NINDS Advisory Council Meeting Minutes, May 26-27, 2005

1. Call to Order and Opening Remarks
2. Report of the Director, Division of Extramural Research
3. Report of the Director, NINDS
4. NEI Neuroscience, Neurodegeneration and Genetics Opportunities
5. Council/Staff Working Group Update
6. Council Subcommittee Reports
7. Proposed Process for Concept Clearance of Initiatives and Concept Approval for Fiscal Year 2006 Proposed Initiatives
8. New Policy on Sharing Model Organisms
9. Update on the NIH Blueprint for Neuroscience Research
10. Update on the Counterterrorism Program
11. Update on the Institute of Medicine's Report on Training and New Investigators
12. Public Comment
13. Council Review of Pending Applications
14. 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
May 26 - 27, 2005

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 163rd meeting on May 26-27, 2005, 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:		May 26, 2005 - 10:30 a.m. to 5:00 p.m.
for the review and discussion of program development, needs, and policy; and
Closed:		May 27, 2005 - 8:00 a.m. to 10:45 a.m.
for the consideration of individual grant applications.

Council members present were:

Mr. Ronald Bartek
Dr. Bruce Bean
Dr. Alicia Conill
Dr. Raymond Dingledine
Dr. J. Donald Easton
Dr. Francisco Gonzalez-Scarano
Dr. John Loeser
Mr. Jeffrey Martin
Ms. Prisca Chen Marvin
Ms. Ellyn Phillips
Dr. Patrick Pullicino
Dr. Sally Shaywitz
Dr. Ira Shoulson
Dr. David Van Essen
Mr. Robert Waterman
Dr. Huda Zoghbi

Council member absent was:

Dr. William Mobley

Council Roster (Attachment 1)

Ex Officio Member present:

Dr. Paul Hoffman, Department of Veterans Affairs

Ex Officio Member absent:

Dr. Geoffrey Ling, Department of Defense

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

Mr. Robi Blumenstein, High Q Foundation
Dr. Brian Davis, University of Pittsburgh
Mr. Hokuto Morita, Tremor Action Network
Ms. Amy Comstock, Parkinson's Action Network
Ms. Carol Walter, Parkinson's Alliance
Mr. Robert Balkam, Restless Leg Syndrome Foundation
Ms. Katie Hood, The Michael J. Fox Foundation for Parkinson's Research
Ms. Joyce Oberderf, The Michael J. Fox Foundation for Parkinson's Research
Dr. Eileen Resnick, Society for Women's Health Research
Chris Peterson, SRI
Ms. Kristie Stoick, Physicians Committee for Responsible Medicine
Dr. Chad Sandusky, Physicians Committee for Responsible Medicine

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. Meena Hiremath
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
Ms. Quandra Scudder
Dr. Laura Mamounas
Dr. Robert Baughman
Ms. Diane Howden
Dr. Robert Finkelstein
Ms. Stephanie Clipper
Ms. Stephanie Fertig
Dr. Ursula Utz
Dr. Kenneth Fischbeck
Mr. Mark Salo
Dr. Lorenzo Refolo
Ms. Michelle Johnson
Dr. Jonathan Horsford
Dr. John Porter
Dr. Jill Heemskerk
Dr. David Owens
Dr. Heather Rieff
Mr. George Bramhall
Ms. Rebecca Desrocher
Ms. Debbie Jarman
Ms. Margaret Jacobs
Dr. Andrea Sawczuk
Dr. JoAnn McConnell
Dr. David Jett
Dr. Michael Nunn
Dr. Tom Miller
Dr. Naomi Kleitman
Dr. Audrey Penn
Dr. Yejun He
Ms. Maureen Hambrecht
Dr. Daofen Chen
Dr. Paul Scott
Ms. Sylvia Parsons
Dr. Gabrielle LeBlanc
Mr. Paul Myers
Dr. Karen Bateman
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
Dr. Nora Gardner
Mr. Jeff Domanski
Ms. Lynn Rundhaugen
Ms. Nancy Hart
Mr. Paul Girolami
Ms. Shannon Garnett
Dr. Audrey Kalehua
Mr. Ray Chaudhuri
Shai Silberberg
Dr. Ned Talley
Mr. Jim Stables
Dr. James Coulombe
Dr. Joe Pancrazio
Dr. Bernard Ravina
Ms. Roxane Kerr
Dr. Laurie Gutmann
Ms. Janice Cordell
Ms. Joanne Odenkirchen
Mr. Peter Gilbert
Mr. Phil Wiethorn

