NINDS Advisory Council Meeting Minutes, September 9-10, 2004

1. Call to Order and Opening Remarks
2. Report of the Acting Director, Division of Extramural Research
3. Report of the Director, NINDS
4. A Bright Future for Research Funded by NIDCD
5. NIH Roadmap, "Re-engineering the Clinical Research Enterprise": Revised NIH Peer Review Criteria
6. NIH Pain Consortium
7. Council Subcommittee Reports
8. Update on Budget for Fiscal Year 2005
9. Concept Approval for FY06 Proposed Initiatives, Dr. Alan Willard
10. Update on Neuroscience Blueprint Plans
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
September 9-10, 2004

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 161st meeting on September 9-10, 2004, at Building 1, Wilson Hall, 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:		September 9, 2004 --10:30 a.m. to 5:20 p.m.
for the review and discussion of program development, needs, and policy; and
Closed:		September 10, 2004 - 8:00 a.m. to 10:10 a.m.
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. William Mobley
Ms. Ellyn Phillips
Dr. William Mobley
Dr. Sally Shaywitz
Dr. Ira Shoulson
Mr. Robert Waterman

Council members absent were:

Dr. Alicia Conill
Dr. Susan Hockfield
Dr. Huda Zoghbi

Council Roster (Attachment 1)

Ex Officio Members present:

Dr. Paul Hoffman, Department of Veterans Affairs

Ex Officio Members absent:

Dr. Geoffrey Ling, Department of Defense

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

Dr. Dietrich Stephan, Translational Genomics Research Institute
Mr. John Softcheck, Washington Fax
Mr. Patrick Doerr, Constella Group, Inc.
Dr. Tina Johnson, Epilepsy Foundation
Dr. Viviana Simon, Society for Women's Health Research
Mr. Robert Balkam, Restless Leg Syndrome Foundation
Ms. Patricia Furlong, Parent Project Muscular Dystrophy
Ms. Trina Stokes, The Parkinson Alliance
Ms. Carol Walton, The Parkinson Alliance
Ms. Patricia Kobor, American Psychological Association
Chris Peterson, SRI

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. Bernard Ravina
Mr. Peter Gilbert
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. Paul Sheehy
Dr. Tom Jacobs
Dr. Yuan Liu
Dr. Alfred Gordon
Dr. Emmeline Edwards
Dr. Ernie Lyons
Dr. Eugene Oliver
Dr. Diane Murphy
Ms. Quandra Scudder
Mr. Jim Stables
Dr. Laura Mamounas
Dr. Robert Baughman
Mr. Phillip Wiethorn
Ms. Diane Howden
Dr. Robert Finkelstein
Ms. Stephanie Clipper
Ms. Stephanie Fertig
Dr. Ursula Utz
Ms. Margaret Jacobs
Dr. Arlene Chiu
Dr. Andrea Sawczuk
Dr. JoAnn McConnell
Dr. David Jett
Dr. Michael Nunn
Dr. Tom Miller
Dr. Naomi Kleitman
Dr. Audrey Penn
Dr. Yejun He
Dr. Christina Vert
Ms. Maureen Hambrecht
Dr. Daofen Chen
Dr. Paul Scott
Ms. Sylvia Parsons
Dr. Jill Heemskerk
Dr. Joe Pancrazio
Mr. Paul Girolami
Dr. Gabrielle LeBlanc
Ms. Robin Latham
Mr. Paul Myers
Mr. Andy Baldus
Dr. Karen Bateman
Dr. Richard Crosland
Dr. Randall Stewart
Ms. Cikena Reid
Ms. Janice Cordell
Ms. Lynn Morin
Dr. Heather Rieff
Ms. Joellen Harper
Dr. Robert Zalutsky
Dr. Katie Woodbury-Harris
Dr. Debra Hirtz
Ms. Debbie Jarman
Dr. Shanta Rajaram
Dr. David Owens
Ms. Margo Warren
Ms. Rebecca Farkas
Dr. Lauren Murphree
Ms. Stacey Chambers
Mr. Jim Remington

