Contact: Kelly Baker
Contact Number: 301-496-9248
Contact Email: kelly.baker@nih.gov
Location:
Building 45
Natcher Conference Center
Conference Room E1/E2
Videocast
The 198th meeting of the National Advisory Neurological Disorders and Stroke Council on February 9, 2017. For more information, visit the Advisory Council web page.
Related Resources
Agenda
February 9, 2017
| Time | Agenda Item |
|---|---|
| 8:00 a.m. | I. Call to Order and Opening Remarks Dr. Walter Koroshetz, Chairperson Director, NINDS |
| 8:05 a.m. |
II. Report of the Director, Division of Extramural Activities, NINDS |
| 8:15 a.m. |
III. Report of the Director, NINDS |
| 9:15 a.m. |
IV. Cerebral Palsy Strategic Planning Dr. Jim Koenig Dr. Codrin Lungu |
| 10:00 a.m. |
BREAK |
| 10:15 a.m. | V. Future of the National Library of Medicine Dr. Patricia Flatley Brennan Director, National Library of Medicine |
| 11:00 a.m. |
VI. Concept Clearance for Proposed Initiatives: Preclinical Neurotrauma Research Initiative Dr. Patrick Bellgowan Prognostic and Monitoring Biomarker Development for Pediatric Concussion |
| 11:45a.m. |
LUNCH |
| 1:00 p.m. | VII. Creating a Sustainable Biomedical Workforce
Dr. Michael Lauer Dr. Jon Lorsch |
| 2:30 p.m. | BREAK |
| 2:00 p.m. |
CLOSED SESSION VIII. Review of Conflict of Interest, Confidentiality, and Council Procedures; |
| 5:00 p.m. | Adjournment (*This time is tentative.) |
Meeting Minutes
Summary of Meeting1
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 199th meeting on February 9, 2017, in the Natcher Conference Center, Building 45, Conference Room E1/E2, on the National Institutes of Health (NIH) campus in Bethesda, Maryland. Dr. Walter Koroshetz, Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson.
In accordance with Public Law 92-463, the meeting was:
Open: February 9, 2017: 8:00 a.m. to 2:45 p.m. for the review and discussion of program development, needs, and policy; and an overview of the NINDS Intramural Program.
Closed: February 9, 2017: 2:45 p.m. to 5:15 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
Dr. Beverly Davidson
Dr. Gordon Fishell
Dr. David Gutmann
Ms. Janet Hieshetter
Dr. David Julius
Ms. Ilene Penn Miller
Dr. Jonathan Mink
Dr. Bruce Ovbiagele
Dr. Steve Perrin (via teleconference)
Dr. Indira Raman
Dr. Steven Roberds
Dr. Ralph Sacco
Dr. S. Lawrence Zipursky (via teleconference)
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:
Dr. Libby O’Hare , Association of Independent Research Institutes
Paul Gross, Cerebral Palsy Research Network/Hydrocephalus Association
Philip Goglas II, Health and Medicine Counsel of Washington
Federal attendees are listed at the end of these minutes.
I. Call to Order and Opening Remarks
Dr. Koroshetz welcomed Council members, visitors, and staff to the 198th 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 15, 2016, Council meeting minutes.
The following future Council meeting dates were confirmed:
- May 18-19, 2017 (Thursday and Friday)
- September 7-8, 2017 (Thursday and Friday)
- February 1-2, 2018 (Thursday and Friday)
- May 24-25, 2018 (Thursday and Friday)
- September 13-14, 2018 (Thursday and Friday)
Approval of Council Operating Procedures—Dr. Finkelstein requested, and the Council voted approval of the 2017 Council operating procedures.
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 Timothy Coetzee, Bruce Ovbiagele, and Ralph Sacco for handling this responsibility for this meeting and the upcoming year. For the current Council round, 142 applications were eligible to be expedited. Eighty (80) of these awards already have been issued, and the others will be issued shortly after Council.
