NINDS Advisory Council Meeting Minutes, May 23-24, 2019

NINDS Advisory Council Meeting Minutes, May 23-24, 2019

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, 2019

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 205th meeting on May 23-24, 2019, in the Natcher Conference Center, Building 45, Conference Room E1/E2 in Bethesda, Maryland. Dr. Nina Schor, Deputy Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Acting Chairperson and Acting Director.

In accordance with Public Law 92-463, the meeting was:

Open:    May 23, 2019: 12:30 p.m. to 6:00 p.m. for the review and discussion of program development, needs, and policy; and

Closed:  May 24, 2019: 8:30 a.m. to 11:00 a.m. for the consideration of individual grant applications.

Council members present:
Dr. Laurence Abbott
Dr. Hollis Cline
Ms. Susan Dickinson
Dr. Gordon Fishell
Dr. Margorie Frazier
Dr. Aaron Gitler
Dr. David Gutmann
Dr. David Hackney
Ms. Janet Hieshetter
Dr. Karen Johnston
Dr. Arnold Kriegstein (via telephone)
Dr. Steve Perrin
Dr. Indira Raman
Dr. Steve Roberds
Ms. Christin Veasley (ad hoc)

Ex officio member present:
Colonel Sidney Hinds, II, M.D., Department of Defense
Christopher Bever, Jr., M.D., Department of Veteran Affairs

Council Roster (Attachment 1)

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

Ron Bartek, Friedreich’s Ataxia Research Alliance
Andrea Compton, Cure DRPLA
Catherine Kebs, Physicians Committee for Responsible Medicine
John Laughner, American Heart Association
Eileen Murray, American Epilepsy Society
Monica Weldon, Bridge the Gap - SYNGAP

Federal attendees are listed at the end of these minutes.

I.  Call to Order and Opening Remarks

Dr. Schor welcomed Council members, visitors, and staff to the 205th meeting of the National Advisory Neurological Disorders and Stroke Council.

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

Approval of Council Minutes—Dr. Finkelstein requested, and the Council voted approval of the February 14-15, 2019, Council meeting minutes.

The following future Council meeting dates were confirmed:

Wednesday & Thursday, September 4-5, 2019
Wednesday & Thursday, February 5-6, 2020
Wednesday & Thursday, May 27-28, 2020
Wednesday & Thursday, September 9-10, 2020                                                
Wednesday & Thursday, February 10-11, 2021
Wednesday & Thursday, May 26-27, 2021
Wednesday & Thursday, September 8-9, 2021

Approval of Council Operating Procedures – Dr. Finkelstein requested, and the Council voted approval of the February 14-15, 2019 Council operating procedures.

Expedited Review Process – Each Council round, a subset of Council members approves 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 Issam Awad, Holly Cline, and Steve Roberds for handling this responsibility for this meeting and the fiscal year. For the current Council round, 189 applications were eligible to be expedited. Sixty (60) of these awards already have been issued, and the others will be issued shortly after Council.

Extramural Announcements

Dr. Nina Schor announced Nancy Hart’s retirement from the Office of Communications and Public Liaison.

Dr. Finkelstein introduced Debbie Eng from the Division of Extramural Activities Office of the Director, Li Jia, Ph.D., and Delany Torres-Salazar, Ph.D. from the Scientific Review Branch.

Dr. Lyn Jakeman introduced Christine Swanson-Fischer, Ph.D., DP Mohapatra, Ph.D., Sahana Kukke, Nick Wymbs from the Division of Neuroscience.

Dr. Amir Tamiz introduced Smriti Iyengar, Sarah Woller, Ph.D., Eric Hudak, Brooks Gross, Ph.D., Julia Bachman, Ph.D., Emily Caporello, Ph.D., Kari Ashmont, Ph.D. from the Division of Translational Research. Dr. Tamiz announced the departure of Christina Vert.

Dr. Linda Porter introduced Danielle Haney, Ph.D., from the Office of Pain Policy.

