Summary of Meeting
May 26-27, 2011
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 181st meeting on May 26-27, 2011, at Building 31, Conference Room 10, Bethesda, Maryland. Dr. Story Landis, Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson.
In accordance with Public Law 92-463, the meeting was:
Council members present were:
Council member absent was:
Dr. Emery Brown
Council Roster (Attachment 1)
Ex Officio Members absent:
Dr. Robert Ruff, Department of Veterans Affairs
Dr. Geoffrey Ling, Department of Defense
Members of the public present for portions of the open meeting included:
Dr. Kurt Brunden, University of Pennsylvania
Shani Silberberg, University of California, San Francisco
Diane Catellier, RTI International
Dr. Andrea Baruchin, Foundation for the National Institutes of Health
Maggie Owner, Lewis-Burke Associates
NINDS employees present for portions of the meeting included:
Other Federal employees present for portions of the meeting included:
Dr. Dan Zaharevitz, NCI
Dr. Susan Old, NHGRI
Dr. Carole Jelsema, CSR
Dr. Laurent Taupenot, CSR
Dr. Pat Manos, CSR
Dr. Jonathan Arias, CSR
Dr. Yuan Luo, CSR
Dr. Jon Ivins, CSR
Dr. Peter Guthrie, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Christine Melchior, CSR
Dr. Gene Carstea, CSR
Dr. Catherine Bennett, CSR
Dr. Mary Custer, CSR
Dr. Seetha Bhagavan, CSR
Dr. Vilen Movsesyan, CSR
I. Call to Order and Opening Remarks
Dr. Landis, Director, NINDS, welcomed Council members, visitors, and staff to the 181st meeting of the National Advisory Neurological Disorders and Stroke Council meeting.
This is the last meeting for four Council members whose terms expire on July 31: Cindy Parseghian, Tim Pedley, John Povlishock, and Vicky Whittemore. Dr. Landis thanked them for their contributions to NINDS. The Council nomination slate with the proposed nominees to replace these members had recently been approved by the Department. The new members will be on board for the next Council meeting on September 15-16.
In keeping with the Institute’s policy of inviting chairs of CSR and NINDS review committees, Dr. Landis introduced Dr. Kurt Brunden, Chair, NINDS NSD-C Committee, who is attending the open session of the Council meeting. Dr. Brunden is Director of Drug Discovery, Center for Neurodegenerative Disease Research, University of Pennsylvania.
Dr. Landis announced the departure of Joellen Austin Harper, Executive Officer, NINDS. Ms. Harper has accepted the position of Associate Director for Management (Executive Officer) at the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina, and will be starting there in mid-June. Her departure will represent a significant loss for NINDS. She has been an extraordinary member of the NINDS leadership team, and Dr. Landis thanked her for her numerous contributions to NINDS. A search committee has been formed and the position will be advertised soon. In the meantime, Maryann Sofranko, Deputy Executive Officer, has agreed to serve as the Acting Executive Officer.
II. Report of the Associate Director for Extramural Research, NINDS
Approval of Council Minutes -- Dr. Finkelstein requested, and the Council voted approval, for the February 3-4, 2011, Council meeting minutes.
The following future Council meeting dates were confirmed:
The following new dates were introduced:
Expedited Review Process - A subset of Council members, prior to the meeting, approve applications with scores within the payline for which there are no unresolved issues. Dr. Finkelstein thanked Kim Zellmer, Louis Ptacek, and Robert Friedlander for handling this responsibility for the last three Council rounds. Three other Council members will take on this responsibility for the next three Council rounds.
For this Council round, 122 applications were eligible to be expedited including 9 career or K applications. Forty four of these (36%) have already been issued and most of the others are ready to go and will be issued shortly after Council. The NIH Funding Strategy delayed several grants from being awarded.
DER Announcements - Dr. Finkelstein introduced new DER staff: Dr. Kip Ludwig, a Program Director in the Repair and Plasticity Cluster, Dr. Jill Morris, a Program Director in the Neurogenetics Cluster, Jamie Roberts, a Program Specialist in the Office of Clinical Research, and Dr. Ron Johnson who is working in the Office of Translational Research on a six month detail assignment in two programs, the Blueprint Neurotherapeutics Network and the Molecular Libraries Initiative. He also mentioned that Dr. Mark Scheideler who was in the Office of Translational Research left NINDS.
