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NINDS Advisory Council Meeting Minutes, May 28-29 2009


Department of Health and Human Services 
Public Health Service
National Institutes of Health
National Advisory Neurological Disorders and Stroke Council

Summary of Meeting 1
May 28-29, 2009

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 175th meeting on May 28-29, 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:  May 28, 2009:  10:35 a.m. to 5:05 p.m.

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

Closed:May 28, 2009:  5:05 p.m. to 5:30 p.m.                      
                       May 29, 2009:  8:20 a.m. to 10:20 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. Emery Brown
Dr. Lucie Bruijn
Dr. Robert Friedlander
Ms. Katherine Hood
Dr. Edgar Kenton
Dr. Helen Mayberg
Dr. Laura Ment
Dr. Luis Parada
Dr. Timothy Pedley
Dr. John Povlishock
Dr. Louis Ptacek
Dr. Caroline Tanner (absent 5/29)
Dr. Gary Westbrook
Dr. Vicky Holets Whittemore

Council members absent were:

Dr. Ralph Dacey 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:

Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance
Donna Meltzer, Epilepsy Foundation
Karla Price, Epilepsy Foundation
Dr. Gregory Bergey, Johns Hopkins University
Dr. Donna Dean, Lewis-Burke Associates, LLC
Ms. Michelle Rodriguez, SRI
Bobbie Peterson, Advanced Genomics Technology Center
Chris Dacosta, PPD Inc.

NINDS employees present for portions of the meeting included:

Dr. Alan Willard
Ms. Ruth Linn
Dr. Scott Janis
Dr. Merrill Mitler
Dr. Claudia Moy
Dr. Deborah Hirtz
Ms. Nena Wells
Dr. Story Landis
Dr. Brandy Fureman
Dr. Linda Porter
Dr. Dan Tagle
Dr. Tom Jacobs
Dr. Yuan Liu
Dr. Emmeline Edwards
Dr. Ernie Lyons
Dr. Laura Mamounas
Dr. Robert Finkelstein
Dr. John Porter
Dr. Jill Heemskerk
Dr. David Owens
Dr. Eugene Golanov
Dr. Jane Fountain
Ms. Lydia Munger-Little
Ms. Lynn Rundhaugen
Ms. Maureen Hambrecht
Dr. Margaret Sutherland
Dr. Amelie Gubitz
Dr. David Jett
Ms. Joellen Harper-Austin
Dr. Beth-Anne Sieber
Dr. May Wong
Dr. Stephen Korn
Dr. Wendy Galpern
Ms. Tracy Chen
Mr. Taek Oh
Mr. Scott Prince
Dr. Daniel Stimson
Mr. James Stables
Ms. Margo Warren
Ms. Lisa Joliet
Dr. Timothy Lavaute
Mr. Ken Frushour
Dr. Ned Talley
Ms. Jennifer Antelman
Dr. Ursula Utz
Dr. Steve Markowski
Dr. Alan Koretsky
Ms. Vanessa Mahon
Dr. Robert Riddle
Mr. Aaron Kinchen
Dr. Tom Miller
Mr. Peter Soltys
Mr. Andrew Skinner
Ms. Sue Titman
Ms. Stephanie Fertig
Ms. Andrea Romaniuk
Dr. Jenny Mehren
Dr. Larry Refolo
Dr. XiaoHui Jiang
Dr. JoAnn McConnell
Dr. Naomi Kleitman
Dr. Audrey Penn
Dr. Daofen Chen
Dr. Randall Stewart
Dr. Robert Zalutsky
Dr. Shanta Rajaram
Mr. Paul Girolami
Dr. Shai Silberberg
Dr. Ned Talley
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
Dr. David Yeung
Ms. Preeti Hans
Dr. Ti Lin
Dr. Paul Scott
Dr. Alexander Runko
Dr. Yolanda Vallejo
Dr. Anna Taylor
Dr. Cara Allen
Ms. Joanne Odenkirchen
Dr. Laurie Gutmann
Dr. Miriam Leenders
Ms. Stacey Chambers
Dr. Richard Crosland
Ms. Natalie Frazin
Dr. Janet He
Dr. Giovanna Guerrero
Ms. Louise Ritz
Dr. Gary Murray
Ms. Lynn Morin
Ms. Janice Cordell
Dr. Jim Gnadt
Ms. Pam Pearson-Green
Dr. Salida Waddy
Dr. Robin Conwit
Ms. Rebecca Desrocher
Dr. Unni Jensen
Ms. Maxine Davis-Vanlue
Dr. Heather Rieff
Ms. Liz Conklin
Dr. Linda McGavern
Ms. Jennifer Khovananth
Dr. Courtney Ferrell
Ms. Kelly Baker
Ms. Jeanette Gordon

