NINDS Advisory Council Meeting Minutes, September 15, 2016

NINDS Advisory Council Meeting Minutes, September 15, 2016

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

Summary of Meeting1
September 15, 2016

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 197th meeting on September 15, 2016, in Building 31, C Wing, 6th Floor, Conference Room 10, on the National Institutes of Health (NIH) campus in Bethesda, Maryland.  Dr. Walter Koroshetz, 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:    September 15, 2016: 8:15 a.m. to 1:40 p.m. for the review and discussion of program development, needs, and policy; and an overview of the NINDS Intramural Program.

Closed:  September 15, 2016: 1:40 p.m. to 4:00 p.m. for the consideration of individual grant applications. September 15, 2016: 4:00 p.m. to 5:00 p.m. for the review of the Board of Scientific Counselors’ Reports

Council members present:

Dr. Laurence Abbott
Dr. Issam Awad
Dr. Amy Brooks-Kayal
Dr. Karen Chen
Dr. Beverly Davidson
Dr. Gordon Fishell
Dr. David Gutmann
Ms. Janet Hieshetter
Dr. David Julius (via teleconference)
Dr. Jonathan Mink
Dr. Bruce Ovbiagele
Dr. Steve Perrin
Dr. Indira Raman
Dr. Steven Roberds
Dr. Ralph Sacco
Dr. S. Lawrence Zipursky

Council members absent:

Dr. Timothy Coetzee
Ms. Ilene Penn Miller

Ex officio members present:

Captain Michael Colston, Department of Defense           

Council Roster (Attachment 1)

Members of the public present for portions of the open meeting included:

Tracy Dixon-Salazar, CURE Epilepsy
Dr. David Holtzman, Washington University in St. Louis
Sarah Martin, Sjogren’s Syndrome Foundation
Dorothy Poppe, Chiari & Syringomyelia Foundation
Dr. Nadine Tatton, The Association for Frontotemporal Degeneration
Paul Gross, Hydrocephalus Association
Alex Ommaya, Association of American Medical Colleges
David Wholley, Foundation for the National Institutes of Health
Philip Goglas, II, Health & Medicine Counsel of Washington
Dr. Raul Saavedra, Retired

Federal attendees are listed at the end of these minutes. 

I.  Call to Order and Opening Remarks

Dr. Koroshetz welcomed Council members, visitors, and staff to the 197th meeting of the National Advisory Neurological Disorders and Stroke Council. 

II.  Report of the Director, Division of Extramural Research, NINDS

Approval of Council Minutes—Dr. Finkelstein requested, and the Council voted approval of the May 26, 2016, Council meeting minutes.

The following future Council meeting dates were confirmed:

February 9-10, 2017             (Thursday and Friday)

May 18-19, 2017                  (Thursday and Friday)

September 7-8, 2017            (Thursday and Friday)

February 1-2, 2018               (Thursday and Friday)

May 24-25, 2018                  (Thursday and Friday)

September 13-14, 2018         (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.  This expedited review process focuses on applications for which there are no unresolved issues.  Dr. Finkelstein thanked Council members Timothy Coetzee, Bruce Ovbiagele, and Ralph Sacco for handling this responsibility for this meeting and the upcoming year.  For the current Council round, 162 applications were eligible to be expedited.  One hundred ten (110) of these awards already have been issued, and the others will be issued shortly after Council.

Extramural Announcements

Dr. Finkelstein introduced the following new staff members: Dr. Jonathan Sabbagh, a new Program Analyst in the Neurodegeneration Cluster; Dr. Keri Small, a new Program Analyst in the Neural Environment Cluster; Dr. Lauren Ullrich, a new Program Analyst in the Office of Diversity Training and Workforce Development; and Dr. Carl Wonders from the NINDS Office of Communications and Public Liaison.

Dr. Ernie Lyons introduced Dr. Tiziana Cogliati, a new Scientific Review Officer in the Scientific Review Branch.

Dr. Claudia Moy, in her role as Acting Director, Office of Clinical Research (OCR), introduced two new Medical Officers: Dr. Adam Hartman and Dr. Codrin Lungu.

Dr. Koroshetz introduced Dr. Maureen Gormley the new NINDS Deputy Director for Management.

III.  Report of the Director, NINDS

NIH and NINDS Leadership Changes—Dr. Koroshetz summarized recent changes to the leadership teams of NIH and NINDS.  Dr. Joshua A. Gordon was appointed director of the National Institute of Mental Health.  Dr. Diana W. Bianchi was named director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.  Dr. Patricia Flatley Brennan was appointed director of the National Library of Medicine.  Dr. Amir Tamiz was selected as director of the NINDS Office of Translational Research.  Dr. Alan Willard, Acting Director, Office of Translational Research, is planning to retire in early 2017.  Ken Frushour, Director, NINDS Budget Office is also leaving the institute.  Ms. Quynh Ly will serve as acting director of the Budget Office until a new director is selected.  Dr. Clinton Wright was named director of the Office of Clinical Research.  Dr. Maureen Gormley was appointed NINDS deputy director for management. 

