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Biennial Report of the Director
National Institutes of Health Fiscal Years 2006 & 2007



Appendices

Appendix C:
Common Fund Strategic Planning Report, FY 2008

National Institutes of Health, Department of Health and Human Services, March 2008

Common Fund Strategic Planning Report, 2008

Scientific staff of the National Institutes of Health (NIH) are implementing new initiatives that have been approved for support through the Common Fund starting in FY 2008. The staff have consulted with experts inside and outside NIH to identify and refine initiatives that will most efficiently and directly meet the scientific need and criteria established for use of the Common Fund. This updated report describes the strategic process that guides the use of the Common Fund, new initiatives that have been chosen for implementation, additional concepts that remain in development, and plans for ongoing identification and development of Common Fund initiatives.

I. Background and Budget of the Roadmap/Common Fund

In FY 2003, Dr. Elias Zerhouni established the NIH Roadmap as a defined, centralized pool of funds to provide virtual “incubator space” or venture capital to support innovative research initiatives that address grand challenges in basic, clinical, and translational research. With funding beginning in FY 2004, the NIH Roadmap became the foundation for the Common Fund. In January 2007, President Bush signed into law the National Institutes of Health Reform Act of 2006, Pub. L. No. 109-482, which reauthorized the NIH, affirming its vital role in advancing biomedical research, and codified the Common Fund.

In FY 2004-FY 2006, the Common Fund was composed of contributions from each of the NIH Institutes and Centers as well as the NIH Office of the Director (OD). In FY 2007 and FY 2008 appropriations action, the Congress directly appropriated resources for the Common Fund to the OD. The following table shows Roadmap/Common Fund dollars and their percentage of NIH Labor/HHS budget authority by fiscal year:

Dollars in Millions FY 2004 Actual B.A. FY 2005 Actual B.A. FY 2006 Actual B.A. FY 2007 Joint Resolution FY 2008 Appropriation
Institute or Center Roadmap/Common Fund Contribution $93.5 $175.7 $247.3 $0.0 $0.0
OD Roadmap/Common Fund Contribution $38.4 $64.0 $85.3 $483.0 $495.6
Roadmap/Common Fund $131.9 $239.7 $332.6 $483.0 $495.6
Roadmap/Common Fund Percent of NIH Labor/HHS Budget Authority 1 0.5% 0.8% 1.2% 1.7% 1.7%


The OD appropriation for FY 2008 included $495.6 million for the Common Fund. The NIH is using those funds to support:
  • a) The cohort of NIH Roadmap/Common Fund research initiatives that began between FY 2004 and FY 2007. The estimated funding for these initiatives (summarized in Section III) in FY 2008 is $464 million.

  • b) The Human Microbiome Project and the Epigenomics program, which have been added to the Common Fund in FY 2008 to support the development of novel research tools, technologies, and resources for research on microbes associated with the human body and epigenetic changes linked to human disease. The Common Fund is providing $32 million to launch these programs in FY 2008 (described in Sections III and IV).

II. Strategic Planning for the Roadmap/Common Fund

Planning and implementation of the Roadmap/Common Fund are highly dynamic processes that are intended to afford NIH the flexibility to quickly respond to new ideas, challenges, gaps, and advances in biomedical research. Nonetheless, decisions on the use of the Common Fund are based on strategic principles that defined the challenges and goals during the creation of the Roadmap and that guide the identification of new initiatives that receive support through this program.

A. Challenges Faced by NIH and the Biomedical Research Enterprise
The evolution of biomedical research in recent decades has led to an explosion of knowledge and technology that has revolutionized our understanding of basic biological systems and transformed the practice of medicine. Many of these advances, such as the Human Genome Project (HGP) and the state-of-the-art research technologies that were developed to complete that project, have created the means to compile vast amounts of biologically-relevant data and the corresponding need for new tools to effectively mine that data for new knowledge. In contrast, some research fields, such as fundamental research to characterize the microbes that live in and affect the human body, have lagged behind because they fall into “gaps” in traditional NIH programmatic approaches and funding mechanisms. The NIH recognized an opportunity to address these challenges by devising a new approach that would meet the research and training needs of biomedical research in the 21st century and accelerate the transformation of scientific knowledge into real benefits for public health.