III.  Report of the Director, NINDS

Dr. Nina Schor, Acting Director, NINDS

NIH and NINDS Budget—Dr. Schor provided an overview of the NIH and NINDS’ budgets, noting that neuroscience is the largest area of NIH funding, and has been the field of choice for Ph.D. students whose training is funded at least partially by NIH. The NIH budget proposed by the House for Fiscal Year (FY) 2020 includes a $2 billion (4.4 percent) increase. In addition to the $1.9 billion general appropriation for FY19, NINDS received set aside funds to support programs through the HEAL (Helping to End Addiction Long-term) Initiative and for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN)® Initiative. Additionally, NINDS will co-manage approximately $170 million of the Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) earmarked funds received by the National Institute on Aging (NIA).

NIH Leadership Changes—Dr. Debara Tucci has been named Director of the National Institute on Deafness and Other Communication Disorders (NIDCD) and is expected to join NIH in September.

Dr. Schor acknowledged the service of retiring NANDS Council members Ms. Janet Hieshetter and Drs. Gordon Fishell, Margie Frazier, David Gutmann, Bruce Ovbiagele, and Steve Perrin.

Dr. Schor described NIH efforts to change the culture to end sexual harassment. NIH Director Dr. Francis Collins has appointed a working group of the Advisory Council to the Director (ACD) to recommend policies and system-wide changes to promote a safe and inclusive environment to prevent harassment and gender discrimination.

Dr. Schor presented an update on the Next Generation Researchers Initiative (NGRI), which aims to address long-standing challenges faced by researchers embarking on and sustaining independent research careers. The major tenets of this initiative are to identify and support Early Stage and “at risk” investigators and to promote sustainable training opportunities that incorporate diversity and inclusion. NINDS has been at the forefront of these issues, consistently funding early stage investigators (ESIs) well past the regular NINDS payline with the aim of supporting these early career scientists at a success rate equivalent to that of established investigators submitting new R01 applications. In addition, NINDS provides bridge funding to investigators whose funding is at-risk of lapsing. Notably, two-thirds of bridge awardees reapply and over half of the applicants are successful at getting an R01 within 1-2 years of being bridged. Furthermore, several years ago, NINDS launched a special program, the Research Program Award (R35), to fund an individual’s neuroscience program for eight years, creating a stable funding environment for outstanding investigators facilitating longer-range, higher-risk research.

Trans-NIH Programs—Dr. Schor highlighted investments in the BRAIN® Initiative, the 2019 BRAIN Investigators meeting, and the new ACD BRAIN® Initiative 2.0 Working Group. She outlined HEAL Initiative efforts to address opioid misuse and addiction and advance the field of pain management.

Science Advances—Dr. Schor summarized recent scientific advances published by NINDS-supported investigators. These published researchers have developed a neural decoder to synthesize audible speech, which has potential for clinical translation to enable individuals with vocal cord paralysis to communicate. High-speed volumetric microscopy in behaving organisms enabled investigators to image freely moving Drosophila larvae and track the position, deformation, and intracellular calcium activity of their proprioceptors. A clinically relevant study of gene silencing therapy successfully blocked production of mutant huntingtin, the protein that is abnormal in Huntington's disease, with antisense oligonucleotides.

Upcoming Events—Gene therapy has been the topic of several recent workshops and symposia. To develop an action plan, NINDS will convene a workshop in September on Next Generation Strategies for Gene-Targeted Therapies of Central Nervous System Disorders.

Seeking Input—In May, NINDS issued a Request for Information (RFI) soliciting input on enhancing neuroscience research at institutions with emerging neuroscience programs. Responses to the RFI will help define research resource needs at institutions where the growth of neuroscience research programs is limited by the lack of access to specialized expertise, instruments or services.

IV.  Introducing NINDS Strategic Planning for 2020–2025

Dr. Nina Schor, Deputy Director, NINDS

Dr. Schor provided Council with an update on NINDS’ strategic planning process. A steering committee has been convened to create task forces for each of four strategic goals. Using input from the scientific and lay communities, task forces will be charged with developing concrete, operational objectives around these strategic goals, and with creating roadmaps for achieving them. Following refinement of objectives and roadmaps, NINDS leadership will synthesize the collected input into a unified strategic plan.

