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Summary of Meeting 1
September 17-18, 2009
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 176th meeting on September 17-18, 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: September 17, 2009: 10:30 a.m. to 4:45 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: September 18, 2009: 8:10 a.m. to 10:50 a.m.
for the consideration of individual grant applications.
Council members present were:
Ms. Susan Axelrod
Dr. Laura Ment
Council members absent were:
|Dr. Luis Parada||Ms. Cindy Parseghian|
Council Roster (Attachment 1)
Ex Officio Member present:
Dr. Robert Ruff, Department of Veterans Affairs
Ex Officio Member absent:
Dr. Geoffrey Ling, Department of Defense
Members of the public present for portions of the open meeting included:
Dr. Philip Haydon, Tufts University
Ms. Christine Peterson, SRI
Ms. Jackie Nelson, Cure CMD
Dr. Amy Akers, Angioma Alliance
Mr. Rick Hanson, Digicon Corporation
Ms. Karla Price, Epilepsy Foundation
Dr. Michael Nunn, The Salk Institute
NINDS employees present for portions of the meeting included:
Dr. Alan Willard
Dr. JoAnn McConnell
Other Federal employees present for portions of the meeting included:
Dr. Stefano Bertuzzi, OD
Dr. Deborah Lewis, CSR
Dr. Peter Guthrie, CSR
Dr. Laurent Taupenot, CSR
Dr. Patricia Manos, CSR
Dr. Keith Crutcher, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Jay Joshi, CSR
Dr. Boris Sokolov, CSR
Dr. Christine Melchior, CSR
Dr. Sam Edwards, CSR
Dr. Aidan Hampson, CSR
I. Call to Order and Opening Remarks
Dr. Landis welcomed Council members, visitors, and staff to the 176th meeting of the National Advisory Neurological Disorders and Stroke Council meeting. Dr. Luis Parada and Cindy Parseghian were unable to attend this meeting. Dr. Landis thanked Robi Blumenstein, Helen Mayberg, Laura Ment, and Carlie Tanner for attending this meeting. Their appointments had been extended since approval of the nomination slate to replace them had been delayed. The newly appointed Council members will be in attendance at the February 2010 meeting. In keeping with the Institute's policy of inviting chairs of CSR and NINDS review committees, Dr. Landis introduced Dr. Philip Haydon, Chair of the CSR Cellular and Molecular Biology of Glia Study Section, who is attending the open session of the Council meeting. Dr. Haydon is Professor and Chair, Department of Neuroscience, Tufts University School of Medicine.
Dr. Landis introduced new NINDS employees: MaryAnn Sofranko, Deputy Executive Officer; Dr. Bill Matthew, Director, Office of Translational Research; and Dr. Petra Kaufmann, Associate Director for Clinical Research. Dr. Walter Koroshetz, Deputy Director, NINDS, introduced Jerry Doyle, Special Assistant to the Deputy Director. Drs. Matthew and Kaufmann made brief remarks regarding their first impressions in the short time that they have been with NINDS. Both will give talks at a future Council meeting.
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 tomorrow when individual grants are discussed.
Approval of Council Minutes—Dr. Finkelstein requested, and the Council voted approval, for the May 28-29, 2009, Council meeting minutes.
The following future Council meeting dates were confirmed
February 4-5, 2010 (Thursday and Friday)
May 27-28, 2010 (Thursday and Friday)
September 23-24, 2010 (Thursday and Friday)
February 3-4, 2011 (Thursday and Friday)
May 26-27, 2011 (Thursday and Friday)
September 15-16, 2011 (Thursday and Friday)
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. For this round, there were 128 applications eligible to be expedited for payment. Of the 74 identified for payment in FY 2009, 62 awards had been issued.
Dr. Finkelstein reminded Council that the NINDS had received approximately $400 million dollars in response to the American Recovery and Reinvestment Act. In order to issue awards by September 30 in response to the various ARRA programs, Council provided early concurrence on 152 ARRA supplements, 240 administrative supplements, and 24 competitive supplements. Several awards did not get issued or were modified based on Council's input. Dr. Finkelstein thanked the Council members for their participation in this process.
