National Advisory Council (NANDSC) Meeting - February 2016

Contact: Kelly P. Baker
Contact Number: 301-496-9248
Contact Email: bakerke@mail.nih.gov
Location:

NIH, Building 31, Conference Room 10

Videocast

The 195^th meeting of the National Advisory Neurological Disorders and Stroke Council on February 4 - 5, 2016. For more information, visit the Advisory Council web page.
 

Related Resources

Agenda

February 4, 2016

February 5, 2016

Meeting Minutes

Summary of Meeting¹
 

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 195th meeting on February 4, 2016, in Building 31, C Wing, 6th Floor, Conference Room 10, 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:

Council members present:

Council Roster (Attachment 1)

Council members absent:
         Dr. E. Antonio Chiocca

Ex officio members present:
         Dr. Christopher Bever, Department of Veteran Affairs
         Captain Michael Colston, Department of Defense

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

Dr. Naomi Kleitman, Craig H. Neilson Foundation
Dorothy Poppe, Chiari & Syringomyelia Foundation
Ronald Bartek, Friedreich's Ataxia Research Alliance
Philip Goglas, II, Health & Medicine Counsel of Washington
Anne McGuinness, Cure CADASIL
Ronnie Bradbury, Cure CADASIL

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 195th meeting of the National Advisory Neurological Disorders and Stroke Council.

Council members Amy Brooks-Kayal, Karen Chen, Gordon Fishell, and David Julius were unable to attend the meeting.

II.  Report of the Associate Director for Extramural Research, NINDS

Approval of Council Minutes—Dr. Robert Finkelstein requested, and the Council voted approval of the September 10, 2015, Council meeting minutes.

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 Amy Brooks-Kayal, Karen Chen, and David Julius for handling this responsibility for this meeting and the upcoming year. For the current Council round, 144 applications were eligible to be expedited, including 7 K Awards, and 4 Small Business Innovation Research (SBIR) applications. Fifty nine (59) of these awards already have been issued, and the others will be issued shortly after Council.

Extramural Announcements

Dr. Finkelstein introduced Dr. Nick Langhals and Dr. Felipe Aguel, new Program Directors in the Repair and Plasticity Cluster.

Dr. Finkelstein introduced Dr. Dana Schloesser, a new Program Analyst in the Channels, Synapses, & Circuits Cluster.

Dr. Finkelstein announced the retirement of Dr. Debbi Bergstrom from the Repair and Plasticity Cluster. He also announced Channels Cluster Program Director, Dr. Brandy Fureman’s departure from NINDS in March.

Dr. Alan Willard, Acting Director, Office of Translational Research, introduced three program analysts, Ms. Shalini Sharma, Dr. Shardell Spriggs and Ms. Oreisa O’Neil. He also introduced AAAS fellow, Dr. John Sheridan.

Dr. Claudia Moy, Acting Director, Office of Clinical Research (OCR), announced the retirement of Dr. Deborah Hirtz.

Dr. Koroshetz introduced Dr. Meghan Mott as his Chief of Staff, Dr. Samantha White as Science Communication and Coordination Specialist in the Office of the Scientific Liaison (OSL), Dr. Chris Palmer in OSL, Dr. Ling Wong as a AAAS Science & Technology Policy Fellow in the NINDS Office of Science Policy and Planning, and Dr. Leah Pogorzala as a Policy Analyst in the NINDS Office of Pain Policy.

Dr. Koroshetz announced the departures of Dr. Elizabeth McNeil, who was Acting Director in OCR, and Caroline Lewis, who was the Associate Director for Management/Executive Officer.

