NINDS Advisory Council Meeting Minutes, February 1, 2018

NINDS Advisory Council Meeting Minutes, February 1, 2018

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

Summary of Meeting1
February 1, 2018

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 201st meeting on February 1, 2018, in the Neuroscience Center Building (NSC), Conference Room C/D/E, in Rockville, 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 1, 2018:  8:00 a.m. to 2:30 p.m. for the review and discussion of program development, needs, and policy; and

Closed:  February 1, 2018:  2:30 p.m. to 3:50 p.m. for the consideration of individual grant applications.

Council members present:
Dr. Laurence Abbott
Dr. Issam Awad
Dr. Amy Brooks-Kayal
Dr. Karen Chen
Dr. Timothy Coetzee (via telephone)
Dr. Beverly Davidson
Dr. Gordon Fishell
Dr. David Gutmann
Ms. Janet Hieshetter
Dr. Bruce Ovbiagele
Dr. Steve Perrin
Dr. Indira Raman
Dr. Steven Roberds
Dr. S. Lawrence Zipursky

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

Ad hoc attendees present:
Dr. Hollis Cline
Ms. Susan Dickinson
Dr. David Hackney
Dr. Karen Johnston

Council members absent:
Dr. Karen Chen

Ex officio members absent:
Dr. Christopher T. Bever, Jr., Department of Veterans Affairs     

Council Roster (Attachment 1)

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

Ronald Bartek, Friedreich’s Ataxia Research Alliance
Philip Goglas II, Dystonia Medical Research Foundation
André Porter, American Society for Biochemistry and Molecular Biology

Federal attendees are listed at the end of these minutes.

I.  Call to Order and Opening Remarks

Dr. Finkelstein welcomed Council members, visitors, and staff to the 201st 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 September 7, 2017, Council meeting minutes.

The following future Council meeting dates were confirmed:

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 fiscal year. For the current Council round, 77 applications were eligible to be expedited. Thirty-seven (37) of these awards already have been issued, and the others will be issued shortly after Council.

Extramural Announcements

Dr. Finkelstein introduced Doe Kumsa, Ph.D., from the Repair and Plasticity Cluster.
Dr. Clinton Wright introduced Jeremy Brown, M.D., from the Division of Clinical Research.
Dr. Maureen Gormley introduced Hilary Fitillis, J.D., and Denise Ford from the Office of the Director.
Dr. Paul Scott introduced Andrew Hooper, Ph.D., from the Office of Science Policy and Planning.
Dr. Amy Adams introduced Nina Hsu, Ph.D., from the Office of Scientific Liaison.
Dr. Meghan Mott introduced Jackie Ward, Ph.D., from the Office of the Director.

III.  Report of the Director, NINDS

Dr. Walter Koroshetz, Director, NINDS

NIH and NINDS Budget—Dr. Koroshetz provided an overview of the NIH and NINDS budgets. The federal government is operating under a Continuing Resolution (CR) until February 8, 2018. Under a CR, NINDS functions at the Fiscal Year (FY) 2017 appropriation level, and non-competing grants are awarded at 90 percent.

The FY18 President’s Budget represents a 26 percent cut to NINDS; the House and Senate proposed budgets representing 4 percent and 7 percent increases, respectively, and both include $43 million for the 21st Century Cures Act that partially funds the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative®.

NINDS Success Rate—Dr. Koroshetz reported that the NINDS FY17 Research Project Grant (RPG) success rate was 18.7 percent.  The NINDS FY17 payline was at the 12th percentile, down from the 15th percentile in FY16, due to: increased commitments to non-competing grants, a significant increase in submitted applications, and an increase in the average cost of research project grants. 

NIH Next Generation Research Initiative—In August 2017, NIH released the Next Generation Researchers Initiative (NGRI) policy to encourage support of Early Stage Investigators (ESIs) and Early Established Investigators (EEIs).  Following the policy’s release, a working group of the Advisory Committee to the NIH Director (ACD) was established to provide advice on its implementation.  In the interim, NINDS implemented the NGRI in FY17 by fully funding nearly all ESI applications to the 25th percentile, and by making bridge awards (R56s) to selected at risk EEIs beyond the payline.

NINDS Research Program Award (R35) – In FY17, NINDS launched the R35 program, with the goal of creating a stable funding environment for outstanding investigators to facilitate longer-range, higher-risk research.  38 awards have been made over the first two years of the program. An FOA announcing the third year of the R35 program will be released in spring 2018.

