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October 31, 2014
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111th Congress

Session I | arrow indicating current page Session II

Testimony before the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Committee on Appropriations United States Senate

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Providing Support for Innovative Research Projects

 

Statement of
Lawrence A. Tabak, D.D.S., Ph.D
Acting Deputy Director, National Institutes of Health
and
Director, National Institute of Dental and Craniofacial Research, National Institutes of Health
U.S. Department of Health and Human Services

 
NIH
 

Good morning, Mr. Chairman.  I am Dr. Lawrence Tabak, Acting Deputy Director of the National Institutes of Health, and Director of NIH’s National Institute of Dental and Craniofacial Research.  It is my pleasure to testify before you today on the NIH’s efforts to fund innovative research, in biomedicine generally and in cancer research particularly.

 

Shortly after WWII, the cornerstones of NIH – its peer review process and its scientific and public advisory structure – were set in place.  Our current grants program, refined through an ongoing iterative process that reflects the changing demands of science and society, continues to rest on this foundation.  Much admired and often imitated throughout the world, the NIH peer review process has produced impressive results.  These results have been widely documented, most recently by Kenneth Manton and his colleagues in their study of the longitudinal correlation of investment in NIH research with a significant decline in mortality in 4 major chronic diseases. 1  The NIH’s grant process has allowed the Agency to fulfill its mission of seeking scientific knowledge to improve the public’s health.

 

Given the rapidity of scientific progress and the remarkable technology that we have available, we know that we must continue to enhance our support for potentially innovative, high-impact research.  There is a tension inherent in our grant-making process.  Given finite resources, how do we balance support for projects that promise more certain results with those that are riskier, but hold the possibility of greater reward?  “Innovation”, “transformation” and “impact” are notoriously more difficult to recognize prospectively than retrospectively.  These challenges do not reduce our responsibility to aggressively engage the issue of supporting the research that has the greatest potential impact. 

 

Current NIH Support for Innovative Research

 

Let me highlight several areas that NIH is engaged in to strengthen our support for more innovative and high impact research.  In June, 2007 NIH launched a comprehensive effort to enhance our peer review system and make it more sensitive to both the impact and innovation of the proposed work.  Extensive input was sought and received from a wide range of stakeholders across the country, which led to a comprehensive report released in February 2008 detailing the challenges facing our current system, and proposals for improvement.  Four interrelated core strategies emerged to enhance our system of peer review: 1) engage the best reviewers; 2) improve the quality and transparency of reviews with a greater focus on scientific impact; 3) provide for fair reviews across career stages and scientific fields with a greater focus on early stage investigators and transformative research; and 4) develop a permanent process for continuous review of peer review.

 

A new review process and a new scoring system has been implemented and was employed for the recent Challenge Grant and Grand Opportunity ARRA programs.  Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of five core review criteria: significance, investigator(s), innovation, approach, and environment.  Under the approach criterion, specific consideration is given to the level of risk. The scoring system will be changed completely to modify previous patterns of review.

 

The NIH Roadmap for Medical Research was introduced by former NIH Director, Dr. Elias Zerhouni in 2003.  The intent of the Roadmap was to support transformative, high-impact research that expands beyond the boundaries of any single NIH Institute or Center and holds significant promise for improving the public’s health.  Congress provided a legal authority for an NIH Common Fund, which institutionalized the Roadmap concept within the NIH Reform Act of 2006 (Pub. L. 109-482).   The Common Fund acts as an incubator space in which new ideas and approaches can be tested, developed, and, ultimately, moved out of the Common Fund and into the larger biomedical research community.  

 

Though the Common Fund has many facets, I will focus on three of its programs that specifically support innovative researchers and projects.  The NIH Director’s Pioneer Award Program, first announced in 2004, is a high-risk research initiative designed to support individual scientists of exceptional creativity who propose pioneering – and possibly transforming – approaches to major challenges in biomedical and behavioral research.  To date, there have been 47 awardees; and already, their work is producing impressive, potentially transformative, results.  For example, in what has turned out to be quite timely research, a Pioneer awardee is employing antigenic cartography to map differences in seasonal influenza strains worldwide.  This knowledge should significantly improve our ability to track the influenza virus and select proper strains for vaccine preparation.  The New Innovator Award Program is targeted to highly creative investigators who are earlier in their careers and who have the potential to produce solutions for broad, important problems in biomedical and behavioral research.

 

Complementing the Pioneer and New Innovator Programs is the Transformative R01 Research Projects Program (T-R01), which will provide support for transformative projects that individual scientists or collaborative investigative teams propose.  The program is specifically designed to support exceptionally innovative, high risk, original and/or unconventional research with the potential to create new or challenge existing scientific paradigms.  Applications for this new program were recently reviewed with a two-stage process.  About 100 of 700 of the applications received met the threshold for transformation potential to be considered further for support.  Applications making this initial cut where then carefully reviewed by a very experienced panel of scientific notables and final funding decisions are to be made during this fiscal year.