Extramural Announcements
Dr. Finkelstein introduced the following new staff members: Dr. Alisa Schaefer, a new Program Analyst in the Division of Extramural Research; Dr. TinaMarie Lieu, a new Program Analyst in the Training Office; Dr. Keri Ashmont, a new Program Analyst in the Repair and Plasticity Cluster; Dr. Emily Carifi, a new Program Analyst in the Neurogenetics Cluster; Dr. Moria Bittman, a new Program Analyst in the Channels, Synapses and Circuits Cluster; Dr. Andrew Breeden, a new Program Analyst in the Channels, Synapses and Circuits Cluster; Dr. Devon Crawford, a new Program Analyst working with Research Quality and on the BRAIN Initiative; and Ms. Jessica Corley, a new Technical Writer-Editor in the NINDS Office of Communications and Public Liaison. Dr. Finkelstein also gave an update on the positions of Dr. Shai Silberberg and Dr. Michelle Jones-London.
Dr. Ernie Lyons introduced Dr. Jimok Kim, a new Scientific Review Officer in the Scientific Review Branch.
Dr. Clinton Wright, Director, Division of Clinical Research (DCR), noted that Dr. Salina Waddy who formerly led NINDS health disparity efforts had taken a position with NIDDK and Ms. Lupe Aquino has taken a position with NCATS. In addition, Dr. Wright introduced Dr. Jeremy Brown, who is on detail from NIGMS and who will lead the NINDS SIREN network program; Ellen Rosenberg, a new Clinical Research Project Manager, and Dr. Carolina Mendoza-Puccini, a new Scientific Program Specialist.
Dr. Amir Tamiz, Director, Division of Translational Research (DTR), introduced Dr. Chuck Cywin in his new role as a Program Director to the Blueprint Neurotherapeutics program; Dr. Victoria Smith and Dr. Natalie Trzcinski, new Program Analysts in DTR.
Dr. Koroshetz announced that Ms. Quynh Ly was selected as the new NINDS Budget Officer.
III. Report of the Director, NINDS
NIH and NINDS Budget—Dr. Koroshetz provided an overview of funding trends and the status of the NIH and NINDS budgets. While NIH is operating under a Continuing Resolution (C.R.), noncompeting grants will be awarded at 90%, with a potential increase to 100% when final federal appropriations for Fiscal Year 2017 (FY17) are approved. The FY17 NINDS budget allocates 85.8% of funds to extramural activities, 10.1% to intramural, and 4.1% to Research Management and Support.
The NINDS payline dropped from the 15th percentile in FY16 to the 12th percentile during FY17. Driven by the growth in the number of neuroscience Ph.D. graduates and NIH policy changes that removed the limits on the number of resubmissions, the number of applications submitted to NINDS has increased by 28% since FY10. Also contributing to the decreased FY17 payline was a large increase (from $766 million to $880 million) in funds committed to the out-years (i.e. non-competing years) of awarded grants. With an average award length of five years, some of those currently committed funds will become available in FY18 and FY19. R01 and “R01 equivalent” grants, including Bridge Awards, Pioneer Awards, and R35s, comprised 61% of the competing and noncompeting extramural NINDS grants awarded in FY16. Dr. Koroshetz noted that R35 grant awards accounted for the equivalent of 1.5 percentile, in effect increasing the payline to the 13.5th percentile.
21st Century Cures Act—The 21st Century Cures Act, signed into law on December 13, 2016, establishes and revises key NIH programs. The Act establishes the NIH Innovation Fund that supports the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative ($1.5B), Precision Medicine Initiative ($1.45B), Cancer Moonshot Initiative ($1.8B), and regenerative medicine ($30M) over a ten-year period. The Act also creates a Next Generation of Researchers Initiative within the NIH Office of the Director (OD) to coordinate, develop, modify, and prioritize policies and programs to improve opportunities for new researchers in partnership with the National Academy of Sciences.
