NINDS Advisory Council Meeting Minutes, September 20-21, 2007

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH

NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL
Summary of Meeting1
September 20-21, 2007

 
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 170th meeting on September 20-21, 2007, 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 20, 2007 - 10:30 a.m. to 5:00 p.m.

for the review and discussion of program development, needs, and policy; and

Closed: September 21, 2007 - 8:15 a.m. to 10:30 a.m.

for the review of the Board of Scientific Counselors’ Reports and for the consideration of individual grant applications.

Council members present were:

Ms. Susan Axelrod
Mr. Robi Blumenstein
Dr. Lucie Bruijn
Dr. Ralph Dacey
Dr. Francisco Gonzalez-Scarano
Dr. Edgar Kenton
Dr. John Loeser
Ms. Prisca Chen Marvin
Dr. Helen Mayberg
Dr. Laura Ment
Dr. Luis Parada
Ms. Cindy Parseghian
Dr. Timothy Pedley
Dr. John Povlishock
Dr. Caroline Tanner
Dr. David Van Essen
Dr. Gary Westbrook
Dr. Vicky Holets Whittemore

Council Roster (Attachment 1)

Ex Officio Member absent:

Dr. Robert Ruff, Department of Veterans Affairs
Dr. Geoffrey Ling, Department of Defense

Members of the public present for portions of the open meeting included:

Dr. Robin Brey, University of Texas Health Science Center at San Antonio
Mr. Ted Shoneck, Tunnell Government Services
Emily Phelps, American Psychological Association
Amy Comstock, Parkinson's Action Network
Beth Roy, Social and Scientific Systems, Inc.
Carol Walton, The Parkinson Alliance
Michelle Rodrigues, SRI International, Inc.
Dane Christianson, Dystonia Medical Research Foundation
Dr. Elaine Brenner, Booz Allen
Rajni Samavedam, Booz Allen
Dr. Kevin Vigilante, Booz Allen
Andrea Inserra, Booz Allen
Dr. Paul McDonald, Booz Allen

NINDS employees present for portions of the meeting include:

Dr. Alan Willard
Ms. Ruth Linn
Dr. Scott Janis
Dr. Frances Yee
Dr. Merrill Mitler
Dr. Claudia Moy
Dr. Robin Conwit
Dr. Melinda Kelley
Dr. Raul Saavedra
Dr. Katrina Gwinn
Ms. Nena Wells
Dr. Story Landis
Dr. Brandy Fureman
Dr. Linda Porter
Dr. Dan Tagle
Dr. Tom Jacobs
Dr. Yuan Liu
Dr. Alfred Gordon
Dr. Emmeline Edwards
Dr. Ernie Lyons
Dr. Diane DiEuliis
Dr. Laura Mamounas
Dr. Robert Baughman
Dr. Robert Finkelstein
Dr. Ursula Utz
Dr. John Porter
Dr. Jill Heemskerk
Dr. David Owens
Dr. Heather Rieff
Ms. Rebecca Desrocher
Dr. Wendy Galpern
Dr. Eugene Golanov
Dr. Jane Fountain
Ms. Lydia Munger
Ms. Lynn Rundhaugen
Ms. Maureen Hambrecht
Dr. Richard Benson
Ms. Carol Rowan
Dr. Audrey Kalehua
Ms. Stephanie Mitchell
Dr. Margaret Sutherland
Dr. Amelie Gubitz
Dr. David Jett
Ms. Yvonne Talley
Ms. Denise Chatman
Ms. Anita Miller
Ms. Brenda Kibler
Mr. Brian Campbell
Ms. Aricia Cottman
Ms. Tracy Chen
Ms. Joellen Harper-Austin
Dr. Rebecca Farkas
Dr. Jenny Mehren
Dr. Cara Allen
Ms. Nancy Hart
Dr. Anna Taylor