Other Federal employees present for portions of the meeting included:

Dr. Dan Hendwerker, NIMH
Dr. Laurent Taupenot, CSR
Dr. Peter Guthrie, CSR
Dr. Carol Hamelink, CSR
Dr. Alexander Yakovlev, CSR
Dr. ReneEtcheberrigaray, CSR
Dr. Suzan Nadi, CSR
Dr. Seetha Bhagavan, CSR
Dr. Vilen Mousesyan, CSR
Chen-Lun Chang, DNRC, OD

I. Call to Order and Opening Remarks

Dr. Landis welcomed Council members, visitors, and staff to the 175th meeting of the National Advisory Neurological Disorders and Stroke Council meeting. Dr. Ralph Dacey and Cindy Parseghian are unable to attend this meeting. This is the last Council meeting for Mr. Robi Blumenstein, Dr. Helen Mayberg, Dr. Laura Ment, and Dr. Carlie Tanner. Dr. Landis thanked each one of them for their special contributions to the Council and expressed her appreciation for their participation. However, they were asked to hold the dates of the next Council meeting as the Department of Health and Human Services has not processed nomination slates as yet.

In keeping with the Institute’s policy of inviting chairs of CSR and NINDS review committees, Dr. Landis introduced Dr. Gregory Bergey, Chair of the NINDS NST-1 subcommittee, who is attending the open session of the Council meeting. Dr. Bergey is Professor of Neurology, Director, Johns Hopkins Epilepsy Center, and Vice-Chair for Neurological Laboratories, Department of Neurology, Johns Hopkins University School of Medicine.

Dr. Landis announced that Peter Soltys became the NINDS Chief Information Officer and Information Resources Management Branch Chief this past January. She thanked the NINDS OD/DER and DIR IT management staff for delivering excellent IT services to users. She also thanked Sue Titman for co-acting for the Branch and CIO functions prior to Peter’s appointment.

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 until late afternoon after which they will go into closed session to hear the Board of Scientific Counselors’ report from the Division of Intramural Research. The public and extramural staff must leave at that time. Tomorrow’s session, where individual grants are discussed, is closed to the public as well.

Approval of Council Minutes—Dr. Finkelstein requested, and the Council voted approval, for the February 5-6, 2009, Council meeting minutes.

The following future Council meeting dates were confirmed

September 17-18, 2009           (Thursday and Friday)

February 4-5, 2010                 (Thursday and Friday)

May 27-28, 2010                    (Thursday and Friday)

September 23-24, 2010           (Thursday and Friday)

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 within the payline for which there are no unresolved issues. For this round, there were 140 applications eligible to be expedited for payment, and 130 awards have been issued. A number of ARRA R21s, R15s, and R03s were also expedited.    

DER Staff Updates -

Dr. Finkelstein introduced the following new DER staff:  Dr. Unni Jensen Program Analyst, Training and Career Development Office; Dr. XiaoHui Jiang, Scientific Research Specialist, Office of Translational Research; Kelly Baker, Committee Management Specialist, Office of the Associate Director for Extramural Research; Dr. Linda McGavern, Project Manager, Office of Translational Research;and Dr. Courtney Ferrell, Program Director Office of Minority Health and Research. Dr. Finkelstein announced that Dr. Brandy Fureman has taken over the epilepsy grant portfolio formerly handled by Margaret Jacobs who retired earlier this year. Dr. Finkelstein announced that Lydia Munger Little, Program Specialist, Office of Translational Research, would be moving to Hawaii and that this was her last week with NINDS.