III. Report of the Director, NINDS

NIH and NINDS Leadership Changes—Dr. Koroshetz summarized recent changes to the leadership teams of NIH and NINDS. Dr. Sally J. Rockey has stepped down as Deputy Director for Extramural Research to become Director of the Foundation for Food and Agriculture Research. Dr. Michael Lauer was appointed as her replacement in September 2015. Dr. Tom Insel has stepped down as Director of the National Institute of Mental Health (NIMH) to join Google Life Sciences/Alphabet. Dr. Bruce Cuthbert is currently serving as Acting Director of NIMH; the search for Dr. Insel’s replacement is ongoing. Dr. Koroshetz invited Council members to contact him with any recommendations for the NIMH Director position.

Dr. Elizabeth McNeil has left the NINDS Office of Clinical Research for a position with Biogen. Dr. Claudia Moy is serving as Acting Director during the search for Dr. McNeil’s replacement. The search is ongoing for a new director of the Office of Translational Research; Dr. Alan Willard continues to serve as Acting Director. Caroline Lewis has left her position as Executive Officer for an Assistant Vice President position at the Uniformed Services University of the Health Sciences; Maryann Sofranko is serving as Acting Executive Officer.

NIH Leadership Changes—Dr. Koroshetz summarized recent changes to the leadership team of NIH.  Dr. Eliseo Pérez-Stable has been named the new Director of the National Institute of Minority Health and Health Disparities.  Dr. Kay Lund is Director of the newly formed Division of Biomedical Research Workforce within the Office of Extramural Research (OER).  Dr. Harold Varmus has stepped down as Director of the National Cancer Institute (NCI); Dr. Doug Lowy is serving as Acting Director.  Dr. Allen Guttmacher is stepping down as Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Dr. Cathy Spong will serve as Acting Director.  Dr. Sally J. Rockey is stepping down as Deputy Director for Extramural Research, NIH; Dr. Larry Tabak will serve as Acting Deputy Director.

NIH and NINDS Budgets—Dr. Koroshetz reported on funding trends and the status of the budget for fiscal year (FY) 2016. The Consolidated Appropriations Act (PL 114-113) (pdf, 1.85MB), passed on December 18, 2015, included $32.1 billion for NIH—a $2 billion increase over the FY15 budget. A large portion of this funding increase is devoted to particular programs, including an $85 million increase to the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative®; $350 million for Alzheimer’s disease research; $200 million to the Precision Medicine Initiative® (PMI); and $100 million for research focused on combatting antimicrobial resistance. Dr. Koroshetz highlighted other provisions of interest included in the bill such as a study to be led by the National Academy of Sciences on policies affecting the next generation of researchers in the US.

Alzheimer’s disease research; $200 million to the Precision Medicine Initiative® (PMI); and $100 million for research focused on combatting antimicrobial resistance. Dr. Koroshetz highlighted other provisions of interest included in the bill such as a study to be led by the National Academy of Sciences on policies affecting the next generation of researchers in the US.

In PL 114-113, NINDS received $1.695 million for FY16, which amounts to a 5.6 percent increase over FY15 funding levels. Included in that amount was an increase of $27.93 million specifically targeted for the BRAIN Initiative®. Not including funding for BRAIN, the general increase to the Institute was 3.925 percent. In response to this increase, FY16 noncompeting grants will be awarded at full committed levels with a payline at the 15th percentile.

Dr. Koroshetz reported on recent funding trends for the Institute. Following a steady decline of pure basic research over an extended period, funding in this area has reached a steady state in recent years. Additionally, the Institute has seen an increase in the number of awards and funding levels for basic disease-related research with, consequently, less funding and awards going to applied clinical and translational research. NINDS has seen an increase in the number of competing RPG applications between FY10 to FY14, but has a success rate that is comparable to other Institutes and Centers (ICs). In FY15, the NINDS success rate was 22 percent.

