NINDS Advisory Council Meeting Minutes, January 29, 2015

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

Summary of Meeting1
January 29, 2015

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 192nd meeting on January 29, 2015, in Building 31, Conference Room 620/630/640, 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 192nd meeting of the National Advisory Neurological Disorders and Stroke Council.

Council member Karen Chen, participated by phone.

II.  Report of Dr. Robert Finkelstein; Director, Division of Extramural Research, NINDS

Approval of Council Minutes — Dr. Finkelstein requested, and the Council voted approval of the September 11-12, 2014, Council meeting minutes.

The following future Council meeting dates were confirmed:

May 28-29, 2015 (Thursday and Friday)
September 10-11, 2015 (Thursday and Friday)
February 4-5, 2016 (Thursday and Friday)
May 26-27, 2016 (Thursday and Friday)
September 15-16, 2016 (Thursday and Friday)


Council Operating Procedures — Each year Council is required to endorse the Council Operating Procedures, which include the Council Delegated Authorities. No changes were made to these procedures this year, and Council voted to approve them.

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 meeting and the upcoming year. For the current Council round, 197 applications were eligible to be expedited, including 6 K Awards, and 4 Small Business Innovation Research (SBIR) applications. 110 of these awards already have been issued, and the others will be issued shortly after Council.

Extramural Announcements — Dr. Finkelstein congratulated Dr. Michelle Jones-London on her appointment as NINDS Director of Diversity Training and Workforce Development. Dr. Finkelstein also congratulated Ms. Maxine Davis and Dr. Yuan Liu on their retirements.

Dr. Ernie Lyons, Chief, Scientific Review Branch, introduced Dr. Joel Saydoff, a new Scientific Review Officer. Dr. Lyons also congratulated Dr. JoAnn McConnell on her retirement.

Dr. Rajesh Ranganathan, Director, Office of Translational Research announced the departures of Drs. Tracey Chen and Rebecca Farkas. In addition, Dr. Ranganathan announced that Dr. Amir Tamiz will be assuming the management of the Blueprint Neurotherapeutics Program.

Dr. Koroshetz introduced Dr. Meghan Mott, a AAAS Science and Technology Policy Fellow in the Office of the NINDS Director. Dr. Amy Adams, Director, Office of the Scientific Liaison (OSL) introduced Dr. Samantha White, a AAAS Science and Technology Policy Fellow in OSL and Dr. Khara Ramos, a new Senior Science Policy Analyst. Dr. Paul Scott, Director, Office of Science Policy and Planning, introduced Dr. Nirupa Goel, a AAAS Science and Technology Policy Fellow in OSPP.

III. Report of the Acting Director, NINDS

NINDS Expedited Award Process
Dr. Koroshetz described the NINDS expedited award process and an analysis comparing the length of time to award across NIH Institutes. The analysis indicated that, in FY13, NINDS had the shortest time from summary statement to award, a success attributed partly to the expedited award process managed by the NINDS Grants Management Branch.

NIH and NINDS Budget

Dr. Koroshetz reported on the status of the NIH and NINDS budgets for FY15. The Consolidated and Further Continuing Appropriations Act of FY15 (Cromnibus; P.L 113-235 was signed by President Obama on December 19, 2014, and provided appropriations for the Federal Government through September 30, 2015 (with the exception of the Department of Homeland Security, which was funded through February 27, 2015). The average increase across NIH in FY15 was 0.31 percent. NINDS and the National Institute of Mental Health (NIMH) each received increases of $12.3 million for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Other key appropriations include: $25 million to the National Institute of Aging (NIA) to support Alzheimer’s disease research and $12.6 million to the Common Fund to support the Gabriella Miller Kids First Research Act. The Cromnibus also included a number of policy riders that affect the NIH in the areas of research reproducibility, support for new investigators, basic biomedical research, and consideration of the burden of disease for research investments. In addition, the NIH will be required to submit an agency-wide five year strategic plan. In FY15, NINDS will award noncompeting grants at full committed levels and competing grants up to the 14th percentile. Administrative cuts will continue to be 17.5 percent for non-modular grants and 12.5 percent for modular grants.

