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NINDS Advisory Council Meeting Minutes, January 30, 2014


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

Summary of Meeting1
January 30, 2014

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 189th meeting on January 30, 2014, in Building 31, Conference Room 10, on the National Institutes of Health (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:

Open: January 30: 8:00 a.m. to 2:45 p.m. for the review and discussion of program development, needs, and policy; and
Closed: January 30: 2:45 p.m. to 5:30 p.m. for the consideration of individual grant applications.

 


Council members present were:

Dr. Ben Barres
Dr. E. Antonio Chiocca
Dr. Robert Darnell
Dr. Byron Ford
Dr. David Ginty
Dr. David Goldstein (via teleconference)
Mr. Paul Gross
Dr. Sharon Hesterlee
Dr. David Holtzman
Dr. David Julius
Dr. Eve Marder
Dr. Kevin McNaught
Ms. Ilene Penn Miller
Dr. Jonathan Mink
Dr. Robert Pacifici
Ms. Amy Comstock Rick
Dr. Ralph Sacco


 


Council Roster (Attachment 1)

Council Members absent:
Dr. Amita Sehgal

Ex Officio Members present:
Captain Michael Colston, Department of Defense
Dr. Robert Ruff, Department of Veterans Affairs

Members of the public present for portions of the open meeting included:
Mr. Jamie Tucker, Parkinson’s Action Network
Dr. Naomi Kleitman, Craig H. Neilson Foundation
Dr. Tom Jacobs, University of Texas
Dr. Thomas Montine, University of Washington
Dr. Dawn Mancuso, Hydrocephalus Association
Dr. Shimere Williams, Lewis-Burke Associates, LLC
Ms. Liz Schreiber, Epilepsy Foundation
Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance
Ms. Taryn Quinlan, NOVA Research Company

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 189th meeting of the National Advisory Neurological Disorders and Stroke Council. 

Dr. Landis introduced Dr. David Julius, a new Council member, who was unable to attend his first meeting this past September.  Dr. Julius is professor and Chair of Physiology and Morris Herzstein Endowed Chair in Molecular Biology and Medicine at the University of California, San Francisco.  Dr. Landis noted that, due to a conflict, Dr. Amita Sehgal was unable to attend this Council meeting, and also congratulated Dr. Eve Marder on being elected to the Institute of Medicine this past fall.   

Dr. Landis reported on the new Office of Scientific Liaison (OSL) within the NINDS Office of the Director.   The goal of this recently created Office is to ensure that NINDS is effectively communicating information on all research conducted and supported by NINDS to its many audiences.   OSL will work closely with the Office of Communications and Public Liaison and the Office of Science Policy and Planning to provide a seamless flow of information on research advances and initiatives to various stakeholders, including scientific and academic communities, as well as policy-makers, patients, and the public.  An important tool in broadly conveying this information will be an enhanced NINDS website.  OSL is responsible for managing and, when appropriate, preparing content for all NINDS external and internal websites, including NINDS-managed websites of major trans-NIH activities such as the NIH Blueprint and the NIH Pain Consortium.  In the coming months, OSL will launch a major redesign of the main public website to enhance usability and navigation so that researchers, staff, patients, and the public can quickly and easily connect with NINDS scientific and public health investments and accomplishments.

Dr. Landis introduced Dr. Amy Bany Adams, Director of OSL.  Dr. Adams served as Director of the NIDCR Office of Science Policy and Analysis (OSPA) from 2008 to 2013, where she was responsible for coordinating scientific planning efforts, conducting policy analyses, and providing evaluation and reporting services for NIDCR, as well managing the NIDCR Dental Public Health Residency program.  Prior to joining NIDCR, Dr. Adams served as an American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellow in the Office of the (NIH) Director, and subsequently served as Special Assistant to Dr. Elias Zerhouni, NIH Director.  Dr. Adams earned her Ph.D. in cell biology from the Yale University School of Medicine, where her research focused on the genetic and cellular basis for neurotransmitter control of behavior in C. elegans.  She received her B.S. in biology from the Massachusetts Institute of Technology.

