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Selected Federal Programs with Nonfederal Funding Participation1

DEPARTMENT OF DEFENSE (DOD)

Dual Use Science and Technology (DUS&T) Program

www.dtic.mil/dust/index.htm

DUS&T is a program with high visibility with Congress that generates applied or advanced technology projects through the creation and/or development of new products or process technologies that benefit the military. The applicant must be a for-profit company or have at least one for-profit firm on its team, and it must bear at least 50 percent of the cost of the effort (required by the fiscal year [FY] 1998 Defense Authorization Act), of which at least half must be “high quality”—that is, cash, labor or consumable materials. DOD funding contributions for approved projects are 25 percent from the Office of Undersecretary of Defense, and 25 percent from the service organization proposing the topic. Funding for the program was $40 million in FY 2002 (financed by a tax on all 6.1–6.3 research funds), $15.9 million in FY 2003, and $14.2 million in FY 2004; the request for FY 2005 is $5.2 million.

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Please note that the descriptions of these examples of collaborative funding of research are based on and often quoted directly from the websites that are cited in each case.



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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs A Selected Federal Programs with Nonfederal Funding Participation1 DEPARTMENT OF DEFENSE (DOD) Dual Use Science and Technology (DUS&T) Program www.dtic.mil/dust/index.htm DUS&T is a program with high visibility with Congress that generates applied or advanced technology projects through the creation and/or development of new products or process technologies that benefit the military. The applicant must be a for-profit company or have at least one for-profit firm on its team, and it must bear at least 50 percent of the cost of the effort (required by the fiscal year [FY] 1998 Defense Authorization Act), of which at least half must be “high quality”—that is, cash, labor or consumable materials. DOD funding contributions for approved projects are 25 percent from the Office of Undersecretary of Defense, and 25 percent from the service organization proposing the topic. Funding for the program was $40 million in FY 2002 (financed by a tax on all 6.1–6.3 research funds), $15.9 million in FY 2003, and $14.2 million in FY 2004; the request for FY 2005 is $5.2 million. 1   Please note that the descriptions of these examples of collaborative funding of research are based on and often quoted directly from the websites that are cited in each case.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Government/Industry Co-sponsorship of University Research (GICUR) Program www.acq.osd.mil/ddre/research/getinvolved.html GICUR fosters cooperative, long-term basic research by universities with industry and/or government laboratories in research areas vital to the advancement of technologies important to DOD. Industry and government share responsibility for research area selection and overall direction as well as funding. For example, in cooperation with the Microelectronics Advanced Research Corporation (MARCO), the Semiconductor Electronics Microelectronics project funds four universities (University of California [UC] at Berkeley, Georgia Institute of Technology, Massachusetts Institute of Technology, and Carnegie Mellon) that in turn lead coordinated research efforts on particular topics by consortias of institutions. Under MARCO, the electronics industry provides at least three dollars for each dollar provided by DOD. Federal funding has averaged approximately $7 million a year since FY 1998. Technology Investment Agreements (TIAs) www.acq.osd.mil/dpap/Docs/RandD%20Text.doc TIAs, authorized by 10 U.S.C. 2371, enable DOD to enter into research agreements other than grants and cooperative agreements. They permit the government to exercise greater flexibility and judgment to achieve program goals because they are not subject to many of the regulatory requirements (most notably, the Baye-Dole Act patent provision) of standard federal grants and cooperative agreements that deter some companies from partnering with the government. Cost sharing of at least half of the project costs is required, however. According to DODs Grant and Agreement Regulations (section 37.215), “The purpose of cost share is to ensure that the recipient incurs real risk that gives it a vested interest in theproject’s success.” TIAs also require “a greater level of involvement of the government program officials in the execution of the research than the usual oversight of a research grant or procurement contract.” Twenty-eight TIAs and cooperative agreements were entered into in FY 2001, with industry paying for 46 percent of the total costs of $114 million (www.acq.osd.mil/dpap/Docs/FY01RPT.doc). For example, in 2000 DARPA entered into a TIA with Motorola, Inc. for an 18-month effort to develop a multichip module sample preparation system for genetic analysis. DOD wanted access to Motorola’s technology, but Motorola does not accept standard government research contracts. Use of the TIA permitted the company to use its existing accounting systems, which were not compliant with FAR, and to negotiate other rights important to Motorola, including alternate disputes resolution procedures, intellectual property rights less stringent than the Bayh-Dole provision, and foreign access to technology. In return, Motorola paid for $1.5 million of the $4.9 million cost of the project.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Thin-Film Photovoltaics Partnerships Program www.nrel.gov/business_opportunities/pdfs/4_44205_loi.pdf The Thin-Film Photovoltaics Partnerships Program is a competitive grant program intended to accelerate the progress of thin film solar cells and module development as well as to address mid- and long-term research and development issues. Cost sharing of up to 50 percent is expected from industry, depending on size of company and type of participation. Cost sharing must be all cash; in-kind is not accepted. The applicant’s level of cost sharing is a factor in the cost evaluation of proposals, in addition to technical merit. No cost sharing is required from academic institutions. Technologies for Metabolic Monitoring and Julia Weaver Fund Research Program www.momrp.org/tmm.jsp The Technologies for Metabolic Monitoring (TMM) and Julia Weaver Fund (JWF) Research Program is a collaborative initiative between the U.S. Army Medical Research and Materiel Command, Juvenile Diabetes Research Foundation (JDRF), NASA, and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Its goal is to unite metabolic monitoring technologies for the military and civilians, align these with the needs of the two populations, and ultimately improve the quality and range of metabolic monitoring technologies available to all. Funding focuses on supporting and assisting in the identification and maturation of potential new, novel, and innovative technologies and techniques for the monitoring and assessment of metabolism, especially those that may apply to the care and long-term health maintenance of diabetic patients. The collaborating entities participate in an advisory group for the research program. TMM/JWF is congressionally supported and secured a total of $9.3 million in federal appropriations through FY 2003. The FY 2004 program announcement anticipated a total of $3 million in awards DEPARTMENT OF ENERGY (DOE) Fusion Science Centers www.sc.doe.gov/grants/Fr03-26.html In 2003, the Office of Fusion Energy Sciences in DOE’s Office of Science issued a notice inviting grant applications for fusion science centers that focus on fundamental issues in fusion plasma science. The University of Maryland/ University of California at Los Angeles and the University of Rochester were selected to host the centers in May, 2004. The duration of the grants is five years and may be renewed once for another five years. Total funding for the two centers