Loan Repayment Program-The Loan Repayment Program (LRP) began eight years ago. The purpose is to make it easier for well-qualified clinicians to go into biomedical or behavioral research. There were 120 applications for the clinical and pediatric research loan repayment programs. NINDS was able to pay 67 applications: 45 for the Clinical Research LRP and 22 for the Pediatric Research LRP. These are success rates of 54% (45/84) for the clinical LRP and 61% (22/36) for the Pediatric Research LRP. Of the 67 awardees, there were 35 MDs, 17 MD/PhDs, 10 PhDs, and 5 with various combinations of "other" degrees. The areas of research included: neurology (16), pediatric neurology (10), emergency medicine/neurocritical care (8), neuropsychology/neuropsychiatry (7), pediatrics (6), neurosurgery (5), neonatology (3), neuroradiology (3), and 10 "other."
DER Announcements-Dr. Finkelstein introduced Dr. Erik Runko, a program analyst with the Neural Environment Cluster. Dr. Finkelstein announced that Dr. Larry Refolo, a program director with the Neurodegeneration Cluster, had left NINDS for a position with the National Institute on Aging, and that Dr. Joseph Pancrazio, a program director with the Repair and Plasticity Cluster, would be leaving in October for an academic position with George Mason University. Dr. Finkelstein summarized their contributions to the Institute and wished them well in their new positions.
Dr. Rebecca Farkas introduced Dr. Jodi Gilman, an AAAS fellow who has started a rotation with the Office of Science Policy and Planning.
III. Report of the Director, NINDS
Dr. Landis indicated that NINDS is recruiting several Program Directors, and that suggestions for potential candidates from Council would be welcome.
New NIH Director: Dr. Francis Collins
Dr. Landis reported that on August 17, 2009, Dr. Francis Collins was sworn in as the 16th Director of the NIH. Dr. Collins was nominated by President Obama on July 8, 2009, and was unanimously confirmed by the full Senate on August 7, 2009. Since his appointment, Dr. Collins has held town hall meetings with NIH Staff (August 17, 2009) and with NIH Constituent Groups (September 9, 2009). In these meetings, Dr. Collins spoke about five opportunities for NIH's future growth: 1) Harnessing advances in high-throughput technologies to obtain comprehensive views of particular biological systems and diseases; 2) Translating basic science discoveries into new and better treatments; 3) Putting science to work for the benefit of health care reform; 4) Exploring research opportunities in global health; and 5) Invigorating and empowering the biomedical research community. NINDS will identify opportunities for growth and partnership in these areas.
Stem Cell Guidelines
On March 9, 2009, President Obama issued Executive Order 13505, permitting the expansion of research on human embryonic stem cells (hESCs). The Department of Health and Human Services and NIH were given 120 days to developing new Guidelines to implement the Executive Order. In response to the draft guidelines issued in the Federal Register on April 23, 2009, the NIH received more than 49,000 comments from patient advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, private citizens, and members of Congress. The final guidelines went into effect July 7, 2009, and included a summary of how the public comments were incorporated. The final guidelines are consistent with the following basic principles: responsible research with hESCs has the potential to improve our understanding of human health and illness and discover new ways to prevent and/or treat illness; individuals donating embryos for research purposes should do so freely, with voluntary and informed consent.
In June 2007, the NIH initiated an extensive evaluation of the peer review process, which resulted in a number of ongoing changes, many of which went into effect in the first half of 2009 (i.e., only a single amendment permitted for new and competing renewal applications; NIH-identified New and Early Stage Investigators).