The Act authorizes the NIH Director to target loan repayment programs to meet workforce or scientific needs related to biomedical research, and establishes prize competitions for research on understudied diseases that lead to improved health outcomes.
Other provisions are designed to decrease regulatory burden and harmonize requirements. This includes establishing an Office of Management and Budget (OMB) Research Policy Board to review regulations with a goal of harmonizing them across federal agencies; directing HHS/NIH to review regulations (e.g., financial conflicts of interest, care and use of lab animals) and harmonize policies to reduce administrative burden; exempting NIH research from compliance with the Paperwork Reduction Act; exempting certain genomic information from Freedom of Information Act (FOIA) requests; and directing issuance of Certificates of Confidentiality (COC) to all NIH researchers collecting sensitive data and expanding the COC requirement to privately funded research. The Act authorizes the NIH Director to require funded recipients to share data and directs NIH to establish a working group to recommend formal policy to enhance rigor and reproducibility as well as statistical methods and data sharing.
NIH IC directors are assigned five-year terms and are responsible for making final funding decisions. In addition, NIH must develop a six-year strategic plan that incorporates coordinated strategic priorities across NIH ICs.
The Act also requires the HHS Secretary to improve collection of information on incidence and prevalence of neurologic disorders, which may take the form of a registry. Relevant information may include natural history, prevention, detection, management, and treatment approaches for the disease as well as development of outcome measures. Appropriations for this activity are not sufficient for in-depth neurologic surveillance.
NIH and NINDS Leadership Changes—Dr. Koroshetz summarized recent changes to the NIH and NINDS leadership teams. Like all Presidential appointees, NIH Director, Dr. Francis Collins, tendered his resignation to be effective on January 20. However, his resignation was returned and he continues to serve as NIH Director. Dr. Diana Bianchi has been named Director of the Eunice K. Shriver National Institute of Child Health and Human Development (NICHD). NIH Associate Director for Data Science, Dr. Philip Bourne, has accepted a position as the Stephenson Chair of Data Science, Director of the Data Science Institute, and Professor in the Department of Biomedical Engineering at the University of Virginia in Charlottesville; Big Data to Knowledge (BD2K) will transition to the National Library of Medicine (NLM). Dr. Patricia Flatley Brennan has been appointed Director of the NLM and will serve as Interim Associate Director for Data Science until Dr. Bourne is replaced.
Changes at the NIH Clinical Center include the appointment of Major General James Gilman, M.D., to the newly created position of hospital CEO and establishment of the Clinical Center Research Hospital Board. Dr. John Gallin was named NIH Associate Director for Clinical Research and Chief Scientific Officer in August 2016. A centralized Office of Research Support and Compliance (ORSC) has been formed within the Office of Intramural Research; the ORSC is responsible for setting policy and standards, quality assurance, regulatory support, education, auditing, and remediation where required.
Dr. Koroshetz announced recent changes to NINDS leadership. Dr. Amir Tamiz has been appointed Director of the Division of Translational Research, and Ms. Quynh Ly has been named Director of the Budget Office. Dr. Alan Koretsky is stepping down as Scientific Director to return to the lab full time; a search for his replacement has been launched.
Dr. Shai Silberberg has been named the NINDS Director of Research Quality. In this capacity, he will lead the Institute’s Rigor Working Group, evaluate impact of new NIH rigor criteria, and, among other activities, develop mechanisms to ensure the assessment of rigor prior to significant NINDS investments.
Dr. Michelle D. Jones-London will provide oversight and leadership as Chief of the new NINDS Office of Programs to Enhance Neuroscience (OPEN) Workforce Diversity. The goal of this new office is to open access and opportunities to increase diversity in the neuroscience workforce.
