NINDS Advisory Council Meeting Minutes, May 28, 2015

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

Summary of Meeting1
May 28, 2015

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 193rd meeting on May 28, 2015, in Building 31, C Wing, 6th Floor, Conference Room 10, on the National Institutes of Health (NIH) campus, Bethesda, Maryland.  Dr. Walter Koroshetz, Acting Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson. 

I.  Call to Order and Opening Remarks

Dr. Koroshetz welcomed Council members, visitors, and staff to the 193rd meeting of the National Advisory Neurological Disorders and Stroke Council. 

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

 
Open: May 28: 8:00 a.m. to 12:50 p.m. for the review and discussion of program development, needs, and policy; and
Closed: May 28: 12:50 p.m. to 4:45 p.m. for the consideration of individual grant applications. May 28: 4:45 p.m. to 5:10 p.m. for the review of the Board of Scientific Counselors’ Reports


Council members present:

Dr. Ben Barres
Dr. Amy Brooks-Kayal
Dr. Karen Chen
Dr. Beverly Davidson
Dr. Byron Ford
Dr. David Ginty
Dr. David Goldstein
Mr. Paul Gross
Dr. David Holtzman
Dr. David Julius
Dr. Kevin McNaught
Dr. Jonathan Mink
Ms. Amy Comstock Rick
Dr. Ralph Sacco
Dr. Lawrence Zipursky (via teleconference))

Council members absent:

Dr. E. Antonio Chiocca
Dr. Timothy Coetzee
Ms. Ilene Penn Miller

Ex officio members present:

Captain Michael Colston, Department of Defense

Council Roster (Attachment 1)

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

Mr. Taylor Scott, Nevus Outreach

Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance

Federal attendees are listed at the end of these minutes. 

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

Approval of Council Minutes—Dr. Finkelstein requested, and the Council voted approval of the January 29, 2015, Council meeting minutes.

 

The following future Council meeting dates were confirmed:

September 10-11, 2015
February 4-5, 2016
May 26-27, 2016
September 15-16, 2016
February 9-10, 2017
May 18-19, 2017
September 7-8, 2017
(Thursday and Friday)
(Thursday and Friday)
(Thursday and Friday)
(Thursday and Friday)
(Thursday and Friday)
(Thursday and Friday)
(Thursday and Friday)

Expedited Review Process—Each Council round, a subset of Council members approve applications in advance of the meeting with scores within the payline.  This expedited review process focuses on applications for which there are no unresolved issues.  Dr. Finkelstein thanked Council members Jonathan Mink, Ilene Miller, and Nino Chiocca for handling this responsibility for this fiscal year.  For the current Council round, 169 applications were eligible to be expedited, including 5 K Awards, and 4 Small Business Innovation Research (SBIR) applications.  Eighty seven of these awards already have been issued, and the others will be issued shortly after Council. 

Extramural Announcements—Dr. Finkelstein introduced and welcomed new staff in the Neurodegeneration Cluster:    Dr. Christine Swanson-Fischer, a Program Analyst, and Dr. Daniel Miller, a Program Director.   Next, he reported that Dr. Claudia Moy has agreed to serve as Acting Chief, International Office while maintaining her position in the Office of Clinical Trials.   He then thanked Dr. Salina Waddy and Stacey Chambers for their work in the H3 Africa Initiative.  Dr. Katrina Gwinn will now assume responsibility for this program. 

III.  Report of the Acting Director, NINDS

NINDS Director— It is anticipated that NIH Director Dr. Francis Collins will announce the new NINDS Director within the next few weeks.  Dr. Koroshetz thanked the entire NINDS staff for their dedication and excellent work throughout the transition period.

NIH and NINDS Budget—Dr. Koroshetz reported on the status of the NIH and NINDS budgets for fiscal year (FY) 2016.  The FY16 President’s Budget (PB) proposes a 3.5 percent increase from FY15 funding levels for NINDS; the overall percent increase for NIH is 3.3.  In the PB, the NINDS recommended the following specific funding increases for FY16:  $23 million for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative; $5.6 million for the Precision Medicine Initiative (PMI); and $600,000 for Pain Research Funding. 

