National Advisory Council (NANDSC) Meeting - September 2015

Open: September 10, 2015: 8:05 a.m. to 2:30 p.m. for the review and discussion of program development, needs, and policy; and

Closed: September 10, 2015: 2:45 p.m. to 5:25 p.m. for the consideration of individual grant applications.

 

Council members present:

Dr. Amy Brooks-Kayal
Dr. Karen Chen
Dr. Timothy Coetzee
Dr. Beverly Davidson
Dr. Byron Ford
Dr. David Goldstein
Dr. David Julius
Ms. Ilene Penn Miller
Dr. Jonathan Mink
Ms. Amy Comstock Rick (via teleconference)
Dr. Ralph Sacco
Dr. Lawrence Zipursky

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

Ad Hoc Consultants present:

Dr. Gordon Fishell
Dr. David Gutmann (via teleconference)
Ms. Janet Hieshetter

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. Walter Koroshetz, Director, NINDS, welcomed Council members, visitors, and staff to the 194th meeting of the National Advisory Neurological Disorders and Stroke Council.

Council member, Nino Chiocca, was unable to attend this meeting. Council member, Amy Rick, participated by phone. Ad hoc member, David Gutmann, also participated by phone.

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 May 28, 2015, Council meeting minutes.

The following future Council meeting dates were confirmed:

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

Expedited Review Process—Each Council round, a subset of Council members approve applications in advance of the meeting with scores within the payline for which there are no unresolved issues. Dr. Finkelstein thanked Amy Brooks-Kayal, Karen Chen, and David Julius, for handling this responsibility for this meeting and the upcoming year. For the current Council round, 182 applications were eligible to be expedited, including 8 K Awards, and 4 Small Business Innovation Research (SBIR) applications. One hundred thirty two of these awards had already been issued, and the others will be issued shortly after Council.

Extramural Announcements—Dr. Finkelstein introduced Melissa Tipton, Committee Management Specialist, Division of Extramural Research; Dr. Christine Swanson-Fischer, Program Analyst, Neurodegeneration Cluster; Dr. Jordan Gladman, Program Analyst, Neurodegneration Cluster; and Dr. Edgardo Falcon-Morales, Program Analyst, Training and Workforce Diversity Office. Next, he congratulated Dr. Raul Saavedra, Scientific Review Officer, Scientific Review Branch, on his retirement. Lastly, he congratulated and bid farewell to Dr. Kip Ludwig who is leaving NINDS/NIH.

Dr. Elizabeth McNeil introduced Ms. Sara Rue, Program Analyst and Ms. Lupe Aquino, Clinical Trials Research Program Manager. In addition, Dr. McNeil announced the departure of Dr. Wendy Galpern.

Dr. Walter Koroshetz announced the departure of Dr. Rajesh Ranganathan, Director, Office of Translational Research. Dr. Alan Willard will be Acting in this role until a replacement is identified.

III. Report of the Director, NINDS

Introduction—Dr. Koroshetz introduced himself to Council and highlighted significant points of his career.  He summarized the guiding principles by which he seeks to lead NINDS, and noted that  achieving the Institute’s goals will entail identifying technologies/new scientific advances that can enable quick jumps, taking advantage of opportunities to incentivize team science problem-solving, and building productive collaborations within NIH and beyond.

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.

Precision Medicine Initiative®—Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle. The Precision Medicine Initiative® aims to revolutionize medicine and generate the scientific evidence needed to move the concept of precision medicine into everyday clinical practice.  The long-term vision is to expand the precision medicine cancer model to other diseases by creating a national research cohort of over 1 million volunteers to generate the knowledge base for precision medicine.  Workshops were held between February and July 2015 to generate public input on relevant issues such as participant engagement and health equity and unique scientific opportunities for the cohort.  Initial fiscal year (FY) 2016 funding opportunities for this Initiative will be announced in the fall of 2015.

NIH Blueprint—The NIH Blueprint for Neuroscience Research was launched in 2004 to accelerate discoveries in neuroscience.  This program is a collaborative effort among 15 NIH ICOs that support neuroscience research.  Although the focus of the NIH Blueprint has changed over time, one consistent component of the effort is that the results should be useful to awardees of all of the participating ICOs.  In recent years, the focus of the NIH Blueprint has evolved into the support of larger, longer-term projects to catalyze research with the potential to transform the basic understanding of the brain and approaches to treating brain disorders.  These projects have included the Human Connectome Project, Grand Challenge in Chronic Pain, and Blueprint Neurotherapeutics Network.  The current memorandum of understanding (MOU) under which the Blueprint program operates expires in September 2016.  Dr. Koroshetz reported that moving forward, the focus will continue on Grand Challenge-level investments based on all or a subset of ICs with a high level of enthusiasm.  The participating ICs will provide funding specifically for these projects.

