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Testimony

Statement by
Dr. Judith L. Vaitukaitis
Director, National Center for Research Resources
National Institutes of Health
on
Fiscal Year 2005 President's Budget Request for the National Center for Research Resources
before the
Senate Subcommittee on Labor-HHS-Education Appropriations

April 1, 2004

Mr. Chairman and Members of the Committee:

I am pleased to present the President's budget request for the National Center for Research Resources (NCRR) for Fiscal Year 2005, a sum of $1,094,141,000, including support for AIDS research, which reflects a net decrease of $84,815,000 over the comparable Fiscal Year 2004 appropriation, due entirely to the phasing out of extramural construction projects for FY 2005.

It is a pleasure once again to have the opportunity to present the accomplishments of NCRR-supported investigators and the future directions for NCRR programs. As a component of the National Institutes of Health, NCRR enables all lines of health-related discovery by supporting the creation and development of critical research resources and technologies. Because significant discoveries can be made at a variety of levels--from molecules to patients, or even patient populations–NCRR supports a wide range of research resources across several disciplines. These resources include state-of-the-art clinical research environments, such as the nationwide network of General Clinical Research Centers. The GCRCs facilitate clinical research and protect the safety of participants in research. Each year more than 10,500 NIH-supported investigators conduct nearly 8,000 research projects at the GCRCs, predominantly through more than a half million outpatient research visits.

NCRR also supports research resources that develop and enhance scientific access to advanced technologies, nonhuman models for the study of human diseases, and career development and training. Because of its trans-NIH focus, NCRR is well-positioned to facilitate research by promoting the sharing of research tools and technologies as well as providing the tools for research collaborations so that research teams may address more complex research problems.

TECHNOLOGY AND INSTRUMENTATION

NCRR strives to ensure that neither the lack of research resources nor technology development becomes rate-limiting for research. Two Nobel Prize winners in 2003 can vouch for the importance of having ready access to NCRR-supported resources. Dr. Roderick MacKinnon of Rockefeller University, co-recipient of the Nobel Prize in Chemistry, was honored for his groundbreaking studies of the structures and functions of ion channels, which control the movement of electrically charged atoms across cell membranes. Ion channel malfunctions can trigger a host of human disorders, including irregular heart rhythms and seizure disorders. Dr. MacKinnon noted that his award-winning discoveries depended on having access to the scientific expertise and advanced research instrumentation available at NCRR-supported resources that specialize in mass spectrometry and crystallography of complex molecules.

The challenge for NCRR is to keep pace with the biomedical community's changing needs for research tools and to ensure that tomorrow's research queries have tomorrow's critical instrumentation and technologies in hand. The research resources and tools needed for scientific investigations change dramatically over time as more complex research queries are posed and require new technologies. Many research tools now considered critical to understanding the cause of disease and protecting the health of Americans were unheard of just a few years ago. For instance, the Magnetic Resonance Imagers, or MRIs, now found in hospitals and medical centers across the country were rare and experimental less than 20 years ago. Dr. Paul Lauterbur of the University of Illinois, Urbana-Champaign, depended on NCRR for many of his investigations into magnetic resonance imaging. Dr. Lauterbur was co-recipient of the Nobel Prize in Physiology or Medicine for his studies that led to the development of MRI. From 1990 to 2000, Dr. Lauterbur headed an NCRR-funded magnetic resonance research center, which helped to facilitate the evolution of MRI into the invaluable diagnostic and clinical research tool that it is today.

CLINICAL RESEARCH RESOURCES

Just as NCRR technology and instrumentation resources laid the foundation for critical discovery in the basic and applied sciences, NCRR also catalyzes clinical and patient-oriented research through the network of GCRCs. In addition, NCRR develops and supplies investigators with clinical-grade biomaterials, such as vectors for gene therapy and human pancreatic islets for transplantation into patients with type I diabetes.