Effective January 2009, all new and competing renewal applications (submitted for FY10) will be permitted only a single amendment. Also at this time, the NIH will revise its data collection approach to identify New and Early Stage Investigators. Between May and June 2009, additional changes will go into effect: enhanced review criteria (guidance to reviewers has been significantly reworded, placing an increased emphasis on overall impact); a new scoring system (e.g., scale goes from 1-9 in whole numbers; four core criteria will get individual scores to help provide additional feedback to investigators); reviewers will use a structured critique and will be asked to identify the strengths and weakness of individual core criteria; new investigator R01 applications will be clustered during review; applications will be discussed in order of the preliminary scores (CSR study sections). Although NIH is still awaiting final approval from the Office of Management and Budget, the final changes to peer review are anticipated to go into effect with applications submitted in January 2010 (for funding in FY11). These changes include soliciting applications with shorter research plans that are more explicitly aligned with the review criteria, and a biosketch bibliography limited to 15 peer-reviewed citations. More information on peer review changes can be found at: http://enhancing-peer-review.nih.gov/
NINDS Strategic Planning
The NINDS is in the final stages of concluding an Institute-wide strategic planning effort that began in September 2006. Although the strategic plan has not been finalized, several of the recommendations that emerged from the process are already being implemented including: hiring Drs. Matthew and Kauffman to head the Offices of Translational and Clinical Research; forming a Division of Extramural Research/Office of Science Policy and Planning (DER/OSPP) analysis working group; forming a medicinal chemistry program; developing strategies to maximize the use of SBIR/STTR set-aside; planning a workshop to discuss strategies for conducting comparative effectiveness research and Translational 2 (T2) research; and initiating changes to the clinical trials application and oversight process. Other recommendations (e.g., conducting environmental disease scans as recommended by the Disease Panel) will require additional thought and planning, and will be implemented incrementally, perhaps in pilot form.
NIH Neuroscience Blueprint
The NIH Neuroscience Blueprint for Neuroscience Research was established in 2004 as a cooperative effort among 16 NIH Institutes/Centers (ICs) that support neuroscience research. During each fiscal year, the participating ICs contribute a small percentage of their funds to a common pool, and as a group, decide how the pool of funds should be spent. Past efforts of the NIH Neuroscience Blueprint included: several training initiatives focused on neuroimaging, computational neuroscience and translational research, the development of the NIH Toolbox for Assessment of Neurological and Behavioral Function, the formation of the Neuroscience Information Framework, and a series of three thematic initiatives focused on neurodevelopment, neurodegeneration, and neuroplasticity. In lieu of proceeding with small, targeted initiatives, the NIH Blueprint Directors have identified three Grand Challenges that have the potential to significantly impact the neuroscience community. These Grand Challenges, which will be allocated significant funding and pursued over the next five years, include: mapping the human connectome, applying the principles of neuroplasticity to dissect the transition from acute to chronic pain, and using a novel approach to develop effective therapies for nervous system disorders.
FY 2010 Budget
Because of the focus of the Obama Administration and Congress on major issues such as the economy and health care reform, it is likely that Congress will not pass a FY10 appropriations bill for the Department of Health and Human Services by the end of FY09 (September 30, 2009), resulting in the passage of a continuing resolution to fund federal programs into the new fiscal year. In budget projections for fiscal year 2010, NINDS is anticipating an increase in grant submissions as a result of the large number of unfunded challenge grants and of shorter grant applications.
Dr. Landis expressed gratitude to the NINDS staff and NANDS Council for their work enabling NINDS to meet the challenges and fulfill the promise of ARRA funds.
IV. Concept Clearance for FY 2010 Proposed Initiatives
Dr. David Jett, Program Director in the Office of Translational Research, presented a new R21 initiative from the NIH CounterACT program, the primary goal of which is to develop medical countermeasures to chemical agents of threat. The proposed initiative will be used to support one to two-year pilot studies to generate tools and proof-of-principle data on the efficacy of candidate therapeutics. This program will be supported using redirected CounterACT funds from the NIH Office of the Director.
Dr. Jill Heemskerk, Program Director in the Office of Translational Research, presented the NIH Blueprint Grand Challenge Program: New Drugs for Diseases of the Nervous System, the goal of which is to find effective therapies for diseases of the nervous system. The five year program will facilitate the translation of the best investigator-initiated ideas and attempt to attract industry by de-risking the most promising disease targets. This program will identify 20 promising validated leads and provide them with access to industry-standard services and expertise and, using go/no go milestones, will gradually focus funds on the two most successful projects. The RFA requiring NANDS Council concept clearance is to solicit investigator ideas for the projects using the U01 cooperative agreement program. It is anticipated that this first set of projects will be discussed at the September 2010 NANDS Council Meeting.
