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Summary of Meeting 1
February 3-4, 2011
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 180th meeting on February 3-4, 2011, 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 3, 2011: 10:15 a.m. to 4:35 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: February 4, 2010: 8:10 a.m.to 10:20 a.m.
for the consideration of individual grant applications.
Council members present were:
|Dr. Ben Barres|
Dr. Thomas Brott
Dr. Emery Brown (teleconference 2/3/11)
Dr. Donna Ferriero
Dr. Robert Friedlander
Dr. Amita Sehgal
Dr. Sharon Hesterlee
Ms. Katherine Hood
Dr. Eve Marder
|Dr. Robert Pacifici|
Ms. Cindy Parseghian
Dr. Timothy Pedley
Dr. John Povlishock
Dr. Louis Ptacek
Dr Amita Sehgal
Dr. Barbara Vickrey
Dr. Vicky Holets Whittemore
Ms. Kimberly Zellmer
Council members absent were::
Dr. Emery Brown(2/4/11)
Dr. Timothy Pedley (2/4/11)
Council Roster (Attachment 1)
Ex Officio Member present:
Dr. Robert Ruff, Department of Veterans Affairs
Ex Officio Member absent:
Dr. Geoffrey Ling, Department of Defense
Members of the public present for portions of the open meeting included:
Dr. Lewis Morgenstern, University of Michigan
Dr. Karen Furie, Massachusetts General Hospital
Ms. Jacqueline Nelson, Cure CMD
Paul Watson, Research Down Syndrome
Pat and Bernard Dunlevy, Research Down Syndrome
Erin Fry, Parent of Child with Down Syndrome
Terryl Rosenberg, Down Syndrome Advocate
Sharon Fleming, Down Syndrome Advocate
Debra Ruh, Down Syndrome Advocate
Sara Ruh, Down Syndrome Advocate
Ron Bartek, FARA
Chris Mell, RTI International
Michelle Rodrigues, SRI International
Virginia Neale, Lewis-Burke Associates
NINDS employees present for portions of the meeting included:
|Dr. Alan Willard|
Ms. Ruth Linn
Dr. Scott Janis
Dr. Merrill Mitler
Dr. Deborah Hirtz
Ms. Nena Wells
Dr. Story Landis
Dr. Linda Porter
Dr. Tom Jacobs
Dr. Yuan Liu
Dr. Ernie Lyons
Dr. Robert Finkelstein
Dr. John Porter
Dr. David Owens
Dr. Jane Fountain
Dr. Margaret Sutherland
Dr. David Jett
Dr. Beth-Anne Sieber
Dr. May Wong
Dr. Stephen Korn
Dr. Wendy Galpern
Ms. Tracy Chen
Ms. Lisa Joliet
Ms. Shannon Garnett
Dr. Raul Saavedra
Mr. Ken Frushour
Dr. Alan Koretsky
Dr. Robert Riddle
Dr. Tom Miller
Mr. Peter Soltys
Dr. Heather Rieff
Dr. Linda McGavern
Mr. Andrew Skinner
Dr. Claudia Moy
Dr. Paul Scott
Dr. Robert Zalutsky
Dr. Laura Mamounas
Dr. Courtney Aklin
Dr. Katherine Jakubs Pahigiannis
Dr. Amelie Gubitz
Ms. Stephanie Fertig
Dr. Timothy Lavaute
Ms. Maureen Hambrecht
Ms. Vanessa Mahone
Dr. Naomi Kleitman
Ms. Margo Warren
Ms. Louise Ritz
Dr. Crina Frincu
Dr. Debra Bergstrom
Captain James Stables
Dr. Jill Heemskerk
Ms. Joanne Odenkirchen
Dr. Elizabeth McNeil
Dr. Birgit Neuhuber
Dr. Ken Cheung
Dr. Minal Banushali
Ms. Nancy Hart
Ms. Martha Diaz-Ortiz
Dr. Michele Rankin
Ms. Preeti Hans
|Dr. JoAnn McConnell|
Dr. Audrey Penn
Dr. Daofen Chen
Dr. Randall Stewart
Dr. Shanta Rajaram
Mr. Paul Girolami
Dr. Shai Silberberg
Dr. Mark Scheideler
Dr. Ramona Hicks
Dr. Debra Babcock
Mr. Peter Gilbert
Ms. Pamela Mayer
