National Advisory Council (NANDSC) Meeting - September 2017

I.  Call to Order and Opening Remarks

Dr. Finkelstein welcomed Council members, visitors, and staff to the 200th 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 18, 2017, Council meeting minutes.

The following future Council meeting dates were confirmed:

Thursday, February 1, 2018

Thursday, May 24, 2018

Thursday, September 13, 2018

Thursday, February 7, 2019

Thursday, May 23, 2019

Thursday, September 5, 2019

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 Beverly Davidson, Janet Hieshetter, and David Gutmann for handling this responsibility for this meeting and the upcoming year. For the current Council round, 74 applications were eligible to be expedited. Fifty (50) of these awards already have been issued, and the others will be issued shortly after Council.

Extramural Announcements

There were no new staff members to introduce.

III.  National Academies Report "Preventing Cognitive Decline and Dementia: A Way Forward"

Dr. Story Landis, Director Emeritus, NINDS, and Dr. Alan Leshner, CEO Emeritus, American Association for the Advancement of Science, and Director Emeritus, National Institute on Drug Abuse (NIDA), presented the recommendations from a 2017 report from the National Academies of Sciences, Engineering and Medicine (NASEM), Preventing Cognitive Decline and Dementia: A Way Forward. The Committee on Preventing Dementia and Cognitive Impairment, co-chaired by Drs. Landis and Leshner, was charged with examining the evidence for interventions that delay or slow age-related cognitive decline (ARCD), mild cognitive impairment (MCI), and clinical Alzheimer’s-type dementia (CATD) and recommending evidenced-based public health strategies and areas for future research.

Following a thorough review of the outcomes of previous reports led by the AHRQ and the Institute of Medicine, the Committee concluded that there is insufficient evidence to justify a public health information campaign to encourage adoption of specific interventions. However, three interventions are supported by “encouraging but inconclusive evidence”, including 1) cognitive training 2) blood pressure management for people with hypertension and 3) increased physical activity. All have minimal risk of harm, and are known to be beneficial for other conditions.

Based on the Committee’s findings, three primary recommendations were put forward:

Recommendation 1

• NIH and others should provide accurate information about potential impacts of these three intervention classes on cognitive outcomes in a place where people can access it (e.g., websites).

Recommendation 2

NIH and other interested organizations should support studies that:

• Identify individuals at higher risk of cognitive decline and dementia and tailor interventions accordingly.
• Increase participation of underrepresented populations to study intervention effectiveness in these populations.
• Include biomarkers as intermediate outcomes.

Recommendation 3

NIH and other interested organizations should support further research to strengthen the evidence base on:

• New antidementia treatments, diabetes treatment, depression treatment, dietary interventions, lipid-lowering treatment/statins, sleep quality interventions, social engagement intervention, vitamin B₁₂ plus folic acid supplementation.

Council members discussed the possibility of investigating these interventions across neurodegenerative disease as well as the challenge of communicating differences between ARCD, CATD, and mild cognitive impairment to the lay public.

IV.  Neuroethics and the BRAIN Initiative

NIH and NINDS Budget—Dr. Koroshetz provided an overview of the NIH and NINDS budget. The Fiscal Year (FY) 2017 NIH budget is $2 billion higher than for FY16 and includes a $400 million increase for Alzheimer’s disease (AD) research and a $140 million increase for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative. The NINDS budget increased from $1.69 billion in FY16 to $1.78 billion in FY17.

FY18 budget planning exercises must take into account the President’s Budget, which calls for a 26% decrease for NINDS, markups from the House and Senate that call for increased funding for specific NIH programs, a possible cap on indirect cost rates, and NINDS’ out-year commitments that will reach $913 billion. Furthermore, NINDS must either move or renegotiate its lease and renovate its Rockville space; either scenario will incur multimillion-dollar costs.