 

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

Approval of Council Minutes — Dr. Finkelstein requested, and the Council voted for, approval of the September 12-13, 2013, Council meeting minutes.

The following future Council meeting dates were confirmed:

 
May 29-30, 2014 (Thursday and Friday)
September 11-12, 2014 (Thursday and Friday)
February 12-13, 2015 (Thursday and Friday)
May 28-29, 2015 (Thursday and Friday)
September 10-11, 2015 (Thursday and Friday)


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 Byron Ford, David Goldstein, and Amy Comstock Rick for handling this responsibility for fiscal year (FY) 2014.  For the current Council round, 86 applications were eligible to be expedited, including 2 Small Business Innovation Research (SBIR) applications.  Thirteen of these awards already have been made, and the others will be issued after Council.

Extramural Announcements—Dr. Finkelstein introduced one new extramural employee:  Dr. Lyn Jakeman, Program Director, Repair and Plasticity Cluster, who will oversee the spinal cord injury and peripheral nerve injury portfolio.

 

III. Report of the Director, NINDS

NIH and NINDS Budget
Dr. Landis reported on the status of the NIH and NINDS budgets for FY2014.  The Omnibus Appropriations Act of 2014 (P.L 113-76) was signed into law on January 17, 2014.  The law includes an additional $1 billion for NIH, but does not completely replace funds eliminated by the sequester, passed as part of the Budget Control Act of 2011 (P.L.  112-25). The law provides a 3.4 percent increase in funding to NIH and a 3.6 percent increase to NINDS, including specific increases to the major neuroscience funders for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative ($22M). NINDS and NIMH are receiving $9.4M each to support BRAIN, with the remainder going to the National Institute on Drug Abuse and the National Institute of Biomedical Imaging and Bioengineering.  NINDS’ proposed funding plan for FY2014 includes a 1 percent cut to most noncompeting grants and will establish an interim payline of the 14th percentile.  Dr. Landis presented NINDS’ FY2013 budget distribution, competing research project grant (RPG) trends over the past five years, and funding trends for competing R01 applications reviewed and funded in FY2013.  Dr. Landis noted that the number of NINDS R01 applications is falling, while the number of R21 applications is rising (a 50% increase from FY2011).  Council members briefly discussed strategies (e.g., increased use of bridge awards, mandatory study section service to increase the quality of review) to temper the effects of the elimination of A2 amended applications.  Data from the Center for Scientific Review suggests that the number of applicants successfully obtaining funding on the original submission (A0), has begun to decline since 2011.  Dr. Landis indicated that NIH was considering a variety of approaches for addressing this trend.

Dr. Landis reported on additional items of interest in the FY2014 Appropriations bill.  NIH is expected to adopt a reasonable agency-wide policy for noncompeting and competing inflation rates that is consistent with the overall funding increase.  Furthermore, NIH is expected to support as many scientifically meritorious new and competing research project grants as possible at a reasonable award level.  NIH also is directed to continue funding STEM (science, technology, engineering, and math) programs in FY2014, based on the same policies that existed at the start of FY2013.  In addition, NIH is expected to maintain funding support for basic biomedical research, ensuring that it remains a key component of the intramural and extramural research portfolio.

BRAIN Initiative
Dr. Landis reported that NIH recently released six funding opportunity announcements (FOAs) in support of the BRAIN Initiative.  Collectively, these opportunities focus on building a new arsenal of tools and technologies to help scientists understand the structure and function of the brain.  NIH plans to invest $40 million in FY2014 through these FOAs, contingent upon the submission of a sufficient number of scientifically meritorious applications.  Awards will be made for three years and cooperative agreements will be put in place to facilitate communication among awardees and between NIH and the awardees.  Letters of intent are due in February and applications are due in March.  In June 2014, the BRAIN Working Group will issue its final report with milestones, timetables, and cost estimates.  The Working Group will continue to communicate with stakeholders, solicit public comment, develop proposals for FY2015 FOAs, and adopt a multiyear NIH BRAIN plan.  President Obama envisioned the BRAIN Initiative to be a national effort, and the Howard Hughes Medical Institute, the Allen Brain Institute, and the Kavli Foundation already are participating.  Through the Office of Science and Technology Policy (OSTP), the White House will hold discussions with companies, philanthropic organizations, foundations, nonprofits, universities, and state governments about making financial and in-kind commitments.  OSTP will also solicit input from the community about what types of partnerships would have the greatest impact.

