NINDS Advisory Council Meeting Minutes, February 16-17, 2012

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

Summary of Meeting[1]
February 16-17, 2012

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 183^rd meeting on February 16-17, 2012, 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:

Council members present were:

 

Council Roster (Attachment 1)

Council member absent was:

Dr. Ben Barres
Dr. Robert Friedlander
Dr. David Holtzman
Ms. Katie Hood
Dr. Louis Ptacek

Ex Officio Members present:

Dr. Robert Ruff, Department of Veterans Affairs

Ex Officio Members 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
Mr. Jeff Wuchich, Alternating Hemiplegia of Childhood Foundation
Mr. Ted Shoneck, Tunnell Government Services, Inc.
Ms. Dawn Mancuso, Hydrocephalus Association
Ms. Maggie Owner, Lewis-Burke Associates LLC
Ms. Susan Axelrod, Citizens United for Research in Epilepsy
Ms. Lori Pellnitz, SRI International

NINDS employees present for portions of the meeting included:

 

Other Federal employees present for portions of the meeting included:

Dr. Keith Crutcher, CSR
Dr. Peter Guthrie, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Seetha Bhagavan, CSR
Dr. Catherine Bennett, CSR
Dr. Yuan Luo, CSR

I. Call to Order and Opening Remarks

Dr. Landis, Director, NINDS, welcomed Council members, visitors, and staff to the 183rd meeting of the National Advisory Neurological Disorders and Stroke Council meeting.

Dr. Landis announced that the following Council members were absent for this meeting: Dr. Ben Barres, Dr. Robert Friedlander, Dr. David Holtzman, Ms. Katie Hood, and Dr. Louis Ptacek. Next, she introduced new staff in the NINDS Office of the Director: Dr. Rajesh Ranganathan, Director, Office of Translational Research; Caroline Lewis, Executive Officer; and Dr. Mary Kay Floeter, who is on a part time detail in the Office of Clinical Research.

II. Report of the Associate Director for Extramural Research, NINDS

Approval of Council Minutes -- Dr. Finkelstein requested, and the Council voted approval, for the September 16-17, 2011, Council meeting minutes.

The following future Council meeting dates were confirmed:

• May 24-25, 2012 - (Thursday and Friday)
• September 20-21, 2012 - (Thursday and Friday)
• January 31-February 1, 2013 - (Thursday and Friday)
• May 23-24, 2013 - (Thursday and Friday)
• September 12-13, 2013 - (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. Dr. Finkelstein thanked Donna Ferriero, Sharon Hesterlee, and Amita Sehgal for handling this responsibility this fiscal year. For this Council round, 153 applications were eligible to be expedited including 9 career or K applications. One hundred seventeen of these have already been issued and most of the others will be issued shortly after Council.

Council Operating Procedures -- Once a year, Council is required to endorse the Council Operating Procedures, which includes the Council Delegated Authorities. Council moved to approve the Operating Procedures.

DER Announcements -- Dr. Finkelstein introduced new DER staff: Dr. Birgit Neuhuber and Dr. Natalia Strunnikova, Scientific Review Officers, Scientific Review Branch; Dr. Charles Cywin, Project Manager, Office of Translational Research; Dr. Carl Potenzieri, Health Program Specialist, Office of Training, Career Development, and Workforce Diversity; Dr. Ipolia Ramadan, Program Analyst, Neural Environment Cluster; Dr. Elizabeth Webber, Program Analyst, Channels, Synapse, Circuits Cluster; Dr. Martin Mendoza, Program Analyst, Office of Clinical Research; and Dr. Ivan Navarro, Program Analyst, Neurodegeneration Cluster.

III. Report of the Director, NINDS

NIH Budget
Dr. Landis reported on the status of the NIH and NINDS budgets for Fiscal Years 12 and 13. Following four continuing resolutions, President Obama signed P.L. 112-74 into law on December 23, 2011, providing Federal appropriations for the remainder of FY12. The passage of this bill resulted in a 0.2% reduction to NIH’s appropriation from FY11 funding levels, and a 0.2% increase ($3.9 M over FY11) to the NINDS appropriation. On February 13, 2012, President Obama released his FY13 budget request, which contained no changes to NIH appropriations over FY12 levels; however, NINDS appropriations were decreased by 0.1% ($1.2 M) over FY12 levels. The National Center for Advancing Translational Science (NCATS) and the National Library of Medicine both received significant FY13 budget increases. Dr. Landis noted that it was very early in the budget process, and that there was a significant level of uncertainty regarding the final budget. Secretary Sebelius is scheduled to testify before the House (March 6) and Senate (March 7) Appropriations Subcommittees on the FY13 DHHS budget. On March 28, Dr. Collins is scheduled to testify before the Senate Appropriations Subcommittee on the FY13 NIH Budget. Dr. Collins is expected to be accompanied by Drs. Fauci (NIAID), Varmus (NCI), Rodgers (NIDDK), and Insel (NCATS / NIMH) to testify. The majority of the NINDS budget ($1.6 B) supports extramural research ($1.4 B), while the remainder supports the NINDS Intramural Research Program ($158 M) and overhead costs ($58 M). In FY12, NINDS anticipates a success rate of 20.4%, and will fund grants to the 14th percentile.