Dr. Finkelstein requested, and was granted, a motion to move forward with both the CounterACT and Blueprint Neurotherapeutics Initiatives.
V. Update on NINDS Budget and the American Recovery and Reinvestment Act
Dr. Finkelstein reported that NIH annually supports about $4.8 billion in neuroscience research and that NINDS provides almost one-third of this money. Appropriations for NINDS have been approximately flat since FY 2006, and actual buying power (taking into account inflation) has been declining steadily during this time. In FY 2009, the NINDS' budget was about $1.59 billion. For FY 2010, the President requested a 1.2% increase ($1.61 billion) over FY 2009, whereas the House bill proposes a 3.6% increase ($1.65 billion) and the Senate bill, a 1.7% increase ($1.62 billion). Based on the President's budget request, NINDS estimates being able to raise the payline to the 13th percentile, and to award 616 competing Research Project Grants.
Dr. Finkelstein reiterated NINDS' commitment to new and early stage investigators (NIs/ESIs), and reported that about $25 million was spent in FY 2009 to support projects past the payline from these investigators. In FY 2009, almost all new investigators were funded up to the 25th percentile and a small number were funded beyond this threshold. Other ways that NINDS supports projects past the payline include: projects with High Programmatic Priority, A0 applications that score at the 16th percentile or better, and projects that come in through an RFA or PAS.
Dr. Finkelstein reported on how the $400 million appropriated to NINDS has been spent to date. $209 million supported 289 RPGs past the payline, $51 million supported 287 administrative supplements, $21 million supported 37 Challenge grants (12 additional NINDS Challenge grants are being funded by the NIH Office of the Director), $41 million supported 21 Grand Opportunity grants (7 of these are being partially funded by the NIH OD), $19 million supported 15 P30 awards, $13 million supported 26 competitive supplements, and $1.5 million supported 124 summer supplements (all dollar figures are approximate).
VI. NIH Public-Private Partnerships
Dr. Koroshetz introduced this session by indicating that three speakers will give brief presentations on existing Public-Private Partnerships (PPPs), with the goal of fostering further discussion on ways that NINDS might identify opportunities to enhance its mission using PPPs, and ways to learn more about the challenges and pitfalls of entering into PPPs.
The Alzheimer's Disease Neuroimaging Initiative (ADNI): A Model for Public-Private Partnership in Neuroscience
- Presented by Dr. Richard Hodes, Director, National Institute on Aging
ADNI was established as a longitudinal, multi-site observational study with the goals of: establishing a brain imaging database in order to identify the best markers for following disease progression; determining the optimal methods for acquiring, processing and distributing data; and validating imaging and biomarker data by correlating it with neuropsychological and clinical data. ADNI sites (57) are supported through a cooperative agreement program funded by both the NIH ($40 million) and by 21 private sector partners ($25 million) through the Foundation for the NIH. In addition to the financial contributions, all ADNI industry sponsors have non-voting representation on the ADNI Steering Committee. After the initial establishment of ADNI, a number of supplemental studies emerged that are also supported through PPPs, including: a PIB/PET study, a supplement to extend the collection of CSF over three years, and a study to conduct whole genome analysis of the ADNI cohort. ADNI aims to provide rapid public access to all raw and processed data; worldwide, ADNI data has been downloaded approximately 200,000 times. In addition, parallel initiatives have been spawned in Europe, Japan, and Australia.
Pharmacologic Bioequivalence between Generic and Brand Name Antiepileptic Drugs
- Presented by Dr. Brandy Fureman, Program Director, NINDS Channels, Synapses & Circuits Cluster
This PPP, established between NINDS and the American Epilepsy Society, was formed to develop a protocol for a clinical trial to study the bioequivalence of brand and generic antiepileptic drugs (AEDs) in people with epilepsy. Bioequivalence measures are pharmacokinetic benchmarks established by the FDA that generic equivalents are required to meet prior to approval. In the approval process for generic drugs, the FDA wraps safety and efficacy studies into bioequivalence studies. If the generic product meets the bioequivalent standard, the FDA assumes that the product also has therapeutic equivalence.