Dr. William Benzing
Dr. Walter Koroshetz
Ms. Tijuanna Decoster
Ms. Marian Emr
Dr. Alexander Runko
Dr. Yolanda Vallejo
Dr. Anna Taylor
Dr. Cara Allen
Dr. Miriam Leenders
Ms. Stacey Chambers
Dr. Richard Crosland
Ms. Janice Cordell
Ms. Jennifer Khovananth
Ms. Kelly Baker
Dr. Petra Kaufmann
Dr. William Matthew
Dr. Rebecca Farkas
Dr. Alfred Gordon
Ms. Quynh Ly
Dr. Jim Gnadt
Ms. Pam Pearson-Green
Dr. Salina Waddy
Dr. Robin Conwit
Mr. Taek Oh
Dr. Erik Runko
Dr. Ned Talley
Dr. Christine Torberg
Mr. Jeff Jiang
Dr. Ursula Utz
Mr. Scott Prince
Dr. Roderick Corriveau
Dr. Michelle Jones-London
Mr. Phillip Wiethorn
Dr. Katrina Gwinn
Dr. Dan Stimson
Ms. Joellen Harper Austin
Dr. Ran Zhang
Dr. Yehun He
Dr. Coryse St. Hillaire-Clarke
Ms. Christiane Robbins
Dr. Riju Srimal
Dr. Fong Wang
Ms. Lynn Morin
Dr. Danilo Tagle
Dr. Francesca Bosetti
Ms. Jon’Lethia King
Ms. Alice Adams
Ms. Laurie Arrants
Other Federal employees present for portions of the meeting included:
Dr. Kevin Walton, CSR
Dr. Peter Guthrie, CSR
Dr. Vilen Movsesyan, CSR
Dr. Joseph Rudolph, CSR
Dr. Yuan Luo, CSR
Dr. Jay Joshi, CSR
Dr. Pat Manos, CSR
Dr. Suzan Nadi, CSR
Dr. Deborah Lewis, CSR
Dr. Carole Jelsema, CSR
Dr. Keith Crutcher, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Laurent Taupenot, CSR
Dr. Seetha Bhagavan, CSR
Dr. Toby Behar, CSR
Dr. Ron Johnson, NHGRI
Dr. Landis, Director, NINDS, welcomed Council members, visitors, and staff to the 180th meeting of the National Advisory Neurological Disorders and Stroke Council meeting.
Dr. Landis introduced six new Council members: Dr. Ben Barres, Stanford University; Dr. Robert Darnell, The Rockefeller University; Dr. Sharon Hesterlee, Parent Project Muscular Dystrophy; Dr. Eve Marder, Brandeis University; Dr. Robert Pacifici, CHDI Management/CHDI Foundation, and Dr. Amita Sehgal, University of Pennsylvania School of Medicine.
Dr. Landis announced the departure of Dr. William Matthew, Associate Director for Translational Research.
In keeping with the Institute’s policy of inviting chairs of CSR and NINDS review committees, Dr. Landis introduced Dr. Karen Furie, Chair, NINDS NSD-K Committee, who is attending the open session of the Council meeting. Dr. Furie is Director, Stroke Service, at Massachusetts General Hospital.
Approval of Council Minutes -- Dr. Finkelstein requested, and the Council voted approval, for the September 23, 2010, Council meeting minutes.
The following future Council meeting dates were confirmed
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 92 applications eligible to be expedited for payment of which 41 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 announced that Dr. Alan Willard had recently assumed the position of Deputy Director, Division of Extramural Research, NINDS. Next, he introduced new DER staff: Dr. Elizabeth McNeil, a Medical Officer/Program Director in the Office of Clinical Research, Dr. Ken Cheung, a biostatistician in the Office of Clinical Research, and Dr. Francesca Bosetti, a Program Director in the Neural Environment Cluster.