NINDS Diversity Activities
In March 2017, the NINDS Diversity Workgroup will release the “Why” survey: Investigating Factors That Influence Career Choice among Neuroscience Trainees. This survey will be sent to current Ph.D. or Ph.D./M.D. trainees and those who finished their degrees in 2008 or later who have applied for funding from NINDS or participated in an NINDS-funded program. The survey is designed to identify factors that influenced their scientific career decisions.
The Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award program supports diverse neuroscience scholars who are doing well in their neuroscience Ph.D. programs to move to the next level. This two-phase award will facilitate completion of the doctoral dissertation and transition of talented graduate students to strong neuroscience research postdoctoral positions, in addition to providing career development opportunities relevant to their long-term career goal of becoming independent neuroscience researchers. The NIH Blueprint intends to commit $1M in FY 2017 to fund approximately 20 awards.
The NINDS Council Working Group (Improving Diversity in the Scientific Workforce) examined how NINDS can leverage the unique strengths afforded by minority-serving institutions and those with a track record of educating underrepresented minority students. Top Working Group recommendations focus on trainees rather than evolving institutions, avoiding a “one-size-fits-all” application, and leveraging the power of networks and collaboration. Next steps will include drafting an institutional initiative.
Other Training Activities—Dr. Koroshetz noted that NINDS has accomplished three out of four training-related activities discussed at the January 2016 Council meeting. First, the jointly sponsored NRSA Institutional Predoctoral Training Program in Neuroscience (T32) is designed to strengthen early-stage training in experimental design, statistics, and quantitative reasoning skills. Second, an NINDS-specific F32 for postdoctoral training restricts funding to the first three years within a postdoctoral laboratory, does not require preliminary data, and encourages early planning and more creative original projects. Third, an NINDS-specific K01 for Postdoctoral Career Development seeks to support exceptional candidates with outstanding project, mentor, plan, and environment for developing the candidate’s research program. This K01 focuses on excellent research projects that require more than four years to complete. The fourth item discussed at the January Council meeting, an NINDS-specific Mentor Award, is still under development.
BRAIN Initiative—The President’s Budget in FY17 calls for an $195M investment in the BRAIN Initiative. The 21st Century Cures Act adds a $10M allocation in FY17, and a total of $1.511B to BRAIN over the next 12 years.
The December 2016 BRAIN Investigators Meeting offered opportunities for interaction across project areas and funding agencies. Needs identified at the meeting included: developing incentives for data sharing and dissemination of new neurotechnologies; encouraging scientists and engineers across many diverse disciplines and sectors to work together in new combinations and teams; developing ways to encourage parallel experimentation and exchange of ideas between animal and human groups and among clinical, translational, and basic investigators; developing public-private partnerships; and involving industry earlier in the process of technology development.
To date, over 160 publications have emerged from the NIH BRAIN Initiative. Exciting advances include development of a new fiberless optoelectrode for activating neurons while minimizing damage typically caused by fibered systems. The tiny electrode enables investigators to stimulate or inhibit and record simultaneously.
The BRAIN Initiative Alliance was formed to coordinate and facilitate communications across the partner organizations. The Alliance’s short-term focus is on a website that serves as a platform for communicating funding opportunities, news, accomplishments, and resources related to the Initiative from across its federal and nonfederal participants.
Translational Stroke Workshop—The NINDS sponsored workshop held in November 2016, brought together key stakeholders to establish a vision for the field and identify next steps toward improving animal models, experimental design, and existing infrastructure, and bridging preclinical and clinical studies in order to increase successful development of new therapies for stroke. Workshop attendees identified the following preclinical barriers: inability of animal models to adequately model naturally occurring strokes and of preclinical endpoints to reflect clinical outcomes; lab practices that lead to the overstatement of efficacy; and challenges associated with the publication of most negative findings. Clinical barriers identified include overly broad inclusion criteria; limitations of the human Rankin scale; and identification of the appropriate timing, duration, or dose for drug testing.
Society for Neuroscience 3D CNS Disease Modeling Workshop—The NINDS sponsored SfN satellite event focused on the application of 3D model systems for studying brain disorders arising from genetic mutations, environmental challenges, and pathogen exposure.