FY12 and FY13 Grant budget policies
Dr. Landis described a number of the grant budget policies that have been put in place for FY12 and are anticipated for FY13. For FY12: there will be no inflationary adjustments for FY12 and future years; the average cost of competing awards will be kept constant at FY11 levels ($392 K); NRSA stipends will increase by 2%; and caps on investigator salaries for competing grants issued on/after 12/23/2011 will be reduced from Executive Level I ($199,700) to Executive Level II ($179,700). Dr. Landis noted that the duration of the salary cap reduction was unclear. Grant budget policies for FY13 proposed in the President’s budget include: 1% reduction (non-competing, non-modular grants) from FY12 levels; average cost of competing awards reduced to $389,000; additional advisory council review of applications from PIs already receiving greater than $1.5M total costs per year.

National Center for Advancing Translational Sciences (NCATS)
NCATS was established on 12/23/2011 with the signing of the FY12 appropriations bill. The NCATS mission is to catalyze the development of innovative methods and technologies that will enhance development, testing, and implementation of diagnostics and therapeutics. A number of translational efforts across NIH have been incorporated into NCATS including: the Clinical and Translational Science Awards (CTSAs), components of the Molecular Libraries Program, Therapeutics for Rare and Neglected Diseases (TRND), the Office of Rare Diseases Research (ORDR), and the FDA-NIH Regulatory Science efforts. In addition, NCATS will include the Bridging Interventional Development Gaps program (a reformulation of the NIH RAID program) and the Cures Acceleration Network. Tom Insel, Director of the National Institute of Mental Health will serve as Acting NCATS Director, and Kathy Hudson, NIH Deputy Director for Science, Outreach, and Policy, will serve as Acting NCATS Deputy Director.

Reauthorization of the Small Business Innovation Research (SBIR) Program
Dr. Landis reported that the SBIR/STTR program was reauthorized through 2017 with the signing of the National Defense Authorization Act for Fiscal Year 2012 by President Obama on December 31, 2011. The Act authorized significant changes including: an increase to the set-aside requirement, an increase to the size of awards, and the expansion of eligibility of venture-backed companies to receive SBIR grants. NIH is awaiting guidance for implementation from the Small Business Administration.

Pain Provisions in the Affordable Care Act
Dr. Landis reported on the implementation of a number of provisions of the Patient Care and Affordable Care Act (P.L. 111-148) related to pain research. For implementation of these provisions, NINDS has been designated the lead Institute on Pain Research. The Act called for the formation of an Interagency Pain Research Coordinating Committee, charged with summarizing advances, identifying gaps, and providing recommendations to avoid duplication, enhance dissemination, and expand collaboration in pain research. Dr. Landis will serve as interim Committee Chair of this 19 member committee, which will hold its first meeting on March 27, 2012. A permanent Chair will be elected at the first meeting of the Committee. In addition, the Act called for an Institute of Medicine (IOM) conference on the state of pain research, care, and education which released their report, “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research” in June 2011.

National Alzheimer’s Project Act (NAPA)
The National Alzheimer’s Project Act (P.L. 111-375) was signed into law by President Obama on January 4, 2011. This law tasks the Department of Health and Human Services with developing a national strategic plan for Alzheimer’s disease (AD), including research, care, and services. A draft plan was released and is open for public comments through March 8, 2012. In addition, NAPA created an Advisory Council on Alzheimer’s Research, Care, and Services, chaired by Dr. Ron Peterson, which is tasked with coordinating federal agencies conducting care, services, and research. The Obama Administration announced an initiative for NIH to dedicate an additional $50M in the FY12 budget for AD research. Of the $50M, $25M will be used to sequence the genomes and exomes of people with AD to identify both risk factors and protective genetic variants. This work will be done by the NHGRI sequencing centers. The remaining $25M will be spent on already peer-reviewed, highly meritorious projects that may not otherwise have been funded. The President’s FY13 budget includes an additional $80M for AD research, which the President proposes to add to the NIH budget. Currently, NIA funds about 70% of AD research and NINDS funds about 10%.

