NINDS Advisory Council Meeting Minutes, February 9-10, 2006

Skip secondary menu
  1. Call to Order and Opening Remarks
  2. Report of the Director, Division of Extramural Research
  3. Report of the Director, NINDS
  4. NIH Peer Review: Continuity and Change
  5. Council/Staff Working Group Update
  6. Concept Approval for FY07 Initiatives
  7. Council Subcommittee Reports
  8. Overview, Division of Intramural Research
  9. Scientific Presentation: "Engineering Chimeric Proteins to Safeguard Neurons"
  10. Review of the Division of Intramural Research Board of Scientific Counselors' Reports
  11. Council Review of Pending Applications
  12. Adjournment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL

Summary of Meeting 1
February 9-10, 2006

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 165th meeting on February 9-10, 2006, at Building 31, Conference Room 10, Bethesda, Maryland. Dr. Story Landis, 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, 2006 - 10:30 a.m. to 5:00 p.m.

for the review and discussion of program development, needs, and policy; and

Closed: February 9, 2006 - 5:00 p.m. to 5:45 p.m.
            February 10, 2006 - 8:10 a.m. to 10:00 a.m.            

for the review of the Board of Scientific Counselors’ Reports and for the consideration of individual grant applications.

Council members present were:

Mr. Ronald Bartek
Dr. Bruce Bean
Dr. Raymond Dingledine
Dr. J. Donald Easton
Dr. Francisco Gonzalez-Scarano
Dr. John Loeser
Mr. Jeffrey Martin
Ms. Prisca Chen Marvin
Dr. Helen Mayberg
Dr. Laura Ment
Dr. William Mobley
Dr. David Van Essen
Mr. Robert Waterman
Dr. Huda Zoghbi

Council members absent were:

Mr. Robi Blumenstein
Dr. Alicia Conill

Council Roster (Attachment 1)

Ex Officio Member present:

Dr. Paul Hoffman, Department of Veterans Affairs
Dr. Geoffrey Ling, Department of Defense (2/9 only)

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

Dr. Eli Mizrahi, Baylor College of Medicine
Dr. Eileen Resnick, Society for Women’s Health Research
Ms. Michelle Rodrigues, SRI
Mr. Andrew Hawkins, Research Policy Alert
Dr. S. Claiborne Johnston, University of California, San Diego
Dr. Rafaela Canete-Soler, University of Pennsylvania
I. M. Grossi, RTI
Kim Ehman, RTI
Mr. Bob Balkam, Restless Legs Foundation

NINDS employees present for portions of the meeting included:

Dr. Alan Willard
Ms. Ruth Linn
Dr. John Marler
Dr. Scott Janis
Dr. Barbara Radziszewska
Dr. Frances Yee
Dr. Merrill Mitler
Dr. Claudia Moy
Dr. Robin Conwit
Mr. Michael Loewe
Dr. Melinda Kelley
Dr. Raul Saavedra
Dr. Katrina Gwinn-Hardy
Ms. Nena Wells
Dr. Story Landis
Dr. Brandy Fureman
Dr. Linda Porter
Ms. Marian Emr
Dr. Dan Tagle
Dr. Tom Jacobs
Dr. Yuan Liu
Dr. Alfred Gordon
Dr. Emmeline Edwards
Dr. Ernie Lyons
Dr. Eugene Oliver
Dr. Diane Murphy
Dr. Laura Mamounas
Dr. Robert Baughman
Dr. Robert Finkelstein
Ms. Stephanie Fertig
Dr. Ursula Utz
Ms. Michelle Johnson
Dr. Jonathan Horsford
Dr. John Porter
Dr. Jill Heemskerk
Dr. David Owens
Dr. Heather Rieff
Mr. George Bramhall
Ms. Rebecca Desrocher
Dr. Wendy Galpern
Mr. George Bramhall
Ms. Rebecca Desrocher
Dr. Wendy Galpern
Ms. Natalie Frazin
Dr. Lauren Murphree
Dr. Richard Youle
Dr. Stephen Korn
Ms. Anita Miller
Ms. Preeti Hans
Mr. Travis Speck
Dr. Eugene Golanov
Dr. Jane Fountain
Ms. Joellen Harper Austin

