National Advisory Council (NANDSC) Meeting - February 2020

Contact: Kelly Baker
Contact Number: 301-496-9248
Contact Email: kelly.baker@nih.gov
Location:

National Institutes of Health (NIH)
Building 35, Porter Building
Conference Room 620/630/640
Bethesda, Maryland 20892

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The 207^th meeting of the National Advisory Neurological Disorders and Stroke Council will be held on Wednesday, February 5 - Thursday, February 6, 2020. For more information, visit the Advisory Council web page.

Related Resources

Agenda

February 5, 2020

 February 6, 2020

Meeting Minutes

Summary of Meeting¹
 

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 207^th meeting on February 5-6, 2020, in the John Edward Porter Neuroscience Research Center, Building 35A, Conference Room 320/630/640 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:       February 5, 2020: 12:30 p.m. to 5:45 p.m. for the review and discussion of program development, needs, and policy; and
Closed:     February 6, 2020: 8:30 a.m. to 12:10 p.m. for the consideration of individual grant applications.

Council members present:
Dr. Laurence Abbott (telephone)
Dr. Issam Awad
Dr. Allan Basbaum
Dr. S. Thomas Carmichael
Dr. Hollis Cline
Ms. Susan Dickinson
Dr. Nita Farahany (telephone)
Dr. Aaron Gitler
Dr. David Hackney
Dr. Karen Johnston
Dr. Arnold Kriegstein
Dr. Claudia Lucchinetti
Dr. Kenneth Maynard
Ms. Eileen Murray
Dr. Indira Raman
Dr. Steven Roberds
Dr. N. Edwin Trevathan
Ms. Christin Veasley

Ex officio member present:
Colonel Sidney Hinds, II, M.D., Department of Defense

Members of the public present for portions of the open meeting included:
Lisa Cash, BETAH Associates, Inc.
Dr. Catherine Krebs, Physicians Committee for Responsible Medicine

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 207th 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 September 4-5, 2019, Council meeting minutes.

The following future Council meeting dates were confirmed:

Wednesday & Thursday, May 27-28, 2020
Wednesday & Thursday, September 9-10, 2020
Wednesday & Thursday, February 3-4, 2021 (updated)
Wednesday & Thursday, May 26-27, 2021
Wednesday & Thursday, September 8-9, 2021

Approval of Council Operation Procedures — Dr. Finkelstein requested, and the Council voted approval of the 2020 NINDS Advisory 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 Indira Raman, Susan Dickinson, and Karen Johnston for handling this responsibility for this meeting and the fiscal year. For the current Council round, 140 applications were eligible to be expedited. A portion of these awards already have been issued, and the others will be issued after Council.

Extramural Announcements

III.  Report of the Director, NINDS

Dr. Walter Koroshetz, Director, NINDS

NIH News — Dr. John J. Ngai has been named director of NIH’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative® and is expected to join NIH in March.

NIH and NINDS Budget — Dr. Koroshetz provided an overview of the appropriations history for NIH and NINDS. In Fiscal Year (FY) 2020, NIH received an appropriation of $40.6 billion, a 6.7% increase over FY 2019, and NINDS received a general appropriation of $2.11 billion to support Institute operations, a 7.5% increase. In addition, the Institute received $266 million for pain research as part of the Helping to End Addiction Long-term (HEAL) Initiative as well as funds from the 21st Century Cures Act for the BRAIN Initiative®, taking the total NINDS budget to $2.446 billion. NINDS also co-manages approximately $205 million of the National Institute on Aging (NIA) appropriation for Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRDs). The Institute’s funding payline remained at the 16th percentile for FY2020.

NINDS News and Events

• NINDS is exploring the possibility of joining the Network of European Funding for Neuroscience Research

• (NEURON) to provide a funding opportunity for U.S.-based scientists to collaborate with investigators supported by NEURON-networked funding organizations from 14 EU countries, Canada, and several non-EU countries.
• The Division of Clinical Research (DCR)/Office of Global Health and Health Disparities and Office of Science Policy and Planning are leading a strategic planning effort to define areas of neurological disparities and inequities and enumerate the most pressing scientific areas to address. In 2020, NINDS will be seeking external scientific input, including a review of the state of the science and the NINDS/NIH portfolio on neurological disparities/inequities as well as a public workshop to identify priorities and guide strategies to address gaps, opportunities, and challenges.