NIH Application Trends—Dr. Koroshetz reported on the number of research project grant (RPG) and R01 grant application and award trends.  NINDS is committed to maintaining a 14th percentile payline for RPGs; however, this has become increasingly difficult due to a number of factors.  In addition to an increase in the number of grant applications received (15% increase since the change to the NIH resubmission policy in FY14), the cost of maintaining the payline has increased 28 percent between FY14 and FY15.

21st Century Cures—The 21st Century Cures Act (HR 6) aims to accelerate the discovery, development, and delivery of life-saving and life-improving therapies.  The current version of this bill authorizes a $1.5 billion increase in NIH funding for the next three years and creates the NIH Innovation Fund, which will be funded by an additional $2 billion in mandatory spending for each of the next five years.  The bill establishes a Capstone Grant Program (similar to the proposed NIH Emeritus program) to facilitate lab closures at the end of a scientist’s career, updates the loan repayment program, and establishes the National Neurological Diseases Surveillance System at the Centers for Disease Control and Prevention (CDC) to collect incidence, prevalence, and other data on neurological diseases.  Also in the bill are provisions to increase NIH’s accountability, including: a requirement for five year, NIH-wide strategic plans, establishment of five-year renewable terms for Institute and Center (IC) Directors, a requirement for IC Directors to review and certify each R-series grant, and a call for the Institute of Medicine to conduct a study on research duplication. 

NIH Strategic Plan—The Consolidated and Further Continuing Appropriations Act of FY15 (Cromnibus; P.L 113-235) included legislative language requiring the NIH to develop and submit to Congress a scientific five-year strategic plan.  The strategic plan likely would include the following provisions intended to enhance NIH stewardship:  develop and implement a vision for the future of the intramural program, including positioning the NIH Clinical Center as a national resource; enhance rigor and reproducibility of NIH-supported science; build on NIH leadership in promoting open data access; conduct analysis and realignment of the HIV/AIDS portfolio; enhance prioritization through partnerships; and strengthen and sustain the biomedical workforce.    

Alzheimer’s Disease Bypass Budget—Legislative language requires a bypass budget for NIH Alzheimer’s disease research to be submitted to the President/Congress.  The Department of Health and Human Services (HHS) Secretary, in addition to the Advisory Council on Alzheimer’s Research, Care, and Services, may review and comment, but not alter, the NIH submission.  The budget will be developed based on the NIH components of the 2015 National Plan to Address Alzheimer’s Disease.  The national Alzheimer’s disease plan was released in May, and NIH is working to develop budget estimates based on elements included in this plan.

Precision Medicine Initiative—Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle.  While significant advances in precision medicine have been made for select cancers, the practice is not currently in use for most diseases.  The Precision Medicine Initiative, launched by President Obama on January 30, 2015, aims to revolutionize medicine and generate the scientific evidence needed to move the concept of precision medicine into everyday clinical practice.  The long-term vision is to expand the precision medicine cancer model to other diseases by creating a national research cohort of over 1 million volunteers to generate the knowledge base for precision medicine.  Achieving this vision will require policy changes, including removing barriers to clinical implementation, updating federal rules protecting research participants, and advancing U.S. Food and Drug Administration (FDA) oversight of precision medicine products.  At this stage of the Initiative, public input is being solicited through a Request for Information and targeted workshops.  It is expected that FY16 funding opportunities will be announced in the fall of 2015. 

Scientific / Programmatic Updates— Dr. Koroshetz highlighted recent scientific and programmatic advances from across the NINDS.  The Division of Extramural Research (DER), in response to a reported decline in fundamental basic research, released a Funding Opportunity Announcement (FOA), “Promoting Research in Basic Neuroscience (PAS-15-029),” aimed at stimulating research that addresses fundamental questions in basic neuroscience.  NINDS, the National Institute of Mental Health (NIMH), the National Institute on Aging (NIA), and the National Institute on Drug Abuse (NIDA) are participating in this effort.  In response to this FOA, 50 applications were submitted, 41 of which were assigned to NINDS.  These applications will be considered at the September Council meeting. 

