|
|
|
Quick Links
NCRR and the 2009 Recovery Act
|
Advisory Council Meeting Minutes - May 18, 2006The National Advisory Research Resources Council convened for its 133rd session at 8:00 a.m. on Thursday, May 18, 2006, in Conference Room 10, Building 31. Dr. Barbara M. Alving, Acting Director, National Center for Research Resources (NCRR), National Institutes of Health (NIH), presided as Chair. The meeting was open to the public until 1:45 p.m., at which time it was closed to the public for the review, discussion, and evaluation of grant applications as provided in Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of Public Law 92-463. ContentsEach link scrolls this page to the corresponding section.
I. Call to Order Council Members PresentDr. Robert J. Beall, Dr. Wah Chiu, Dr. Kenneth G. Cornetta, Dr. Randall E. Dalton, Dr. Machi F. Dilworth (Liaison Member, NSF), Dr. Mark H. Ellisman, Dr. Catherine C. Fenselau, Dr. James G. Fox, Dr. Joan S. Hunt, Dr. Cynthia E. Keppel, Dr. Barbara B. Knowles, Dr. Bettie Sue Masters, Dr. John E. Maupin Jr., Dr. Thomas G. McGuire, Col. (Dr.) Debra M. Niemeyer, Dr. Paul G. Ramsey, Dr. Arthur W. Toga, Ms. Sheila C. Zimmet Council Members AbsentDr. Kelly D. Garcia, Dr. Roland F. Hirsch, (Liaison Member, DOE), Dr. Stuart M. Zola Special Invited Guests for Open SessionDr. Keith O. Hodgson, Director, Stanford Synchrotron Radiation Laboratory and Professor of Chemistry, Stanford University; Dr. Peter C. M. van Zijl, Professor of Radiology, Biophysics, and Oncology, Johns Hopkins University, and Director, F. M. Kirby Research Center, Kennedy Krieger Institute; Dr. Philip C. Andrews, Professor of Biological Chemistry, University of Michigan Medical School; Dr. Bruce J. Tromberg, Professor of Biomedical Engineering, University of California, Irvine Staff of Other NIH ComponentsDr. Carlos E. Caban, OER Dr. Khalid Masood, CSR; Dr. Marc L. Rigas, CSR; Dr. Ross D. Shonat, CSR; Dr. Margaret D. Snyder, OER/OD/NIH; Dr. Barbara J. Thomas, CSR Others PresentDr. Donna J. Dean, Lewis-Burke Associates, LLC; Mr. Stephen J. Heinig, Senior Staff Associate, Division of Biomedical and Health Sciences Research, Association of American Medical Colleges, Washington, D.C. Open SessionI. Call to Order: Dr. Barbara M. Alving, Acting Director, NCRRDr. Alving welcomed Council members and guests to the 133rd meeting of the National Advisory Research Resources Council. She announced that the following Council members would not be present due to scheduling conflicts: Dr. Kelly D. Garcia, Dr. Roland F. Hirsch, and Dr. Stuart M. Zola. Also, Col. (Dr.) Peter Demitry has resigned as ex-officio member of the Council. He has been replaced by Col. (Dr.) Debra Niemeyer. II. Consideration of Minutes: Dr. Barbara M. Alving, Acting Director, NCRRThe minutes of the Council meeting held on January 19, 2006, were approved as written. III. Future Meeting Dates: Dr. Barbara M. Alving, Acting Director, NCRRThe next Council meeting will be held on Thursday, September 21, 2006. IV. Personnel Update: Dr. Barbara M. Alving, Acting Director, NCRRNIH Personnel
NCRR Personnel
Division for Clinical Research Resources
Division of Research Infrastructure
Division of Comparative Medicine
Division of Biomedical Technology
Office of Review
Office of Grants Management
Office of the Director
Office of Science Policy and Public Liaison
V. NCRR Budget Retreat—Maximizing Synergies and Efficiencies for NCRR-funded Programs: Dr. Barbara M. Alving, Acting Director, NCRRRepresentatives from all NCRR divisions and offices participated in a budget retreat held on April 14, 2006. During the retreat, each division provided a brief overview of its programs, with specific attention paid to the roles and responsibilities of budgeting. Retreat participants then explored strategies to maximize synergies and efficiencies for NCRR-funded programs. Three strategies were discussed: Managing a Portfolio and Increasing Efficiencies; Forging Strategic Partnerships; and Fostering Translational Research and Other Trans-NCRR Collaborations. At the end of the discussion, participants identified overarching action items. On April 27, a majority of the NCRR staff participated in a post-retreat meeting. The meeting provided an opportunity to refine, finalize, and prioritize the action items that emerged from the retreat. As progress is made in this area, NCRR will call on Council members for input and guidance.