III. Report of the Director, NINDS
Dr. Landis provided updates on a number of issues, including: the One Mind for Research initiative, spearheaded by Patrick Kennedy; the NIH and NINDS budget for FY11 and FY12; the creation of the National Center for Advancing Translational Sciences (NCATS); NIH and NINDS support for beginning investigators; and the Advisory Committee for the Director (ACD) workgroup on the Future of the Biomedical Research Workforce.
One Mind for Research
One Mind for Research is an effort that is being spearheaded by Patrick Kennedy. It involves a national collaboration of public and private partnerships with a focused effort on brain disorders, from neurodegenerative disorders to psychiatric disorders to conditions affecting combat veterans. This effort launched on May 23, 2011, with a series of scientific discussions and generated a 10-year plan for neuroscience: From Molecules to Brain Health. Participants in this conference included: Vice President Joe Biden, NIH Institute Directors, academic researchers, representatives from the Society for Neuroscience, Members of Congress, and patients.
On April 15, 2011, the NIH received its FY11 appropriation in the form of a Continuing Resolution which will support the Agency for the remainder of the fiscal year, ending September 30, 2011. NIH’s appropriation was reduced 0.9% from FY10 funding levels, which resulted in a decrease of $14.37M for NINDS. On February 14, 2011, President Obama released his Budget Request for FY12, which contained a 2.6% increase over FY11 levels for NIH ($1.66 billion for NINDS). Following the release of the President’s budget, the Senate Appropriations Committee held its Hearing on the FY12 NIH Budget on May 11, 2011. Drs. Collins, Varmus, Shurin, Rogers, and Fauci testified at this hearing on behalf of the NIH. At this time, no hearing of the House Appropriations Committee has been scheduled. In May, 2011, the House Appropriations Committee released spending limits for the 12 annual appropriations bill consistent with the spending levels outlined in the FY12 budget resolution (H. Con.Res.34) passed by the House in mid-April. This spending framework would reduce discretionary spending in FY12 by $30.3 billion over FY11 levels -- $121 billion less than proposed in President Obama’s FY12 budget. Under the draft House allocations, the Labor-HHS-Education Appropriations Subcommittee, which establishes annual funding levels for the NIH, would absorb the largest decrease, falling to $139.2 billion, a reduction of $18.2 billion over FY11 spending levels. In addition, the House established a floor for new competing grants and a ceiling on the average costs for grants.
Creation of the National Center for Advancing Translational Sciences (NCATS)
The NCATS is a new Center proposed by Dr. Collins with the mission of catalyzing the development of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Following its anticipated launch in FY12, NCATS is intended to: facilitate – not duplicate – other translational research activities supported by NIH; complement – not compete with – the private sector; and to reinforce – not reduce – NIH’s commitment to basic research. Translational efforts across NIH will be moved into NCATS and no new funds will be allocated to NCATS at this time. The following existing programs are proposed for inclusion in NCATS: components of the Molecular Libraries Program, Therapeutics for Rare and Neglected Diseases (TRND), the Office of Rare Diseases Research (ORD), Rapid Access to Interventional Development (RAID), the Clinical and Translational Science Awards (CTSAs), the FDA-NIH Regulatory Science efforts, and the Cures Acceleration Network (if appropriated).
Support for Beginning Investigators
Dr. Landis highlighted a number of ongoing efforts both at NINDS and at NIH to assist investigators at the start of their independent careers.
Future of the Biomedical Research Workforce
Dr. Landis reported that a working group of the ACD has been established with a charge to: develop a model for a sustainable and diverse U.S. biomedical research workforce that can inform decisions about training the optimal number of people for the appropriate types of positions that will advance science and promote health AND to make recommendations for actions that NIH should take to support a future sustainable biomedical infrastructure. Among the issues to be addressed by this working group are: the appropriate size of the workforce, the appropriate composition of positions that should be supported and the best way to train and support people for these positions. This Committee will be co-chaired by Drs. Shirley Tilghman and Sally Rockey.
IV. Budget Update
Dr. Finkelstein provided the Council with a brief update on the NINDS budget for Fiscal Years 2011 and 2012. The final of seven Continuing Resolutions (CRs) in FY11 supports NIH through September 30, 2011. This CR provides a 1.3% decrease in NIH’s budget for FY11, and a 0.9% decrease ($14.369 M) in NINDS’ budget. Dr. Finkelstein reported that between 2007 and 2010, NINDS had been receiving very small increases in the budget, which had not been keeping up with inflation. Moreover, in terms of real dollars, the doubling of the NIH budget that occurred between 1999 and 2003 has been almost completely undone. NINDS’ appropriation for FY11 was $1.622 billion, 86.7% of which supports the Extramural Research Program ($1.406 billion), 9.7% supports the NINDS Intramural Research Program, and 3.6% supports overhead costs (Research Management & Support).