Ms. Margaret Jacobs
Dr. Andrea Sawczuk
Dr. JoAnn McConnell
Dr. David Jett
Dr. Michael Nunn
Dr. Thomas Miller
Dr. Naomi Kleitman
Dr. Audrey Penn
Dr. Yejun He
Ms. Maureen Hambrecht
Dr. Daofen Chen
Dr. Paul Scott
Dr. Gabrielle LeBlanc
Mr. Paul Myers
Dr. Richard Crosland
Dr. Randall Stewart
Ms. Cikena Reid
Ms. Lynn Morin
Dr. Robert Zalutsky
Dr. Katie Woodbury-Harris
Dr. Debra Hirtz
Dr. Shanta Rajaram
Ms. Rebecca Farkas
Ms. Stacey Chambers
Dr. Richard Benson
Ms. Lynn Rundhaugen
Mr. Paul Girolami
Ms. Shannon Garnett
Dr. Audrey Kalehua
Dr. Ray Chaudhuri
Dr. Shai Silberberg
Dr. Ned Talley
Dr. James Coulombe
Dr. Joe Pancrazio
Ms. Roxane Kerr
Dr. Laurie Gutmann
Ms. Joanne Odenkirchen
Mr. Phil Wiethorn
Ms. Holly Campbell
Dr. John Lynch
Dr. Michelle Jones-London
Dr. Mark Scheideler
Dr. Robert Riddle
Ms. Daphne Robinson
Dr. Ramona Hicks
Ms. Donna James
Dr. Debra Babcock
Ms. Christina Vert
Ms. Lesley Whipp
Mr. Mutema Nyankale
Ms. Cheryl Schadler
Dr. Lorenzo Refolo

Other Federal employees present for portions of the meeting included:

Dr. Linda Rodman, OD
Dr. William Benzing, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Yong Yao, NIMH
Dr. Roger Miller, NIDCD

I. Call to Order and Opening Remarks

Dr. Story Landis, Director, NINDS, welcomed Council members, guests, and staff to the 165th Council meeting. In keeping with the Institute's policy of inviting chairpersons of review committees, Dr. Eli Mizrahi (Chair of the NINDS Training Grant and Career Development Review Committee) from Baylor College of Medicine attended the open session of the Council meeting. In other Council news, this is the last Council meeting for Dr. Paul Hoffman of the Department of Veterans Affairs. A new ex officio Council member will be identified from the VA before the next Council meeting. Dr. Landis expressed her appreciation to Dr. Hoffman for his dedicated service. Dr. Alicia Conill and Dr. Robi Blumenstein are not able to attend this Council meeting.

II. Report of the Director, Division of Extramural Research

Dr. Finkelstein, Director, Division of Extramural Research, informed the Council that they would be in open session until 4:45 p.m., after which they will go into closed session to hear the Board of Scientific Counselors' report from the Division of Intramural Research. The public and Extramural staff must leave at that time. Tomorrow's session, where individual grants and future funding programs are discussed, is closed to the public as well.

Conflict of Interest
The 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. Council members were also reminded that they need to remove themselves from discussions of applications from any institution from which they have received an honorarium for one year from the time the honorarium was received. If the Council member's participation is deemed critical to the discussion, however, an authorization may be granted by the Institute.

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 as the Council Executive Secretary, who will then refer the questions to the appropriate staff member for response.

Consideration of Minutes of Previous Council Meeting
The minutes of the Council meeting of September 15-16, 2006, were considered and accepted as written.

Consideration of Dates for Future Council Meetings
The following dates for future Council meetings were reconfirmed and new dates for 2008 were discussed:

May 25-26, 2006 (Thursday and Friday)
September 14-15, 2006 (Thursday and Friday)
February 15-16, 2007 (Thursday and Friday)
May 24-25, 2007 (Thursday and Friday)
September 20-21, 2007 (Thursday and Friday)

New Dates:
 
February 7-8, 2008 (Thursday and Friday)
May 29-30, 2008 (Thursday and Friday)
September 18-19, 2008 (Thursday and Friday)

Other Items

Expedited Review Process-- Dr. Finkelstein reported that the Grants Management Branch has succeeded in expediting 36 applications for award. A total of 159 applications had received Council concurrence for expedited review.

Reports Book-- The Reports Book consists of applications that have been designated for funding since the last Council meeting. It includes interim actions that have been taken during FY 2005, the status of applications that were identified for High Program Priority (HPP) for October 2005 Council, as well as an HPP status report for FY 2005. Council responded affirmatively to Dr. Finkelstein's suggestion that the Reports Book be sent to Council members in the form of a CD.

