NINDS Advisory Council Meeting Minutes, February 4, 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
February 4, 2010
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 177th meeting on February 4, 2010, 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 4, 2010: 10:00 a.m. to 2:45 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: February 4, 2010: 2:45 p.m.to 4:50 p.m.
for the consideration of individual grant applications.
Council members present were:
| Ms. Susan Axelrod Dr. Thomas Brott Dr. Emery Brown Dr. Lucie Bruijn Dr. Donna Ferriero Dr. Robert Friedlander Ms. Katherine Hood Dr. Edgar Kenton |
Ms. Cindy Parseghian Dr. Timothy Pedley Dr. John Povlishock Dr. Louis Ptacek Dr. Barbara Vickrey Dr. Gary Westbrook Dr. Vicky Holets Whittemore Ms. Kimberly Zellmer |
Council member absent was:
Dr. Ralph Dacey
Council Roster (Attachment 1)
Ex Officio Member present:
Dr. Geoffrey Ling, Department of Defense
Ex Officio Member absent:
Dr. Robert Ruff, Department of Veterans Affairs
Members of the public present for portions of the open meeting included:
Dr. Dale Pelligrino, University of Chicago
Dr. Sara Shnider, National Academy of Sciences, Institute of Medicine
Fred Batzold, Pharmaceutical Product Development, Inc.
Mr. Ronald Bartek, Friedreich’s Ataxia Research Alliance
Ms. Michelle Rodrigues, SRI
Mr. Roderick Corriveau, Coriell Institute for Medical Research
Mr. Rick Hanson, Digicon Corporation
Ms. Karla Price, Epilepsy Foundation
Ms. Donna Mullins, Spinal Muscular Atrophy Foundation
Ms. Donna Meltzer, Epilepsy Foundation
Ms. Amy Rick, The Parkinson Alliance
NINDS employees present for portions of the meeting included:
|
Dr. Alan Willard
|
Dr. JoAnn McConnell Dr. Naomi Kleitman Dr. Audrey Penn Dr. Daofen Chen Dr. Randall Stewart Dr. Shanta Rajaram Mr. Paul Girolami Dr. Shai Silberberg Dr. Joe Pancrazio Mr. Phil Wiethorn Dr. Michelle Jones-London Dr. Mark Scheideler Dr. Ramona Hicks Dr. Debra Babcock Ms. Christina Vert Mr. Peter Gilbert Ms. Pamela Mayer Dr. Ran Zhang Dr. William Benzing Dr. Walter Koroshetz Ms. Tijuanna Decoster Ms. Marian Emr Ms. Preeti Hans Dr. Ti Lin Dr. Alexander Runko Dr. Yolanda Vallejo Dr. Anna Taylor Dr. Cara Allen Ms. Joanne Odenkirchen Dr. Miriam Leenders Ms. Stacey Chambers Dr. Richard Crosland Ms. Natalie Frazin Dr. Giovanna Guerrero Ms. Louise Ritz Ms. Janice Cordell Ms. Jennifer Khovananth Ms. Kelly Baker Dr. Petra Kaufmann Dr. William Matthew Dr. Jodi Gilman Dr. Rebecca Farkas Dr. Alfred Gordon Ms. Quynh Ly Dr. Jim Gnadt Ms. Pam Pearson-Green Dr. Salida Waddy Dr. Robin Conwit Ms. Rebecca Desrocher Ms. Andrea Frydl Mr. Taek Oh |
Other Federal employees present for portions of the meeting included:
Dr. Emmeline Edwards, NCCAM
Dr. Alexander Yakovlev, CSR
Dr. Vilen Mouvsesyah, CSR
Dr. Peter Guthrie, CSR
Dr. Suzan Nadi, CSR
Dr. Keith Crutcher, CSR
Dr. Laurent Taupenot, CSR
Dr. ReneEtcheberrigaray, CSR
Dr. Sam Edwards, CSR
I. Call to Order and Opening Remarks
Dr. Landis welcomed Council members, visitors, and staff to the 177th meeting of the National Advisory Neurological Disorders and Stroke Council meeting. Dr. Landis introduced four new Council members: Dr. Thomas Brott, Professor of Neurology and Director for Research, Mayo Clinic; Dr. Donna Ferriero, Professor of Neurology and Pediatrics and Vice Dean of Academic Affairs, School of Medicine, University of California, San Francisco; Dr. Barbara Vickrey, Professor and Vice Chair of the Department of Neurology at the University of California, Los Angeles; and Kimberly Zellmer, an attorney and an advocate for research on Batten disease, Leawood, Kansas.