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs over the initial five-year grant is expected to be nearly $12 million. The host institution is required to provide at least 15 percent matching funds for the center. NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA) Research Partnership Centers spd.nasa.gov/research_centers.html The Space Partnership Development (SPD) Office, part of NASA’s Office of Biological and Physical Research, exists to enable industry to conduct research and develop products on the International Space Station (ISS) and other NASA space and ground missions. One component of the SPD is a program with 15 research partnership centers, each working with companies, universities, and other organizations in a specific field of research. Each center is a consortium of academia, government, and industry partnering to develop new or improved services and products, usually through collaborative research conducted in outer space. NASA provides an annual base grant and the centers receive cash and in-kind contributions from industry, universities, research institutions, and other governmental agencies (federal, state, and local). In FY 2002, the ratio of non-NASA to SPD funding was 2.15:1. The centers received $33.1 million from industry and $30.6 million from other sources, with $29.6 million from SPD and $4.3 million from other NASA centers. Of the total of $63.7 million in nonfederal funding, $33.0 million was cash and the rest was in-kind. NATIONAL INSTITUTES OF HEALTH (NIH) Academic Public Private Partnership Program (AP4) dtp.nci.nih.gov/docs/ap4/handbook/index.html Modeled after the Industry/University Cooperative Research Center Program of the National Science Foundation, AP4 is a partnership initiative whose goal is to conduct novel cancer therapeutic, prevention, diagnostic, and imaging research to hasten the translation of research findings into clinical trials. The research occurs at an academic center with the advice and support of industry, nonprofit institutes, government partners, and the National Cancer Institute (NCI). Formed by NCI through its Developmental Therapeutics Program in the Division of Cancer Treatment and Diagnosis, the effort was initiated in July 2003 through the mechanism of inviting applications for one-year planning grants. Planning grant applicants are expected to utilize the funds to study the feasibility of developing the pharmaceutical/non-profit/academic interactions necessary to establish and support an AP4 Center, and to actually prepare the application. NCI intends to

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs use approximately $1.124 million in FY 2004 appropriations to fund up to 15 planning grants. Alzheimer’s Disease Neuroimaging Initiative (ADNI) grants.nih.gov/grants/guide/rfa-files/RFA-AG-04-005.html www.fnih.org/images/Prelim2003ar.pdf This public-private partnership initiative will develop a multisite, longitudinal, prospective, naturalistic study of normal cognitive aging, mild cognitive impairment, and early Alzheimer’s disease as a public domain research resource. A primary goal of ADNI is to identify the biomarkers of disease progression that are most promising for use as surrogate endpoints in clinical trials. ADNI was established by an RFA issued by the National Institute on Aging (NIA) in October 2003. Other partners involved in the consortium include academic investigators, the Food and Drug Administration, the Alzheimer’s Association, the Institute for the Study of Aging, and participating pharmaceutical and medical imaging companies. The companies that contribute funds will be on the steering committee for the project, but they will not have special privileges, such as early access to the data. The clinical, imaging, and biological data will be made available, with appropriate safeguards to ensure participant privacy, to all scientific investigators in the academic and industrial research communities. Biological samples of blood and cerebrospinal fluid will be equitably distributed to qualified scientists, based on the quality and significance of proposed studies for them. Cell lines will also be established for distribution to qualified scientists. One U01 cooperative agreement award will be made to the successful applicant, which will support the other parts of ADNI—including the coordinating center, the neuroimaging center, and the clinical sites—through subcontracts. The plan is to spend $60 million on the initiative over five years, with approximately $40 million coming from NIA and $20 million from pharmaceutical and medical imaging companies. Private-sector funding for the initiative is arranged through the Foundation for the NIH (FNIH) (because NIH staff cannot solicit funds from private companies), which will accept monies and transfer them to the institute to help pay for the program. Eli Lilly and Company has pledged $2.5 million over five years and FNIH is discussing pledges with additional companies. Animal Models of Diabetic Complications Consortium www.amdcc.org Established in late 2001, the intent of this initiative is to assemble a cross-disciplinary consortium to develop innovative animal models that closely mimic the human complications of diabetes. The consortium will consist of eight mouse engineering and phenotyping units from different institutions and a coordinating

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs and bioinformatics unit. The administrative and funding instrument to be used for this program will be a cooperative agreement as set out in an RFA involving the National Institute of Diabetes and Digestive and Kidney Diseases, the National Heart, Lung, and Blood Institute (NHLBI), the National Eye Institute, the National Institute of Dental and Craniofacial Research (NIDCR), and the JDRF. NIH intended to commit approximately $4.5 million in FY 2001 to fund up to five or six of the former and to fund the latter as well. JDRF intended to commit up to $500,000 to this program. Best Pharmaceuticals for Children www.fda.gov/opacom/laws/pharmkids/contents.html The Best Pharmaceuticals for Children Act of 2002 called for FNIH (www.fnih.org/aboutus/board.shtml) to raise funds to enable testing of drugs that are approved for adult use and used off-label to treat children but have not been tested for treatment of children for safety and efficacy. The public-private collaborative subsequently created is headed by a 15-member advisory committee representing patient groups and the American Academy of Pediatrics. Contributors include AstraZeneca LP, Aventis Pharmaceuticals Inc., Boehringer Ingelheim Cares Foundation, Inc., Dr. and Mrs. Samuel E. Broder, Eli Lilly and Company Foundation, Novartis Pharmaceuticals Corporation, Pfizer Inc., Merck Company Foundation, and Wyeth. Merck made the first contribution of $1 million over three years, and pledges totaled $3.6 million at the end of 2003 (www.fnih.org/images/Prelim2003ar.pdf). Cooperative Research Program for Improved Hemophilia Therapy www.nhlbi.nih.gov/funding/fromdir/cong/cj.htm The FY 2005 NHLBI budget indicates that the Institute and the National Hemophilia Foundation are planning a cooperative research program to improve treatments for bleeding disorders such as hemophilia or von Willebrand disease. The program was in the proposal stage at the time that this report was completed and no further details concerning it were available. Endocrine Pancreas Consortium www.cbil.upenn.edu/EPConDB/ The public-private Endocrine Pancreas Consortium originally sought to identify all genes expressed in the developing endocrine pancreas and to generate both microarray and bioinformatics tools, which could be used to study development, function, and disease progression in type 1 diabetes. A supplemental objective was added in FY 2001 to screen cDNA libraries for clones that might be useful as markers for beta cell precursors. NIDDK and the Juvenile Diabetes

