New Roadmap Emphasis Areas for 2008

The Roadmap Begins

Soon after becoming the Director of the National Institutes of Health (NIH), in May 2002, Elias A. Zerhouni, M.D. convened a series of meetings to chart a "roadmap" for medical research in the 21st century. Since its inception, the NIH Roadmap for Medical Research has been an “incubator space” for programs that, due to their cross-cutting relevance and/or complexity, warrant concerted attention from NIH as a whole. The initiatives have been jointly funded by all Institutes and Centers (ICs) via the NIH Common Fund, and all of the initiatives are collectively planned and administered by trans-NIH teams.

The First Initiatives

After considerable consultation with internal and external communities, NIH funded the first set of Roadmap Initiatives in fiscal year 2004. The activities that emerged from this first group of initiatives are deepening our understanding of biology, stimulating interdisciplinary research teams, and reshaping clinical research. The reshaping of the clinical research enterprise is intended to accelerate medical discovery, increase the number of clinician scientists, and enhance the participation of communities of clinicians in clinical research.

Out from the Incubator

This first cohort of Roadmap initiatives will gradually transition out of the “incubator space” by fiscal year 2014. To draw new projects into the incubator, NIH began a process of soliciting new ideas for the next set of Roadmap trans-NIH strategic initiatives for funding consideration in fiscal year 2008.

Criteria for New Roadmap Initiatives

Recognizing that the NIH Institutes and Centers (ICs) frequently and regularly collaborate to fund research, the IC Directors established special criteria for initiatives to be funded via the Roadmap. The criteria that potential Roadmap initiatives must meet are as follows:

• 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 synergistically must 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

The New Idea Solicitation Process

Through the summer and fall of 2006, NIH solicited ideas for initiatives that meet these criteria from: (1) external panels of scientific consultants; (2) from the internal NIH community and, (3) from the broad stakeholder communities

The Office of Portfolio Analysis and Strategic Initiatives (OPASI) Facilitates the Process

To facilitate the prioritization of ideas, OPASI coordinated a programmatic review of the submitted ideas concerning their responsiveness to the criteria. In addition, to further inform the decision-making process, OPASI and the ICs worked together to provide a preliminary assessment of the currently funded portfolio of research related to several of the broad areas highlighted by the ideas.

Implementation

Informed by this analysis and following extensive scientific discussion, the IC Directors selected thirteen broad areas that will undergo further concept development over the upcoming months. During concept development, these broad areas will be refined into specific initiatives, keeping in mind the Roadmap criteria. Although these areas are very broad and many possible initiatives may be envisioned, those that move forward will be expected to have a transformative impact on the way science is conducted.

Possible Topics for Major Roadmap Initiatives

The IC Directors have selected five topics to be developed for further consideration as Major Roadmap Initiative Proposals:

• Microbiome – The Microbiome is the full collection of microbes (bacteria, fungi, viruses, etc.) that naturally exist within the human body. Initiatives in this area would focus on developing a deeper understanding of these communities of microbes in order to determine how they affect human health.
• Protein Capture/Proteome Tools – The Proteome is the complete set of proteins in the body. Efforts in this area would support developing and making available to the scientific community high quality probes specific to every protein in the human and in desired animal models. This would allow the ability to characterize protein function in health and disease and to monitor the markers of a disease in order to deploy early prevention efforts and to identify potential therapeutic targets.
• Phenotyping services and tools – A human Phenotype is the total physical appearance and constitution of a person, often determined by multiple genes and influenced by environmental interactions. Initiatives in this area would encourage the development of resources to systematically catalog human phenotypes in an effort to characterize complex diseases and disorders.
• Inflammation as a common mechanism of disease – While significant breakthroughs have occurred in our understanding of inflammation, research is needed to further understand inflammatory processes. Because inflammation is broadly implicated in many diseases and conditions, this initiative would be valuable in uncovering as-yet-unknown immune mechanisms and mediators of inflammation as well as genetic factors, environmental triggers, and the relationship of inflammation to disease.
• Epigenetics – Epigenetics is the study of stable genetic modifications that result in changes in gene expression and function without a corresponding alteration in DNA sequence. The epigenome is a catalog of the epigenetic modifications that occur in the genome. Epigenetic changes have been associated with disease, but further progress requires the development of better methods to detect the modifications and a clearer understanding of factors that drive these changes.