Ms. Margaret Jacobs
Dr. JoAnn McConnell
Dr. Thomas Miller
Dr. Naomi Kleitman
Dr. Audrey Penn
Dr. Yejun He
Dr. Daofen Chen
Mr. Paul Myers
Dr. Randall Stewart
Ms. Cikena Reid
Dr. Robert Zalutsky
Dr. Debra Hirtz
Dr. Shanta Rajaram
Ms. Stacey Chambers
Mr. Paul Girolami
Dr. Shai Silberberg
Dr. Ned Talley
Dr. Joe Pancrazio
Mr. Phil Wiethorn
Dr. John Lynch
Dr. Michelle Jones-London
Dr. Mark Scheideler
Dr. Robert Riddle
Dr. Ramona Hicks
Dr. Debra Babcock
Ms. Christina Vert
Ms. Maxine Davis-Vanlue
Mr. Peter Gilbert
Dr. Lorenzo Refolo
Ms. Sylvia Parsons
Ms. Pamela Mayer
Dr. Ran Zhang
Dr. William Benzing
Dr. Manfred Schubert
Ms. Natalie Frazin
Dr. Walter Koroshetz
Ms. Tijuanna Decoster
Mr. Mutema Nyankale
Mr. Steve Markowski
Captain James Stables
Dr. Richard Crosland
Mr. Anthony Petruccelli
Ms. April Toney
Ms. Nicole Williams
Mr. Gavin Wilkom
Ms. Joanne Odenkirchen
Dr. Laurie Gutmann
Mr. King Bond
Ms. Pamela Pearson-Green
Ms. Marian Emr
Dr. David Yeung
Ms. Preeti Hans
Ms. Michelle Johnson
Dr. Ti Lin
Ms. Lisa Joliet
Dr. Paul Scott
Ms. Shannon Garnett
Dr. Stephen Korn

Other Federal employees present for portions of the meeting included:

Dr. Stefano Bertuzzi, OD
Joyce Rogers, OD
Dr. Melissa Riddle, NIDCR
Dr. Carol Hamelink, CSR
Dr. Joanne Fujii, CSR
Dr. Geoffrey Schofield, CSR
Dr. Deborah Lewis, CSR
Dr. Creighton Phelps, NIA
Dr. Beth-Anne Sieber, NIMH
Dr. John Bishop, CSR
Dr. Jon Ivins, CSR
Dr. Dana Plude, CSR
Dr. Biao Tian, CSR
Dr. Pat Manos, CSR
Dr. Peter Guthrie, CSR
Dr. Seetha Bhagavan, CSR
Dr. Jay Joshi, CSR
Dr. Toby Behar, CSR
Dr. Alex Yakovlev, CSR

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I. Call to Order and Opening Remarks

Dr. Story Landis, Director, NINDS, welcomed Council members, visitors, and staff to the 170th meeting of the National Advisory Neurological Disorders and Stroke Council meeting and introduced five new Council members:

Dr. Luis Parada-Dr. Parada is the Southwestern Ball Distinguished Chair in Basic Neuroscience Research and the Diana & Richard C Strauss Distinguished Chair in Developmental Biology, University of Texas Southwestern Medical Center. Dr. Parada is also the Director of the Center for Developmental Biology and Professor of Cell Biology.

Cindy Parseghian-Ms. Parseghian is President of the Ara Parseghian Medical Research Foundation which is a non-profit organization dedicated to funding research projects to find a treatment and cure for Niemann-Pick Type C disease (NP-C) and related neurodegenerative disorders.

Dr. Timothy Pedley-Dr. Pedley is the Henry and Lucy Moses Professor of Neurology and Chairman of the Department of Neurology at Columbia University's College of Physicians and Surgeons, and Neurologist-in-Chief at the Neurological Institute of New York Presbyterian Hospital at Columbia University Medical Center.

Dr. John Povlishock-Dr. Povlishock is Professor and Chair, Department of Anatomy and Neurobiology, Co-Director of the Virginia Commonwealth University Neuroscience Center, and Director, Commonwealth Center for the Study of Brain Injury.