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Research Foundation International (JDRF) awarded two resource-related grants in FY 1999 to the Washington University Genome Sequencing Center and the University of Pennsylvania Center for Bioinformatics to establish the consortium. A database (EPConDB) and tools to query sequence and expression data generated have been created under the aegis of the Beta Cell Biology Consortium (www.betacell.org/). The Etiology, Pathogenesis and Treatment of ALS grants.nih.gov/grants/guide/rfa-files/RFA-NS-04-003.html This public/private partnership was formed to solicit applications to support research in the causes, pathobiology of motor neurons and associated cell types, and the diagnosis and treatment of amyotrophic lateral sclerosis (ALS). The National Institute of Neurological Disorders and Stroke (NINDS), the Department of Veterans Affairs (VA), and the ALS Association intend to commit a total of approximately $2.4 million in FY 2004 to fund approximately 10 new grants in response to this RFA. An applicant may request a project period of up to 2 years and a budget for direct costs of up to $275,000 over the course of two years for NIH awards, or a budget for direct costs of up to $500,000 over the course of two years for VA awards. Gene Therapy Approaches for Cystic Fibrosis and Other Heart, Lung, and Blood Diseases grants.nih.gov/grants/guide/rfa-files/RFA-HL-93-008.html This public-private program encourages innovative, high-risk gene therapy directions by new or established investigators through pilot/feasibility studies. Established in 1992 by NHLBI and the Cystic Fibrosis Foundation (CFF), NHLBI issued an RFA for program project grants for research on gene therapy approaches to cystic fibrosis (CF) and other heart, lung, and blood disease. Applicants could request up to $1.33 million in total costs for the first year. Up to $250,000 of the $1.33 million could be used to fund non-CF -related pilot/feasibility studies. For CF-related pilot/feasibility studies, CFF indicated it would provide each grantee up to $500,000 per year in additional funds in direct costs per year. Gene Therapy Core Centers grants.nih.gov/grants/guide/rfa-files/RFA-DK-97-010.html This public-private initiative invites applications for core center grants to support gene therapy research on cystic fibrosis and other genetic diseases of interest to NIDDK. Cosponsored in 1992 by NIDDK and CFF, in FY 1993 NIDDK awarded two five-year grants on a competitive basis, using the core (P30) grant mechanism. In FY 1998 and FY 1999, NIDDK continued the initial