Research on rare diseases is one area where the GCRCs are ideally positioned to catalyze clinical research. Rare disease research is challenging in part because few patients with a particular rare disease can be recruited from any one clinical center. The nationally distributed network of the GCRCs makes them well-suited for enabling multicenter studies of rare conditions. Therefore, NCRR has partnered with the NIH Office of Rare Diseases and other groups to launch a network of Rare Diseases Clinical Research Centers. The network provides researchers with access to sufficient numbers of affected patients for statistically meaningful studies. The network also facilitates collaborations among scientists from multiple disciplines and institutions.

To ensure the safety of human subjects participating in clinical research projects, clinical investigators must adhere to Federal, state and local regulations, policies, and guidelines. Yet these necessary responsibilities place heavy demands on the time of already-busy clinician investigators. To address this issue, NCRR established a new GCRC staff position known as the Research Subject Advocate (RSA). The RSA assists GCRC investigators, nurses, and staff to underscore the safe and ethical conduct of clinical studies and represents the interests of research participants. NCRR plans to extend and strengthen the role of RSA in an approach that complements that undertaken by the host institution.

HEALTH DISPARITIES

NCRR also supports clinical research studies on health disparities, or diseases that disproportionately affect racial and ethnic minority populations. NCRR has joined with the National Institute of Mental Health to establish three Comprehensive Centers on Health Disparities. These Centers will further develop the capacity of Research Centers in Minority Institutions' (RCMI) medical schools to conduct basic and clinical research in type 2 diabetes and cardiovascular disease, both of which disproportionately affect minority populations. The Centers will provide support to further develop the requisite research infrastructure, recruit magnet clinical investigators, recruit and develop promising junior faculty, and facilitate substantial collaboration between the RCMI grantee institutions and more research-intensive universities. NCRR also supports a Stroke Prevention and Intervention Research Program that focuses on minorities, as well as a mentored clinical research career development program to provide clinical research training for doctoral and postdoctoral candidates in minority institutions.

BIOINFORMATICS AND COMPUTER NETWORKS

Whether studying clinical manifestations of disease or the basic biology of cells and tissues, today's biomedical researchers generate vast data sets. This data deluge has increased scientific demand for access to scaleable computation and modern management tools. A related and equally important trend is the fact that biomedical research projects are becoming broader in scope. For example, neuroscientists now want to correlate brain images with events at cellular and molecular levels, including gene expression. These broad research projects require large multidisciplinary teams, gathered from scientists distributed across the country.

To meet the challenges associated with these trends, NCRR supports the development of bioinformatics tools, including the software programs or algorithms that help scientists manage and analyze their data. NCRR also is instrumental in the creation of high-performance computer networks that link laboratories throughout the United States. A few years ago, NCRR joined with the National Science Foundation, Internet2, and investigators from several universities to establish the Biomedical Informatics Research Network (BIRN). The BIRN provides the tools for researchers to pool their data and to use federated databases so that they can oversee the integrity of their data, use bioinformatics tools for data mining, and visualize their data. In FY 2004, NCRR began expanding the number of BIRN sites in order to establish a national infrastructure of bioinformatics tools and provide access to scaleable computing that, in turn, is linked to a nationally distributed network of modern imaging capabilities for studies of degenerative brain disorders.

Other components of the BIRN network will link underserved institutions, such as doctoral degree-granting minority institutions and institutions in states that have received limited NIH research funding because they include very few research trained investigators, otherwise known as Institutional Development Award (IDeA) states. The networks will foster collaborative research and help investigators create a virtual critical mass of investigators. The BIRN also will foster collaborations across institutions located at remote sites. NCRR plans to establish a network for institutions with medical schools that are associated with NCRR's Research Centers in Minority Institutions (RCMI) Program. This electronic network will facilitate their participation in large clinical trials and other research studies and help define the factors contributing to health disparities among minority populations and ways to overcome those factors.

In concert with other NIH components, NCRR participates in many NIH Roadmap initiatives–for example, development of a National Electronic Clinical Trials and Research (NECTAR) network, which will form the backbone for all clinical research networks. An important component of NECTAR will be the standardization of patient data collection and storage procedures, which will facilitate data sharing by investigators. NCRR also supports other trans NIH Roadmap initiatives, including the National Centers for Biomedical Computing, Exploratory Centers for Interdisciplinary Research, and National Technology Centers for Networks and Pathways.