III. Report of the Director, NINDS

Science in the New Administration

Dr. Landis reported that the Obama administration has indicated strong support for the importance of scientific research. Two recent steps taken by the new administration include the appointment of Dr. John Holdren as Director, Office of Science and Technology Policy (OSTP) and the formation of the President’s Council of Advisors on Science and Technology (PCAST), a distinguished 19 member panel, which will advise the President on issues where an understanding of science, technology and innovation is key to forming policy. Among the members of PCAST that represent the biomedical sciences are Drs. Harold Varmus and Eric Lander.

On March 9, 2009, President Obama issued an Executive Order permitting the expansion of research on human embryonic stem cells. The Department of Health and Human Services and NIH were tasked with developing new guidelines for the implementation of this Executive Order. President Obama also issued a Presidential Memo asking OSTP to develop strategies to guarantee scientific integrity throughout the executive branch. This action has been reflected by changes in the process for nominating new members of Council. On April 27, 2009, President Obama gave an additional endorsement of science in his address to the National Academy of Sciences. In his address, the President called for doubling the budget of the National Science Foundation, the National Institute of Standards and Technology, and the Department of Energy’s Office of Science; he announced the formation of the Advanced Research Projects Agency for Energy; and he called for tripling the number of NSF graduate research fellowships.

Budget

The FY09 budget was passed as part of an Omnibus appropriations bill on February 25, 2009. This budget represented a 3.1% increase for the NIH overall, and a 2.7% increase for NINDS, which was typical of most Institutes and Centers. The NIH Office of the Director received a 12.2% increase, which was in part to supplement shortfalls to the National Children’s Study. Additionally, the NIH received over $10 billion as part of the American Reinvestment and Recovery Act of 2009 (Public Law 111-5), which was signed by President Obama on February 17, 2009. Included was $500 million allocated for high-priority buildings and facilities repair and construction projects on the NIH campus. Some of these funds will be used to complete the Porter Neuroscience Research Center. In FY09, the NINDS raised its payline to the 11th percentile for most grant applications and to the 16th percentile for A0 applications (i.e. first time submissions), as discussed at the September 2008 NANDS Council meeting. In addition, Early Stage Investigator R01s are being paid to the 25th percentile in FY09.

President Obama released his FY10 budget on May 7, 2009. This budget calls for a 1.4% increase to NIH and a 1.2% increase to NINDS, which is the average increase for most Institutes. Also included in the President’s budget was $6 billion allocated for cancer research, and $211 million allocated for autism spectrum disorders. On March 26, 2009, NIH Acting Director, Dr. Raynard Kington testified before the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies (Labor-HHS) on NIH’s implementation of ARRA. On May 21, 2009, Dr. Kington testified before the Senate Appropriations Subcommittee on Labor-HHS. At this hearing, other NIH witnesses included Dr. Anthony Fauci, Director, NIAID; Dr. Elizabeth Nabel, Director, NHLBI; and Dr. John Neiderhuber, Director, NCI. Dr. Landis noted that only two Senators were present at the hearing, reflecting the perception that NIH is well-funded due to the ARRA appropriation. Although NIH’s FY10 budget is not of issue, the FY11 budget is of concern due to the influx of applications expected from investigators receiving two year ARRA awards that will be ending.