Other Federal employees present for portions of the meeting included:

Dr. Ralph Nitkin, NICHD
Dr. Charlotte McGuinness, NCI
Dr. Mary Sheetz, OS
Dr. Nick Steneck, OS
Dr. Margaret Snyder, OD
Dr. Lynn Hudson, OD
Dr. William Benzing, CSR
Dr. David Armstrong, CSR
Dr. Rossana Berti, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Sherry Stuesse
Dr. Biao Tian, CSR
Dr. Seetha Bhagavan, CSR
Dr. John Bishop, CSR
Dr. Christine Melchior, CSR
Dr. Daniel Kenshalo, CSR
Dr. Anita Miller Sostek, CSR

1. Call to Order and Opening Remarks

   Dr. Story Landis, Director, NINDS, welcomed Council members, guests, and staff to the 163rd Council meeting. NINDS periodically invites, as guests of the Council, the chairpersons of review committees and study sections as part of the Institute's continuing effort to strengthen the liaison between initial review groups and the Council. Dr. Landis introduced Dr. Brian Davis, Chair of the Neurodifferentiation, Plasticity, and Regeneration Study Section in CSR. Dr. Davis is Associate Professor, Department of Medicine, University of Pittsburgh. Council member Dr. William Mobley and Ex Officio member Dr. Geoffrey Ling were unable to attend this Council meeting. Dr. Landis announced the appointment of the new budget officer, Mr. George Bramhall, who has worked in the budget office for a number of years.

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2. Report of the Director, Division of Extramural Research

   Government in the Sunshine Act and the Federal Advisory Committee Act

   Dr. Robert Finkelstein, Director, Division of Extramural Research, reviewed the Government in the Sunshine Act and the Federal Advisory Committee Act, which require the Department of Health and Human Services to open to public observation as many advisory committee meetings as possible, including the National Advisory Councils. The NANDS Council meeting was open to the public, except during the review of grant applications. Notice of the date and place for the Council meeting was published in the Federal Register thirty days prior to the meeting.

   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 applicants request support for their applications from Council members, the Council members must respond that they are 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 February 10-11, 2005, were considered and accepted as written.

   Consideration of Dates for Future Council Meetings

   The following dates for future Council meetings were reconfirmed:

   September 15-16, 2005		(Thursday and Friday)
   February 9-10, 2006		(Thursday and Friday)
   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)

   Other Items

   Expedited Review Process--Dr. Finkelstein reported that of the 220 applications eligible for expedited award, 87 have already been issued. The Grants Management Branch is to be commended for completing these awards. In addition, as a result of the change in policy to allow expedited processing of K awards, 14 K awards have been made. Under the leadership of Scientific Review Administrator, Dr. Raul Saavedra, the Training Review Committee met a month earlier than normal and was able to review and score the K applications earlier than usual.

   Reports Book--The Reports Book consists of applications that have been designated for funding since the last Council meeting. It includes the status of applications that were identified for High Program Priority (HPP) at the February 2005 Council. It is possible that, as funds become available later in the fiscal year, more of the HPP applications may be paid. If so, Council will be informed at the October Council meeting.

   Staff Action--Dr. Emmeline Edwards, acting Deputy Director of the Division of Extramural Research, has accepted the Deputy Director position permanently. Formerly Program Director with the Systems and Cognition Cluster, Dr. Edwards managed over 300 grants and had a major impact on the neuro-cognitive field. In other staff actions, new staff include Dr. Robert Riddle, Program Director with the Neurogenetics cluster; Dr. Ned Talley, Program Director with the Channels, Synapses and Circuits cluster; Dr. David Owens, Program Director with Repair and Plasticity; Dr. Laurie Gutmann, Clinical Trials; Dr. Shantadurga Rajaram, Scientific Review Administrator; Ms. Rebecca Desrocher, an intern from the HHS Emerging Leaders program assigned to the Systems and Cognitive Neuroscience cluster; and Dr. James Coulombe, Program Director detailed to the Systems and Cognitive Neuroscience cluster.