New NIH Definition of Clinical Trials—NIH revised its definition of clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health related biomedical or behavioral outcomes.  For due dates on or after January 25, 2018, all clinical trials must be submitted to a Funding Opportunity Announcement (FOA) that permits clinical trials applications.  A NINDS notice will be released directing applicants submitting clinical trials to appropriate FOAs.

Optimize NIH—In response to a White House OMB memorandum to improve efficiency and effectiveness across the government, the Department of Health and Human Services (HHS) launched ReImagine HHS.  Under ReImagine HHS, NIH leadership developed the Optimize NIH plan to increase efficiency and effectiveness of administrative functions, and to improve NIH operations, business processes, and coordination. Following acceptance of the Optimize NIH plan by HHS and OMB, the authority of the NIH Director to hire was reinstated on October 18, 2017. 

Leadership ChangesAlex M. Azar, II, was sworn in on January 29, 2018 as the new Secretary of HHS.  Recent changes at NIH include departure of Dr. Roderic Pettigrew as director of the National Institute of Biomedical Imaging and Bioengineering, where Dr. Jill Heemskerk is now acting director. Dr. Josie Briggs has retired as the director of National Center for Complementary and Integrative Health; Dr. David Shurtleff is acting director.  NINDS welcomed Deputy Director, Dr. Nina Schor from University of Rochester, where she served as chair of the Department of Pediatrics. Ongoing NINDS leadership searches include Scientific Director, Director of Neuroscience, and BRAIN Director.

AMP Parkinson’s Disease — NIH has partnered with industry and nonprofit organizations to launch the Accelerated Medicine Partnership (AMP) for Parkinson’s Disease (PD) program. The initiative will focus on identifying and validating biomarkers and new therapeutic targets for PD. 

Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS)—NINDS is leading a trans-NIH effort in ME/CFS. Through collaborative research centers, NIH invested $7M in FY17 to accelerate clinical and biological understanding of the syndrome.

NIH Addressing the Opioid Epidemic —The U.S. is facing an epidemic with 63,000 overdose deaths in 2016. Dr. Collins, NINDS and NIDA have been meeting weekly to develop a plan to address the epidemic. NIH is prepared to meet the President’s goal of managing the opioid crisis and will expand its efforts considerably if Congress appropriates additional funding to stem the crisis.

BRAIN Initiative—The Fourth Annual BRAIN Initiative Investigators’ Meeting will be held the week of April 9th in Bethesda, MD and will provide a forum for discussing exciting scientific developments and potential new directions, and for identifying areas for collaboration and research coordination. In addition, efforts are underway to formally revisit the priorities identified in the BRAIN 2025 report to provide an updated scientific vision for the second half of the Initiative.  Lastly, the Neuroethics Division of the BRAIN Multi-Council Working Group is finalizing a set of Neuroethics Guiding Principles for the NIH BRAIN Initiative.

IV.  Institutional Translational Training Programs (T32)

Dr. Amir Tamiz
Director, Division of Translational Research

Dr. Stephen Korn
Office of Training and Workforce Development

Dr. Stephen Korn, Office of Training and Workforce Development and Dr. Amir Tamiz, Division of Translational Research, NINDS, presented an initiative proposing support for Institutional Training programs in translational research.  These programs would support the training of advanced graduate students, postdoctoral fellows and clinicians conducting basic, disease-related research projects that are informed by translational considerations and principles.   Programs could include features such as clinical exposure, internships with pharmaceutical and biotech companies and cross-disciplinary training.

Council proposed developing partnerships with pharma and biotech.  Council voted to approve concept clearance for the initiative.

V.  Promoting Opportunities for Women and Under-Represented groups in Neuroscience through New Faculty Hiring

Dr. Stephen Korn
Office of Training and Workforce Development

Dr. Michelle Jones-London
Office of Programs to Enhance Neuroscience Workforce Diversity

Dr. Korn and Dr. Michelle Jones-London, Office of Programs to Enhance Neuroscience Workforce Diversity, NINDS, presented an initiative designed to promote hiring of diverse faculty (e.g. women, underrepresented minorities, and persons with disabilities) in tenure-track or equivalent positions.  The initiative aims to create an environment for success of individual hires and to increase selection and retention of women and underrepresented groups over the long term. Applications will be required to include a plan for mentoring, inclusion, and fostering success for diversity hires; a detailed accounting of prior diversity hires; and a detailed plan for future diversification through hiring practices.

Council voted to approve the initiative, suggesting that activities to strengthen the cohort be incorporated into the program, such as plenaries and meetings for awardees. Council discussed strategies institutions could use to recruit successful job candidates as well as duration of the program to allow for flexibility related to child-rearing responsibilities.  