Strategic Planning

NINDS is in the process of completing an Institute-wide strategic planning process that began in September 2006. At the NANDS council meeting in February, each of the planning modules presented reports of their recommendations. NINDS is currently in the process of coalescing these recommendations into a single, unified strategic plan, which will be finalized by September 2009 and posted for public comment. Some of the recommendations resulting from the planning process have been implemented, including: creating the Office of Translational Research and hiring a director for that Office; creating Division of Extramural Research-Office of Science Policy and Planning (DER-OSPP) analysis working group to track institute investments on an ongoing basis and evaluate the success of NINDS programs; creating the Office of Clinical Research (recruitment for Director is underway); and initiating changes to the funding strategy for clinical trials. Most of the recommendations that require a significant new investment are on hold until priorities are established. NINDS will have annual implementation plans.

Emerging Themes

Comparative Effectiveness Research

The desire of the Obama administration to identify a strategy to deal with health care costs and provide universal health care coverage to all Americans has prompted a new emphasis on Comparative Effectiveness Research (CER). The perception is that these health care issues can only be dealt with if data are available that point to the most effective treatments for disease. This has resulted in a huge effort to define CER in such a way that all stakeholders can agree upon, and that is distinct from cost-effectiveness. The definition that has been agreed upon by the Federal Coordinating Council for Comparative Effectiveness Research is as follows: “Comparative effectiveness research is the systematic investigation of alternative interventions for the prevention, diagnosis, or treatment of health conditions. The purpose of this research is to inform patients, providers, and communities about effective health care to improve a comprehensive array of health-related outcomes for diverse populations of patients. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, alternative management approaches, behavioral change strategies, and delivery system interventions. This research utilizes a variety of data sources and methods.”

In addition, the NIH has an internal Comparative Effectiveness Research Coordinating Committee co-chaired by Dr. Elizabeth Nabel, Director, NHLBI, and Dr. Richard Hodes, Director, NIA. NINDS Deputy Director, Dr. Walter Koroshetz, is also a member of this committee. Four hundred million dollars in ARRA funds is being transferred from the Agency for Healthcare Research and Quality (AHRQ) to NIH for the purpose of CER research, and discussions are currently underway to determine what NIH studies will be supported with these funds. Currently ongoing are discussion regarding NIH’s role in the future of CER. One outcome of these discussions is the finding that most NIH Institutes already have experience conducting CER trials (e.g. NINDS’ aspirin vs. Warfarin studies), making the agency well-placed to continue these studies. Alternatively, Congress has proposed the establishment of an independent agency to run Comparative Effectiveness Studies.

Translational Research

Translational Research has become a high priority for patient groups, and as a result, Senator Arlen Specter, D-PA, introduced the Cures Acceleration Network Act, which would increase the budget of the NIH by $10 billion and would establish a Federal agency dedicated to advancing science from the laboratory into clinical practice. NIH received $24 million to set up the Therapeutics for Rare and Neglected Diseases Program. This program, headed by the Office of Rare Diseases, received funding for five years to focus on all stages of preclinical development. One component of this program is the development of the Gateway to Rare and Neglected Disease (GRAND) Therapeutics, a 501(c)(3), which will provide partners from the private sector an opportunity to participate in NIH’s drug development process. The Director of the NINDS’ Office of Translational Research, Dr. Bill Matthew, will likely serve on the internal steering committee for GRAND, as many rare neurological diseases fall under the auspices of this program.

NINDS has a number of programs engaged in translational research designed to accelerate the development of cures for neurological disorders, including the anti-epileptic drug development program, the SMA project, and translational research Cooperative Agreement Program. In addition, NINDS focused on Translational Research as one element of the strategic planning process.

Peer Review Update (provided by Dr. Alan Willard, Chief, Scientific Review Branch, NINDS)

Over two years ago, the NIH began a process to enhance the peer review system. This process commenced with an extensive data collection, diagnostic and evaluation phase that ended in March 2008, and continued with the ongoing implementation of recommendations resulting from the initial diagnostic phase. 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). This change includes soliciting applications with shorter research plans that are more explicitly aligned with the review criteria, in an attempt to reduce the reviewer focus on preliminary data. More information on peer review changes can be found at: http://enhancing-peer-review.nih.gov/.