Council Operating Procedures-- Once a year, Council is required to endorse the Council Operating Procedures, which includes the Council Delegated Authorities. Council moved to approve the Operating Procedures.

Staff Actions-- Dr. Finkelstein introduced the following new staff: Dr. Eugene Golanov, Program Director in the Neural Environment Cluster; Dr. Ramona Hicks, Program Director in the Repair and Plasticity Cluster; Dr. Debra Babcock, Program Director in the Systems and Cognitive Neuroscience Cluster; Dr. Jane Fountain, Program Director in the Neural Environment Cluster; Dr. Stephen Korn, Director of Training and Career Development; Donna James, Program Analyst in the Neural Environment Cluster; and Preeti Hans, Program Analyst in the Systems and Cognitive Neuroscience Cluster. In addition, several new Grants Management Specialists have joined the Grants Management Branch: Tony Petruccelli, Anita Miller, Mutema Nyankale, and Lesley Whipp. Travis Speck is also working in the Grants Management Branch as a Presidential Management Fellow.

III. Report of the Director, NINDS

FY 2007 Budget At the last Council meeting, Dr. Landis presented the FY 2006 financial plan, which was based on the President's budget of $1.55 billion. An RPG payline of 12 percent was projected. This was to be achieved by reducing modular grants by 10 percent and non-modular by 15 percent, and Council concurred with this plan. The President's FY 2006 budget was recently signed into law; however, we did not anticipate a 1 percent across-the-board cut, which amounted to a $15.5 million reduction in our budget. In order to maintain the 12th percentile, Council members suggested an across-the-board 2.35 percent cut to grants with out-year funding in 2006. NIH adopted the policy to reduce continuing grant budgets by 2.35 percent. The President's FY 2007 budget has now been released. The overall NIH budget is maintained at FY 2006 levels, but most Institutes/Centers (I/Cs) will receive a .7 percent decrease, due to a greater percentage of the budget going to the NIH Office of the Director. The I/Cs will also be contributing more for Roadmap initiatives. The result is a $15 million decrease in FY 2007 as compared to FY 2006. Because many of the grants that were funded during the budget-doubling period are coming in for re-competition, we anticipate maintaining the payline at 12 percent or better in FY 2007. We may not know the FY 2007 final budget until this time next year. We hope to fund as many grants in FY 2006 as in FY 2005. Among the Institute's priorities is its commitment to training and supporting new investigators and to working with other institutes to maximize use of resources. We have transferred a number of grants above our payline but within another I/C's payline to them. We are reviewing applications assigned to NINDS to ensure that they are within our core mission.

NIH Projects: OPASI-- At the last Council meeting, Dr. Landis discussed the plans for the creation of the NIH Office of Portfolio Analysis and Strategic Initiatives (OPASI). It is now operational. The purpose of OPASI is to coordinate the NIH-wide portfolio. It will analyze how much NIH spends on specific diseases, respond to constituent needs, identify NIH-wide scientific opportunities and public health needs, and coordinate funding of cross-I/C research areas. The Neuroscience Blueprint is an example of multiple-institute coordination. OPASI will also evaluate the effectiveness of programs and will help direct resources where they are needed. OPASI has three divisions: Resource Development and Analysis, Strategic Coordination, and Evaluation. It is advised by a high-level Steering Committee Working Group. NIH is recruiting now for an eminent scientist interested in a broad outlook on the biomedical sciences in the U.S. to direct OPASI. The office will have a budget to fund the trans-NIH projects for which it has identified a need, including future Roadmap projects. The OPASI budget will be made up of contributions from the I/Cs.

Chemical Counterterrorism-- In the FY 2006 budget, there was $50 million set aside to fund research related to the development of products that would benefit the civilian population in the case of chemical attack. NIAID is the coordinating body for all of the I/Cs' counterterrorism programs. NINDS is an interested participant due to our interest in research countering nerve gas, blistering agents, cyanide, and other agents that affect the nervous system. The program is led by Dr. Robert Baughman, Dr. David Jett, and Dr. Joseph Pancrazio. The recently-released initiatives in this program were for centers of excellence, research projects, SBIR awards for therapeutics development, and for diagnostic technologies. There will be four more years of funding for these projects, beyond 2006. Another program in the works results from discussions with DoD to run a clinical trial on midazolam, which might be of benefit to counter nerve gas exposure. Several other initiatives will be released in the future.