Enhancing the Reproducibility and Transparency of Research Findings 
Dr. Landis reported on NIH efforts to enhance the transparency and reproducibility of research findings.  NIH has identified multiple approaches to enhance reproducibility that involve raising community awareness, enhancing formal training, improving the evaluation of applications, protecting the integrity of science by adoption of more systematic review processes, and increasing funding stability for investigators.  A training module on enhancing reproducibility and transparency of research findings, with an emphasis on good experimental design, is currently being developed.  NIH also is developing a peer reviewer checklist with a focus on the strength of the “experimental premise” and a Data Discovery Index (DDI) that will promote data sharing and allow discovery, access, and citation of biomedical data.  NIH will develop an improved biosketch that places greater emphasis on the scientific impact of the investigator, create new grant mechanisms that offers greater stability for investigators, and by consider grant mechanisms that allow more flexibility and a longer support period.  PubMed Commons (http://www.ncbi.nlm.nih.gov/pubmedcommons/) was recently introduced as a forum to enable authors to share opinions and information about scientific publications in PubMed.  All authors of publications in PubMed are eligible to become members.  To date, more than 2,000 authors have joined and contributed over 700 comments.   Dr. Landis noted that a number of scientific journals, including Science and Nature have modified their manuscript submission policies in response to these issues.  Council members noted that it was crucial that NIH frame these initiatives appropriately, to avoid creating the false impression that most NIH research is not reproducible.  Council members also discussed the importance of highlighting the successes of biomedical research.

Parkinson’s Disease (PD) 2014 Meeting
Dr. Landis briefly reported on the PD research planning meeting (PD2014) held at NIH in January 2014.  The goal of the PD 2014 Meeting was to identify a defined set of research recommendations necessary to advance PD research and treatment.  The report from the meeting will be presented to and discussed by Council today.  Next steps include an analysis of the NIH PD portfolio, coordination with the Michael J.  Fox Foundation, the 2015 Parkinson’s Action Network Forum, and development of an implementation plan for PD research.

 

IV.  Report from the NINDS Parkinson’s Disease 2014 Conference

Dr. Thomas Montine, Alvord Professor and Chair, Director of Neuropathology, University of Washington, presented the report and recommendations from the NINDS conference, Parkinson’s Disease 2014: Advancing Research, Improving Lives.

As the primary NIH Institute supporting PD research, and in accordance with the Morris K. Udall Parkinson’s Disease Research Act (P.L.  105-78), NINDS is responsible for convening PD research planning efforts.  Preconference planning for Parkinson’s Disease 2014 began in the summer of 2013 by convening three panels of international experts from academia, industry, and government to formulate the highest priorities for advancing PD research.  The three panels (focused on clinical, translational, and basic research) were charged with developing up to 12 independent prioritized research recommendations.   Each panel reached consensus on the content and priority of recommendations, and drafts of the recommendations were posted and distributed prior to the conference.

The Parkinson’s Disease 2014 conference took place January 6-7, 2014, with 206 attending in-person and over 400 attending virtually.  Panel members and the audience together developed a vision for PD research and reached a broad consensus on strategy to achieve that vision.  A report based on conference feedback and input subsequently has been developed.  The PD research visionis to develop precision medicine for the molecular and clinical heterogeneity of PD, fill knowledge gaps, and support key infrastructure.  This vision will be achieved by pursuing the following synergistic opportunities that cut across all three research areas: creating a genetic risk architecture for PD motor and non-motor symptoms, and for disease progression; bridging from molecular clues to mechanisms, both molecular and pathogenic; developing technologies to measure PD processes; and preventing, slowing, or stopping the progression of PD.