The strategic goals identified by the Steering Committee include:

  • Be a model of excellence for supporting and performing significant, innovative, and rigorous neuroscience research.
  • Be a model of excellence for funding and conducting neuroscience research training and career development programs and ensuring a vibrant, talented, and diverse neuroscience work force.
  • Promote a supportive work culture for biomedical research and the neuroscience community.
  • Promote the timely dissemination of accurate and rigorous information about scientific discoveries and their implications for neurological health.

Council members discussed implementation of NINDS’ strategic planning efforts including alignment with other NINDS mission-relevant ICs. Members asked about ESIs and the success rate of those that receive awards with scores beyond the NINDS payline. Dr. Finkelstein indicated that their success rate is at least as high as that of ESIs within the payline.

V.  Next Generation Researchers Initiative Update

Dr. Michael Lauer, Deputy Director for Extramural Research, NIH

Dr. Lauer indicated the 21st Century Cures Act includes a provision for the NIH Director to develop, modify, and prioritize policies to promote opportunities for new researchers to achieve earlier research independence and enhance workforce diversity. In response, the NIH ADC formed an NGRI Working Group. In December 2018, the Working Group released recommendations focused on five themes: modifying the original NGRI policy; supporting early-stage and at-risk investigators; providing training opportunities for diversity and inclusion; monitoring outcomes, including workforce stability; and engaging scientists across career stages in policy and strategic discussion.

Dr. Lauer reported a substantial increase in the number of ESIs who have received R01 or equivalents awards since the implementation of the NGRI policy.

VI.  Overview of the Division of Neuroscience

Dr. Lyn Jakeman, Director, Division of Neuroscience, NINDS

Dr. Jakeman presented an overview of the Division of Neuroscience (DON) organization. The DON mission is to support and foster high-quality research through programmatic oversight, assistance and outreach to a diverse community of stakeholders. DON staff work in six clusters grouped by scientific area: channels, synapses, and circuits; neurodegeneration; neural environment; neurogenetics; repair and plasticity; and systems and cognitive neurosciences.

DON program staff manage a large portfolio of applications and awards for the Institute including research project grants, fellowships and training awards, clinical trials, NINDS Small Business Innovation Research (SBIR) Grants, selected congressional special programs (e.g., AD/ADRD, Blueprint, BRAIN, Common Fund, HEAL), as well as Center Grants and Cooperative agreements. In this capacity, DON staff guide scientists through the NIH grant process from pre-application to post-award closeout.

Between 1995 and 2018, the total NINDS extramural grants budget increased by $0.3 billion with inflation taken into account. The percentage of R-type awards across NINDS has remained stable over this time period, despite shifting paylines. However, there has been a gradual decrease in the percentage of cooperative agreement mechanisms (U01s, P01s, P30s, P50s, and U54s) in order to maintain the NINDS payline. Dr. Jakeman noted that NINDS invests across the research spectrum including basic research, disease related research, applied translational and applied clinical research.

Council members asked about hiring at NINDS to manage Congressionally mandated programs such as HEAL, BRAIN and AD/ADRD. Members noted NINDS has been successful in receiving approval to hire additional staff.

Council members discussed mechanisms for enhancing collaborations between basic and translational/clinical researchers.

VII. Initiatives Requiring Concept Clearance

  1. Data Harmonization, Curation, and Secondary Analysis of Existing Clinical Datasets
    Patrick Bellgowan
    Repair and Plasticity Cluster, DON, NINDS


    This Initiative seeks to promote discovery and validation of clinically relevant hypotheses through secondary analysis of clinical research data connected across two or more existing multiple-site datasets. The RFA would use a phased mechanism and require a NINDS-relevant disease area, multidisciplinary teams, and data transparency. The goal is to use common date elements and make curated data more broadly available to the scientific community.

    Council voted to approve the proposed concept.
     