New Initiatives of Interest

On January 20, 2015, President Obama announced plans for a Precision Medicine Initiative during his State of the Union Address, the goal of which is to accelerate the development of effective treatments tailored to individual patients. This initiative will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. Funding for this Initiative would support biomedical research at NIH and regulation of diagnostic tests by the Food and Drug Administration (FDA).

NIH Application Trends

Dr. Koroshetz reported on the number of research project grant (RPG) and R01 grant applications and awards from FY12-FY14. The number of NIH RPG and R01 applications and awards has remained fairly flat over this three-year period. Over this same period, there has been an increase in the number of NINDS competing RPG applications, resulting in an overall decline in the success rate. Despite these issues, the payline has remained stable at the 14th percentile.

U.S. Medical Research Funding Trends

After a period of doubling during the years 1998–2003, funding for U.S. medical research has experienced a decade of decline. In a review published in JAMA (2015; 313:174-89; “Anatomy of Medical Research”), Moses and colleagues provide a broader perspective of the state of U.S. biomedical funding. They note that U.S. science investment increased 6 percent per year from 1994 to 2004 but only 0.8 percent per year from 2004 to 2012, with total investment representing only 4.5 percent of total health care expenditures. They also describe how the United States is falling behind its global competition, with U.S. funding declining from 57 percent to 44 percent of the global investment in science. During the time that U.S expenditures in biomedical research were declining, China tripled its funding of science and increased the size of its scientific workforce.

Recommendations from the NIH Advisory Committee to the Director (ACD)

Dr. Koroshetz provided updates from several ongoing ACD working groups, including the Physician Scientist Workforce Working Group, the Intramural Research Program Working Group, and the Diversity in Biomedical Research Working Group.

The Physician-Scientist Workforce Working Group (PSW WG) of the ACD was charged with developing approaches that could inform decisions about the development of the PSW, analyzing the size and composition of the PSW while considering the impact of NIH funding policies, assessing the needs and career opportunities for PS trainees, and identifying incentives and barriers to entering the PSW. The report from the PSW WG was released in June 2014 and included a number of recommendations related to these issues. The Long-Term Intramural Research Program (LT-IRP) Planning Working Group was charged with evaluating the NIH IRP and providing recommendations on its long-term planning efforts. The LT-IRP report was released in December 2014 and provides recommendations for intramural research and infrastructure/facilities. The Diversity in Biomedical Research Working Group (DBRWG) was charged with developing recommendations focused on key transition points in the biomedical science workforce pipeline. The overarching goal of enhancing the diversity of the NIH-funded workforce is to merge social science with biomedical research training to develop and test new approaches to training and mentoring on a large scale. A resulting DBRWG report recommendation is to establish the NIH IRP “Hub” for innovation in scientific workforce diversity.

The Office of Training, Career Development, and Workforce Diversity is supporting parallel efforts to shorten clinician-scientist training programs. NINDS will target the neurology PSW in conjunction with efforts at NIGMS and NIH-wide with the goal to reduce the total years of education/experience prior to receiving an R01 grant by incorporating research experience into residency.

NINDS Research Support—Dr. Koroshetz highlighted a number of new and ongoing research programs supported by NINDS, including: an initiative to stimulate basic neuroscience research (PAS-15-029); a competition co-sponsored with the American Epilepsy Society and the Epilepsy Foundation to develop seizure prediction algorithm; a Centers Without Walls program to speed the pace of research on difficult problems in epilepsy (e.g. identification of epilepsy genes [Epi4K] and understand sudden unexpected death in epilepsy [SUDEP]); a workshop co-sponsored by the National Heart, Lung, and Blood Institute (NHLBI), the National Eye Institute (NEI), the Office of Disease Prevention, and the Office of Research on Women’s Health focused on the diversity of small vessel biology and the need for integration of research findings across model systems, organ systems, and technologies. In addition, Dr. Koroshetz reviewed a number of new programs initiated by the NINDS Office of Translational Research to help investigators more effectively translate their basic science discoveries.

