Selected Federal Programs with Nonfederal Funding Participation1
DEPARTMENT OF DEFENSE (DOD)
Dual Use Science and Technology (DUS&T) Program
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.
Government/Industry Co-sponsorship of University Research (GICUR) Program
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)
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.
Thin-Film Photovoltaics Partnerships Program
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
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
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
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
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)
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
use approximately $1.124 million in FY 2004 appropriations to fund up to 15 planning grants.
Alzheimer’s Disease Neuroimaging Initiative (ADNI)
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
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
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
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
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
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
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
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
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
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
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
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
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.
Grants for Research on Innovative Approaches to Disease Prevention through Behavior Change
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)
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
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.
International Type 1 Diabetes Genetics Consortium (T1DGC)
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
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)
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
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)
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
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.
National Cancer Institute/Affymetrix Human Transcriptome Project (HTP)
Initiated in 2001, this project is a collaboration between the private-sector research firm Affymetrix and NCI to determine the gene expression profiles of normal, precancerous, and cancerous cells, leading eventually to improved detection, diagnosis, and treatment. As part of NCI’s Cancer Genome Anatomy Project, HTP’s goal is to generate the complete collection of transcribed elements of the human genome.
Neurobiology of Diabetic Complications
This public-private collaborative program supports research on the mechanisms by which diabetes results in painful, disabling peripheral neuropathy, autonomic neuropathy, impaired counter-regulation and hypoglycemia unawareness, and other neurological complications. In FY 2000, NINDS, NIDDK, and JDRF awarded 18 two- to four-year grants on diabetic neuropathy. The NIH institutes managed the review and the JDRF suggested reviewers, encouraged applications and provided part of the funding. These were awarded under two initiatives supported by special statutory funds for type 1 diabetes (RFA-NS-99-005 and RFA-NS-00-002).
NIH Challenge Grants and Partnerships Program
The FY 2000 Public Health and Social Services Emergency Fund appropriation included $20 million for an NIH Challenge Grants and Partnership Program. The purpose of the legislation was to promote joint ventures between NIH and the biotechnology, pharmaceutical, and medical device industries. One-on-one matching of federal dollars by qualified organizations that are conducting R&D activities in biomedical research or biotechnology with commercial potential or conducting research in promising therapies was required.
Partnerships: Hepatitis B and Vector Borne Diseases Control
In this partnership initiative, NIAID uses the U01 cooperative agreement funding mechanism to develop and test products for certain infectious diseases. A key component of this initiative is the development of productive partnerships between the federal government, universities, and the biotechnology, chemical, and/or pharmaceutical industries. All projects must demonstrate the substantive involvement of a for-profit company, defined as the commitment of one or more of resources such as funds, personnel, or in-kind contributions of materials and/or
reagents, data management resources, or regulatory support. Industry invests little in the commercialization of products to control a number of infectious diseases of great public health importance because it foresees little profit. This initiative is aimed at stimulating industry to participate by providing funding that reduces investment risks for companies, for example, providing critical decisionmaking data for industry through support of antimicrobial screening; formulation, toxicology, and pharmacokinetics; regulatory filing; and clinical trials.
Partnerships for Vaccine and Diagnostic Development
This initiative is basically the same as the Hepatitis B and Vector Borne Diseases Control partnership initiative except it is focused on the development of vaccines against and diagnostics for group A streptococci and group B streptococci and vaccines against Helicobacter pylori. Substantial involvement of industry is also required in this program.
Challenge Grants: Biodefense Product Development
This NIAID public-private initiative was established in 2004 to support further development of previously identified products against NIAID Category A, B, and C priority pathogens, including vaccines, adjuvants, therapeutics, and diagnostics. Under this program, partnerships among government, industry, academic institutions, and non-profit research organizations are encouraged. All projects must demonstrate substantive investment by industry participants, including funding, personnel, and in-kind contributions of materials, reagents, or other resources. With an anticipated July 2005 award date, this RFA will use the mechanism of the NIH challenge grant-cooperative agreement, and the applicant will be solely responsible for planning, directing, and executing the proposed project. The approximately four to eight awards will be made for a period of up to three years and will be performance based. The estimated total funds (direct and facilities and administrative costs) available for all awards for the duration of the program will be $30 million.
