STRATEGIES TO LEVERAGE RESEARCH FUNDING
Guiding DOD’s Peer Reviewed Medical Research Programs
Michael McGeary and Kathi E. Hanna, Editors
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
THE NATIONAL ACADEMIES PRESS
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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 No. W81XWH-04-C-0077 between the National Academy of Sciences and the U.S. Department of Defense. 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.
Library of Congress Cataloging-in-Publication Data
Strategies to leverage research funding : guiding DOD's peer reviewed medical research programs / Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs, Medical Follow-Up Agency and Board on Health Sciences Policy ; Michael McGeary and Kathi E. Hanna, editors.
p. ; cm.
Includes bibliographical references.
ISBN 0-309-09277-9 (pbk.)
1. Medicine—Research—United States—Finance. 2. United States. Dept. of Defense. [DNLM: 1. United States. Dept. of Defense. 2. Biomedical Research—economics—United States. 3. Research Support—methods—United States. W 20.5 S8986 2004] I. McGeary, Michael G. H. II. Hanna, Kathi E. III. Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs.
R854.U5S754 2004
362.1072073—dc22
2004022342
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COMMITTEE ON ALTERNATIVE FUNDING STRATGIES FOR DOD’S PEER REVIEWED MEDICAL RESEARCH PROGRAMS
Joseph S. Pagano, Chair, Lineberger Professor of Cancer Research and Director Emeritus,
Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine
Samuel Broder, Executive Vice President,
Celera Genomics, Rockville, Maryland (member until May 25, 2004)
Eric G. Campbell, Assistant Professor,
Institute for Health Policy, Department of Medicine, Massachusetts General Hospital, Harvard Medical School
Thomas C. Caskey, President and Chief Executive Officer,
Cogene Biotech Ventures, Ltd., Houston, Texas
Robert Cook-Deegan, Director,
Center for Genome Ethics, Law, and Policy, Institute for Genome Sciences and Policy, Duke University
Maryann Feldman, Chair,
Technical Innovation and Entrepreneurship and
Professor of Business Economics,
Rotman School of Management, University of Toronto
MaryAnn Guerra, Vice President,
Research Operations, Translational Genomics Research Institute, Phoenix, Arizona
Musa Mayer, Consumer and Author,
New York
Frank E. Samuel, Jr., Science and Technology Advisor to Governor of Ohio
Project Staff
Michael McGeary, Study Director,
Medical Follow-Up Agency
Reine Y. Homawoo, Senior Program Assistant,
Medical Follow-Up Agency
David Butler, Senior Program Officer,
Board on Health Promotion and Disease Prevention (July 2004)
Jennifer Pinkerman, Research Associate,
Medical Follow-Up Agency (through May 2004)
Susan McCutchen, Research Associate,
Division of Behavioral and Social Sciences and Education (June 2004)
Kathi E. Hanna, Consultant
Sara Davidson Maddox, Editor
IOM Staff
Frederick (Rick) Erdtmann, Director,
Medical Follow-Up Agency
Andrew Pope, Director,
Board on Health Sciences Policy
Pamela Ramey-McCray, Administrative Assistant,
Medical Follow-Up Agency
Andrea Cohen, Financial Associate
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:
Irwin Feller
Emeritus Professor of Economics
Institute for Policy Research and Evaluation
Pennsylvania State University
Mauro Ferrari
Ohio State University
National Cancer Institute
Mark Frankel
Program Director
American Association for the Advancement of Science
Hedvig Hricak
Chair, Department of Radiology
Memorial Sloan-Kettering Cancer Center
Jerald Sadoff
Chief Executive Officer
Aeras Global TB Vaccine Foundation
Richard L. Sprott
Executive Director
Ellison Medical Foundation
Thomas P. Stossel
American Cancer Society Professor of Medicine
Harvard Medical School
Palmer W. Taylor
Sandra & Monroe Trout Professor of Pharmacology
Dean, School of Pharmacy & Pharmaceutical Sciences
University of California, San Diego
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Robert A. Frosch and Peter M. Howley. Appointed by the National Research Council and Institute of Medicine, respectively, they were 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.
Preface
In 1992, in response to efforts of breast cancer survivors to direct more funding to understanding breast cancer and new and better ways to treat it, the U.S. Congress inserted a line-item in the fiscal year (FY) 1993 appropriation for the Department of Defense (DOD) that provided $210 million for peer-reviewed research on breast cancer. The U.S. Army Medical Research and Material Command implemented the congressional mandate by establishing the Breast Cancer Research Program (BCRP). Congress has not only continued to insert a line-item in the DOD budget each year for BCRP, it has added line-items for research on neurofibromatosis (FY 1996), prostate cancer (FY 1997), ovarian cancer (FY 1997), chronic myelogenous leukemia (FY 2002), tuberous sclerosis (FY 2002), and prion diseases (transmissible spongiform encephalopathies) (FY 2002). In addition, in FY 1999, Congress established a program of peer-reviewed research on military service-related topics, such as laser eye injury and trauma care.