Alzheimer’s Disease-Related Dementia Program—NINDS is releasing multiple FY16 funding opportunity announcements (FOAs) focused on Alzheimer’s Disease-Related Dementias (ADRD) that will amount to approximately $17.8 million, supported through dedicated funds appropriated to the NIA for this purpose. The FOAs will be focused on: biomarkers for small vessel vascular contributions to cognitive impairment and dementia (VCID), basic research on diffuse white matter disease in VCID, biomarkers for Lewy body dementia, tau biology and contribution to neurogeneration, and health disparities in dementia. The 2016 ADRD Summit, hosted by NINDS in collaboration with NIA, will take place on the NIH campus on March 29-30.

Mind Your Risks Campaign—Mind Your Risks is a new NINDS-led public education campaign in partnership with the Million Hearts ®, NHLBI, and NIA, to raise awareness among middle-aged individuals with hypertension that controlling blood pressure may decrease their risk for dementia and stroke later in life. It also provides scientific evidence for doctors who wish to discuss this topic with their patients. The campaign launched with a public service announcement in the “stroke belt” states.

The BRAIN Initiative®—Approximately $150 million has been appropriated for the BRAIN Initiative® in FY16. As part of the Program, a BRAIN Neuroethics Workgroup has been established to advise NIH on the neuroethics questions important for BRAIN, draft relevant guidance documents to address critical ethical issues, and consider proposed funding areas for BRAIN projects for questions of ethical risk. A workgroup meeting is being held February 9th with BRAIN PIs who are conducting invasive human studies.

Dr. Koroshetz briefed council on The BRAIN Initiative® Alliance, a collaboration among multiple federal agencies and private organizations. The aim of this organization is to coordinate and facilitate communication from its many members nationally and abroad. International partnerships exist to foster collaborative research in areas of mutual interest. Currently, there are jointly supported research projects involving Danish and U.S. scientists focused on the exchange of scientific information.

Dr. Koroshetz highlighted the launch of the new BRAIN website and summarized significant scientific advances and tools being developed as a result of the Initiative.

Update on Concussion Research—The Sports Health Research Program is an innovative partnership among the National Football League (NFL), the NIH, and the Foundation for the NIH. It was launched in 2012 with a founding $30 million commitment from the NFL to support high impact research, with an initial focus on Traumatic Brain Injury. Currently, the program is conducting two studies to try to understand the neuropathology of chronic traumatic encephalopathy (CTE) and to develop an imaging technology to accurately detect the disease. In concert with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NINDS will form a working group of Council to discuss the next highest priority opportunities in concussion research. A workshop will be held to help facilitate creation of a research plan to be approved by Council and presented to FNIH.

Programs in Chronic Fatigue Syndrome—Dr. Koroshetz updated Council on the recent developments at NIH surrounding Myalgic Encephalitis/Chronic Fatigue Syndrome (ME/CFS). ME/CFS affects between 800,000 and 2.5 million people in the U.S., predominantly women. As the cause of ME/CFS is unknown, and the symptomology traverses many different organ systems, Dr. Francis Collins, Director, NIH, tasked the Institute Directors with working together to address this public health problem. Dr. Avi Nath, from the NINDS Division of Intramural Research is leading an NIH-wide protocol to begin a variety of neurologic and immunologic studies on patients with this disorder. Dr. Vicky Whittemore, Program Director, NINDS, is leading a trans-NIH working group to develop an extramural research program in ME/CFS with the goal of advancing research on the cause, prevention, diagnosis, pathophysiology, and treatment of ME/CFS.

Pain Research Programs—The National Pain Strategy: A Comprehensive Population Health Level Strategy for Pain is being released in February. The strategy includes specific goals, actions, time frames, and resources for pain prevention, treatment, management, education, reimbursement, and research. The National Pain Research Strategy includes a focus on the continuum of pain—pain as a temporal process beginning with an acute phase that may process to a chronic maladaptive state. The NIH Pain Policy Office is working to communicate ways that patients can best manage pain while preventing opioid addiction and overdoses. These efforts are in collaboration with other federal agencies, such as the CDC, which has developed guidelines and recommendations for prescribing opioids for chronic pain.