Advances—Dr. Koroshetz described the recent findings of Dr. Carsten G. Bönnemann, a pediatric neurologist from the NINDS Division of Intramural Research who identified two patients with PIEZO2 mutations that had unique neuromuscular and skeletal symptoms and a selective loss of discriminative touch perception.
Dr. Koroshetz also reported on the approval of Spinraza (nusinersen) by the Food and Drug Administration (FDA). Spinraza, the first drug approved to treat children and adults with spinal muscular atrophy (SMA) is a new anti-sense therapy that increases the SMN2 protein levels, leading to a milder phenotype of the SMN mutation. The work that led to this novel treatment provides a compelling reason for the continued support of basic science. This FDA approval represents not only a milestone for the SMA field, but provides a model for interaction between NIH funded academic investigators, foundations, and industry.
2016 Intramural Awards—Dr. Koroshetz highlighted recent NINDS Intramural investigators that had received awards in 2016. Dr. Antonina Roll-Mecak, a tenure track investigator, received the Gibco Emerging Leader Prize from the American Society of Cell Biology and was a finalist for the National Blavatnik Science Scholar Award. Dr. Danny Reich received the Baranik Prize for Innovation in Multiple Sclerosis Research from the National Multiple Sclerosis Society. Dr. Mark Hallett received the Lifetime Achievement Award from the Association of Indian Neurologists and the National Friendship Award and medal from the People’s Republic of China. Dr. Zu-Hang Sheng was named a Fellow of the American Association for the Advancement of Science.
In January, Presidential Early Career Awards for Scientists and Engineers were presented to Dr. Maria Lehtinen, Boston Children’s Hospital and Harvard Medical School, and Dr. Daniel O’Connor, Johns Hopkins University.
Dr. Koroshetz announced the retirement of Dr. Alan L. Willard, NINDS Acting Deputy Director. His prior NINDS positions include Scientific Review Administrator, Chief of the Scientific Review Branch, and Deputy Director of the Extramural Research Program. Over his 19 years at NINDS, he has done much to enhance the peer review process, earning him wide community respect in addition to several NIH Merit Awards. Dr. Koroshetz invited Dr. Willard to address the Council and other meeting participants, where he reminisced about the many changes that have occurred at NINDS over the past two decades, from technological advances to Council recommendations that were the forerunners of trans-NIH activities such as the Common Fund. He described how he was inspired not only by the accomplishments of NINDS but also the richness of experience his colleagues bring to the Institute. He encouraged the audience to continue sharing their enthusiasm about neuroscience with others they encounter in their lives.
IV. Cerebral Palsy Strategic Planning
Dr. Jim Koenig, Program Director of the NINDS Neural Environment Cluster, provided an update on strategic planning for research on cerebral palsy (CP), one of the most common childhood neurological disorders. CP is a heterogeneous group of neural developmental disorders that affect muscle tone, movement, posture, and, in some cases, speech and cognition. CP affects 2 to 4 per 1,000 children, and in low-birthweight or premature birth populations, CP incidence increases tenfold.
To inform development of the plan, NINDS and NICHD partnered with the American Academy of Cerebral Palsy and Developmental Medicine on two workshops: one focused on clinical science around CP and treatment decisions and a second focused on basic and translational research in CP. From these two workshops, three priority areas were identified: basic and translational research, clinical research, and workforce development. Basic and translational research priorities include clarifying mechanisms and establishing biomarkers. Priorities in clinical research include considering the entire lifespan, enhancing treatment options, revisiting or updating study designs in the field, maximizing the potential of existing registries and databases, and developing better data metrics. Workforce development priorities focus on enhancing training of next-generation investigators, attracting researchers to the field, and leveraging expertise across specialties (i.e., including bioengineers, computational scientists, trialists, placental scientists, etc., in the workforce). Accomplishments to date include establishment of the CP Research Network (CPRN) to address the goal of maximizing the potential of databases and registries; development and publication of CP common data elements; and development of a CP Tool Kit for families with a newly diagnosed individual.