  2. NINDS Human Cell and Data Repository (NHCDR) Re-Competition for FY 2020
    Christine Swanson-Fischer
    Neurodegeneration Cluster, DON, NINDS


    The NHCDR mission is to provide well-characterized patient-derived source cells and induced pluripotent stem cell (iPSC) lines to both academic and industry investigators to advance the study of neurological disorders. The NHCDR catalog includes 240 fibroblast cell lines and 247 iPSC lines from neurological disorders (e.g., AD, Huntington’s Disease, Parkinsonism) as well as control lines. NHCDR lines have been used in studies reported in high-impact journals for a number of diseases. The proposed re-competition in 2020 would use a milestone-driven approach and support expansion of iPSCs and source cells for additional neurological disorders within the NINDS mission and related trans-NIH initiatives.

    Council voted to approve the proposed concept.
     
  3. Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01, R21)
    Vicky Whittemore
    Trans-NIH ME/CFS Working Group
    Channels, Synapses and Circuits Cluster, DON, NINDS


    Program announcements for R01 and R21 applications are proposed to encourage new investigators working in related fields to study various aspects of ME/CFS syndrome. This would allow for referral to the appropriate NIH Institute through statements of priority areas of research. A special emphasis panel has been established to review all ME/CFS syndrome grant applications. A working group of the NINDS Council is charged with addressing the challenges of ME/CFS syndrome research and will provide recommendations to Council in September.

    Council voted to approve the proposed concept.
  4. Initiatives for Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias
    Roderick Corriveau
    Neurodegeneration Cluster, DON, NINDS


    Outcomes of the 2019 ADRD Summit, including research recommendations and milestones, will be presented at the September Council meeting; if approved, those milestones will be delivered to the National Alzheimer’s Project Act (NAPA) Council and become part of the National Plan to Address Alzheimer’s Disease. Past NINDS funding of AD/ADRD and related dementias was reviewed showing a significant upward trend in the NINDS AD/ADRD portfolio as a function of additional funds transferred from NIA to NINDS. NINDS FY 2020 FOA Proposed AD/ADRD Concepts were presented to Council.

    No formal concept vote was required as these are Congressionally-mandated programs with specifically appropriated set-aside funds.

    **The following initiatives were highlighted by Dr. Finkelstein:
  5. Discovery of Biomarkers and Biomarker Signatures for Neurological Disorders FOA (R61/R33)
    Program Director: Dr. Mary Ann Pelleymounter
     
  6. Blueprint Translational Devices Research Education Program (R25)
    Program Manager: Dr. Kari Ashmont/ Program Director: Nick Langhals
     
  7. SBIR/STTR HEAL RFAs
    Program Director: Stephanie Fertig
    - HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 – Clinical Trial Optional)
    - HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Optional)
     
  8. Office of Training & Workforce Development Initiatives
    Program Director: Dr. Steve Korn
    - Reissue of an RFA for the CNCDP K12 program – FOA RFA-NS-16-003: Child Neurologist Career Development Program (CNCDP) (K12)
    - Re-Issue of the NINDS Postdoctoral Mentored Career Development Award (K01)
    - Re-issue of the NINDS Ruth L. Kirschstein National Research Service Award (NRSA) for Training of Postdoctoral Fellows (F32)
    - Re-issue of the Jointly Sponsored Ruth L. Kirschstein National Research Service Award for Institutional Predoctoral Training Programs in the Neurosciences (T32)
     

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 313 research career development and institutional training grant applications with primary assignment to NINDS, and 180 of them (58 percent) were scored/percentiled in the amount of $12.4 million first-year direct costs. It is anticipated that, of the research career development and institutional training grant applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $5.73 million (82 grants).

Research Project and Center Awards – The Council reviewed a total of 1,570 research project and center applications with primary assignment to NINDS, and 914 of them (58 percent) were scored in the amount of $363.4 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 $113.6 million (291 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 one Javits nomination at this meeting: Leslie Griffith, M.D., Ph.D. (Brandeis University).

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 106 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 67 of them (63 percent) were scored in the amount of $26.3 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 $4.98 million (13 grants).

IX.  Adjournment

The meeting was adjourned at 11:00 a.m. on Friday, May 24, 2019.
 