Dr. Landis reported on a number of organizational changes currently under discussion at NIH. One of the recommendations of the Science and Management Review Board (SMRB), an advisory committee to HHS authorized by the NIH Reform Act of 2006, was to develop a focused, integrated, and systematic approach for building new bridges to link basic discovery research with therapeutics development and clinical care. To accomplish these goals, the SMRB recommended that the current NIH structure related to translational medicine and therapeutics development should be reorganized to capitalize best upon emerging scientific opportunities, adapt to and help shape the evolving landscape, create a home for the recently authorized Cures Acceleration Network (CAN) should money be appropriated to this effort, and leverage existing NIH resources to speed the delivery of new, more effective medical products to patients. To this end, the SMRB recommended the creation of a new NIH Center with the mission of supporting and strengthening translational medicine and therapeutics development. In addition to CAN, the Center would house some extant NIH programs, such as the Molecular Libraries Program, the Therapeutics for Rare and Neglected Diseases Program, the NIH Rapid Access to Interventional Development Program, the Clinical and Translational Science Awards, and the NIH-FDA Regulatory Science Initiative. In response to the SMRB's recommendation, the NIH is planning to implement this recommendation and establish the National Center for Advancing Translational Sciences (NCATS) effective October 1, 2011.
Dr. Landis reported that a corollary of the formation of NCATS was the dissolution of the National Center for Research Resources (NCRR). The NCRR was formed in 1962 to provide laboratory scientists and clinical researchers with the tools and training they need to understand, detect, treat and prevent a wide range of diseases. NCRR supports research to: develop versatile new technologies and methods, provide access to state-of-the art technologies and instruments, and to develop and provide access to critical animal models for a broad range of human disorders. In addition, NCRR supports programs to: establish clinical research infrastructure, and to enhance development programs for underserved states and institutions. Dr. Landis noted that all of these programs would be maintained, but they would be moved to other NIH Institutes and Centers. It is anticipated that the dissolution of NCRR will be completed by September 30, 2011.
In addition to considering the organization of translational research at the NIH, the SMRB was tasked with evaluating a potential merger of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA). Because different forms of addiction share similar biological roots, the SMRB recommended that the NIH form a single Institute focused on substance use, abuse, and addiction (drugs, alcohol, tobacco, gambling) research, and related public health initiatives. Moreover, the Committee recommended that all NIDA and NIAAA portfolios not related to basic, translational, and/or clinical research relevant to addiction should be moved to other institutes. A Committee of NIH IC Directors has been appointed to develop a plan to implement this recommendation by October 1, 2012.
Dr. Landis reported on two current efforts underway by the Institute of Medicine including the Advancing Pain Research, Care, and Education Conference and the Public Health Dimensions of the Epilepsies Conference. The Advancing Pain Research, Care, and Education Conference is one of several pain research-related provisions in the Patient Protection and Affordable Care Act (PPACA; P.L. 111-148) which was signed into law by President Obama on March 23, 2010. The outcomes from this conference will be reported to Congress in June 2011. In addition, the Act authorized the formation of an Interagency Pain Research Coordinating Committee tasked with identifying critical gaps in Pain Research, and providing recommendations regarding the dissemination of pain care information. This Committee will have 19 members including 7 from various federal agencies (i.e. NINDS, NIDCR, CDC, FDA, AHRQ, VA and DOD), 6 public members, and 6 professional/scientific representatives. NINDS is currently designated as the acting lead for this Committee. In addition, the Act stated that the NIH Pain Consortium, which consists of 23 NIH Institutes and Centers and Offices involved in Pain Research, should recommend pain research initiatives for the NIH Office of the Director's Common Fund at least once per year. Dr. Landis noted that NIH will develop a process to implement this provision. Additionally, Dr. Landis reported that NIH's 2009 investment in chronic pain research was $384 million dollars, contributed to by nearly all NIH Institutes and Centers.