Work on the NINDS Strategic Plan continues. Taskforces will operationalize goals of NINDS’ Strategic Plan to:

• 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 the timely dissemination of accurate and rigorous information about scientific discoveries and their implications for neurological health.
• Promote a supportive work culture for biomedical research and the neuroscience community.

Addressing Gender Disparities—Dr. Koroshetz provided an overview of statistical evidence of gender disparities in neuroscience and neurobiology. According to a 2017 National Science Foundation (NSF) report, women account for 51% and men for 49% of PhDs earned in these fields; however, beginning at the postdoctoral level, the percentage of women is outpaced by that of men—women account for 46% of postdocs, 44% of assistant professors, 39% of associate professors, and 26% of professors. Other faculty such as instructors and lecturers are primarily women (71%). 

A comparison of NINDS applicants and awards from 2015 through 2019 shows that, on average, women accounted for fewer applicants and awardees than men. Women were equally represented at early career stages but made up a lower percentage of awardees as they moved along the pipeline. For example, the percentage of female NINDS awardees (51%) was slightly higher than males at the predoctoral level, but the percentage of male awardees surpasses that of female awardees at the established investigator level, with men making up 77% of the awardees. However, these percentages reflect differences in the number of women and men for awards, because women and men have similar success rates at all career stages. The percentage applying of female first-time NINDS R01 awardees has increased about five percentage points since the early 1990s.

NINDS “Why?” Survey —Dr. Koroshetz presented results of the NINDS “Why” Survey of NINDS applicants and appointees who were current or recent graduates (PhD in 2008 or later). The survey is designed to obtain information on factors that influence individual career choices in order to inform future training programs and initiatives. Preliminary survey results show significant differences between men and women although many of the effect sizes are small. Women are less interested in academic research positions from the beginning, and more women are engaged in scientific non-research and teaching-focused careers than men.  A higher percentage of women value work-life balance; while a greater percentage of men value autonomy. Fewer women feel positive about their relationships with their primary training advisors.  Women are not as confident about their potential to be independent researchers and have fewer first-author peer-reviewed publications (3.36) than men (4.33). Dr. Koroshetz read some of the comments received through the WHY survey such as:

“Research science is NOT a family-friendly career. Maternity leave options are incredibly poor, most institutions do not offer quality childcare, and the time and energy required to successfully navigate the peer-review process for publications and funding offer so little ROI that I cannot justify following this path.”

“The reason why I cannot continue in academia is because I am a mother. I did not realize that I cannot afford childcare on a postdoctoral salary and that the time demands of being a parent really affect how much time I can spend in lab…We leave academia not because we want to but because we have no other choice.”

Opportunities for Intervention-Ongoing and proposed policies and programs to address gender inequities at NIH and NINDS include policies and programs that emphasize: including women when they are  underrepresented in a field (i.e., BRAIN Initiative K99/R00); extending the eligibility window for all training grants to accommodate childbirth/adoption; requiring a plan for childcare offerings in applications for NIH conference grant support as an allowable expense; adding funds to provide technicians and other research support to postdocs and vulnerable investigators; and faculty cohort hiring programs like the NIH Common Fund-approved Faculty Institutional Recruitment for Sustainable Transformation (FIRST) concept to create cultures of inclusive excellence at NIH-funded institutions. Both NIH and NINDS have extension policies for childbirth including adding one year within the 4-year K99/R00 eligibility window  and an ESI eligibility extension of one year. Under the NINDS Kirschstein National Research Service Award (NRSA) for Training of Postdoctoral Fellows (F32) FOA, NINDS indicates “in addition to standard, automatic NIH leave policies, fellows who have children while supported by this FOA, either through childbirth or adoption, are encouraged to consider requesting a six-month extension of their fellowship. NINDS may provide one six-month extension to ensure that fellowship research and training can be completed.”

In an effort to obtain input from the scientific community about factors that may contribute to underrepresentation of women, other underrepresented groups, and geographically diverse institutions, NIH issued a Request for Information (RFI) in December 2019. Responses were due January 15, 2020.

IV.  Discussion of Director’s Report

Council members commented on the need to understand the message women entering academia are receiving that makes them less confident about their future success. Members asked about support to both the individual as well as the environment in supporting biomedical careers of women that have children by encouraging an “it takes a village” approach. It was noted that childcare is a major issue for female biomedical researchers that NIH is working on addressing.