Dr. Montine presented the highest priority recommendations in each research area:
Clinical

  1. Define prodromal PD and determinants of subtypes to initiate proof-of-concept prevention trials.
  2. Develop effective treatments and companion biomarkers for dopa-resistant features of PD (including motor and non-motor symptoms).
  3. Characterize the long-term progression of PD and determine mechanisms that underlie the heterogeneity in clinical presentation and rates of progression.

Translational

  1. Develop patient stratification tools with emphasis on slow- versus fast-progressing PD, prodromal PD, and NMS.
  2. Develop positron emission tomography (PET) imaging agents and assays to measure alpha-synuclein burden.
  3. Develop resources with greater power to predict outcomes in clinical trials, especially iPS cell lines from sporadic, dominant, and recessive PD.

Basic

  1. Develop transmission models of pathologic alpha-synuclein and tau, and determine the mechanisms of propagation, release, and uptake, including the role of “strains.”
  2. Elucidate the normal and abnormal function of alpha-synuclein and its relationship to other PD genes (e.g., ATP13A2, GBA, LRRK2, PINK1, and PARK2).
  3. Develop a deeper understanding of neural circuit dynamics, how these relate to behavior and motor control, and the impact of therapeutic interventions.

Lower prioritized recommendations in each research area also were reviewed.  Council briefly discussed several of the recommendations as well as NINDS plans to implement the highest priority recommendations.  In addition, Ms. Comstock Rick emphasized the importance of presenting the recommendations in an easily digestible format for use by PAN and other similar organizations.

Approval of Parkinson’s Disease Recommendations Report—Dr. Montine requested, and the Council voted for, approval of the 2014 Parkinson’s Disease Recommendations Report.

 

V.  NINDS Translational Programs: A Proposed Redesign

Dr. Rajesh Ranganathan, Director, Office of Translational Research (OTR), NINDS, reported on the proposed redesign of NINDS translational programs.

NINDS’ guiding principles for translational research are to get therapeutics to humans (not bench to bookshelf); to establish fail-early, fail-fast approaches to portfolio management; and to create partnerships and handoffs.  OTR programs that support research across the translational research continuum include the Anti-Convulsant Screening Program, Exploratory/Developmental Projects in Translational Research (tR21), Cooperative Program in Translational Research (U01), Blueprint Neurotherapeutics (BPN), Small Business Programs (SBIR & Small Business Technology Transfer [STTR]), Countermeasures Against Chemical Threats (CounterACT), and R01s for assays and probes.

In considering how to maximize NINDS’ efforts in the translational research space, an internal working group was established to identify principles for further advancement these programs.  Included in these principles are developing a tailored approach to research programs, catering to the various modalities (e.g. devices, small molecules, and biologics), accelerating transition points, managing risk (more points for attrition), due diligence, and flexibility.  Employing these principles, NINDS intends to replace the current tR21 and U01 programs with three new programs:  Blueprint 2.0 for small molecules, Cooperative Research to Enable and Advance Translational Enterprise (CREATE) for Biologics and Biotechnology Products, and CREATE for Devices.  Blueprint 2.0 will be funded through a custom blend of NIH contracts or UH2/UH3 awards to Principal Investigators (PIs).  This mechanism provides five years of combined funding and permits for attrition between stages and for intermediate milestones.  For the three proposed programs, clinical trials must be planned and completed within a maximum of two years and cost less than $3M (four years and $3M for CREATE Devices).  Office of Clinical Research safety and Scientific Review Board protocol reviews would be integrated into the new programs.

The timeline goals are to receive concept approval in January 2014, publish FOAs in June 2014, award first funding in August 2014, and present new grants to Council in January 2015.  In parallel, NINDS would begin redesign to cover the scope of the remaining 80 percent of tR21 grants.  Council expressed enthusiasm for the proposed changes and discussed how the NINDS translational program compares with and should interact with the National Center for Advancing Translational Sciences (NCATS).  Council members also suggested that metrics to measure success be established at the outset of implementing these changes.