The BRAIN Initiative®—Dr. Koroshetz reported on a number of scientific advances that have begun to emerge from The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative®.  He announced that a town hall meeting and reception will be held on October 20, 2015, at the Society for Neuroscience meeting, to provide attendees with updates and outreach information on the Initiative.

Aging of the NIH Workforce—The average age of NIH grantees has been steadily increasing.  From FY98 to FY14, there was a significant drop in the number of research program grant (RPG) direct cost dollars awarded to the 36-40 and 41-45 age groups and a concurrent growth in the 46-50, 51-65, and over-65 age groups.  In response, NIH implemented policies to increase the number of R01s awarded to new investigators (NIs) and early-stage investigators (ESIs).  In addition, the agency is considering a new award, The Capstone Award, to facilitate the successful transition of research programs.  Individuals who receive a Capstone Award would not be eligible to have Principal Investigator (PI) status on subsequent awards from NIH.

NINDS Diversity Workgroup Updates—The NINDS Diversity Workgroup, composed of staff from across the NINDS, meets monthly to discuss strategies for enhancing diversity in the neuroscience workforce.  Activities of the Workgroup include the development of a survey to gather input about the factors influencing individual career choices, and the formation of a partnership with the Prince Georges County Memorial Library System to promote neuroscience education and awareness among students from groups primarily underrepresented in neuroscience research.  In addition, the NINDS is participating in an NIH-wide program HiSTEP, which seeks to expand the pipeline of students interested in biomedical and healthcare careers by inviting high school students from schools with a large population of financially-disadvantaged to participate in a 5-week, full-time summer internship program.

Leadership Changes at NINDS—Dr. Koroshetz summarized leadership changes at NINDS.  Dr. Alan Willard is serving as Acting Deputy Director of NINDS.  Dr. Elizabeth McNeil is Acting Director of the Office of Clinical Research (OCR); the search is ongoing for a Director.  Dr. David Owens is serving as Acting Deputy Director of the Division of Extramural Research.  Dr. Claudia Moy has been named Acting Chief of the Office of International Activities within OCR.  Dr. Rajesh Ranganathan has left the Office of Translational Research; Dr. Alan Willard currently is serving as Acting Director.

Recent NINDS Activities—Dr. Koroshetz highlighted recent successes in the translational U award program, including a small molecule therapy for Alzheimer’s that has transitioned to the National Institute for Aging for clinical trial funding, and the approval of an Investigational New Drug (IND) biologic therapy for stroke.  In addition, Dr. Koroshetz highlighted several research advances from both the extramural and intramural programs, and briefly discussed the community response to the recently established NINDS Research Program Award (RPA; R35).

IV.  NINDS Budget Presentation

Dr. Koroshetz reported on funding trends and the status of the NINDS budget for FY16.  The budget has remained fairly flat over the past five years and has not reached FY11 levels due to sequestration imposed by the Budget Control Act of 2011 (P.L. 112-25) (PDF, 190 KB).  The FY16 President’s Budget proposes a 3.47 percent increase from FY15 funding levels for NINDS; the overall increase for NIH is 3.3 percent.  The House and Senate FY16 budgets also call for increased funding for NIH.  New NIH funding has been proposed for:  The BRAIN Initiative®, the Office of Pain Policy, the Precision Medicine Initiative®, and Alzheimer’s disease research, all high-priority areas of the current administration.  In FY15, 86 percent of the NINDS budget went to support extramural programs; 9.9 percent to the intramural program; and 4 percent to Research Management & Support (RMS).

Dr. Koroshetz reported on recent RPG and R01 grant applications and award trends.  The number of RPG applications has increased by about 1,000 between FY10 and FY14.  NINDS is committed to maintaining a 14th percentile payline for investigator-initiated research; however, doing so has become increasingly difficult due to greater numbers of grant applications received. Since the changes to the NIH resubmission policy were made in 2014, NINDS has seen a 15 percent increase in the number of RPG applications.  As the number of payline awards increased by 28 percent in FY15, and the average cost of an individual award increased from $330K to $350K, the cost of maintaining the payline has increased by 34 percent compared with FY14.  Dr. Koroshetz noted that training support has remained stable. Moving forward, Dr. Koroshetz indicated that NINDS intends to preserve the number of unsolicited investigator-initiated applications that are awarded.

Council members requested an overview of the NINDS training and career portfolio at the next Council meeting.