3. Report of the Director, NINDS

   The President's Budget, FY 2006--The House and Senate appropriation hearings have concluded. The President requested a .5 percent increase for NIH. NIH represented 37 percent of the HHS budget in 1998 and is now 41 percent. It is 20 percent of the Labor, HHS appropriation. Work has started on the FY07 budget, with NIH's budget due in early June. Specific information will be shared with Council as soon as it is available.

   Conflict of Interest Regulations--There are now "Interim Guidelines" in place, which will be in effect indefinitely. There has been concern both within and outside NIH about staff retention and recruitment, due to the new regulations. The two, visible scientists on which the new regulations could potentially have had an impact, Dr. James Battey, Director of the National Institute on Deafness and Other Communications Disorders; and Dr. David Swartz, asked to direct the National Institute of Environmental Health Sciences, have both resolved in NIH's favor. This is a hopeful sign that NIH recognized the potential, negative impact of the Guidelines and that they may be changed.

   NIH-Wide Actions--The institute directors recently attended three retreats, led by Dr. Zerhouni: 1) Managing in Hard Times, 2) An Assessment of the NIH Roadmap, and 3) The NIH Budget.

   1. Managing in Hard Times - The challenge to NIH is to balance broad, institute-wide priorities with the individual I/C's mission-specific priorities. One method is to conduct cross-portfolio analyses to look for opportunities for savings. To address the issues of possible overlapping portfolios, problems of several separate coding systems, and to perform other cross-cutting functions, NIH created an Office of Portfolio Analysis and Strategic Initiatives. Several issues that are currently managed by many different offices will be consolidated in OPASI, such as Burden of Illness, knowledge management, strategic initiatives such as Roadmap, and cross-NIH planning. Another suggestion for "managing in hard times" was to re-visit the distinction between institutes and centers. I/Cs can be defined as either "enabling" I/Cs, which primarily provide infrastructure support, or mission-driven I/Cs. A subcommittee will look at NIH's role in determining the priorities and structure of enabling I/Cs. The discussion about improving NIH's efficiency led to questions about I/Cs' sharing clinical networks and sharing training programs. As cost-saving and possible consolidation efforts go forward, we need to ensure that our institute interests are not compromised. For our part, we need to look at the rate of increase of grant awards and the number of awards per PI, both by a single institute and by multiple institutes.

   2. Roadmap - There was recognition that the Roadmap is not a single set of initiatives, but a process, with initiatives moving in and out of the overall Roadmap plan, as necessary. The budget will eventually maximize at 1.2 percent of the NIH budget. Attention focused on Re-engineering the Clinical Research Enterprise, one of the Roadmap goals. In light of the Institute of Medicine's recommendation to transform NCRR into the lead I/C for clinical research, an announcement soliciting translational research centers was withdrawn so that NIH could decide on the best way to structure a major investment in clinical and translational research.

   In response to a question about a new NINDS Scientific Director, Dr. Landis informed Council that the position has been offered to a candidate, and they are currently in negotiations.

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4. NEI Neuroscience, Neurodegeneration and Genetics Opportunities