 

Cancer Initiatives

 

Given your particular interest in Cancer research, I will highlight several of many highly innovative programs supported by the National Cancer Institute.  Forthcoming are new Physical Science-Oncology Centers where physicists, chemists, mathematicians and biologists will work collaboratively to develop new perspectives on the physical forces involved in cancer.  Initial competing awards will be funded with FY 2009 appropriated funds; the plan is to fund administrative supplements to the parent grant with ARRA dollars.  Remarkably, 7 Nobel laureates either applied for or participated in the review of this exciting new program, together with 24 members of the National Academy of Sciences and 9 National Academy of Engineering members who were included among the groups that applied for this opportunity.  This is clearly not business as usual!

 

Many questioned the decision to invest so many international resources in the human genome project – an effort that could not guarantee that its knowledge would lead to immediate medical applications.  Recently, however, Genome Wide Association Studies are helping to reveal the genetic roots of a rapidly expanding array of diseases.  NCI’s Cancer Genome Atlas Project recently announced [September 2008] the first results of its large-scale, comprehensive study of the most common form of brain cancer, glioblastoma.  The team discovered new genetic mutations and other types of DNA alterations with potential implications for the diagnosis and treatment of glioblastoma.

 

NCI also has invested in innovative research into biomarkers – molecules found in the body that can signal an abnormal process or disease, and can be meaningful in understanding the presence of disease or response to treatment.  In 2006, NCI, the U.S. Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services collaborated to form the Oncology Biomarkers Qualification Initiative (OBQI).  OBQI was designed to qualify biomarkers for use in clinical trials and, ultimately, to speed better agents to cancer patients.  For example, researchers are assessing the use of positron emission tomography (PET) to detect fluorodeoxyglucose (FDG), a potential biomarker in non-small cell lung cancer and non-Hodgkin's lymphoma clinical trials.  FDG-PET is an imaging test that uses a radioactive sugar molecule to produce images that show the metabolic activity of tissues.  In FDG-PET scanning, the high consumption of the sugar by cancer cells - as compared to the lower consumption by normal surrounding tissues - identifies these cells as cancer.  FDG's presence can be detected by PET imaging in tumors as small as one centimeter.  FDG-PET clinical trials could have significant impact on patient management by validating a tool that can identify response to treatment and help facilitate new drug development.

 

Conclusion

 

Thomas Kuhn, the pioneering American intellectual who popularized the concept of “paradigm shifts,” underscored the importance of what he called “normal” science in determining the consequences of revolutionary discoveries.  Both revolutionary and evolutionary research is essential in our efforts to improve human health.  Not long ago, vaccines against cancer seemed an unlikely development.  Then, scientists at the National Cancer Institute developed a virus-like particle technology that formed the basis for new commercial vaccines that target specific cancers.  In June 2006, the U.S. Food and Drug Administration approved the vaccine Gardasil, which is highly effective in preventing infections from the four types of human papilloma virus (HPV) that cause the majority of cervical cancers in women. The vaccine, made by Merck & Co., Inc., is based on laboratory research and technology developed at the National Cancer Institute.  NCI played a pivotal role in what holds promise to be a major public health success story.  Worldwide use of this vaccine could save the lives of 200,000 women each year. 

 

NIH has examined, and strengthened, its support for innovation: among scientists across all career stages; and for scientific research projects from laboratory to clinic to community.  We have sought out ways to remove the roadblocks that have hindered interdisciplinary cooperation and the exploration of unconventional leads.  Through the Common Fund and its programs; through initiatives undertaken by NIH Institutes and Centers; and, as early studies suggest, from our enhanced approach to peer review, we are already discovering unexpected connections between disciplines, diseases, and biological processes. 

 

NIH continues to enhance its ability to identify and support innovative and high-impact research through the creation of experimental spaces for testing new ideas; the introduction of novel programs; and the invention of new approaches to assess results.  Supporting innovative research and pioneering researchers is a top NIH priority.  If NIH is to continue along this path, NIH’s stakeholders – the whole of the Nation, and researchers around the world – must themselves embrace a new paradigm.  If we agree to accept more risk, we must also accept more risk of failure. To do otherwise is to hinder innovation.  As Elias Zerhouni often noted, “The best way to ensure failure in science is to try to ensure success.”  Therefore, we must identify the amount of risk that is acceptable and in that context balance NIH’s research portfolio to support an optimal balance of innovative and evolutionary research.

 

This concludes my statement, Mr. Chairman.  I will be happy to answer any questions you may have.

 
 

1Manton, KG, Gu, Xi-Liang, Lowrimore, Gene, Ullian, Arthur, Tolley, H. Dennis (2009) NIH funding trajectories and their correlations with U.S. health dynamics from 1950 to 2004. Proc Natl Acad Sci USA Early Edition, www.pnas.org/cgi/doi/10.1073/pnas.0905104106.

 
 

 

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