VI. Legislative and Budget Updates: Barbara M. Alving, Acting Director, NCRROn April 6, 2006, Dr. Elias A. Zerhouni, Director, NIH, testifed on the FY 2007 budget request before the House Appropriations Subcommittee on Labor, HHS, and Education. Dr. Zerhouni, who was the principal witness, was accompanied by Drs. John E. Niederhuber, Acting Director, NCI; Elizabeth G. Nabel, Director, NHLBI; Anthony S. Fauci, Director, NIAID; Francis S. Collins, Director, NHGRI; and Griffin P. Rodgers, Acting Director, NIDDK. NCRR is now in the process of answering congressional questions that were submitted subsequent to the hearing. The NIH Senate Appropriations hearing is scheuled for May 19, 2006. Dr. Zerhouni will testify, and the subcommittee has invited Drs. Niederhuber, Nabel, Fauci, and Collins to accompany Dr. Zerhouni. The President's budget request for FY 2007 was released on February 6, 2006. The FY 2007 program level for the NIH is $28.4 billion, the same as the FY 2006 level. For NCRR, the President's budget request is $1.1 billion including support for AIDS research, a decrease of $0.9 million below the FY 2006 appropriation. No funds for extramural construction are included in the FY 2007 request. Included in the FY 2007 request is NCRR's support for the trans-NIH Roadmap initiatives estimated at $13.3 million or 1.2 percent of NCRR's FY 2007 budget request. It also includes funds for the initiative led by NCRR on behalf of the NIH Roadmap—the Clinical and Translational Science Awards (CTSAs), as well as NCRR support for two new NIH programs—the Genes, Environment, and Health Initiative; and the Pathway to Independence Program. VII. Updates on NCRR Workshops: Dr. Harold L. Watson and Dr. John (Jack) D. Harding, Division of Comparative Medicine; Dr. Michael H. Sayre, Division of Research Infrastructure; and Dr. Peter T. Highnam, Senior Advisor to the Director, NCRRDr. Alving introduced four brief presentations on recently held NCRR workshops. These workshops stemmed from the NCRR FY 2007 Budget Retreat, held in August 2005. Navigating the Translational Researcher Through a Complex of Animal and Biological ResourcesDr. Watson reported that 50 participants attended the workshop held March 6-7, 2006. The workshop explored creating a comprehensive resource portal for researchers to find and effectively utilize all NIH-supported animal model and related biological resources. This portal, or Animal Information Center, would enhance access and retrieval of information from existing model databases and accommodate the addition of new ones. Participants discussed potential users for this new resource, challenges in developing it, and the use of existing tools and technologies in the development of the portal. Next steps include cataloguing existing animal model databases and selecting a disease category—or specific disease—to develop a scalable prototype model. Council members Drs. Mark Ellisman, Barbara Knowles, Arthur Toga, Stuart M. Zola, and Robert J. Beall (or a representative to be named later from the Cystic Fibrosis Foundation) volunteered to be part of the effort to help move forward the agenda.
Genetic Tools for Optimizing the Use of Rhesus Macaques for Translational ResearchDr. Harding noted that the purpose of this workshop was to define the next generation of genetic tools needed to optimize the use of rhesus macaques in translational research. The Division of Comparative Medicine considers this to be a timely topic, because the rhesus is the most widely used nonhuman primate for translational studies directly related to human health. In addition, a set of first-generation genetic tools has been developed for the rhesus, and its genome has been determined. Currently, there is a need to define the next generation of genetic tools. A total of 80 participants attended the workshop, held April 19-20, 2006. Participants discussed currently available genetic tools and their specific application areas. Workshop panels developed short lists of major tools used today and those needed for the near future. Overall recommendations included the development of the following: phenotypic data for each rhesus at the National Primate Research Centers (NPRCs) and a related database available to all researchers; a single nucleotide polymorphisms (SNP) map of the rhesus; a repository containing blood samples and cell lines derived from each rhesus at the NPRCs; and reagents and sequences for other macaques.