B. Goals of the Roadmap/Common Fund
To respond to new opportunities and fill important research gaps, the NIH developed the Roadmap program (funded through the Common Fund) in consultation with leading experts from academia, industry, government, and the public. The NIH Roadmap/Common Fund supports wide-ranging and ambitious initiatives related to emerging opportunities and challenges. These activities focus on fundamental barriers to basic, clinical, and translational research that often require new multidisciplinary approaches, collaborations, synergies between basic science, clinical research, and informatics, as well as new training approaches for scientists. The Common Fund facilitates transformative research or technology development with cross-cutting relevance to many research disciplines, diseases or conditions, and biological questions.

Three broad categories of research have been identified that encompass the goals of the Roadmap/Common Fund: New Pathways to Discovery; Research Teams of the Future; and Reengineering the Clinical Research Enterprise. Initiatives funded through the first and second cohorts fit into one of these major themes, which will continue to be primary focus areas for the foreseeable future. Specific elements within each theme area will evolve as programs transition out of the Common Fund and new ideas are developed. (Section III lists the current programs that address the goals of the three overarching themes.)

C. Identification of Ideas and Criteria for Use of the Common Fund
NIH is committed to a broad, representative process for proposing, reviewing, and selecting concepts for new initiatives to be developed and implemented through the Common Fund. Ideas can be submitted by members of the extramural or intramural scientific community, health professionals, patient advocates, or the general public. After a public comment period, current initiatives were chosen for inclusion in the Common Fund by Institute and Center (IC) Directors and the NIH Director in consultation with the Advisory Council to the Director. For FY 2009 and future years, the newly-formed Council of Councils, which includes representation from each of the individual IC advisory councils, will participate in the prioritization of Common Fund projects, among other activities.

Specific criteria have been established to guide the ongoing development of Common Fund initiatives. Projects chosen for support must meet all five criteria:
  • The proposed initiative must be truly transforming. It must have high potential to dramatically affect how biomedical and/or behavioral research is conducted over the next decade.
  • The outcomes from the proposed initiative must synergistically promote and advance the individual missions of NIH ICs to benefit health.
  • The proposed initiative must require participation from NIH as a whole and/or address an area(s) of science that does not clearly fall within the mission of any one IC or OD program office.
  • The proposed initiative must be something that no other entity is likely or able to do.
  • There must be a public health benefit to having the results of the research in the public domain.
D. Transition of Common Fund Initiatives
As a virtual incubator space for trans-NIH research initiatives, the Common Fund supports initiatives for a limited amount of time (5-10 years). This defined period of funding is intended to be catalytic—that is, the Roadmap initiatives are designed to establish new resources, tools, and technologies that will then be available for the broad scientific community to incorporate into research efforts funded through more typical mechanisms. Likewise, fundamental knowledge gaps that are filled through Roadmap projects will stimulate research proposals in many fields that can be submitted for review and funding by appropriate Institutes or Centers. The Roadmap is also intended to catalyze the development of critical research services that benefit the mission of all the Institutes and Centers and that, once developed, can be supported through the Institutes and Centers. Thus, the rigorous selection processes allow innovative initiatives to enter the incubator space for short-term support to prove their value to the research community.

At the end of the defined funding term, each initiative will have one of several possible outcomes. Programs that were designed from the outset to achieve their goals within the timeframe of support by the Common Fund will end. Other programs may end due to unmet objectives. Innovation often requires risk, and a fundamental goal of Roadmap programs is to foster innovative approaches to complex problems. Therefore the NIH encourages risk taking in the Roadmap and expects that some Roadmap programs may not be successful. Finally, many initiatives are expected to transition to other sources of support once the Roadmap “incubation” period has ended. If the programs have proven utility to the research missions of the Institutes and Centers, the Institutes and Centers either individually or via joint funding mechanisms will provide continued support. Alternatively, programs may continue to be funded via private foundations or research institutions. From the beginning of the funding period, each initiative has a transition plan that describes the anticipated path after Common Fund goals are achieved. Advanced planning for the strategic transition or termination of all initiatives selected for Common Fund support ensures that the program remains nimble and capable of responding to high-priority opportunities in a timely manner.