Scientific Advances-- There have been numerous recent scientific advances funded by NINDS, and the following are just two examples:

1. The discovery of a gene for Tourette Syndrome (TS), which is a major breakthrough in this disease. TS is a neuro-psychiatric disorder variable in its phenotype. The research was funded by an initiative conceived by Dr. Finkelstein. The gene discovery was ranked number five in the list of most significant advances in 2005 by Science magazine. NINDS decided to add TS to its Genetic Repository, run by Dr. Katrina Gwinn-Hardy, and NIMH has agreed to help fund this.

2. GENSAT--This is a large project begun during the budget-doubling period. GENSAT's goals are to identify the spatial patterns and cellular locations of 12,000 genes expressed in the mouse CNS throughout development, and to develop new genetic research tools. GENSAT was begun by Dr. Gabrielle Leblanc and is now managed by Dr. Laura Mamounas. A recent article published by Dr. Jim Surmeier in Nature Neuroscience took the mice in GENSAT and made an important observation relevant to Parkinson's disease.

Public Educational Efforts-- Marian Emr, Director, Office of Communication and Public Liaison, has been working hard with several groups to educate the public about many neurological disorders. Two examples are:

1. Stroke Awareness--The campaign to make people aware of the need to go to a hospital at the first signs of a stroke has traditionally been aimed at an English-speaking audience. Recently, NINDS has worked with the National Council of La Raza (NCLR) to extend the stroke awareness program to Hispanic audiences. These efforts include a Spanish-language "toolkit" that will be disseminated to over 100 Hispanic community-based organizations across the U.S. NCLR volunteers have been trained to educate groups and individuals about stroke risk and warning signs.

2. The Specialized Program of Translational Research in Acute Stroke (SPOTRIAS) Program includes public educations efforts. The Houston SPOTRIAS has engaged middle school children to educate them on the causes and symptoms of stroke and need to get to the hospital right away. This is a pilot to test whether it is successful in getting more Spanish-language parents to the hospital at signs of a stroke.

Staff Change Announcement-- Dr. Audrey Penn has announced that she will step down from the Deputy Director position at the end of the year. The Institute owes her a debt of gratitude for her service over the past 11 years. She has served as Acting Director twice for long periods of time and guided the Institute through difficult times. There will be a symposium in her honor in the fall. She will continue to work in the Institute in her areas of interest. A search will begin to identify candidates with a clinical background with the same level of commitment, dedication, and vision as Dr. Penn has had. The Search Committee will be led by Dr. Thomas Insel, Director, National Institute of Mental Health. Council was asked to bring any candidates to the attention of the Search Committee.

Council News-- Dr. Landis announced that Dr. David Van Essen was just elected President of the Society for Neuroscience. She also announced that ex officio member Dr. Geoffrey Ling from the Uniformed Services University of the Health Sciences recently returned from service in Iraq and welcomed him back to Council.

IV. NIH Peer Review: Continuity and Change

Dr. Antonio Scarpa, Director, Center for Scientific Review (CSR), reported that NIH's peer review has produced an effective partnership between the federal government and research institutions. It has created the best academic medical centers, the best biomedical and biotechnology research, has made possible the best cures and the best prevention, and has been imitated by other institutions both within the U.S. and abroad. CSR's mission is to see that NIH grant applications receive fair, independent, expert, and timely reviews, free from inappropriate influences, so that NIH can fund the most promising research. The burden on CSR has almost doubled in the last seven years. Applications for review have grown from approximately 30,000 in 1998 to over 50,000 in 2005. CSR reviewed 2,558 NINDS applications in 2002 and 4,478 in 2005, which is 8.7 percent of all applications reviewed by CSR in 2005. Due to the increase in the number and complexity of applications over time, CSR has implemented several changes. It has increased communication between CSR, the I/Cs, the reviewers, and the applicants; increased uniformity; increased efficiency; and has begun a review of the Initial Review Groups with the possibility of realignment. Future changes include shortening the review cycle, addressing the concern that clinical research is not properly evaluated, and improving the assessment of innovative, high-risk/high-reward research. CSR is also committed to strengthening efforts to recruit and retain high-quality reviewers. Encouraging more electronic reviews, either by telephone, video, or asynchronous electronic discussions, may improve efficiency. The three challenges facing CSR today are the dramatic increase in applications, reviewers are getting harder to find, and the budget has remained flat. CSR is looking at the possibility of reducing the number of reviewers while simultaneously imposing a new page limit for applications and basing priority scores on score variance rather than consensus.

