NINDS Advisory Council Meeting Minutes, September 23, 2010
Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Neurological Disorders and Stroke Council
Summary of Meeting[1]
September 23, 2010
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 179th meeting on September 23, 2010, at Building 45, Conference Room E1/E2, 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:
Dr. Thomas Brott
Dr. Emery Brown
Dr. Ralph Dacey
Dr. Donna Ferriero
Dr. Robert Friedlander
Ms. Katherine Hood
Dr. Edgar Kenton
Dr. Timothy Pedley
Dr. John Povlishock
Dr. Louis Ptacek
Dr. Barbara Vickrey
Dr. Vicky Holets Whittemore
Ms. Kimberly Zellmer
Council member absent was:
Dr. Lucie Bruijn
Dr. Gary Westbrook
Council Roster (Attachment 1)
Ex Officio Members present:
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. Zach Hall, Retired
Annette Lockwood, Spastic Paraplegia Foundation
Dr. Michael Nunn, Salk Institute
Angela Ostrom, Epilepsy Foundation
Lori Pellutz, SRI International
Takisha Schulterbrandt, SAIC
Gregory Nero, Vangent, Inc.
Andrea Baruchin, Foundation for the NIH
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. Robert Elliott, CSR
Dr. Carol Hamelink, CSR
Dr. Laurent Taupenot, CSR
Dr. Alexander Yakovlev, CSR
Dr. Aiden Harpson, CSR
Dr. Jon Ivins, CSR
Dr. Paek Lee, CSR
Dr. Joseph Rudolph, CSR
Dr. Keith Crutcher, CSR
Dr. Seetha Bhagavan, CSR
Dr. Toby Behar, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Biao Tian, CSR
Dr. Vilen Movsesyan, CSR
Dr. Samuel Edwards, CSR
Dr. Mary Custer, CSR
Dr. Catherine Bennett, CSR
Dr. Suzan Nadi, CSR
Dr. Kevin Walton, CSR
I. Call to Order and Opening Remarks
Dr. Landis, Director, NINDS, welcomed Council members, visitors, and staff to the 179th meeting of the National Advisory Neurological Disorders and Stroke Council meeting.
Dr. Landis stated that it was necessary to extend the terms of five members past their July 31st term date since the nomination slate to replace them is still pending review by the Department of Health and Human Services. Dr. Landis thanked Susan Axelrod, Ralph Dacey and Edgar Kenton for attending this meeting. Due to previous conflicts, Lucie Bruijn and Gary Westbrook are unable to attend.
Next, Dr. Landis introduced Dr. Riju Srimal who has recently joined the NINDS Office of Science Policy and Planning as an AAAS Science and Technology Policy Fellow.
II. Report of the Associate Director for Extramural Research, NINDS
Approval of Council Minutes -- Dr. Finkelstein requested, and the Council voted approval, for the May 27, 2010, Council meeting minutes.
The following future Council meeting dates were confirmed
February 3-4, 2011 (Thursday and Friday)
May 26-27, 2011 (Thursday and Friday)
September 15-16, 2011 (Thursday and Friday)
February 9-10, 2012 (Thursday and Friday)
May 24-25, 2012 (Thursday and Friday)
September 20-21, 2012 (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 136 applications eligible to be expedited for payment of which 120 awards had been issued.
DER Announcements -- Dr. Finkelstein introduced new DER staff: Dr. Crina Frincu, Health Program Specialist, Office of Clinical Research; Dr. Coryse St. Hillaire-Clarke, Program Analyst, Neurogenetics Cluster; and Christiane Robbins, Health Program Specialist, Training Office. He then introduced three employees who have taken on new responsibilities all within the Office of Translational Research: Dr. Linda McGavern, Research Project Manager; Stephanie Fertig, Research Project Manager; and Christina Vert, Program Specialist.
III. Report of the Director, NINDS
ARRA Funding Status
Dr. Landis reported that all of the $402 million in funds received by the NINDS through the American Recovery and Reinvestment Act (ARRA) would be obligated by the end of FY10 (September 30, 2010). The last of NINDS’s remaining funds were used to support projects in response to the NIH Director’s Opportunity for Research in Five Thematic Areas (RC4s). In addition, 3 of NINDS’s RC4 applications were supported with funds from the NIH Office of the Director.