Dr. Finkelstein recapped the discussion from the February 2011 meeting of the NANDS Council in which four potential FY11 budget scenarios and their potential effects on the payline percentile were discussed:
The actual outcome as previously noted, was a 0.9% budget reduction for NINDS. NIH policy for managing this budget reduction is to not provide inflationary increases to the out-years of most grants, and to cut grants an additional 1%. After enacting the policies, the NINDS has able to maintain its payline at the 14 %tile for all of FY2011. Dr. Finkelstein noted that the appropriation for FY2012 is even more uncertain than FY2011.
V. Update on NINDS Strategic Planning Implementation
Dr. Paul Scott, Director of the NINDS Office of Science Policy and Planning, reported on the status of implementing the NINDS Strategic Plan. In 2010, NINDS completed “NINDS Strategic Priorities and Principles,” focused on: what NINDS does well and should continue, what NINDS could do better, and new ways for NINDS to do business moving forward. For the main part of the planning effort, NINDS charged three panels with addressing these issues in the context of the basic, translational, and clinical research portfolios. One additional panel focused on NINDS' disease missions. Each module consisted of: an external panel made up of scientists, clinicians, industry, and NGO reps and an internal working group of NINDS staff. In general, panels were charged with: reviewing current activities at NINDS; identifying strengths, weaknesses and gaps; looking forward to future challenges and opportunities; suggesting creative, pragmatic ways to leverage existing resources; recommending priorities and strategies to maximize NINDS effectiveness towards its mission. Reports from each of the panels (basic, translational, clinical, disease) and a synthesis report are publically available on the NINDS website.
The implementation of planning recommendations is currently underway using the following general principles:
Illustrative examples of implementation based on these principles are provided below.
Invest across the full spectrum of basic, translational, and clinical research: Each panel made recommendations related to the proper balance of research within the Institute. In response to the overall need for better analysis of our programs, and for greater awareness of the dynamics of this research balance, the NINDS has formed the Analysis Working Group (AWG), co-chaired by Drs. Robert Finkelstein and Paul Scott. This group is currently engaged in analyses of the NINDS portfolio broken out in two ways: Basic/Translational/Clinical research and Investigator-initiated vs. Institute-influenced. Dr. Scott described some of the questions being addressed in these analyses and indicated that a future Council discussion would be focused on the findings from these analyses.
Promote basic, translational and clinical research according to their distinct needs: Dr. Scott described illustrative examples of how NINDS has implemented recommendations from each of the basic, translational and clinical panels aimed at promoting research in each of these areas.
Basic Research: The Basic Research Panel recommended eliminating the R21 mechanism as it was felt by the panel that this mechanism was being used by NINDS in a confusing way, and that other mechanisms existed that could support the type of research being solicited by this program. Prior to implementing this recommendation, the AWG analyzed the R21 portfolio, looking at a number of issues, including: who was using this mechanism, the type of research being supported, and the outcomes and impact of this research. This analysis suggested that in fact the R21 did support a body of research that was critical to NINDS’ mission, but that in some cases may not have met the stated goals of the program (e.g. to support only applications of truly ground-breaking impact). In addition, the analysis indicated that success rates for New and Early Stage Investigators were lower for the R21 than for the R01. As a result of this analysis, NINDS issued a notice in the NIH Guide (NOT-NS-10-017), modifying the R21 program goals and encouraging New and especially Early Stage Investigators seeking first time funding from the NINDS to apply for R01s.
Translational Research: The Translational Research Panel recommended that NINDS assess ways that the Small Business Research Program (SBIR) and Small Business Technology Transfer Program (STTTR) could be used more effectively to target specific research needs. These programs are supported through a Congressionally-mandated set-aside of 2.8% and allow domestic small business concerns to engage in research and development that has the potential for commercialization. As a result of this recommendation, NINDS convened a panel to more comprehensively assess the SBIR/STTR program, which has since resulted in a restructuring of the program’s management, by centralizing it within the Office of Translational Research and hiring dedicated staff to oversee it. In addition, the NINDS SBIR program is working with the NINDS Grants Management Branch to develop strategies to expedite awards.
Clinical Research: The Clinical Research Panel recommended that all clinical trials should have feasibility studies, as well as a specified planning period to ensure that full scale implementation is tenable. In response to these recommendations, the NINDS Office of Clinical Research (OCR) developed a milestone-driven cooperative agreement mechanism to support all investigator-initiated Phase III Clinical Trials (PAR-11-73). Moreover, OCR developed a new policy for early evaluation of Phase III trial feasibility (NOT-NS-10-009).
