National Advisory Council (NANDSC) Meeting - September 2020

Contact: Kelly Baker
Contact Number: 301-496-9248
Contact Email: kelly.baker@nih.gov
Location:

Videocast for open session and WebEx for staff both days. More details TBA

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The 209^th meeting of the National Advisory Neurological Disorders and Stroke Council will be held on Wednesday, September 9 - Thursday, September 10, 2020. For more information, visit the Advisory Council web page.
 

Related Resources

Agenda

September 9, 2020

Open Session

September 10, 2020

Closed Session

Meeting Minutes

Summary of Meeting¹
 

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 209^th meeting on September 9-10, 2020 via WebEx remote meeting. 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:       September 9, 2020: 1:00 p.m. to 5:40 p.m. for the review and discussion of program development, needs, and policy; and
Closed:    September 10, 2020: 1:00 p.m. to 4:57 p.m. for the consideration of individual grant applications.

Council members present:
Dr. Allan Basbaum
Dr. S. Thomas Carmichael
Dr. Hollis Cline
Ms. Susan Dickinson
Dr. Nita Farahany
Dr. Aaron Gitler
Dr. David Hackney
Dr. Karen Johnston
Dr. Arnold Kriegstein
Dr. Claudia Lucchinetti
Dr. Kenneth Maynard
Ms. Eileen Murray
Dr. N. Edwin Trevathan
Ms. Christin Veasley

Ad Hocs present:
Dr. Gina Poe
Dr. Timothy Ryan
Dr. Sameer Sheth

Ex officio member present:
David Brody, M.D., Ph.D., Department of Defense
Christopher Bever, Jr., M.D., Department of Veterans Affairs

Members of the public present for portions of the open meeting included:
Jes’Terieuz Howard, George Washington University
John Laghner, American Heart Association
Catharine Krebs, Physicians Committee for Responsible Medicine
Kathy Sedgwick, NOVA Research Company
Lisa Chen, Calibre

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 209th meeting of the National Advisory Neurological Disorders and Stroke Council.

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

Approval of Council Minutes — Dr. Finkelstein requested, and the Council voted approval of the May 27-28, 2020, Council meeting minutes.

The following future Council meeting dates were confirmed:

Wednesday & Thursday, February 3-4, 2021 (updated)
Wednesday & Thursday, May 26-27, 2021
Wednesday & Thursday, September 8-9, 2021
Wednesday & Thursday February 2-3, 2022
Wednesday & Thursday, May 18-19, 2022
Wednesday & Thursday, September 7-8, 2022

Expedited Review Process – Each Council round, a subset of Council members approves applications in advance of the meeting with scores within the payline. This expedited review process focuses on applications for which there are no unresolved issues. Dr. Finkelstein thanked Council members Indira Raman, Susan Dickinson, and Karen Johnston for handling this responsibility for this meeting and the fiscal year. For the current Council round, 190 applications were eligible to be expedited. A portion of these awards already have been issued, and the others will be issued after Council.

Extramural Announcements

All extramural introductions were posted to the NINDS Electronic Council Book (ECB).

III.  Report of the Director, NINDS

Dr. Walter Koroshetz, Director, NINDS

NIH News — DDr. Koroshetz announced the selection of three new NIH Institute Directors: Dr. Michael F. Chiang, National Eye Institute; Dr. Rena N. D’Souza, National Institute of Dental and Craniofacial Research; and Dr. Lindsey A. Criswell, National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Budget — For the Fiscal Year (FY) 2021 budget, the House Markup provides NINDS with a 1.7 percent increase over FY 2020. However, the President’s Budget provides an average 8.6 percent cut across NIH Institutes and Centers (ICs). NINDS expects to operate under a Continuing Resolution (CR) throughout much of the next year and is taking a conservative approach to budget planning going forward.

The FY 2020 budget distribution includes extramural funding (66.8%) as well as allocations for the Helping to End Addiction Long-term (HEAL) Initiative and Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative® that NINDS manages for multiple Institutes. In addition, NINDS administers approximately $212.5 million of the Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD) monies received by the National Institute of Aging (NIA).