NIH and NINDS Budgets—Dr. Koroshetz reported on funding trends and the status of the budget for fiscal years (FY) 2016 and 2017.  The current FY ends September 30, 2016.  Congress must pass a new appropriations bill or a Continuing Resolution (CR) to continue to fund the government past September 30.  Dr. Koroshetz reviewed the recent history of continuing resolutions.   He also reviewed the flat budget between ’04 and ’15 that resulted in a steady decline in NIH purchasing power.  The NIH budget did increase by 6% in FY16.  The President’s FY17 Budget proposes unchanged funding levels for NINDS from FY16, the House proposes a 3.3 percent increase, and the Senate a 6.4 percent increase.  However, it is anticipated that a CR will be passed and FY17 funding will remain at FY16 levels.  Without an increase in funding comparable to the ’16 increase, NINDS will be forced to lower the payline from the 15th to the 12th percentile to meet the increases in out-year commitments over the past 3 years that resulted from a 25% increase in applications.

Dr. Koroshetz highlighted funding and success rates for various NINDS grant programs, but specifically focusing on the NINDS Centers program portfolio.  The P30 grant supports shared resources and facilities for research by a number of investigators from different disciplines who provide a multidisciplinary approach to a common research problem.  Nineteen Centers were funded in FY16 and an internal analysis suggested that this program provides a valuable service to researchers.  NINDS has decided to retain the P30 grant program, but to lower the annual direct costs from $400,000 to $300,000 in FY17.  NINDS did establish an R24 grant mechanism that provides up to $175,000 per year in direct costs for high-impact resources. 

Council members discussed the FY17 budget.  Concern was expressed over the lack of Bridge Awards being funded this September Council round but were informed that Bridge Awards for the September Council grants would be reviewed at the January Council. 

Gender Issues at NIH/NINDS—Dr. Koroshetz discussed a recently published Washington Post article that discussed the issue of gender bias in the NIH intramural program.  Dr. Koroshetz noted that the NINDS leadership philosophy is to strive for a gender-balanced workforce and that a plan is being developed to address the concerns raised in the article and further balance the workforce. 

Gender bias in the extramural community is also a concern of the NIH.  A recently published study found that women with PhDs were significantly less likely than men to have received at least one R01 award (Ginther, Kahn, and Schaffer, 2016).  This is despite equal gender representation among post-doctoral fellows.  It was found that women were not at a significant disadvantage in securing R01 awards if they apply.  In fact, new-investigator women were 2 percentage points more likely to be funded than comparable men.  However, women submit fewer applications.  Planning to have children and childbirth were thought to be major reasons why young female scientists drop out of the pipeline before obtaining their first academic job.

In response to this issue, NINDS will pilot a program with the Postdoctoral National Research Service Award (NRSA) program that will provide a 6 month extension on an F32 to Postdoctoral Fellows who have a baby for whom they are primary caregiver.  The extension will be fairly automatic for childbirth.  The current NIH policy for NRSA postdocs allows for a leave of absence but does not extend funding if additional time is needed to complete training. 

NINDS Extramural Structure—NINDS is altering its extramural structure to better fit its needs.  Currently, there is an Office of Clinical Research, Office of Translational Research, and Division of Extramural Research, which includes the Scientific Review Branch, Grants Management Branch, Administrative Services Branch, and Extramural Research Program.  The new structure will include a Division of Clinical Research, Division of Translational Research, Division of Neuroscience, and the Division of Extramural Activities.  The latter will oversee the activities of the prior three divisions in terms of scientific coordination.  NINDS is seeking a new director for the Division of Neuroscience. 

Dr. Koroshetz highlighted events and activities of interest. 

  • President Obama will host the White House Frontiers conference in Pittsburgh, PA on October 13.The conference will focus on building U.S. capacity in science, technology, and innovation—the BRAIN Initiative and Precision Medicine Initiative will be highlighted.
  • The 10th Anniversary of NINDS Nonprofit Forum was held yesterday.Discussion focused on natural history databases, biomarker identification, data integration and management, and clinical outcome measures.
  • NINDS is working to put together a comprehensive research approach to chronic fatigue syndrome.
  • The HHS Opioid Research Agenda is focusing on research using rigorous methods to estimate the prevalence and costs of chronic pain in the general population and in primary care settings for defined pain conditions and population groups.