Establish a data-driven process to identify unmet scientific opportunities and public health needs within and across neurological diseases: Both the Disease Panel and the Translational Research Panel recommended that NINDS develop a methodology for obtaining an environmental scan of the research landscape in its disease areas. Development of a disease landscape will facilitate the identification of research gaps and opportunities, and will inform strategies for investment in specific disease areas based on quantitative, data-driven approach. The Office of Science Policy and Planning is currently piloting an approach for assessing the landscape for a number of diseases.
Support research resources and technical advances that catalyze new discoveries: The Basic Research Panel provided several recommendations for management and support of Research Resources including: establishing stringent criteria for selecting and funding resources, and annually reviewing resources against a pre-determined set of criteria. In response to these recommendations, the AWG analyzed a number of ongoing resource projects with the goal of identifying key issues related to which resources to fund, how to monitor progress, and what information is needed for prospective evaluations. This analysis led to the development of a proposal for management of NINDS research resources, which was presented to the NANDS Council in May 2010.
Adopt a culture of evaluation and continuous improvement across all NINDS programs: All of the planning panels made recommendations to this regard, with the essence of this recommendation captured by the Disease Panel: “Rigorous evaluation of initiatives helps the institute to learn what works and to justify, to the scientific community, Congress, and the public, the use of limited resources for targeted purposes.” In response to these recommendations, NINDS has formed a working group to develop guidelines for the prospective evaluation of initiatives and programs.
VI. Initial Implementation of the Diversity and Disparity Planning Panel Recommendations
Dr. Landis reviewed the recommendations resulting from the Workforce Diversity and Health Disparities planning efforts and reported on the initial implementation efforts. The panel focused on Workforce Diversity made a number of recommendations related to the training of a diverse workforce, including:
NINDS has taken a number of steps towards addressing the administrative issues raised by the panel including: incorporating the diversity programs for individuals into the Training Office, to create a new Office of Training, Career Development and Workforce Diversity; focusing the efforts of an Office of Special Programs to be headed by Dr. Al Gordon on the SNRPs and new programs to increase faculty diversity; establishing an internal working group with representation from clusters and offices; establishing a Council working group for diversity. It is anticipated that these reorganizations will provide the necessary infrastructure to more efficiently implement some of the programmatic recommendations.
The Health Disparities panel made a number of recommendations across a range of areas, including: vision, strategic plan and priority setting, inclusion of disparity in NINDS disease related initiatives, engagement of staff across NINDS, collaboration with other NIH and federal entities; evaluation, training and accountability; patient recruitment, enrollment and retention in clinical trials and dissemination of information. To date, NINDS has taken a number of steps towards implementation of these recommendations including: integration of disparities research efforts into the Office of Clinical Research, establishment of an internal working group focused on Health Disparities, and initiation of a planning effort related to health disparities in stroke.
VII. Clearance for FY 2011 Proposed Initiative
Dr. Margaret Sutherland, Program Director, Neurodegeneration Cluster, NINDS, presented a concept for a Neurochip Initiative. The goal of this initiative would be to coordinate genetic efforts for adult onset neurodegenerative diseases across government agencies, both within and outside the NIH and to develop a single genetic platform that captures:
Dr. Finkelstein did not call for a formal vote for moving this concept forward as there was limited enthusiasm from the NANDS Council for Neurochip in its current form. The idea will be discussed further within the institute to determine if elements of it are worth pursuing.
VIII. Council Subcommittee Reports
Clinical Trials Subcommittee — Dr. Thomas Brott/Dr. Timothy Pedley, Co-Chairs
A report by Dr. Claudia Moy on NeuroQOL (Neurology Quality of Life Instrument) was presented during the open session of the Subcommittee meeting that met the night before.
Basic and Preclinical Programs Subcommittee — Dr. John Povlishock, Chair
No summary was provided as all Council members were present for the Subcommittee meeting held that morning.
Training, Career Development and Special Programs Subcommittee — Dr. Eve Marder, Chair
No summary was provided as all Council members were present for the Subcommittee meeting held that morning.
IX. Overview, Division of Intramural Research (DIR)
Dr. Alan Koretsky, Scientific Director, NINDS, reported briefly on the status of new hires in the Intramural Research Program (IRP). Over the last several years, the NINDS IRP has lost 14 faculty members to retirement, new opportunities, and as the result of tenure decisions. Dr. Koretsky reported during this time, nine of these positions have been filled, and the IRP has developed a number of new mechanisms to facilitate future recruitment.