Approval of Concept Clearance for New Translational Programs—A motion to accept concept clearance for Blueprint 2.0, CREATE Biologics and Biotechnology, and CREATE Devices to replace tR21 and U01 programs was approved unanimously with Council members’ suggestions being taken into consideration.

Dr. Ranganathan reported on the proposed NINDS Rigor, Reproducibility, and Robustness (R3) program.   The primary short-term objective of the program is to allow NINDS to generate critical experimental data to increase the likelihood of success of therapy development projects and clinical trials.  The R3 program would utilize a contract mechanism to support decisions in newly proposed translational programs and would test key preclinical findings for NINDS clinical networks, such as NeuroNext, but not necessarily provide a strict “replication” of findings.

The proposed five-year pilot phase would occur as follows.  Selected projects would be nominated by NINDS program staff, recommended in consultation with ad hoc external experts, approved by the Extramural Science Committee, and tied to an existing or to-be-awarded grant.  The project would occur either prior to the commencement of grant funding, prior to the release of funds at predefined stages (e.g., transition from UH2 to UH3), or in parallel with funding of translational or clinical work.  Ideally, these would be short, well-defined studies (three, six, or nine months in length).

The structure of the contract would be a suite of three to five contracts with access to in vitro and in vivo models covering key NINDS disorders, transgenic and interventional disease models, specialized academic or private laboratories via subcontracting, and large animal models.  This structure would allow NINDS to compete studies between contractors and select the best bid.  NINDS has conducted market research to identify 29 U.S./international preclinical contract research organizations (CROs) suitable to conduct these studies.  The R3 program is estimated to cost $3M/year with options to increase funding.  Four to six studies would be conducted concurrently, with an average cost of $500-750K.  An interim evaluation of the program is proposed after three years or when 20 studies are completed.  The Council discussed a number of issues related to this proposal, including: how to select projects for the R3 program (e.g., basic findings with obvious clinical implication), the need to define specific parameters / findings for replication of projects brought into the program, how and whether to engage the investigator of the original study, how to limit costs of the proposed program, and concern that this program could lead to the perception that NINDS is regulating the scientific research community.

Approval of Pilot R3 Program—A motion to accept the pilot R3 program was approved by Council with two oppositions and one abstention.

 

VI.  Council Operating Procedures: Proposed Supplement Cap Increase

Dr. Alan Willard, Deputy Director, Division of Extramural Research, NINDS, presented a proposed change to the NINDS delegated authority for awarding administrative supplements.  The proposal is to drop the distinction between “large” and other grants for funding supplements without prior Council approval.  The threshold for Council approval would become $100,000 (direct costs) for all supplements.

NINDS has $15M in total annual supplement expenditures.  Supplements made without Council approval account for $7-10M.  From 160-200 supplements are awarded annually, with a median award amount of $40,000.  The range of supplement awards in FY2013 was from $1,500 to $6M.  The three major types of supplements are requests from PIs to meet unanticipated needs, requests from PIs to take advantage of new opportunities, and solicitations via FOAs.  The Council discussed how other NIH Institutes and Centers handle administrative supplements, with regard to both the cap requiring Council approval, and the timing of submission and review.

Approval of Change to Council Operating Procedures—A motion to accept the proposed change in delegated authority to award supplements was approved unanimously.

 

VII. Report from Institute/Center Directors’ Leadership Forum

Dr. Landis reported on the NIH Leadership Forum, and also noted new NIH appointments, recent research advances, and recently launched NINDS programs.

NIH Leadership Forum 
NIH leadership, including Institute and Center Directors, participated in a January retreat that focused on topics including developing mechanisms to increase funding stability, improving the NIH biosketch, and enhancing peer review’s ability to identify the most promising science and emerging opportunities.  

