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Summary of Meeting 1
February 5-6, 2009
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 174th meeting on February 5-6, 2009, 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:
Open: February 5, 2009: 10:30 a.m. to 4:50 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: February 6, 2009: 8:10 a.m. to 9:55 a.m.
for the consideration of individual grant applications.
Council members present were:
Ms. Susan Axelrod
Dr. Laura Ment
Council Roster (Attachment 1)
Ex Officio Members present:
Dr. Robert Ruff, Department of Veterans Affairs
Dr. Geoffrey Ling, Department of Defense (2/6/09 only)
Members of the public present for portions of the open meeting included:
Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance
Dr. Anne Rutkowski, CURE CMD
Beth Roy, Social and Scientific Systems, Inc.
Donna Meltzer, Epilepsy Foundation
Rick Hansen, Digicon Corporation
Ms. Michelle Rodriguez, SRI
Dr. Merit Cudkowicz, Massachusetts General Hospital
Dr. Howard Federoff, Georgetown University
NINDS employees present for portions of the meeting included:
Dr. Alan Willard
Ms. Margaret Jacobs
Other Federal employees present for portions of the meeting included:
Dr. Mary Affeldt, NIDA
Dr. Stefano Bertuzzi, OD
Dr. Jacob Hoots, OD
Dr. Daphne Robinson, NIAID
Dr. Malcolm Smith, NCI
Dr. Jonathan Ivins, CSR
Dr. Seetha Bhagavan, CSR
Dr. Aftab Ansari, CSR
Dr. ReneEtcheberrigaray, CSR
Dr. Mary Custer, CSR
Dr. Jay Joshi, CSR
Dr. Laurent Taupenot, CSR
Dr. Joy Gibson, CSR
Dr. Pat Manos, CSR
Dr. Deborah Lewis, CSR
Dr. Geoffrey Schofield, CSR
Dr. Carol Hamelink, CSR
Dr. Peter Guthrie, CSR
Dr. Aiden Hampson, CSR
Dr. Landis welcomed Council members, visitors, and staff to the 174th meeting of the National Advisory Neurological Disorders and Stroke Council meeting. Dr. Landis announced that effective on January 1 Dr. Audrey Penn has an emeritus appointment in the Office of the Director in NINDS. Among departures, Dr. Landis mentioned that Dr. John Marler, who had been on sabbatical from his position as Associate Director for Clinical Research, had taken a position with the FDA and that Dr. Melinda Kelley with the Office of Science Policy and Planning will be leaving NINDS for a position with NHLBI.
II. Report of the Associate Director for Extramural Research, NINDS
Dr. Robert Finkelstein, Associate Director for Extramural Research, NINDS, informed the Council that they would be in open session today and in closed session to the public tomorrow when individual grants are discussed.
Approval of Council Minutes—Dr. Finkelstein requested, and the Council voted approval, for the September 18-19, 2008, Council meeting minutes.
The following future Council meeting dates were confirmed
May 28-29, 2009 (Thursday and Friday)
September 17-18, 2009 (Thursday and Friday)
February 4-5, 2010 (Thursday and Friday)
May 27-28, 2010 (Thursday and Friday)
September 23-24, 2010 (Thursday and Friday)
Expedited Review Process—A subset of Council members, prior to the meeting, approve applications within the payline for which there are no unresolved issues. For this round, there were 136 applications eligible to be expedited for payment, and 100 awards have been issued.
DER Staff Updates—Dr. Finkelstein reported on Margaret Jacobs’ retirement at the end of February thanking her for her enormous contributions to epilepsy research. Dr. Finkelstein introduced the following new DER staff: Dr. Salina Waddy, Program Director, Office of Minority Health and Research; Ms. Jennifer Antelman, Health Program Specialist, Office of Clinical Research; Dr. James Gnadt, Program Director, Systems and Cognitive Neuroscience Cluster; Dr. Miriam Leenders who is on detail from the intramural program as a Health Program Specialist working with Dr. Ned Talley in the Channels, Synapses, and Circuits Cluster; and Dr. Anna Taylor, Health Program Specialist, Office of the Associate Director for Extramural Research.
III. Report of the Director, NINDS
FY 2009 Budget
Since Congress has not yet passed an omnibus appropriations bill for FY 2009, NIH is operating at FY 2008 budget levels on a Continuing Resolution [Public Law 110-329: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009]. The CR expires on March 6, 2009, but will probably be extended, since an omnibus bill is unlikely to be passed by then. The CR means that NINDS will probably maintain its payline at the 10th percentile for most grant applications. Most R01 applications from new investigators will be paid to the 20th percentile.
Bills under consideration in the House and Senate would increase the NIH budget by 2.9-3.5 percent. For a budget increase within this range, NINDS will probably be able to increase its payline to the 11th percentile.