Dr. Vicky Holets Whittemore-Dr. Whittemore is Vice President and Director of Science at the Tuberous Sclerosis Alliance (TS Alliance).

Dr. Landis invited suggestions for Council nominees to replace the four members rotating off of Council next July.

In keeping with NINDS' policy of inviting chairpersons of review committees and study sections, she introduced Dr. Robin Brey, Chair of the NINDS Training and Career Development Review Committee. Dr. Brey is Professor of Medicine/Neurology, Associate Dean for Research, School of Medicine, University of Texas Health Science Center at San Antonio. Council ex officio members Dr. Robert Ruff and Dr. Geoffrey Ling were unable to attend today's meeting.

NINDS Staff Announcements:

Dr. Robert Baughman, NINDS Associate Director for Technology Development, will be leaving NINDS on October 1, 2007. He has been appointed Vice President and Executive Director of the Okinawa Institute of Science and Technology in Japan. His departure is a major loss for NINDS, the Neuroscience Blueprint, and NIH. Dr. Baughman was wished the best of luck in his new position.

Dr. Henry McFarland has stepped down as Clinical Director of NINDS. In July, Dr. Mary Kay Floeter was named Acting Clinical Director until a permanent replacement for Dr. McFarland is identified. Dr. Landis asked that candidate names for the position be forwarded to her.

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 May 24-25, 2007, Council meeting minutes.

The following future Council meeting dates were confirmed:
      February 7-8, 2008 (Thursday and Friday)
      May 29-30, 2008 (Thursday and Friday)
      September 18-19, 2008 (Thursday and Friday)
      February 5-6, 2009 (Thursday and Friday)
      May 28-29, 2009 (Thursday and Friday)
      September 17-18, 2009 (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 one hundred and twelve applications eligible to be expedited for payment, and thirty-seven have been issued. The rest will be issued when there is an FY 2008 budget.

DER Staff Updates- Dr. Finkelstein introduced Dr. David Yeung, a new program specialist in the Counterterrorism program. Dr. Eugene Oliver, program director in the Neurodegeneration Cluster, had recently retired from NIH. Dr. Oliver had been at NIH for thirty-five years. He played a key role in establishing the Udall Centers, managed hundreds of grants in neurodegenerative research, and helped found several disease-related working groups. He will be greatly missed by the Institute.

Loan Repayment Program-The Program began six years ago. The purpose is to make it easier for well-qualified people to go into biomedical or behavioral research. There were 118 applications for clinical and pediatric research loan repayment. The budget of $2.6 million allowed NINDS to make 49 awards; 27 were for clinical research and 21 for pediatric research. Forty-one were to M.D. or M.D./Ph.D.s, and seven were to Ph.D.s.

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III. Report of the Director, NINDS

Dr. Landis introduced three new staff/fellows in the NINDS Office of Science Policy and Planning: Dr. Cara Allen; and Dr. Anna Taylor and Dr. Jennifer Mehren, AAAS Fellows.

Pioneer and Innovator Awards-Yesterday, 12 new Pioneer and Innovator Awards were announced. Five of the Pioneer awardees conduct research having to do with neurology: Peter Bearman, Ph.D., Columbia; Emery Brown, M.D./Ph.D., MGH and MIT; Takeo Hensch, Ph.D., Harvard; Frances Jensen, M.D., Children's; and Gina Turrigiano, Ph.D., Brandeis. Three of the Innovator awardees are in neurology: Ed Boyden, Ph.D., MIT; Mark Johnson, M.D./Ph.D., Brigham; and James Shorter, Ph.D., University of Pennsylvania. The Pioneer awards will be managed by NIGMS, and the Innovator awards will be turned over to the appropriate Institute.

Budget-NIH does yet have an FY 2008 budget. The President's budget is $1.537 billion for NINDS. Both the House and Senate budgets are higher for NIH. We may get a budget by December; otherwise, we will be operating on a continuing resolution, which maintains FY 2007 levels.