VI.  NIH Director’s Perspective

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

Dr. Francis Collins
Director, National Institutes of Health

NIH Director, Dr. Francis Collins, presented an overview of the opioid crisis and described key NIH efforts in this area.  Opioids are overprescribed and not effective for chronic pain. Available Medication Assisted Treatments (MATs) for opioid use disorders to prevent/reverse overdose are drastically underutilized. Dr. Collins emphasized the need for evidence-based guidelines for using MATs and for determining the most effective time-course to counteract addiction over the long-term.  Dr. Collins highlighted the critical role NINDS and NIDA have in finding new, non-addictive pain medicines, overdose reversal treatments, and medications to inhibit addiction.

Council members discussed whether acute opioid treatment of pain in children may potentiate future addiction. Dr. Collins indicated that CDC is issuing guidance to address opioid prescribing practices.

VII.  Proposed Special Council Review (SCR) Process

Dr. Robert Finkelstein
Director, Division of Extramural Activities

Dr. Finkelstein presented a revised NINDS process for Special Council Review (SCR) that reflects Council feedback from the September 2017 meeting.  The policy is designed to enable NINDS to support a larger and more diverse pool of investigators. The new policy: (1) lowers the funding threshold that requires special review of a pending application by the National Advisory Neurological Disorders and Stroke (NANDS) Council and; (2) sets a more stringent payline for pending applications that cause an investigator to exceed this threshold.  Under NIH’s current SCR policy, NINDS has disapproved only 2 applications since 2012. Dr. Finkelstein stressed that a PI’s ability to commit time and effort commensurate with the application’s complexity and scope will be evaluated.

Council discussed the proposed NINDS SCR initiative, including whether the $1 million trigger is too low, given rising grant costs, and exemptions for special initiatives with earmarked funding streams.  Council voted to approve the NINDS SCR process as proposed.

VIIIa. Overview: Public-Private Partnership to Address the Opioid Crisis

Dr. Linda Porter
Director, Office of Pain Policy

Dr. Linda Porter, Office of Pain Policy, NINDS, outlined the Public-Private Partnership between PhRMA, industry, the Foundation for the NIH (fNIH), and NIH to address the opioid epidemic and pain management crisis. The Partnership has developed a research plan utilizing the following approaches: 1) focused medication development to prevent and reverse overdose and for pain treatment; 2) data sharing and asset repurposing to accelerate drug development; 3) clinical endpoints in development and testing of overdose and use treatments along with finding biomarkers for pain that could be predictive of treatment response; and 4) a pain clinical trials research network to test compounds and new drugs.

A Data Sharing and Asset Repurposing Project to Accelerate Drug Development

Dr. Michael Oshinsky
Systems and Cognitive Neuroscience Cluster

Dr. Michael Oshinsky, Division of Neuroscience, NINDS, described the data-sharing project, which focuses on leveraging existing drug development knowledge.  Project goals include enabling companies to access data that will bring products to market sooner and repurposing assets that have been developed for other neurological disorders (e.g., depression, epilepsy). A committee comprising representatives from NIH, industry, and FDA will analyze the data package of compounds for repurposing and identify potential industry partners to collaborate on developing new medications. 

VIIIb. Initiatives Requiring Concept Clearance:

  1. A Clinical Trials Network for Pain
    Dr. Clinton Wright,
    Director, Division of Clinical Research

    NIH in partnership with FDA, academia and industry will support a Clinical Trial Network for Chronic Pain to accelerate drug testing and biomarker validation. This network will also provide resources to help navigate the regulatory approvals process.
     
  2. Biomarkers to Accelerate the Development of Non-Addictive Pain Medications
    Dr. Amir Tamiz
    Director, Division of Translational Research

    Dr. Tamiz outlined the NINDS Biomarker Strategy: Application to Pain Initiative.  Program goals include discovering, optimizing, and validating objective mechanistic markers associated with pain conditions to enrich clinical study populations and demonstrate therapeutic target engagement.  There will be a Notice of Interest to encourage submission of applications focused on pain biomarkers in response to NINDS’ fit-for-purpose validation process FOAs.

    Council discussed funding sources for the proposed pain related initiatives. They noted that further development of these initiatives is dependent on budget appropriations which have yet to be enacted. The initiatives were voted on together. Council approved the Biomarkers, and Clinical Trials Network initiatives in preparation for funding appropriations which Council expects will be put forward to stem the opioid crisis.
     