In keeping with the Institute’s policy of inviting chairs of CSR and NINDS review committees, Dr. Landis introduced Dr. Dale Pelligrino, Chair of the CSR Brain Injury and Neurovascular Pathologies Study Section, who is attending the open session of the Council meeting. Dr. Pelligrino is Professor, Department of Anesthesiology, College of Medicine, University of Illinois at Chicago and Professor and Director, Neuroanesthesia Research Laboratory.
Dr. Landis announced that Dr. Luis Parada had resigned from Council and that Dr. Ralph Dacey would be unable to attend this meeting.
Dr. Landis introduced three new employees within the Office of the Director, NINDS: Gregory Roa, a Medical Science Writer in the Office of Communications and Public Liaison (OCPL); Andrea Frydl, a Health Communication Specialist in the NIH Administrative Fellows Program, who recently joined OCPL; and Dr. Katie Jakubs, Health Science Policy Analyst, Office of Science Policy and Planning (OSSP). Leaving NINDS is Dr. Giovanna Guerrero, who has been with OSPP since 2008 as a Health Science Policy Analyst, and who is moving to Grand Rapids, Michigan, as Head of Science Policy and Special Programs at the Van Andel Institute. She was wished well in her new position and told that she will be sorely missed.
II. Report of the Associate Director for Extramural Research, NINDS
Dr. Robert Finkelstein, Associate Director for Extramural Research, NINDS, informed the Council that due to the impending weather, the closed session for the discussion of individual grants scheduled for the next day would be moved to the end of today.
Approval of Council Minutes — Dr. Finkelstein requested, and the Council voted approval, for the September 17-18, 2009, Council meeting minutes.
The following future Council meeting dates were confirmed
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)
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 130 applications eligible to be expedited for payment. Of the 81 identified for payment in FY 2010, all awards had been issued.
Council Operating Procedures — Once a year, Council is required to endorse the Council Operating Procedures, which includes the Council Delegated Authorities. Council moved to approve the Operating Procedures.
DER Announcements — Dr. Finkelstein introduced Dr. Rebecca Farkas, a new Program Director in the Office of Translational Research, and Dr. Debbie Bergstrom, on detail from the NINDS intramural program, working in the Neurodegeneration Cluster.
Dr. Finkelstein next announced that Dr. Emmeline Edwards, Deputy Director, Division of Extramural Research, had recently assumed a position as Director, Division of Extramural Research, with the National Center for Complementary and Alternative Medicine. Dr. Edwards attended the morning session and the Institute thanked her for her many contributions to NINDS and wished her well in her new position.
III. Report of the Director, NINDS
NINDS Budget in FY10 and FY11
Dr. Landis reported that between FY06 and FY10, NINDS’ budget has increased, though not as fast as inflation. The NINDS budget distribution for FY10 is similar to previous years: 87.2% ($1.43 billion) to support research programs in the extramural community (e.g. grants, contracts, and training); 9.3% ($153 million) to fund the Intramural Research Program; and 3.4% ($56.5 million) to cover overhead expenses, including facilities and staff. For FY10, the NINDS payline will be set at the 13th percentile. In addition, for the first two council rounds of FY10, NINDS will be paying most first submission R01s (i.e. A0s) to the 16th percentile in order to accelerate research that analysis shows is highly likely to be funded upon resubmission. NINDS places a priority on fostering the next generation of researchers and, in general, is funding New Investigator (NI) R01s to the 20th percentile and carefully-considered Early Stage Investigator (ESIs) R01s to the 30th percentile. As in the past, most modular grants are cut by 12.5% and non-modular grants by 17.5% in order to fund new RPGs. Between FY06 and FY10, the NINDS success rate (which is partially a function of how many grants received) has increased by 3%.