   Dr. Paul Sieving, Director, National Eye Institute (NEI), reported that in 1968, Congress authorized the formation of the NEI, which coincided with the separation of the fields of ophthalmology and otolaryngology. The President's proposed FY06 budget for NEI is $673.5 million. Eighty five percent of those funds is budgeted for extramural research, 10.2 percent for intramural research, 3.3 percent for management and support, and 1 percent for the National Eye Health Education Program. As one of the neuroscience institutes, the NEI is a member of the trans-NIH Neuroscience Blueprint initiative. The NIH Blueprint organizes fifteen institutes and centers to develop tools, create resources, promote public/private partnerships, and combines their resources to speed treatment discovery. NEI can be particularly helpful to the advancement of neuroscience research. The eye can be used as a complete, experimental system for drug testing: it is a self-contained organ; as a pair, one can be used as the control; and it includes several different cell types. One of the most important diseases being researched is age-related macular degeneration (AMD). AMD is the hemorrhaging and death of the photoreceptors and is the leading cause of blindness in adults over 65. Nine million Americans have AMD, and 1.8 million are legally blind. A link between AMD and Alzheimer's disease is being explored. A common variant of the Complement Factor H gene on human Chromosome 1q31 has been identified as a risk factor for developing AMD. Investments in genomics and genetics research may also lead to identifying risk factors. Another important research area is in glaucoma. Glaucoma is ganglion cell disease (neurodegeneration) resulting from elevated intraocular pressure. Researchers are looking into what triggers ganglion disease and why the cells die. Another important research area is in aberrant CNS visual processing: strabismus and amblyopia. Clinical trials are being conducted by the Pediatric Eye Disease Investigator Group (PEDIG), which is a network of university and community-based pediatric eye care practitioners. Begun in 1997, PEDIG has 64 centers with 126 investigators. PEDIG investigators have found that patients require much less patching time than previously believed to get results. They have also learned that their findings can be applied in patients up to 18 years of age. Last, research on diseases of the retina has expanded in recent years. Advances in gene therapy and the development of the Encapsulated Cell Technology Device are being applied to retina diseases. NEI has been instrumental in creating the National Ophthalmic Disease Genotyping Network, which can deliver diagnostic genotyping through a centralized process and store data in a shared database for future clinical trials. The Network is expected to make genotyping available to a large number of patients, serve as a clearinghouse for ophthalmic genetics information, provide centralized access for blood collection, lead to standardization of clinical phenotype descriptors, and identify patients for future clinical trial participation. Two final areas of eye research are the use of adult stem cells to treat Limbal Stem Cell Deficiency and the use of the retinal prosthesis implantable electrode array to correct retina problems. NEI participates in several projects with other neuroscience institutes, among them are the Neuroscience Blueprint Microarray Consortium, the Gene Expression Nervous System Atlas Project, the Neuromouse Project, cross-cutting training programs, and shared, core grants.

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5. Council/Staff Working Group Update

   Project 1--Dr. Finkelstein reported that at the last Council meeting, Council members were asked how they could work more closely with staff to further the mission of the Institute. The project selected by Council to achieve that goal was for a joint Council/staff group to work together to evaluate the success or failure of selected NINDS programs. The first step was a conference call between the staff and Council members who have volunteered to work on the project. The outcome was the decision to develop criteria for evaluating success and to conduct both a retrospective analysis, applying the criteria to past initiatives; and a prospective analysis, looking at successes and determining how they originated. The goal of the second conference call was to suggest what the criteria should be. Everyone agreed that the main criterion should be the impact on public health. Therefore, the steps that led to recent public health advances should be analyzed. The assumption was that once the process was understood, the Institute would have the criteria to evaluate its current initiatives. Project 1's goal is to identify the steps that led to recent public health advances, and the goal of Project 2 is to evaluate the success of NINDS initiatives and investigator-initiated research using interim measures. For Project 1, it was decided that the committee would not be limited to advances in neurology or to advances funded by NIH. One approach is to get a list of drugs recently approved by the FDA as examples of "successes." The committee will develop a list of questions that will need to be answered for each success.

   Project 2 (Dr. Paul Scott) was conceived by staff, who felt it would result in important information for the Institute to have as it plans for the future. The goal of this project is to evaluate the outcome of NINDS initiatives, and then compare those outcomes with the results of investigator-initiated research. The working group formed to manage this project identified the following measures to be collected for past initiatives: Did the initiative lead to grants, high-impact publications, or translational research or clinical trials; did it bring in new investigators, both new to the field or new to a research career; did the research stimulate additional grant proposals? The other part of the project is to develop a way to compare the outcomes of Institute-initiated actions with investigator-initiated research.

   In the discussion that followed the presentations, Council members expressed strong support for Project 2 in particular but requested a more detailed comparison plan for Institute-initiated versus investigator-initiated research. They conveyed their reservations about putting too much emphasis on "impact on public health" as an outcome measure, since dissemination problems can impede the impact of a therapeutic advance on public health. Rather, staff could assess the potential impact on public health. Council members suggested adding the development of animal models as an outcome measure for Project 2 and suggested reduction in stroke as one of the successes Project 1 evaluates retrospectively. The role of diagnosis should not be overlooked when evaluating research successes. There was support for consolidating the two projects. Caution was expressed in applying the results too rigidly to future funding decisions. Many discoveries have occurred by researchers who did not know where their research would lead. Although there was some interest in including broad advances in public health supported by NIH, such as in breast cancer and AIDS, it was the Council consensus to confine the current projects to neuro-related advances.

