Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Neurological Disorders and Stroke Council
Summary of Meeting1
May 23-24, 2013
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 187th meeting on May 23-24, 2013, in Building 31, Conference Room 10, on the NIH campus, Bethesda, Maryland. Dr. Story Landis, Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson.
In accordance with Public Law 92-463, the meeting was:
Council members present were:
Council Roster (Attachment 1)
Council Members absent:
Dr. Byron Ford
Dr. Kevin McNaught
Ex Officio Members present:
Dr. Robert Ruff, Department of Veterans Affairs
Captain Michael Colston, Department of Defense
Members of the public present for portions of the open meeting included:
Dr. Dawn Mancuso, Hydrocephalus Association
Ms. Ashly Westrick, Hydrocephalus Association
Dr. Amy Adams, NIDCR
Dr. Shimere Williams, Lewis and Burke Associates
Ms. Michelle Rodrigues, SRI International
Dr. Naomi Kleitman, Craig H. Neilson Foundation
Mr. Jamie Tucker, Parkinson’s Action Network
Mr. Robert Yates, Social & Scientific Systems, Inc.
Ms. Emily Smith, RTI International
Dr. Tom Jacobs, University of Texas
Ms. Janet Luczak, Technical Resources International, Inc.
Dr. Stefano Bertuzzi, The American Society for Cell Biology
Federal attendees are listed at the end of these minutes.
I. Call to Order and Opening Remarks
Dr. Story Landis, Director, NINDS, welcomed Council members, visitors, and staff to the 187th meeting of the National Advisory Neurological Disorders and Stroke Council meeting.
Dr. Landis introduced the new Department of Defense ex officio Council member, Captain Michael Colston. Captain Colston is Director, Mental Health Program, Clinical and Program Policy, Office of the Assistant Secretary of Defense (Health Affairs).
Dr. Landis announced that this was the last meeting for Drs. Thomas Brott, Donna Ferriero, Barbara Vickrey, and Ms. Kim Zellmer and thanked them all for their service throughout their term which ends July 31, 2013.
Due to a conflict for Dr. Alan Koretsky, NINDS Scientific Director, the usual May Council intramural presentation is postponed to the next Council meeting.
Dr. Landis introduced Dr. Tara Schwetz, an AAAS Science and Technology Policy Fellow in the Office of Pain Policy at NINDS. She will be supporting efforts of the NIH and the Interagency Pain Research Coordinating Committee to develop a population health level strategic plan for pain prevention, management, education and research.
Dr. Landis congratulated Council member, Dr. Ben Barres, on his recent election into the National Academy of Sciences.
II. Report of the Associate Director for Extramural Research, NINDS
Approval of Council Minutes -- Dr. Finkelstein requested, and the Council voted approval, for the January 31-February 1, 2013, Council meeting minutes.
The following future Council meeting dates were confirmed:
Expedited Review Process -- Each Council round, a subset of Council members approve applications in advance of the meeting with scores within the payline for which there are no unresolved issues. Dr. Finkelstein thanked Drs. David Ginty, David Holtzman, and Kevin McNaught for handling this responsibility for FY13. For the current Council round, 152 applications were eligible to be expedited including 2 K applications and 1 Phase 2 SBIR application. Eighty four of these awards have already been made, and the others will be issued after Council.
DER Announcements -- Dr. Finkelstein, Director, Division of Extramural Research (DER), NINDS, introduced Dr. Patrick Hussmann, a program analyst who recently joined the Neural Environment Cluster.
OTR Announcements -- Dr. Rajesh Ranganathan, Director, Office of Translational Research (OTR), introduced two new members of the office: Adrienne Ivory, a new program analyst with the Blueprint Neurotherapeutics Network and Karrah Benson, a program coordinator supporting the Anticonvulsant Screening Program. Next, he announced the departure of 4 members of the OTR staff: Dr. Jeff Jiang, Dr. Eric Nelson, Ms. Jon'lethia King, and Mr. Gregg Peterson.