Other Federal employees present for portions of the meeting included:

Dr. Rene Etcheberrigaray, CSR
Dr. Yingying Li-Smerin, CSR
Dr. Christine Melchior, CSR
Dr. David Armstrong, CSR
Dr. Bernard Driscoll, CSR
Dr. Robert Elliott, CSR
Dr. Biao Tian, CSR
Dr. Edwin Clayton, CSR
Dr. Mike Selmanoff, CSR

1. Call to Order and Opening Remarks

   Dr. Story Landis, Director, NINDS, welcomed Council members, guests, and staff to the 161st Council meeting and introduced new Council members: Dr. Francisco Gonzalez-Scarano, Dr. John Loeser, Ms. Prisca Chen Marvin, and Dr. David Van Essen. In keeping with the Institute's policy of inviting a chairman of a review committee, Dr. Roger Simon of the NINDS Training Grant and Career Development Review (NST) Committee attended the open session of the Council meeting.

   Four Council members were unable to attend: Dr. Alicia Conill, Dr. Geoffrey Ling, Dr. Huda Zoghbi, and Dr. Susan Hockfield. Dr. Zoghbi participated by teleconference in the closed session. Dr. Hockfield was recently appointed President of the Massachusetts Institute of Technology, and subsequently expects to find it difficult to fulfill her Council responsibilities. Therefore, the Institute will begin a search for a replacement to complete her term.

   Dr. Landis introduced Dr. Richard Benson, a new Program Director in the Office of Minority Health and Research. He was previously the interim director of the Stroke Division and Assistant Attending and Director of Community Stroke Education at St. Luke's-Roosevelt Hospital Center in New York. Other program directors have just been hired or are in the process, and they will join us at the next Council meeting.

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2. Report of the Acting Director, Division of Extramural Research

   Government in the Sunshine Act and the Federal Advisory Committee Act

   Dr. Alan Willard, Acting Director, Division of Extramural Research, NINDS, 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 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. Alan Willard as the Council Executive Secretary, who will then refer the questions to the appropriate staff member for response. In response to questions from Council members, Dr. Willard clarified what are approved types of communication with potential applicants and what is disallowed.

   Consideration of Minutes of Previous Council Meeting

   The minutes of the Council meeting of May 27-28, 2004, were considered and accepted as written.

   Consideration of Dates for Future Council Meetings

   The following dates for future Council meetings were reconfirmed:

   February 10-11, 2005		(Thursday and Friday)
   May 26-27, 2005		(Thursday and Friday)
   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)

   Other Items

   Expedited Review Process--One hundred sixty-six applications were eligible for expedited award, and twenty-five had been awarded prior to this Council meeting.

   Reports Book--The Reports Book consists of applications that have been designated for funding since the last Council meeting. It includes a section on the status of applications that were identified for High Program Priority.

   Loan Repayment Program--The program began three years ago. The purpose is to recruit and retain highly qualified health professionals to biomedical and behavioral research careers by countering the growing economic disincentives to embark on such careers, using as an incentive the repayment of educational loans. Applications submitted this Council round were in the clinical research and pediatric research program areas. NINDS received over 100 applications, and the Institute was allocated $2.6 million for the program. Fifty one awards were made: Thirty one went to MDs, 13 went to Ph.D.s, 5 went to MD/Ph.D.s, and one each went to a DVM/PhD and a DO. Twenty seven grantees were assistant professors, 2 were associate professors, and the remainder were in pre-faculty positions. In terms of specialty, 18 were in neurology, 9 were in pediatric neurology, 5 in neurosurgery, and the rest varied in specialty.