The majority of the first cohort of initiatives funded through the NIH Roadmap/Common Fund continues to receive support in FY 2008 through the Common Fund. In general, these research initiatives are expected to transition out of the Common Fund by 2013. In the meantime, each of these initiatives and all new initiatives are subject to objective reviews to ensure high quality research and to monitor progress. Continuation of support by the Common Fund is based in part on the outcome of these evaluations.

III. Implementation of the NIH Roadmap/Common Fund Strategic Plan, FY 2004-2008

FY 2008 funding continues support for the first cohort of NIH Roadmap/Common Fund initiatives. To take advantage of new opportunities, the NIH maintains a degree of flexibility in the allocation of funds. Emerging opportunities that have been identified and prioritized by the NIH for support by the Common Fund include the NIH Director's New Innovator Awards, which were first awarded in FY 2007, and the Human Microbiome Project and the Epigenomics program, which began implementation in FY 2008.

A. New Pathways to Discovery: Facilitates the development of research tools and/or methodologies that are of use to wide swaths of the scientific community; fills fundamental knowledge gaps to result in new scientific paradigms. Seven components comprise this theme, including two new initiatives for FY 2008.

  1. Molecular Libraries and Molecular Imaging
    Establishes a national network of Centers and various supporting technologies for the discovery and development of small molecule probes to interrogate biological pathways.

  2. Building Blocks, Pathways, and Networks
    Focuses on new technologies that are necessary to accelerate the process of scientific discovery and the understanding of biological pathways.

  3. 3) Bioinformatics and Computational Biology
    Develops informatics and computational tools tailored to handle the large amount of s cientific data generated using cutting-edge discovery technologies.

  4. Nanomedicine
    Establishes a network of Nanomedicine Centers at academic institutions, to study how molecular structures are constructed and how they function.

  5. Structural Biology
    Establishes Centers for Innovation in Membrane Protein Production that aim to formulate new methods and techniques for producing ample quantities of cellular membrane proteins that are of a quality suitable for structural and functional studies.

  6. Human Microbiome Project (new for FY 2008, see section IV)
    Develops tools and generates resources to facilitate characterization of the human microbiome and analysis of its role in human health and disease.

  7. Epigenomics (new for FY 2008, see section IV)
    Develops comprehensive reference maps of the human epigenome and new technologies for epigenomic analysis to define the relationship between the epigenome and human health and disease.

B. Research Teams of the Future: Supports investigators in new ways, encouraging team approaches to complex problems and highly innovative research.
  1. Interdisciplinary Research
    Overcomes barriers to interdisciplinary research by building teams, training scientists in multiple disciplines, and changing academic research culture.

  2. Director's Pioneer Award
    Supports visionary scientists to carry out extensive, high-risk, highly innovative research. These investigators perform research that is broad in its scope and may contribute to a transformation of new, fundamental principles within that research niche.

  3. Public-Private Partnerships
    Provides a point of leadership and coordination for the harmonization, streamlining, and optimization of the NIH partnership activities.

  4. NIH Director's New Innovator Awards (new in FY 2007)
    Stimulates highly innovative research and supports promising new investigators who propose exceptionally creative approaches that have the potential to produce an unusually high impact on the research enterprise.

C. Reengineering the Clinical Research Enterprise: Changes clinical research infrastructure to improve the ability to systematically leverage medical resources. This includes proposals and policy decisions that affect the culture and manner in which research is conducted.
  1. Clinical Translational Science Awards (CTSAs)
    Transforms how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS)
    PROMIS is a revolutionary effort to enhance the precision of measures of patient-reported symptoms and function.

  3. Translational Research Core Services
    Makes available, on a competitive basis, certain critical resources needed for the development of therapeutic agents and to bridge the gap between discovery and clinical testing so that more efficient translation of promising discoveries may take place.

  4. Clinical Research Policy Analysis and Coordination
    Serves as a focal point for the ongoing coordination, streamlining, and optimization of policies and requirements concerning the conduct and oversight of clinical research.