Dr. Landis also reported on the Public Health Dimensions in the Epilepsies Conference being conducted by the IOM. This conference will have 21 sponsors, including HHS, NIH, FDA, CDC, and Vision 20/20, a coalition of non-governmental epilepsy organizations. A committee of experts in epilepsy and relevant areas will review and make recommendations in the following areas: the public health burden of the epilepsies for patients and families; priorities for population health studies to inform treatment and prevention; access to health and human services and quality of care; education and training for professionals working with people with epilepsy, and improved understanding of epilepsy in patients and the general public.
Dr. Landis provided an update on NINDS's current planning efforts. Throughout the planning process, NINDS focused on how scientific investments should be managed and supported rather than on what specific scientific areas should be supported. For the main part of the planning effort, NINDS charged three panels with addressing these issues in the context of the basic, translational, and clinical research portfolios. One additional panel focused on NINDS's disease missions. The implementation of planning recommendations is currently underway using the following principles: balance opportunities and needs across the spectrum of research - basic, translational, and clinical, monitor programs to determine whether they are meeting their intended goals, and actively manage the translational and clinical sciences portfolios (but not basic science) by setting priorities based on opportunity and need. As a result, NINDS has closed programs, managed others actively, and set priorities for the year ahead. In FY11, NINDS will be starting a network for early phase clinical trials (Phase II) of neurological disorders (NEXT), the Parkinson's Disease Biomarkers Identification Network (PD-BIN), and the Epilepsy Centers without Walls. Funds for these new initiatives were made available in part as a result of closing the Microarray Consortium and the Clinical Research Collaboration.
The most recent parts of the NINDS planning effort are focused on Workforce Diversity and Health Disparities Research. The Workforce Diversity panel, chaired by Dr. Zach Hall, presented its recommendations to the NANDS Council in September 2010. The Health Disparities Panel, chaired by Dr. Lewis Morgenstern, will present its recommendations later in the NANDS Council meeting. Panels were asked to look at ongoing NINDS efforts in these areas and to provide the Institute with actionable recommendations regarding success of current programs / investments, immediate priorities and future investments, and advice on designing effective programs and improving internal processes. Dr. Landis reviewed some of the recommendations provided by the Workforce Diversity Panel and indicated that following the report of the Health Disparities panel, a Council working group would be set up to look at ways to implement both sets of recommendations.
Dr. Finkelstein reported that the estimated total spending on neuroscience research at NIH in FY09 was $5.32 billion, and that NINDS accounted for approximately 30% of this investment. In FY10, NINDS's budget was approximately $1.64 billion dollars, a figure that when adjusted for inflation has been decreasing steadily since the end of the doubling of the NIH budget in 2003. Of this $1.64 billion, approximately 87% of NINDS funds are used to support the Division of Extramural Research, which funds grants and contracts to investigators across the U.S. Approximately 10% of the NINDS budget is used to support research on the NIH campus in the Division of Intramural Research, and the remaining 3% is used to cover overhead costs. In FY10, the NINDS payline was at the 14th percentile.
On February 1, 2010, the FY11 budget request was submitted to Congress as part of the President's Budget (PB) request. In a typical year, Congress would pass a series of appropriations bills establishing the budgets for all Federal agencies for the upcoming fiscal year prior to its start on October 1st. Instead, Congress has passed a series of short-term Continuing Resolutions (CRs) to fund the government for FY11, holding agency budgets at FY10 levels. The current CR is set to expire on March 4, 2011, and FY11 budgets continue to remain uncertain. NINDS typically sets its payline at the beginning of the fiscal year, using the best available information regarding what the upcoming budget might be. At this time in 2010, NINDS was operating under the assumption that the worst case scenario would be a flat budget, as the PB represented a 1.5% increase for NIH and the Senate had passed a budget with a 3% increase for NIH. Based on these estimates, NINDS set the payline for FY11 at the 14th percentile. As a result of this action, investigators up to the 14th percentile received letters indicating that their funding was "highly likely" but that they should not make any commitments. In the past, NINDS has always been able to meet its projected payline, so typically investigators interpret the "highly likely" letter to mean that they will be funded. In the months following the mid-term election, Congress has become increasingly concerned with the overall levels of Federal discretionary spending, and has taken a number of actions which suggest that NIH might receive a budget cut for the remainder of FY11. As a result of these projections, NINDS had determined that it is necessary to tentatively reduce the payline to the 10th percentile for the remainder of FY11. Dr. Finkelstein reported on a number of different budget scenarios that NINDS is working with, and noted that depending on the outcome of the FY11 budget negotiations, NINDS may be able to restore the payline to the 11th or 12th percentile. In addition, he noted that appropriations for FY12 are more uncertain, with the President's Budget scheduled to be released on February 14th 2011.