DER is moving forward with the development of the previously discussed R35 program.  The goal of this program is to provide longer-term support and increased flexibility to investigators whose outstanding records of research achievement demonstrate their ability to make major contributions to neuroscience.  It is proposed that R35 awards will support the overall research programs of NINDS-funded investigators for up to 8 years, at a maximum of $750,000 direct costs per year.  This greater funding stability will provide investigators increased freedom to embark upon research that breaks new ground or extends previous discoveries in new directions.  It will also allow principal investigators to take greater risks and to undertake research projects that require a longer timeframe.

The NINDS Office of Translational Research successfully handed off two potential therapies, including: to Q-therapeutics, an amyotrophic lateral sclerosis (ALS) cell therapy developed through NINDS U01 program; and to Biogen/ISIS, an antisense therapy that is being tested in clinical trials for myotonic dystrophy.  Synthonics, supported by the NINDS Small Business Innovation Research (SBIR) program, recently announced a $2-4 million agreement with a leading manufacturing company in its development of a longer-lasting and more consistent release orally-administered formulation of levodopa. The Office of Clinical Research recently completed enrollment of two studies supported through the NINDS Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) program.

The BRAIN Initiative— The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is part of a Presidential focus aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a revolutionary new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space.Major areas of focus of the BRAIN Initiative include cell-type classification, novel tools for cells and circuit diagrams, technology to monitor neural activity, precise interventional tools, theory and data analysis tools, advancement of human neuroscience, and integration of approaches.  Dr. Koroshetz updated the Council on the current activities of the BRAIN program.  Six BRAIN FOAs were issued in FY14 and 10 in FY15.  A Notice of Intent has been released for FY16 research opportunities using invasive neural recording and stimulating technologies in the human brain.  An industry partnerships workshop is being held in June to help build the first public-private partnerships in the BRAIN Initiative space.  The total investment in the BRAIN Initiative was $80 million in FY15 and the FY16 President’s Budget calls for a total investment of $150 million for the BRAIN Initiative.  Dr. Koroshetz reviewed some of the recent scientific discoveries to result from BRAIN Initiative investments.

NIH Blueprint— The NIH Blueprint for Neuroscience Research was launched in 2004 to accelerate discoveries in neuroscience.  It is a collaborative effort among the 15 NIH Institutes, Centers, and Offices that support neuroscience research.   The collaborative pools resources and expertise from the participating ICs to conduct cross-cutting, challenging research that would be too large for only one Institute to handle.  The current memorandum of understanding (MOU) under which Blueprint operates expires in September 2016, and the Program is seeking input on future priorities.  A retreat will be held in summer 2015 to discuss proposed funding priorities for neuroscience research.

Discussion -- Council members discussed the impact of the resubmission policy on the number of NINDS grant applications received and efforts to maintain the payline.  Council offered suggestions to maintain the payline, including making deeper cuts in the amount of funding offered per award, limiting the percentage of salary that a PI can include on a grant, and looking at indirect cost rates.

IV.  Anticonvulsant Screening Program Working Group Report 

Dr. Amy Brooks-Kayal, Chief and Ponzio Family Chair in Pediatric Neurology, Children’s Hospital Colorado; Professor of Pediatrics, Neurology and Pharmaceutical Sciences, University of Colorado, reported on the NINDS Anticonvulsant Screening Program (ASP) Working Group report.

The NINDS ASP was established in 1975 as part of a larger Antiepileptic Drug Development program that included basic and clinical research with both extra- and intramural components.  The ASP arm was created to address a critical need for new anti-seizure medications and promote industry interest in their development.  The current NANDS Council Working Group was formed in July 2014.  This group was tasked with assessing the ASP’s response to the 2012 ASP report and developing an updated set of findings and recommendations on the effectiveness of the ASP and the value of the Program within the current landscape of epilepsy research and drug development.  Dr. Brooks-Kayal provided an overview of conclusions and recommendations of the 2015 ASP Working Group report. 