NINDS FY11 and FY12 budget
On February 1, 2010, President Obama released his budget for FY11 signifying the beginning of a new budget cycle which will conclude with Congressionally-approved spending bills in late 2010. In the President’s proposal, which held non-defense discretionary spending at current levels, the Department of Health and Human Services’ budget decreased by 0.1%; however, NIH received a 3.2% budget increase (NINDS received a 2.8% increase to $1.7 billion). Dr. Landis reported that the NINDS budget increase was primarily based on past investments (FY08) in the areas represented by the NIH Director, Dr. Francis Collins’ 5 themes: genomics and other high throughput technologies, translational medicine, benefitting health care reform, global health, and reinvigorating biomedical research. As FY10 comes to a close, fiscal appropriations bills for FY11 have not been passed by Congress, making it necessary to fund the government through a Continuing Resolution (CR). It is expected that the CR will last at least through mid-November, and possibly later. It is possible that NIH will be without a final FY11 budget until March or April of 2011. Given the uncertainty in the upcoming fiscal year, NINDS has made the decision to continue forward with FY10 policies, setting the payline at the 14th percentile. In addition, NINDS will continue the policy of funding Early Stage Investigators (ESIs) at a higher payline, perhaps to the 20th percentile or higher (with each case considered individually). Dr. Landis noted that NINDS will no longer fund New Investigators (who are not also ESIs) at a higher payline except in rare cases. The final NINDS funding strategy for FY11 will be based not only on the final budget, but also on the number of applications received. It is anticipated that both the NINDS FY11 funding strategy and the FY12 President’s Budget will be discussed in greater detail at the February 2011 meeting of the NANDS Council.
Scientific Management Review Board (SMRB)
The Scientific Management Review Board (SMRB) was authorized by the NIH Reform Act of 2006 and signed into law by the President in January 2007. The NIH Reform Act provides certain organizational authorities to HHS and NIH officials regarding NIH institutes and centers (ICs) and the Office of the Director. The purpose of the SMRB is to advise HHS and NIH officials on the use of those organizational authorities. The SMRB, chaired by Dr. Norman Augustine, currently consists of 9 NIH IC Directors and 11 people from outside the NIH. It was initially tasked with: 1) analyzing and making recommendations regarding the fiscal sustainability and utilization of the NIH Clinical Center, 2) making recommendations regarding the optimal organization of the overall NIH intramural research program, and 3) providing recommendations regarding whether organizational change within NIH could further optimize research into substance use, abuse, and addiction, and maximize human health and/or patient well being (for example, should NIDA and NIAAA be merged). These charges were taken on by two working groups of the SMRB, the Intramural Research Program (IRP) Workgroup (Tasks 1 and 2 above), and the Substance Use, Abuse, and Addiction (SUAA) Workgroup (Task 3 above). Each of these working groups provided their recommendations to Dr. Collins at the September 2010 meeting of the SMRB. The primary recommendations of the SUAA workgroup were to: 1) create a new NIH Institute which would oversee all addiction research (drug, alcohol, tobacco, and gambling) and to 2) move to other NIH ICs (e.g. NIDDK and NICHD) parts of the current NIDA and NIAAA portfolios that are not focused on addiction. These recommendations are currently under consideration by Dr. Collins. The primary recommendations of the IRP workgroup related to the sustainability and utilization of the NIH Clinical Center are that it should: 1) function as a national resource with more streamlined oversight and that it should 2) have a stable, responsive budget underpinned by priority setting which should be a line item in the budget of the NIH OD. These recommendations have been temporarily tabled due to the newly established Translational Medicine and Therapeutics working group, which has been charged with: 1) assessing the NIH landscape of programs supporting translational medicine and therapeutics development and 2) providing recommendations regarding their optimal organization.
NINDS Strategic Planning
NINDS is in the final stages of completing an Institute-wide Strategic Planning effort that commenced in 2006. Rather than focusing on what types of science should be supported by NINDS, this planning exercise charged four external advisory panels (focused on basic, translational, clinical research, and disease missions) with addressing more global questions associated with how NINDS should support science and manage scientific investments. The reports of these four panels were presented at the February 2009 meeting of the NANDS Council, and a summary of these reports is available on the NINDS website. In addition, a fifth panel (comprised of two subcommittees) was established to consider NINDS’s efforts in Workforce Diversity (chaired by Dr. Zach Hall) and Health Disparities (chaired by Dr. Lewis Morgenstern). The Workforce Diversity Subcommittee will report to the NANDS Council later this morning, while the Health Disparities Subcommittee will report at a future NANDS Council meeting.
How Criterion Scores Influence the Overall Impact Score for NIH Peer-Reviewed Applications
Dr. Alan Willard, Chief, NINDS Scientific Review Branch, reported findings from recent analyses conducted by the Reporting Branch of the Division of Information Services, NIH Office of Extramural Research. This analysis was conducted as part of the “continuous review of peer review,” to ensure that the changes implemented in response to the NIH-wide effort to “Enhance Peer Review” were having the desired effect to “fund the best science, by the best scientists, with the least amount of administrative burden.” The current analysis examines the relationship between individual criterion scores (i.e. scores for approach, innovation, significance, investigator, environment) and the overall impact score the application receives in all FY10 Research, Research Center, and SBIR/STTR applications across NIH. These analyses indicate that the score for “approach” most strongly correlates with the overall impact score. Moreover, factor analysis suggests that there are two factors that influence the overall impact score, the first of which is a conceptual grouping of approach, significance, and innovation, and the second of which is investigator and environment.