Precision Medicine Initiative®—The NIH Precision Medicine Initiative® received $200 million in funding for FY16. The long-term vision of this initiative 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.

Trans-NIH Policy Discussions—The NIH-Wide Strategic Plan was published on December 16, 2015. As a result of this plan, NIH is discussing how to best improve its stewardship. Issues under discussion include whether NIH should focus more on supporting a broad and diverse portfolio of investigators, a minimum percent effort by PIs, and whether NIH should establish shared regional research resources and facilities to improve access to cutting-edge technologies and reduce costs by economies of scale.

NIH has collected data from all of the ICs on the number of grants funded after receiving a score within their operating payline(s) and those that were funded via select pay—the term for out-of-order, exception-funded proposals. Unlike NINDS, many ICs do not publish their payline. Analyses of NINDS data indicate a consistent approach by the Institute to fund almost all applications within the payline. Much of what NINDS pays outside of the payline is to new investigators or via the High Program Priority process.

Neuroscience Training—Dr. Koroshetz discussed the primary issues affecting training in neuroscience. The number of graduate students is increasing dramatically while the time to independence is also dramatically increasing. Compared to other scientific fields, the number of trainees and fellows receiving Ph.D.s in neuroscience has dramatically increased over the past 10 to 15 years. Tools have become more sophisticated, and an increased degree of sophistication is needed for data analysis. There are new emphases on attracting scientists from outside biology and on rigor in experimental design and statistical analysis. The funding climate became much more competitive during the 12 flat NIH budget years, and there is concern that associated pressures has led to a decline in career mentoring. There is also concern that attempts to increase diversity in trainees is not translating as well as hoped into diversity in the academic workforce.

The IOM Neuroscience Forum, Defining the Expertise Needed for a 21st Century Neuroscience Workforce, discussed many of the aforementioned issues. The IOM concluded that training for neuroscientists needs more mentoring, experimental and analytical skills, communication and writing skills, lab and office management, and ethics in science. Training in neuroscience also needs tracks for those coming from physical and computational backgrounds, a focus on team science, and tracks for translational science.

IV.  NINDS Training and Training Mechanisms

Dr. Stephen Korn, Director, The Office of Training, Career Development and Workforce Diversity (OTCDWD), NINDS, provided an overview of NINDS-supported training activities. OTCDWD supports the training of students (high school through graduate school), postdoctoral fellows, clinician-scientists, and faculty across NINDS research areas. The office also creates and supports programs to prepare diverse students and fellows to pursue research careers in neuroscience. Specific programs seek to enhance diversity of the neuroscience workforce by supporting individuals from underrepresented ethnic/racial minority groups or disadvantaged backgrounds, individuals with disabilities, and individuals re-entering the biomedical research workforce.

Dr. Korn reviewed the opportunities and programs available to trainees through NINDS grant awards, including predoctoral fellowships (F awards), mentored career development (K), and institutional programs (T32s, K12, and R25). In FY14, 4.7 percent of the NINDS extramural budget was devoted to NINDS training programs (e.g. NRSAs and K awards), and Dr. Korn provided an overview of award trends and success rates for various programs. Overall, NINDS funds more fellowships relative to other ICs but supports a relatively small number of T32s. Moreover, the number of NINDS T32s has decreased by about 25 percent since 2009, largely due to non-renewal of postdoctoral T32s that lacked a cohesive “program.”

Dr. Diane Lipscombe, Professor of Neuroscience; Interim Director, Brown Institute for Brain Science, Brown University, provided her perspective on the value of predoctoral neuroscience training activities at NINDS. She made the argument that T32 training grants, in particular, are the best value added training opportunities available in the neuroscience field. The T32s provide a framework upon which institutions can build upon, and serve as a catalyst for the transfer of information across graduate programs. The T32 grants are an essential avenue for NINDS to impact the next generation of neuroscientists. Following Dr. Lipscombe’s presentation, Dr. Korn made three proposals for Council consideration: 1) redesign the T32 program to incorporate more quantitative skills, 2) develop a new mentor award, and 3) initiate an NINDS-specific F32 program with the goal of facilitating a more rapid transition to independence.

