When Dr. Elias Zerhouni undertook his post as Director of the National Institutes of Health (NIH) in 2002, he introduced the concept of a “roadmap” for medical research that would identify significant opportunities and challenges that should be addressed by NIH as a whole—not just by individual Institutes or Centers. Convening a series of meetings involving more than 300 nationally recognized leaders in industry, government, academia and the public the work on creating the Roadmap commenced. These meetings provided the framework for the NIH Roadmap and thereby, the future of medical research.
The Roadmap’s initial vision and priorities were divided into three broad themes, New Pathways to Discovery, Research Teams of the Future and Re-engineering the Clinical Research Enterprise, each with its own set of initiatives. (See page 13 for a breakdown of the themes and the initiatives.)
A good deal of progress has been made in the intervening years, including the creation of the National Technology Centers for Networks and Pathways, the Molecular Libraries Screening Center Network (MLSCN), the NIH Director’s Pioneer Awards and Clinical Research Networks/NECTAR, among others.
The Roadmap initiatives have generated funding opportunities for a variety of organizations, including small businesses, individuals, not-for-profits and academic institutions. Below are listed some relevant Roadmap solicitations and notices, with more information and funding sources to be found at: http://nihroadmap.nih. gov/grants/index.asp.
Notice of Opportunity for Fast Track Entry of Assay Development Projects into the Roadmap Molecular Libraries Screening Center Network NOT-RM-07-012 Solicitation of Compounds for High Throughput Screening (HTS) in the Molecular Libraries Screening Centers Network (MLSCN) NOT-RM-07-005
NIH Director’s Pioneer Award Program (DP1) RFA-RM-08-013
Notice of Intent to Publish a Limited Solicitation for Pilot Projects in Informatics for Clinical and Translational Science Awards NOT-RR-07-012
One initiative of the Roadmap, found under the theme of Research Teams of the Future, may be of special interest to small businesses—the Public-Private Partnership Program. While this program does not provide funding, it will, among other tasks, serve as the point of contact for entities wishing to partner with the NIH. The program is to provide contact information, as well as advice concerning the initiation, establishment and implementation of new partnerships, complementing the ongoing effort of the Institutes and Centers in their work with the private sector. For more information on the Public-Private Partnership program, visit: http://nihroadmap.nih.gov/publicprivate/.
With the first wave of projects successfully underway, the NIH spent the second half of 2006 soliciting the scientific community, patient advocates and the public at large, for ideas to form new initiatives that would address challenges in biomedical research. Following considerable scientific discussion, the decision was to focus on four broad areas: Major Roadmap Initiatives, Pilot Studies, Coordination Areas and Strategic Planning Areas, with requests for applications (RFAs) relating to these initiatives and studies to be released on a variable timeline in late 2007 through mid-2008.
In May 2007, four specific topics were chosen by the Institutes and Centers’ Directors to move forward as Major Roadmap Initiatives. The first two, Microbiome and Epigenetics Programs, are to be implemented as five year programs. The remaining two programs, Protein Capture Tools and Phenotyping Services/Tools, are being implemented in stages, with second phase funding contingent on outcomes of the first phase research. Only one Pilot Program was chosen for support at the May meeting—the Genetic Connectivity Map (CMAP). (See topics with descriptions and potential funding opportunities below).
As for the working groups attached to Coordination Areas and Strategic Planning Areas, their activities are still ongoing. The Coordination Area groups are assessing current efforts in the areas of Regenerative Medicine, Pharmacogenomics and Bioinformatics.
The Strategic Planning Area groups are focusing their activities on topics in Training/Careers, Health Disparities and Science of Science Administration. For more information concerning the Coordination Areas and Strategic Planning, visit: http://nihroadmap.nih.gov/grants/sbir-sttr.asp.
It is essential to note that the Roadmap is not set in stone and that it will change as knowledge and technology move forward. Creating sweeping change in an agency as large as the NIH and in an area as critical as human health cannot be done overnight, but can certainly create unique opportunities for innovative small businesses. The Roadmap is an effective tool for small firms in the health care market, allowing them to follow what areas/challenges the NIH considers crucial to the future of health care. This can ultimately lead to funding, either through NIH initiatives directly or through contracting/partnering with other businesses.
Areas that are deemed important to NIH and hold promise for the future will likely receive funding in one way or another. A statement that, given the 8.2 percent increase in spending provided to the NIH by the 109th Congress from FY2007 to FY2008, seems to hold true.
Microbiome- The proposed Human Microbiome Project is focused on characterizing the microbial content of sites in the human body and then examining whether or not changes in the microbiome can be related 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. These epigenetic changes have been associated with diseases. A catalog, the epigenome, was created, noting the epigenetic modifications that are known to occur in the genome, but further progress requires the development of better methods to detect the modifications and a clearer understanding of factors causing the changes.
As of this publication’s printing, there are no solicitations currently listed for these initiatives.
Protein Capture Tools / Proteome Tools- This initiative would support developing high-quality probes, specific to every protein in the human body, as well as those in requested animal models, and making them available to the scientific community. The information would allow the characterization of protein function in both health and in disease and would provide a way to monitor the markers of a disease.
Phenotyping Services and Tools- The goal of programs in this area would be the development of resources to catalog human phenotypes, ultimately characterizing complex diseases and disorders.
Genetic Connectivity Map (CMAP)- CMAP is an effort to discover and demonstrate the linkages between diseases, drug candidates and genetic manipulation.
With so many areas to cover, it is important to network and stay connected to potential funding sources at the NIH. Each Institute and Center has a liaison for the Roadmap. The relevant contact for each can be found on the NIH Roadmap site, visit http://nihroadmap.nih.gov/ricl.asp.
The NIH also provides a tool to assist those seeking funding. It is the electronic publication called the NIH Guide. The Guide, published weekly, provides highlights of all NIH funding opportunities and notices. To learn more and to register to receive the publication, visit: http://grants.nih.gov/grants/ guide/WeeklyIndex.cfm.
And though it would not meet the criteria of Phase III commercialization funding, the SBIR/STTR program also has Roadmap-relevant opportunities. These can be found by visiting: http://nihroadmap.nih.gov/grants/sbir-sttr.asp.
Ultimately, the NIH Roadmap is creating opportunities for small businesses and the future of medical research certainly looks bright, when looking in the right directions. ♦
This area of the Roadmap addresses the need to advance understanding of complex biological systems and the accessibility of technologies, databases and resources. With the completion of the human genome sequence and recent discoveries in molecular/cell biology a better medical research “toolbox” is in the works.
Initiatives
This area of the Roadmap encourages scientists of varying disciplines to collaborate and expand their approach to the scientific enterprise. This should stimulate new ways of combining skills and disciplines, in both the physical and biological sciences. The intent is to accelerate scientific findings from bench to bedside.
Initiatives
The NIH is focused on the transition of basic research discoveries into drugs, treatments and methods for prevention and the simplification of the regulatory process. NIH intends to promote better integration of existing clinical research networks, improve the training of clinical researchers and encourage the development of technologies to advance the assessment of clinical outcomes.
Initiatives