Dr. Koenig outlined five steps for moving forward: (1) seek input from workshop sponsors and organizers; (2) post a draft Plan on NINDS/NICHD websites and invite comment from workshop participants and the public; (3) revise and finalize the Plan based on feedback and share it with stakeholders; (4) develop research initiatives to fill knowledge gaps; and (5) present the final Strategic Plan and a proposal for initiatives for approval at a future Council meeting.
Council members discussed opportunities for cross-sector and trans-NIH collaborations. Prospective partners might include investigators involved in imaging studies under the BRAIN Initiative.
V. Future of the National Library of Medicine
Dr. Patricia Flatley Brennan, Director, National Library of Medicine, NIH, presented an overview of the National Library of Medicine, the world's largest biomedical library and producer of digital information services. She described the role of NLM in using data science approaches to address important social and medical problems by providing the foundation and tools for discovery. NLM was created in 1838 in a medical army surgeon’s tent, and, over time, the focus of NLM has moved from cataloging the collection through digitizing and pushing the Internet to democratizing access to the literature. Today, nearly 300 years later, NLM resources are used by over 4 million people a day.
Dr. Brennan described attributes that make data the substrate of discovery. Data must be findable, accessible, interoperable, and reusable. In addition, Dr. Brennan described three areas of computational development that are essential to the reuse of data for future inquiry: analytics, visualization, and management.
Dr. Brennan outlined her vision for the future of NLM. First, high-value data sets must be identified and their individual purposes preserved. This may involve helping scholars, investigators, and IC directors envision what a data set should be like 15 years into the future. Next, consideration must be given to how to prepare for data of the future. Finally, the safety and accessibility of high-value data sets (i.e., physical safety as well as avoidance of intrusion or inappropriate use) must be assured. Dr. Brennan described steps taken by NLM towards advancing these goals. For example, by October 2017, PubMed Central’s full-text database will accept data sets attached to individual studies, making each study’s data set accessible at the point of engagement. ClinicalTrials.gov is working on trial declaration and results reporting. Current needs include improving safety and accessibility of high-value data sets and accelerating observational trials. In the future, there will be a demand for robust, sustainable, scalable storage solutions and new analytics grounded in emerging mathematics.
NLM is developing a strategic plan and working with several IC directors to develop a blueprint for the next phase of data science at NIH, one that integrates lessons learned from BD2K and should lead to NIH-wide and NLM-specific solutions. Short-term needs include creating mechanisms that determine high-value data sets in a systematic way and locate and forecast their cost and utilization; implementing efficient, secure preservation strategies that facilitate access and reuse; reengaging and stimulating intramural and extramural efforts in standards; developing new methods for data management and data-driven discovery; growing a talented workforce; engaging with government, national, and global collaboratives; fostering open science; and ensuring integration of lessons learned from BD2k and Cloud Pilot.
Council members discussed the need for post-discovery validation of machine learning results, how NLM can support team science while maintaining user privacy, the importance of informing potential users about available data and how to use them, and how to encourage academic institutions to integrate data-driven science approaches into the curriculum.
VI. Concept Clearance for Proposed Initiatives
Drs. Lyn Jakeman and Patrick Bellgowan, Program Directors, Repair and Plasticity Cluster, NINDS, requested concept clearance for the Translational Outcomes Project in NeuroTrauma. Preclinical Neurotrauma Research (PNR) initiative. The initiative will be supported by a one-time donation of $9.2M made by The Vivian L. Smith Foundation to the FNIH for the exclusive purpose of funding basic research in brain injury, spinal cord injury, and stroke for a new research initative of NINDS’s choosing.