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs two centers and funded a new center. In each case, through separate awards, CFF awarded the centers up to $500,000 per year in direct costs for 5 years for pilot and feasibility studies to develop gene therapy for cystic fibrosis. To be eligible for CFF funding, applicants had to provide the CFF with a copy of the NIDDK review. In the 2004 recompetition, NIDDK assumed funding for pilot and feasibility studies. The three existing centers were refunded, a fourth center was added, and their name was changed to Molecular Therapy Core Centers. Global Network for Women’s and Children’s Health Research gn.rti.org The Global Network for Women’s and Children’s Health Research is a collaborative effort to create an international research network to improve the health of women and children throughout the world. It was formed by the National Institute of Child Health and Human Development (NICHHD) and several other NIH institutes (National Institute of Allergy and Infectious Diseases [NIAID], National Cancer Institute, NIDCR, National Institute of Mental Health (NIMH), National Center for Complementary and Alternative Medicine), the Fogarty International Center, and the Bill and Melinda Gates Foundation. The network was initiated in 2001 with $15 million each from the Gates Foundation and NICHD. The other institutes are providing financial, technical, scientific, training, and administrative support. The first eight scientific team units, consisting of a U.S. principal investigator and a senior scientist in a developing country, were funded in 2003, with each receiving approximately $500,000 per year over five years. In addition, there is funding for a data coordinating center at RTI International and for special projects. Grants for Research on the Effects of Hypoglycemia on Neuronal and Glial Cell Function grants.nih.gov/grants/guide/rfa-files/RFA-NS-02-008.html This public-private initiative focuses on elucidating the effects of acute and recurrent episodes of hypoglycemia on glial and neuronal cells of the developing and mature central nervous system. The National Institute of Neurological Disorders and Stroke (NINDS), the NIDDK, and the JDRF funded six grants in September 2002 intended to enhance understanding of the effects of hypoglycemia on brain function and lead to new targets for therapeutic intervention of this serious complication. According to the RFA for this initiative, NINDS and NIDDK intended to commit approximately $1.25 million in FY 2002. JDRF intended to commit up to $250,000 in additional funds to cofund research project grants that are both scientifically meritorious and fit within the JDRF mission and research emphasis areas.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Grants for Research on Innovative Approaches to Disease Prevention through Behavior Change grants.nih.gov/grants/guide/rfa-files/RFA-OD-98-002.html www.od.nih.gov/behaviorchange/index.htm In 1997, a large number of NIH components (12 institutes and 5 offices) and the American Heart Association (AHA) cosponsored an RFA inviting applications for a four-year research grant program to test interventions designed to achieve long-term health behavior change. AHA sponsored semi-annual grantee workshops associated with the RFA. The sponsoring organizations committed approximately $8 million annually from FY 1999 to FY 2002 to fund 15 research grants selected on the basis of the scientific review. A Behavioral Change Consortium comprised of NIH program staff, research investigators at the individual sites, and representatives from co-sponsoring private foundations was established to explore the opportunities for further collaboration across the studies. In 2003, a summary report of the research effort was released (www.od.nih.gov/behaviorchange/summary/summary.htm). Immune Tolerance Network (ITN) www.immunetolerance.org/ ITN is a consortium of approximately 80 basic and clinical scientists and physicians at more than 40 institutions in the United States, Canada, and Europe. Its purpose is to conduct basic and clinical trials on ways to improve the success of kidney transplants and pancreatic islet transplants by selectively disabling immune cells that attack transplanted tissues while allowing other immune cells to function normally and to induce tolerance in autoimmune diseases, asthma, and allergy. ITN was established in 1999 by NIAID, NIDDK, and JDRF. ITN is headquartered at the UC San Francisco and is funded by a joint contract from NIH and JDRF. The initiative was funded for $144 million over 7 years, with $130 million from NIH and $14 million from JDRF. JDRF also provides discretionary funding directly to ITN to finance research-related activities that cannot be supported with federal funding. Innovative Research on Human Mucosal Immunity grants.nih.gov/grants/guide/rfa-files/RFA-AI-99-011.html This public-private initiative offered exploratory/developmental research grants to attract new investigators and support novel research into understanding the human mucosal immune system. Cofunded by NIAID and the National Institute of Dental and Craniofacial Research (NIDCR) and the Crohn’s and Colitis Foundation of America, approximately 15 grants in FY 2000 totaling $3.1 million were to be awarded.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs International Type 1 Diabetes Genetics Consortium (T1DGC) www.t1dgc.org/ T1DGC is an international collaborative (with Asia-Pacific, European, North American, and United Kingdom networks) to facilitate the genetic analysis of Type 1 diabetes via the sharing of reagents, methods, strategies, samples, knowledge, and data at all levels of the research effort. A joint initiative of NIH and JDRF, the consortium will transmit collected DNA samples to the Center for Inherited Disease Research for whole-genome scan analysis, provide resources for genetic analyses to the scientific community, and deposit samples, at least initially, in a regional network repository. Recruitment has started in the four regional networks. JDRF provided the organizational funding, supplies complementary funding when needed, and is an ongoing participant in consortium agenda and decisions. Islet Cell Resource (ICR) Centers icr.coh.org/ Ten regional ICR centers were established in September 2001 to both provide clinical grade human islets to investigators engaged in islet transplantation protocols throughout the country and optimize the procedures used to obtain such islets. The ICR initiative was developed by the National Center for Research Resources (NCRR), NIDDK, and JDRF. In addition to the centers, NCRR is supporting an administrative and bioinformatics coordinating center (ABCC). Over their five-year duration, the awards made to these centers should reach a total of up to $11million in direct costs, plus $3.5 million to the ABCC to support the ICR infrastructure. NIDDK and JDRF are providing additional financial support based on the number of islet cell preparations made annually by each of the awardees. A representative of JDRF serves on the ICR sterring committee. Mouse Sequencing Consortium (MSC) www.genome.gov/10002191 Formed in October 2000, MSC was a public-private partnership coordinated by FNIH. This program was established to speed up the determination of the DNA sequence of the mouse genome and make the information available to the public quickly and without restrictions. Six NIH institutes (NCI, National Human Genome Research Institute, National Institute on Deafness and Other Communication Disorders, NIDDK, NINDS, NIMH) provided funding in the amount of $34 million; Wellcome Trust, $7.75 million; SmithKline Beecham, $6.5 million; Merck Genome Research Institute, $6.5 million; and Affymetrix, Inc. $3.5 million; for a total of approximately $58 million. The funding principally supported