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6. Council Subcommittee Reports

   Training and Career Development Subcommittee

   Dr. Bruce Bean, Chair of the Subcommittee, summarized three main issues:

   1. Expedited K Awards - The Subcommittee was highly enthusiastic about the success of the new policy to expedite the K awards.

   2. Renewal of K24 Mechanisms - Although K24 grants can be renewed, investigators have not been successful. Since K24s are targeted at mid-career clinical researchers, by the time the awardees reach the end of the award period, reviewers no longer consider them "mid-career" and have been not looked favorably on the applications. The Subcommittee members and staff are in agreement that renewing the K24s should be encouraged to support patient-oriented research and prolong the time period available for the awardees to mentor young investigators, as required by the grant. Dr. Raul Saavedra suggested the possibility of revising the grant criteria language to allow K24 awardees who are beyond "mid-career" to apply for renewal, and that one of the conditions of the award would be based on a demonstrated record of successful mentoring.

   3. Feasibility Study for Evaluating Research Training - This is the first step of a proposed study for evaluating training at NINDS, NIMH, and NIDA. The NIH Office of Research Evaluation is funding the study. Dr. Nora Gardner presented the contractor's findings to the Subcommittee. The feasibility study from Westat determined that research success was measured by research productivity, and the gold standard for that was an investigator with an NIH grant. The elements necessary to evaluate the NIH training programs would be: to determine where grantees are now, what types of activities are they engaged in, what their sources of funding are, are they publishing, and if they have NIH grants. The data sources to be used would be PubMed and NIH databases. The research questions Westat proposed include what are the training career outcomes, how do trainees progress, do awards that require individual competition produce better outcomes than institutional grants, and how do the outcomes differ among I/Cs' training programs. The evaluation would be done on 1600 trainees with all three types of training awards The cost and duration of the study were estimated to be $350,000 and 18 months. The Subcommittee expressed interest in clearly defining the goals of the study. They were also concerned that the outcomes seemed to focus on academic careers. Success should include careers in industry and government. Subcommittee members made the following recommendations: 1. Have staff experienced in training programs involved in advising the contractor regarding the goals of the study. 2. Pay more attention to how existing data can be identified and extracted. Address the question of mining individual institutions' databases or tables for information about their own trainees.

   At the conclusion of the presentation, Council members suggested adding additional measures besides award of new grants and publication of papers to the evaluation of trainees. Consider "external benchmarks," as well, which would include private biomedical careers. Dr. Davis suggested using the Association of Neuroscience Departments and Programs database (http://www.andp.org), which has information about neuroscience trainees.

   Clinical Trials Subcommittee

   Dr. Donald Easton, Chair of the Subcommittee, reported on the following items:

   1. An update on current activities of the Clinical Trials Working Group. 2. An update on the NIH Conflict of Interest policies, 3. A discussion about promoting new elements into the evaluation of patients by medical students and residents in the future: how to teach medical students to do patient histories, physicals, examinations, and differential diagnoses, with the view to prepare all physicians in academic medical centers and in the field to be participants in clinical trials. 4. Dr. Shoulson raised a concern about recruiting and training people to participate on DSMBs and recommended spending time thinking about how to do this. 5. A report by Dr. Scott Janis on the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS) program. There are now six centers around the country that are studying a spectrum of areas related to acute stroke.

   Basic and Preclinical Programs Subcommittee

   Dr. Raymond Dingledine, Chair of the Subcommittee, reported that the Subcommittee discussed the Neuroscience Blueprint plans for FY05 and FY06. The primary goal of the Blueprint institutes is to develop resource toolkits and to improve the infrastructure for doing neuroscience research. The Subcommittee also discussed NINDS's activities in the area of medical counter measures for chemical attack, undertaken in response to a request by the President. The goal is to support the development of new drugs available for use as early response measures to a chemical terrorist attack. Most of the chemical threats under consideration result in neurological disorders. The multi-step approach is as follows: Step 1) Screening appropriate targets to be countered, Step 2) Developing those through animal models and partnering with the Army labs to determine efficacy, Step 3) Putting small molecules through drug development process, and Step 4) Carrying out Phase I clinical trials in humans. After this step, the FDA will consider human safety and animal efficacy data. NIH is developing special screening centers to test the targets, once the assays have been identified. The Subcommittee also talked about how to coordinate the program: whether to use the NIH network of academic centers and SBIR grantees or to contract the project out to a private company.