Supporting Connectivity for Biomedical ResearchDr. Sayre reported on the workshop held April 24, 2006, that brought together experts and researchers from the biomedical and computer networking communities and federal science agencies. The purpose was to identify and discuss key challenges to improving network connectivity and utilization across a broad spectrum of users, including those with access to cutting-edge networks and those who have little or no connectivity. The charge to the group was to examine best practices for implementing collaborative research networks and to identify key needs and priorities for cyberinfrastructure development during the next three to five years. The workshop encouraged efforts to strengthen existing partnerships and build new partnerships among funding agencies, academic organizations, and the private sector to better coordinate, expand, and optimize investments in network infrastructure. In particular, the workshop sought to leverage natural intersections between biomedical research and health care in order to broaden community participation in health research and facilitate development of clinical and translational research networks.
Ensuring the Inclusion of Clinical Research in the National Health Information NetworkDr. Highnam noted that the workshop, held May 9, 2006, was jointly sponsored by NCRR, the Agency for Healthcare Research and Quality, and the nonprofit organization FasterCures. The workshop's purpose was to create a plan to incorporate clinical and translational research as part of the emerging Nationwide Health Information Network (NHIN). Workshop participants included experts representing academic research, health care providers, consumers, federal and private payers, pharmaceutical and industry representatives, consultancies, and multiple government agencies. Keynote presentations were followed by a panel session that provided the diverse group of attendees with the opportunity to establish a common ground and to discuss research and local prototypes of health information exchange. During breakout sessions, participants developed a list of key steps that need to be taken to include research in the NHIN activities. Meeting participants identified two sets of cases—related to patient accrual and phase-four post-market surveillance—that would provide concrete examples of requirements and issues. In addition, many participants expressed the desire for an organizational voice for the clinical research informatics community and the need for a more formal model, such as the Connecting for HealthSM approach to be applied to research.
VIII. Genome-Wide Association Studies: Dr. Anthony R. Hayward, Division for Clinical Research Resources, NCRR
Dr. Hayward informed the Council of the May 15, 2006
release of a notice (NOT-OD-06-071 To ensure maximum benefit to the public health, the NIH is considering policy and programmatic steps to promote broad and consistent sharing of GWAS data for all NIH-supported GWAS genotype-phenotype datasets, such as strong encouragement for early release of phenotype and genotype data, and the development of a central database to serve as a common GWAS repository (consistent with human subject protection issues). Recognizing the range of issues to be considered, the NIH plans to undertake an extensive public consultation effort through interactions with scientific and public stakeholders. The specific plans for these activities will be announced broadly in the near future. Among the potential topics to be considered are: the creation of a central genotype-phenotype database that could serve as a common data repository for all NIH-supported GWAS; requirements for submission of data to such a common repository; appropriate policies for access to GWAS data; standards for participant protection in this rapidly evolving area of science; publication polices that recognize the interests of the researchers who collect samples and associated data; and intellectual property considerations for inventions arising from the use of GWAS data. Dr. Hayward is the NCRR point of contact. Anyone interested in submitting comments should contact him directly.
Dr. Hayward also announced that NCRR will be reissuing
the RFA for the Clinical and Translational Science
Awards. The submission date for the applications will
be January 17, 2007. Additional Information about the
upcoming RFA was issued in the NIH Guide (NOT-RM-06-016
IX. Biomedical Technology Resource Centers—Overview: Dr. Michael T. Marron, Director, Division of Biomedical Technology, NCRRDr. Marron explained that the Division of Biomedical Technology supports more than 50 specialized Biomedical Technology Resource Centers (BTRCs) across the country, primarily at major academic institutions and health centers. These BTRCs support the discovery, development, and dissemination of powerful, leading-edge technologies that have broad application to the study of biology and medicine. They serve as a hub for both multidisciplinary and interdisciplinary research, which ultimately introduces new tools and technologies to the biomedical research community. BTRCs mainly are built around core technology development but also are involved in training, dissemination, service, and collaborations. The Division supports five technology areas: information technology; optical/spectroscopic technology; imaging technology; technology for structural biology; and technology for systems biology. Over the years, the BTRCs have been responsible for the development of several leading technologies such as MRI, peptide sequencing by mass spectrometry, multi-photon microscopy, and use of synchrotron X-rays for structural biology. The median length for a BTRC award is 10 years. The awards have been leveraged effectively, with BTRC users receiving more than $700 million in funding from other NIH Institutes or Centers. Dr. Marron then introduced the Principal Investigators from four NCRR-supported BTRCs who presented the details of their work at the following centers: the Synchrotron Radiation Structural Biology Resource, headed by Dr. Keith Hodgson; the Resource for Quantitative Functional MRI, headed by Dr. Peter van Zijl; the National Resource for Proteomics and Pathways, headed by Dr. Philip Andrews; and the Laser Microbeam and Medical Program, headed by Dr. Bruce Tromberg.