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs work at three DNA sequencing laboratories: the Whitehead Institute for Biomedical Research in Cambridge, MA, the Washington University School of Medicine in St. Louis, MO, and the Sanger Centre in the United Kingdom. The project’s goal of generating three-fold coverage of the mouse DNA sequence in six months, representing at least 95 percent of the full complement of mouse DNA, was achieved (www.nhgri.nih.gov/10002158). The effort was continued and broadened, and the international Mouse Genome Sequencing Consortium published a high-quality draft sequence of the mouse genome and a comparative analysis of the mouse and human genomes in the December 5, 2002, issue of Nature. Multilateral Initiative on Malaria (MIM) www.who.int/tdr/diseases/malaria/mim.htm Founded in 1997, is an international collaboration in scientific research against malaria. MIM’s U.S. governmental supporters include NIH’s Fogarty International Center, National Library of Medicine, and NIAID. FNIH is the fiscal agent, collecting and distributing funds that enable the initiative to develop training programs. During the period 2000-2002, FNIH received funding from GlaxoSmithKline, the Gates Foundation, the Ellison Foundation, Burroughs Wellcome Fund, Wellcome Trust, the Rockefeller Foundation, the United Nations Foundation, and the World Bank. The governments of Norway, Sweden, The Netherlands, Demark, the United Kingdom, Germany, and Canada have also provided significant funding. Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers www.niams.nih.gov/rtac/funding/grants/muscular_dystrophy_2004.htm The NIH Muscular Dystrophy Cooperative Research Center (MDCRC) Program was established in October 2003 as a public-private collaboration among the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Neurological Disorders and Stroke, the National Institute of Child Health and Human Development, and the Muscular Dystrophy Association (MDA) to fund three extramural centers (University of Pittsburgh, University of Washington, and University of Rochester) for research on the muscular dystrophies, a group of genetic diseases that result in muscle weakness and wasting. The institutes will fund the three centers (selected through competitive peer review) at $1 million a year each in direct costs for five years. MDA will provide up to $500,000 in supplemental funding per center per year for three years. A 2004 RFA anticipates funding of up to three additional centers in FY 2005. The program was renamed in honor of Senator Paul Wellstone in 2004.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs whose mission is to diminish the spread of tuberculosis by developing new medicines. A number of organizations (e.g., American Society for Tuberculosis Education and Research, Bill and Melinda Gates Foundation, CDC, International Union Against Tuberculosis and Lung Disease, Lupin Laboratories,NIH) provide advice, guidance, and support for the alliance. While preference is given to joint ventures involving institutions in TB-endemic countries, stakeholders are selected based on research and development capabilities. The alliance establishes clear, predefined milestones, specific criteria and go/no-go decision points, and designs innovative agreements leveraging intellectual property rights to ensure the availability of novel technologies. The alliance periodically issues requests for proposals, which are evaluated and considered for investment by a scientific advisory committee. The Charlotte Geyer Foundation www.charlottegeyer.org/ The Charlotte Geyer Foundation awards provide one year’s funding to exceptional proposals to give investigators the opportunity of advancing and improving projects to the point at which they are able to successfully compete for an R01 or other award. In practice, these are one-year awards of up to $100,000 to researchers whose proposals have been reviewed by NCI and were ranked within ten percentage points of the NCI pay line. More than 100 proposals have been funded since 1991; 17 proposals were funded in the year 2003. More than 85 percent of the funded proposals go on to receive NCI funding. Kleberg Foundation Rat Genome Sequencing Project www.hgsc.bcm.tmc.edu/projects/rat/ In 2001, the Robert J., Jr. and Helen C. Kleberg Foundation in San Antonio, Texas, gave $4.2 million to the Baylor College of Medicine in conjunction with a joint award from NHLBI and National Human Genome Research Institute (NHGRI) of $37.7 million to sequence the DNA of laboratory rats within two years. Baylor’s Human Genome Sequencing Center was the lead institution in a sequencing consortium that also includes Celera Genomics, Genome Therapeutics, The Institute for Genome Research, The University of Utah, Children’s Hospital Oakland Research Institute, Medical College of Wisconsin, and University of British Columbia Genome Sciences Center. The Rat Genome Sequencing Consortium completed a rough draft of the sequence of the rat genome in November 2002. A more refined sequence and three-way comparison of the rat, mouse, and human genome were published in the April 1, 2004, issue of Nature. According to the president of Baylor, “Seed funding from private philanthropic institutions has proven vital to Baylor’s ability to secure large NIH grants. The recent $4.2 million commitment from the Kleberg Foundation provides an excellent

