best practices and determine whether the large-scale approach adds value to the traditional models of research would also provide highly useful information for future endeavors Recommendation 1: NIH and other federal funding agencies that support large-scale biomedical science (including... research • Examine the current state of large-scale science in biomedical research (what is being done and how) • Examine other potential models of large-scale biomedical research Copyright © 2003 National Academy of Sciences All rights reserved Unless otherwise indicated, all materials in this PDF File provided by the National Academies Press (www.nap.edu) for research purposes are copyrighted by the . 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. Policy Board, 15
2 DEFINING LARGE-SCALE SCIENCE” IN BIOMEDICAL
RESEARCH 17
Examples of potential large-scale biomedical research
projects, 20
Genomics,
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