NINDS Success rate—Dr. Koroshetz reported that the NINDS FY17 success rate is approximately 20%. The NINDS payline dropped to the 12th percentile due primarily to an increase in the commitment to noncompeting grants and to the launch of the R35 program which provides eight years of funding for an investigator’s research program, taking these PIs and their current commitments out of other research funding lines.

Alzheimer’s Disease-Related Dementias (ADRD)—Dr. Koroshetz provided an overview of the policies, initiatives, and projects emerging from the National Plan to Address Alzheimer’s Disease. The NIH received a $400 million funding increase in FY17 to support implementation of the AD/ ADRD priorities identified in the National Plan. This program is overseen by the National Institute on Aging (NIA) with significant contribution by NINDS.

P30 Cores—NINDS intends to temporarily suspend funding for new P30 centers in an effort to prioritize limited resources. It is anticipated that the BRAIN Initiative will launch a new P30 program to disseminate resources and tools to the neuroscience community. NINDS will monitor the impact of this program and reassess whether gaps continue to exist as the budget stabilizes.

NINDS R21—Due to the growing number of Institutes withdrawing from the Parent R21 FOA, NINDS has been receiving an increasing number of applications outside of its mission. As a result, effective January 8, 2018, NINDS will withdraw from the Parent R21 and release its own R21 funding announcement.

NIH New Definition of Clinical Trials—Effective January 25, 2018, applications proposing research in human subjects must be submitted to a clinical trial specific FOA. NINDS is working with the Center for Scientific Review to ensure that clinical trial FOAs, parent or NINDS-specific, are available to fit research conducted by NINDS investigators.

Next Generation Researchers Initiative—The NIH Next Generation Researchers Initiative (NGRI) aims to encourage successful independent careers for Early Stage Investigators (ESIs), and retain them as they become Early Established Investigators (EEIs). NINDS implemented the NGRI for FY17 by fully funding most ESI applications up to the 25th percentile and by issuing one year bridge awards to applications from EEIs past the payline, up to the 25th percentile.

NIH Pain Consortium—Operating within the NINDS Office of the Director, the NIH Office of Pain Policy (OPP) manages and coordinates activities of the Interagency Pain Research Coordinating Committee and the NIH Pain Consortium, and tracks consortium funding ($480 million annually). Dr. Koroshetz reported on the formation of public-private partnerships to accelerate development of novel, safe pain therapies. Furthermore, the National Academy of Science will host a workshop on Advancing Therapeutic Development for Pain and Opioid Use Disorders through Public-Private Partnerships on October 11, 2017.

BRAIN Initiative—With nearly $250 million in FY17 funding for the BRAIN Initiative, NIH is investing in ambitious team science approaches to tackle major questions in neuroscience. NIH will formally revisit BRAIN’s 2025 priorities to provide an updated scientific vision to guide the second half of the initiative.

NINDS Landis Award for Outstanding Mentorship—Designed to reward outstanding mentorship of pre-and postdocs and incentivize good mentorship, the NINDS Landis Award provides supplementary support to NINDS investigators who have provided superior mentorship so that they can mentor additional trainees. Annual supplement requests will rotate between mentors at different career stages. In FY17, supplements will be awarded to early-career mentors.

NINDS R25 Program—The R25 mechanism supports institutional NINDS training programs that enable physician-scientists to compete for funding to engage in research during and after residency in preparation for independent research careers. Most awardees had PhD training before clinical training; however, the recently released renewal allows participants to enroll in a PhD program after residency.

V.  A Perspective on Diversity

Dr. Eric Nestler, President, Society for Neuroscience (SfN), and Director, Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, described strategies for improving diversity in the neuroscience community. These efforts aim to increase awareness of barriers to recruitment and retention of women and minorities in neuroscience, identify tangible steps to reduce such barriers, improve understanding of implicit biases and subconscious behaviors that limit success, and strengthen a sense of productivity and satisfaction within institutions. The long-term goal is to increase the recruitment, retention, and promotion of women and minorities in neuroscience. Promoting respect, collegiality, inclusion, collaboration, and cooperation will increase faculty and student productivity and improve science and patient care.