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 budgets of individual NIH Institutes were constructed based on a 6% increase to stipends as well as on contributions to specific NIH initiatives including Therapeutics for Rare and Neglected Diseases (TRND) and the Basic Behavioral & Social Sciences Opportunities Network (OppNet). In addition, the major factor contributing to the FY11 budgets of individual NIH Institutes is past investments in the areas represented by Dr. Collins’ 5 themes: genomics and other high throughput technologies, translational medicine, benefitting health care reform, global health, and reinvigorating biomedical research. Several factors contribute to the difficult task of fiscal planning for FY11 including: uncertainty surrounding the number of two year ARRA awards that will come in for renewal, uncertainty regarding the number of unfunded ARRA applications that will come in as R01s, and lack of a final budget.
NINDS Strategic Planning Effort
NINDS is in the final stages of bringing to closure an Institute-wide Strategic Planning effort that commenced in 2006. Rather than mandating what science should be supported by NINDS, this planning exercise charged four external advisory panels 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 now a summary of these reports has been prepared for public comment.
Dr. Landis indicated that the planning process underscored the need for NINDS to more actively manage its research investments. Four guiding principles will be used to manage these investments moving forward: balance opportunities and needs across the spectrum of research (basic, translational and clinical), monitor funding portfolio to ensure that it does not drift unintentionally, monitor programs to determine whether they are meeting their intended goals, and actively manage translational and clinical sciences by setting priorities based on opportunity and need. NINDS identified a number of ongoing programs that, for various reasons, will be completed (i.e. NIH Neuroscience Microarray Consortium, Gene Expression Nervous System Atlas [GENSAT], NEPTUNE); restructured (applications for the Morris K. Udall Centers of Excellence for Parkinson’s Disease Research program and for the NINDS Institutional Center Core Grants (P30) to Support Neuroscience Research program will be accepted only one time per year); or revised (the NINDS Clinical Research Consortium will be phased out and re-formulated as a clinical trials network). In addition, NINDS will strategically focus efforts in the high-priority areas of PD Biomarker discovery and Epilepsy.
Peer Review
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 were in effect during the July 2009 review meetings. The changes included: enhancing review criteria, developing template-based critiques, modifying the scoring scale (1-9 with corresponding criteria), altering the order of review (New and Early Stage Investigators are clustered together), and shortening the review cycle. As these changes have been implemented with varying degrees of uniformity, the Center for Scientific Review is working to ensure consistency such that reviews are informative not only to the investigators that submit them but to the Institutes and Councils
IV. Analysis of the NIH Exploratory Developmental Research Grant Program (R21)
Dr. Povlishock reported on a discussion of the Basic and Preclinical Subcommittee addressing whether NINDS should continue its participation in the NIH Exploratory/Developmental Research Grant Program (R21). This discussion was spurred, in part, by a recommendation of the Basic Planning Module advising that NINDS eliminate unsolicited R21s and increase the budget of R03 awards to support pilot projects. These recommendations emerged due to ongoing confusion by both investigators and review committees over NINDS’ use of the R21 mechanism, particularly with respect to an increased emphasis on “research with ground breaking impact” when compared with other NIH institutes. In advance of the Subcommittee meeting, data was requested from Extramural Program Staff to inform a discussion on the future of NINDS’ participation in the NIH-wide R21 program. Questions addressed by the analysis presented included: what were the demographics of the investigators that successfully obtain R21s, what type of research is being supported using this mechanism, and what was the impact of the research supported? This analysis led to the conclusion that R21s fill an important need in NINDS’ research portfolio, and the Subcommittee’s recommendation that NINDS should continue to participate in the NIH Parent announcement with the following modifications: NINDS should align its research objectives with the NIH Parent R21 announcement, NINDS should discourage New and Early Stage Investigators from applying for this mechanism as a source for funding, emphasizing that R01 success rates are much higher than R21 success rates for these investigators.
V. NINDS Participation in the High Priority, Short-Term Project Award (R56)
Dr. Finkelstein reported that NINDS was considering funding about 15 projects through the High Priority, Short-Term Project Award (R56) program (i.e. Bridge Awards). The NINDS recently signed on to the R56 mechanism, which provides short-term funding for R01 applications with scores just beyond the payline. This mechanism has not been used by NINDS in the past, but is under consideration at this time in an attempt to manage the “post-ARRA cliff” by taking on as few out-year commitments as possible in FY10, and because the NIH Director’s Bridge Award (NDBA) program had been suspended. Over the past 3 years (FY07-FY09), 99 NINDS grantees have been supported through this program, and to date, more than 80% of these investigators successfully obtained a competing renewal. At the present time, NINDS is considering 1 year Bridge Awards to type two applications with scores between the 14th and 25th percentile. In a limited number of cases, the Institute will consider making awards to applications that are ineligible for revisions.