Osteoarthritis Initiative Public-Private Consortium
The Osteoarthritis Initiative (OAI) is a $60 million collaborative consortium between NIH and pharmaceutical companies to pool funds and expertise to create a public repository of osteoarthritis patient data, radiological information, and biological specimens. OAI is coordinated from the public sector by the NIAMS and NIA, with additional support from six other NIH institutes and centers. The
private-sector partners are Merck, Novartis Pharmaceuticals Corporation, and Pfizer. Four clinical centers (University of Maryland School of Medicine, Ohio State University, University of Pittsburgh, and Memorial Hospital of Rhode Island), and a data coordinating center (UC San Francisco) were chosen in July 2002 from competitively reviewed applications submitted in response to Requests for Proposals. All partners have agreed that clinical data and x-ray information will be freely accessible to qualified scientists everywhere. For other resources that are limited (such as biological specimens), priority will be given to researchers studying promising biomarkers that will be made widely available for research and commercial use. The private-sector members of the consortium pool their resources, expected to total approximately $22 million, with NIH’s appropriated funds through FNIH. In addition, Siemens Medical is collaborating with the OAI by enabling the NIH discounted purchases of the 3T field-strength magnets for each of the clinical centers and working with NIH to insure the highest performance of these systems.
Overcoming Barriers to Early Phase Clinical Trials Initiative
In this public-private partnership, five industry partners (Aventis Pharmaceuticals Inc., Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, and Novartis Pharmaceuticals Corporation) and a private nonprofit group (Friends of Cancer Research) collaborate with the National Cancer Institute to reduce health disparities among underserved populations. Funds from the private sector partners are provided through FNIH. The initiative works to increase access to early phase clinical trials and to identify and overcome the barriers that prevent their participation. For example, six cancer centers chosen by an NIH peer review committee were awarded grants in August 2003 to design and implement new approaches to recruiting elderly and minority volunteers to clinical trials. The private sector partners contribute to this $5.7 million initiative through FNIH.
Pathogenesis and Treatment of Cystic Fibrosis
This public-private initiative involves grants to conduct basic research on the pathogenesis of cystic fibrosis and its complications, related applied cell and molecular biology, translational, and clinical research, and potential therapies. In 1995, NIDDK, NHLBI, and CFF cosponsored the RFA for this program. For FY 1996, $2 million in total costs were to be committed by NIDDK and $1 million by NHLBI to fund applications submitted in response to this RFA. An additional $2 million were to be committed by CFF to fund applications not funded by NIDDK
or NHLBI. Approximately 15 awards were anticipated. The committee did not identify any information indicating whether and how the funds were distributed.
Training Programs in Diabetes Research for Pediatric Endocrinologists
This public-private initiative established joint programs for the research training and career development of pediatric endocrinologists to foster development of a diverse and highly trained workforce of pediatric endocrinologists able to lead research efforts in the area of pediatric diabetes. NIDDK, the American Diabetes Association (ADA), and JDRF awarded seven combined T32/K12 training program grants in FY 2002 and FY 2003, with NIDDK intending to commit approximately $1.5 million to the initiative in FY 2002.
Transitional Career Development Award in Women’s Health Research
This award is designed to support career development experiences leading to independence for clinical investigators interested in patient-oriented or population-based research related to women’s health. Salary for the first two years is funded by Pfizer Women’s Health of Pfizer, Inc. (through a grant to FNIH), allowing awardees to conduct clinical research in the NIH intramural program. This is followed by two years at an academic institution, funded by 12 NIH institutes and centers and the Office of Research on Women’s Health (ORWH) through K22 Career Transition Awards.
Translational Research for the Prevention and Control of Diabetes
In 2002, this initiative was established to solicit research to translate recent advances in the prevention and treatment of type 1 or type 2 diabetes into clinical practice for individuals and communities at risk. It was formed by several NIH institutes (NIDDK, the National Eye Institute [NEI], the National Institute of Nursing Research [NINR], the Office of Behavioral and Social Sciences Research, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention [CDC]), and ADA. An expansion of an earlier program announcement sponsored by NIDDK, NEI, NINR, and ADA (grants.nih.gov/grants/guide/pa-files/PA-01-069.html), this NIH research demonstration and dissemination project (R18) is the award mechanism used to fund this initiative. The R18 is designed to support the testing and evaluation of interventions and activities that lead to application of existing knowledge to disease control and prevention.