X. Technology Development for Structural Biology: Dr. Keith O. Hodgson, Director, Stanford Synchrotron Radiation Laboratory and Professor of Chemistry, Stanford UniversityDr. Hodgson spoke about the use of synchrotron X-rays in biomedicine. The Synchrotron Radiation Structural Biology Resource at the Stanford Synchrotron Radiation Laboratory (SSRL) provides scientists with access to synchrotron radiation, a name given to X-rays or light produced by electrons circulating in a storage ring at nearly the speed of light. Extremely bright X-rays are used to investigate various forms of matter in exquisite detail, down to atomic and molecular levels. At Stanford, synchrotron X-rays are used to investigate the structural biology of complex molecular machines, membrane systems, and macromolecular assemblies. By using synchrotrons, researchers can create a three-dimensional "picture," showing every atom of a protein or macromolecule. Studying molecular form at the atomic scale is important, because the structural details can determine its function or malfunction. For example, examination of membrane proteins is helping scientists to understand multi-drug resistance in the treatment of infection. Most multi-drug resistance is attributed to pumps in the cell membranes that recognize and expel much-needed antibiotics. The SSRL Resource Center also has been used to study the structures of RNA polymerase and ribosomes—cellular "machines" that direct the manufacture of proteins. In addition, synchrotron-based crystallography has provided critical information about the molecular architecture and function of cell membrane channels, transporters, and electron transfer complexes.
XI. The Developing Brain—Imaging Technology and Its Clinical Translation: Dr. Peter C. M. van Zijl, Professor of Radiology, Biophysics, and Oncology, Johns Hopkins University, and Director, F. M. Kirby Research Center, Kennedy Krieger InstituteDr. van Zijl noted that the Resource for Quantitative Functional Magnetic Resonance Imaging combines facilities at the Kennedy Krieger Institute and the Center for Imaging Science at Johns Hopkins University. As one of eight NCRR-supported national resources for magnetic resonance, the resource center is dedicated to developing novel brain imaging techniques for application in the study of children, the elderly, and subjects with neurological and psychiatric disorders. Dr. van Zijl explained that brain function, physiology, and structures are constantly changing as the brain develops. Investigators face the challenge of determining which changes are normal and which are due to disease. The magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) technology developed in the center is being used to study motor learning in autistic children, motor function in children with attention deficit/hyperactivity disorder, and brain function in individuals at risk for developing Huntington's disease. Scientists also are studying mental retardation, trauma, impaired brain development, autism, working memory, psychosis, cancer, stroke, and the link between abnormal brain chemistry patterns and disease. In addition, the resource center disseminates software programs, databases, and reports; it also provides training in pulse sequence optimization, data analysis, and data interpretation. The resource center's new projects focus on reducing the need for patient compliance in difficult populations, assessing tissue changes via multi-modality MRI/MRS, and examining alterations in brain function, physiology, and/or pathology during brain development.
XII. National Resource for Proteomics and Pathways: Dr. Philip C. Andrews, Professor of Biological Chemistry, University of Michigan Medical School, Ann ArborDr. Andrews explained that the National Resource for Proteomics and Pathways (NRPP) is one of several NCRR-funded proteomics, glycomics, and mass spectrometry centers in the United States. The NRPP was established to develop computational and bioinformatics tools for proteomics, provide the datasets required to build predictive organismal models, and develop technologies needed to produce proteomics data. Proteomics is rapidly growing in all areas of biological research. Advances in proteomics have led to precisely measuring the levels of expressed proteins and their modified forms. This information can lead to new insights on cell-signaling pathways, cellular differentiation, and other processes that affect the progression of disease.