Collectively, these mandated activities are known as the Department of Defense Congressionally Directed Medical Research Programs (CDMRP). In recent years, CDMRP appropriations have totaled more than $350 million and funded more than 700 new awards annually to investigators in university, nonprofit research institutes, and in industrial, state government, and federal laboratories throughout the United States.
CDMRP is distinguished by its emphasis on innovation, especially in translational research, achieved primarily by supporting new ideas and bringing in new investigators. CDMRP uses a peer review system recommended by a 1993 Institute of Medicine (IOM) report that was modeled after the National Institutes of Health (NIH) system, but with a notable addition, the participation—not just
representation—of patient advocates, then unprecedented and still unusual in government research programs. The peer review system is two-tiered, first reviewing research proposals for scientific quality, then reviewing them for programmatic relevance. Consumer advocates serve on both the first and the second-tier panels. CDMRP’s performance has met with the approval of scientists, the satisfaction of legislators and their constituents, pride on the part of the program’s administrators, and results.
In 1992, DOD was downsizing in response to the end of the Cold War, and it was relatively easy to find room in the DOD budget for a program meeting an urgent public need. Today, in the aftermath of the September 11, 2001, terrorist attack, DOD’s budget situation is different. DOD’s mission has expanded to fight wars in Afghanistan and Iraq and maintain the peace in other hot spots around the world, and the demands on the DOD budget have escalated. There is heavy downward pressure on the other activities of DOD, including CDMRP, which had a budget of more than $390 million as recently as FY 2002.
At the direction of Congress, DOD asked the Institute of Medicine to conduct a study exploring the possibility of attracting nonfederal funds to augment CDMRP’s appropriated funds. The IOM appointed a committee to identify sources and means of nonfederal funding that could augment CDMRP’s resources and strengthen it through creative partnering.
The Committee was well aware of the larger context for biomedical research support, in which tight budgets not only affect CDMRP but also the largest source of public funds, the National Institutes of Health. Importantly, the charge was not to evaluate CDMRP or recommend whether it should be maintained, curtailed, or phased out nor to consider other sources of federal co-funding, such as NIH. Rather the task given was to assess the potential for leveraging nonfederal resources to achieve the goals of CDMRP.
Members of the Committee sought to identify some innovative collaborative funding arrangements that CDMRP could use and that also could serve as models for other federal agencies and searched for imaginative solutions. For example, the Committee reviewed a variety of examples of innovative public-private cost sharing, partnerships, and other joint ventures in support of research and development (R&D), not only involving federal agencies, but also state and international agencies (examples are briefly described in Appendix A). A two-day workshop with presentations from representatives of nonfederal funding sources—including foundations, voluntary health agencies, universities, state research and economic development agencies, industry and venture capital—as well as of exemplary public-private research collaborations—was most informative and set the bases for models and sources that the Committee might realistically recommend (the workshop agenda is in Appendix C). Also, the Committee commissioned a paper reviewing economic studies of public-private collaboration in R&D and looked at the literature on the uses of cost-sharing and matching to augment federal research budgets (the paper is in Appendix D).
The report that follows assesses the extent of nonfederal sources of funding for research and details a variety of opportunities for leveraging nonfederal funding from the numerous sources examined. There are many examples in which the coordination of effort or the pooling of resources, or both, have leveraged research results that could not have been achieved otherwise. At the same time, the report is realistic about the extent to which these joint efforts are likely to generate a significant amount of additional resources for CDMRP.
The Committee would like to thank the many individuals and organizations that provided information and expert judgment, especially those who participated in the workshop on short notice. They and their organizational affiliations are listed in the agenda for the workshop (Appendix C). Several organizations submitted statements which were carefully considered by the committee—the Amyotrophic Lateral Sclerosis Association on April 27, 2004, during the public statement period of the workshop, and the National Coalition for Osteoporosis and Related Bone Diseases on May 20, 2004, by letter. Others who assisted were Greg Downing, National Cancer Institute; Neil Buckholtz and Susan Molchan, National Institute on Aging; James Schuttinga and Karen Pla, Office of the NIH Director; John Lowe and Kelly Robbins of the Henry M. Jackson Foundation for the Advancement of Military Medicine; Geoffrey Frisch of the Centers for Disease Control Foundation; and John Moore, CDC. The CDMRP staff was most helpful, including the director, Col. Kenneth Bertram, M.D., Ph.D., deputy director, Lt. Col. Calvin Carpenter, and several program directors, including Patricia Modrow, Ph.D., Leo Giambarresi, Ph.D., and Richard H. Kenyon, Ph.D.