   Dr. Landis informed Council that this is the third part of the Federal counterterrorism program: it began with attention to infectious diseases, continued with nuclear radiation and now is focused on chemical counterterrorism. Dr. Baughman explained that this effort is funded by a budget separate from the NINDS budget, which will be approximately $30 million per year for five years. The activities in which NINDS is involved complement our mission to support research on neurological disorders.

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7. Proposed Process for Concept Clearance of Initiatives and Concept Approval for Fiscal Year 2006 Proposed Initiatives

   In response to Council's request for more involvement in the initiative development process, Dr. Finkelstein presented a proposed model for Council to consider. Phase I, to take place January through July, includes a step where Council members are given the opportunity for feedback soon after the concepts are developed. After the Council feedback period, the Extramural Division holds its planning retreat, where all of the concepts are presented and discussed. The proposals are then submitted to Council for discussion and concurrence. Dr. Landis makes the final funding decisions following the Council meeting. Phase II repeats the process from July through December. It is the Institute's goal to make the process as transparent as possible and to welcome Council input.

   Council asked to know the impact on the payline when considering initiative concepts. Staff will conduct a full assessment of the budget and will share with Council the outlook for FY06 after that review is completed. Council also asked that the information provided on concepts include key but not highly detailed information. In response to a question about Council-initiated concepts, it was recommended that, like Institute-initiated concepts, the concept process begin with a workshop. The purpose of workshops is to assess the state of the field, the level of interest in the extramural community, and to provide guidance in shaping the initiative. Initiatives are based on an analysis of what is already being done in a particular field and where gaps in research are.

   There is one initiative concept, presented to Council for their concurrence at this Council meeting: Translational Research in Muscular Dystrophy. Dr. John Porter described the need to promote research that would translate progress in the genetic/pathogenic mechanisms underlying the disease into potential effective therapies. The concept originated with the Muscular Dystrophy Coordinating Committee, which recommended that the grants be milestone-driven. Council voted to concur with the initiative concept.

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8. New Policy on Sharing Model Organisms

   Dr. Danilo Tagle, Program Director, Neurogenetics Cluster, NINDS, reported that NIH recently released a new policy designed to promote the more effective sharing of model organisms that are generated through NIH grants. The Institute welcomes Council suggestions for implementing the new policy.

   The NIH is interested in ensuring that the research resources developed with NIH funding are made readily available in a timely fashion to the research community for further research, development, and application. Sharing reinforces open scientific inquiry, encourages diversity of analysis and opinion, promotes new research, allows testing of new or alternative methods for analysis and replication of results. Sharing also avoids the duplication of expensive and extensive efforts in generating the resource. The new policy was announced in the NIH Guide for Grants and Contracts in October 2004 and applies to new, competing and non-competing grants, cooperative agreements, contracts. To illustrate the problem, of the almost 200 fundable applications with animal subjects submitted for May Council, 46 involve creating genetic animal models, and only 2 have an adequate sharing plan. A sharing plan must include several elements, such as the type of model; related research resources and data; what the specific resource is, such as mouse, targeted ES cell, DNA construct, protocols, reagents; the time frame for sharing; the distribution site; and the technology transfer and intellectual property plan (MTA). There are two ways to share the models; either the PI ships them out directly or the PI can send them to an existing repository, depending on the organisms. To fund the sharing procedure, the PI can either include the plan in their application or apply for an administrative supplement. Some outstanding questions that NIH will need to address are whether the requirement applies to models developed with non-government funding, if there should be an initiative seeking models, if PIs should be required to submit the models to a particular repository, and how to better disseminate this policy.