BRAIN Initiative—The BRAIN Initiative, announced by President Obama in April 2013, is aimed at revolutionizing the scientific community’s understanding of the human brain. The Initiative received $25 million in new NIH funding in FY15, which brings the total funding to $74 million including $10 million from the Blueprint for Neuroscience Research and $40 million base funding established in FY14. FY15 funding opportunities and Initiative updates can be found at http://braininitiative.nih.gov/.

Other News—In the NINDS Intramural Program, early-stage investigator Kevin Briggman has been named a Pew Scholar, and Antonia Roll-Mexak will receive the Biophysical Society Dayhoff Award in February.

NIH is honoring Santiago Ramón y Cajal, the father of modern neuroscience, with an exhibit of the scientist’s original neural cell illustrations from the Cajal Institute in Madrid, Spain. The exhibit opened November 7, 2014, with a ribbon-cutting ceremony in the Porter Neuroscience Research Center. The drawings will be on display through April 2015.

IV. The R35 Grant Mechanism
Dr. Finkelstein reported on NIH’s plans to pilot a research program-based funding mechanism (R35). The impetus for creating this award mechanism stemmed from the following issues:

  1. Federally funded Principal Investigators (PIs) spend 42 percent of their time fulfilling pre- and post-award administrative requirements.
  2. Funding levels for a given PI are unstable.
  3. Neuroscience translational tools and models
  4. Short duration grants require PIs to publish quickly, possibly discouraging rigorous, longer timeline, groundbreaking research.

The guiding principles of the NIH R35 award are to provide sustained and flexible support to investigators with outstanding records of research productivity who propose to conduct exceptional research. Supported investigators will have more freedom to perform research that breaks new ground or extends previous discoveries in new directions. Dr. Finkelstein reviewed the core features of the NINDS pilot R35 award, including eligibility criteria, the proposed funding range and duration, required effort, and submission and renewal requirements. He highlighted key elements of the application (e.g., no specific aims and a focus on the PIs past research contributions) and outlined proposed approaches for peer review and Council review of R35 applications. Potential approaches for short- and long-term evaluation of the pilot also were reviewed.

Council members discussed the scope of the R35 award, potential review criteria, mitigation of the effect of the R35 program on the payline, whether the Javits award should be continued, whether R35 awardees should be permitted to apply for additional NINDS funding, and whether the program should be targeted to applicants submitting their first competitive renewal. Council members expressed concern about this award mechanism focusing solely on first-time R01 renewals, and suggested strategies for accommodating these applications. Council also suggested that there be some ability at the administrative level to eliminate funding after a five-year review for grants that are deemed unsuccessful. However, caution should be taken in the way failures are assessed—the point of this grant is to allow higher-risk research, which can take a longer time to succeed, to be funded . Overall, Council expressed enthusiasm about this grant mechanism.

V.  Results from the NETT Evaluation

Dr. Ray Dorsey, Professor of Neurology, Co-Director of the Center for Human Experimental Therapeutics, University of Rochester Medical Center, presented an overview of the NIH Neurology Emergency Treatment Trials (NETT) network and key findings from the NETT program evaluation. NETT is a clinical research network of emergency medicine physicians, neurologists, and neurosurgeons who work together to efficiently develop more and better treatments for patients with acute neurological disorders through execution of NINDS-sponsored clinical trials. Dr. Dorsey provided a brief summary of each of the trials conducted through the NETT program. In addition, Dr. Dorsey reviewed the evaluation results, highlighting key findings regarding operational efficiency (e.g., clinical trial recruitment and enrollment) and overall performance and impact of the network. The evaluation noted that NETT’s impact could be increased by conducting more trials through established infrastructure, improving contracting processes, and engaging key groups such as minorities, junior investigators, and other network investigators. NETT is poised to conduct trials of neurological emergencies beyond stroke and, possibly, public health emergencies.