IV.  BRAIN Initiative

Dr. Koroshetz provided an overview of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative®.  This initiative was announced three years ago by President Obama with the intent to give scientists the tools needed to get a dynamic picture of the brain in action.  BRAIN is focused on circuits and networks, measuring the fluctuating electrical and chemical patterns within circuits, and understanding how all of this helps generate our unique behavior and thoughts.  The goal is to make circuit normalization/compensation the target of innovation.

Dr. Koroshetz highlighted the seven high priority research areas of BRAIN and gave examples of research activities in each area.  He noted exciting research findings from BRAIN, including advances in optical instrumentation and probe development, new tools for studying cell lineage in whole organisms, and the 3D reconstruction of whole brain neural activity in the zebrafish.

The third round of BRAIN grant awards will be announced in October 2016, bringing NIH’s total FY16 investment to just over $150 million.  Dr. Koroshetz reviewed funding and investments in BRAIN by each participating IC and reviewed planned FY17 FOAs.  He also highlighted major upcoming challenges for the BRAIN Initiative, including data solutions to enable open sharing, neuroethics and societal implications of new technologies, balancing team science and individual lab discovery science, diversifying pool of applicants, and smart integration with the European Union’s Human Brain Project.

Council members discussed continued Congressional support of the BRAIN Initiative and it was noted that the project has bipartisan support.  Council suggested pursuing efforts to get industry more involved.

V.  ADRD Summit 2016 Report

Dr. Roderick Corriveau, Program Director, Neurodegeneration Cluster, NINDS, discussed the 2016 ADRD Summit.  The 2016 ADRD Summit was hosted by NINDS in collaboration with the National Institute on Aging (NIA) on March 29-30, 2016 on the NIH Campus.  The 2016 ADRD Summit was mandated by the National Plan to address Alzheimer’s disease as a follow-up to the 2013 ADRD Summit.  Over 500 key opinion leaders, researchers, clinicians, and other professionals were in attendance to review and assess the progress on the research recommendations developed during the 2013 ADRD Summit, refine and add new recommendations based on recent scientific discoveries, solicit input, and update priorities and timelines for the National Plan addressing ADRD.  Thirty-seven updated recommendations resulted from the 2016 Summit addressing special research priorities for ADRDs, including frontotemperal dementia, Lewy body, mixed, and vascular dementias. 

Dr. David Holtzman, Andrew B. and Gretchen P. Jones Professor and Chairman, Department of Neurology, Washington University School of Medicine, St. Louis, provided an overview of the 2016 ADRD Summit report.  Dr. Holtzman highlighted the primary recommendations from each of the 6 major topic areas and the overarching science that illustrates the issues discussed at the meeting.

Approval of ADRD Summit 2016 Report—A motion to accept the ADRD Summit 2016 Report was approved unanimously.

VI.  Discussion of Parkinson’s Disease Accelerating Medicines Partnership (PD-AMP) Project

Mr. David Wholley, Director, Division of Research Partnerships, Foundation for the National Institutes of Health (FNIH), provided an overview of the Accelerating Medicines Partnership (AMP).  Managed through FNIH, the AMP brings government, industry, and non-profit organization partners together to identify and validate the most promising biological targets for therapeutics.  The partners have designed a bold milestone-driven research plan to strategically address Alzheimer’s disease, Type 2 diabetes, rheumatoid arthritis, and systemic lupus erythematosus.  Mr. Wholley reviewed AMP’s budget, governance, membership, and program development process.

Dr. Margaret Sutherland, Program Director, Neurodegeneration Cluster, NINDS, discussed the rationale for an AMP for Parkinson’s disease as well as details of the proposed project.  The overarching goal of a PD-AMP is to identify and validate PD targets for therapeutic development through use of a systems biology big data approach, capitalizing on recent advances in PD genetics, human induced pluripotent stem cell technology, and analysis platforms for RNA sequencing, epigenomic and proteomic data.  Dr. Sutherland described the two projects that are being developed under PD-AMP, which will focus on: (1) targets and assays and (2) clinical biomarkers. 

Council expressed enthusiasm for the PD-AMP project.  Members suggested that the new PD-AMP project could benefit from coordination with NIA-sponsored trials in AD.  Council members also suggested identifying an internal champion at each AMP partner organization in order to leverage expertise and promote collaboration.  Council noted that the data resulting from PD-AMP would require careful quality control.

VII.  Presentations by the Division of Intramural Research, NINDS

Update from the Scientific Director of Intramural Research—Dr. Alan Koretsky provided an update on the NINDS Intramural Research Program (IRP).  He focused on the NINDS budget for the intramural program, which totaled about $163 million in FY16.  Challenges for the FY16 budget included increasing costs, administrative burden, and an increasing Clinical Center budget.  The IRP will operate based on anticipated flat funding levels in FY17.  Dr. Koretsky noted that he will be stepping down as director of the IRP.