V. The NIH Strategic Plan - Dr. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health

Dr. Larry Tabak, Principal Deputy Director, NIH, provided an overview and status update of the NIH-wide Strategic Plan.  The Consolidated and Further Continuing Appropriations Act of FY15 (P.L. 113-235)  (PDF, 1.5 MB) included legislative language mandating NIH to develop and submit to Congress a scientific five-year strategic plan.  NIH is developing this Plan to outline a vision for biomedical research that will pursue fundamental knowledge about the nature and behavior of living systems and apply that knowledge to extend healthy life and reduce illness and disability.  NIH senior leadership and staff from all 27 Institutes, Centers, and Offices, with input from the Advisory Committee to the Director of NIH, have developed a framework for the Strategic Plan.

The framework identifies areas of opportunity that apply across biomedicine as well as unifying principles to guide NIH in supporting the biomedical research enterprise.  These areas of opportunity focus on fundamental science, health promotion/disease prevention, and treatments/cures.  The aim is to exemplify ICO priorities by identifying major cross-cutting Agency themes.  After incorporating feedback from the public comment period, feedback is now being requested from the National Advisory Councils.  The NIH-wide Strategic Plan is due to Congress in December 2015.

Council members discussed the benefits and drawbacks of the framework structure and content, and offered suggestions for trans-NIH themes and emerging opportunities that have not been captured by the Plan.  Council suggested metrics be considered to determine success of the health-related research efforts by other government agencies.

VI. Future of the Javits Award - Dr. Robert Finkelstein

Future of the Javits Award—Dr. Finkelstein provided a brief history of the Javits Award program and discussed the potential overlap of this program with the newly developed RPA (R35) program.  As both the Javits award and the newly developed NINDS Research Program Award have similar criteria and are for similar lengths of time, NINDS proposed the following changes to the Javits Award program:

• Make the award more selective by funding only one award per Council round.
• Increase the length of the award from seven to ten years.
• Publicize the award more vigorously to enhance its prestige.
• Maintain diversity of recipients.

Council members discussed the proposed changes.  They believed that now that gender disparity issues have been resolved for the Javits, that the number of awards should not be reduced.  NINDS will continue with the two award programs as they stand and develop evaluation parameters to determine productivity of the awards.

Funding New Investigators—Dr. Anna Taylor, Health Science Specialist, Division of Extramural Research, NINDS, discussed support for investigators in the early stages of their careers.  Over the years, NIH has launched multiple initiatives and policies in an effort to create a more stable funding environment for early career investigators (New [NIs] and Early Stage Investigators [ESIs]) and to address the aging of the NIH-supported workforce.  NINDS does not currently have a published policy to support early career investigators; however, in recent years, NIs and ESIs up to the 25^th percentile have been considered for funding.

Dr. Taylor presented the results of an analysis looking at whether a payline advantage at the time of an investigator’s first R01 influences his/her ability to obtain subsequent R01 funding.  Findings from a limited cohort of investigators indicate that approximately 50 percent of NIs receive subsequent R01 support from NINDS regardless of whether their first R01 was funded within or outside of the payline.

Council members discussed NINDS support for investigators in early stages of their careers.  Council requested data on the average age of first R01 for NINDS-supported investigators.

VII. Optimizing Council Closed Session - Dr. Robert Finkelstein

Dr. Finkelstein proposed changes to make the Council closed sessions more productive.  This would entail dividing Council members into three groups to review a portion of the upcoming closed session agenda and prioritizing the meeting discussion.  Council members expressed support for this change but suggested that a single subgroup of Council members review the agenda items for each meeting.  Council also requested more information in their pre-meeting materials, including more complete and consistent grant support information and access to the grants being discussed.  

VIII. Update on the BRAIN Initiative®

Dr. Alan Willard, Acting Deputy Director, NINDS, and Dr. Ned Talley, Program Director, NINDS Channels, Synapses and Circuits Cluster, provided an update on the BRAIN Initiative®.  The NIH component of the BRAIN Initiative® is guided by the long-term scientific plan, BRAIN 2025 (PDF, 1.22 MB): A Scientific Vision, which details seven high-priority research areas.  These include cell-type classification, novel tools for cells and circuit diagrams, and technology to monitor neural activity among others.

Dr. Talley summarized the BRAIN awards made in FY14 and FY15.  The total NIH investment in the BRAIN Initiative® was $85 million in FY15, supporting 125 awards.  Of that total, 67 new awards, totaling more than $38 million, went to 131 investigators working at 125 institutions in the United States and eight other countries.  These awards will expand NIH efforts to develop new tools and technologies to understand neural circuit function and capture a dynamic view of the brain in action.  Projects include proposals to develop soft self-driving electrodes, ultrasound methods for measuring brain activity, and the use of deep brain stimulation to treat traumatic brain injuries.  Dr. Talley reported on the upcoming Request for Applications for FY16. The FY16 President’s Budget calls for an additional investment of $70 million in the BRAIN Initiative®.

