NINDS Advisory Council Meeting Minutes, February 15-16, 2001

• I. Call to Order and Opening Remarks
• II. Report of the Associate Director for Extramural Research
• III. Discussion of the NAS Report: "Addressing the Nation's Changing Needs for Biomedical and Behavioral Scientists"
• IV. Report of the Acting Director, NINDS
• V. Presentation: "Novel Approaches Toward the Pathogenesis and Treatment of Multiple Sclerosis"
• VI. Presentation: "On the Outside, Looking In and On the Inside, Looking Out: The Role of Experiential Learning About Chronic Illness and Disability in Medical Education"
• VII. Council Subcommittee Reports
• VIII. Overview, Division of Intramural Research, NINDS
• IX. Report of the Former Director, NINDS
• X. Review of the Division of Intramural Research Board of Scientific Counselors' Reports
• XI. Council Review of Pending Applications
• XII. Adjournment

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Neurological Disorders and Stroke Council

Summary of Meeting¹
February 15-16, 2001

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 150th meeting on February 15, 2001 in Building 45, Conference Room E1/E2, National Institutes of Health, Bethesda, Maryland. Dr. Audrey Penn, Acting 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 15, 2001 --10:30 a.m. to 4:00 p.m.

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

Closed: February 15, 2001 - 4:00 p.m. to 5:15 p.m. and February 16, 2001 - 8:40 a.m. to 11:10 a.m.

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

Council members present were:

Mr. Robert V. Abendroth
Dr. Keith Black
Ms. Jeanne Carpenter
Dr. Martha Denckla
Dr. John Griffin
Dr. Julian Hoff
Ms. Kathleen Hunter
Dr. Daniel Lowenstein *
Dr. Peter MacLeish
Mr. Bradley Margus
Dr. John Mazziotta
Dr. Jerome Posner
Dr. Joshua Sanes
Dr. Richard Tsien
*participated in closed session by telephone

Council members absent were:

Dr. Lydia Villa-Komaroff
Dr. Uta Francke
Council Roster

Ex Officio Members present:

Dr. Paul Hoffman, Department of Veterans Affairs

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¹For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) when a real or apparent conflict of interest might occur.

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

Mr. Glenn K. Davis -- National Ataxia Foundation, Chesapeake Chapter
Ms. Carolyn K. Davis -- National Ataxia Foundation, Chesapeake Chapter
Ms. Pamela Moore--Capitol Publications
Ms. Dianne Flescher--Epilepsy Foundation
Mr. Ron Bartek--Friedreich's Ataxia Research Alliance
Ms. Natalie Ochs--The Blue Sheet
Dr. Gerald Fischbach - Columbia University
Dr. Ruth Fischbach - Columbia University
Dr. Alicia Conill - Conill Institute
Ms. Alicia Conill - Miami, Florida

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NINDS employees present for portions of the meeting included:

Dr. Audrey S. Penn
Dr. Constance Atwell
Dr. Cheryl Kitt
Dr. Al Kerza
Dr. William Heetderks
Dr. Paul Nichols
Ms. Margaret Jacobs
Dr. Katherine Woodbury-Harris
Dr. Robert Baughman
Dr. Eugene Oliver
Mr. Phillip Wiethorn
Ms. Shirley Broderick
Dr. Alan Willard
Dr. Arlene Chiu
Mr. Gahan Briethaupt
Dr. Mary Ellen Cheung
Dr. Yuan Liu
Ms. Mary Miers
Ms. Joellen Harper
Dr. Toby Behar
Dr. Emmeline Edwards
Ms. Quandra Scudder
Ms. Cikena Reid
Dr. Lynn Morin
Dr. Carlos Pena
Dr. Lewis Rowland
Dr. Katrina Gwinn-Hardy
Ms. Chris Davis
Mr. Mark Salo
Ms. Tarsha McCrae
Dr. Paul Sheehy
Dr. Lillian Pubols
Mr. Levon Parker
Ms. Nena Wells
Dr. Gabrielle Leblanc
Ms. Maureen Hambrecht
Ms. Ruth Linn
Mr. Andy Baldus
Dr. Robert Zalutsky
Mr. Kevin Kirby
Dr. Paul Scott
Dr. Story Landis
Mr. George Bramhall
Dr. David Eckstein
Mr. Paul Girolami
Dr. Diane Murphy
Dr. Henry Khachaturian
Dr. Robert Finkelstein
Mr. James Stables
Dr. Jill Heemskerk
Dr. Meredith Temple-O'Connor
Mr. Sudip Parikh
Dr. Guy McKhann
Ms. Debbie Jarman
Ms. Mary Graham
Dr. Jennifer Pinto-Martin
Mr. Kenny Bond
Dr. Piotr Kozlowski
Dr. Todd Horich
Dr. Martin Roland

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Other Federal employees present for portions of the meeting included:

Dr. Walter Schaffer, OD
Dr. Christine Melshior, CSR
Dr. Gillian Einstein, CSR
Dr. Dan Kenshalo, CSR
Dr. Michael Nunn, CSR
Dr. Carole Jelsema, CSR
Dr. Jay Joshi, CSR

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I. Call to Order and Opening Remarks

Dr. Audrey Penn, Acting Director, NINDS, welcomed Council members, guests and staff to the 150^th Council meeting. She mentioned that Morton Kondracke had recently resigned from the Council. She announced that Council member Dr. Peter MacLeish was installed as the George H. W. and Barbara P. Bush Chair of Neuroscience at the Morehouse School of Medicine in Atlanta. Dr. Penn introduced Dr. Robert Miller, Professor, Department of Neuroscience, Case Western Reserve University, Cleveland, Ohio, and Chair of the Center for Scientific Review (CSR) Molecular, Cellular & Developmental Neuroscience-2 Initial Review Group, as a special visitor.