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs example of such leveraging. This private grant helped us obtain a $37.7 million public grant to support the rat genome sequencing project.” Bovine Genome Sequencing Project www.hgsc.bcm.tmc.edu/projects/bovine/ The Kleberg Foundation subsequently gave Baylor $2 million toward the Bovine Genome Sequencing Project, which initially was to be a three-year public-private collaboration between Baylor, Texas A&M University, the National Institutes of Health, the State of Texas, and several corporations (www.bcm.tmc.edu/development/kleberg.htm). The eventual contributors to the collaboration when it was launched in December 2003 were NHGRI, $25 million; U.S. Department of Agriculture, $11 million; State of Texas, $10 million; Genome Canada, $5 million; Commonwealth Scientific and Industrial Research Organization of Australia, $1 million; and three New Zealand companies, Agritech Investments Ltd., Dairy Insight Inc., and AgResearch Ltd., $1 million each. The sequencing is being carried out at Baylor and Genome British Columbia. Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) www.cff.org CFFT is the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. Among other activities aimed at boosting the pipeline of drugs for cystic fibrosis, CFFT offers milestone-based matching awards up to $25 million for preclinical and clinical research to companies to develop promising potential drugs. More than two dozen of these alliances have been formed. Through Therapeutic Development Network2 (TDN) funding, CFF has created partnerships with the private-sector research firms Chiron, Proteome, Copernicus, SciClone, and Inspire. The network also can function as a contract research organization for small companies that lack expertise, providing access to CFF-accredited care centers and patients. In 2003, CFFT spent $12.9 million on research grants, $22.4 million on TDN awards to 18 clinical research centers, and $2.7 million on clinical and research fellowship grants. International Malaria Genome Sequencing Consortium www.tigr.org/tdb/e2k1/pfa1/ This public-private consortium, the first multicenter international basic science collaboration in the malaria field, was formed in 1966 to sequence the genome of the human malaria parasite Plasmodium falciparum, clone 3D7. The 2   The Therapeutic Development Network was established by CFF to conduct early-phase clinical studies with novel therapies for CF.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs publication reporting this genome sequence appeared in the October 3, 2002, issue of Nature (pp. 498-511). The genome was sequenced by The Institute for Genomic Research and the Malaria Program of the Naval Medical Research Center (chromosomes 2, 10, 11, and 14); the Wellcome Trust Sanger Institute (chromosomes 1, 3-9, and 13); and the Stanford Genome Technology Center at Stanford University (chromosome 12). The PlasmoDB website (plasmodb.org) at the University of Pennsylvania also provides access genome data produced by the consortium. The approximately $29 million project was funded in the United States by the Burroughs Wellcome Fund ($7.7 million), NIAID ($3.4 million), and DOD ($5.3 million), and in the United Kingdom by the Wellcome Trust ($12.5 million). The Kresge Foundation www.kresge.org/ The Kresge Foundation provides grants to institutions on a conditional or challenge basis to build their capacity, help them broaden and deepen their bases of support from the private sector, and encourage volunteer involvement in the fund raising effort and beyond. Foundation assistance is directed toward the maintenance or expansion of institutions rather than for program or operating support. Initially, grants were made directly to institutions; by the early 1960s, however, the challenge concept had become a formal component of the foundation’s policies. In 2001, the foundation awarded 164 grants totaling $111.5 million. An example is a $750,000 grant made to Baylor College of Medicine to construct a Biology of Inflammation Center. To meet the challenge grant and complete the project, Baylor had to raise approximately $7 million. The 2003 Annual report notes that, since its establishment, the Foundation has awarded 8,364 grants totaling $2.028 billion. Medicines for Malaria Venture (MMV) www.mmv.org MMV was established in 1999 and is a nonprofit foundation that operates through public-private partnerships. Its goal is to bring public, private, and philanthropic sector partners together to fund and provide managerial and logistical support for the discovery and development of new medicines to treat and prevent malaria in disease-endemic countries. Funding and support has been received from a number of organizations, including the Bill and Melinda Gates Foundation, ExxonMobil Corporation, International Federation of Pharmaceutical Manufacturers Associations, World Bank, Wellcome Trust, and the World Health Organization. As of April 2004, MMV had 21 projects and plans to expand its portfolio, following the September 2003 announcement that the Gates Foundation would continue to support MMV with $40 million over the next five years.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs The Whitaker Foundation www.whitaker.org/ In 1992, the Whitaker Foundation and NSF jointly offered research grants to engineers, physical scientists, and health professionals to find ways of reducing the cost of health care without compromising its quality. This was accomplished through a series of competitive grant programs that supported research and education in biomedical engineering at academic institutions in the United States and Canada. In 1993, the foundation made 12 awards for a total investment of $6.5 million; NSF made a similar investment. In 1994, the foundation collaborated on a one-year program with NCRR; the foundation made 4 awards totaling $3.8 million and NCRR made 3 totaling $3.6 million. The foundation plans to spend all of its assets and close in 2006, and will not consider new applications. In its final round of research grants, 44 new awards totaling $10 million were made to 34 U.S. colleges and universities. In the final round of construction grants, awards totaled $24 million to six universities; these leveraged other grants and gifts totaling about $90 million. From the start of the program through 2003, 414 fellowships had been awarded, representing more than $53 million. STATE AND LOCAL GOVERNMENT California Breast Cancer Research Program (CBCRP) www.cbcrp.org CBCRP was established in 1993 and is administered by a small staff in the Office of the President of UC. CBCRP is funded from a portion of the state’s two-cent tax on tobacco, voluntary tax check-offs on state personal income tax forms, and individual contributions. In 2003 California taxpayers donated $646,664 via their personal state income tax forms. The program funds researchers at California institutions. Since 1994 CBCRP has awarded nearly $150 million in 569 grants to 62 institutions in California. In 2004, the tenth funding cycle, the program made 43 awards totaling $14.6 million. They include 14 career development awards (10 postdoctoral fellowships, 4 dissertations), 14 collaborative grants, 7 larger-scale projects, and 10 high-risk/high-reward IDEA (Innovative Development and Exploratory Award) grants pursuing novel approaches to breast cancer issues (www.cbcrp.org/media/pr/061604.php). The program has co-funded a few awards with the DOD Breast Cancer Research Program, but the philosophy of the program is to fill gaps not funded by other research programs in order to jump-start new areas of investigation and foster new collaborations. In fact, the program’s legislative mandate is to “fund innovative and creative research, with a special emphasis on research that complements, rather than duplicates, the research funded by the federal government and other entities.” For example, in the clinical area, with NCI funding large clinical

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs trials, CBCRP gives priority to small preclinical or pilot studies of new approaches to therapy. Although CBCRP is small relative to NIH, foundation, and industry funding of breast cancer research, it explicitly tries to “influence this larger research system to go in new, creative directions” by funding high-risk ideas that, if successful, can obtain funding from other sources. The program’s annual report cites specific instances of IDEA grants that later received support from NIH, the Komen Foundation, and industry (www.cbcrp.org/publications/reports/page_08.php). California Institutes for Science and Innovation www.ucop.edu/california-institutes/about/about.htm The institutes were announced by the state of California in 2000 as a way to focus public and private resources and expertise on research areas considered key in sustaining California’s economic growth and competitiveness in the global marketplace. Four research centers have been established by the state government and supported by the state, UC, and private industry: California Institute for Bioengineering, Biotechnology, and Quantitative Biomedical Research (QB3) California Nanosystems Institute (CNSI) California Institute for Telecommunications and Information Technology [CAL-(IT)2] Center for Information Technology Research in the Interest of Society (CITRIS). The institutes, located on UC campuses, are basic research centers concentrating on complex scientific challenges that demand multidisciplinary strategies and state-of-the-art equipment and facilities. They are also intended to foster university-industry collaborations in the research and training expected to produce the next generations of high-technology products and scientists. The state is investing $100 million over five years in each institute, which must be matched by two dollars in non-state funding for every state dollar. At latest count, QB3, CNSI, CAL-(IT)2, and CITRIS were collaborating with 16, 30+, 40+, and 20+ companies, which were also providing substantial resources to the centers (www.ucop.edu/california-institutes/partners/partners.htm). The centers are also leveraging federal dollars. In 2002, CAL-(IT)2 received a grant for $4.3 million from NIH to train students at the interface of biology and computer science, and in 2003 it was awarded $12.5 million over five years by NSF to develop information sharing tools and organizational strategies for first responders to disasters, after providing the seed money to develop the project. CNSI received an NSF grant for $17.7 million over five years to establish a nanoscale science and engineering center. CITRIS is co-awardee with the University of