III. Report of the Director, NINDS
NIH and NINDS Budget (FY13 and FY14)
Dr. Story Landis, Director, NINDS, provided Council with an update on the FY13 and FY14 budgets for NINDS and NIH. In FY13, the NINDS budget was 5.7% less than FY12 due to a 5% budget cut resulting from the sequester, passed as part of the Budget Control Act of 2011 (P.L. 112-25) and a 0.7% budget cut resulting from transfers to the Department of Health and Human Services to aid in the implementation of the Patient Care and Affordable Care Act (P.L. 111-148). The NIH Budget as a whole was reduced by about $1.7B and the NINDS by about $92M. To implement these cuts, individual Institutes and Centers were encouraged by the NIH Office of the Director to develop their own plans to balance cuts across Extramural, Intramural, and Research Management and Support (RMS). In response to these cuts, NINDS will cut 3.5% from RPG non-competing grants, the Division of Intramural Research, and Research Management and Support (RMS). Despite these cuts, NINDS will maintain commitments to training and career awards and will pay grants to the 14th percentile, due to increased efficiencies in clinical trials, program closures, and grant turnover. Dr. Landis acknowledged that having individual NIH Institutes develop unique budget implementation plans was likely confusing for investigators and institutions; however she noted that this strategy helped Institutes maximize available funds across NIH. NINDS anticipates supporting 686 competing RPGs in FY13, with a success rate of 19%.
The President’s Budget request for FY14 was submitted to Congress on April 10, 2013. Included in this request was a $31.3 billion FY14 budget for the NIH, which reinstates all funds cut by the sequester and provides a 1.5% increase to NINDS. On May 15, 2013, Dr. Collins, accompanied by Drs. Landis, Fauci, Gibbons, Hodes, and Varmus testified before the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education. On March 21, 2013 the House of Representatives passed H. Con. Res 25, the budget resolution for FY14, which establishes spending limits for subsequent appropriations bills. Under this resolution, the NIH budget for FY14 is projected at $20B, a 33% reduction over FY12.
Dr. Landis reported on a plan outlined in the President’s FY14 Budget Proposal to reorganize Science, Technology, Engineering, and Mathematics (STEM) education programs across the Federal Government. In his proposal, the President instructed that resources for STEM programs should be focused at the US Department of Education, the National Science Foundation, and at the Smithsonian Institution. This reorganization will result in the termination of 78 programs at 9 agencies, totaling $176.4M (including 9 (of 24) NIH programs, totaling $27.6M). These changes resulted following a series of reports from the Government Accountability Office over the past several years describing the need to better manage overlapping programs across the federal government (see reports from 2006, 2012, 2013). Moreover, America Competes Reauthorization Act of 2010 (P.L. 111-358), directed the White House Office of Science and Technology Policy to form a National Science and Technology Council Committee on STEM Education (CoSTEM) to coordinate STEM education activities and programs of the Federal Agencies and to develop and implement a 5 year STEM education strategic plan (see 2012). Notably, there was no NIH representation on this Committee, as the working definition of STEM Education used by CoSTEM seemed to specifically exclude post-doctoral research fellowships. Nevertheless, several NIH programs were eliminated, including three post undergraduate programs. At this time, there is a hold on funding new K-12 STEM grants / contracts in FY13 and on re-issuing the Science Education Partnership Award (SEPA) FOA. In addition, decisions on awards of non-competing projects in FY14 and beyond will be left to the funding unit.
Brain Research through Advancing Innovative Neurotechnologies (BRAIN)
Dr. Landis reported on the BRAIN initiative, announced by President Obama on April 2, 2013, from the East Wing of the White House. BRAIN is described by Dr. Collins, NIH Director, as a bold new research effort to revolutionize our understanding of the human mind which builds on the President’s State of the Union call for historic investments in research and development to fuel the innovation, job creation, and economic growth. The Initiative promises to accelerate the development and application of new tools and technologies to construct a dynamic picture of brain function that integrates neuronal and circuit activity over time and space. Such cutting-edge capabilities, applied to both simple and complex systems, will open new doors to understanding how brain function is linked to human behavior and learning, and the mechanisms of brain disease.
The BRAIN Initiative will be supported by a partnership with several agencies within (e.g. NIH, NSF, and DARPA) and outside (e.g. Allen Institute for Brain Science, Howard Hughes Medical Institute, the Salk Institute for Biological Studies, and the Kavli Foundation) the Federal Government. A plan for the NIH component of the BRAIN initiative will be developed by a working group of the Advisory Committee of the NIH Director selected for visionary leadership and expertise in areas of experimental neuroscience, technology development, computation and theory, and human neuroscience. This working group has been charged with articulating the scientific goals of the initiative, and developing a multi-year plan, including timetables, milestones and costs. In FY14, NIH will contribute $40M towards the BRAIN Initiative, comprised of funds from the NIH Neuroscience Blueprint ($10M), the NIH Office of the Director ($10M), NINDS ($7.5M), NIMH ($7.5M), NIDA ($4.0M), and NIBIB ($1.0M). It is anticipated that this will be a multi-year effort.
IV. Overview of NINDS Training Program
Dr. Stephen Korn, Director, Office of Training, Career Development and Workforce Diversity (OTCDWD), NINDS, provided Council with an update on NINDS Training efforts and led a discussion regarding the future of the K24 and K25 programs. The NINDS OTCDWD is responsible for managing the Institute’s fellowship (Fs), career development (Ks) research education (R25s), and training programs (Ts), and through these programs supports graduate students, postdoctoral fellows and clinical residents.