Dr. Lawrence Tabak, Principal Deputy Director, NIH, elaborated on the December 2010 recommendations to NIH by the Scientific Management Review Board that were discussed earlier in the day by Dr. Landis. The SMRB recommended (12 favored; 1 opposed) that a new translational medicine and therapeutics center be created. In addition, the Board endorsed and supported the NIH's commitment to undertake a more extensive and detailed analysis to evaluate the impact of the new Center on relevant extant programs at NIH, including NCRR. A working group of Institute Directors has been tasked to form an NCATS working group and providing recommendations on: NCATS draft mission, primary functions, and the legal authorities needed to carry out said functions; NCATS organizational design; governance model; and communication strategies. Dr. Tabak reviewed the working draft of the mission statement as well as a model of existing NIH programs that may be subsumed by the new Center. In addition to the IC Directors NCATS working group, a working group of the Advisory Council to the Director has been formed and charged with: identifying where NIH can contribute to streamlining therapeutic and diagnostic development; recommending ways that NCATS can tap strengths of extant programs, the authorities under the Cures Acceleration Network, and capabilities of potential partners; proposing new models for how NCATS could build partnerships with biotechnology and pharmaceutical companies; and suggesting metrics and timelines by which success of NCATS can be measured.
Following the SMRB's December 2010 recommendations, Dr. Collins established the NCRR Task Force to perform an analysis of all NCRR activities for possible inclusion in NCATS, the potential impact of moving those activities on NCRR, and whether NCRR programs should be moved elsewhere at the NIH. The Task Force concurred with the recommendations of the SMRB to propose transfer of the Clinical and Translational Science Awards (CTSA) program from NCRR to NCATS. In addition, the Task Force concluded that many of the programs that would remain in NCRR after the proposed CTSA transfer would benefit from the enhanced scientific adjacency that would be achieved by transfer of these programs to other Institutes or Centers. To facilitate planning of these potential transfers, a "straw model" was drafted, which provided a framework that stakeholders across NIH and from the extramural community could comment on. The NCRR Task Force will make final recommendations to the NIH Director in February 2011, and will report the results of its analysis to the SMRB in February. The NCATS Working Group will make its initial recommendations to the NIH Director by March 2011, and if approved, proposed program and staff changes are planned to take effect October 1, 2011.
Dr. Tabak reported that over the past 30 years, the NIH has had a "less than impressive" impact on the diversity of the NIH-funded scientific workforce. Moving forward, he noted that NIH is working towards enhancing the framework by which diversity programs are implemented and ensuring that programs clearly articulate a "compelling interest" in diversity (e.g. how does diversity improve the quality of NIH's training education programs or NIH's ability to recruit and retain the best researchers). Dr. Tabak noted that NIH is actively reviewing both program data on the diversity of the NIH-funded scientific workforce, and all active diversity targeted FOAs to determine the best options for moving forward (e.g. implementation of minimum evaluation metrics requirements and sunset provisions to ensure that diversity-targeted programs are effective). In addition, Dr. Tabak noted that NIH has established the Diversity Task Force as part of the governance structure to facilitate NIH-wide strategic planning.
Dr. Lewis Morgenstern, Professor of Epidemiology, Neurology, Emergency Medicine, and Neurosurgery, and Director, Stroke Program at the University of Michigan, provided a summary of the findings and recommendations of the NINDS Advisory Panel on Health Disparities Research. This Panel, which was charged with reviewing health disparities research at NINDS, focused its recommendations on six areas. Prior to elaborating on the recommendations of the Panel, Dr. Morgenstern noted that NINDS should study Health Disparities for the following reasons: no group should suffer more than another, disparities are expensive, and disparities are large and pervasive in the neurologic diseases.