IV. Report of the Associate Director, Office of Clinical Research, NINDS
Dr. Petra Kaufmann reported on ongoing efforts by the NINDS Office of Clinical Research to advance clinical research through broader access to clinical research data. Although data sets from large multi-center clinical trials are of great value, not only for the study’s primary findings, but for the opportunities they provide for additional post doc research, meta-analysis, and the planning and design of future trials, generating them requires significant time and investment. To facilitate the generation of more harmonized, high quality data sets, and to further facilitate data sharing, the NINDS has initiated the Common Data Elements (CDEs) Project. Use of these CDEs will facilitate the comparison of results across studies and more effectively aggregate information into significant metadata results. In addition, the NINDS currently provides clinical data to the National Technical Information System when it is requested by a researcher; however, this process is suboptimal, and the Institute is currently investigating other strategies to broaden data access, potentially through the use of a repository of datasets. In the near future, the NINDS Office of Clinical Research will provide online examples of consent form language that would allow for broad data sharing.
V. Report from the NINDS Strategic Planning Advisory Panel on Workforce Diversity
Dr. Zach Hall, Chair of the NINDS Planning Advisory Panel on Workforce Diversity, presented a summary of the panel’s findings and recommendations. This panel was charged with reviewing current NINDS investments in workforce diversity in the neurosciences, and to make recommendations for current and future programs that will further the broader goals of NINDS by engaging all segments of our society. In preparing their recommendations, Dr. Hall noted that the panel recognized the need for programs at multiple stages of career development, that support the needs of both minority individuals and of institutions that serve large numbers of minorities.
- NINDS Diversity Programs Directed to Individuals
NINDS supports a number of programs directed towards individual trainees, including the Kirschstein NRSA Pre-Doctoral Fellowship Awards to Promote Diversity in Health-Related Research (F31), Research Supplements to Promote Diversity in Health-Related Research, Career Development Awards to Promote Diversity in Neuroscience Research (K01), and Collaborative Neurological Science (CNS) Awards (S11). Dr. Hall noted that the panel agreed that NINDS programs for individual trainees have been generally successful, and that they be continued with particular attention paid to effective mentorship and to institutional commitment. In addition, the Panel recommended establishing an F32 Diversity Program for Post-Doctoral Fellows, and increasing the number of K01 awards and broadening the scientific scope of this program. - NINDS Diversity Programs Directed to Institutions
Currently, the NINDS supports T32 Pre-and Post-Doctoral Training Programs, as well as the Neuroscience Scholars Program (R25), and the Specialized Neuroscience Research Program (SNRP) (U54). The Panel recommended that the R25 Program be continued and that the diversity requirement for institutions receiving pre- and post-doctoral training funds (T32) be strengthened. Although the SNRP program has had many successful outcomes, the Panel recommended several fundamental changes to strengthen the overall program, including a reduction in the number of SNRP awards (to focus resources on the most effective centers), and the development of milestones to accommodate different stages of growth. - Diversity in the NINDS Intramural Research Program (IRP)
The Panel noted that diversity efforts in the NINDS IRP were widely divergent: that the NINDS Summer Internship Program in the Neurological Sciences (SIP) was highly effective at attracting diverse trainees, but that the overall efforts to recruit and train minority trainees at the pre-doctoral, post-doctoral, and investigator levels should be strengthened. - Internal Administration of NINDS Diversity Programs
Many of the NINDS diversity and health disparities programs described are housed in the Office of Minority Health and Research. In the view of the Panel, diversity efforts should be formally separated from health disparities activities and refocused on training, career development, and enhancing institutional infrastructure. Moreover, the Panel recommended that NINDS foster collaborations with diversity programs in other NIH ICs and perform an investment/asset analysis to organize information about diversity programs across NIH. In addition, the Panel recommended the development of a comprehensive database and tracking program for all individuals in NINDS diversity programs.
Dr. Landis solicited, and was granted, NANDS Council acceptance of the Workforce Diversity Subcommittee’s portion of the report. The entire report will be released and discussed in more detail when the Health Disparities Subcommittee has completed its section.
VI. Status of P30 Program
Dr. Stephen Korn, Director of Training and Career Development, NINDS, reported on the outcomes to date for the Initiative to Support New Faculty Recruitment to Enhance Research Resources through Biomedical Research Core Centers (P30). This two year, ARRA-funded program was designed to enable research institutions to hire new, junior tenure-track faculty by providing up to $1 million in direct costs to support salary and start-up packages. In addition, the applicant institutions were required to: provide security to the new hire for five years, preferably through tenure-track promotion, hire postdoctoral researchers, and to use the entirety of the funds in support of the new hire. NINDS received 82 applications and supported 18 awards, resulting in 28 tenure-track hires (with one additional hire pending).