  5. The National Electronics Clinical Trials and Research Network (NECTAR)
    Addresses the growing role of informatics in the medical field, particularly in conducting clinical trials. This initiative supports pilot studies that will provide the basis for a unified informatics system. This program has merged with the CTSAs for FY 2008 and beyond.

  6. The National Clinical Research Associates (NCRA)
    Establishes and trains cadres of community-based health practitioners to conduct clinical research in collaboration with academic researchers. This program has merged with the CTSAs for FY 2008 and beyond.

IV. Ongoing Development of Common Fund Initiatives

To plan for the use of new funds expected to become available in FY 2008, the NIH undertook an intensive, wide-ranging, and transparent planning process that solicited input from NIH staff and scientists, extramural researchers, and the broader stakeholder community on gaps in knowledge or tools that impede certain types of research from moving forward. After reviewing and prioritizing more than 300 ideas for new initiatives, the NIH selected two major programs for implementation beginning in FY 2008 with resources from the Common Fund. Each of these multicomponent programs represents the integration of several original ideas submitted for review. Other concepts remain under consideration for future implementation. The process of solicitation, review, and prioritization of concept proposals that could advance the mission of the NIH as a whole and that meet the criteria for Common Fund support will continue in FY 2008 and will be repeated each year to allow emerging opportunities to be identified.

A. New Common Fund Initiatives for Implementation in FY 2008
The two initiatives being launched in FY 2008—the Human Microbiome Project and the Epigenomics program—are associated with the general theme of “New Pathways to Discovery.” These programs each respond to the Common Fund goals of advancing basic knowledge and developing new tools or resources that will be broadly applicable to many research fields. In FY 2008, the NIH is spending a combined $32 million from the Common Fund on the first year of funding for these initiatives.
  • Human Microbiome Project: The human body contains ten times as many microbial cells—bacteria and other micro-organisms—as it does human cells. These microbes, which are found in locations throughout the body, are thought to have a profound influence on many biological processes, including development, immunity, and nutrition. However, technical difficulties in isolating and studying many of these organisms have limited our ability to fully understand the effects of the microbiome on human health and disease. The Human Microbiome Project will generate resources and support the development of new technologies and computational approaches to facilitate the characterization of the highly complex human microbiome. This project will improve our knowledge of how changes in the microbiome correlate with changes in human health.

  • Epigenomics: The human epigenome is the collection of all stable, “epigenetic,” modifications of the human genome structure that do not change the DNA sequence. Some human diseases are known to be associated with epigenetic changes, but little is known about the factors that cause these changes. Moreover, new tools are needed to more efficiently detect epigenetic changes and correlate them with specific diseases or health conditions. The Epigenomics program will support efforts to map all common epigenetic changes in the human genome and to develop new technologies and data analysis tools for detecting and studying epigenetic modifications. Public databases will be made available to the broad research community to facilitate progress in epigenomics research.
B. Concepts in Development for Future Implementation
Two additional programs are being refined for possible future implementation. Each of these initiatives, if chosen for funding, also represents the synthesis of multiple ideas submitted through the proposal review and prioritization process. The process of soliciting, reviewing, and developing new concepts that meet the criteria for Common Fund support will continue in FY 2008 and future years to ensure that the Roadmap/Common Fund rapidly identifies and responds to emerging scientific opportunities.

  • The Protein Capture Tools/Proteome Tools project will develop and disseminate high quality probes that can be synthesized reproducibly for the detection and analysis of proteins. Such tools would enable researchers to characterize protein function in health and disease and would reveal new targets for disease prevention and therapy. This initiative, if implemented, would address the general theme of “New Pathways to Discovery.”

  • The Phenotyping Services and Tools project will develop resources for the systematic characterization of human phenotypes—the total physical appearance and constitution of an individual—to facilitate the study of complex diseases. If funded, this initiative would be part of the “Reengineering the Clinical Research Enterprise” theme area.
1Adjusted for Type I Diabetes, Global Fund for AIDS, Superfund, Secretary's transfer authority for NLM.

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