Highlights of the Panel's recommendations are as follows:
Vision, strategic plan, and priorities
The Panel recommended that NINDS adopt a mission statement articulating its commitment to health disparities research, and develop a clear strategic plan which should be used to document the approach for research in health disparities, from basic science through health services research. Moreover, the Panel recommended that NINDS establish a systematic, data-driven priority-setting process which would be used to identify conditions with high overall burden of disease.
Organizational structure, scope, and collaboration
The panel recommended that NINDS establish a new office for health disparities research whose leader would report directly to the Director, NINDS. In addition, the Panel recommended that the work of this office include all research that is designed to directly investigate health disparities. Dr. Morgenstern emphasized the importance of collaborations and partnerships across NINDS, NIH, the Federal Government, and NGOs.
Evaluation and accountability
The Panel recommended that NINDS develop and monitor metrics for the evaluation of the success and impact of health disparities efforts and report outcomes on an annual basis. Suggested metrics include: citation metrics, changes in health outcomes.
The Panel recommended that NINDS develop specific training programs in health disparities research.
Recruitment, enrollment, and retention into clinical trials
The Panel recommended that NINDS develop a training module for investigators on effective strategies on recruitment for health disparities research. Moreover, the Panel recommended that NINDS create a repository of recruitment data (both successes and failures) populated by investigator progress report data, and encourage investigators to publish race/ethnicity-specific data.
The Panel recommended that NINDS engage in scientifically sound community outreach programs and partner with other agencies involved in health messages to minority populations.
Dr. Shai Silberberg, Program Director, Channels, Synapses, and Circuits Cluster, NINDS, recapitulated a discussion held by the Basic and Preclinical Subcommittee on how to maximize the value of pre-clinical studies. Dr. Silberberg noted that the success rate from first-in-human studies to registration is ~10%, the failure largely due to lack of efficacy. In addition, Dr. Silberberg highlighted recent studies which stress the importance of transparent reporting of preclinical studies used in support of translational or clinical grant applications. These findings have led a number of constituent groups (e.g. Stroke Therapy Academic Industry Roundtable, Alzheimer's Drug Discovery Foundation, European ALS/MND group) to develop guidelines and best practices for reporting preclinical studies in their various fields. This led to the question of what role, if any, should NINDS play to increase the predictive value of pre-clinical studies.
The working hypothesis presented by Dr. Silberberg was that better reporting of data used in support of translational and clinical applications will help identify the studies with most promise. This hypothesis led to the development of a straw man proposal in which NINDS would develop a set of guidelines for investigators to report their findings from in vitro and in vivo studies. Such guidelines could include elements of the experimental design (e.g. rationale for animal/cellular models, route/timing of drug delivery/dosing, sample size calculation, blinding, randomization) and of the results (e.g. adequate dose-response, reproducibility, potential sources of variability). Dr. Silberberg reported that the Subcommittee expressed overall support for the development and publication of such guidelines, and went on to note the importance of involving journals in this process. Moreover, the Subcommittee emphasized the need for incorporating these issues into the training of young investigators, and the need for NINDS to find a way to place value on negative data. The Subcommittee recommended the formation of a Council working group to help develop these guidelines moving forward.
Dr. Finkelstein reviewed the current trends in awards made to foreign institutions, and the criteria used by NINDS to make these awards. There are a number of specific criteria that are unique to foreign awards including that: "the project presents special opportunities for furthering research programs through the use of unusual talents, resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing United States resources", and that "the project has significant relevance to the mission and objectives of the awarding Institute or Center (IC) and has the potential for significantly advancing the health sciences in the United States." Among the issues discussed by the NANDS Council were: the definition of "special opportunities" and "unusual talents, resources"; the criteria for funding a new foreign application vs. transferring a domestic grant to a foreign site; whether the PIs "other support" should be considered when making a decision to transfer; whether one year of transitional funding should be provided in the event that a transfer is denied; and whether competing continuing applications should be accepted from foreign sites.