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9. Update on the NIH Blueprint for Neuroscience Research

   Dr. Robert Baughman, Associate Director for Technology Development, NINDS, reported that in February 2004, Dr. Zerhouni announced the formation of the NIH Blueprint for Neuroscience Research, the intent of which was to leverage the resources of the neuro-related I/Cs to accelerate neuroscience research. The original 14 I/Cs, which eventually grew to 16, quickly inventoried their existing activities, consulted with the extramural community, and formed an organizational structure. An overall plan and rationale were developed and then launched at the 2004 Society for Neuroscience Conference. The assessment of neuroscience research revealed that, as of 2004, $4.5 billion was going into neuroscience, and that there existed over 60 cooperative agreements among the I/Cs that spanned a broad spectrum of programs, from training to pediatric neuroimaging and gene expression. The Blueprint goal is to pool resources and expertise to take advantage of economies of scale; reduce redundancy; confront challenges too large for any single Institute or Center; and develop resources, tools, and infrastructure that will serve the entire neuroscience community. Currently, the Blueprint budget, to which the participating I/Cs contribute, is $6.9 million. It will grow to $27.7 million of new dollars per year by FY09. In addition, the NIH Director has pledged to contribute $12 million a year for 4 years. Therefore, the total budget for all Blueprint projects will exceed $150 million by FY2010. In terms of structure, the NINDS and NIMH Institute directors co-chair the Blueprint Directors group and provide direction to the Blueprint Coordination Committee. The BPCC has project teams that, in turn, interact with the extramural community. The FY05 Blueprint Initiatives include training courses in neurobiology; the creation of a Neuroscience Information Framework; an International Neuroinformatics Consortium; expansion of the Gene Expression Nervous System Atlas (GENSAT), the Neuroscience Microarray Consortium, and the Pediatric MRI Study of Normal Brain Development initiative. For FY06, a neuromouse project, cross-institute neuroscience training programs, new neuroscience core grants and programs in the neurobiology of disease, neuroepidemiology project, computational neuroscience, and neuroimaging are planned. For the future, the Blueprint group has suggested supporting the development of better imaging tools and databases, micro-imaging of neuronal activity, the development of a unified neuroepidemiology instrument and an antibody resource. There is detailed information about the Blueprint on the following website: http://neuroscienceblueprint.nih.gov.

   Dr. Landis invited Council comments. There was wide-spread support for the various Blueprint programs. Dr. Zoghbi suggested encouraging non-coding RNA primate models for use in neuroscience research, and Dr. Pullicino suggested coordinating on vascular disease research. Mr. Martin supported allowing NIH grantees to enter data into the RNA database directly and have it overseen by a cross-I/C group.

   On another subject, Dr. Landis announced this is the last Council meeting for Dr. Sally Shaywitz, Dr. Ira Shoulson, Ms. Ellyn Phillips, and Dr. Patrick Pullicino, due to the expiration of their terms of service. Dr. Landis thanked them for their advice and counsel and expressed the hope that they will continue to be engaged in NINDS's activities.

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10. Update on the Counterterrorism Program

    Dr. Landis reported that NINDS' participation on the NIH Counterterrorism effort is represented by Dr. Robert Baughman, Dr. Rebecca Farkas, Dr. Joseph Pancrazio, and Dr. David Jett. Dr. Jett will transition from the Office of Minority Health and Research to work full time on the counterterrorism program. Over the last several years, there have been significant federal efforts on counterterrorism. NINDS has had a long-standing interest in some of the targets of the compounds under discussion and has been working towards expanding our program. In 2002, the Army Institute for Chemical Defense contacted NINDS for assistance in developing treatments. NINDS has had a supplement program and has posted a fact sheet on the Institute's website with information about their programs. NINDS has also worked with a variety of agencies, including the White House Office of Science and Technology Policy, DOD, the Department of Homeland Security, FDA and others, to gain a better understanding of what kind of chemical threats might be relevant. NINDS's counterterrorism programs complement their interest in civilian anti-convulsant treatment and in neuroprotective agents. The Institute has held a series of workshops to help shape the Institute's counterterrorism plan. The programs are funded by separate, HHS funding, and NIAID has taken the lead role in coordinating the programs at NIH. Fifty million dollars has been allocated for FY06, $30 million of which is expected to be devoted to chemicals that affect the nervous system. Reasons for NINDS involvement are the preponderance of threatening agents that affect the nervous system, the expertise within the Institute, and the expectation that the research will have some applicability to their areas of interest. The general strategy is to create a translational research pipeline.