V.  NIH Communication: Making the Connections

Dr. John Burklow, Director, Office of Communications and Public Liaison, NIH

Dr. Burklow described how the NIH Office of Communications and Public Liaison helps advance the NIH mission through communications with many audiences. Key message concepts include the value of investing in medical research; progress in and the health impact of NIH research; the economic impact of NIH research; and the importance of basic, clinical, and translational research.

Dr. Burklow discussed the breadth and depth of NIH messaging to the community including   NIH initiatives and issues, and in particular messaging about the new coronavirus (COVID-19).  NIH coordinates its communications with Health and Human Services and other federal agencies. In addition to the NIH website (in English and Spanish), NIH provides online wellness toolkits and publishes NIH Research Matters, NIH News in Health, and The NIH Record. NIH television features have included a medical drama (2004), the First in Human documentary on the Discovery Channel (2017), and a 60 Minutes segment on gene therapy for sickle cell anemia

(March and December 2019). A Ken Burns produced documentary which will begin streaming in April on The Gene

will feature Dr. Collins and others across NIH.

Council members commented on ways to disseminate messages about traditional and nontraditional pathways to becoming a scientist that feature a diverse scientific workforce.

VI.  NINDS Communication: Sharing Our Science and Engaging with Partners

Dr. Amy Adams and Ms. Alissa Gallagher, Office of Neuroscience Communications and Engagement (ONCE), NINDS

Dr. Adams described the NINDS Office of Neuroscience Communications and Engagement (ONCE) which aims to foster knowledge about the brain and nervous system and share information about neuroscience discoveries and research programs through strategic, comprehensive engagement with public and scientific communities. This is in keeping with the NINDS strategic planning process goal to promote the timely dissemination of accurate and rigorous information about scientific discoveries and their implications for neurological health. ONCE uses a dialogue/engagement approach to communicate with NINDS’ many stakeholders and partners—the research/scientific community, media/journalists, patients and caregivers, advocacy groups, the general public, other federal agencies, and Congress. NINDS further targets its communication to sub-audiences such as trainees, early career investigators and established investigators to ensure a diverse demographic.

Ms. Gallagher outlined media relations work such as preparing scientific spokespeople to talk to reporters and public health education campaigns (e.g., Know Stroke, MindYourRisks®), as well as tools like the Migraine Trainer™: A Pediatric Migraine App(pdf, 288 KB)(pdf, 288 KB) that provides behavioral management techniques that may help kids and teens control their headaches.

Dr. Adams described NINDS social media activities, websites, and the NINDS searchable Disorders pages providing factual, unbiased online information on almost 300 neurological and stroke related disorders. The NINDS webpage gets upwards of 81 million views a year. NINDS pays particular attention to being transparent with its appropriations, funding and awards which is posted via interactive graphs on its website.
Council members suggested incorporating short patient interview clips on what to do following a diagnosis. Council members indicated NINDS can indicate how its current research is helping to fill in the gaps in current clinical care and advance disease management.

Council members commented on the need for scientists to integrate ethics into training to make ethics a part of the research culture from the beginning. It was suggested that NINDS connect with the National Academy of Science’s Science and Entertainment Exchange, which increases public awareness, knowledge, and understanding of science through its representation in television, film, and other media.

VII. The National Center for Complementary and Integrative Health (NCCIH) Strategic Priorities for Pain Research

Dr. Helene Langevin, Director, National Center for Complementary and Integrative Health

Dr. Langevin presented an overview of NCCIH strategic priorities for pain research. Pain is represented in the top four reasons adults report for using complementary interventions, many of which are categorized as mind and body practices (e.g., hypnosis, massage, acupuncture, and yoga).

The recent Neuroscience Blueprint workshop on Interoception—the processes by which the body senses, interprets, integrates, and regulates signals from within itself—highlighted the need to understand the interface between the musculoskeletal and nervous systems. A seminal study on the effect of manual therapy on rats that had repeated use injury of fibrosis, inflammation and stiffness from pulling a lever found that daily massage and stretching of the rat’s limb

reduced the inflammation and fibrosis.