National Research Service Awards (NRSAs; Ts and Fs)
The Individual (F; 1.2%) and Institutional (T; 1.1%) NRSA programs at NINDS represent approximately 2.3% of the Institute’s total budget, compared to an average of 3.4% across NIH. NINDS supports two T32 programs: the Jointly Sponsored Predoctoral Training Program in the Neurosciences (JSPTPN), which supports 1st and 2nd year doctoral students, and the NINDS T32 program, which supports advanced doctoral students and postdoctoral fellows. The JSPTPN provides broad-based neuroscience training and 7 NIH ICs currently support 181 students at 24 programs. The NINDS T32 program supports 219 trainees across 50 programs.
The primary purpose of the Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented NIH-supported independent investigators. The program is designed to facilitate a timely transition from a mentored postdoctoral research position to a stable independent research position with independent NIH or other independent research support at an earlier stage than is currently the norm. Beginning in January 2014, candidates with 4 or less years of research experience from completion of their doctoral degree or residency will be eligible. Following the mentored phase, the individual may request up to 3 years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for regular research grant support (R01). Since 2007, NINDS has funded 88 K99s, 75% of which have transitioned to tenure-track positions (65% to an R00). Of K99/R00 awardees that have completed the R00, 76% have successfully obtained an R01 or an NIH Director’s New Innovator Award.
Dr. Korn provided Council with and update on the outcomes obtained through the mentored clinician career development awards programs. The goal of these programs is to train clinicians towards an independent research career. For these programs combined, approximately 75% of K awardees have obtained independent research funding following the completion of their K award.
Dr. Korn briefly described two additional programs run out of the NINDS OTCDWD, the NIH Loan Repayment Program, a Congressionally-mandated program, whose purpose is to encourage health professionals to stay in research rather than leave for a more lucrative activity because of debt; and the ARRA P30 program which provided up to $1 million per institution to hire tenure-track faculty. Lastly, Dr. Korn discussed the proposed discontinuation of NINDS participation in the mentored career development award for quantitative scientists (K25), and in the mid-career award in patient-oriented research (K24).
V. Update from Office of Special Programs in Diversity
Dr. Courtney Ferrell Aklin, Program Director. Office of Special Programs in Diversity, NINDS provided Council with an update on the Specialized Neuroscience Research Program (SNRP). The SNRP RFA was reissued for FY13 in response to a number of recommendations from the NINDS Diversity Workforce Panel, Chaired by Dr. Zach Hall, and in response a number of Supreme Court cases limiting race/ethnicity conscious selection policies in government programs. In its current form, the purpose of the SNRP is to increase the quality of the education of scientists from diverse backgrounds underrepresented in neuroscience research. In addition, the SNRP program seeks to promote opportunities for degree-granting institutions to improve their research infrastructure to support neuroscience research excellence, and to increase the academic preparedness of students from diverse backgrounds to pursue advanced neuroscience research careers. Eligible institutions include those: with NINDS funding of less than $25M total cumulative cost for FY10 – FY12 and with a Carnegie classification rating of either Special focus medical school or research universities with high research activity. As designed, the SNRP program has 3 key elements: the research program, the enrichment program and the program evaluation.
VI. Discussion of R21 Mechanism
Dr. Christine Torborg, Health Science Policy Specialist, Office of Science Policy and Planning, NINDS, presented Council with an update of the NINDS program that supports R21 Exploratory/Developmental Grants. R21s are awarded for a maximum of two years and cannot be renewed. Over the two year funding period, the award, which encourages exploratory and developmental research projects in the early and conceptual stages, cannot exceed $275,000 direct costs. Dr. Torborg recounted an analysis of the R21 program conducted by the Institute in 2009, which concluded that R21s fill an important niche in NINDS’ research portfolio. However, since 2009, the total amount spent by NINDS on R21s has increased by nearly $30 million dollars, due largely to an increase in the number of R21s submitted by established investigators.
VII. Discussion of High Program Priority Process
Dr. Finkelstein provided Council with an update on the Institute’s use of the HPP and Bridge award program. The goal of the HPP program is to fund high quality, mission-critical R01 and R21 applications with scores within 10 percentile points of the payline. In contrast, the goal of the Bridge award program is to provide one year of support to allow PIs to prepare a revised or new application. Criteria for the two programs vary somewhat, with HPP criteria focused primarily on the proposed project and Bride criteria focused primarily on the investigator.