NIH leadership discussed multiple approaches to enhancing support for extramural investigators.  One possible approach is the creation of new grant mechanisms that place more emphasis on the potential or accomplishments of the investigator rather than on the specific project.  Stability and flexibility could be increased through larger budgets and longer awards.  These new grant mechanisms would address the issue of perverse incentives as a cause of irreproducibility and would decrease the time spent writing grants and increase time spent performing research.  When considering such an award, the Leadership discussed a number of proposed or existing award programs as potential models.  The NIH Common Fund Pioneer Award (http://commonfund.nih.gov/pioneer/index) provides $500K direct funding for five years with at least 51 percent effort to individuals of exceptional creativity proposing paradigm-shifting research.  These applications undergo special review with an interview.  Another potential model to provide stable and flexible support for investigators is NCI’s proposed Outstanding Investigator Award (OIA).  As proposed, the OIA will provide long-term, flexible support to experienced investigators with outstanding records of research productivity who are likely to continue to conduct seminal cancer research.  The OIA would provide $600K direct funding for seven years (with the possibility of a three-year extension) with at least 50 percent effort.  Institutions would nominate applicants and provide 20 percent salary support for the duration of the award.  The application would describe the broad scientific questions to be addressed and give a detailed description of five of the PI’s significant accomplishments.  The proposed NIGMS Research Program Award (RPA) would support all of the research in the investigator’s laboratory that is relevant to the mission of NIGMS by aggregating related research projects into one grant.  The award would allow the investigator to explore new areas of inquiry without requiring a change in scope or a new application.  The focus is on quality of past and proposed work and efficiency.  RPA would provide $150K to $750K of direct funding with 50 percent effort for five years with special consideration upon renewal.  The Council expressed enthusiasm for the general concept articulated in this proposal.  However, Council members discussed a number of issues related to the scope and implementation of the program, including:  a preferred focus on excellence rather than innovation, strategies for selecting applicants, the fate of the Javits / MERIT awards programs, the importance of quality review, the impact of such a program on the payline, and the concern that the appropriate safety nets be put in place for investigators whose grants are aggregated in the proposed manner.

Dr. Landis described NIH awards targeted towards earlier career stages, including the Early Independence Award, K99/R00 awards, and the New Innovator Awards.  The NIEHS Outstanding New Environmental Scientist (ONES) program is intended to identify the most talented early-stage investigators who intend to make a long-term commitment to research in the environmental health sciences and assist them in launching an innovative research program focused on the understanding of environmental exposure effects on health.  The award provides 50 percent salary support but requires 80 percent institutional commitment.  Council members agreed that the most important goal for a new investigator was to submit and obtain R01 funding, and advised that NINDS not encourage alternative avenues of support such as that proposed in the ONES program.  In addition, Council members noted that the most difficult transition for early career investigators occurred when they attempt to obtain a  second R01 or renew their first R01. 

NIH leadership also discussed how best to present a PI’s accomplishments when applying for grants.  Past performance of an applicant is an essential element in review, and the current biosketch format does not always provide an accurate assessment of an applicant.  NIH seeks an approach to better emphasize the applicant’s actual contributions instead of the applicant’s academic and research pedigree.  Potential changes to the biosketch include replacing “15 peer-reviewed publications” with narratives describing up to five of the applicant’s most significant contributions.  Each narrative would occupy a half page, include background information, major findings and impact of work, the role of the applicant, and up to four citations.  By implementing these changes to the biosketch, NIH aims to encourage review of the narrative information rather than focusing on the applicant’s past performance.   This would involve the review and enhancing of NIH peer review.  Biomedical science is evolving rapidly, but the overall structure of NIH peer review study sections is relatively static; the last major reorganization took place 13 years ago.  NIH leadership are discussing how NIH could proactively identify emerging fields of science to couple the “state” of scientific fields to study section organization and ensure a dynamic system that is responsive to changes in scientific opportunities.  The Council agreed that modifications to the biosketch would not address the tendency of study sections to rely on bibliometric measures and publication in top tier journals in their assessment of an applicant.  Council members noted that assessing an investigator’s past and recent productivity required effort from study section members that extends far beyond the information presented by the applicant.  Suggestions proposed included providing pdf files of the most recent high-impact publications, providing narratives focused on recent productivity (e.g. 5 years), and providing a mixture of narratives that highlights recent productivity as well as “greatest hits.”