VI. Council Subcommittee Reports
Training, Career Development and Special Programs Subcommittee — Dr. Gary Westbrook, Chair
Dr. Westbrook reported that the Training Subcommittee had an informational session during which Council procedures for expediting K awards were discussed. In addition, the Subcommittee was presented with a demonstration of a new web-based training tracking system for use by both trainees and NINDS staff. Lastly, the Subcommittee discussed the criteria used to judge the success various training mechanisms.
Clinical Trials Subcommittee — Dr. Thomas Brott and Dr. Timothy Pedley, Co-Chairs
Dr. Pedley reported that all key items discussed by the Subcommittee will be presented with the proposed initiatives for concept clearance later in the meeting.
Basic and Preclinical Programs Subcommittee — Dr. John Povlishock, Chair
The future of NINDS’ participation in the R21 program (discussed earlier) was the primary focus of the Subcommittee. Dr. Povlishock had no additional items to report.
VII. Concept Clearance for FY 2010 Proposed Initiatives
Dr. Brandy Fureman, Program Director in the Channels, Synapses and Circuits Cluster, presented a package of initiatives to accelerate research in the epilepsies. These initiatives are designed to encourage a shift in the research focus from seizure control to preventing and curing epilepsy. The proposed initiatives include: an Epilepsy Centers Without Walls program, designed to promote collaborative research to address specific challenges identified as priorities; a cooperative program in translational research which will solicit milestone-driven R21 and U01 proposals targeted to antiepileptogenesis and treatment of intractable epilepsy; and an epilepsies EUREKA Program, which is designed to encourage innovative approaches to epilepsy research.
Dr. Petra Kaufmann, Director of the Office of Clinical Research, presented a proposal for NINDS-NET, a research network for clinical neuroscience. This proposed network will provide a framework to test the most promising new drugs in biomarker-informed, phase II clinical trials for neurological indications, and, in particular, rare diseases. Secondary goals of the network will be to leverage institutional clinical research infrastructure, decrease time and cost between trial design and execution, and to maintain the flexibility necessary to rapidly develop investigator teams for the design and execution of promising therapies.
Dr. Walter Koroshetz, Deputy Director, NINDS, presented a proposal designed to accelerate the identification of biologic markers of Parkinson’s disease and disease progression, the absence of which is a barrier to the successful development of PD therapies. The proposed initiative features a discovery phase to identify the best biomarker candidates and a second phase to identify which of these candidates may be informative in a phase II clinical trial. At the core of the proposed initiative is a cohort study, which, in addition to informing the biomarker discovery process, will provide a valuable set of standardized clinical data.
Dr. Daofen Chen, Program Director in the Systems & Cognitive Neuroscience Cluster, presented a proposed initiative, designed to capitalize on the development of the “DARPA Arm,” developed by Deka Research and Development. Developed as part of DARPA’s “Revolutionizing Prosthetics” program, the arm is a fully-functional, electromechanical prosthetic limb. The proposed initiative will solicit competitive supplements for NINDS-funded researchers to conduct research leading to a neural interface for this device.
Dr. Finkelstein requested, and was granted, a motion to move forward with the initiatives.
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.
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 176 research career development and institutional training grant applications; of this total, 123 applications had primary assignment to NINDS, and 97 of them (78.9 percent) were recommended for support in the amount of $16.6 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 $6.4 million.
Research Project and Center Awards
The Council reviewed a total of 1996 research project and center applications; of this total, 1271 applications had primary assignment to NINDS, and 748 of them (58.9 percent) were recommended for support in the amount of $216.3 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 $65.0 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, one Javits award was recommended.
Small Business Innovation Research and Small Technology Transfer Award Programs
The Council reviewed a total of 307 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 166 applications had primary assignment to NINDS and 96 of them (57.8 percent) were recommended for support in the amount of $26.9 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 $4.0 million.
IX. Adjournment
The meeting was adjourned at 4:50 p.m. on Thursday, February 4. Following adjournment, Council completed a brief survey on enhancing peer review provided by the Office of Extramural Research, Office of the Director.
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 Strok
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.
(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 updated February 8, 2011
National Institute of Neurological Disorders and Stroke
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