Funding — The NINDS aims to keep the payline at or above the 14th percentile and, in recent years, has maintained a 16th percentile payline. With the expectation of a CR in FY 2021, the payline will drop to the 14th percentile for the start of FY 2021 but may go up if there is a budget increase. NINDS paid both years of the R21s out of 2020 funds to relieve pressure on the 2021 budget. NINDS also has funds for COVID-19 supplements, the R35 program, and Requests for Applications (RFAs) in particular areas.

The NINDS funding portfolio centers on advancing the Institute’s mission. Most of the competing budget supports the ingenuity of the research enterprise and funds investigator-driven research proposals within an annually established payline; in addition, NINDS designs programs and funding opportunities to capitalize on scientific opportunities (e.g., BRAIN), fill gaps (e.g., basic neuroscience), rise to meet public health challenges (e.g., ADRD, HEAL, COVID-19), and train and sustain the biomedical workforce (e.g., R35).

In some cases, NINDS funds meritorious applications beyond the payline (i.e., Select Pay) to ensure the health of the neuroscience research community and to fill scientific gaps. Examples include bridge awards to investigators with limited other lab support to prevent loss of personnel and infrastructure; early-stage investigators (ESIs; within ten years of terminal degree) to equalize their R01 success rates with those of established investigators; grants that bring diverse perspectives to excellent science (e.g., tools, skills, or workforce); and high-risk, potentially high-impact applications that offer exceptional opportunities for progress.

COVID-19 — COVID has had a significant negative impact on research progress that likely will continue for a number of years. FY 2020 COVID-19 expenditures have gone to support: urgent administrative and competitive supplements to study the neurological aspects of COVID; a surveillance database to track the long term neurological manifestations of SARS-CoV2; and funded extensions for vulnerable post-docs supported on F32s, K22s, and F99s, caught in the transition to their first faculty position. 

NINDS has funded five supplements to collect clinical, imaging, and other data on neurologic aspects of COVID-19. The virus is known to cause blood clot formation throughout the body that can cause strokes and, in children, multisystem inflammatory syndrome, which can cause stroke as well as inflammation of the heart and other organs. Following recovery from COVID-19 infection, rare cases of acute necrotizing hemorrhagic encephalopathy, acute disseminated encephalomyelitis, anti-NMDA receptor encephalitis, transverse myelitis, and Guillain Barré Syndrome have been reported. Emergence of post-COVID syndrome with a high rate of reported fatigue increases the potential for long-term disability.

NIH has been at the forefront of efforts to understand, prevent, and treat COVID-19 infections, launching a number of high-profile efforts including the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trials. ACTIV trials are testing whether neutralizing monoclonal antibodies can treat SARS-CoV-2 infection (ACTIV-2 and 3); safety and efficacy of a treatment regimen consisting of three host targeted immune modulators (ACTIV-1); and anticoagulants and antiplatelet treatment to prevent thrombosis in SARS-CoV-2 infection (ACTIV-4). NINDS is involved in the latter program. NINDS is also involved in the NIH Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. NINDS is targeting underserved populations.

COVID-19 has had a profound impact on research. Clinical trial enrollment has been disrupted, animal colonies have been lost, labs were shut down and are just beginning to reopen. Early reports suggest that women, parents with young children and ESIs may be disproportionately affected. NIH is closely monitoring the impacts on the biomedical workforce. An NIH analysis of R01 and RPG applications submitted between May 1 and June 5, 2020 found that the number of applications was about 10 percent higher than at the same time last year, and the proportion of applications with female Principal Investigator (PI) applicants was stable. Data will continue to be assessed and shared through NIH Deputy Director for Extramural Research Mike Lauer’s Open Mike Blog. Although NINDS found no change in submission patterns from applications by career stage, applications from women, or applications from underrepresented minorities, whether this pattern reflects broader impact is uncertain due to small numbers and fluctuations. NINDS will continue to watch these data closely and update Council at NANDS meetings.