Triggers and Environmental Determinants of Diabetes in Youth (TEDDY)
TEDDY is a public-private consortium formed to identify newborns at high genetic risk and follow them for the development of type 1 diabetes, with a goal of organizing international efforts to identify infectious agents, dietary factors, or other environmental factors that trigger type 1 diabetes in genetically susceptible individuals. Several NIH institutes (NIDDK, NIAID, NICHD, the National Institute of Environmental Health Sciences [NIEHS]), CDC, ADA, and JDRF are the sponsors of this project. Seven cooperative agreements were signed in September 2002 for a data coordinating center and six clinical centers.
Type 1 Diabetes TrialNet
TrialNet is a collaborative network of clinical centers, experts in diabetes and immunology, and specialized laboratories and other facilities. It was formed in September 2001 by NIDDK, NICHD, NIAID, JDRF, and ADA. It consists of 14 clinical centers in the United States and Canada funded by grants from NIDDK and the 4 international clinical centers (in Italy, Finland, the United Kingdom, and Australia) funded by JDRF. According to the RFA for this initiative (grants.nih.gov/grants/guide/notice-files/NOT-DK-01-006.html), approximately $4.8 million in total costs per year will be committed to provide personnel and supplies to the Clinical Centers in order to complete DPT-1 and initiate planning for future studies, with a cap of approximately $242,000 per clinical center per year in total costs.
Understanding Hypoglycemia Unawareness in Patients with Type 1 Diabetes
This public-private initiative fosters basic and clinical research on molecular mechanisms underlying hypoglycemia unawareness and novel approaches to prevent or reverse this condition in diabetic patients. In September 2002, NIDDK, NINDS, NICHD, NINR, and JDRF awarded eight research grants relevant to hypoglycemia unawareness for funding periods of two to five years. The RFA for this initiative indicated that the NIH institutes intended to commit approximately $3.25 million in FY 2002 to fund four to eight grants, and that JDRF intended to commit up to $500,000 in additional funds to co-fund research project grants that are both scientifically meritorious and fit within their mission and research emphasis areas.
Other NIH Programs with Federal-Private Funding
Bioengineering for Disease Prevention and Control: National Center for Research Resources (NCRR) and the Whitaker Foundation (RFA-RR-94-005).
Cooperative Program on Retinal Degenerative Disease Research: NEI and the Foundation Fighting Blindness. Supports R01grants; R41, R42, R43, R44 small business grants; K08, K23, K24 career development awards (PA-00-009).
Cooperative Study Group for Autoimmune Disease Prevention: NIAID, NIDDK, NICHD, NIDCR, NIAMS, ORWH, and JDRF. Supports U19 multi-project cooperative agreements (RFA-AI-00-016).
Diabetes Centers of Excellence: NIDDK, NIAID, and JDRF. Funds P01 program project grants (RFA-DK-99-002).
Foodborne Illnesses, Gastrointestinal and Renal Complications: NIDDK and the American Digestive Health Foundation. Funds R01 and R21 grants (RFADK-00-008).
Health Care Access, Quality and Insurance for Low-Income Children: Agency for Health Care Policy and Research and the David and Lucile Packard Foundation. Supports U01 cooperative agreements (RFA-HS-99-005).
Helicobacter pylori and its Relationship to Digestive Diseases and Cancer: NIDDK, NCI, NIAID, Office of Research on Minority Health (ORMH), and the American Digestive Health Foundation. Supports R01 research project grants; R29 FIRST awards; R03 small grants (RFA-DK-97-003).
Hepatitis C: Natural History, Pathogenesis, Therapy and Prevention: NIDDK, NCI, NIAID, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, Office of AIDS Research, ORMH, and the American Digestive Health Foundation. Funds R01 grants (RFA-DK-98-017).
Human Islet Transplantation into Humans: NIDDK, NIAID, and JDRF. Funds R01 grants and Interactive Research Project Grant awards (RFA-DK-99-006)
Indo-US Vaccine Action Program Starr Grants: Funds donated to the NIAID Restricted Gift Fund by the Starr Foundation. Supports supplements to current grants or R03 awards (NOT-99-097).