 

New NIH Appointments
Dr. George F.  Koob has been appointed Director of the National Institute of Alcohol Abuse and Alcoholism (NIAAA).  He is the first neuroscientist to direct NIAAA.  Dr. Philip E.  Bourne has been appointed Associate Director for Data Science (ADDS).  He will direct the Common Fund Big Data Initiative (BD2K) to enable biomedical scientists to capitalize on big data. 

NINDS Research Highlights
Dr. Landis highlighted four major NINDS-funded research findings that occurred during the past year including:

  • The glymphatic system may clear toxic molecules from the brain during sleep.  Xie et al., 2013
  • An RNAi screen of over 21,000 genes in human cells identified 4 promising genes that interact with parkin, a protein that tags damaged mitochondria as waste and is linked to PD and other mitochondrial disorders.  Hasson et al., 2013
  • Advances in cryo-EM allow visualization of the structure of TPV-1, a channel protein involved in pain sensation, in a resting state and bound to spider toxin/capsaicin-like compound.  Cao et al., 2013; Liao et al., 2013
  • A newly developed closed-skull mouse model of traumatic brain injury revealed that initially beneficial inflammatory response can ultimately contribute to cell death, and that immediate introduction of antioxidants can reduce tissue damage.  Roth et al., 2013

New NINDS Initiatives
StrokeNet is one of three programs recently launched at NINDS.  StrokeNet is a network of 25 regional stroke centers working with nearby satellite facilities that will span the country.  The network provides a national clinical coordinating center, central institutional review board, and national data management center—all intended to streamline stroke research.  NeuroBioBank is an NINDS-, National Institute on Mental Health (NIHM)-, and National Institute of Child Health and Human Development (NICHD)-led network of five brain and tissue repositories that collect, evaluate, store, and distribute brain and other tissues to researchers.  The Sports and Health Research Program is an NINDS, National Football League (NFL), and Foundation for the National Institutes of Health (FNIH) partnership that has issued its first eight awards on traumatic brain injury.

 

VIII. Javits Discussion

Dr. Finkelstein provided Council with an update on the gender disparity that exists in the funding of NINDS Javits Neuroscience Investigator Awards (R37).  The Senator Jacob Javits Neuroscience Investigator Award is a conditional, seven-year research grant given to scientists for their superior competence and outstanding productivity.  Javits Awards provide long-term support to investigators with a history of exceptional talent, imagination, and preeminent scientific achievement.  The award is initially for a period of four years, after which, based on an administrative review, an additional project period of three years may be awarded.  Since the program’s inception in FY1984, more than 600 Javits Investigator Awards have been made.  Investigators do not apply for Javits Awards; NINDS staff and Council members nominate potential awardees from an eligible pool of applicants.  NINDS leadership vets candidates with advice from Council members with subject-matter expertise.  All Javits nominations must be approved by Council prior to their award.  However, a gender disparity exists with the currently used selection criteria.  From FY2005 to FY2011, only 4 of 45 Javits awards were given to women.  Changes to the nomination process began with the February 2012 Council, but since that time, only 1 of 18 Javits Awards has gone to a woman.  Council members discussed strategies for modifying the Javits criteria and process to address the gender disparity, and in general supported approaches that retained broad candidate pools for selection of awardees.  In addition, Council members expressed support for the proposed new mechanism described earlier in the meeting by Dr. Landis as a means to reward sustained excellence.

 

IX.  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 requiring specific discussion.  Prior to discussion of the grants, Dr. Finkelstein reminded Council members regarding conflict of interest and confidentiality.

Conflict of Interest—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, Council Executive Secretary, who then will refer the question to the appropriate staff member for response.