VIII. Concept Clearance for FY 2014 Proposed Initiatives
Dr. Robin Conwit, Program Director in the NINDS Office of Clinical Research, requested concept clearance for an NINDS Clinical Trial Methodology Course. NINDS has run a Clinical Trials Methods in Neurology course via a contract awarded to the University of Rochester for the past 5 years. The contract supported the development and implementation of a short course in clinical trial methodology targeted to junior neurology/neurosurgery faculty and fellows focused primarily on early phase (Phase I, II or pilot) trials. It is anticipated that the successful applicant to this proposed FOA soliciting R25 applications will incorporate many features of the existing course, and will also incorporate new technological advances in neurology and neurosurgery and flexible clinical trial designs, with expert faculty in these developing areas.
Dr. Mona Hicks, Program Director in the NINDS Repair and Plasticity Cluster, requested concept clearance to promote collaboration and further analysis of high quality, legacy traumatic brain injury (TBI) clinical research data. TBI is a complex, major health problem that requires large data sets to address many of the critical gaps in knowledge. To this end, the Department of Defense (DOD) and the National Institutes of Health (NIH) are collaborating to create and advance the Federal Interagency TBI Research (FITBIR) Informatics System, which was launched in July 2011 and is currently accepting data from new research studies. To accelerate the process of populating FITBIR with data, the NINDS proposes to solicit applications from investigators with high quality TBI clinical research data from completed studies, a strategy that originated from discussions with the FITBIR Strategic Vision Committee meeting in November 2012. Archiving high quality legacy data and/or federating FITBIR with other TBI databases were strongly recommended in order to “jump start” the process of populating it with data that can be shared with other investigators.
Dr. Finkelstein requested and was granted, a motion to move forward with the development of both of these concepts.
IX. NeuroNEXT Update
Dr. Petra Kaufmann, Director, Office of Clinical Research, NINDS provided Council with an update on the progress of the NINDS NeuroNEXT program, the goal of which is to test promising therapeutics in Phase 2 clinical trials. In addition, the program seeks to: accelerate drug development through an established clinical trials infrastructure, decrease the time between trial design and trial completion, and to coordinate public / private sector efforts. Dr. Kaufmann described progress towards each of these goals, notably the execution of a reliance agreement with the central IRB (Mass General) and of a master clinical trial agreement. The NeuroNEXT has initiated its first trial, Spinal Muscular Atrophy Biomarkers in the Immediate Postnatal Period of Development. Additionally, Dr. Kaufmann described the status of 89 proposals submitted to date and the strategies currently underway to implement a number of recommendations provided to NeuroNEXT by an external panel of experts, including: streamline the application, evaluation and approval process for trials; accelerate timelines; peer-review projects prior to the full development of study protocols. Lastly Dr. Kaufmann requested feedback from the NINDS Council on the use of the NeuroNEXT infrastructure to conduct trials on rare pediatric diseases with the understanding that the industry partner pays all of the clinical trials costs, if the network is not at study capacity. The proposed trials will be studies falling under the Best Pharmaceuticals for Children Act (BPCA), which was enacted to improve pediatric therapeutics through an increased knowledge base.
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.
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 324 research career development and institutional training grant applications; of this total, 314 applications had primary assignment to NINDS, and 188 of them (58 percent) were scored in the amount of $7.7 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 $4 million (67 grants).
Research Project and Center Awards
The Council reviewed a total of 1,875 research project and center applications; of this total, 1,352 applications had primary assignment to NINDS, and 1023 of them (54.6 percent) were scored/percentiled in the amount of $296.5 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 $67.3 million (243 grants).
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, four Javits awards were recommended.
Small Business Innovation Research and Small Technology Transfer Award Programs
The Council reviewed a total of 112 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 105 applications had primary assignment to NINDS and 64 of them (57.1 percent) were scored in the amount of $18.3 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 $2.5 million (6 grants).
The meeting was adjourned at 9:50 a.m. on Friday, May 24.
NINDS employees present for portions of the meeting included:
Other Federal employees present for portions of the meeting included:
Mr. Dever Powell, OD
Ms. Tara Schwetz, OD
Dr. Sharon Low, CSR
Dr. Jonathan Irving, CSR
Dr. Laurent Taupenot, CSR
Dr. Wei-Qin Zhan, CSR
Dr. Samuel Edwards, CSR
Dr. Rene Etcheberrigaray, CSR
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
Story C. Landis, Ph.D.
National Advisory Neurological Disorders
and Stroke Council
National Institute of Neurological Disorders
These minutes will be formally considered by the Council at its next meeting. Corrections or notations will be incorporated in the minutes of that meeting.
Last updated August 29, 2013