  3. Stroke Preclinical Assessment Network (SPAN)
    Dr. Francesca Bosetti
    Neural Environment Cluster

    Drs. Francesca Bosetti and James Koenig, Division of Neuroscience, NINDS, presented a proposal for a Stroke Preclinical Assessment Network (SPAN) to test neuroprotective agents in controlled experimental pre-clinical settings before moving to clinical trials. Up to six academic sites with stroke modeling expertise will test compounds in parallel during phase I. If a compound is found not to be efficacious, it will be dropped from testing, allowing the network to invest more in interventions that show early promise.  Promising compounds will go through clinical trial testing which can be supported though NINDS StrokeNet.

    Council voted to approve concept clearance for the proposed network.

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 284 research career development and institutional training grant applications with primary assignment to NINDS, and 173 of them (60.9 percent) were scored in the amount of $21.8 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 $8.3 million (69 grants).

Research Project and Center Awards – The Council reviewed a total of 1,548 research project and center applications with primary assignment to NINDS, and 885 of them (57.2 percent) were scored/percentiled in the amount of $272.7 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 $62.3 million (220 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 two Javits nominations at this meeting: Stanley Thomas Carmichael, M.D., Ph.D. (University of California, Los Angeles) and Michael W. Young, Ph.D. (The Rockefeller University).

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 149 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 78 of them (52.3 percent) were scored in the amount of $23.39 million first-year direct costs.  It is anticipated that, of the SBIR and STTR applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $3.01 million (11 grants).

X.  Adjournment

The meeting was adjourned at 3:50 p.m. on Thursday, February 1, 2018.

NINDS employees present for portions of the meeting included:

Dr. Amy Adams
Dr. Deborah Babcock
Ms. Kelly Baker
Dr. Francesca Bosetti
Dr. Chris Boshoff
Dr. Patrick Bellgowan
Dr. Moria Bittmann
Dr. Vanessa Boyce
Dr. Andrew Breeden
Mr. Ryan Calabrese
Mr. Roger Campbell
Dr. Emily Carifi
Ms. Stacey Chambers
Dr. Daofen Chen
Dr. Robin Conwit
Dr. Roderick Corriveau
Dr. Devon Crawford
Dr. Diana Cummings
Dr. Charles Cywin
Dr. Karen David
Dr. Tijuanna Decoster
Dr. Edgardo Falcon
Ms. Stephanie Fertig
Dr. Robert Finkelstein
Ms. Hillary Fitilis
Dr. Jane Fountain
Ms. Alissa Gallagher
Ms. Marie Gill
Mr. Paul Girolami
Dr. Jim Gnadt
Dr. Maureen Gormley
Dr. Amelie Gubitz
Dr. Mohamed Hachicha
Ms. Preeti Hans
Ms. Nancy Hart
Dr. Janet He
Ms. Monique Hill
Dr. Nina Hsu
Dr. David Jett
Dr. Michelle Jones-London
Dr. John Kehne
Dr. Jimok Kim
Dr. Brian Klein
Dr. Jim Koenig
Dr. Steve Korn
Dr. Walter Koroshetz
Dr. Doe Kumsa
Dr. Pascal Laeng
Ms. Christine Lam
Dr. Nick Langhals
Dr. Miriam Leenders
Dr. TinaMarie Lieu
Dr. Cara Long
Dr. Codrin Lungu
Ms. Quynh Ly
Dr. Ernie Lyons
Dr. Laura Mamounas
Dr. Linda McGavern
Ms. Barbara McMakin
Dr. Meghan Mott
Dr. Daniel Miller
Dr. Jill Morris
Dr. Claudia Moy
Dr. Birgit Neuhuber
Dr. Ana Olariu
Dr. Michael Oshinsky
Dr. David Owens
Dr. Katie Pahigiannis
Ms. Josabeth Paredes
Dr. Mary Ann Pelleymounter
Dr. Leah Pogorzala
Dr. Linda Porter
Dr. Shamsi Raeissi
Dr. Shanta Rajaram
Dr. Ipolia Ramadan
Dr. Khara Ramos
Dr. Matthew Raymond
Dr. Robert Riddle
Dr. Heather Rieff
Dr. Cheryse Sankar
Dr. Alisa Schaefer
Dr. Nina Schor
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
Dr. Carol Taylor-Burds
Ms. Melissa Tipton
Dr. Christine Torborg
Dr. Natalie Trzcinski
Dr. Lauren Ullrich
Dr. Ursula Utz
Ms. Christina Vert
Ms. Joanna Vivalda
Dr. Jackie Ward
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

Other federal employees present for portions of the meeting included:

Dr. Laurent Taupenot, 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.


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.