Clinical and Translational Science Awards (CTSAs) and Clinical Research-CTSAs are the centerpiece of the NIH Roadmap effort to re-engineer the clinical research enterprise. The purpose of the CTSA program is to create an academic home for clinical investigators and to create a national consortium of centers to transform how translational and clinical research is conducted. There is also a training component to the program. Twenty-four awards have been made so far, with the goal of funding sixty centers. It is important that clinical neuroscience become an integral part of the CTSAs, including participating in their training programs. Dr. Landis encouraged Council members to become involved in the CTSA program. The website is: http://ctsaweb.org

Trans-NIH Issues-In June, Dr. Zerhouni initiated a trans-NIH effort to examine the NIH peer review system with the goal of optimizing its efficiency and effectiveness. The effort involves both external and internal working groups. In addition, there is an opportunity for patient advocacy and foundation groups to provide input. The NIH working group is being led by Dr. Lawrence Tabak, who will make a presentation on this effort later in the day.

OPASI-The incoming director of the new Office of Portfolio Analysis and Strategic Initiatives, Dr. Alan Krensky, spoke at the last NINDS Council meeting about his vision for OPASI. The original purpose of the new office was to create tools to analyze the NIH portfolio, manage strategic initiatives (Roadmap), and evaluate NIH's programs. The Neuroscience Blueprint is an excellent model of a trans-NIH program, working together to advance neuroscience research in a concerted way. There may be an opportunity for funds for Blueprint projects from the OPASI budget.

Biomedical Research Workforce-Dr. Zerhouni is concerned about the advancing age of NIH principal investigators (PIs), the number of new PIs, and the increasing number of PIs over 65. NIGMS conducted a study of their PIs and found that it took an individual an average of 15 years from their B.S. degree to their first grant, 6.7 years from a B.S. to a Ph.D., and 5 years from Ph.D. to assistant professor. There will most likely be efforts at NIH to shorten those times. NINDS is also concerned, especially about the number of clinician-scientists. Council requested data on MDs going into neuroscience research.

Mentored K Awards-The number of K08 (Mentored Clinical Scientist Award) applications remained stable until the last Council round, when NINDS received 6 applications rather than the normal 25 to 30. The K23 program, designed to provide support for patient-oriented research, began in 1999 and has grown steadily since then. However, an analysis of first-time applications shows that both K08 and K23 Type 1 applications have declined from 2005 to the present. The decline in first-time K08 applications is not unique to NINDS. An NIH working group will be formed to analyze the problem and develop recommendations to address it.

Genome-Wide Association Studies (GWAS)-GWAS are flourishing and have been critical to the discovery of treatments for Restless Legs Syndrome and multiple sclerosis. However, they are very costly, and it is unclear at the outset if they will yield useful results. NINDS has supported some GWAS research: 1) support a major repository from which the research community has derived significant benefits and 2) fund several investigator-initiatives genome studies. In light of the costs and the potential benefits of genome-wide studies, the Institute needs to decide the level of its commitment to GWAS studies. Council members advised caution in funding GWAS, recommended focusing on phenotype, and suggested supporting meta-analyses to verify results. NINDS could also take advantage of the samples being collected by PD-DOC, which includes clinical data and environmental risk factor data. There are many opportunities for funding GWAS which have to be weighed carefully in the context of the overall budget and likelihood of benefit.