Integrative Approaches to the Study of Motility of the Gastrointestinal Tract: NIDDK, ORWH, and the American Digestive Health Foundation. Funds R01 and R21 grants (RFA-DK-99-004).
Mentored Clinical Scientist Awards in Nephrology: NIDDK and the National Kidney Foundation. Supports K08 clinical scientist development awards (PAR-98-064).
Mouse Models of Diabetic Complications Consortium: NIDDK, NHLBI, NEI, NIDCR, and JDRF. Supports U01 cooperative agreements (RFA-DK-01-009).
NINDS Administrative Supplements: FDA-Approved Compound Screens for Neurodegeneration: NINDS, Huntington’s Disease Society of America, the ALS Association, and the Hereditary Diseases Foundation. (NOT-NS-01-009).
Paul B. Beeson Career Development Awards in Aging: NIA, the John A. Hartford Foundation, the Atlantic Philanthropies, and the Starr Foundation. Supports K23 patient-oriented research career development awards and K08 mentored clinical scientist development awards (RFA-AG-05-001).
Physician and Scientist Training Program in Urologic Research: NIDDK and the American Foundation for Urologic Diseases. Supports T32 training grants and K12 mentored clinical scientist development program awards (RFA-DK-98-005).
R21 Fast Track Grants For Parkinson’s Disease Research: NINDS, National Institute on Deafness and Other Communication Disorders, NIEHS, NIMH, the Michael J. Fox Foundation for Parkinson’s Research, the Parkinson’s Disease Foundation/National Parkinson’s Foundation, and the Parkinson’s Alliance. Supports R21 exploratory/developmental research grants (RFA-NS-02-006).
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
The CDC Foundation
Established by Congress in 1992, the foundation forges partnerships with CDC to boost its programs. As an independent nonprofit organization, the foundation can accept funding and create programs that help donors and CDC scientists achieve common goals. It can find funding partners, negotiate deals, hire people, manage program budgets, identify experts, and report to donors. In the period 2002 to 2003, the foundation’s revenues were $17.1 million and expenses were $10.2 million, of which $8.1 million were expended through cost-reim-bursement agreements for programs. Thirty-seven corporations and 23 foundations that were supporting programs initiated as of July 2000 or are currently active are listed at the foundation website. Twenty-four global health programs with their partners were listed in July 2004, including:
Asian Rotavirus Surveillance Program—Phase II: GlaxoSmithKline and Program for Appropriate Technology in Health
Development of Rapid Assessment Methods and Tools for Displaced Persons: the Andrew W. Mellon Foundation
Global Field Epidemiology and Laboratory Training Program—Kenya: Ellison Medical Foundation
Lilly International Laboratory Fellowships: Eli Lilly and Company
STD Control in the Russian Federation: Becton Dickinson and Company.
The Foundation also supports programs that promote healthy lifestyles, including:
Avon-CDC Foundation Mobile Access Program: Avon Foundation
Price Fellowships for HIV Prevention Leadership: Price Foundation
Promoting Better Health for Young People through Physical Activity and Sports: MetLife Foundation
Among the research and education programs supported are:
Antimicrobial Resistant Bacteria Educational Program: AB Biodisk, Abbott Laboratories, Becton Dickinson and Company, bioMérieux, Inc., Dade Microscan, Inc., Merck & Co., Inc., Ortho-McNeil Pharmaceutical, Inc., Roche, and GlaxoSmithKline
Applied Epidemiology Training Program for Medical Students: Pfizer Inc.
Estimation of Prevalence of Erectile Dysfunction in the U.S.: National Foundation for Sexual Health Medicine, Inc. and Pfizer Inc.
NATIONAL SCIENCE FOUNDATION (NSF)
Engineering Research Centers Program (ERC)
NSF’s ERC Program was created in 1985 to develop a government-industry-university partnership to strengthen the competitive position of U.S. firms in world trade. ERCs develop and maintain partnerships with member firms and other practitioner organizations. Member organizations serve on ERC’s Industrial/ Practitioner Advisory Board and are expected to provide access to key industrial facilities and personnel for ERC faculty and students, knowledge of industrial practice, and needs for future technological innovation. The research centers are funded by the National Science Foundation (80 percent) and by nonfederal cash and in-kind resources from industry, states, and other sources (20 percent). Members pay cash membership fees. Members also may provide the center in-kind and sponsored project support and/or provide support directly to ERC faculty for relevant sponsored projects. Some centers also receive cash and in-kind donations from nonmember organizations. Cost sharing at a level equal to 20 percent of the total amount requested from NSF is required and must be shown and
justified in the proposal budget. Annual funding for centers ranges from $3.1 million to $19.4 million. NSF’s contribution ranges from $1.0 million to $3.0 million per year, averaging $2.5 million per year.