IV. American Recovery and Reinvestment Act (ARRA)Update

Dr. Robert Finkelstein reported that the American Recovery and Reinvestment Act (ARRA) was signed into law February 17, 2009, with the goals of stimulating the economy, creating and preserving jobs, and advancing scientific research. ARRA appropriated approximately $10 billion to NIH, $8.2 billion of which is dedicated to extramural scientific research across NIH’s 27 Institutes and Centers (NINDS’ allocation was $402 million). Dr. Finkelstein reported on the various strategies being used by NIH and NINDS to utilize ARRA funds.

Supporting existing and pending peer-reviewed projects

NINDS estimates that about half of its ARRA allocation will be used to support meritorious R01s, R21s, R15s, and R03s that scored outside the payline. In addition, research grants that were previously peer-reviewed and funded are eligible to receive administrative supplements to support research that falls within the scope of a NINDS-funded project. While multiple mechanisms are eligible for supplementing, budgets will generally not exceed 50% of the cost of the parent grant in a given year. NINDS will have two receipt dates in FY09 (May 1st and July 1st), and potentially a third receipt date in FY10. For the May 1st receipt date, NINDS received approximately 1600 supplement applications which were reviewed by NINDS program staff, senior staff, and by the NINDS Director.

Supporting programs that stimulate the creation of new projects

Challenge Grants

Through this program, the NIH and NINDS will support research projects in 15 Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation or research methods that would benefit from an influx of funds. Within each broad Challenge Area, specific Challenge Topics have been identified that address the missions of the various NIH Institutes and Centers. To date, NIH has received approximately 20,000 applications (NINDS: 1,100). It is anticipated that the NIH Office of the Director will fund 200 or more grants, and that NINDS will fund 40 or more grants, each up to $1 million in total costs over a two year period.

Research and Research Infrastructure “Grand Opportunities” (GO Grants)

The GO Grant program is designed to research endeavors that propose to develop and implement critical research innovations to advance the research enterprise, stimulate future growth and investments, and advance public health and health care delivery. This program will support large-scale research projects that accelerate critical breakthroughs, early and applied research on cutting-edge technologies, and new approaches to improve the synergy and interactions among multi and interdisciplinary research teams. NINDS received approximately 200 letters of intent in response to this solicitation, and anticipates spending $20 million on this program.

Competitive Revisions

Competitive revisions (supplements) will be awarded to researchers to accelerate the tempo of scientific research on active grants. The program allows investigators to submit applications to extend the scope of their currently funded research program. Competitive revision applications will be reviewed by the study sections that reviewed the parent grant application. NINDS estimates that it will spend $10 million to support a portion of the approximately 140 applications received.

Supplements providing summer research experiences for students and science educations (presented by Dr. Stephen Korn, Director of Training and Career Development, NINDS)

The goal of this supplement program is to provide researchers additional funds to encourage students to pursue research careers in the health related sciences, and to provide educators from non-research intensive institutions (including elementary, middle and high school teachers and community college faculty) with short-term research experiences in NIH-funded laboratories. NINDS received 338 applications and made 124 awards in response to this initiative. The awards will support 31 high school students, 306 undergraduates and 12 science educators. In making funding decisions, applications were placed into one of four scoring bind and were reviewed based on the applicant’s focus on the mentoring and specific research plan for the student.

P30 initiative to support new faculty recruitment

The purpose of this program is to provide funding to institutions to hire and provide start-up packages to newly-independent investigators with the goal of augmenting and expanding the institution’s community of multidisciplinary researchers.  This program will support new faculty hires through P30 cores, and for the purpose of this initiative, a core is defined as “a community of multidisciplinary researchers focusing on areas of biomedical research relevant to NIH, such as centers, departments, programs and/or trans-departmental collaborations or consortia.”  NINDS estimates that it will support 13 of these awards.

NINDS will participate in several additional NIH ARRA initiatives in addition to these programs.