Economic Stimulus Package and its Potential Impact on NINDS
There are House and Senate versions of proposed legislation [The American Recovery and Reinvestment Act of 2009] to stimulate the U.S. economy. Each of these bills would provide a two-year increase in the NIH budget. Although the stimulus funds are temporary, they represent a tremendous opportunity for NIH.
The House version of the Recovery Act has passed [H.R.1.EH] and would provide:
The Senate version [H.R.1.AS2] would provide:
If the Act called for an increase in the NIH base budget, NINDS could increase its payline for R01 grants. However, because the Act calls for temporary stimulus funds, a payline increase is not feasible. As currently written, the legislation requires NIH to spend the stimulus funds within two years, but a typical R01 grant spans four to five years.
In addition to the timing of the stimulus, NINDS must also consider its intent. Two primary goals of the stimulus are "to preserve and create jobs" and to "spur… technological advances in science and health." In keeping with those goals, 2-year grants could be made available to scientists whose labs are in danger of closing.
Once the Recovery Act has passed and the stimulus has been implemented, allocation of the funds will be reported at www.recovery.gov. (Note: On February 17, 2009, the President signed The American Recovery and Reinvestment Act into law. The final version provides: $7.4 billion to the ICs, $800 million to the NIH Common Fund, $1.3 billion to NCRR, $500 million for the NIH campus, and $400 million transferred from AHRQ to fund comparative effectiveness research.)
Implementation of Changes to Enhance Peer Review
Dr. Alan Willard, Chief, Scientific Review Branch, gave an update on the phased implementation of changes to peer review. These changes are the product of the NIH Peer Review Self-Study, an effort launched in June 2007 to evaluate the efficiency and fairness of peer review. The changes follow the recommendations of four working groups that were tasked with meeting four goals: (1) Engage the Best Reviewers, (2) Improve the Quality and Transparency of Review, (3) Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages, and (4) Conduct Continuous Review of Peer Review.
Changes Already in Place
Other Changes to be Implemented at May 2009 Review Meetings
Changes for January 2010 Due Dates and Later
IV. Reports of the NINDS Planning Modules
Dr. Paul Scott, Director, Office of Science Policy and Planning, summarized the status of the Institute-wide strategic planning effort. The primary goal is to evaluate how well NINDS is carrying out its mission to reduce the burden of neurological disease, and to generate a set of concrete recommendations where gaps or weaknesses are identified. Four planning modules, each consisting of an external advisory panel and an internal NINDS working group, were established to evaluate four areas of investment:
The modules engaged in an iterative process, with the external panels formulating questions and the internal groups providing relevant data. Multiple opportunities were provided for public input, including a Request for Information that was posted on the NINDS web site and sent to patient advocacy groups. During the planning effort, there was an evident need for a fifth planning module to review NINDS' diversity efforts, from enhancing diversity in the workforce to reducing racial and gender disparities in public health. This module has been assembled but has not yet met. Today, the original four modules presented their preliminary findings and recommendations. These will be incorporated into a draft plan, which will be posted for public comment and finalized by spring 2009.
Diseases Module – Summary presented by Dr. Pedley
Task and Procedures
This group was charged with evaluating how NINDS should invest in research across the spectrum of neurological disorders, taking into account factors such as disease burden and scientific opportunity. The group identified five major areas of need, and formed five working groups to articulate specific recommendations.
Key Findings and Recommendations
Assume more leadership in organizing disease-specific consortia designed to enhance collaboration and resource/data-sharing among investigators.
Establish an expert panel to monitor changes in technology (e.g., in nanoscience, genomics, neuroimaging and informatics) and advise NINDS on how these could be applied to disease research.
Develop additional programs to help investigators gain rapid access to new technologies.
Provide more support for the application of systems-mathematical-computational approaches to disease research.
Clinical Science Module – Summary presented by Dr. Cudkowicz
Task and Procedures
This group was tasked with assessing the scope and direction of clinical research supported by NINDS. The group identified three areas of concern: (a) How to balance NINDS' priorities in clinical research against its priorities in basic and translational research; (b) How to set priorities within clinical research; and (c) How to plan and implement clinical trials more efficiently.
Key Findings and Recommendations – Balancing Clinical, Basic and Translational Research
Key Findings and Recommendations – Setting Priorities within Clinical Research
Key Findings and Recommendations – Implementation of Clinical Trials
Leading in the development of standardized outcome measures, which would allow comparison of results across different clinical studies and different disease entities.
Fostering the construction and management of clinical research databases. In addition to lacking standardized outcome measures for generating data, clinical researchers lack standardized ways to name, collect, organize and mine their data. NINDS could confront this problem by developing an intramural program with expertise in database construction and management.