PROTEOMICS

The availability of complete genomes for a variety of organisms provides an important first step in understanding many complicated biological questions, including the molecular basis for disease. The next step in this process will be to develop technologies to quantitate spatiotemporal differences in the levels of gene expression, assess post-translational modifications of proteins, and characterize protein-protein interactions in both healthy and diseased cells.

NCRR will support the development of the necessary technology and infrastructure to advance the science of proteomics. An advanced proteomics center will focus on multiple technologies, including techniques for protein purification, structural techniques, mass spectrometry, and DNA microarray instrumentation along with the necessary bioinformatics.

CONCLUSION

I have today noted two important trends in biomedical research—the rapid accumulation of data and the broadening scope of research studies. To these, I must add a third trend—namely, the increasingly collaborative nature of biomedical science. Some of today's most pressing questions in biomedical science are so complex, so multifaceted, that they cannot be addressed by a single investigator or even a single research laboratory. In many cases, teams of scientists with diverse skills and backgrounds are needed to get the job done.

It is my belief that this emphasis on interdisciplinary collaborations, as evidenced by the multiple NIH Roadmap initiatives related to this area, will bring about unprecedented gains in biomedical science, and ultimately lead to improved health of all U.S. citizens. Finally, as the research paradigm evolves toward greater complexity, the infrastructure required to support that research must evolve too.

I will be happy to respond to any questions you may have.

Department of Health and Human Services
National Institutes of Health
National Center for Research Resources
Judith L. Vaitukaitis, M.D.

Dr. Vaitukaitis is currently serving as Director, National Center for Research Resources, a position she has held since 1993. Prior to that, she served as the NCRR Deputy Director (1991-1993) and the Director of NCRR's General Clinical Research Centers Program (1986-1991).

Following house staff training in internal medicine at Bellevue Hospital (Cornell), the Memorial-Sloan Kettering Hospital in New York City and University Hospital in Boston (1966-69), Dr. Vaitukaitis completed postdoctoral training in reproductive endocrinology at Boston University School of Medicine and at the National Institute of Child Health and Human Development (NICHD). She also served as a Senior Investigator in the National Institute of Child Health and Human Development's intramural program in Bethesda. She returned to Boston in 1974 as an Associate Professor of Medicine at Boston University School of Medicine where she conducted basic and clinical research studies in reproductive endocrinology. She served as Professor of Medicine at Boston University School of Medicine (1977-86). She also directed Boston University's General Clinical Research Center (1977-86) and headed the Section on Endocrinology and Metabolism at Boston City Hospital (1974-86).

She has delivered nearly 300 invited lectures, has published over 165 scientific papers in both basic and clinical research, and has had four publications selected as Citation Classics. She is Editor of one book, Clinical Reproductive Neuroendocrinology. She has served as a member of numerous editorial boards of scientific journals and has served on many advisory boards and committees for the National Institutes of Health, other Federal agencies, universities, private foundations as well as scholarly societies. She has served as a member of the Liaisons of the Board of Health Sciences Policy, Institute of Medicine; and International Scientific Advisory Board, Joint Infrastructure Fund, The Wellcome Trust and Office of Science and Technology, UK. She is a charter member of the NICHD's Hall of Honor, in recognition of her research contributions while an intramural investigator with NICHD.

She is an elected member of the American Society for Clinical Investigation, Association of American Physicians, The Endocrine Society, and the Institute of Medicine of the National Academy of Sciences.

Department of Health and Human Services
Office of Budget
William R. Beldon

Mr. Beldon is currently serving as Acting Deputy Assistant Secretary for Budget, HHS. He has been a Division Director in the Budget Office for 16 years, most recently as Director of the Division of Discretionary Programs. Mr. Beldon started in federal service as an auditor in the Health, Education and Welfare Financial Management Intern program. Over the course of 30 years in the Budget Office, Mr. Beldon has held Program Analyst, Branch Chief and Division Director positions. Mr. Beldon received a Bachelor's Degree in History and Political Science from Marshall University and attended the University of Pittsburgh where he studied Public Administration. He resides in Fort Washington, Maryland.

Last revised: April 12, 2004

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