   Staff Changes--Dr. Willard introduced the following new staff: Dr. Lauren Murphree, a new program analyst in the Technology Development group; Dr. David Owen, a postdoctoral fellow in the Intramural program who is on detail to the Repair and Plasticity cluster; Stephanie Fertig, program analyst in the Repair and Plasticity cluster; and Stacey Chambers, program analyst for International Activities. By way of departures, Mr. Gahan Breithaupt, Acting Executive Officer has moved to NIAMS; Dr. Arlene Chiu of the Repair and Plasticity cluster has accepted the position of Associate Director for Science Research Administration at the National Institute of Biomedical Imaging and Bioengineering; Dr. Mary Ellen Michel has joined the staff of the National Institute on Drug Abuse; program analysts Dr. Sussan Paydar and Dr. Maureen Beanan have moved to the National Institute of Allergy and Infectious Diseases; and Dr. Ronnie Horner has accepted a position at the University of Cincinnati. With Gahan Breithaupt leaving, the following staff changes have been made: Joellen Harper is Acting Executive Officer; Andy Baldus is Acting Deputy Executive Officer, and Paul Myers is Acting Budget Officer.

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3. Report of the Director, NINDS

   Dr. Landis announced that the theme for this Council meeting would be collaboration with other NIH institutes. The NIH Roadmap for Medical Research, in which all NIH I/Cs are participating; the Pain Consortium, in which NINDS is joined by two other institutes; and the Blueprint for the Brain, a project that tasks the institutes with brain-related research to work together toward common goals, are all examples of NINDS's collaboration and interaction at NIH. In keeping with the goal of having neuro-related I/C directors speak at NINDS Council meetings, Dr. James Battey, Director of the National Institute of Deafness and Other Communication Disorders, was asked to speak about NIDCD's activities. Previously, Dr. Thomas Insel has spoken to Council about NIMH.

   Porter Neuroscience Center -- Phase I is complete. The Porter Center was a major project undertaken by the Intramural Program. The vision was created by Dr. Gerry Fischbach and Dr. Steven Hyman and involved scientists from all of the neuroscience institutes. The scientists are organized by their areas of research, rather than by their institute affiliations. The second phase has been approved by Congress, but funds have not yet been appropriated.

   Clinical Research Center -- Up-to-date, modern wards and lab space have been added to the CRC. The new Center opened on September 22. The opening will give NIH an opportunity to give the public a better understanding of the research conducted by NIH and in the extramural program. This has been an inter-institute effort that serves most of the I/Cs.

   Conflict of Interest --Congress asked NIH to review its conflict-of-interest guidelines in light of last year's media coverage of the subject relative to some NIH staff's consulting arrangements. The issue relates to potential conflicts for NIH scientists between outside activities for which they are compensated and their federal roles. Dr. Zerhouni convened a Blue Ribbon panel to draft recommendations, which were then presented by Dr. Zerhouni to Congress. NIH is continuing to work on guidelines that help staff completely avoid any perception of conflict of interest and at the same time allow participation in the biomedical scientific and research enterprise. Some of the recommendations that are likely to be implemented are that no senior official can consult with private industry, non-senior staff will be limited to 25 percent of their income that can be obtained by consulting fees and not more than half of that from any one source, scientists may not receive speaking honoraria, all prizes will have to be approved by the NIH Director's office, and new restrictions on stock holdings in biotechnology. Staff will be able to write, publish, teach, and participate in clinical activities. Many of the recommendations will need to be implemented legislatively.

   Public Access to NIH-Funded Research -- There has been increasing interest to make published studies based on NIH-funded research more easily available to the public, and there is congressional pressure to pass legislation making all articles based on research funded by NIH available to the public on Pub Med. There is concern that any new system of access not compromise the review process currently in place, before publication of scientific data. The NIH Director's office has solicited comment from I/C directors, advocacy groups, and journal editors. The results of the Director's meetings can be found in NIH Guide Notice OD-04-064 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html), and the public comment period has been extended to November 16.