NINDS employees present for portions of the meeting included:

Dr. Amy Adams
Dr. Kari Ashmont
Dr. Deborah Babcock
Dr. Julia Bachman
Ms. Kelly Baker
Dr. Pat Bellgowan
Dr. Moria Bittman
Dr. Francesca Bosetti
Dr. Nancy Bowen
Dr. Andrew Breeden
Mr. Ryan Calabrese
Dr. Emily Caporello
Dr. Emily Carifi
Ms. Stacey Chambers
Dr. Catherine Chang
Dr. Ben Churn
Dr. Roderick Corriveau
Dr. Devon Crawford
Dr. Diana Cummings
Dr. Charles Cywin
Dr. Will Daley
Dr. Karen David
Dr. Tia Decoster
Ms. Debbie Eng
Dr. Carlos Faraco
Ms. Stephanie Fertig
Dr. Robert Finkelstein
Ms. Marie Gill
Mr. Paul Girolami
Dr. Jim Gnadt
Dr. Maureen Gormley
Dr. Brooks Gross
Dr. Amelie Gubitz
Dr. Mohamed Hachicha
Dr. Danielle Haney
Ms. Preeti Hans
Dr. Nancy Hart
Dr. Adam Hartman
Mr. Brandon Hartsell
Dr. Janet He
Dr. Nina Hsu
Dr. Eric Hudak
Dr. Li Jia
Dr. Lyn Jakeman
Dr. Sophia Jeon
Dr. Michelle Jones-London
Dr. Barbara Karp
Dr. Brian Klein
Dr. Jim Koenig
Dr. Doe Kumsa
Prof. Sahana Kukke
Dr. Pascal Laeng
Ms. Christine Lam
Dr. Nick Langhals
Dr. Tim LaVaute
Dr. Miriam Leenders
Ms. Liza Litvina
Dr. Codrin Lungu
Ms. Quynh Ly
Dr. Ernie Lyons
Dr. Laura Mamounas
Dr. Marguerite Matthews
Ms. Barbara McMakin
Dr. Carolina Mendoza-Puccini
Dr. Daniel Miller
Dr. Marilyn Moore-Hoon
Dr. DP Mohapatra
Dr. Jill Morris
Dr. Claudia Moy
Dr. Glen Nuckolls
Dr. Ana Olariu
Ms. Oreisa O’Neil
Dr. Michael Oshinsky
Dr. David Owens
Dr. Mary Ann Pelleymounter
Dr. Leah Pogorzala
Dr. Shamsi Raeissi
Dr. Shanta Rajaram
Dr. Robert Riddle
Dr. Becky Roof
Dr. Jonathan Sabbagh
Dr. Cheryse Sankar
Dr. Cristina Saugar-Lanchas
Dr. Alisa Schaefer
Dr. Nina Schor
Dr. Paul Scott
Dr. Joonil Seog
Ms. Hawa Sesay
Ms. Shalini Sharma
Dr. Beth-Anne Sieber
Dr. Shai Silberberg
Dr. Shardell Spriggs
Dr. Natalia Strunnikova
Dr. Christine Swanson-Fischer
Dr. Ned Talley
Dr. Amir Tamiz
Dr. Anna Taylor
Dr. Carol Taylor-Burds
Dr. Michael Tennekoon
Dr. Natalie Trzcinski
Dr. Christine Torborg
Dr. Delany Torres
Dr. Lauren Ullrich
Dr. Ursula Utz
Dr. Joanna Vivalda
Dr. Laura Wandner
Ms. Margo Warren
Dr. Tish Weigand
Dr. Samantha White
Dr. Vicky Whittemore
Dr. Clinton Wright
Dr. Ling Wong
Dr. May Wong
Mr. Nick Wymbs
Dr. Ye Yan
Dr. Robert Zalutsky
Dr. Ran Zhang

Other federal employees present for portions of the meeting included:

Dr. Laurent Taupenot, CSR
Dr. Wei-Qin Zhao, CSR
Dr. Peter Guthrie, CSR
Dr. Elyse Schauwecker, CSR
Dr. Yolanda Vallejo, NIDCR


We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.

 

______
Date

_____________________________
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

______
Date
_____________________________
Walter Koroshetz, M.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.