The proposed initiative’s objective is to develop and validate a reproducible battery of preclinical functional outcomes that address injury heterogeneity and are closely aligned with feasible and sensitive clinical assessments in traumatic brain and/or spinal cord injury. A successful proposal should include clinical collaborations and a multidisciplinary approach, and the outcome measures should provide diagnostic and/or predictive specificity. In addition, the proposals will include a data-sharing component, as a portion of the donation was set aside to build data-sharing capacity. A phased innovation funding mechanism is proposed: a two-year UH2 preparatory phase followed by a three-year UH3 validation and dissemination phase with a cooperative agreement.
Council voted to approve concept clearance for this initiative.
Dr. Bellgowan requested concept clearance for an initiative to support biological measures of pediatric concussion and persistent symptoms. The objective of this initiative is to facilitate discovery and improve clinical care of pediatric concussion. It is expected that investigators would submit proposals to develop biological measures for pediatric concussion that help predict which patients will have persistent symptoms and that could be used to monitor recovery. Each year, an estimated 750,000 U.S. emergency department visits are accounted for by youth presenting symptoms of concussion, with up to 33% experiencing persistent symptoms greater than 28 days, and no objective markers currently exist for predicting or monitoring the course of recovery.
A single U01 Cooperative Agreement with Milestones (5 years) is proposed. Key features would include identifying biological measures for concussion and course of recovery; data collection in a pediatric cohort ages 9–14 (to match the NIH ABCD study); inclusion of cohorts with acute injury and persistent symptoms; and an accelerated data-sharing plan.
Council voted to approve concept clearance for this initiative.
VII. Creating a Sustainable Biomedical Workforce
Dr. Michael Lauer, Deputy Director for Extramural Research, NIH, and Dr. Jon Lorsch, Director, National Institute of General Medical Sciences, presented “The Biomedical Research Workforce: Supporting More Investigators Sustainably and Efficiently.” In his presentation, Dr. Lauer summarized recent publications that have characterized the biomedical research system as “unsustainable” and “hypercompetitive” and described various analyses that support claims that too many scientists are competing for too few dollars, that the age distribution of NIH PIs and medical school faculty has shifted toward older individuals, and that funding success rates for all age brackets are less than half of what they were in the 1980s. Furthermore, investigators are spending more time seeking funding and less time on research, with the heaviest burden falling on young or new faculty members.
Proposed solutions for mitigating the sustainability problem include restricting the support for an individual investigator by limiting the number of grants or total amount of funding that an investigator can have. However, these approaches fail to consider that (1) all grant mechanisms are not the same, and that (2) different types of research activities incur different levels of cost. Dr. Lauer described the Research Commitment Index (RCI), a new tool developed by OER to measure the grant support an investigator receives without penalizing them for doing more expensive research. Essentially a modified grant count approach, seven points are assigned to each R01 equivalent, fewer points for each R03 or R21, and more points for each P50 or U54.
In addition, Dr. Lauer described the Relative Citation Ratio (RCR), a field-normalized metric developed by the NIH Office of Portfolio Analysis, that shows the citation impact of one or more articles relative to the average NIH-funded paper, is another way to measure investigator output. Dr. Lauer described an analysis of more than 71,000 investigators funded by NIH between 1996 and 2014 where the relationship between an investigator’s grant support (using RCI points per year) and productivity (weighted RCR per year) was assessed. Results of this analysis showed that as investigators receive increased amounts of funding, their productivity increases by smaller and smaller increments, ultimately reaching a point of diminishing returns. An analysis of the 7,304 NINDS PIs included showed the similar results.
Dr. Lauer concluded that by limiting the resources that any one individual could receive, it could be possible to increase the number of investigators NIH supports with the available funds without adversely affecting the overall productivity of the system.