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IV. FY 2008 Budget Issues

Dr. Finkelstein reported that the estimated total spending on neuroscience research by NIH in FY 2007 is five billion dollars. NINDS supports the largest portion of that, at 30 percent. We are now engaged in the FY 2008 budget process. The President has proposed a 3.1 percent decrease in the NIH budget, totaling $28.329 billion, which would result in a budget of $1.537 for NINDS. The House and Senate have each proposed higher budgets for NIH. We are hopeful that a budget agreement will be made and signed by the President by late fall. An analysis of the NIH and NINDS budgets over the last several years shows a significant decline in the percentage increase over each successive year. The number of applications has almost doubled from FY 2000 to FY 2007; however, the budget for competing grants has only increased by approximately 10 percent. In light of the budget situation, the NIH Director has been concerned about funding new PIs and supporting first-time grantees. To address these problems, each institute was given a target number of new PIs to fund in FY 2007, based on an average of new PIs funded over the last five years. NINDS' goal was 128, which we attained. To keep vulnerable grantees funded, NIH provided funds for 38 "bridge awards" to NINDS investigators. Looking forward to FY 2008, a tentative budget based on the President's recommendations was presented. In spite of the estimated 3.1 percent decrease, NINDS may be able to raise the payline to the 10th percentile, due to a reduction in the commitment base and the elimination of a common fund contribution. Other options for additional funds are to decrease the administrative cuts to grants, increase stipends, or make other choices. Council priorities were to fund the highest quality research and reduce the percentage cuts for quality research, as well as increase the number of grants funded.

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V. Reevaluation of Peer Review at NIH

Dr. Lawrence Tabak, Director, National Institute of Dental and Craniofacial Research, reported on the efforts to enhance peer review at NIH. A summary of this effort is available at: http://enhancing-peer-review.nih.gov/

Following his presentation. Dr. Tabak received several questions from Council. In response to a question about the primary-secondary grant idea, Dr. Tabak clarified that a PI would have a primary grant which would more closely reflect the resources needed to conduct the proposed research. It would then be more difficult to receive additional grants. There was support for more extended-year grant opportunities, such as the Javits program, where a total of seven years of research funding is awarded with an administrative review between the fourth and fifth years. The PI could include a rationale for an extended-years' grant in their grant application. In light of states' retreating from providing support for basic salaries, the burden on academic institutions and the government has increased. This may explain why PIs submit multiple grant applications. One suggestion was to put pressure on institutions with large endowments, perhaps by lowering the cap that the Federal government pays. A Council member reiterated that it is important to fund the best science, and that the proposal to make a second grant submitted by an excellent investigator more difficult to earn may not be consistent with this goal. The "primary-secondary" idea may result in NIH funding a greater number of PIs but not necessarily the best science. Council discussed the variance of indirect costs among institutions and the high indirect costs of wealthy academic institutions. The increase in building new research facilities, which accelerated during the NIH doubling period, resulted in higher indirect costs. There was also a discussion about linking peer review to NIH's primary goal to reduce the burden of disease, and making that a priority when it conflicts with the goal to fund the best science. Weighing the context in which the application is found and statistics on burden of disease would lead reviewers to score an application differently than if the application is reviewed independent of those considerations. One model is to have the reviewers base their score on the science or to have a matrix of scores based on the science, the significance, etc., and the Institutes/Centers (I/Cs) choose which applications to fund based on their priorities. The problems with that model were discussed. The quality of study section chairs and members and strategies for attracting the best reviewers was discussed. On a related subject, Dr. Tabak explained that Dr. Toni Scarpa's committee is studying how to streamline the application process. Dr. Tabak's committee and Dr. Scarpa's committee will work together on recommendations to the NIH Director. The issue of re-thinking the rationale for triaging a certain percentage of applications was raised. Some feedback Dr. Tabak has received recommended doing away with triaging applications; however, the burden on study sections would increase significantly. One idea is to have the study sections prioritize all of the applications at the conclusion of the review. Dr. Tabak informed the Council that his committee's recommendations will not be based on the amount of support recommendations get but will be based on the best ideas. A Council member stated that Dr. Tabak's goal to improve the peer review process is an important one, regardless of the financial situation, but that as long as budgets are so tight, not all good science will be funded. Application reviews need to be seen as fair and unbiased. Dr. Landis explained that Dr. Scarpa's committee is weighing the pros and cons of electronic review. Both groups are working hard to receive external advice and input and will continue to do so until the end of February. Pilots will be created and analyzed in March and April.