Industry/University Cooperative Research Centers Program (I/UCRCs)
Initiated in 1973, NSF’s I/UCRCs program develops long-term partnerships among industry, academe, and government. These university-based centers start with a small investment from NSF, which is intended to seed partnered approaches to new or emerging research areas. Each center is established to conduct research of interest to both the industry and the university with which it is involved, with the provision that the industry must provide major support to the center at all times. Centers are expected to gradually become fully supported by university, industry, state, and/or other non-NSF sponsors. NSF supports I/UCRCs through a cooperative leveraging mechanism. In FY 2000, NSF contributed approximately $5.2 million, a relatively small amount compared with the $68 million contributed by other funding sources. In FY 2003, I/UCRC research resulted in approximately $75 million in R&D funding investments by member firms. The total industrial R&D investment attributable to I/UCRCs in FY 2003 was approximately $100 million. Each center is expected to maintain at least $300,000 of industrial support through membership fees, have at least six industrial members, and a plan to work toward self-sufficiency from NSF.
Materials Research Science and Engineering Centers Program (MRSECs)
MRSECs are interdisciplinary materials research and education centers. They are expected to have strong links to and actively collaborate with industry, national laboratories, other universities, and other sectors. Interdisciplinary materials research and education centers are funded by NSF (90 percent) and by nonfederal cash and in-kind resources from industry, states, and other sources (10 percent). Contributions can be from any nonfederal source, including nonfederal grants or contracts. However, contributions counted as cost sharing toward projects of another federal agency may not be counted toward meeting the specific cost sharing requirements of the NSF award. The 2004 program solicitation (www.nsf.gov/pubs/2004/nsf04580/nsf04580.pdf) indicates that awards range from $1 million to $5 million a year with an average of $1.9 million a year. Awards are made for an initial duration of up to six years, but the level of funding for the last two of those years is contingent upon the outcome of a thorough external review.
Nanoscale Science and Engineering Centers Program (NSECs)
NSECs are interdisciplinary research centers that address nanoscale science and engineering research problems too complex and multifaceted for individuals or small groups of researchers to tackle separately. Each NSEC must include partnerships with industry, government laboratories, and/or other users of research outcomes. NSECs receive NSF funding (90 percent) and nonfederal cash and in-kind resources from industry, states, and other sources (10 percent). Cost sharing at a level equal to 10 percent of the total amount requested from NSF is required and must be shown and justified in the proposal budget. In addition, contributions counted as cost sharing toward projects of another federal agency may not be counted toward meeting the cost-sharing requirement. The centers are funded by five-year cooperative agreements at between $1 million and $4 million a year, depending on the scope of the proposal, and they are eligible to compete for one five-year renewal.
Partnerships for Innovation (PFI)
The PFI program was established in 2000 as a result of a Congressional appropriation of $8.5 million to initiate a new innovation partnership effort. Partnerships must undertake one or a combination of research, technology transfer, and/or commercialization; workforce education and/or training; or establishing the infrastructure to enable innovation activities to take place. The program supports partnerships of colleges and universities with state and local governments and private sector organizations, including for-profit firms, nonprofit organizations, other academic institutions, entrepreneurs and venture capitalists, trade and professional associations, and federal laboratories. The lead organization must be a college or university (California Institute of Technology, Eastern Iowa Community College, University of Florida, and Tufts University are among the institutions with programs in 2004) and at a minimum there must be private sector partners. NSF offers two- and three-year grants for up to $600,000 in total costs. The cost-sharing requirement is 10 percent of the total amount requested from NSF. NSF funded 58 partnerships, 24 in the first round ($21 million) of awards, 12 in the second round ($7 million), and 23 more in 2002 and 2003.