The NINDS Assistant Clinical Investigator Program—Dr. Avindra Nath, Senior Investigator and Clinical Director, Division of Intramural Research, NINDS, provided an overview of the clinical training programs at NINDS.  The purpose of the Assistant Clinical Investigators (ACI) program is to identify promising investigators post-fellowship/residency and provide a mentored environment towards establishing an independent research program.  The program focuses on recruiting early career investigators.  Dr. Nath presented the current ACIs and their research focus.  He also noted the residency program in neurology and neurosurgery and the robust, cross-disciplinary clinical fellowship program.

VIII.  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, NINDS Advisory 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 398 research career development and institutional training grant applications with primary assignment to NINDS, and 229 of them (57 percent) were scored in the amount of $23.78 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 $6.98 million (99 grants).

Research Project and Center Awards – The Council reviewed a total of 1,670 research project and center applications with primary assignment to NINDS, and 924 of them (56.1 percent) were scored/percentiled in the amount of $286.1 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 $68.66 million (258 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.  Council approved three Javits nominations at this meeting.

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 131 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 71 of them (54.2 percent) were scored in the amount of $25.36 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 $5.99 million (15 grants).

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

Dr. Alan Koretsky

This portion of the meeting, to review and evaluate the Division of Intramural Research Board of Scientific Counselors’ Reports, was closed to the public.

X.  Adjournment

The meeting was adjourned at 5:00 p.m. on Thursday, September 15.

NINDS employees present for portions of the meeting included:

Dr. Amy Adams
Dr. Felipe Aguel
Dr. Guadalupe Aquino
Dr. Deborah Babcock
Ms. Kelly Baker
Dr. William Benzing
Dr. Francesca Bosetti
Dr. Emily Carifi
Ms. Stacey Chambers
Dr. Daofen Chen
Ms. Mary Coats
Ms. Janice Cordell
Dr. Roderick Corriveau
Dr. Diana Cummings
Dr. Charles Cywin
Dr. Karen David
Ms. Alison Davis
Dr. Tijuanna Decoster
Ms. Marian Emr
Dr. Edgardo Falcon
Dr. Robert Finkelstein
Dr. Jane Fountain
Mr. Ken Frushour
Ms. Shannon Garnett
Dr. Marie Gill
Mr. Paul Girolami
Dr. Jim Gnadt
Dr. Amelie Gubitz
Dr. Katrina Gwinn
Ms. Nancy Hart
Dr. Yejun (Janet) He
Dr. Lyn Jakeman
Dr. Scott Janis
Dr. Michelle Jones-London
Dr. John Kehne
Dr. Jim Koenig
Dr. Alan Koretsky
Dr. Walter Koroshetz
Ms. Christine Lam
Dr. Nick Langhals
Dr. Tim LaVaute
Dr. Miriam Leenders
Ms. Quynh Ly
Dr. Ernie Lyons
Dr. Laura Mamounas
Dr. Linda McGavern
Ms. Barbara McMakin
Dr. Daniel Miller
Dr. Jill Morris
Dr. Claudia Moy
Dr. Birgit Neuhuber
Dr. Glen Nuckolls
Dr. Ana Olariu
Dr. David Owens
Dr. Mary Ann Pelleymounter
Dr. Leah Pogorzala
Dr. Linda Porter
Dr. Shanta Rajaram
Dr. Matthew Raymond
Dr. Robert Riddle
Ms. Sara Rue
Ms. Lynn Rundhaugen
Dr. Jonathan Sabbagh
Dr. Joel Saydoff
Dr. Dana Schloesser
Dr. Paul Scott
Ms. Shalini Sharma
Dr. Beth-Anne Sieber
Dr. Shai Silberberg
Mr. Andrew Skinner
Dr. Shardell Spriggs
Dr. Randall Stewart
Dr. Marg Sutherland
Dr. Christine Swanson-Fisher
Dr. Amir Tamiz
Dr. Anna Taylor
Dr. Carol Taylor-Burds
Ms. Melissa Tipton
Dr. Christine Torborg
Dr. Lauren Ullrich
Dr. Ursula Utz
Dr. Salina Waddy
Dr. Letitia Weigand
Dr. Samantha White
Dr. Vicky Whittemore
Dr. Alan Willard
Dr. Ling Wong
Dr. May Wong
Dr. David Yeung
Dr. Robert Zalutsky
Dr. Ran Zhang

Other federal employees present for portions of the meeting included:

Dr. Bruce Reed, CSR
Dr. Elyse Schauwecker, CSR
Dr. Laurent Taupenot, 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


Walter Koroshetz, M.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.


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.