I would like to thank the members of the Committee, who took on this assignment on short notice and attended three meetings and the workshop in a compressed time frame. The mix of expertise and experience was stimulating and well suited for the task. We learned from each other and came to know and regard well this significant biomedical research enterprise of the Department of Defense.
Finally, I would like to thank the study staff for the superb job they did at all levels despite the constraints imposed by a six-month deadline.
Joseph S. Pagano, M.D.
Chair
Figures, Tables, and Boxes
FIGURES
1-1 |
CDMRP budget and program planning and execution cycle, |
|||
1-2 |
Distribution of extramural award funding among types of research support, FY 2002, |
|||
1-3 |
Distribution of extramural award funding among areas of research, FY 2002 (in percentages), |
|||
2-1 |
Foundation grant dollars by purpose, 2002, |
TABLES
1-1 |
CDMRP Award Results, FY 1993-FY 2003, |
|||
1-2 |
Funding History of CDMRP Core Programs (in millions of dollars), |
|||
2-1 |
Federal Obligations for Health R&D by Source, FY 1997-FY 1999 (in millions of dollars), |
|||
2-2 |
Expenditures for Biomedical and Behavioral R&D at Universities and Colleges, FY 2001 (in thousands of dollars), |
|||
2-3 |
The 12 Largest VHAs in Research Grant Expenditures, FY 2002, |
|||
3-1 |
Typology of Federal/Nonfederal Funding Arrangements, |
BOXES
1-1 |
CDMRP Core Programs, |
|||
2-1 |
The CDC Foundation, |
|||
2-2 |
The Juvenile Diabetes Research Foundation International, |
|||
2-3 |
Example of State-Funded Biotechnology Development: North Carolina Biotechnology Center, |
|||
2-4 |
Example of State-Funded Medical Research: Ohio’s Third Frontier Project, |
|||
4-1 |
Avon Foundation-NCI “Progress for Patients” Awards Program, |
|||
4-2 |
FNIH, |
|||
4-3 |
Example of a TIA, |
|||
D-1 |
Examples and Objectives of “Social Venture Capital” in International Health, |
Abbreviations and Acronyms
AAFRC
American Association of Fundraising Counsel
ABC2
Accelerate Brain Cancer Cure
ABCC
administrative and bioinformatics coordinating center
ACCP
Alliance for Cervical Cancer Prevention
AD
Alzheimer’s disease
ADA
American Diabetes Association
ADNI
Alzheimer’s Disease Neuroimaging Initiative
AHA
American Heart Association
AICR
American Institute for Cancer Research
ALS
amyotrophic lateral sclerosis
AP4
Academic Public-Private Partnership Program
ARL
Army Research Laboratory
ARMF
Applied Research Matching Fund
ATP
Advanced Technology Program
AUTM
Association of University Technology Managers
BCRP
Breast Cancer Research Program
BIO
Biotechnology Industry Organization
BRCAl
breast cancer 1 gene
Bt
Bacillus thuringiensis
CAD
Canadian dollar
CAL-(IT)2
California Institute for Telecommunications and Information Technology
CBCRP
California Breast Cancer Research Program
CDC
Centers for Disease Control and Prevention
CDMRP
Congressionally Directed Medical Research Programs
CF
cystic fibrosis
CFF
Cystic Fibrosis Foundation
CFFT
Cystic Fibrosis Foundation Therapeutics, Inc.