One of the principal resources of the NRPP is ProteomeCommons.org
XIII. Translating Optical Technologies from Benchtop to Bedside: Dr. Bruce J. Tromberg, Professor of Biomedical Engineering, University of California, IrvineDr. Tromberg explained that the Laser Microbeam and Medical Program (LAMMP), located within the Beckman Laser Institute and Medical Clinic, is dedicated exclusively to the use of lasers and optics in biology and medicine. LAMMP core research emphasizes the development of optical instrumentation and biophysical models of the interactions between light and tissue. One of its primary goals is to translate basic science into clinical medicine. LAMMP-supported activities within the Beckman Laser Institute have resulted in the development of several technologies with broad academic and commercial impact. Training of undergraduate, graduate, and post-graduate students in biomedical optics occurs each year, with LAMMP-trained scientists now working as faculty in biomedical optics programs at approximately 18 academic centers around the world. Technology development has resulted in over 15 patents, 4 startup companies, more than 15 licenses, and over $20 million in licensing royalties. LAMMP provides both laser microbeam and microscopy technologies for optical manipulation and functional imaging of living cells, as well as laser medical translational technologies for monitoring, treating, and imaging preclinical animal models and human subjects. Among the laser microbeam technologies pioneered by LAMMP are laser "tweezers" and "scissors" and non-linear optical microscopy. Laser tweezers utilize a focused laser beam that generates sufficient force to grasp a cell without damage, while laser scissors are used to cut, microdissect, or ablate cells. LAMMP medical technologies have been developed for spectroscopy and imaging of thick tissues such as breast, brain, and muscle—as well as superficial tissues such as skin, oral cavities, airways, and the gastrointestinal tract. Broad applications of these technologies include cancer detection, cardiovascular disease, neuroscience, and metabolic syndrome, with special emphasis on early disease detection, monitoring, therapy, high-risk subjects, and multi-modality imaging.
XIV. NIH Roadmap for Interdisciplinary Research Consortia: Dr. Gregory K. Farber, Health Scientist Administrator, NCRRDr. Gregory Farber presented an update on the status of the Interdisciplinary Roadmap Consortium Program, which awards grants to fund Exploratory Centers for Interdisciplinary Research. The purpose of these exploratory centers is to unite researchers from multiple disciplines to begin working on a difficult biomedical problem. The program is managed by NCRR and involves all NIH Institutes and Centers. In the first phase of this trans-NIH initiative (FY 2004 through FY 2006), 21 Exploratory Centers for Interdisciplinary Research were awarded in various scientific areas, using the P20 mechanism. The second phase of this program (FY 2007 through FY 2011) will focus on supporting a series of linked awards for interdisciplinary research. Each group of these linked awards will be considered a consortium with an allowable budget of roughly $3 million in direct costs per year. Applications to this program will not be restricted to the initial P20 awardees. A new two-stage application process, including a pre-application and a full proposal stage, has been adopted for the awards. In the pre-application phase, research teams can submit a 25-page overview of their research plans. NCRR is currently conducting a peer review of these pre-applications, which were due on April 18, 2006. Results of the pre-application evaluations will be available to applicants by September 15, 2006. The trans-NIH Project Team and Interdisciplinary Working Group will use the results of the review to issue invitations to a select number of consortia to submit a full proposal, due on December 19, 2006. Consortia awards will be made in September 2007. The Council will be provided with an additional report during the next meeting's closed session.
Closed SessionThis portion of the Council meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2). Council members discussed procedures and policies regarding voting and confidentiality of application materials, Committee discussions, and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. XV. Application ReviewThe Council considered 276 applications and recommended 276 for a total first-year amount of $215,373,040 (direct costs). AdjournmentThe Council adjourned at 3:30 p.m. on May 18, 2006. CertificationWe hereby certify that, to the best of our knowledge, the foregoing minutes and supplements are accurate and complete.
/s/
/s/ These minutes will be formally considered by the Council at its next meeting; corrections or notations will be incorporated into the minutes of that meeting. Attachment: NOTE: Open Session materials are available from the Executive Secretary or the Committee Management Office, NCRR. |
| National Institutes of Health (NIH) Bethesda, Maryland 20892 |
Department of Health and Human Services |