Dr. Willard noted the efforts of the BRAIN Neuroethics Workgroup, which was created in response to recommendations from the 2014 NIH workshop, Ethical Issues in Neuroscience Research.  The workgroup is a consultative ethics group to work with BRAIN leadership and investigators to provide ethics consultations, advise on ethics issues, and provide an overall ethics framework for the BRAIN Initiative.

IX. Council Consideration of Pending Applications

This portion of the meeting, involving specific grant review, was closed to the public. The Council gave special attention to applications from foreign institutions and other applications requiring specific discussion. Prior to discussion of the grants, Dr. Finkelstein reminded Council members regarding conflict of interest and confidentiality.

Conflict of Interest—Regulations concerning conflict of interest were reviewed.  Council members were reminded that materials furnished for review purposes and discussion during the closed portions of the meeting are considered privileged information. All Council members present signed a statement certifying that they had not been involved in any conflict-of-interest situations during the review of grant applications.

Confidentiality—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 288 research career development and institutional training grant applications with primary assignment to NINDS, and 184 of them (63.8 percent) were scored in the amount of $12.43 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 $5.27 million (64 grants).

Research Project and Center Awards – The Council reviewed a total of 1,665 research project and center applications with primary assignment to NINDS, and 939 of them (56.4 percent) were scored/percentiled in the amount of $292.2 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 $72.66 million (261 grants).

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 139 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 69 of them (50 percent) were scored in the amount of $20.875 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 $3.46 million (11 grants).

X. Adjournment

The meeting was adjourned at 5:25 p.m. on Thursday, September 10.

NINDS employees present for portions of the meeting included:
Dr. Amy Adams
Ms. Lupe Aquino
Ms. Kelly Baker
Dr. Patrick Bellgowan
Dr. Francesca Bosetti
Ms. Stacey Chambers
Dr. Daofen Chen
Dr. Robin Conwit
Ms. Janice Cordell
Dr. Roderick Corriveau
Dr. Charles Cywin
Dr. Karen David
Dr. Tijuanna Decoster
Ms. Marian Emr
Ms. Stephanie Fertig
Dr. Robert Finkelstein
Dr. Jane Fountain
Mr. Ken Frushour
Dr. Brandy Fureman
Ms. Shannon Garnett
Ms. Marie Gill
Dr. Jordan Gladman
Mr. Paul Girolami
Dr. Jim Gnadt
Dr. Katrina Gwinn
Ms. Preeti Hans
Dr. Yejun (Janet) He
Dr. Deborah Hirtz
Dr. Lyn Jakeman
Dr. Scott Janis
Dr. David Jett
Dr. Li Jia
Dr. Michelle Jones-London
Dr. John Kehne
Dr. Jim Koenig
Dr. Alan Koretsky
Dr. Steve Korn
Dr. Walter Koroshetz
Ms. Christine Lam
Dr. Pascal Laeng
Dr. Tim LaVaute
Dr. Miriam Leenders
Dr. Kip Ludwig
Ms. Quynh Ly
Dr. Ernie Lyons
Dr. Laura Mamounas
Dr. Linda McGavern
Dr. D. Elizabeth McNeil
Dr. Daniel Miller
Dr. Jill Morris
Dr. Claudia Moy
Dr. Birgit Neuhuber
Dr. Glen Nuckolls
Dr. Joanne Odenkirchen
Dr. Michael Oshinsky
Dr. David Owens
Ms. Diedra Prophet
Dr. Ipolia Ramadan
Dr. Matt Raymond
Dr. Robert Riddle
Ms. Louise Ritz
Dr. Rebecca Roof
Ms. Lynn Rundhaugen
Dr. Raul Saavedra
Dr. Paul Scott
Dr. Beth-Anne Sieber
Dr. Shai Silberberg
Mr. Andrew Skinner
Dr. Randall Stewart
Dr. Coryse St. Hillaire-Clarke
Dr. Natalia Strunnikova
Dr. Christine Swanson-Fischer
Dr. Amir Tamiz
Dr. Anna Taylor
Dr. Christine Torborg
Dr. Ursula Utz
Dr. Ashlee Van’t Veer
Ms. Joanna Vivalda
Dr. Salina Waddy
Ms. Margo Warren
Ms. Nena Wells
Dr. Samantha White
Dr. Vicky Whittemore
Dr. Derek Wilkinson
Dr. Alan Willard
Dr. May Wong
Dr. David Yeung

Other federal employees present for portions of the meeting included:

Dr. Seetha Bhagavan, CSR
Dr. Christine Piggee, CSR
Dr. Elyse Schauwecker, CSR
Dr. Laurent Taupenot, CSR

We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.
_____________________________
Robert Finkelstein, Ph.D.
Executive Secretary
National Advisory Neurological Disorders
and Stroke Council

Director, Division of Extramural Research
National Institute of Neurological Disorders
and Stroke
_____________________________
Walter 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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For 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.