V. Policy Options for PI’s with Multiple Grant Awards

Dr. Jane Fountain, Program Director in the Neural Environment Cluster, reported that a number of NINDS investigators hold four or more R01 equivalent grants, and that the subject of whether or not this should be restricted in some way has come up in a number of different forums, including previous NANDS Council meetings. Having large numbers of grants allows investigators the flexibility to pursue multiple scientific avenues, and some degree of stability while their grants go through the competitive renewal process. In some cases however, large numbers of grants held by one investigator may support overlapping or derivative science. NIGMS has a policy that limits the amount support to “well-funded” laboratories that have over $750,000 direct costs. That Institute supports new projects in well-funded laboratories only when distinctively promising work will be pursued. The Institute’s default position is to not pay such applications. NINDS feels that a policy that limits the dollars available to an investigator would place an unfair bias against clinical investigators, and therefore NINDS is proposing to add an additional degree of scrutiny when a PI receives a meritorious score on the fifth or more grant.  In FY08, there were 29 such investigators, and although the cost savings would not be great ($15 million if funding was declined for all 29 investigators), this added scrutiny would provide NINDS with the flexibility to fund only the best science. With Council approval, NINDS proposes to post a NIH Guide Notice informing investigators that if they have an application with a meritorious score for the fifth grant or above, NANDS Council will evaluate the appropriateness of the request for support.

VI. Concept Clearance for FY 2010 Proposed Initiatives 

Dr. Ned Talley, Program Director in the Channels, Synapses, and Circuits Cluster, presented the EUREKA (Exceptional, Unconventional Research Enabling Knowledge Acceleration) Initiative, proposing that it be renewed in FY10 with a $2 million set-aside (EUKERA awards are R01s with $200,000 budgets for 5 years). This program began last year and was initiated by NIGMS in response to the perception that peer review forces applications towards conservative proposals. To counter this perception, the EUREKA program uses a different application format and review process to solicit applications that focus on the challenge and impact of the idea. Dr. Povlishock noted that the Basic and Preclinical Programs Subcommittee had discussed the EUREKA program in the subcommittee, and felt that it should continue into FY10. Dr. Finkelstein requested, and was granted, a motion to continue EUREKA for FY10.

Dr. Margaret Sutherland, Program Director in the Neurodegeneration Cluster, presented a concept to develop Public Private Partnerships (PPPs) between the NINDS and foundations to fund four year, non-renewable grants to determine whether a presumptive target is causally linked to Huntington’s disease. Projects coming in through this program would use best practice guidelines established by the HD and triplet repeat communities. Dr. Finkelstein requested, and was granted, concept clearance for this initiative. Dr. Landis indicated that PPPs would be a topic of discussion at a future NANDS Council meeting.

VII. Council Subcommittee Reports 

Training, Career Development and Special Programs Subcommittee

--Dr. Gary Westbrook, Chair

Dr. Westbrook presented a summary of the discussion held during the open session of the training and special programs subcommittee. During the subcommittee meeting, three topics were discussed:

Funding of MD/PhD students

The committee discussed a proposal to support MD/PhD students earlier in their training and specifically to fund research (rather than medical school) years. The committee was supportive of the plan to develop an F31 to support dissertation research years of dual-degree students in scientific areas relevant to the mission of NINDS. The possibility of using an F32 mechanism to support post-MD, pre-PhD students was discussed briefly so that candidates could receive postdoctoral level salaries.

Proposed Change in K24 Requirements

A new plan for the use of the K24 was proposed. Under the new plan, the K24 recipients must be involved in a programmatic mentoring effort (e.g., R25, residency program, etc.) and have a research component. The committee was supportive of this plan, and recommended that each program identify a unifying theme or goal at the time of application so that success of the program could be evaluated.

Mentored Ks and R01s

A policy change was proposed to encourage mentored K recipients to apply for R01s at any point during their K award. The change would remove the salary cap for the K and provide up to 75% of base salary for candidates that receive an R01 during the first 3 years of their mentored K award.