Research Training and Career Development Programs – The Council reviewed a total of 306 research career development and institutional training grant applications with primary assignment to NINDS, and 166 of them (54.3 percent) were scored in the amount of $12.6 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 $7.4 million (73 grants).

Research Project and Center Awards – The Council reviewed a total of 1,339 research project and center applications with primary assignment to NINDS, and 719 of them (53.7 percent) were scored/percentiled in the amount of $198 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 $55.5 million (226 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.   The discussion and selection of Javits from this Council round are being deferred to the May 2014 meeting.

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 129 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 69 of them (53.5 percent) were scored in the amount of $16.9 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 $3.7 million (15 grants).

 

X.  Adjournment

The meeting was adjourned at 5:30 p.m. on Thursday, January 30.

NINDS employees present for portions of the meeting included:

Dr. Alan Willard
Ms. Ruth Linn
Dr. Scott Janis
Ms. Nena Wells
Dr. Story Landis
Dr. Yuan Liu
Dr. Ernie Lyons
Dr. Robert Finkelstein
Dr. John Porter
Dr. David Owens
Dr. Jane Fountain
Dr. Beth-Anne Sieber
Dr. May Wong
Dr. Stephen Korn
Dr. Tracy Chen
Ms. Shannon Garnett
Mr. Ken Frushour
Dr. Linda McGavern
Dr. Claudia Moy
Dr. Paul Scott
Dr. Robert Zalutsky
Dr. Laura Mamounas
Dr. Courtney Ferrell Aklin
Dr. Amelie Gubitz
Ms. Louise Ritz
Dr. Crina Frincu
Dr. David Yeung
Dr. Chuck Cywin
Dr. Rajesh Ranganathan
Dr. Martin Mendoza
Dr. Ipolia Ramadan
Dr. Timothy Lavaute
Dr. Ursula Utz
Dr. Elizabeth Webber
Dr. Audrey Penn
Dr. JoAnn McConnell
Dr. Margaret Ochocinska
Dr. Amir Tamiz
Dr. Katie Pahigiannis
Dr. Patrick Hussmann
Dr. Vicky Whittemore
Ms. Barbara McMakin
Dr. Andrey Kuzmichev
Mr. Peter Gilbert
Dr. Lyn Jakeman
Dr. Miriam Leenders
Ms. Kristin Perkins
Ms. Preeti Hans
Dr. Daofen Chen
Dr. Randall Stewart
Dr. Shanta Rajaram
Dr. Shai Silberberg
Dr. Ramona Hicks
Dr. Debra Babcock
Dr. Walter Koroshetz
Ms. Tijuanna Decoster
Dr. Anna Taylor
Ms. Kelly Baker
Dr. Rebecca Farkas
Ms. Quynh Ly
Dr. Salina Waddy
Dr. Christine Torborg
Dr. Roderick Corriveau
Dr. Michelle Jones-London
Dr. Yejun He
Dr. Coryse St. Hillaire-Clarke
Dr. Francesca Bosetti
Dr. Kip Ludwig
Dr. Jill Morris
Ms. Jamie Roberts
Ms. Christina Vert
Dr. Petra Kaufmann
Dr. William Benzing
Dr. Margaret Sutherland
Ms. Marian Emr
Dr. David Jett
Dr. Ned Talley
Mr. Taek Oh
Dr. D. Elizabeth McNeil
Dr. Wendy Galpern
Ms. Karin French
Dr. John Kehne
Ms. Margo Warren
Dr. Raul Saavedra
Ms. Christine Lam
Dr. Brandy Fureman
Dr. Hao Wang
Dr. Jim Koenig
Ms. Stacey Chambers
Dr. Rebecca Roof
Ms. Stephanie Fertig
Mr. Jaron Lockett
Dr. Linda Porter
Ms. Diana Cummings
Dr. Robin Conwit
Dr. Christopher Thomas


 


Other Federal employees present for portions of the meeting included:

Dr. Laurent Taupenot, CSR
Dr. Alexei Kondratyev, CSR

 

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.

 

1For 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 May 13, 2014