Dr. Nestler identified these tangible steps to reduce barriers: increased transparency around resources, salaries, and promotions; uniformity that levels the playing field; mentoring and sponsoring (e.g., the NINDS/SfN’s Neuroscience Scholars Program), and affirmative attention (i.e., considering inclusion and diversity for every symposium, panel, or search committee).

Council members discussed ways NIH and NINDS can improve diversity in the neuroscience community.

VI.  NINDS Programs for Enhancing Diversity in Neuroscience Research

Dr. Michelle Jones-London, Office of Programs to Enhance Neuroscience Workforce Diversity (OPEN-WD), NINDS, provided an update on NINDS programs designed to enhance diversity in the biomedical workforce, and presented a proposal for a new institutional diversity effort: Neuroscience Education, Training, and Workforce (NETWork) for Diversity Program (U54).

NINDS is committed to the development of a diverse biomedical research at all career stages and supports several activities to promote diversity in science, including: F31 predoctoral fellowships, K22 and K01 career development awards for junior faculty, and institutional R25s through the NIH Blueprint Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (ENDURE) Program.

To further enhance these existing efforts, NINDS is proposing a Neuroscience Education, Training, and Workforce (NETWork) for Diversity Initiative to strengthen neuroscience research at undergraduate, graduate, and medical institutions serving underrepresented students. This program is aimed at institutions with a demonstrable track record of educating and graduating underrepresented students, regardless of their historical mission. Through the NETWork for Diversity Program, NINDS aims to: strengthen neuroscience research at undergraduate, graduate, and medical institutions serving underrepresented students; provide support for students performing meritorious research in these supportive environments; increase the academic preparedness and research skills of students from diverse backgrounds and encourage them to pursue advanced neuroscience research careers; provide opportunities and resources for eligible institutions to implement effective approaches to training in neuroscience research; and to help faculty develop their mentoring skills.

Council members discussed ways to help applicants identify partner institutions that already are providing optimal training opportunities. Council voted to approve the proposed program.

VII.  Concept Clearance for Proposed Initiative: A “Fit for Purpose” NINDS Biomarker Strategy: Discovery through Development

Dr. Mary Ann Pelleymounter, Division of Translational Research, NINDS, requested concept clearance for “A Fit for Purpose NINDS Biomarker Strategy: Discovery through Clinical Practice.” It is anticipated that development of this program, the goal of which is to facilitate the development of late stage validation biomarkers to improve the quality and efficiency of clinical research, would enhance existing NINDS support for the biomarker discovery process.

Two milestone-driven FOAs are proposed. FOA 1 would support analytical validation, multisite correlational studies with rigorous analyses, and retrospective and/or prospective clinical data and clinical samples. FOA 2 would support a preparatory phase to ensure multisite, prospective evaluation of clinical utility in human subjects.

Council discussed whether NINDS investment was most appropriate at the validation stage or would be more valuable at earlier discovery stages. Council also discussed complex barriers to biomarker validation such as the regulatory approval process and moving into humans from animals.

Council voted to approve concept clearance for the proposed initiative.

VIII. Proposed Changes to the Special Council Review Process

Dr. Robert Finkelstein presented an overview of the current Special Council Review (SCR) process and a proposal to implement a more rigorous policy at NINDS. The policy would be triggered if an application raises the PI’s support above the $1 million direct cost threshold with a number of exclusions (e.g. SBIR, training).

Estimates presented suggest that if NINDS were to fund about half of all applications subject to the proposed SCR policy, between $25 and $40 million per year would be recovered that could be applied to the NGRI program, increase the payline, or support new initiatives.

Council discussed the proposed policy changes. Several aspects of the proposal require further discussion: impact of PI funding sources (i.e., special NIH-wide projects and non-NIH support) and how to define “extraordinary opportunity.”

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, 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 289 research career development and institutional training grant applications with primary assignment to NINDS, and 165 of them (57.1 percent) were scored in the amount of $12.3 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 $5.5 million (73 grants).