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11. Update on the Institute of Medicine's Report on Training and New Investigators

    Dr. Landis reported that she co-chairs a subcommittee of I/C directors charged with addressing issues related to new investigators. The committee found that there is an increasing gap between a researcher's post-doctoral training to fully independent research. As a consequence of the institute directors' discussion on "Managing in Hard Times," a committee was formed to devise strategies that would: 1) facilitate an investigator's ability to receive his or her first R01 earlier in their research career and 2) maintain a healthy cohort of new and talented NIH-supported independent investigators. Three recent reports have provided guidance to the committee for achieving these two goals: 1) NRC Report, "Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research," 2) NRC Report, "Advancing the Nation's Health Needs: NIH Research Training Programs," and 3) NAS Report, "Policy Implications of International Graduate Students and Postdoctoral Scholars in the United States." One problem that has not yet been settled is the definition of "new investigator." A uniform definition needs to be agreed upon so that programs can be designed to target young investigators for independent research. The Committee has developed several discussion topics, including standardizing career transition programs, determining consistent definitions, developing a tracking system for pre- and postdocs, defining "best practices" related to training, and many others. The Committee's first successful project has been to create a career K22/Research R22 Transition Program. The plan is for all I/Cs to participate in this program, which would offer up to five years of support in two phases: Phase I: 1-2 years of mentored support at $82,000 total cost per year, and Phase II: 1-3 years of independent support contingent on securing an independent research position. The total cost per year would be $213,000. The candidate would be strongly encouraged to apply for an R01 during Phase II. The advantages of this plan are that it creates e a standardized transition program across NIH and provides an opportunity for a new investigator to develop independent research projects. The main drawbacks are that a uniform program may not address a specific I/C's needs, and the increased costs to the I/C. The second strategy to support new investigators was an R03 Transition Program, which uses the small grant (R03) mechanism to transition individuals from postdoctoral status to an independent researcher. It provides total costs of $71,000 per year for three years of independent research in a mentor's lab. It could be used to conduct preliminary research to support an R01 application and would be open to non-U.S. citizens. The applicants must have less than ten years of research experience beyond degree.

    A Council member noted that an institution may have concerns about the additional equipment costs associated with a grantee under the R03 program. Dr. Landis responded that NINDS could consider issuing a "matching supplement program" for the R03 institutional grantees to cover those costs. Support was expressed for the first strategy, due to its additional advantage of enabling the Institute to track trainees.

    The New Investigators Committee recognized that there needs to be improved mechanisms for collecting data and tracking trainees supported by NIH. Two possible ways of enhancing data collection are: 1) request or require that all non-competing renewal grant applications for research projects identify all NIH-supported predocs and postdocs and 2) request or require the submission of appointment forms for all predocs and postdocs supported by NIH research grants.

    Dr. Landis asked Council to think about the possibility that the Institute may have to decide whether, in order to meet the budget requirements of NRSA awardees next year, it will have to reduce the amount of funding budgeted for another purpose. There will be a discussion of this issue at the next Council meeting.

    The New Investigator Committee has inventoried the strategies used by various I/Cs to increase the likelihood that a new investigator will transition to an R01. NINDS gives special attention to new investigators when considering applications for High Program Priority. Other I/Cs use a different payline, don't apply the automatic length of award and budget cuts to new investigators' grants, set a success rate goal, and allow unsuccessful new R01 applicants to submit a five-page response to the summary statements for Advisory Council review. Council members variously supported: a separate payline for new investigators, the rebuttal letter approach, and the R22/K22 program.

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12. Public Comment

    Dr. Chad Sandusky from the Physicians Committee for Responsible Medicine read a statement regarding an NINDS funded program.

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13. 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 114 research career development and institutional training grant applications; of this total, 83 applications had primary assignment to NINDS, and 57 of them (68.7 percent) were recommended for support in the amount of $8.1 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 $3.4 million.

    Research Grant Awards

    The Council reviewed a total of 2,230 research grant applications; of this total, 1,386 applications had primary assignment to NINDS, and 885 of them (63.9 percent) were recommended for support in the amount of $260.2 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 $84.1 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 six investigators as Javits awardees.

    Small Business Innovation Research and Small Technology Transfer Award Programs

    The Council reviewed a total of 225 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 114 applications had primary assignment to NINDS and 61 of them (53.5 percent) were recommended for support in the amount of $12.3 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 $5.2 million.

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14. Adjournment

    The meeting was adjourned at 10:45 a.m. on Friday, May 27, 2005.

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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.

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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.

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