Mind and body practices can bring together physical therapy, neuroscience, orthopedics, and rheumatology to reach a better understanding of pain as a whole. The Neurocircuitry of Force-Based Manipulations Workshop convened neuroscientists studying mechanosensation and clinical investigators in the field of manual therapies to explore potential neural and extraneural mechanisms of biomechanical force-based manipulations and interventions. The Workshop identified a need for better imaging methods to objectively measure structural abnormalities of myofascial tissues.

Studies of local and psychological effects of acupuncture have shown that the technique modulates pain at the needle site, affects local sensory modulation, and influences activity of brain regions responsible for the emotional components of pain. Although acupuncture is included in the most recent clinical guidelines for the initial treatment of chronic low back pain, insurance coverage is often lacking, and opiates continue to be prescribed. For these reasons, NCCIH is leading the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program that supports multiple studies designed to investigate whether these nonpharmocological techniques can be implemented in a healthcare system context.

Another NCCIH strategic priority is natural products, which are used in a large segment of the population, often without evidence of benefit. Of particular interest are natural products for pain. Last year, NCCIH organized a Natural Products and Pain Workshop: The Search for Nonopioid Analgesics that led to a coordinated initiative and collaboration with NINDS and the National Center for Advancing Translational Sciences (NCATS) to build a development pipeline of natural products for pain.

The use of cannabinoids, especially cannabidiol (CBD), for pain is another area of interest. Because these products are proliferating at a rapid pace well ahead of the science, NCCIH has funded nine grants to look at potential analgesic effects and also their negative effects including interactions with drugs.

As part of the strategic planning process for 2021–2026, NCCIH is reexamining how natural products and mind and body practices fit within the domains of dietary, psychological, and physical treatment and overlap with other fields such as pharmaceutical drugs and devices. 

VIII. NINDS Efforts to Improve Rigor and Transparency

Dr. Shai Silberberg, Program Manager and Director, Office of Research Quality (ORQ), NINDS

Dr. Silberberg presented on issues involving rigor and transparency in preclinical research and described current and proposed NINDS actions designed to address them. NINDS’ holistic perspective of preclinical research quality recognized the evidence of a lack of transparency in reporting, deficiencies in experimental procedures that can lead to risk of bias, and use of perverse incentives (i.e., “publish or perish”). Transparency can be improved by changing review of articles and grants, and experimental procedure deficiencies can be addressed through education and awareness. Moving from perverse incentives to rigor requires a culture change.

NINDS in-house clinical trial reviews specifically assign three reviewers to focus on the rigor of the key supporting data. At a recent workshop, journal editors, funders, investigators, and NINDS reviewers agreed on core essential parameters that all grant applications and scientific publications that include in vivo animal experiences should report on: randomization, blinding, sample size estimation, and data handling (e.g., inclusion and exclusion criteria). Following the workshop, Nature revised its review process by lifting restrictions on the length of methods sections; requiring authors to indicate where the four reporting parameters are stated in their papers; helping reviewers and editors examine statistics more closely; and encouraging authors to be more transparent (e.g., by providing raw data).

NINDS created the Office of Research Quality (ORQ) to promote rigor and transparency in all areas of NINDS research, training, and public education. Dr. Silberberg highlighted NIH enhancements to grant review, which include rigor of published and unpublished prior research that serves as key support for the proposed project; rigor of the proposed research; consideration of relevant biological variables; and authentication of key biological and/or chemical resources. A roundtable with conference organizing bodies reached a consensus on a core set of measures designed to boost transparency at scientific meetings. Some conferences and academic institutions are implementing these measures on a voluntary basis. ORQ efforts to address deficiencies in experimental procedures include numerous presentations and advising on activities designed to enrich understanding and change in neuroscience as well as online resources to promote rigor.

IX. Initiatives Requiring Concept Clearance

1. Creation of an Educational Platform on the Principles of Rigorous Research

Dr. Shai Silberberg, Program Manager and Director, Office of Research Quality, NINDS
An initiative to create a free educational platform on the principles of rigorous research was proposed. The platform would target all career stages and be comprehensive, modular, adaptable, upgradeable, and readily available. Module content would be developed by the scientific community. A coordinating center funded under a cooperative agreement would focus on platform development, coordination, harmonization, data management, and evaluation. Proposed steps include selecting a list of modules, a coordinating center, and module developers, and creating, harmonizing, evaluating, and refining the platform.
Council voted to approve the proposed concept.