Clinical Trials Subcommittee--Dr. Laura Ment, Chair

The Subcommittee did not have an open session.

Basic and Preclinical Programs Subcommittee--Dr. John Povlishock, Chair

Dr. Povlishock reported on the subcommittee’s discussion of NINDS’ use of small grant mechanisms. In particular, the discussion was focused on two inter-related recommendations from the Basic Module of the Strategic Planning Panel: 1) Eliminate unsolicited R21s and 2) Utilize the R03 mechanism to support pilot projects. These two recommendations arose following the observation that support for R01s has declined over the past 5 years. The subcommittee agreed that while there was confusion surrounding the use of the R21 mechanism from many parties (e.g. review, investigators, and institutions); there are inadequate data to address the relevance and impact of the R21 on the NINDS’ mission. The subcommittee requested that this topic be revisited at a future date with additional data.

VIII. Overview, Division of Intramural Research 

Dr. Alan Koretsky, Scientific Director, NINDS, discussed the current state of the NINDS Clinical Research Program. He indicated that one of the challenges faced by the program is that it lacks a critical mass of personnel in any one particular neuroscience sub-discipline. Dr. Koretsky also noted that the lack of clinical faculty makes it difficult to attract clinical fellows, leading to a limited number of treatment-based clinical protocols and a diminished ability to sustain clinical activities.  The Division of Intramural Research (DIR) has identified programmatic strengths, (e.g. Neuroimmunology, Neurovirology, Neurogenetics, Stroke, Surgical Neurology, and Movement Disorders/Cortical Plasticity), and is attempting to capitalize on these strengths in the recruitment of new faculty in one effort to attract new clinical researchers. Other efforts to increase the presence of clinical research at NINDS DIR include: a program to help outstanding DIR clinical investigators transition to independence, and a search for candidates to head the Office of the Clinical Director (currently headed by Dr. Mary Kay Floeter).

IX. Scientific Presentation:  NIMH-NINDS Project in Very High Field MRI

Drs. Koretsky and Peter Bandettini reported on developments in the NIMH/NINDS Functional MRI Core Facility. Since its inception in 1999, this facility has grown to house a number of MRI scanners of increasing field strength, the latest addition of which is an 11.7 Tesla scanner. The core currently has an annual budget of over $2.2 million, during which time it services over 30 users, maintains 60 active protocols, and scans over 5000 subjects. Dr. Koretsky reported that the facility was being used for a number of different research applications, including: 1) mapping networks involved with specific behavior, stimulus or performance; 2) determining correlates of behavior; 3) characterizing clinical populations; 4) assessing recovery and plasticity; and 5) presurgical mapping. Dr. Bandettini described the benefits of utilizing the high field technology, including an increased signal to noise ratio, increased functional and anatomical contrast, higher resolution, and shorter scan times.

X. Review of the Division of Intramural Research Board of Scientific Counselors’ Reports

In closed session, Dr. Koretsky presented the findings and recommendations of the Board of Scientific Counselors based on their review of specific DIR laboratories/units during 2008. The Council discussed the reports of the Board and accepted them.

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 125 research career development and institutional training grant applications; of this total, 85 applications had primary assignment to NINDS, and 57 of them (67.1 percent) were recommended for support in the amount of $8.0 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 $2.7 million.

 Research Project and Center Awards

The Council reviewed a total of 2,642 research project and center applications; of this total, 1,361 applications had primary assignment to NINDS, and 787 of them (57.8 percent) were recommended for support in the amount of $225.2 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 $79.2 million.

Senator Jacob Javits Neuroscience Investigator Awards

The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period. Candidates are nominated and selected at each Council meeting. At this meeting, no Javits awards were recommended.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 200 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 109 applications had primary assignment to NINDS and 71 of them (65.1 percent) were recommended for support in the amount of $14.6 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 $3.4 million.

VII. Adjournment

The meeting was adjourned at 10:20 a.m. on Friday, May 29.

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.

Last updated February 8, 2011