Chimpanzees in Biomedical Research
In response to a Congressional Request for an analysis of the current and future need for the use of chimpanzee use in biomedical research, a report was released by the IOM in December 2011 entitled, “Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity.” The report concludes that while past research on chimpanzees has been valuable, most current biomedical chimpanzee research is unnecessary. In addition, the report established criteria for determining when future studies are necessary. Dr. Collins moved to accept and implement the IOM committee recommendations and established a Council of Councils working group headed by Drs. Dan Geschwind and Kent Lloyd to make recommendations for implementation of the IOM report. While awaiting the working group recommendations, the NIH will not fund any new projects utilizing chimpanzees. There are 110 NIH-supported chimpanzee studies, 2 of which are funded by the NINDS. Both of these are non-invasive comparative neuroanatomy studies.

Biomedical Research Workforce Working Group
This workgroup of the NIH Advisory Committee to the Director, co-chaired by Drs. Shirley Tilghman and Sally Rockey, is charged with developing a model for a U.S. biomedical research workforce and recommending NIH actions to support a future biomedical infrastructure. The group is taking a two-tiered approach that includes conducting a descriptive analysis of key aspects of the workforce and developing a conceptual framework to organize the analysis. The group released an RFI which closed in October 2011, soliciting input on the most important issues for the working group to address. The two most commonly cited issues of concern to the community were Supply and Demand (19%), and Ph.D. characteristics (17%).

Formation of Institute of Substance Use, Abuse and Addiction
Dr. Landis reported on the latest developments to create a new NIH Institute focused on substance use, abuse and addiction research comprised of large portions of the NIDA and NIAAA portfolios. In addition, Dr. Landis noted that as a result of the creation of this new Institute, a number of programs would be relocated. An RFI, which closes May 11, 2012, has just been released soliciting new scientific opportunities and public health needs in substance use, abuse and addiction research that may emerge as a result of the formation of this new Institute.

IV. Discussion of NINDS Budget Strategy

Introduction
Dr. Robert Finkelstein, Director, NINDS Division of Extramural Research

Dr. Finkelstein introduced a series of presentations focused broadly on the question “How can NINDS spend its extramural budget most effectively?” This issue has become increasingly challenging as the NINDS continues to face fiscal constraints. To address it, NINDS has begun to analyze past and current expenditures and is considering potential “core principles” to guide future funding decisions. To provide context for the presentations and the subsequent discussion, Dr. Finkelstein presented Council with a brief history of NINDS expenditures and an overview of the current NINDS budget.

Discussion of Past NINDS Expenditures
Dr. Christine Torborg, Health Science Policy Analyst, Office of Science Policy and Planning, NINDS
Dr. Anna Taylor, Health Program Specialist, Division of Extramural Research, NINDS

Dr. Torborg discussed how NINDS funding for various grant mechanisms has evolved since 1995. She explained, for example, that the percentage of the NINDS extramural grants budget supporting R01s has varied significantly both positively and negatively since 1995. She also showed that funding for P01 grants has steadily decreased, and that funding for Phase III clinical trials and preclinical therapy development grants increased. The increase in support for Phase III clinical trials was shown to be largely due to increased funding for ongoing trials.

Analysis of NINDS Expenditures by Scientific Focus
Dr. Taylor presented the results of a pilot analysis designed to address the question of whether the balance of Basic and Applied research has changed over time. The group analyzed the NINDS competing portfolio for two years (2002 and 2010) and assigned a percent effort to the following categories: Basic; Basic, Basic; Disease-Related, Applied; Translational, and Applied; Clinical. An example of a result from this analysis was that the percentage of competing funds supporting investigator-initiated disease-focused research (Basic; Disease-Related, Applied; Translational; and Applied; Clinical) was increased in 2010 compared with 2002. The results obtained when analyzing Investigator-initiated R01s were similar to the overall NINDS portfolio. Additional time points will be analyzed to confirm these results.

Identifying NINDS Core Principles for Changing Times 
Dr. Amelie Gubitz, Program Director, Neurodegeneration, NINDS

Dr. Gubitz presented the results of NINDS discussions aimed at developing potential core principles for the Institute. Such principles could potentially help guide decisions in a challenging fiscal environment. As a result of this exercise, the following core principles were proposed: 1) Fund the Best Science, 2) Advance the NINDS Mission, 3) Find/Improve Treatments, 4) Train and Maintain an Effective Workforce, and 5) Run a Tight Ship. Dr. Gubitz elaborated on each of the principles and provided examples of potential implementation strategies for each principle.