NIH has made accommodations for loss of research time by extending time constraints for ESIs as well as fellowship, career development, and training awards. For example, NINDS T32 application receipt dates were extended to June 29, 2020.

Discussion of Director’s Report and COVID-Related Activities

Council members discussed ongoing COVID-related challenges such as reduced productivity of working parents in light of childcare issues and noted how the virus has highlighted issues around health disparity, equity, and bias in research. The pandemic has accelerated the transformation of how investigators interface with research participants. Many NINDS grants are moving toward digital communications that not only are necessary with social distancing but also offer advantages for the future.

Report of the Director, Part 2: Combating Racism and Promoting Equity at NINDS
Dr. Walter Koroshetz, Director, NINDS

NINDS seeks to reduce the burden of neurological disease for all people and has outlined what NINDS can do to combat racism and promote equity—as an employer and a funding agency. As an employer, NINDS can increase outreach to those with diverse backgrounds when hiring for positions within the extramural program and Office of the Director and when recruiting young scientists into the intramural program. It can scale up intramural training programs that include underrepresented groups, and provide an inclusive environment and culture that promotes diversity. NINDS plans to set up PROACTIVE, a workplace support network that organizes and trains a cadre of peer advisors to provide support, guidance, and resource information to coworkers related to a wide variety of workplace issues.
As a grant funding agency, NINDS can combat racism and promote equity by (1) attracting more individuals from underrepresented populations into neuroscience and (2) supporting research that reduces the disproportionate burden of neurological disease borne by underserved populations. To address gaps in the diversity of perspectives brought to neuroscience, NINDS can build connections between successful pipeline programs (starting with early exposure to science) and address leaks along the path to science careers; identify and root out bias in peer review and other aspects of funding decisions; support programs to “break the ice” at the faculty level (e.g., select pay, the NIH Common Fund’s Faculty Institutional Recruitment for Sustainable Transformation (FIRST) program); and develop and track metrics in a transparent way.

NINDS is engaged in health equity strategic planning toward funding a spectrum of research from basic science through clinical studies and training the next generation of health disparities investigators. Evidence from the NINDS-funded REasons for Geographic And Racial Differences in Stroke

(REGARDS) study demonstrates that more research is required with a health equity lens. Only 40 percent of the black-white stroke incidence disparity is attributable to prevalence of traditional risk factors; 60 percent of the remaining disparity factors are unclear. The NINDS Health Disparities and Inequities in Neurological Disorders (HEADWAY) Workshop (September 23–24, 2020) will focus on areas of priority and potential interventions to address the most impactful areas to achieve health equity.
Research targeted at barriers to neurohealth must take into account what NIH can and cannot do. For example, it is difficult for NIH to affect socioeconomic factors significantly, but NIH can conduct research on how to attenuate health effects of negative socioeconomic conditions; it is hard for NIH to change access to healthcare, but NIH can promote telehealth and other measures that reduce cost and improve access.
Dr. Koroshetz concluded that racism and inequity are longstanding problems and that now is the time to take action. 

Discussion of Director’s Report and Efforts to Combat Racism and Promote Equity at NINDS
Barriers and solutions to address racism and inequities include study section bias, implementing a public communications campaign telling stories of people who have entered the field, providing more support in grant writing and rewriting, and discussing all training applications so that applicants can benefit from full panel comments when revising proposals. It was noted that all K99 diversity applications are discussed during review.

IV.  Closed Session Updates

Dr. Robert Finkelstein, Director, NINDS Division of Extramural Research

Dr. Finkelstein will issue a call for volunteers to serve on a Council Working Group to optimize the closed session. Among the many items discussed during the closed session are Congressionally mandated federal initiatives such as BRAIN, HEAL and AD/ADRD. Additionally, these federal initiatives are discussed during open sessions on a rotating basis (HEAL in September, BRAIN in February 2021, and AD/ADRD in May 2021).