CIA
Central Intelligence Agency
CIHR
Canadian Institutes of Health Research
CITRIS
Center for Information Technology Research in the Interest of Society
CMLRP
Chronic Myelogenous Leukemia Research Program
CNSI
California Nanosystems Institute
CRADA
Cooperative Research and Development Agreement
CSI
Congressional Special Interest
CSO
Common Scientific Outline
DARPA
Defense Advanced Research Projects Agency
DCA
Defense Cooperation Account
DFID
Department for International Development
DHHS
Department of Health and Human Services
DNA
deoxyribonucleic acid
DOD
Department of Defense
DOE
Department of Energy
DTI
Department of Trade and Industry
DUS&T
Dual Use Science and Technology (DUS&T) Program
EMBRAPA
Brazilian Agricultural Research Corporation (Empresa Brasileira de Pesquisa Agropecuária)
EPA
Environmental Protection Agency
ERC
Engineering Research Center
FDA
Food and Drug Administration
FNIH
Foundation for the National Institutes of Health
FY
fiscal year
GC
Genome Canada
GICUR
Government/Industry Co-sponsorship of University Research Program
GUIRR
Government-University-Industry Research Roundtable
HEFCE
Higher Education Funding Council of England
HEI
Health Effects Institute
HER2
Human Epidermal Growth Factor Receptor 2
HHMI
Howard Hughes Medical Institute
HIPAA
Health Insurance Portability and Accountability Act
HTP
Human Transcriptome Project
IAVI
International AIDS Vaccine Initiative
ICR
Islet Cell Resource Center
IDEA
Innovative Developmental and Exploratory Awards
IOM
Institute of Medicine
IP
intellectual property
ISS
International Space Station
ITN
Immune Tolerance Network
I/UCRC
Industry/University Cooperative Research Centers Program
IUCRP
Industry-University Cooperative Research Program
JDRF
Juvenile Diabetes Research Foundation International
JIF
Joint Infrastructure Fund
KTEC
Kansas Technology Enterprise Corporation
LLNL
Lawrence Livermore National Laboratory
MARCO
Microelectronics Advanced Research Corporation
MDA
Muscular Dystrophy Association
MDCRC
Muscular Dystrophy Cooperative Research Center Program
MIM
Multilateral Initiative on Malaria
MMV
Medicines for Malaria Venture
MRSEC
Materials Research Science and Engineering Centers Program
MSC
Mouse Sequencing Consortium
MTA-CRADA
material transfer agreement CRADA
NASA
National Aeronautics and Space Administration
NBCC
National Breast Cancer Coalition
NCBC
North Carolina Biotechnology Center
NCI
National Cancer Institute
NCRA
National Cooperative Research Act
NCRR
National Center for Research Resources
NEI
National Eye Institute
NF
neurofibromatosis
NFRP
Neurofibromatosis Research Program
NGA
National Governors Association
NGO
nongovernmental organization
NHGRI
National Human Genome Research Institute
NHLBI
National Heart, Lung, and Blood Institute
NIA
National Institute on Aging
NIAID
National Institute of Allergy and Infectious Diseases
NIAMS
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NICHD
National Institute of Child Health and Human Development
NCRR
National Center for Research Resources
NIDCR
National Institute of Dental and Craniofacial Research
NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases
NIEHS
National Institute of Environmental Health Sciences
NIH
National Institutes of Health
NIMH
National Institute of Mental Health
NINDS
National Institute of Neurological Disorders and Stroke
NINR
National Institute of Nursing Research
NIST
National Institute of Standards and Technology
NSB
National Science Board
NSEC
Nanoscale Science and Engineering Centers Program
NSF
National Science Foundation
NVCA
National Venture Capital Association
OAI
Osteoarthritis Initiative
OCRP
Ovarian Cancer Research Program
OIG
Office of Inspector General
OIT
Ontario Innovation Trust
OMB
Office of Management and Budget
ORDCF
Ontario Research and Development Challenge Fund
ORMH
Office of Research on Minority Health
ORWH
Office of Research on Women’s Health
OST
Office of Science and Technology
PCRP
Prostate Cancer Research Program
PFI
Partnerships for Innovation
PhRMA
Pharmaceutical Research and Manufacturers of America
PPP
public-private partnership
PRMRP
Peer Reviewed Medical Research Program
QB3
California Institute for Bioengineering, Biotechnology, and Quantitative Biomedical Research
R!A
Research!America
R&D
research and development
RAD
Research Area Directorate
RFA
Request for Applications
RFP
Request for Proposals
RJV
research joint venture
SARS
Severe Acute Respiratory Syndrome
SBIR
Small Business Innovation Research Program
SEMATECH
Semiconductor Manufacturing Technology Consortium
SGC
Structural Genomics Consortium
SPD
Space Partnership Development
SPORE
Specialized Programs of Research Excellence
SRIF
Science Research Investment Fund
SSTI
State Science and Technology Institute
STAR
Strategic Technology and Research Fund
STC
Science and Technology Center
STTR
Small Business Technology Transfer Program
T1DGC
International Type 1 Diabetes Genetics Consortium
TATRC
Telemedicine and Advanced Technology Research Center
TB
tuberculosis
TCRF
Technology Commercialization Research Fund
TDN
Therapeutic Development Network
TEDDY
Triggers and Environmental Determinants of Diabetes in Youth
TGEN
Translational Genomics Research Institute
TIA
Technology Investment Agreement
TMM
Technologies for Metabolic Monitoring
TOBI
tobramycin solution for inhalation
TSCRP
Tuberous Sclerosis Complex Research Program
UC
University of California
UK
United Kingdom
U.S.
United States
USAMRDC U.S.
Army Medical Research and Development Command
USAMRMC U.S.
Army Medical Research and Materiel Command
USDA U.S.
Department of Agriculture
VA
Department of Veterans Affairs
VHAs
voluntary health agencies
WHO
World Health Organization