Promoting a Diverse and Sustainable NINDS Workforce
Dr. Anna Taylor, Division of Extramural Research (DER), NINDS, presented the results of an analysis of the number of R01-equivalent grants, level of NIH funding (both Direct and Total costs), and number of RCI points held by PIs who received research grants from NINDS during FY 2016. Most PIs (95%) had three R01-equivalents or fewer. On average, investigators with one R01-equivalent had $300,000 in direct costs; those with two had $500,000 in directs. Slightly more than 1,000 PIs received $250,000 or less; the majority (87%) received $750,000 or less. Most PIs had an RCI of 7 points, with a smaller peak at 14 points; only 251 NINDS PIs had RCIs above 20 points. Dr. Taylor explained that applying different theoretical thresholds of support (e.g. 20 RCI points, $750K DC, or 3 R01 equivalents) to the NINDS PIs would capture largely non-overlapping cohorts of investigators, suggesting the added value of using multiple metrics for decision-making.
Dr. Finkelstein listed other parameters to consider for an optimal funding strategy, including: maximizing research productivity/impact, ensuring a high quality training environment, promoting scientific rigor, and increasing PI diversity (e.g., women, underrepresented groups).
Drs. Lauer and Lorsch responded to questions from Council members and reiterated key points from their presentation.
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, 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 325 research career development and institutional training grant applications with primary assignment to NINDS, and 184 of them (56.6 percent) were scored in the amount of $15.86 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 $6.37 million (77 grants).
Research Project and Center Awards – The Council reviewed a total of 1,504 research project and center applications with primary assignment to NINDS, and 840 of them (55.8 percent) were scored/percentiled in the amount of $254.28 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 $54.95 million (189 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 145 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 81 of them (55.8 percent) were scored in the amount of $32.28 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 $4.73 million (9 grants).
IX. Adjournment
The meeting was adjourned at 5:15 p.m. on Thursday, February 9, 2017.
NINDS employees present for portions of the meeting included:
Dr. Amy Adams
Dr. Deborah Babcock
Ms. Kelly Baker
Dr. Patrick Bellgowan
Dr. William Benzing
Dr. Moria Bittmann
Dr. Francesca Bosetti
Dr. Andrew Breeden
Dr. Jeremy Brown
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
Dr. Edgardo Falcon
Ms. Stephanie Fertig
Dr. Robert Finkelstein
Ms. Shannon Garnett
Dr. Marie Gill
Mr. Paul Girolami
Dr. Jim Gnadt
Dr. Amelie Gubitz
Dr. Mohamed Hachichat
Dr. Yejun (Janet) He
Dr. Lyn Jakeman
Dr. Scott Janis
Dr. Sophia Jeon
Dr. Li Jia
Dr. Michelle Jones-London
Dr. John Kehne
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. Miriam Leenders
Dr. Cara Long
Dr. Codrin Lungu
Ms. Quynh Ly
Dr. Ernie Lyons
Dr. Laura Mamounas
Dr. Linda McGavern
Ms. Barbara McMakin
Dr. Daniel Miller
Dr. Jill Morris
Dr. Meghan Mott
Dr. Claudia Moy
Dr. Birgit Neuhuber
Dr. David Owens
Dr. Mary Ann Pelleymounter
Dr. Shamsi Raeissi
Dr. Shanta Rajaram
Dr. Ipolia Ramadan
Dr. Khara Ramos
Dr. Matthew Raymond
Dr. Robert Riddle
Ms. Sara Rue
Ms. Lynn Rundhaugen
Dr. Jonathan Sabbagh
Dr. Alisa Schaefer
Dr. Paul Scott
Ms. Shalini Sharma
Dr. Beth-Anne Sieber
Dr. Shai Silberberg
Mr. Andrew Skinner
Dr. Victoria Smith
Dr. Shardell Spriggs
Dr. Randall Stewart
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
Dr. Elizabeth Webber
Dr. Letitia Weigand
Dr. Vicky Whittemore
Dr. Alan Willard
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. Dana Schloesser, OD
Dr. Laurent Taupenot, CSR
Dr. Biao Tian, CSR
Dr. Seetha Bhagavan, 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.