The 2020 ETSP Working Group priorities include enhancing early consideration of ADME issues in the screening process; prioritizing development and implementation of epileptogenesis and disease modification testing models for more rapid translation to humans; and encouraging testing of non-small-molecule therapies. The Group recommends that NINDS proactively explore and conduct outreach to identify drugs that have novel mechanisms and targets. Council noted the ETSP addresses the unmet needs of people with epilepsy, including drug refractory epilepsy, epileptogenesis, and disease modification.

V.  Neuroscience Research at the National Institute on Deafness and Other Communication Disorders

Dr. Debara Tucci, Director, National Institute on Deafness and Other Communication Disorders (NIDCD)

Dr. Tucci presented an overview of neuroscience research conducted and supported by NIDCD. The NIDCD mission is to support research and research training on the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language and to improve the lives of the millions of people with these disorders.

Hearing impairment affects 37.5 million Americans, the majority of whom are candidates for hearing aids; however, only a minority actually use hearing aids, due in part to high cost, lack of insurance coverage, stigma (especially ageism), accessibility, and the perception that hearing aids don’t work well. Approaches to improve hearing aid technology include: (1) smart hearing aids using deep neural networks to segregate sounds and isolate and amplify desired speech sounds; and (2) brain-controlled hearing aids that monitor listener brainwaves to identify the most likely environmental source of auditory attention for selective amplification. An estimated 14 to 25 million people worldwide could benefit from a cochlear implant (CI), but only 1 to 2 percent of potential implant candidates have received a CI. These devices electrically stimulate the auditory nerve directly. Barriers to CI include cost (related to electrodes that require highly skilled labor and are produced in only a few facilities worldwide) and the need for sophisticated surgery and postsurgery rehabilitation. A lack of easy design changes has stymied advances in CI technology. Machine-made thin-film electrodes have potential to decrease costs and increase functionality. NIDCD has a collaboration with theLawrence Livermore National Laboratory to make prototype CI electrodes with the hope of promoting the next generation of CI devices.

A research group is using machine-fabricated thin-film electrodes to make an implant for bilateral vestibular hypofunction. The proof of concept was successful, and the implant is being used in human clinical trials. One challenge has been the ability to implant the electrodes in the inner ear while conserving residual hearing. There is also some work to develop a combined cochlear implant and vestibular prosthesis.

The human peripheral olfactory system is of interest because of its regenerative capacity. The olfactory epithelium is able to support life-long neurogenesis, recover after injury, and restore its projection into the central nervous system. Olfactory function declines with aging. Biopsies of nasal tissue show a decrease in olfactory epithelium and increased patches of respiratory epithelium, so that, over time, the olfactory system may lose the capacity to regenerate.

Anosmia (loss of smell) is a strong predictor of COVID-19. Understanding the mechanism of anosmia raises a number of potential implications such as whether olfactory neurons serve as an entry point to the brain and enable intracranial manifestation of the infection. The prevailing theory is that SARS-CoV-2 affects the non-neural cells located near the apical surface of the olfactory epithelium; these cells are intimately associated with the olfactory neurons and surround sensory dendritic cilia that project into the nasal air space. Support cell infection can cause changes in the olfactory mucus or imbalances that can inhibit olfactory signaling. These changes can reverse rapidly, which is consistent with the fact that most COVID-19 patients recover olfactory function within a few weeks. The possibility remains that the olfactory sensory neurons are directly infected. NIDCD is supporting studies related to mechanisms underlying anosmia. NIDCD is one of the lead Institutes in the RADx initiative, which supports new nontraditional approaches, including rapid detection devices and home-based testing technologies, that address gaps in current COVID-19 testing techniques. NIDCD is supporting analysis of postmortem tissue from patients who died due to COVID-19 to evaluate the olfactory periphery and olfactory bulb for COVID-related changes in histology, cell morphology, tissue degeneration, immune responses, vasculature, and gene expression and to elucidate possible morphological and molecular changes in taste epithelium associated with CoV-2 infection and associated dysgeusia. 