Enhancing efforts to train clinical researchers. There is a dearth of researchers capable of leading a clinical trial at a single site, let alone a multi-center trial. To confront this issue, NINDS offers institutional and individual grants that support training in clinical research (T32 and K23 awards). NINDS should expand these programs and devise new ones.
Strengthening the NINDS Clinical Trials Group. The Clinical Trials Group, a part of the Division of Extramural Research, works with the Clinical Trials Subcommittee to handle concept clearance and final approval of trials costing >$1 million. Group members are talented and committed, but many would benefit from additional hands-on experience in clinical research. Meanwhile, the Group should help cultivate the skills of clinical researchers in the NINDS intramural program. With their research experience supplemented by training in regulatory and administrative processes, these individuals would be poised to provide expert advice to other clinical researchers.
Translational Science Module – Summary presented by Dr. Federoff
Task and Procedures
This group was charged with evaluating NINDS support of translational research, developing recommendations for improvement, and developing criteria for selecting diseases and strategies for future translational investment. As defined by the group, translational research begins with an understanding of disease mechanism(s) and ends with an Investigational New Drug approval (IND) or Investigational New Device Exemption (IDE) from the FDA. Possible products of translational research include methods for disease screening, diagnosis, and prevention; treatments such as drugs, biologics, surgeries and behavioral interventions; and tools to predict treatment response. Because the research is product-driven rather than hypothesis-driven, it involves unique challenges, and stakeholders, with industry, foundations, and the financial sector figuring prominently. It may require large investments at high risk.
The module identified major topics in translational research – from progress in specific diseases to common challenges across diseases – and broke into subgroups to address each one. These topics were then reviewed by the entire group and distilled into several cross-cutting recommendations. In addition to these recommendations, Dr. Federoff noted the importance of creating a smooth transition from basic to translational research and from translational to clinical.
Key Findings and Recommendations
Basic Science Module – Summary presented by Dr. Westbrook
Task and Procedures
This group was tasked with reviewing NINDS' investment in basic neuroscience research. Areas of special focus included: the balance among basic, clinical and translation research; the balance among different areas within basic research; funding mechanisms; training; and shared resources. Subgroups were formed to review these topics and to develop recommendations. At the outset, basic research was defined as research on the functions of the normal nervous system, as well as disease mechanism research and other "disease-related" basic research.
Key Findings and Recommendations
The P01 grant should be eliminated to help restore R01 funding. Council members raised concern that P01s may be necessary to bring basic scientists into collaborative, disease-focused projects, and to educate them about clinical areas where their research can be applied. Other members countered that there are other means to support collaboration and knowledge sharing between basic and clinical scientists, including multi-investigator R01 grants.
The Small Grant program (R03) should be used to support small, exploratory or pilot projects that may lack the preliminary findings usually required to secure an R01. The description of the R03 in the NINDS funding guidelines should be revised to reflect this purpose.
The Exploratory/Developmental Grant program (R21) should be eliminated. The R21 has a reputation for being a safe haven for new investigators, but in fact, has become a trap. Since 1998, there has been an increase in applications for R21s, but not a corresponding increase in awards. With the proposed change in the focus of the R03, the R21 also becomes redundant.
There has been an increase in U01 awards that requires further investigation and justification. There has been a substantial proliferation of U01 projects supported by NINDS, from 3.7 percent of the grants budget in 2003 to 9.5 percent in 2008. While U01s are valuable for funding milestone-driven research, there is concern that they are diverting funds away from R01 investigator-initiated grants.
NINDS should continue to invest in institutional (T32) training grants, as these support academic programs capable of reaching many individuals.
Future investment in T32 grants should be weighted toward late-stage predoctoral students (in the 2nd year of their Ph.D. programs and later), as opposed to early-stage predoctoral students or postdoctoral fellows. Broad-based training for early predoctoral students is adequately served by the Jointly Sponsored Institutional Predoctoral Training Program in the Neurosciences, in which NINDS participates. Meanwhile, focused training for postdocs is adequately served by individual (F32) training grants. Late-stage predoctoral students who have committed to an area of investigation tend to fall through the cracks.
More effort should be made to train Ph.D. scientists in disease, rather than train M.D. scientists in basic research. Rather than expanding programs to recruit clinicians into research (K08 and K23), T32 predoctoral grants could be oriented toward disease-related research. This recommendation provoked mixed reactions from Council.
The NIH Pathway to Independence (K99/R00) program, which supports the transition from a postdoc to a faculty position, has shown early signs of success. If outcomes continue to be positive, the program should be expanded.
Training grant applications place heavy burdens on applicants and reviewers. These burdens may improve with ongoing changes in NIH-wide peer review, but should be monitored.