   Chemical Terrorism Activities -- NINDS has begun involvement in chemical terrorism programs, which will be reported on at greater length at a future Council meeting. After 9/11, it was recognized that the nation was not adequately prepared to respond to chemical and biological threats. NIAID has taken the lead in funding research in this area, and NCI has gotten involved, as well. Many of the biological agents affect the nervous system and have the potential to effect civilians as well as the military. In April, NINDS partnered with the U.S. Army Medical Research Institute to sponsor a successful workshop on Counterterrorism and Neuroscience (http://www.ninds.nih.gov/news_and_events/proceedings/counterterrorismworkshop2004.htm). In 2003, NINDS published an announcement that solicited applications for administrative supplements for research aimed at protecting the nervous system from the harmful effects of a chemical/biological terrorist attack. NINDS will issue another announcement making another $500,000 available for additional supplements in 2005 while working on joint programs for 2006, coordinated by NIAID, and involving several I/Cs and agencies.

   Comments from Council members included the suggestion to see if funds are available from the Department of Education's loan repayment program for MDs and women in science for NINDS grantees and for NINDS to discuss the possibility of getting funds from DOD for bioterrorism research.

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4. A Bright Future for Research Funded by NIDCD

   Dr. James Battey, Director, National Institute on Deafness and Other Communication Disorders (NIDCD) reported that the Institute had a budget of about $383,000,000 in FY2004. These funds were used to support roughly one thousand research and research training grants and contracts to better understand the normal and disordered processes of hearing, balance, smell, taste, voice, speech, and language. NIDCD has focused its attention on developing training and career development pathways that will expedite the entry of new investigators into NIDCD's portfolio, particularly physician-scientists.

   Recently, attention has been focused on identification of the many genes that underlie hereditary hearing impairment, a disorder that compromises the development of normal communication skills in roughly 1 in 2,000 children. Over 80 genes have been mapped, and about 40 genes identified, whose mutation results in non-syndromic hereditary hearing impairment. Identification of these genes has revealed hitherto unknown molecular pathways in the inner ear that are essential for normal auditory function. In some cases, genotypic diagnosis can aid clinicians in selecting the best strategy for helping individuals with hearing impairment. Discovery of genes involved in hearing impairment and other communication disorders will remain a priority for NIDCD in the near future.

   Otitis media, or middle ear infection, remains a major public health challenge, with costs in excess of $5 billion a year in the United States. The emergence of bacterial pathogens resistant to first-line antibiotics has made the search for alternative strategies to treat and prevent otitis media a high priority for NIDCD. These strategies include preventing pathogenic bacterial adhesion to the middle ear mucosa, understanding the unique features of the biofilm bacterial growth state that promotes chronic otitis media, and developing candidate vaccines directed against the major pathogens.

   Research using a range of animal models has revealed information of great potential utility for improving human health. Based on new basic understanding of the mechanism that underlies directional hearing in the fly, scientists are working to develop a smart, directional hearing aid for individuals with moderate to severe hearing impairment. This device will improve speech intelligibility in environments with high levels of background noise, which is a common complaint among individuals using hearing aids at the present. Studies of chemosensory receptors in mosquitoes reveal candidate mechanisms involving a specific chemosensory receptor used by mosquitoes to identify targets for a blood meal. By intervening in this process, it may be possible to reduce the incidence of mosquito bites for individuals in regions of the world where malaria is a major cause of morbidity and mortality.

   The future for research progress in all of NIDCD's mission areas is bright, given: (1) the availability of large public databases that expedite gene discovery and function; (2) a plethora of biologically diverse animal models to glean new insights; (3) a stream of talented young investigators to seize the challenge of research in NIDCD's mission areas; and (4) a willing cadre of individuals with communication disorders willing to participate in clinical studies to develop and validate improved intervention strategies.

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5. NIH Roadmap, "Re-engineering the Clinical Research Enterprise": Revised NIH Peer Review Criteria

   Dr. Robert Star, Senior Scientific Advisor, NIDDK, reported that the NIH Roadmap stresses the importance of clinical, translational, and interdisciplinary research. In January 2003, a Roadmap Clinical Research Summit recommended improved review of clinical research applications, and the I/C Directors approved of the recommendations in August 2004. NIH's criteria for changes in the review process are: NIH will provide a rigorous and fair review, the review criteria will be evenly applied, changes made to the review criteria must be made known to the reviewers and applicants, changes should be kept to a minimum, and review criteria could be modified by RFAs. The Summit developed a standard review criteria opening paragraph, which reads, "An application need not be strong in all categories to be judged likely to have a major scientific impact." The review criteria have been revised to address the following questions: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field? Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the project original and innovative? Are the investigators appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project? Does the scientific environment contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment or subject populations, or employ useful collaborative arrangements? Is there institutional support? These criteria will be announced in the NIH Guide, in the application form instructions, in individual request for application announcements, and on NIH websites. They will go into effect January 2005 for the October 2005 Council round. Training of the scientific review administrators and an evaluation component are included in the revised criteria plans.