Council members discussed findings of the report and provided suggestions for improvement of the Program, including the inclusion of developmental models of epilepsy, consideration of the different types of epilepsy that occur across the lifespan, screening strategies for drug development for comorbidities, and increased collaborative efforts to develop new models.

Approval of Anticonvulsant Screening Program Working Group Report—Dr. Finkelstein requested, and the Council voted for, approval of the Working Group’s report.

V.  Update from the Scientific Director of Intramural Research:  Response to the Blue Ribbon Panel Report on the NINDS Intramural Research Program

Dr. Alan Koretsky, Scientific Director, NINDS, provided an update on the Institute’s response to the Blue Ribbon Panel Review of the NINDS Intramural Research Program (IRP).  The Blue Ribbon Panel report was presented to the NINDS Council by Dr. Darnell at the September 2014 meeting.

Dr. Koretsky summarized IRP strengths identified by the Blue Ribbon Panel and gave an overview of the history of the NINDS IRP and distinctive features of the Program.  Overall, the Panel found the NINDS IRP to be very active and a great place to conduct science.  The Panel report provided 15 specific recommendations in 3 major areas:  faculty development; training; and science and clinical infrastructure.  Dr. Koretsky summarized the recommendations provided in each of these areas, as well as strategies to address the recommendations.

Council members discussed NINDS’ response to the Blue Ribbon Panel report and provided additional recommendations, including enhancement of residency training programs, increased faculty diversity, and mechanisms to utilize NINDS resources and facilities.

VI. Concept Clearance for Proposed Initiatives

Planning Grant for Morris K. Udall Center without Walls for Parkinson’s Disease Research (R34)—Dr. Beth-Anne Sieber, Program Director, Neurodegeneration Cluster, NINDS, requested concept clearance for a planning grant mechanism for Parkinson’s Disease research.  The proposed grant mechanism would establish a one-year R34 planning grant program to facilitate the development of consortia to plan Parkinson’s disease “Center without Walls” applications, which is anticipated to be part of the evolution of the Udall Centers Program.  This effort would promote the formulation of new interdisciplinary teams that are uniquely poised to address critical challenges in Parkinson’s disease research.  Council voted to approve concept clearance for the R34 planning grant.

Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01)—Dr. Glen Nuckolls, Program Director, Neurogenetics Cluster, NINDS, requested concept clearance for a new initiative called Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases.  This initiative would focus on acquiring knowledge and refining tools to facilitate the design of upcoming trials; developing biomarkers and outcome measures that enable future trials to be well-powered and shorter in duration; and characterizing clinical cohorts and testing recruitment strategies that will increase the likelihood of successful trials.  Council voted to approve concept clearance for the Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases initiative.

VII.  Review of Conflict of Interest, Confidentiality, and Council Procedures

In the closed session, Dr. Koretsky presented the findings and recommendations of the Board of Scientific Counselors based on their review of specific Division of Intramural Research laboratories/units during 2014.  The Council discussed the reports of the Board and accepted them.

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, 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 407 research career development and institutional training grant applications with primary assignment to NINDS, and 243 of them (59.7 percent) were scored in the amount of $21.9 million first-year direct costs.  It is anticipated that, of the research career development and institutional training grant applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $6.5 million (96 grants).

Research Project and Center Awards – The Council reviewed a total of 1,824 research project and center applications with primary assignment to NINDS, and 1,026 of them (56.3 percent) were scored/percentiled in the amount of $420.45 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 $88 million (343 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 six Javits nominations at this meeting.

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 111 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 63 of them (56.7  percent) were scored in the amount of $18 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 $4.6 million (18 grants).

IX.  Adjournment

The meeting was adjourned at 5:10 p.m. on Thursday, May 28.