A Council member asked about the possibility of allowing the principal investigator (PI) to respond in real time during the review. There was support for a stricter page limit for applications and an elimination of the requirement for appendices except in the case of clinical research applications. A question was raised about requiring grantees to serve on review committees. However, the response was that there was concern that the quality of reviews may suffer if reviewed under those conditions, and it may raise the expectations of the reviewers for their own grant applications.

V. Council/Staff Working Group Update

Dr. Robert Finkelstein and Dr. Paul Scott, Director, Office of Science Policy and Planning, gave an update on the Council/Staff Working Group. At a recent Council meeting, Council members asked for an analysis of the measurement of success for Institute initiatives. The project was divided into two teams. Team 1, led by Dr. Scott, was to research interim measures of success. Dr. Finkelstein's team analyzed the impact on public health as the ultimate criterion for success. For Team 2, it was decided that the best way to accomplish their goal was to analyze the discovery process of several public health breakthroughs. This would lead to the identification of common features that could be used to develop metrics to predict or evaluate the success of an initiative. Dr. Linda Porter, Program Director in the Systems and Cognitive Neuroscience Cluster, presenting on behalf of Team 2, described the development process for three of the breakthroughs the group analyzed: Gleevec for CML, cochlear implants, and tPA for stroke. The other case studies the group analyzed were tysabri for multiple sclerosis, sumatriptan for migraine, gabapentin for pain, statins for heart disease, combination therapy for ALL, and MRI for diagnostic imaging. Common themes were the importance of early investigator-initiated research, NIH support at some point in the process, and strong leadership. Dr. Dingledine noted that one of the common themes was a prolonged period of basic research, followed by an accelerated period of directed commercialization, which then led to a product. Can the basic research period be speeded up? Progress in basic research is partly dependant on technology development and on serendipity. Council members asked if it would be helpful to scan scientific findings and brainstorm in order to identify promising science and ways to move it forward. What are the Institute's processes for identifying a public health need and selecting the methods to support research to meet that need? One Council member suggested adding successes in informatics, perhaps teaming with other institutes, and writing these findings up for a Brain Success Stories paper. Are there catalysts the Institute can use to speed up and direct research toward a successful outcome? NINDS can be helpful in fostering interactions among people with similar interests but who have not previously worked together.

Dr. Scott presented Team 1's "evaluation of interim success." His group looked at the reasons why initiatives have been done and determined general as well as initiative-specific measures of success. Data were collected on initiatives from 1998, when they first began, to 2005. The committee did not include other I/Cs' initiatives which NINDS joined, nor did it include contracts. Five general reasons were given for issuing initiatives: 1) to fill a science gap, 2) to develop a needed resource, 3) provide needed infrastructure, 4) develop a new mechanism, and 5) to provide training and career development opportunities. The general measures used were if the project attracted new investigators, either new to the field or new to NINDS; and if they lead to high-impact publications. The applications that were submitted in response to the 24 "science gap" initiatives, from FY 2000 - FY 2002, were compared to the unsolicited applications submitted during the same time period. The percentages of new investigators and investigators new to NINDS were slightly higher in the initiatives group than in the unsolicited group. A comparison of impact between articles published as a result of initiative research versus unsolicited research showed them to be almost equal. Since each initiative has distinctive characteristics, eight projects were looked at in detail to determine the steps that were taken that led to success. Three of them were discussed in detail: 1) the role of parkin and other proteins in Parkinson's Disease, 2) support for microarray centers for research in the nervous system, and 3) the Specialized Program of Translational Research in Acute Stroke. Dr. Finkelstein suggested a study comparing the applications that would be funded if the payline were increased by 1 percentage point, which would cost approximately $15 million, versus spending the equivalent amount on initiatives. During Council remarks, Mr. Waterman noted: 1) the length of time of the basic research; the National Academies is looking at ways to speed this up, 2) the importance of investigator-initiated research, 3) the crucial role of cross-disciplinary work, 4) the importance of animal models, 5) the role of "champions" in research, 6) the role that failures play in moving science forward, 7) Government-private cooperation, 8) "patient push" and patient cooperation in supporting research, and 9) the challenge of implementing successful treatments. Council confirmed the critical role program staff play in keeping up with the state of the science and in identifying ideas that need further support. They are responsible for both convening groups of scientists who can discuss moving science forward, and for intervening when they see a particular need.