   Dr. Star stated that his committee is a trans-NIH, clinical research workforce, with representatives from each I/C (Dr. Marler represented NINDS). The goal of the committee was to develop an integrated, multidisciplinary, diverse workforce that can meet future clinical research needs and to establish a robust, academic, research discipline. The committee must address how clinical research is taught and to increase the complexity of scientific and regulatory knowledge needed by researchers. The committee also acknowledges that clinical research is evolving to a team approach, rather than that of an individual investigator working on a project in isolation. The academic environment of the clinical researcher needs to be assessed, and reducing the barriers to the career pathway of an investigator needs to be addressed, as well. The committee has issued a career development award for post-docs, and to encourage recruitment into clinical research, a Roadmap multidisciplinary career development program has been announced. One of the goals of the committee is to link existing networks so that various clinical studies that the institutes are doing can be done more efficiently and effectively and at a lower cost. Another goal is to find physicians trained in clinical research who will enroll patients into clinical trials. The idea is to accelerate translational research into practice. The committee is also reviewing clinical research training programs in order to assess best practices.

   Council suggested adding a clinical research component to standard medical education and suggested involving private industry in the committee's goals. Other issues raised by Council members were the concern that physicians who participate in clinical research have less opportunity to get tenure, the fact that some study section members are not active clinical researchers, and the need for a central repository for clinical trials information.

   Update on the High Throughput Screening Assay Roadmap Initiative

   Dr. Robert Baughman, Associate Director, Technology Development reported that the NIH Roadmap consists of three broad categories: 1) New Pathways of Discovery, 2) Research Teams of the Future, and 3) Re-engineering the Clinical Research Enterprise. Each category has several components, and among the components of New Pathways to Discovery is the project in which NINDS is taking the lead, the Molecular Libraries Assay Development Initiative. The Molecular Libraries Initiative invites research that will: 1) develop small molecule probes as research tools and therapeutic leads for novel biological targets, 2) include high throughput screening and medicinal chemistry on large collection of compounds, 3) target agonists, antagonists, and reporters, and 4) not be non-redundant with private sector efforts. The Assay Development Initiative is a trans-NIH, one-year, R03 small grant award that invites proposals to adapt existing, well-characterized assays to high throughput screening. The goal is to produce a steady stream of novel assays/targets for the molecular libraries screening centers. The initiatives are funded by NIH Roadmap funds, but the I/Cs can pay applications that do not get paid by the Roadmap account. The Request for Applications will be reissued each year, so that P.I.s can reapply, and funding will increase each year for the next several years.

   In response to a question, Dr. Baughman explained that the National Center for Biotechnology Information is creating a new database to manage the data associated with the compounds. Mr. Bartek asked whether applications not funded by the Roadmap funds could be fast-tracked and given an opportunity for funding faster than it would take to resubmit and be re-reviewed; the response is that this can be achieved if I/Cs pay out of their own funds. In response to a question about follow up of assays, Dr. Baughman replied that follow up to the initial stages done in the Molecular Libraries Centers will be the responsibility of the individual I/Cs.