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VI. NINDS Initiatives - Planning and Assessment

Initiatives are designed by Institute staff, with the input of Council and the external scientific and lay community. An update will be given at the next Council meeting on some of the ongoing initiatives and Council members will be asked for their ideas for evaluating the initiatives' progress. Council will also be asked whether the Institute programs are still relevant and whether NINDS should begin new efforts to address particular needs. One program that has just undergone evaluation is the Udall Centers of Excellence program. Congress mandated the funding of a set of research centers on Parkinson's disease in 1997. Eleven centers have been funded, in addition to a data organizing center. Council requested an evaluation of the program, which has been completed and will be presented by Dr. Dacey.

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VII. Working Group Report on the Evaluation of the Morris K. Udall Centers of Excellence in Parkinson's Disease Research

Council member, Dr. Ralph Dacey, reported on the Working Group's evaluation of the Morris K. Udall Centers of Excellence in Parkinson's disease research which is available at: http://www.ninds.nih.gov/research/parkinsonsweb/udall_centers/udall_Recommendations_Report_2007.pdf

The discussion that followed the presentation included questions about the utility of the evaluation, given the absence of a control group; whether other disease groups could benefit from the centers model; whether only to fund investigator-initiated centers or to issue a program announcement, as was done for the Udall Centers; whether standardized criteria need to be developed for all of the centers; collaboration versus competition; and the quality and level of productivity of each center. The evaluation did not answer the question of whether a centers' program is more effective than funding investigator-initiated research. The Working Group recommended that NINDS staff participate in a new Coordinating Committee. Dr. Landis stated that the report will be posted on the NINDS website and that the Udall Centers and NINDS will prepare responses to the Working Group's recommendations.

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VIII. Concept Clearance for FY 2009 Proposed Initiatives

Council voted to approve the concepts for the following initiatives:

  • NINDS ImPACT Program: Fostering Immediate Practice-Altering Clinical Trials (Phase II and III)
  • Axonal Damage in Multiple Sclerosis: Strategies for Protection and Repair
  • Understanding and Preventing Brain Tumor Dispersal
  • Collaborative Activities to Promote Translational Research (CAPTR)

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IX. Council Subcommittee Reports

Training, Career Development, and Special Programs Subcommittee
Dr. Francisco Gonzalez-Scarano, Chair

Training Award Success Rates for FY 2007, October 2007-Dr. Korn presented a summary of the success rates for training programs for October 2007 (FY08). The number of applications and awards were presented in relation to the ratio of applications and awards at the same time in fiscal year 2007.

First K99 to R00 Transition at NINDS-Dr. Korn described some demographics of the first four cycles of K99/R00 applications. He then described the first successful K99 recipient to obtain an independent position and successfully converted to the R00 phase of the Pathway to Independence Award

Proposed Change to K02 Funding Level Due to NIH-Mandated Change in Policy Regarding a Concurrent R01-NINDS requires 75 percent effort for K02 recipients, but often the funding allocated does not provide 75 percent of the investigators' salaries. This is not generally a problem, because K02 recipients are still considered somewhat in training (although they have independent status). However, this does become a problem by year four of the grant. Applicants are required to bring in additional R01 or equivalent support by the beginning of year four to keep the K02, but cannot collect salary from the additional grant(s). At this point, they are expected to bring in salary commensurate with their research effort, which, due to the current salary structure, they are typically unable to do. Staff proposed leaving the budget structure for the K02 unchanged until the candidate receives an R01. Once they receive an R01, allow them to collect up to 80 percent of their actual salary for the K02. The subcommittee recommended allowing K02 recipients who have gotten an R01 to collect up to 80 percent of their actual salary. They asked that NINDS collect data on the rank and salary levels of the current K02 awardees to inform a decision as to whether to increase the allowable salary in the first three years of the program.

