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
|OD Roadmap/Common Fund Contribution
|Roadmap/Common Fund Percent of NIH Labor/HHS Budget Authority 1
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
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
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
Specific criteria have been established to guide the ongoing development of Common Fund
initiatives. Projects chosen for support must meet all five criteria:
D. Transition of Common Fund Initiatives
- 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.
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.
B. Research Teams of the Future: Supports investigators in new ways, encouraging team approaches to complex
problems and highly innovative research.
- 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.
- 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) 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.
Establishes a network of Nanomedicine Centers at academic institutions, to study how
molecular structures are constructed and how they function.
- 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.
- 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.
- 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.
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.
- Interdisciplinary Research
Overcomes barriers to interdisciplinary research by building teams, training scientists in multiple disciplines,
and changing academic research culture.
- 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.
- Public-Private Partnerships
Provides a point of leadership and coordination for the harmonization, streamlining, and optimization
of the NIH partnership activities.
- 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.
- 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.
- Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS is a revolutionary effort to enhance the precision of measures of patient-reported symptoms and function.
- 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.
- 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.
- 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.
- 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
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.
B. Concepts in Development for Future Implementation
- 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.
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.
1Adjusted for Type I Diabetes, Global Fund for AIDS, Superfund, Secretary's transfer authority for NLM.
- 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
- 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