Research Project and Center Awards—The Council reviewed a total of 1,654 research project and center applications with primary assignment to NINDS, and 900 of them (54.4 percent) were scored/percentiled in the amount of $308.7 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 $132.1 million (248 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 146 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 75 of them (51.4 percent) were scored in the amount of $21.36 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 $2.48 million (12 grants).

X.  Adjournment

The meeting was adjourned at 6:00 p.m. on Thursday, September 7, 2017.

NINDS employees present for portions of the meeting included:

Dr. Amy Adams
Dr. Deborah Babcock
Ms. Kelly Baker
Ms. Sarah Bell
Dr. Patrick Bellgowan
Dr. Moria Bittmann
Dr. Andrew Breeden
Dr. Emily Carifi
Ms. Stacey Chambers
Dr. Daofen Chen
Dr. Robin Conwit
Ms. Janice Cordell
Dr. Roderick Corriveau
Dr. Devon Crawford
Dr. Diana Cummings
Dr. Charles Cywin
Dr. Karen David
Dr. Tijuanna Decoster
Dr. Kristin Dupre
Ms. Marian Emr
Ms. Stephanie Fertig
Dr. Robert Finkelstein
Dr. Jane Fountain
Ms. Marie Gill
Mr. Paul Girolami
Dr. Jim Gnadt
Dr. Amelie Gubitz
Dr. Mohamed Hachicha
Ms. Preeti Hans
Ms. Nancy Hart
Dr. Janet He
Dr. Lyn Jakeman
Dr. David Jett
Dr. Michelle Jones-London
Dr. Jimok Kim
Dr. Brian Klein
Dr. Jim Koenig
Dr. Steve Korn
Dr. Walter Koroshetz
Dr. Pascal Laeng
Ms. Christine Lam
Dr. Nick Langhals
Dr. Tim LaVaute
Dr. Miriam Leenders
Dr. Cara Long
Ms. Quynh Ly
Dr. Ernie Lyons
Ms. Barbara McMakin
Dr. Meghan Mott
Dr. Daniel Miller
Dr. Jill Morris
Dr. Claudia Moy
Dr. Birgit Neuhuber
Dr. Ana Olariu
Dr. David Owens
Dr. Katie Pahigiannis
Dr. Mary Ann Pelleymounter
Dr. Leah Pogorzala
Dr. Shanta Rajaram
Dr. Ipolia Ramadan
Dr. Khara Ramos
Dr. Nagarajan Rangarajan
Dr. Matthew Raymond
Dr. Robert Riddle
Dr. Heather Rieff
Dr. Cheryse Sankar
Dr. Alisa Schaefer
Dr. Paul Scott
Ms. Shalini Sharma
Dr. Beth-Anne Sieber
Dr. Shai Silberberg
Dr. Andrew Skinner
Dr. Victoria Smith
Dr. Shardell Spriggs
Dr. Randall Stewart
Dr. Natalia Strunnikova
Dr. Marg Sutherland
Dr. Christine Swanson-Fisher
Dr. Ned Talley
Dr. Amir Tamiz
Dr. Anna Taylor
Ms. Melissa Tipton
Dr. Christine Torborg
Dr. Natalie Trzcinski
Dr. Lauren Ullrich
Dr. Ursula Utz
Ms. Christina Vert
Ms. Joanna Vivalda
Ms. Margo Warren
Dr. Elizabeth Webber
Dr. Letitia Weigand
Dr. Samantha White
Dr. Vicky Whittemore
Dr. Ling Wong
Dr. May Wong
Dr. Clinton Wright
Dr. David Yeung
Dr. Robert Zalutsky
Dr. Ran Zhang

Other federal employees present for portions of the meeting included:

Dr. Paul Sato, Office of AIDS Research, NIH
Dr. Elyse Schauwecker, CSR
Dr. Laurent Taupenot, CSR
Dr. Biao Tian, 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.