NINDS employees present for portions of the meeting included:

Dr. Amy Adams

Dr. Deborah Babcock

Ms. Kelly Baker

Dr. Patrick Bellgowan

Dr. Francesca Bosetti

Ms. Stacey Chambers

Dr. Daofen Chen

Dr. Robin Conwit

Dr. Roderick Corriveau

Dr. Chuck Cywin

Dr. Karen David

Dr. Tijuanna Decoster

Ms. Marian Emr

Ms. Stephanie Fertig

Dr. Robert Finkelstein

Dr. Jane Fountain

Mr. Ken Frushour

Dr. Brandy Fureman

Dr. Wendy Galpern

Ms. Marie Gill

Mr. Paul Girolami

Dr. Jim Gnadt

Dr. Nirupa Goel

Dr. Katrina Gwinn

Ms. Nancy Hart

Dr. Dietrich Haubenberger

Dr. Yejun (Janet) He

Dr. Deborah Hirtz

Dr. Patrick Hussmann

Dr. Lyn Jakeman

Dr. Scott Janis

Dr. David Jett

Dr. Michelle Jones-London

Dr. John Kehne

Dr. Jim Koenig

Dr. Steve Korn

Dr. Walter Koroshetz

Ms. Christine Lam

Dr. Tim LaVaute

Dr. Miriam Leenders

Ms. Quynh Ly

Dr. Ernie Lyons

Dr. Laura Mamounas

Dr. Linda McGavern

Dr. Kip Ludwig

Dr. Derek Wilkinson

Dr. D.  Elizabeth McNeil

Dr. Meghan Mott

Dr. Claudia Moy

Dr. Sarah Norring

Dr. Glen Nuckolls

Dr. Margaret Ochocinska

Dr. Joanne Odenkirchen

Dr. Michael Oshinsky

Dr. David Owens

Dr. Katie Pahigiannis

Dr. Mary Ann Pelleymounter

Dr. Audrey Penn

Dr. Linda Porter

Dr. Ipolia Ramadan

Dr. Khara Ramos

Dr. Rajesh Ranganathan

Ms. Louise Ritz

Ms. Lynn Rundhaugen

Dr. Raul Saavedra

Dr. Paul Scott

Dr. Beth-Anne Sieber

Dr. Shai Silberberg

Mr. Andrew Skinner

Dr. Randall Stewart

Dr. Coryse St. Hillaire-Clarke

Dr. Amir Tamiz

Dr. Anna Taylor

Dr. Christine Torborg

Dr. Ursula Utz

Dr. Ashlee Van’t Veer

Ms. Christina Vert

Ms. Joanna Vivalda

Dr. Salina Waddy

Dr. Patricia Walicke

Dr. Hao Wang

Ms. Margo Warren

Dr. Elizabeth Webber

Dr. Letitia Weigand

Ms. Nena Wells

Dr. Samantha White

Dr. Vicky Whittemore

Dr. Alan Willard

Dr. May Wong

Dr. Robert Zalutsky

Mr. Peter Gilbert

Ms. Diedra Prophet

Dr. Birgit Neuhuber

Dr. Daniel Miller

Dr. Diana Cummings

Ms. Shannon Garnett

Dr. Joel Saydoff

Dr. Pascal Laeng

Dr. Brian Klein

Dr. Cara Long

Dr. Alan Koretsky

Dr. Christine Swanson-Fischer

Dr. Jill Morris

Ms. Preeti Hans

Other federal employees present for portions of the meeting included:

Dr. Alexei Kondratyev, CSR

Dr. Laurent Taupenot, CSR

Dr. Cate Bennett, CSR

Dr. Wei-Qin Zhao, CSR

Dr. Valerie Durrant, CSR

Dr. Linda MacArthur, CSR

Dr. Vilen Movsesyan, CSR

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
_________________
Walter Koroshetz, M.D.
Chairperson
National Advisory Neurological Disorders
and Stroke Council

Acting 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.

Last Modified January 29, 2016