Council discussed the possibilities for NETT moving forward, and suggested adding external stakeholder assessments to any future evaluations of the program. Council also recommended that the network include academic centers located in parts of the country that currently are excluded.

VI. Concept Clearance for Proposed Initiatives

SIREN Emergency Network—Dr. Patricia Walicke, Senior Health Science Administrator, Office of Clinical Research and Office of the Director, NINDS, requested concept clearance for the Strategies to Innovate Emergency Care Clinical Trials Network (SIREN). SIREN is a trans-NIH emergency medicine network that will replace two existing NIH networks, NETT and the Resuscitation Outcomes Consortium (ROC), upon their completion in 2016. The objectives of SIREN are to efficiently execute high-impact clinical research in emergency medicine, create synergies by bringing together investigators and NIH scientists from diverse disciplines, and share infrastructure to optimize use of NINDS and NIH resources during fiscal austerity. The goal is to complete at least four large (over 1,000 participants) randomized clinical endpoint trials over a five-year period. Dr. Walicke reviewed the infrastructure, peer review process, and innovative cost structure of the proposed network. The Request for Applications (RFA) for network infrastructure will be published in November 2015 with an application receipt date in February 2016. Council voted to approve concept clearance for SIREN.

Adolescent Brain Cognitive Development (ABCD) Study—Dr. Patrick Bellgowan, Program Director, Repair and Plasticity Cluster, NINDS, requested concept clearance for NINDS to join the NIDA-led ABCD study, a large longitudinal cohort study to prospectively examine the effects of substance use on the human brain during early adolescence into young adulthood. Participating ICs include the National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Cancer Institute (NCI), the National Institute of Mental Health (NIMH), the National Institute on Minority Health and Health Disparities (NIMHD), and the NIH Office of Behavioral and Social Sciences Research. Dr. Bellgowan reviewed the five main assessments that will be conducted as part of this study. Council voted to approve concept clearance for NINDS to join the Initiative.

VII. NIH Reproducibility Update

Dr. Shai Silberberg, Program Director, Channels, Synapses, and Circuits Cluster, NINDS, provided an update on NIH efforts to enhance reproducibility in research. Building upon efforts begun at NINDS and NCI, NIH convened an ad hoc working group to examine the problem and develop principles for NIH-wide initiatives to address the issue. These principles include:

  1. Increasing community awareness
  2. Enhancing formal training of investigators
  3. Improving the review of grant applications while protecting the integrity of the science
  4. Increasing funding stability for investigators and enabling them to use more appropriate and complex study designs.

The working group identified trans-NIH actions (or pilots) to address these principles. Dr. Silberberg reviewed the FOAs for these pilots focused on topics such as review criteria pertaining to the strength of data, checklist and reporting standards, changes to the NIH Biosketch, approaches to reduce “perverse incentives” to publish, support for replication studies, and training.

In June, 2014, NIH held a joint workshop with the Nature Publishing Group and Science on the issue of reproducibility and rigor of research findings, which was attended by editors representing over 30 basic/preclinical science journals in which NIH-funded investigators have published most often. The workshop focused on the common opportunities in the scientific publishing arena to enhance rigor and further support research that is reproducible, robust, and transparent. Workshop attendees reached consensus on a set of principles to facilitate these goals. A number of journals agreed to endorse these principles, which were publicized in editorials in November issues of Nature and Science.

Council discussed: whether training grant applications should be evaluated for training in rigor, ways to improve training of young scientists, and whether current study section practices at NINDS are adequate to ensure evaluation of the strength of data used in support of applications.

VIII.  Biennial Report: Inclusion of Women and Minorities as Subjects in Clinical Research

Ms. Marie Gill, Health Program Specialist, Office of Clinical Research, NINDS, presented an overview of key findings and recommendations from the Inclusion of Women and Minorities as Subjects in Clinical Research biennial report. Congress mandates that women and minorities must be included in all NIH-funded clinical research in appropriate numbers based on the scientific question being studied. NIH ensures compliance through evaluation of inclusion at peer review, time of initial grant award, and annually over the grant period. Ms. Gill reviewed the NINDS breakdown of clinical research enrollment in FY13 and FY14 by gender and ethnic subgroups.