Discussion
Dr. Paul Scott, Director, Office of Science Policy and Planning, NINDS

Dr. Scott led the Council in a discussion focused on how the NINDS could effectively spend its extramural budget based on the data and principles identified by the previous speakers. Council members raised and discussed many issues. They were particularly interested in the potential funding shift towards disease-related basic and applied research, but emphasized that more time points should be analyzed and discussed before reaching any conclusions.

V. Bridge Award Discussion

Dr. Alan Willard, Associate Director, Division of Extramural Research, NINDS

Dr. Willard provided an update on the use of Bridge Awards at NINDS. Bridge (R56) awards have been used by NINDS since 2007 to provide one year of funding for R01s with scores just beyond the payline. These awards permit NINDS to maintain specific projects or PIs without incurring multi-year commitments. Dr. Willard described the current selection criteria used by NINDS when identifying bridge award candidates, and the success of investigators in successfully obtaining a new grant following the bridge award.

VI. Working Group Report on the Anticonvulsant Screening Program (ASP)

Dr. Robert Pacifici, Chief Scientific Officer CHDI; Chair, NINDS ASP Working Group

Dr. Pacifici discussed the findings and recommendations of a Council Working Group charged with evaluating the effectiveness of the ASP and with making recommendations for the future of the program in terms of its focus, strategies, and configuration. The NINDS ASP was established in 1975 as part of a larger Antiepileptic Drug Development program that included basic and clinical research, and extra- and intramural components. The ASP was added to address a critical need for new anti-seizure medications and to promote industry interest in their development. Researchers from academia and industry submit compounds for screening in a series of rodent seizure models, and ~30,000 compounds have been screened to date. Following their evaluation, the ASP working group concluded that while the ASP has facilitated the development of a number of new antiepileptic drugs (AEDs), the situation for treatment-resistant epilepsy remains largely unchanged. Therefore, the working group recommended that the ASP shift its focus to address the most critical unmet needs in epilepsy and adapt to an epilepsy drug development landscape that has evolved. To this end, the working group recommended that the ASP revise its mission to focus on: 1) disease modification, 2) pharmacoresistant epilepsies, and 3) epilepsy comorbidities. Moreover, the working group recommended that under new leadership, the ASP refine their operating procedures to maximize the quality of compounds screened, and to select and/or develop new models for incorporation into the program. Lastly, the working group recommended that the NINDS explore options for making data on screened compounds publically available, establish an advisory board to oversee changes made to the ASP, and develop processes and metrics for tracking future progress of the ASP. The Council voted unanimously to accept the recommendations of the ASP Working Group.

VII. Council Consideration of Pending Applications

This portion of the meeting, involving specific grant review, was closed to the public. The Council gave special attention to applications from foreign institutions and other applications which needed specific discussion. Prior to the discussion of the grants, Dr. Finkelstein reminded Council regarding conflict of interest and confidentiality as follows:

Conflict of Interest

The regulations concerning conflict of interest were reviewed. Council members were reminded that materials furnished for review purposes and discussion during the closed portions of the meeting are considered privileged information. All Council members present signed a statement certifying that they had not been involved in any conflict of interest situations during the review of grant applications.

Confidentiality

During the closed session, any information that is discussed and the outcome of any recommendation are considered privileged information. They may not be discussed outside of the closed session. If an applicant requests support for his or her application from a Council member, the Council member must respond that he/she is not permitted to discuss the application. Any inquiry should be referred to Dr. Robert Finkelstein, the Council Executive Secretary, who will then refer the questions to the appropriate staff member for response.

Research Training and Career Development Programs

The Council reviewed a total of 99 research career development and institutional training grant applications; of this total, 88 applications had primary assignment to NINDS, and 59 of them (67.0 percent) were recommended for support in the amount of $10.0 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 $3.9 million.

Research Project and Center Awards

The Council reviewed a total of 1,623 research project and center applications; of this total, 1,306 applications had primary assignment to NINDS, and 692 of them (53.0 percent) were recommended for support in the amount of $180.8 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 $42.2 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 167 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 138 applications had primary assignment to NINDS and 86 of them (62.3 percent) were recommended for support in the amount of $22.4 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 $4.8 million.

VIII. Adjournment

The meeting was adjourned at 10:40 a.m. on Friday, February 17.

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.

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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.