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Southern California of a $5.5 million grant from NSF and the Department of Homeland Security to develop a large-scale cybersecurity testbed for the development of new defenses against computer worms and viruses. Indiana 21st Century Science and Technology Fund www.21fund.org/ In July 1999, Indiana established a 21st Century Research and Technology Fund with an appropriation of $50 million dollars to stimulate the process of diversifying the state’s economy by developing and commercializing advanced technologies. Awards have been made in three broad categories: science and technology commercialization, centers of excellence, and entrepreneurial activities. In addition the fund provides cost-share on behalf of federal proposals submitted by Indiana-based entities. The fund emphasizes the creation of academic- and commercial-sector partnerships, with awards based on peer review, requiring excellence in the science or technological objective and a clear commercialization plan. Significant leverage from the partners involved in the projects is expected. Awards are made for periods of up to two years in amounts of up to $5 million, though the fund’s board has indicated that awards above $2 million will be uncommon. Kansas Technology Enterprise Corporation (KTEC) www.ktec.com KTEC is a state-chartered corporation established in 1987 to stimulate economic development in Kansas by fostering innovation and development of technology. Among other types of assistance to businesses in Kansas, it administers the Applied Research Matching Fund (ARMF) program to seed and early-stage investment capital for Kansas entrepreneurs, with investment made through either a royalty agreement or convertible debentures, and any financial returns reinvested in other projects. Funding may be made to companies working alone or in collaboration with universities, business incubators, or other companies. In 2003, for example, KTEC entered into 13 ARMF agreements, in which KTEC invested $1.1 million, matched by $2.2 million in matching funds. The Technology Commercialization Seed Fund (TCSF) invests in companies working alone or in collaboration with universities, business incubators, or other companies. Companies must match ARMF and TCSF investment with 150 percent of the amount of KTEC funding (60/40 split). KTEC seeks a return on its investment through either convertible debentures, equity, or in some cases, royalty investments. The Strategic Technology and Research (STAR) Fund assists researchers at Kansas Board of Regents’ universities compete for federal and private grants by helping to provide matching funds. STAR provides 75 percent of the matching dollars required by a federal program; the remaining 25 percent must be provided by the

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs university through waiver of indirect costs, direct financial support, or support from non-institutional cosponsors. In cases in which a state matching requirement is not explicit, such as partnership programs, applicants may request STAR Funds to enhance their chances for a federal award or for industry funding. In FY 2003, KTEC investments resulted in 34 company startups, 54 technologies, 53 patents, and $1.64 million in royalties. South Carolina Technology Alliance www.sctech.org/ The alliance was established to prepare a technology-capable workforce, create a business environment friendly to technology-intensive companies, invest to expand the base of rapidly growing companies and start-up business, and invest in world-class university research programs directly linked to South Carolina industry. Funding comes from local, state government, technology entrepreneurs, various grants, personal contribution and from services provided to stakeholders. Legislation signed in 2004 (Act 187) commits a total $500 million for technology-based economic development. It comprises three major provisions. The South Carolina Life Sciences Act facilitates borrowing up to $250 million for university construction and improvement projects encouraging research and technology-based economic development. Multiple tax credits for recruitment and expansion of large life science facilities are provided; to receive them, more than $100 million must be invested in the new facility and it must create a minimum of 200 full-time, high-paying jobs. The state is also allowed to issue up to $250 million in general obligation bonds to pay for infrastructure improvements. The Venture Capital Investment Act of South Carolina created two funds within the Department of Commerce. One is the South Carolina Venture Capital Fund ($50 million total; up to $5 million equity, near-equity, and seed capital of up to $5 million or 15 percent of the committed capital of the South Carolina based investor, whichever is less). The other is the South Carolina Technology Innovation Fund (administration contracted to a separate nonprofit, small grants connected to the state’s research universities). The South Carolina Research University Infrastructure Act increases the state’s debt limit by half a percent to provide as much as $250 million for facility and infrastructure improvements at the state’s three research universities (Clemson University, The Medical University of South Carolina, and the University of South Carolina-Columbia). Projects must advance economic development and creation of a knowledge-based economy. State of Ohio’s Third Frontier Project www.ohio3rdfrontier.org/ A $1.1 billion initiative, this 10-year project was established in 2002 to expand Ohio’s high-tech research capabilities and promote innovation and com-

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs pany formation to create high-paying jobs. Research is supported by funds from appropriations and a bond sale for matching grants to private firms and organizations for economic development projects. The project includes the Third Frontier Action Fund ($500 million over 10 years), a Biomedical Research and Technology Transfer Fund, and Wright Centers of Innovation, a capital improvement program for research facilities ($500 million over 10 years). One partnership created under the project is the Center for Stem Cell and Regenerative Medicine established in Cleveland by Case Western Reserve University in 2003. Its industry partners include Athersys, Viacell, Aastrom, StemCyte, Copernicus, VirxSys, and Cognate Therapeutics The Center was awarded $10.8 million to build the facility and another $8.6 million to finance research. It must raise 2 dollars for every state dollar awarded. Translational Genomics Research Institute (TGen) www.tgen.org/ TGen began in 2002 as an effort by the state of Arizona to create a biotechnology industry. It involves academic affiliation agreements with the three state universities in Arizona and collaborative relationships and related formal agreements with research and clinical organizations in Arizona and nationally (e.g., the Mayo Clinic, Banner Healthcare, and Virginia Piper Cancer Center at Scottsdale Healthcare). As TGen’s work progresses from basic science to translational research to clinical applications, its agreements with medical research and healthcare delivery entities will cover collaborative research, clinical trials, and shared use of facilities. Arizona’s state government has committed $30 million to this effort over 10 years. Other key contributors include universities and colleges pledged resources and faculty support, the Flinn Foundation ($10 million), the Virginia G. Piper Trust ($5 million), the Salt River Pima-Maricopa Indian Community ($5 million), the City of Phoenix (donation of land and construction of research facilities), health care providers (e.g., Banner Health Systems), local corporations, and private individuals. University of California Industry-University Cooperative Research Program (IUCRP) ucdiscoverygrant.org/welcome.asp IUCRP was created in 1996 at UC Berkeley as a matching grant program to fund university-industry cooperative research projects in the area of biotechnology. It expanded to include electronics manufacturing and new materials, communications and networking, digital media, and information technology for the life sciences. The program provides grants for collaborative research partnerships with industry, in which companies provide matching funds and both parties share in the project’s results. Initially, UC provided $3 million, which was quickly