Dr. Elizabeth McNeil, Acting Associate Director, Office of Clinical Research (OCR), NINDS, reviewed research plans specific to phase III clinical trials and implications for the enrollment of women and minorities, and described a new monitoring system developed by NIH to track the inclusion of women in minorities in clinical studies. Dr. McNeil reported on current OCR efforts to ensure the appropriate inclusion of women and minorities in phase III trials.

Council members discussed possible ways to balance the need to do phase III trials in a manner that may inform clinical treatment with current fiscal constraints. Council offered suggestions to improve the enrollment of Hispanics to clinical trials.

Approval of Biennial Report: Inclusion of Women and Minorities as Subjects in Clinical Research—Dr. Finkelstein requested, and the Council voted for, approval of the Biennial Report.

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—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.

Research Training and Career Development Programs—The Council reviewed a total of 337 research career development and institutional training grant applications with primary assignment to NINDS, and 195 of them (57.8 percent) were scored in the amount of $22.78 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 $6.06 million (77 grants).

Research Project and Center Awards—The Council reviewed a total of 1,771 research project and center applications with primary assignment to NINDS, and 961 of them (54.3 percent) were scored/percentiled in the amount of $261.8 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 $55.85 million (253 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 four Javits nominations at this meeting.

Small Business Innovation Research and Small Business Technology Transfer Award Programs —The Council reviewed a total of 124 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 71 of them (57 percent) were scored in the amount of $17.9 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 $4.8 million (18 grants).

X.  Adjournment

The meeting was adjourned at 3:45 p.m. on Thursday, January 29.

NINDS employees present for portions of the meeting included:

Dr. Amy Adams
Dr. Deborah Babcock
Ms. Kelly Baker
Dr. Patrick Bellgowan
Dr. Francesca Bosetti
Dr. Ashura Buckley
Ms. Stacey Chambers
Dr. Tom Cheever
Dr. Daofen Chen
Dr. Robin Conwit
Ms. Janice Cordell
Dr. Roderick Corriveau
Dr. Chuck Cywin
Dr. Karen David
Ms. Maxine Davis
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. Amelie Gubitz
Dr. Katrina Gwinn
Ms. Nancy Hart
Dr. Dietrich Haubenberger
Dr. Yejun (Janet) He
Ms. Monique Hill
Dr. Deborah Hirtz
Dr. Patrick Hussmann
Dr. Adrienne Ivory
Dr. Lyn Jakeman
Dr. Scott Janis
Dr. David Jett
Dr. Li Jia
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
Dr. Yuan Liu
Ms. Quynh Ly
Dr. Ernie Lyons
Dr. Laura Mamounas
Dr. JoAnn McConnell
Dr. Linda McGavern
Ms. Barbara McMakin
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
Dr. Matthew Raymond
Dr. Robert Riddle
Ms. Louise Ritz
Dr. Rebecca Roof
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. Natalia Strunnikova
Dr. Ned Talley
Dr. Amir Tamiz
Dr. Anna Taylor
Dr. Chris Thomas
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. Pamela Wernett
Dr. Samantha White
Dr. Vicky Whittemore
Dr. Alan Willard
Dr. May Wong
Dr. Dave Yeung
Dr. Robert Zalutsky
Dr. Ran Zhang


 

Other Federal employees present for portions of the meeting included:

Dr. Cate Bennett, CSR
Dr. Seetha Bhagavan, CSR
Dr. Samuel Edwards, CSR
Dr. Peter Guthrie, CSR
Dr. Suzan Nadi, CSR
Dr. Christine Piggee, CSR
Dr. Alexei Kondratyev, CSR
Dr. Carole Jelsema, CSR
Dr. Wei-Qin Zhao, CSR
Dr. Debra Egan, NHLBI
Dr. David Lathrop, NHLBI
Dr. Monica Shah, NHLBI
Dr. Jeremy Brown, OECR/NIH
 

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

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 J. 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.