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6. NIH Pain Consortium

   Dr. Linda Porter, Program Director, Systems and Cognitive Neuroscience Cluster reported that the NIH Pain Consortium is co-chaired by three I/C directors: Dr. Story Landis of NINDS, Dr. Patricia Grady of NINR, and Dr. Lawrence Tabak of NIDCR and is represented by 19 I/Cs. The goals of the Pain Consortium are to develop a comprehensive, long-term pain research agenda, identify key opportunities in pain research, pursue the pain research agenda through public-private partnerships, and to increase visibility for NIH pain research. Almost $173 million was spent on pain research by NIH in 2002, half of which was spent on clinical research. Forty percent funded basic research and 10 percent funded translational research. NINDS' budget for pain research increased from approximately $49 million in FY02 to $59 million in FY03 and is projected to remain near that level through 2005. Pain research is of particular interest to NINDS because it is mediated by the nervous system. Among the grants in the NINDS pain portfolio are those related to understanding pain mechanisms, determining why certain pain is disease or population specific, developing animal models and drug delivery devices, and improving therapies for pain management. NINDS has the largest pain portfolio of the NIH I/Cs at almost $60 million, with NIDA funding the second-largest at roughly $25 million. The Pain Consortium identified several aspects of pain research as high priority areas in need of support. They determined that much more needs to be known about the basic mechanisms and pathophysiology of pain, and that translation of basic research into human pain management needs to be facilitated. They also identified the need to develop strategies for informing patients and care-givers of research discoveries relevant to pain management. Avenues to develop novel pain therapies need to be optimized, and roadblocks to their development should be lifted. Furthermore, we need a better understanding of the prevalence of chronic pain conditions and co-morbidities through broad, well validated epidemiologic studies. The strategies to achieve these goals include creating a website (http://painconsortium.nih.gov), which was accomplished by NINDS and NIDCR; conducting a workshop on novel pain therapies; creating a traveling pain display; hosting a symposia highlighting NIH-funded pain research; and sharing resources among I/Cs. Two initiatives have been released through the Pain Consortium. They were collaborative efforts between NINDS and NIDCR to promote different aspects of cranio-facial research. The Pain Consortium is a unique opportunity to develop a comprehensive strategy on pain research, and the committee members are committed and enthusiastic.

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7. Council Subcommittee Reports

   Training and Career Development Subcommittee

   Dr. Bruce Bean, Chair of the Training, Career Development, and Special Programs Subcommittee reported that committee reviewed proposed changes to the language pertaining to the institutional commitment for K08 and K23 awards. The new language emphasizes the necessity for having a clear commitment by the grantee institution for the training program trainee. It also makes explicit the expectation that the training experience will enable the trainees to apply for independent research funding. The Training Committee was given an update by Marina Volkov from NIMH on the beginning of an effort by NIMH and NIDA to evaluate these training programs. The first stage will determine what outcomes should be evaluated, whom to interview, who the control groups are, etc. NINDS will apply for funds to join this effort. The Training Committee also discussed Dr. Mobley's idea for a new award or mechanism to produce training programs for K awardees within institutions. There would be a training officer in the institution who could serve as a focus for developing training programs and serve as a clearinghouse for information on award programs. Finally, the committee discussed the importance the availability of information on each award program, particularly on the NINDS website.

   Infrastructure and Neuroinformatics Subcommittee

   Dr. Bruce Bean, substituting as the Chair of the Infrastructure and Neuroinformatics Subcommittee, reported that the Subcommittee reviewed the progress of the P30 Core Grant Program, which is in its second year of implementation. Thirteen have been awarded since NINDS introduced the program, with a 30 percent success rate. The Subcommittee heard two reports on Roadmap RFAs: 1) Phase One of the High Throughput Molecular Screening Assay Development and 2) National Centers for Biomedical Computing. Dr. Dietrich Stephan gave a report on the highly successful NINDS/NIMH Microarray Consortium project. The purpose is to provide microarray access to NINDS and NIMH grantees. This program is a model for Internet-based informatics, linking together a number of sites and providing public access.