Also, the IC Directors recognized that other concepts highlighted through the idea nomination process are potentially important. However, they are not appropriate at this time for selection as major Roadmap Initiatives. These areas were designated for development through smaller pilot studies proposals:

• Genetic Connectivity Map – The Connectivity Map is an effort to discover and demonstrate the linkages between diseases, drug candidates, and genetic manipulation.
• Transient Molecular Complexes – Transient Molecular Complexes are temporary molecular complexes that are continuously created and destroyed within our cells. Our current level of understanding of cellular biology and the complex interactions that lead to the development and progression of diseases is primarily based upon easily characterized static models (which do not include transient complexes). Understanding interactions within transient complexes is essential for robust modeling that can accurately describe how diseases develop and progress.

More Opportunities for Trans-NIH Coordination

In addition, other areas of research that were not selected for further development as potential Major Roadmap Initiative Proposals were highlighted as areas where additional information would be useful in determining next steps. The Roadmap idea gathering phase highlighted issues within each of these areas that the ICs may need to address, but more information concerning the current research portfolio and efforts to coordinate activities in these areas is needed. The question to be determined is whether current administration of research in these areas is optimally coordinated or whether additional efforts are needed. Therefore, Roadmap Coordination groups will assess current efforts in the following areas, and if deemed necessary, will propose activities that the NIH may undertake to foster collaborations across organ systems or disease areas:

• Regenerative Medicine – Tissue Engineering and Regenerative Medicine involves the engineering of healthy, functional tissues/organs in vitro for implantation and the remodeling or regeneration of tissue in vivo to repair, replace, preserve, or enhance tissue/organ function.
• Pharmacogenomics – Pharmacogenomics applies the power of genomics to the prediction of individual responses to medication. By determining the variations in the human genome that predict likelihood of response (or susceptibility to adverse effects), the type and dose of medication can be adapted to each person's unique genetic makeup, thereby assuring greater efficacy and greater safety of treatment.
• Bioinformatics – Bioinformatics applies principles of information sciences and technologies to make the vast, diverse, and complex life sciences data more understandable and useful.

Planning for the Future

Finally, the Roadmap idea nomination process highlighted areas where broad strategic thinking and planning are needed to fully address the needs expressed by the community. For these areas, groups will work with members of the broad community over the course of several months to articulate a coherent plan that could involve possibly restructuring of existing programs, assessing the efficacy of different types of programs, or development of new initiatives. These Roadmap Strategic Planning Activities will be focused on the following topics:

• Training/Careers – This initiative seeks to address concerns with current NIH training programs. Staff will collaborate with academic institutions and scientific societies to determine what the scientific workforce should look like and to define multiple career paths and training programs to foster the development of an optimal workforce.
• Health Disparities – Numerous offices and programs at NIH support research on understanding the causes of and potential interventions for addressing health disparities across population groups in the US. NCMHD currently serves as the NIH lead for strategic planning and coordination of research funding in this area. The roadmap strategic planning effort in this area will determine whether additional activities such as further analysis of the current NIH portfolio to determine gaps in this area or new methods to promote coordination of activities in this area across the agency would be of added value in support of current NCMHD activities.
• Science of Science Administration – This concept is an attempt to determine the most effective administrative approaches (eg., review processes or funding mechanisms) for achieving programmatic goals such as high innovation, support of junior investigators, productive research teams, etc.

Determining Funding Priorities

Plans for each of the above will be developed over the next few months with input from a Council of Councils which will be an Advisory Council composed of members from Advisory Councils for all ICs and from the Council of Public Representatives. The plans will then be reviewed by IC Directors in order to determine Roadmap funding priorities beginning in fiscal years 2008 and 2009.

These plans will receive final review and priority recommendations in late Spring, 2007 by the IC Directors before being forwarded to the NIH Director, who will consult with the Advisory Committee to the Director before selecting the new Roadmap initiatives in Summer/Fall 2007.

Announcing Results

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