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

Common Fund Strategic Planning Report, 2008

I. Background and Budget of the Roadmap/Common Fund

• 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

• 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.

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

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.
   
   

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.
   
   

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

• 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.

• 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.