   NINDS/NIMH Microarray Consortium

   Dr. Dietrich Stephan, Director, Neurogenomics Program, Translational Genomics Research Institute, Phoenix, Arizona, reported that the purpose of the NINDS/NIMH-funded consortium is to provide state-of-the-art technologies derived out of the human genome project to neurological and mental health disorders to NIH-funded grantees. The project began in 2002 with the building of the infrastructure by the three consortium members, Duke University, UCLA, and the Translational Genomics Research Institute (TGen). The scope and goals are to provide these technologies to NIH-funded researchers so that they do not need to incur the cost and training to reproduce them. The users are able to perform both expression profiling and snip genotyping. The technologies deconstruct the entire molecular make-up of a person with a disorder and compare it with a person without the disorder. The consortium offers the highest quality technology, in terms of expression profiling and single, neocleotide polymorphism genotyping. There is also a research and development component, to keep up with and adapting the latest technologies. Training of researchers is also available at each of the three centers. It is a fee-for-service operation, whereby the investigator pays the reagent fees to have a genome or transcriptome scanned. All of the personnel and infrastructure costs are paid by the awards. The turn-around time is between one and two months. Since its inception, approximately 5,000 arrays have been performed for 124 projects. Applications for services are increasing, and the consortium has recently received a request to do 6,500 samples within three months. Requests for services are entered in a web-based program and are all peer-reviewed. All of the data generated by the consortium are posted on the website six months after they are generated. The consortium is also involved in amassing a large dataset and tying in with other projects, such as Gensat and the Human Brain Project. Efforts to measure the success of the program have been made by soliciting feedback from users and by gauging demand on the consortium. The ultimate goal of the consortium is to further each researcher's research so that they can get to the endpoint of an improved diagnostic or therapeutic in as little time as possible. The website for the project is the following: http://arrayconsortium.tgen.org

   Clinical Trials Subcommittee

   Dr. Donald Easton, Chair of the Clinical Trials Subcommittee, reported that one of the recommendations that came out of the Stroke Progress Review Group was for NINDS to take the lead in organizing large clinical trials for primary prevention of vascular injury to the brain as well as support and encourage investigator-initiated clinical trials aimed at primary prevention of stroke. The Subcommittee heard a report by Dr. Barbara Radziszewska of a workshop she organized on this topic last January. Primary prevention has not received the attention it needs. The Subcommittee discussed the best groups to invest in novel approaches to prevention. The next report was from Dr. Scott Janis about a proposed revision to the current acceptance policy for R21 applications. The Institute will now accept clinical research projects provided they do not include a clinical intervention and they have adequate safety monitoring plans. The final report was a proposal to restructure the mechanism for submitting an application for a multi-site clinical trial. The proposed new mechanism would require multi-site clinical trial applications to be submitted as individual applications (i.e., each recruiting site submitting their own application) rather then as one single application thereby resulting in more administrative control over trials by the institute and more effective management problems that occur in these trials (such as difficultly in recruiting patients).

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8. Update on Budget for Fiscal Year 2005

   In response to questions by Council members at the last Council meeting, Mike Loewe, Chief of the Grants Management Branch, explained how individual grant award amounts are calculated, for both modular and non-modular grants. The process includes calculating the recommended budget amount and making administrative adjustments in accordance to NIH and NINDS policy.

   Dr. Willard reminded Council that a draft FY05 budget was presented at the May Council meeting. Based on assumptions made at the time,one of which was that NINDS would receive the President's proposed funding level ($1.546 billion, an increase of 2.6%), $312 million would be available for all competing grants. Another assumption was that OMB will mandate a maximum increase of no more than 1.9% for non-competing awards. Since an automatic increase of 3% has been built in, the mandatory limit would result in an effective cut of 1/1% on non-competing awards. The standard reductions in grant budgets would be maintained, at 7% for modular grants and 12.5% for non-modular grants, and it was assumed that the number of applications would increase in FY05 by 12%. We do not have a final budget yet; however, we now know that we will have fewer funds available for competing awards. Part of the reason is that some FY05 grants have been paid with FY04 funds, which increases the non-competing grant budget. We now assume we will have approximately $293 million available for competing grants. The actual average cost of a grant has increased by 5%, not the 3% we had previously assumed. The fraction of NINDS grants that receive a particular percentile is actually more than that percentile. In FY2004, actually 26% of grants got a 19 percentile (the payline for FY04). After applying the new assumptions, we have arrived at an estimated 16 percentile and a 20% success rate for FY05.