X. New Beginnings in the Office of the Clinical Director
Dr. Avi Nath, Clinical Director, NINDS, presented an overall structure and vision for the Office of the Clinical Director including the development of a clinical trials program. A search for a director to head this program is underway. The program will have several components and will provide assistance in the protocol development, biostatistical analysis and regulatory affairs. This will be accomplished largely by restructuring existing resources and filling of vacancies. A clinical fellowship program will focus on training the next generation of academic neurologists who will develop expertise in translational neuroscience and use a multidisciplinary approach. Efforts are also underway to establish a Translational Neuroscience Center, which will have units for drug development, neuropathology and neurodegeneration.
In addition, Dr. Nath presented ongoing research on the neuropathogenesis of retroviral infections. The human immunodeficiency virus infected macrophages/ microglial cells in the brain to cause a productive infection and it also infects astrocytes where it becomes persistent. These cells may be an important reservoir for the virus. Dr. Nath noted that his laboratory has shown that the infected cells release Tat protein which can interact directly with the NMDA receptors on neurons to cause neurotoxicity. The protein can be produced by HIV-infected cells despite the use of antiretroviral therapy and can travel along neuronal pathways and thus act at distant sites. Continuous presence of the protein is not required as it may set up a cascade of events leading to glial cell activation and neurodegeneration. These findings were suggested to have important implications for a number of other neurological diseases where there has been demonstrated expression of human endogenous viruses and the possibility thus exists that proteins formed by these viruses could drive the pathophysiology of these diseases.
XI. Review of the Division of Intramural Research Board of Scientific Counselors’ Reports
In closed session, Dr. Koretsky presented the findings and recommendations of the Board of Scientific Counselors based on their review of specific DIR laboratories/units during 2010. The Council discussed the reports of the Board and accepted them.
XII. Council Consideration of Pending Applications
This portion of the meeting, involving specific grant review, was closed to the public. The Council gave special attention to applications from foreign institutions and other applications which needed specific discussion. Prior to the discussion of the grants, Dr. Finkelstein reminded Council regarding conflict of interest and confidentiality as follows:
Conflict of Interest
The regulations concerning conflict of interest were reviewed. Council members were reminded that materials furnished for review purposes and discussion during the closed portions of the meeting are considered privileged information. All Council members present signed a statement certifying that they had not been involved in any conflict of interest situations during the review of grant applications.
During the closed session, any information that is discussed and the outcome of any recommendation are considered privileged information. They may not be discussed outside of the closed session. If an applicant requests support for his or her application from a Council member, the Council member must respond that he/she is not permitted to discuss the application. Any inquiry should be referred to Dr. Robert Finkelstein, the Council Executive Secretary, who will then refer the questions to the appropriate staff member for response.
Research Training and Career Development Programs
The Council reviewed a total of 110 research career development and institutional training grant applications; of this total, 79 applications had primary assignment to NINDS, and 47 of them (59.5 percent) were recommended for support in the amount of $6.8 million first-year direct costs. It is anticipated that, of the research career development and institutional training grant applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $2.9 million.
Research Project and Center Awards
The Council reviewed a total of 2,392 research project and center applications; of this total, 1,406 applications had primary assignment to NINDS, and 789 of them (56.1 percent) were recommended for support in the amount of $251.1 million first-year direct costs. It is anticipated that, of the research grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $72.7 million.
Senator Jacob Javits Neuroscience Investigator Awards
The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period. Candidates are nominated and selected at each Council meeting. At this meeting, two Javits awards were recommended.
Small Business Innovation Research and Small Technology Transfer Award Programs
The Council reviewed a total of 204 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 133 applications had primary assignment to NINDS and 78 of them (58.7 percent) were recommended for support in the amount of $17.9 million first-year direct costs. It is anticipated that, of the SBIR and STTR applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $6.0 million.
The meeting was adjourned at 10:30 a.m. on Friday, May 27.
We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.
Robert Finkelstein, Ph.D.
National Advisory Neurological Disorders and Stroke Council
Director, Division of Extramural Research
National Institute of Neurological Disorders and Stroke
Story C. Landis, Ph.D.
National Advisory Neurological Disorders and Stroke Council
National Institute of Neurological Disorders and Stroke
These minutes will be formally considered by the Council at its next meeting. Corrections or notations will be incorporated in the minutes of that meeting.
Last updated August 30, 2011