The issue of bioequivalence between brand and generic AEDs has been growing in recent years, as groups including the Epilepsy Foundation have argued that there is enough variability in the standards set by the Food and Drug Administration (FDA) for generic approval that cause problems for people with epilepsy. The FDA reported that, in 2002, the use of generic AEDs results in an estimated annual savings of $56.7 billion. The controversy remains: Does generic substitution cause problems for people with epilepsy? Although there have been many patient reports of problematic side effects from the use of generic AEDs, the FDA's current position is that there are no reliable data to suggest that there is a problem with the way that generic formulations are approved. This PPP will develop a clinical trial protocol for a prospective, multicenter trial to address this issue in patients with epilepsy.
Public-Private Partnerships with Rare Disease Communities
- Presented by Dr. Dan Tagle, Program Director, NINDS Neurogenetics Cluster
Dr. Tagle described a PPP between the NINDS and Lysosomal Storage Disease community. This PPP was formed due to the nature of LSDs which are represented by multiple advocacy groups with different goals and agendas. This partnership was initiated through a series of workshops that helped to identify shared goals between NINDS and LSD groups, and also led to consensus on approaches for forwarding this partnership. While the LSDs are individually rare, collectively their frequency is comparable to that of cystic fibrosis, one of the most common genetic diseases in the US. Major advocacy and voluntary groups, therefore, organized into a coalition called the Lysosomal Storage Disease Research Consortium (LSDRC), which then formally partnered with NINDS in 2004. The common goal of this partnership is to support preclinical or translational research specifically addressing the neurological aspects of LSDs. The PPP led to the development of a Funding Opportunity Announcement (PAS04-120) for which NINDS has sole responsibility of the peer review process. After each NINDS funding cycle, applicants can forward unfunded applications to LSDRC for additional funding consideration. To date, NINDS has funded 12 projects, and the LSDRC 13. Together, these projects cover a range of LSDs and therapeutic approaches. NINDS has since made similar arrangements for two other rare diseases (Ataxia-telangiectasia and dystonia).
Following the three presentations, the NANDS Council had a discussion about several issues relating to PPPs including: how to strategically prioritize potential partners and projects, how to most effectively attract potential partners, and the importance of maintaining transparency as partnerships develop.
VII. Council Subcommittee Reports
Training, Career Development and Special Programs Subcommittee -- This Subcommittee did not meet.
Clinical Trials Subcommittee -- Dr. Laura Ment, Chair
Dr. Ment reported that Drs. Koroshetz and Hirtz discussed Comparative Effectiveness Research and NINDS' efforts towards developing a workshop on this topic.
Basic and Preclinical Programs Subcommittee -- Dr. John Povlishock, Chair
Dr. Povlishock reported that discussion of the NINDS R21 program was tabled until the next NANDS Council meeting, as ARRA responsibilities have prevented NINDS staff from obtaining the necessary data for this discussion. In addition, the subcommittee was updated on the CounterACT initiative and the Optimization of Small Molecular Probes initiative.
VIII. 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.
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 119 research career development and institutional training grant applications; of this total, 78 applications had primary assignment to NINDS, and 64 of them (82.1 percent) were recommended for support in the amount of $8.2 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 $2.5 million.
Research Project and Center Awards
The Council reviewed a total of 4,265 research project and center applications (including ARRA applications); of this total, 2,400 applications had primary assignment to NINDS, and 1,076 of them (44.8 percent) were recommended for support in the amount of $377.4 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 $152.9 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 243 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 159 applications had primary assignment to NINDS and 97 of them (61.0 percent) were recommended for support in the amount of $22.6 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 $5.9 million.
The meeting was adjourned at 10:50 a.m. on Friday, September 18.
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.
(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