Funding of Residents and Fellows-There is a paucity of clinicians conducting basic research (applying for the K08 programs), due in part to limited funding for early research training for these clinicians to prepare them to be competitive for a K award. In addition, for institutional programs that have enacted a new neurology research track residency, residents cannot receive funding from traditional sources (i.e., K awards) to conduct research as part of their training. In order to increase the pipeline of clinicians (neurologists and neurosurgeons) that are competitive for K08s, the NINDS proposed a two-fold approach: The first component would be to issue an R25 RFA designed to support funding for residents to do research. This mechanism would provide a means for institutional oversight as well as an incentive for institutions to participate. Participating residents would be expected to apply for an F32 or K award at the end of, or shortly after, residency. The second component would be to issue an F32 PAR for fellows. After only one year of research training, residents may not be prepared for or competitive for K awards. This fellowship would provide an alternative, interim funding mechanism with a somewhat lower bar than a K award to allow for additional research training and experience to make these candidates more competitive for K awards. The subcommittee supported the concepts of supporting the research training of clinicians during residency as well as a bridging award to support these candidates as they transition from residency to becoming competitive for K awards. They were enthusiastic about the R25 mechanism to accomplish this. It was determined that an F32 was probably not an appropriate mechanism, and the subcommittee asked that NINDS consider how to bridge residents into fellowship research.

Basic and Preclinical Programs Subcommittee
Dr. David Van Essen, Chair

The subcommittee discussed whether NINDS should encourage any changes in research publication procedures in order to improve the dissemination of research results. They discussed the results of a meeting held in June in St. Louis that was entitled, "PubMed Plus." The purpose of the meeting was to look at new directions in publications and data mining. The meeting brought together editors, neuroinformatics experts, bioinformatics experts, librarians, journal publishers, and NIH representatives. The four working groups were: 1) Capturing metadata to enhance data mining, 2) Improving linkages between journal articles and data repositories, 3) Sustainability and standardization of journal supplementary materials, and 4) Sharing manuscripts reviews across neuroscience journals. The outcome of the PubMed Plus meeting was discussed in relation to the existing trans-NIH data sharing policy. The consensus of the subcommittee was to support formulating an action plan to foster data sharing and to provide for more efficient strategies for data management. Any new policy consideration should include input from the extramural community and should serve the neuroscience community as a whole. It was noted that NINDS and Blueprint have the ability to develop ideas for improvements to the existing data-sharing policy that could be considered by NIH. Blueprint can also provide incentives for better data sharing and data management. Supplemental grants are also potentially useful for facilitating data-sharing. Other comments noted that the neuroscience community can become more effective at utilizing existing resources such as NCBI and Roadmap programs and can become more involved with the bioinformatics community on a broad scale. The second issue discussed was the 10-year limitation on the length of P01 Program Project and unsolicited P50 Center Grant Awards. The consensus of the subcommittee was that the ten-year sun setting policy for P01s should be continued. The investigator-initiated P50 Center Grant mechanism could be used for research projects that involve special patient material repositories or cohorts. An Announcement or Notice should document and publicize this change in policy. Existing P50s that do not meet this criterion could be converted to P01s. The budget impact of such conversions should be managed so that the total Centers line does not change. The P30 mechanism could be used for other types of basic research-related cores when applicable.

Clinical Trials Subcommittee
Dr. Laura Ment, Chair

There was no business to discuss in open session.

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X. 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 as 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 125 research career development and institutional training grant applications; of this total, 72 applications had primary assignment to NINDS, and 49 of them (68.1 percent) were recommended for support in the amount of $5.9 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 $1.1 million.

Research Grant Awards

The Council reviewed a total of 2,117 research grant applications; of this total, 1,200 applications had primary assignment to NINDS, and 712 of them (59.3 percent) were recommended for support in the amount of $204.7 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 $57.7 million.

Senator Jacob Javits Neuroscience Investigator Awards

The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period. Candidates are nominated and selected at each Council meeting. At this meeting, the Council recommended one investigator as a Javits awardee.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 148 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 92 applications had primary assignment to NINDS and 46 of them (50.0 percent) were recommended for support in the amount of $9.3 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 $5.2 million.

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XI. Adjournment

The meeting was adjourned at 10:30 a.m. on Friday, September 21.

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.

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.

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Last updated December 03, 2008