VI. Concept Approval for FY07 Initiatives

The following initiatives were presented to Council:

1. Nuclear Structure/Function Defects in the Pathogenesis of the Muscular Dystrophies.
2. Parkinson's Disease Cohort Study Administrative Supplements

Council voted for approval for both initiative concepts.

VII. Council Subcommittee Reports

Training, Career Development, and Special Programs Subcommittee, Dr. Bruce Bean, Chair

1. K02 Program--This program's goal is to help junior scientists in clinical environments move to independent research careers. The K02 provides salaries for 75 percent of the PI's time to do research for a maximum of five years. Salaries in the fourth and fifth years are contingent on receiving R01 support. This program has been very successful and has had a 40 percent success rate. The institution's requirements to provide facilities, supplies, and benefits have not been explicitly described in the announcement. The subcommittee's proposal is to require the institution to provide specific information about their plans to support the K02 awardees. Subcommittee members will draft language for NINDS' consideration.

2. K99/R00 Pathway to Independence Award--This is an NIH-wide mechanism to promote independent research for MDs or PhDs, from training to R01 award. It is a five-year award divided into two phases: The first phase is a continuation of mentored training, providing up to $90,000 per year. Phase two provides up to three years of independent funding at $249,000 per year. Citizens and non-citizens are eligible. It is restricted to candidates applying within the first five years of their post-doctoral research training. The reviews will be done by the I/Cs. Dr. Landis added that there will be 170 awards made in FY 2007, and NINDS will fund 12. The subcommittee also discussed having a different payline for new investigators. At the last Council meeting, NINDS was strongly encouraged to think about creative ways to help new investigators get their first R01. In response, the Institute decided to increase the payline for new investigators applying for R01s by 3 percentage points. This will likely result in 3 -4 additional, funded applications. The subcommittee approved the new policy and recommended applying it retroactively to the September 2005 Council round, to complete a full fiscal year. The new policy will be reviewed at the beginning of the next fiscal year. The Institute also funds new investigators through its HPP mechanism and will continue to look for ways to support new investigators.

Clinical Trials Subcommittee, Dr. Don Easton, Chair

The Clinical Trials Subcommittee opened with a report by Dr. John Marler on the status of the Clinical Research Collaboration (CRC) project. The CRC is designed to encourage practitioners to get more involved in clinical research studies. A corollary project is a pilot project that would integrate awareness of the importance of participating in clinical trials into medical school curriculum and residency programs. The funding announcement for the Emergency Neurology Network has been issued. The goal is to create a clinical research network of emergency medicine physicians, neurologists, and neurosurgeons who will work together to efficiently develop more and better treatments for patients with acute neurological disorders through execution of NINDS-sponsored clinical trials.

The Subcommittee heard a presentation from Dr. Brandy Fureman on conflict of interest in clinical research projects funded by NINDS. The Institute is interested in developing more formal policies for potential conflict involving both principal investigators and their primary institutions. She asked for the subcommittee's input. One idea suggested was to integrate the new policy into the grant application itself.

Dr. Clay Johnston, from the University of California, San Francisco, gave a presentation on the results of his NINDS-supported project to independently evaluate the expenditures and the clinical impact of NINDS funded clinical trials. He assessed 28 trials, which had a total cost of $335 million. At 10 years, the trials resulted in a projected benefit of 470,000 quality-adjusted life years. The cost to the patients to obtain those additional quality-adjusted life years was $3.6 billion. The net benefit of those years was $15.5 billion. The subcommittee discussed the methodology that was used and other aspects of the study. The study will be written up and submitted for publication.

Basic and Preclinical Programs Subcommittee, Dr. Ray Dingledine, Chair

1. Neuroscience Blueprint--This is a multi-institute program that began two years ago. One of the major goals is to support major research in fields that are important to the institutes interested in neuroscience. The Blueprint has a $10 million budget in FY 2006, and budgets of $20 million and $30 million in the subsequent years. In FY 2006, a number of initiatives were begun: developing courses in the neurobiology of disease, a neuroscience information network, a neuro-mouse initiative, P30 core grants, and an effort to encourage the speed at which neuroimaging can occur. For FY 2007, the focus will be on neurodegeneration, in FY 2008, the focus will be development, and in FY 2009, plasticity. There will be a workshop next month to discuss the mechanisms of neurodegeneration, which occur in a variety of disorders. The participants will look for translational opportunities and advancing diagnostic capabilities. Several NIH institutes will participate, and a summary report and Request for Proposals will be developed from the workshop. The findings will be posted on an NIH website.