Each training program should be evaluated by a set of outcome measures tailored to its unique goals.
Overview and Discussion
Dr. Landis asked the Module co-chairs to indicate which of their recommendations deserve the highest priority. The chairs of the clinical and translational panels were not able to attend this portion of the meeting, so their priority statements were made by other panel members.
V. Council Subcommittee Reports
Training, Career Development and Special Programs Subcommittee--Dr. Westbrook, Chair
The subcommittee discussed supplements to the Research Education Programs for Residents and Fellows in Neurology and Neurosurgery (R25). This initiative funds the development of institutional programs to train medical residents and fellows for careers in research. Participating residents and fellows may apply for supplements that provide salary support, and these applications will be reviewed internally by NINDS.
Temporary Suspension of K24 Applications
The Midcareer Investigator Award in Patient-Oriented Research (K24) provides support for clinicians to engage in patient-oriented research and to act as mentors for beginning clinical investigators. Following a review of past applications and the original program announcement language, the subcommittee found that the program lacks a clear definition of mentoring. The program will be temporarily suspended pending further evaluation. Statement added 5-12-2010: As of August 2009, NINDS resumed accepting K24 applications. Please see NOT-NS-09-016 for details of NINDS priorities for the K24 program, and the NINDS training website for additional details.
Training Ph.D.’s for Disease-Related Research
The subcommittee discussed ways to improve the recruitment and training of Ph.D.’s in disease-related research. One possibility might be a program modeled after HHMI's Med Into Grad Initiative or the HHMI-NIBIB Interfaces Initiative.
Clinical Trials Subcommittee--Dr. Laura Ment, Chair
Women and Minorities in Clinical Research
The subcommittee reviewed the participation of women and minorities in NINDS-funded clinical trials. By congressional mandate, NIH-funded clinical research must include women and minorities in appropriate numbers based on the scientific question under study. From 2005 to 2008, there were more females than males enrolled in NINDS-funded clinical studies. During the same period, enrollment of Hispanic, African American, American Indian/Alaska Native and Asian individuals increased, and the number of participants of unknown or unreported race decreased. The subcommittee discussed ways to continue this positive trend, including sending clinical trials coordinators into communities with large minority populations, and translating public outreach materials into Spanish.
Clinical Trial Implementation
Working with the Clinical Trials Group, the subcommittee has proposed a new procedure for concept clearance and implementation of Phase III clinical trials. Under this procedure, implementation would occur in three phases over a 5-7 year period: Concept clearance (year 1), planning/start-up/feasibility (years 2-3), and completion (years 4-7). Funding would be committed at each phase of the trial. A major change from current procedure is the elimination of the planning grant, which provides seed funds for writing trial protocols, organizing trial sites and other aspects of the trial. Under the new procedure, these activities would be built into trial implementation.
Basic and Preclinical Programs Subcommittee--Dr. Povlishock, Chair
The subcommittee reviewed NIH's center programs in neurological disease research, including the Udall Centers of Excellence in Parkinson's Disease (NINDS), the Wellstone Muscular Dystrophy Cooperative Research Centers (NINDS), and the Alzheimer's Disease Research Centers (NIA). Discussion focused on how to maintain program balance, encourage collaboration, and foster innovation. A consensus emerged that in the interests of increasing program balance and reducing administrative burden on NINDS staff, it is probably more effective to support these centers through a grant (P50) steered by a coordinating committee, rather than through a cooperative agreement (U54). It was agreed that the coordinating committee should play a role in fostering collaboration within each program, and that yearly or twice-yearly meetings would enhance collaboration and innovation by center investigators. To support these meetings and other collaborative efforts, NINDS could provide modest seed funds ($100,000/1 year), and should encourage participation by advocacy groups.
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.
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.
Research Training and Career Development Programs
The Council reviewed a total of 141 research career development and institutional training grant applications; of this total, 95 applications had primary assignment to NINDS, and 77 of them (81.1 percent) were recommended for support in the amount of $14.2 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 $5.0 million.
Research Project and Center Awards
The Council reviewed a total of 1,868 research project and center applications; of this total, 1,124 applications had primary assignment to NINDS, and 646 of them (57.5 percent) were recommended for support in the amount of $206.0 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 $57.5 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, no Javits awardees were recommended.
Small Business Innovation Research and Small Technology Transfer Award Programs
The Council reviewed a total of 184 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 107 applications had primary assignment to NINDS and 57 of them (53.3 percent) were recommended for support in the amount of $13.8 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 $3.2 million.
The meeting was adjourned at 9:55 a.m. on Friday, February 6.
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 Strok
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.
(1) For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) in which a real or apparent conflict of interest might occur.
Last Modified February 8, 2011