VI. Update from the Scientific Director of Intramural Research (DIR)

Dr. Lorna Role, Scientific Director, NINDS

Dr. Role provided an overview of the NINDS intramural research program (IRP). NINDS plays a role in producing the best, most diverse generation of neuroscientists; modeling best practices in conducting research; and sustaining a healthy and supportive workplace. In the IRP, the investigator is supported rather than individual projects, and this provides a stable funding environment that encourages investigators to do high-risk, high-reward research enabling them to respond rapidly to new ideas and technological developments as well as emerging medical challenges. The spectacular synergies and trans-NIH interactions for intramural investigators also contribute to an optimal environment for career development. NINDS encourages interactions between NINDS intramural investigators and neuroscientists with many other NIH Institutes and Centers. Dr. Role noted that NINDS is developing a strategic plan that involves the extramural and intramural research programs. The DIR budget ($199 million) aims to maximize resources for science by minimizing administrative issues and seeking operational efficiencies.

Over the past 18 months, NINDS has promoted three Staff Clinicians to Assistant Clinical Investigators (ACIs), three ACIs to Tenure Track Investigators (TTIs), and two TTIs to Tenured, Senior Investigators. In addition, two new Basic Neuroscience Tenure Track Investigators were hired.

In terms of the COVID response procedures, the NINDS DIR management has addressed two sets of challenges: the health and safety of approximately 1,500 NINDS intramural staff who work in multiple buildings. During the first phase, NIH focused on mission-critical, and COVID-related work. In early May, the NINDS Return to Physical Workspace (RTPW) working group was formed to develop plans to ensure and support safety of staff, and establish requirements for personal protective equipment, cleaning strategies, and communication methods. Dr. Role summarized three intramural projects that exemplify research strengths and the program’s flexibility: camelid nanobodies to counter COVID

, receptor expression and synaptic targeting in studies of autism spectrum disorder, and new paradigms for voltage-activated potassium (Kv) channel mechanisms and lipid regulation. The nanobody project uses high-affinity nanobodies (NIH-CoVnb-112) to block SARS-CoV-2 spike pseudovirus infection in cells transfected with human ACE2. The autism-associated variants project found that NLGN4X traffics to the surface but NLGN4Y does not due to a single amino acid difference that is surrounded by a cluster of NLGN4X autism-associated variants. The Kv channel project is exploring the role of lipids in regulating channel activity.

Organizational improvements designed to enhance transparency and communication have included efforts to diversify group membership (i.e., scientists as well as budget and administrative operations, and research facilities management staff), with the Office of the Scientific Director as the hub. NINDS-specific processes have been introduced or emphasized in the domain of equity, diversity, and inclusion. NINDS is using professional coaches and counselors for ongoing consultation to ensure that people develop the knowledge and skills required to be good managers.

New initiatives and facilities are designed to strengthen fundamental and clinical neuroscience research and enhance interactions between these groups. Recruitment has focused primarily on systems neurobiology with human translation (e.g., the marmoset program) and structural molecular neurobiology (i.e., imaging, neurotomography, and cryo-EM). The Office of the Scientific Director has implemented a new series of special collaborative initiatives and interest groups that are intended to stimulate or incentivize high-risk, high-reward basic-clinical collaborations, basic-clinical blended special interest groups, and the NIA-NINDS Center for Alzheimer's Disease and Related Dementias (CARD) that will be an intramural hub for 80 related activities. The NINDS DIR imaging facility has been enhanced through the purchase of cryo-EM and participation in the collaborative Multi-Institute Cryo-EM Facility. 

VII. General HEAL Update

Dr. Linda Porter, Director, Office of Pain Policy

Dr. Porter presented an update on the pain management component of the NIH HEAL Initiative, including the status of programs in preclinical pain research and clinical research in pain management. HEAL receives an annual allocation of $500 million for scientific solutions to address the opioid crisis. In the early years, more funding went to the opioid component, but the strategy is moving toward balanced funding for opioid and pain research.