2. P01s and P50s--These will no longer be in percentage. They will be considered within their own group only.

3. Neuroinformatics - How can the neuroscience community make the best use of the growing number of computational resources becoming available through a variety of NIH initiatives. Dr. Van Essen emphasized the importance of neuroinformatics in neuroscience. Although the Human Brain Project is being phased out, approximately six other projects remain that are neuroscience related. Better coordination and communication are needed. A meeting at the end of March will discuss the challenges and opportunities in this field. Roadmap has funded seven centers for biological computation, all of which have some neuroscience relevance and two are primarily neuroscience related. The Neuroscience Information Framework is a one-year contract to design a more sophisticated way to access the range of neuroinformatics and bioinformatic tools and capabilities for researchers. Implementation would begin in year two. Dr. Landis explained that neuroinformatics does not fit within OPASI's or the Roadmap's mandates but possibly a subset of Blueprint institutes would be interested. The committee meeting in March will discuss which projects individual institutes should take the lead on and what could be led by a consortia of institutes.

At the next Council meeting, Dr. Landis suggested that the subcommittees bring topics that may warrant a discussion by all of the Council members to the full Council meeting.

VIII. Overview, Division of Intramural Research

Dr. Landis reported on the recruitment of the DIR Scientific Director. Currently, the responsibility is being shared among Dr. Gene Major, Dr. Henry McFarland, and Dr. Landis. The Institute is in final negotiations with a candidate and anticipates making an announcement in the near future. The new hire would begin service on October 1. The candidate has proposed integrating groups of investigators, recruiting scientists with clinical and translational interests, and hiring investigators who will bridge between existing laboratory branches.

Dr. Roscoe Brady and Dr. Karen Nelson have retired.

IX. Presentation: "Engineering Chimeric Proteins to Safeguard Neurons"

Dr. Richard Youle, Chief, Biochemistry Section, Surgical Neurology Branch, Division of Intramural Research, NINDS, reported that cells die normally during tissue turnover, embryo morphogenesis and anti-viral defense using their endogenous biochemical pathways of apoptosis. Genetic studies have shown that Bcl-2 family member proteins are key regulators of programmed cell death pathways and that Bcl-2 and Bcl-xL inhibit apoptosis very early or at the initiation of the process. Following CNS trauma and stroke the programmed cell death machinery intrinsic to neurons can be activated and exacerbate neuron damage and patient morbidity. We have engineered protein chimeras to target neurons and deliver anti-apoptotic members of the Bcl-2 family into cells that inhibit neuron apoptosis in several models in vitro and in vivo. These chimeric Bcl-2 proteins have potential to protect neurons following transient insults to the nervous system such as spinal cord injury.

X. Review of the Division of Intramural Research Board of Scientific Counselors' Reports

In closed session, Dr. Landis presented the findings and recommendations of the Board of Scientific Counselors based on their review of specific DIR laboratories/units during 2005. The Council discussed the reports of the Board and accepted them.

XI. Council Review 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, which needed specific discussion.

Research Training and Career Development Programs

The Council reviewed a total of 143 research career development and institutional training grant applications; of this total, 104 applications had primary assignment to NINDS, and 81 of them (77.9 percent) were recommended for support in the amount of $15.4 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 $7.5 million.

Research Grant Awards

The Council reviewed a total of 2,105 research grant applications; of this total, 1,312 applications had primary assignment to NINDS, and 771 of them (58.8 percent) were recommended for support in the amount of $224.5 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 $47.0 million.

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. At this meeting, the Council recommended two investigators as Javits awardees.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 193 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 113 applications had primary assignment to NINDS and 64 of them (56.6 percent) were recommended for support in the amount of $10.0 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 $3.3 million.

XI. Adjournment

The meeting was adjourned at 10:00 a.m. on Friday, February 10, 2006.

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

Story C. Landis, Ph.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.


1 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.

Top

Last updated September 15, 2008