Science and Technology Centers: Integrative Partnerships Program (STCs)
Launched in 1989, STCs are science, mathematics, and engineering research centers established to promote these areas of study, initiate efforts to improve the
quality of education in these areas, and combine the relevant resources at universities with federal laboratories and private industry to enhance the transfer of knowledge among these different groups. The centers (25 initially; 11 in 2004) are expected to conduct world-class research in a variety of disciplines with partner institutions or organizations from other sectors that invest intellectual resources in and provide funding for the center. These partnerships include multi-institutional collaborations with other universities and colleges, national laboratories, research museums, private sector research laboratories, state and local government laboratories, and international collaborations. STCs receive NSF funding (70 percent) and nonfederal cash and nonfederal cash and in-kind resources from industry, states, and other sources (30 percent). Cost sharing at a level equal to 30 percent of the total amount requested from NSF is required. STC budgets may range from $1.5 million to $4.0 million per year for five years, and each center is eligible to compete for one five-year renewal. As of 1995, the original 25 centers had generated $1.48 in nonfederal support for every dollar of NSF funding. NSF anticipates there will be another round of funding for the program in 2005.
NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
Advanced Technology Program (ATP)
A government-industry partnership formed in 1990, ATP provides cost-shared multi-year funding to individual companies and to industry-led joint ventures to encourage the development of challenging, high-risk, high-payoff technologies. ATP has strict cost-sharing rules. Joint ventures (two or more companies working together) must pay at least half the project costs; they can receive funds for research and development activities for up to five years with no funding limitation other than the announced availability of funds. Large Fortune 500 companies participating as a single firm must pay at least 60 percent of total project costs. Small and medium-sized companies working on single-firm projects are not required to provide cost sharing of direct costs but must pay a minimum of all indirect costs associated with the project. ATP does not fund product development, instead entering into cooperative agreements and playing a substantial role by providing technical assistance and monitoring the technical work, business progress, and expenditure of federal funds. Private industry bears the costs of product development, production, marketing, sales and distribution. Between 1990 and September 2003, 709 awards were made, with 1,433 participants; ATP provided $2.114 billion, matched by $1.987 billion from companies. For FY2004, a single company can receive up to a total of $2 million for R&D activities for up to 3 years. The range of funding is $434,176 to $31,478,000; the average is $2,971,402.
ENVIRONMENTAL PROTECTION AGENCY
Health Effects Institute (HEI)
Chartered in 1980, HEI is an independent, nonprofit corporation that conducts research on the health effects of pollutants from motor vehicles and from other sources in the environment. It is supported jointly by the U.S. Environmental Protection Agency and 27 automobile companies, and has funded more than 170 studies and published more than 100 research reports and several special reports. In FY 2003, HEI declared total revenues and support in the amount of $6,151,066 and total scientific expense of $4,667,397.
Alliance for Cervical Cancer Prevention (ACCP)
ACCP was established in 1999 by a Bill and Melinda Gates Foundation five-year, $50 million grant. Made up of five international organizations: International Agency for Research on Cancer, Pan American Health Organization, EngenderHealth, and JHPIEGO (affiliated with Johns Hopkins University) and the Program for Appropriate Technology in Health, the alliance has a shared goal of working to prevent cervical cancer in developing countries.
American Institute for Cancer Research (AICR)
AICR’S grants program funds research projects with matching support from for-profit corporations. The program gives companies access to leading researchers in the field of diet, nutrition, and cancer, and use of AICR’s NCI-approved peer review system. The program provides up to $75,000 per year (plus 10 percent for indirect costs) for renewable, two-year grants, providing companies with a cost-effective means to support high-quality research efforts. Matching funds may result from tax-deductible donations from collaborating corporations or individuals. AICR reserves the right to decline outside funds deemed inappropriate or that may result in a conflict of interest.
Global Alliance for TB Drug Development (TB Alliance)
Launched in 2000, TB Alliance is a public-private partnership and not-for-profit organization based on the premise of shared risks and incentive for partners
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
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.
Rat Genome Sequencing Project
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
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
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)
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
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
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
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)
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.
The Whitaker Foundation
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)
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
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
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
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
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)
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
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
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
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-
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)
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)
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
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.
Genome Canada (GC)
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.
Ontario Research and Development Challenge Fund (ORDCF)
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)
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.
Joint Infrastructure Fund (JIF)
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
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)
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.