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs expanded to $8 million by a $5 million contribution from the State of California. Within three months, the program received applications with commitments totaling nearly $8 million in cash from California biotechnology firms. In 1998, the State of California increased its contribution to $12 million a year, while UC continued to provide $3 million. In 1998-1999, matching funds from industry and private contributions exceeded $15 million. In 1999-2000, and during the 2001-2003 fiscal years, combined funding was between $50 million and $55 million a year, more than half of it from industry. The program’s UC Discovery Grant is jointly funded by the state, UC, and California R&D firms. To qualify, the projects must have committed matching support (at least $1 of private funding for every $1 of public funding) that represents new investment by California businesses. On average, each state dollar is matched by $1.57 from industry and 68 cents from UC. In addition, each industry dollar qualifies for California’s 24 percent tax credit on investments in university research. CANADA Genome Canada (GC) www.genomecanada.ca/home.asp?l=e In 2000, GC was incorporated to support a national genomics research initiative by funding large-scale, peer-reviewed genomics projects whose scale and scope are such that they cannot be funded through existing mechanisms, national or international. The organization received $160 million (CAD) from the national government to establish five genome centers across Canada and fund genomic research and infrastructure projects on a 50-50 matching basis. Subsequently, GC received additional government funding. As of 2004, more than $379 million had been awarded for 78 research projects and research platforms, matched by $848 million in funds pledged by other partners. According to Louis Siminovitz, emeritus professor, University of Toronto, and a National Academyof Sciences member interviewed by Thomas Caskey and Michael McGeary on April 19, 2004, the matching required from each project has proven to be a difficult hurdle in many cases. Initially, GC required all matching to be from private sources, but this proved infeasible and eventually provincial government funds were allowed to be counted as matching. The provincial governments, however, have different capacities and willingness to provide matching funds. The start of some projects was delayed for months after they were approved while the matching funds were secured. Some otherwise meritorious projects could not be funded for lack of matching. Principal investigators reported spending large amounts of time lining up and then securing matching funds.

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Ontario Research and Development Challenge Fund (ORDCF) www.ontario-canada.com/ontcan/en/rts/cf/cf_intro.jsp Created in 1997 by the Ontario government, ORDCF is an $800 million (CAD) program with a mandate to promote research excellence and partnerships between research institutions and business. It supports ground-breaking research in emerging fields such as genomics/proteomics and photonics, as well as in established sectors such as biomedical, agri-food, communications, information technology, and automotive. Funding is open to research institutions (including hospitals, universities, and colleges) on a competitive basis, for longer-term discovery research of interest to the private sector and shorter-term research with more immediate industrial applications. Under the terms of the program, the province contributes 40 percent, private sources 40 percent, and the research institutions 20 percent of the cost of each project. To date, the province has invested $453 million in 104 research projects. Private sector and research institution partners have invested an additional $1.2 billion, bringing the total value of Challenge Fund supported research projects to more than $1.6 billion. Structural Genomics Consortium (SGC) www.sgc.utoronto.ca/ www.sgc.ox.ac.uk/ SGC is a $95 million (CAD) effort launched in April 2003 by a public-private partnership. The objective is to develop the infrastructure and technologies necessary to determine 200 human protein structures per year and, within the first four years, determine the three-dimensional structure of more than 350 medically significant proteins and deposit them in a public database. The consortium consists of the Wellcome Trust, GlaxoSmithKline, and four Canadian research funding agencies: GC, Canadian Institutes of Health Research (CIHR), ORDCF, and Ontario Innovation Trust (OIT). The sites will be the University of Toronto and University of Oxford. The Wellcome Trust and GlaxoSmithKline initiated the project and are contributing £18 million and £3 million, respectively ($52 million CAD). GC and the Ontario government’s Research and Development Challenge Fund are each contributing $15 million. OIT is contributing $7.2 million and CIHR $6 million. UNITED KINGDOM Joint Infrastructure Fund (JIF) www.wellcome.ac.uk/en/1/biosfgjif.html The £750 million JIF initiative was launched in 1998 by the UK Department of Trade and Industry’s (DTI) Office of Science and Technology (OST), the

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Strategies to Leverage Research Funding: Guiding Dod’s Peer Reviewed Medical Research Programs Higher Education Funding Council of England (HEFCE), and the Wellcome Trust. The purpose of JIF was to provide UK researchers with major equipment and new or renovated facilities needed to conduct cutting edge scientific research. DTI and the Wellcome Trust put in £300 million each and HEFCE contributed £150 million. Through five rounds of awards, 153 projects at 42 universities have been funded by the program. The applications were reviewed for scientific excellence by expert advisory boards of the appropriate research council or, in the case of biomedical and biological sciences, of the Wellcome Trust. The second level of review and final decisions were made by a Joint Executive Committee co-chaired by the Director General of Research Councils and the Director of the Wellcome Trust. The committee included representatives from the Wellcome Trust, the Research Councils and HEFCE, Scottish Higher Education Funding Council, Higher Education Funding Council for Wales, and Department of Higher Education & Further Education, Training and Employment, Northern Ireland. Science Research Investment Fund (SRIF) www.ost.gov.uk/research/funding/infrastructure.htm JIF (see above) was succeeded in July 2000 by the new £1 billion SRIF sponsored by the same three organizations: OST, HEFCE, and the Wellcome Trust. The Wellcome Trust put in £225 million. The £675 million from the government was for university science infrastructure with the awards allocated according to research excellence and research income rankings. Most of the Wellcome Trust’s funding (£150 million) was for biomedical science infrastructure projects drawn from the highest quality applications not funded by the government because of fiscal constraints; the remainder was for replacement or renovation of biomedical research buildings. The same peer review process used for JIF is being used for SRIF. Universities were expected to contribute 25 percent of the cost from non-SRIF sources. The government added another $1 billion for a second round of funding, in February 2003, for which the non-SRIF contribution was reduced to 10 percent.