Council members discussed the redesign of early stage predoctoral neuroscience programs (T32s) to enhance training in experimental design, statistics, and quantitative reasoning. Council suggested hosting regional training programs across the country focused on neuroscience curriculum development. The proposed curriculum should also include an emphasis on research ethics. Council suggested providing additional funds for successful programs to support new curriculum development.

Council also discussed a proposed award for incentivizing and rewarding outstanding mentors, particularly the eligibility, nomination process, and vehicle for providing the award. Council recommended opening the award to faculty at all career stages, having an open nomination process, and providing unrestricted funding for the award. In developing the award, Council suggested that NINDS consider how supported mentors might train their trainees to also become mentors.

Lastly, Council members discussed the proposed NINDS F32 program. NINDS is concerned that too much time in post-doctoral fellowships is spent past the “training” period, delaying a post-doc’s transition to an independent career. This is thought to be incentivized by the current market dynamics associated with the required data to successfully obtain an F32, thereby encouraging later and safer applications. NINDS proposes to develop an F32 awards where funding would not extend beyond year 3 in a single lab, and no preliminary data would be required in the application. Council expressed enthusiasm for the F32 as well as the potential development of a new mechanism to support postdocs in years 4-6 in a given postdoc lab. They noted that in order for this new approach to be successful, study sections would need to be re-trained to evaluate the individual and not whether the science will be successful.

V. NINDS Strategies to Enhance Diversity of Neuroscience Researchers

Dr. Michelle Jones-London, Director, Diversity Training and Workforce Development, NINDS, provided an overview of NINDS strategies to enhance the diversity of the neuroscience workforce. These strategies include: identifying diverse students early in the pipeline to recruit and prepare trainees (e.g., NIH Blueprint ENDURE); developing meaningful mentorship and connecting diverse individuals to support scientific and professional development networks (e.g., Neuroscience Scholars Program at Society for Neuroscience); providing resources for retaining researchers and eliminating barriers for career transition (e.g., Diversity K22 and K01); and assessing and monitoring the NINDS investment (e.g., Outcomes of Diversity Supplement Program). To further assess the career trajectory of neuroscience trainees, a subcommittee of the NINDS Diversity Workgroup has developed a survey entitled “Investigating Factors that Influence Career Choice among Neuroscience Trainees.” This survey will be released in August 2016, to current Ph.D. students and individuals who finished their Ph.D. in 2008 or later. Dr. Jones-London concluded by summarizing future plans and growth opportunities for NINDS-supported diversity programs.

Council members discussed innovative strategies used by diversity programs at their home institutions that may be useful to NINDS. They discussed whether a transition program at earlier career stages is something NINDS should explore, and approaches for increasing diversity in NINDS’ science/disease-focused initiatives. Council suggested that the Institute take the lead in bringing scientific rigor to the diversity issue by trying to understand the science of diversity.

VI. 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 266 research career development and institutional training grant applications with primary assignment to NINDS, and 168 of them (63.2 percent) were scored in the amount of $12.44 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 $9.19 million (72 grants).

Research Project and Center Awards— The Council reviewed a total of 1,603 research project and center applications with primary assignment to NINDS, and 853 of them (53.2 percent) were scored/percentiled in the amount of $230.7 million first-year direct costs. It is anticipated that, of the research grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $59.78 million (268 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 158 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 83 of them (52.5 percent) were scored in the amount of $24.5 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 $1.56 million (5 grants).

VII. Adjournment

The meeting was adjourned at 3:55 p.m. on Thursday, February 4.

NINDS employees present for portions of the meeting included:

Other federal employees present for portions of the meeting included:

Dr. Christine Piggee, CSR
Dr. Alexei Kondratyev, CSR

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

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.