HEAL programs to enhance pain management include drug target discovery and optimization; device and drug optimization; preclinical drug screening; biomarkers and endpoints; longitudinal studies; and clinical trials. HEAL drug target discovery and validation programs include the Preclinical Screening Platform for Pain (PSPP) that takes in small molecules, biologics, devices, and natural products from academic or industry asset owners worldwide and assesses their potential as analgesics before moving through additional evaluation tiers. The HEAL program covers a wide array of scientific research from basic to translational to address the opioid crisis and better understand pain to ensure appropriate pain management and optimization of non-addictive therapies to treat pain. This is done through a vast network of pain management clinical trials covering many facets of pain i.e. back pain, knee pain, post-operative pain management, and cancer induced pain.

As HEAL has evolved, important cross-cutting issues—data sharing and harmonization, health disparities and research diversity, community engagement, and stigma— have led to the implementation of strategies to address them. This includes Harmonization of Patient-reported Pain Outcomes Data; research supplements to promote diversity of the pain research workforce;  a virtual HEAL investigator meeting on best practices to enhance inclusion of diverse populations in HEAL clinical trials;  a virtual workshop focused on opportunities, challenges, and benefits of engaging patients in the research process; and a Notice of Special Interest (NOSI) on availability of administrative supplements to support strategies to reduce stigma in pain management and opioid use disorder (OUD) and treatment.

New HEAL Concepts for 2021 include managing comorbid chronic pain and OUD, HEAL studies to enhance phenotyping of study participants with chronic overlapping pain conditions, and a coordinated suite of funding opportunities supporting early-phase therapeutic development for pain.

VIII. Update on Early Phase Pain Investigation Clinical Network (EPPIC-Net)

Dr. Clinton Wright, Director, Division of Clinical Research

The goals of EPPIC-Net are to provide academic and industry investigators with expert infrastructure and support for early-phase clinical testing of pain therapeutics across populations and the lifespan. As well as reducing reliance on opioids by accelerating early-phase clinical trials of non-addictive drug and device pain therapeutics.

The EPPIC-Net Infrastructure, which functions as a hub and stroke model across the country is funded through cooperative agreements, and NIH’s other transactional authority. NIH’s EPPIC-Net has developed a streamlined research proposal submission, review and award process to help get awards out the door quickly and initiate clinical trials.

Applicants include academics, industry, and a medical center. The EPPIC-Net team, clinical coordinating center, and data coordinating center ensure a robust system to engage patients (i.e., community outreach, education webinars, digital platform, recruitment dashboard) is in place before the first trial is funded. This also includes recruitment and retention plans to ensure representation, diversity, and inclusion in clinical trials.

IX.  Initiatives Requiring Concept Clearance

1. HEAL Analgesic Development Preclinical and Translational Programs
2. HEAL Initiative: Preparatory Studies for Target Validation and Initial Translational Efforts for Analgesic Development
   Dr. Michael Oshinsky, Division of Neuroscience
   The proposed concept would realign and focus HEAL pre-clinical and translational analgesic development efforts into a benchmarked suite of funding opportunities. At the discovery stage, planning grants and large projects for initial translation efforts will include assays, animal models, basic science studies, and initial chemistry studies for probes to work on those targets. It is hoped that these can move to the optimization stage and lead to an IND and first-in-human studies. Separate Funding Opportunity Announcements will be rolled into one early team project so that the work can be accomplished sequentially in a U mechanism. Progress will be evaluated annually, and it is accepted that there will be significant attrition. The Innovation Grants to Nurture Initial Translational Efforts (IGNITE) and Blueprint Neurotherapeutics (BPN) programs will play a role.
   
   Council voted to approve the above proposed initiatives.
   
   The following concept clearances are reissues of existing programs presented in the past.
    