2. Gene-Targeted Therapeutics Development Network for Ultra-Rare Neurological Disease

Dr. Chris Boshoff, Program Director, Division of Translational Research, NINDS

The proposed network would provide resources and funding for the scientific community to develop gene-targeted therapies from bench to bedside for ultra-rare diseases, including diseases within NINDS’ mission that are amenable to individualized therapy approaches. Expected outcomes include timely delivery of therapeutics to patients with ultra-rare diseases, accelerated advancement of discoveries from academia to the clinic, and standardized and harmonized best practices and protocols.

Council voted to approve the proposed concept; there was one abstention.

Dr. Finkelstein presented two successful initiatives that are being reissued:

1. BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs eTeamBCP (U01 Basic Experimental Studies with Humans Optional)
2. Countermeasures Against Chemical Threats (CounterACT) Exploratory/Developmental Projects in Translational Research (R21 Clinical Trial Not Allowed)

Council voted to approve these renewals.

X. Council Consideration of Pending Applications

This portion of the meeting, involving specific grant review, was closed to the public.  The Council gave special attention to applications from foreign institutions and other applications 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 385 research career development and institutional training grant applications with primary assignment to NINDS, and 243 of them (63 percent) were scored in the amount of $33.1 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 $12.4 million (115 grants).
Research Project and Center Awards – The Council reviewed a total of 1,556 research project and center applications with primary assignment to NINDS, and 883 of them (57 percent) were scored/percentiled in the amount of $333.1 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 $78.1 million (263 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: Frances E. Jensen, M.D. (University of Pennsylvania).

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 180 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 91 of them (51 percent) were scored in the amount of $39.4 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 $10.7 million (20 grants).

IX.  Adjournment

The meeting was adjourned at 12:10 p.m. on Thursday, February 6, 2020.

NINDS employees present for portions of the meeting included:

Amy Adams
Kari Ashmont
Debra Babcock
Julia Bachman
Kelly Baker
Rahul Banerjee
Patrick Bellgowan
Bill Benzing
Francesca Bosetti
Andrew Breeden
Carol Taylor-Burds
Ryan Calabrese
Emily Carifi
Stacey Chambers
Daofen Chen
Bo-Shiun Chen
Robin Conwit
Janice Cordell
Roderick Corriveau
Devon Crawford
Charles Cywin
Karen David
Kristin Dupre
Debbie Eng
Judy Fabrikant
Robert Finkelstein
Christine Swanson Fischer
Jane Fountain
Megan Frankowski
Marie Gill
Paul Girolami
Brooks Gross
Mohamed Hachicha
Danielle Haney
Adam Hartman
Brandon Hartsell
Janet He
Rebecca Hommer
Marilyn Moore-Hoon
Nina Hsu
Eric Hudak
Lyn Jakeman
Scott Janis
Michelle Jones-London
John Kehne
Brian Klein
Jim Koenig
Stephen Korn
Walter Koroshetz
Kranthi Kotha
Sahana Kukke
Joseph Kurdziel
Christine Lam
Cristina Saugar Lanchas
Nick Langhals
Timothy LaVaute
Miriam Leenders
Quynh Ly
Ernest Lyons
Laura Mamounas
Linda McGavern
Barbara McMakin
Daniel Miller
Jill Morris
Claudia Moy
Glen Nuckolls
Ana Olariu
David Owens
Mary Pelleymounter
Leah Pogorzala
Linda Porter
Carolina Mendoza-Puccini
Shamsi Raeissi
Shanta Rajaram
K Rezaizadeh
Robert Riddle
Lorna Role
Becky Roof
Cheryse Sankar
Alisa Schaefer
Paul Scott
Hawa Eve Sesay
Beth-Anne Sieber
Shai Silberberg
Andrew Skinner
Shardell Spriggs
Kalynda Stokes
Natalia Strunnikova
Edmund Talley
Amir Tamiz
Anna Taylor
Christine Torborg
Natalie Trzcinski
Lauren Ullrich
Ursula Utz
Laura Wandner
Margo Warren
Vicky Whittemore
Ling Wong
May Wong
Nick Wymbs

Other federal employees present for portions of the meeting included:

John Burklow, NIH
Dr. Peter Guthrie, CSR
Dr. Helene Langevin, NCCIH
Dr. Laurent Taupenot, CSR
Dr. Wei-Qin Zhao, CSR

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.

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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.