VII. Council Subcommittee Reports
Clinical Trials Subcommittee—Dr. Thomas Brott/Dr. Timothy Pedley, Co-Chairs
Dr. Brott reported that the Clinical Trials Subcommittee discussed a number of the challenges associated with data sharing (discussed earlier by Dr. Kaufmann). The remainder of the subcommittee meeting was used to discuss the NINDS Clinical Trial Methods course. This course is intended to introduce investigators to the essentials of effective clinical trial design (with a focus on Phase I and Phase II trials) and implementation (e.g. enrollment, data management, and biostatistics). The Subcommittee discussed ways of measuring success of the program and of enhancing outreach for the course.
Basic and Preclinical Programs Subcommittee—Dr. John Povlishock, Chair
Dr. Povlishock reported on items discussed by the Basic and Preclinical Programs Subcommittee. These included the NIH Blueprint Neurotherapeutics Program, the SBIR program, a pilot program for the independent replication of biomedical studies, and the temporal realignment of the P30 Neuroscience cores. Dr. Povlishock updated the Council on the NIH Blueprint Neurotherapeutics Program, designed to bridge the gap in drug development between academic and industry research. The Network offers neuroscience researchers a “virtual pharma” to develop promising hit compounds from chemical optimization through Phase I clinical testing. Successful applicants will receive: funding to conduct biological testing, access to a full range of industry-style drug development services and expertise, and control of the intellectual property for drug candidates. The NIH Blueprint anticipates funding approximately 10 applications beginning in FY11, and an additional 10 in FY12.
An update on the NINDS Small Business Program was provided. This is a Congressionally-mandated set-aside program comprising 2.8% of the NINDS budget (~$40 million in FY10). This program is designed to use US-owned small businesses to meet federal R&D needs and to stimulate technology innovation. The program includes two phases, the first of which consists largely of feasibility studies, and the second of which is primarily for development and commercialization. NINDS made 54 awards through this program in FY09, ranging from technology and tool development to therapeutics and diagnostics. Dr. Povlishock reported that NINDS is currently implementing recommendations from the NINDS Small Business Working Groups, including changes to the program administration, accelerating the review process, promoting commercialization, and facilitating program outreach.
Dr. Povlishock discussed a pilot program presented to the Subcommittee to evaluate the need, feasibility, and cost associated with independent replication of key research findings and to better understand the predictability of models and consistency of results between laboratories. For this pilot, three projects were selected for replication, with the consent of the originating lab, and support to both the originating lab and to the replicating lab.
Lastly, Dr. Povlishock discussed an effort to align the start dates of all P30 awards. This effort would facilitate a more consistent review, evaluation, and funding. This action necessitates the award of supplements to currently-funded programs to prevent gaps in funding until they are up for renewal.
Training, Career Development and Special Programs Subcommittee—Dr. Timothy Pedley, Acting Chair
Dr. Pedley reported on the Subcommittee’s discussion of a proposal to establish a national K12 Program for Neurosurgeons. The goal of this new program would be to provide financial support and protected research time for residents who are at the transition point between their residency training program and their first faculty position. The first two years of the award would be supported by K12 funds, and the final three years would be supported by the institution. The program would be overseen by a national advisory council of senior physician-scientists who would interview candidates and facilitate the career development of awardees. The Subcommittee believed that this was a meritorious idea that should be considered by NINDS.
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.
Confidentiality
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 106 research career development and institutional training grant applications; of this total, 72 applications had primary assignment to NINDS, and 52 of them (72.2 percent) were recommended for support in the amount of $7.3 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 $2.2 million.
Research Project and Center Awards
The Council reviewed a total of 1,837 research project and center applications; of this total, 1,153 applications had primary assignment to NINDS, and 658 of them (57.1 percent) were recommended for support in the amount of $190.7 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 $44.8 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 238 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 148 applications had primary assignment to NINDS and 97 of them (65.5 percent) were recommended for support in the amount of $24.2 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 $1.8 million.
IX. Adjournment
The meeting was adjourned at 4:20 p.m. on Thursday, September 23.
We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.
Robert Finkelstein, Ph.D.
Executive Secretary
National Advisory Neurological Disorders and Stroke Council
Director, Division of Extramural Research
National Institute of Neurological Disorders and Stroke
Story C. Landis, Ph.D.
Chairperson
National Advisory Neurological Disorders and Stroke Council
Director
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 February 8, 2011
National Institute of Neurological Disorders and Stroke
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