3. Reissue: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)
   Dr. Emily Caporello, Division of Translational Research
    
4. Reissue: Analytical and Clinical Validation of Biomarkers for Neurological Disorders and Conditions
   Dr. Mary Ann Pelleymounter/Dr. Carol Taylor-Burds, Division of Translational Research
    
5. Reissue: Innovation Grants to Nurture Initial Translational Efforts (IGNITE)
   Dr. Becky Roof, Division of Translational Research
    
6. Reissue: NIH Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 - Clinical Trial Optional)
   Dr. David Jett, Division of Translational Research
    
7. Reissue: NINDS Exploratory Neuroscience Research Grant (R21 - Clinical Trial Optional)
   Dr. Tim LaVaute, Division of Neuroscience
    
8. Reissue: Smart Health and Biomedical Research in the Era of Artificial Intelligence and Advanced Data Science
   Dr. Sahana Kukke, Division of Neuroscience
    
9. Reissue: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain
   Dr. Michael Oshinsky, Division of Neuroscience
    
10. Reissue: BRAIN Initiative: Targeted BRAIN Circuits Planning Projects –Targeted BCPP (R34)
    Dr. Karen David, Division of Neuroscience
     
11. Reissue: BRAIN Initiative: Targeted BRAIN Circuits Projects-TargetedBCP (R01)
    Dr. Karen David, Division of Neuroscience
     
12. Reissue: NeuroNEXT Clinical Trials (U01 Clinical Trial Optional)
    Dr. Janice Cordell and Dr. Codrin Lungu, Division of Clinical Research
     
13. Reissue: NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)
    Dr. Janice Cordell and Dr. Codrin Lungu, Division of Clinical Research
     
14. Reissue: NINDS Ruth L. Kirschstein National Research Service Award (NRSA) for Training of Postdoctoral Fellows (F32 Clinical Trial Not Allowed)
    Dr. Steve Korn, Office of Training & Workforce Development
     
15. Reissue: NIH Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN)
    Dr. Michelle Jones-London, Office of Programs to Enhance Neuroscience Workforce Diversity

Council voted to approve the above proposed initiatives.

X.  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 335 research career development and institutional training grant applications with primary assignment to NINDS, and 194 of them (58 percent) were scored in the amount of $14.2 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 $6.3 million (91 grants).
Research Project and Center Awards – The Council reviewed a total of 1,417 research project and center applications with primary assignment to NINDS, and 788 of them (56 percent) were scored/percentiled in the amount of $273.1 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 $122.7 million (319 grants).

Senator Jacob Javits Neuroscience Investigator Awards – The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period.  Candidates are nominated and selected at each Council meeting.  Council approved two Javits nominations at this meeting: Cameron McIntyre, Ph.D. (Case Western Reserve University), and Kathleen Joyce Millen, Ph.D. (Seattle Children’s Hospital). Javits nomination for Dr. Millen was conditionally approved pending HFT resolution.

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 187 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 102 of them (55 percent) were scored in the amount of $48.5 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 $14.5 million (24 grants).

XI.  Adjournment

The meeting was adjourned at 4:57 p.m. on Thursday, September 10, 2020.

NINDS employees present for portions of the meeting included:

Amy Adams
DeAnna Adkins
Diana Andriola
Kari Ashmont
Debra Babcock
Shaunna Bach
Julia Bachman
Kelly Baker
Linda Bambrick
Karen Barnes
Jennifer Beierlein
Patrick Bellgowan
Alister Bennett
Karrah Benson
Richard Benson
Bill Benzing
Rebecca Berman
Melissa Bojos
Naomi Booker
Francesca Bosetti
Andrew Breeden
Ann-Marie Broome
Ryan Calabrese
Roger Campbell
Emily Caporello
Stacey Chambers
Chi Chang
Maria Charlier
Denise Chatman
Thomas Cheever
Daofen Chen
Bo-Shiun Chen
Severn Churn
Liz Conklin
Robin Conwit
Roderick Corriveau
Devon Crawford
Diana Cummings
Charles Cywin
William Daley
Karen David
Sara Dauber
Sara Dodson
Argenia Doss
Nadia Douaji
Kristin Dupre
Debbie Eng
Judy Fabrikant
Christina Fang
Carlos Faraco
Cassie Fields
Mary Kay Floeter
Robert Finkelstein
Trevelyan Floyd
Jane Fountain
Megan Frankowski
Alissa Gallagher
Marie Gill
Paul Girolami
Jim Gnadt
Kalynda Gonzales Stokes
Maureen Gormley
Brooks Gross
Amelie Gubitz
Mohamed Hachicha
Simon Halegoua
Maureen Hambrecht
Danielle Haney
Adam Hartman
Brandon Hartsell
Janet He
Rebecca Hommer
Nina Hsu
Eric Hudak
Xan Humphries
Smriti Iyengar
Lyn Jakeman
Scott Janis
Sophia Jeon
Dave Jett
Lisa Joliet
Michelle Jones-London
Jenny Kim
Brian Klein
Christine Koch-Paiz
Jim Koenig
Walter Koroshetz
Sahana Kukke
Joseph Kurdziel
Pascal Laeng
Christine Lam
Nick Langhals
Timothy LaVaute
Pamela Leach
Crystal Lee
Miriam Leenders
Genevieve Lind
Liza Litvina
Cara Long
Codrin Lungu
Quynh Ly
Timothy Lyden
Ernie Lyons
Laura Mamounas
Marguerite Matthews
Amber McCartney
Linda McGavern
Carolina Mendoza-Puccini
Mirela Milescu
Daniel Miller
DP Mohapatra
Marilyn Moore-Hoon
Jill Morris
Claudia Moy
Paul Myers
John Ngai
Glen Nuckolls
Ana Olariu
Mara Olenick
Lola Olufemi
Oreisa O’Neil-Mathurin
Michael Oshinsky
David Owens
Tatiana Pasternak
Michele Pearson
Mary Ann Pelleymounter
Marlene Peters-Lawrence
Erna Petrich
Leah Pogorzala
Linda Porter
Rebecca Price
Shamsi Raeissi
Shanta Rajaram
Ranga Rangarajan
K. Paul Rezaizadeh
Robert Riddle
Becky Roof
Cheryse Sankar
Joel Saydoff
Rachael Schacherer
Alisa Schaefer
Nina Schor
Paul Scott
Shalini Sharma
Siddharth Shenoy
Beth-Anne Sieber
Shai Silberberg
Mario Skiadopoulos
Kobina Smith Mensah
Peter Soltys
Shardell Spriggs
Natalia Strunnikova
Maripierre Surpris
Christine Swanson-Fischer
Edmund Talley
Amir Tamiz
Anna Taylor
Carol Taylor-Burds
Michael Tennekoon
Christine Torborg
Delany Torres
Natalie Trzcinski
Alexander Tuttle
Lauren Ullrich
Ursula Utz
Andrea Varea
Joanna Vivalda
Laura Wandner
Jackie Ward
Keith Whitaker
Samantha White
Vicky Whittemore
Sarah Woller
Ling Wong
May Wong
Clinton Wright
Ye Yan
Bob Zalutsky
Ran Zhang

Other federal employees present for portions of the meeting included:

Dr. Rebecca Baker, NIH OD
Dr. Andrea Beckel- Mitchner, NIMH
Tina Chang, CSR
Dr. Lauren Hill, NIMH
Dr. Carole Jelsema, CSR
Dr. Aleksey Kazantsev, CSR
Dr. Roger Miller, NIDCD
Pragya Prakash, NIDCD
Dr. Elyse Schauwecker, CSR
Ali Shaker, CIT
Dr. Laurent Taupenot, CSR

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

 

______
Date

_____________________________
Robert Finkelstein, Ph.D.
Executive Secretary
National Advisory Neurological Disorders
and Stroke Council

Director, Division of Extramural Research
National Institute of Neurological Disorders
and Stroke

______
Date
_____________________________
Walter Koroshetz, M.D.
Chairperson
National Advisory Neurological Disorders
and Stroke Council

Director
National Institute of Neurological Disorders
and Stroke

These minutes will be formally considered by the Council at its next meeting. Corrections or notations will be incorporated in the minutes of that meeting

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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.