Dr. Stephen Korn, Director of Training and Career Development, NINDS, presented an initiative with the goal of increasing the number of independently-funded neurosurgeon research. This initiative was modeled after a successful National K12 program for Pediatric Critical Care Physicians, administered by NICHD. This two phase program combines a national Institutional award (K12) with a subsequent individual award (K or R) with continuing ties to the institutional program. This program is designed to provide neurosurgeons with a number of the tools necessary to build a successful research career, including: mentoring oversight, protected time and space, and a cohort of junior neurosurgeon researchers. Dr. Finkelstein requested and was granted concept clearance for this initiative.
Clinical Trials Subcommittee-Dr. Thomas Brott / Dr. Timothy Pedley Co-Chairs
Dr. Petra Kaufmann, Director, NINDS Office of Clinical Research, reported on the enrollment status of the current NINDS-supported Phase III Clinical Trials. She noted that of the 30 NINDS Phase III trials, approximately 1/3 had completed enrollment, 1/3 were enrolling on target, and 1/3 were not enrolling on target. The Subcommittee discussed strategies for improving enrollment from both the perspective of the patient as well as the referring physician. Prospectively, NINDS will have a recruitment specialist to support investigators in enrollment efforts and to monitor enrollment against pre-specified milestones.
Dr. Brott reported that the Subcommittee also discussed the Biennial Report Certifying NINDS Compliance with Inclusion Guidelines.
Basic and Preclinical Programs Subcommittee-Dr. John Povlishock, Chair
The Basic and Preclinical Programs Subcommittee discussed the topic: How can NINDS Increase the Predictive Value of Pre-clinical Studies? This topic was presented to the full Council by Dr. Shai Silberberg (see minutes above).
This portion of the meeting, involving specific grant review, was closed to the public. The Council gave special attention to applications from foreign institutions and other applications which needed specific discussion. Prior to the discussion of the grants, Dr. Finkelstein reminded Council regarding conflict of interest and confidentiality as follows:
Conflict of Interest
The regulations concerning conflict of interest were reviewed. Council members were reminded that materials furnished for review purposes and discussion during the closed portions of the meeting are considered privileged information. All Council members present signed a statement
certifying that they had not been involved in any conflict of interest situations during the review of grant applications.
During the closed session, any information that is discussed and the outcome of any recommendation are considered privileged information. They may not be discussed outside of the closed session. If an applicant requests support for his or her application from a Council member, the Council member must respond that he/she is not permitted to discuss the application. Any inquiry should be referred to Dr. Robert Finkelstein, the Council Executive Secretary, who will then refer the questions to the appropriate staff member for response.
Research Training and Career Development Programs
The Council reviewed a total of 144 research career development and institutional training grant applications; of this total, 92 applications had primary assignment to NINDS, and 76 of them (82.6 percent) were recommended for support in the amount of $15.4 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 $7.9 million.
Research Project and Center Awards
The Council reviewed a total of 2,029 research project and center applications; of this total, 1,371 applications had primary assignment to NINDS, and 798 of them (58.2 percent) were recommended for support in the amount of $210.9 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 $36.9 million.
Senator Jacob Javits Neuroscience Investigator Awards
The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period. Candidates are nominated and selected at each Council meeting. At this meeting, no Javits awards were recommended.
Small Business Innovation Research and Small Technology Transfer Award Programs
The Council reviewed a total of 231 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 148 applications had primary assignment to NINDS and 92 of them (62.2 percent) were recommended for support in the amount of $24.2 million first-year direct costs. It is anticipated that, of the SBIR and STTR applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $4.9 million.
The meeting was adjourned at 10:15 a.m. on Friday, February 4.
We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.
Robert Finkelstein, Ph.D.
National Advisory Neurological Disorders and Stroke Council
Director, Division of Extramural Research
National Institute of Neurological Disorders and Stroke
Story C. Landis, Ph.D.
National Advisory Neurological Disorders and Stroke Council
National Institute of Neurological Disorders and Stroke
These minutes will be formally considered by the Council at its next meeting. Corrections or notations will be incorporated in the minutes of that meeting.
(1) For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) in which a real or apparent conflict of interest might occur.
Last Modified March 11, 2011