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9. Concept Approval for FY06 Proposed Initiatives, Dr. Alan Willard

   The Institute conducts a retreat twice a year for staff to present proposals for the following fiscal year. The proposals are then discussed in detail and ranked by the Extramural Science Committee. Those approved to go forward for Council concurrence have been provided to Council:

   1. Accelerating therapy development for tuberous sclerosis
   2. Delivery of RNAi
   3. Non-human lentiviral models
   4. Basic and clinical research of Rett
   5. Interactions between stem cells and the microenvironment in vivo
      

   Questions were raised pertaining to the concepts not chosen by staff, if a running list was kept of all initiative concepts, and what the sources are for the initiatives. Initiative concepts can be proposed by staff, Council members, or mandated by Congress or HHS. For example, the Department of HHS has mandated that NIH fund three translational stem cell centers of excellence in FY05. Dr. Landis attended a leadership forum of all I/C directors which discussed how to revitalize the clinical research enterprise, how human capital is being managed at NIH, and priority-setting by NIH in the context of disease burden and scientific opportunities. It is a complicated process to balance investigator-initiated research with direction from the institute and how to determine areas of emphasis. If NIH does not develop a credible, understandable, transparent mechanism for setting priorities, it will be done for us. This is a major issue for NIH and NINDS.

   There was also a question about the variability of paylines across institutes. Dr. Landis responded that NICHD funded at the 12th percentile this year, and the consequence was that PIs with applications between the 12th and 19th percentile (NINDS's payline in FY04), redirected their applications to NINDS.

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10. Update on Neuroscience Blueprint Plans

    Dr. Landis reported that there have been many projects where several I/Cs have worked together, and the Neuroscience Blueprint is one of those projects in which NINDS is participating. The idea is to look prospectively at what the research needs are and how to allocate resources to meet those needs. The Blueprint Consortium originated with 8 I/Cs and has grown to include 14. The Consortium is focusing on tools that neuroscientists can use to improve their research, and was commissioned by Dr. Zerhouni to determine a "tool kit" for neuroscience for the 21st century. To accomplish this, the group invited ideas from the extramural community and conducted an inventory of what was already in use. Some of the ideas that have come out of the process are: a gene expression map, a panel of antibodies, better imaging tools, collecting transgenic mice with all of the genes of interest in the nervous system, and a better way to share information about clinical trials. There was concern about the weight being placed on behavioral research. There was also a discussion about whether or how much money I/Cs should contribute to Blueprint initiatives, particularly if they are not directly relevant to the I/C's mission. The group agreed to create a collaborative consortium of all neuroscience I/Cs, to expand on the existing projects, and to support new projects, which will be decided upon by the group. Some projects have wide agreement and will be widely supported. The projects of more limited interest will be funded only by the affected I/Cs.

    Dr. Landis concluded the public session by informing Council that, in light of Council's interest, there will be a discussion of the burden of disease and research opportunities at the next Council meeting.

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11. 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 120 research career development and institutional training grant applications; of this total, 70 applications had primary assignment to NINDS, and 48 of them (68.6 percent) were recommended for support in the amount of $6.8 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 $3.6 million.

    Research Grant Awards

    The Council reviewed a total of 2,145 research grant applications; of this total, 1,202 applications had primary assignment to NINDS, and 781 of them (65.0 percent) were recommended for support in the amount of $222.8 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 $67.1 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 eight investigators as Javits awardees.

    Small Business Innovation Research and Small Technology Transfer Award Programs

    The Council reviewed a total of 226 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 90 applications had primary assignment to NINDS and 45 of them (50.0 percent) were recommended for support in the amount of $7.9 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 $5.7 million.

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12. Adjournment

    The meeting was adjourned at 10:10 a.m. on Friday, September 10.

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

Alan L. Willard, Ph.D.
Acting Executive Secretary
National Advisory Neurological Disorders and Stroke Council
Acting 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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