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II. Report of the Associate Director for Extramural Research

Government in the Sunshine Act and the Federal Advisory Committee Acts

Dr. Constance Atwell, Associate Director for Extramural Research, NINDS, reviewed the Government in the Sunshine Act and the Federal Advisory Committee Acts, 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 the Board of Scientific Counselors' Reports and 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 did not participate in the discussion of, or vote on, an application from any organization, institution, or any part of a university system, of which they are an employee, consultant, officer, director or trustee, or in which they have a financial interest. Institutions or organizations which have multi-campus institution waivers, or are specifically designated as separate organizations under 18 U.S.C. 208(a), are exempt from this provision.

Consideration of Minutes of Previous Council Meeting

The minutes of the Council meeting of September 14-15, 2000, were considered and accepted as written.

Consideration of Dates for Future Council Meetings

The following dates for future Council meetings were reconfirmed:

• May 24-25, 2001 (Thursday and Friday)
• September 13-14, 2001 (Thursday and Friday)
• February 14-15, 2002 (Thursday and Friday)
• May 30-31, 2002 (Thursday and Friday)
• September 12-13, 2002 (Thursday and Friday)

The following dates were confirmed:

• February 6-7, 2003 (Thursday and Friday)
• May 22-23, 2003 (Thursday and Friday)
• September 18-19, 2003 (Thursday and Friday)

Inclusion of Women and Minorities as Subjects in Clinical Research

Council is required every two years to review the NINDS part of the NIH report for tracking the inclusion of women and minorities as subjects in clinical research. The Council members had received in advance of the meeting the report for NIH prepared by the Office of Research on Women's Health and the report of the Recruitment Data for NINDS Clinical Studies for Fiscal Years 1997 through 1999.

Dr. Mary Ellen Cheung, Program Director, Repair and Plasticity, NINDS, has primary responsibility for gathering the information from the program clusters and conducting an analysis. A review of the reports indicated that NINDS does have very good participation of men and women from all ethnic groups in our clinical research. There are some areas in which the Institute would like to improve; namely, in the Phase III clinical trials and perhaps in the Institute's intramural program, in particular. Council concurred with this report.

Council General Recommendations

At each February meeting, the Council considers the general guidelines for delegated authority, which allows Program staff to take some administrative actions without prior approval by Council. The Council endorsed staff's recommendation for approval of the current guidelines without changes. A copy of the Council General Recommendations is attached to these minutes as Appendix 1.

Other Items

Program Announcements/Requests for Applications- Dr. Atwell reminded Council of the many Program Announcements (PAs) and Requests for Applications (RFAs) published in the NIH Guide for Grants and Contracts since the last meeting. Copies had been e-mailed to Council members prior to this meeting.

Reports Book- Dr. Atwell called Council's attention to the Reports Book, which includes a list of all funding actions since the previous Council meeting. She highlighted the last section, which provides the status of applications designated as High Program Priority (HPP).

Expedited Review Process- No applications were awarded prior to Council because of the late appropriation.

New Staff- Dr. Atwell introduced the following new staff members in the Division of Extramural Research, NINDS. New program directors include: Dr. Piotr Koslowski in the Neural Environment Cluster; Dr. Katrina Gwinn-Hardy in the Neurogenetics Cluster; Dr. Jennifer Pinto-Martin in the Clinical Trials Cluster, and Dr. Gayathri Jeyarasasingam and Dr. Reginald Cole in the Office of Minority Health and Research. New grants management specialists include Ms. Aricia Cottman and Ms. Chris Davis. Dr. Scott Janis joined the Clinical Trials Cluster as a program analyst.

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III. Discussion of the NAS Report: "Addressing the Nation's Changing Needs for Biomedical and Behavioral Scientists"

Dr. Penn introduced Dr. Marvin Cassman, Director, National Institute of General Medical Sciences. Dr. Cassman began his report by clarifying that the response to the report he is providing to Council is his own analysis of the key issues and problems presented by the report, not an official NIH response. He noted that a formal NIH response is planned, but has not been sufficiently developed to be presented at this time.

He continued by stating that this National Academy of Sciences (NAS) report is the 11^th in a series that was initiated in 1975 when the legislation establishing NRSAs was initially established. The legislation requires that this report be prepared by NAS on a regular basis, and Dr. Cassman believes this is the most provocative report to date.

One of the most significant concerns raised by the report is that the number of PhDs awarded annually in basic biomedical sciences is well above that needed. Dr. Cassman noted that this is not a new suggestion in the biomedical research community, in that other studies by NAS, as well as the RAND Corporation and The American Society for Cell Biology have offered similar conclusions. One of the recommendations from the current report was for NIH to evaluate how to implement reductions in graduate programs, and that the NIH should consider consolidating its oversight of research training and training-related activities. This recommendation suggests that over the past two decades, the numbers of students on research grants has proliferated, compared to the number of students on training grants. The solution to this problem suggested in the report is for National Research Service Award support for graduate students and postdoctoral fellows to be increased gradually, and at the predoctoral level, for NIH to provide at least 50 percent of its research training support through training grants and fellowships. However, the report also acknowledges that the research enterprise is currently dependent on many graduate students and fellows who are not currently on training grants, and that these balances cannot be shifted rapidly without hindering research progress.

The report also notes that there is an increasing prevalence of non-US citizens being supported directly from research grants, and nearly all of the growth in US PhD programs is from foreign students, many of whom will continue to live and work in the US after completing their education. To address this issue, the report recommends the development of clear goals in the education of these individuals.

In considering a response to these suggestions, it must be understood that while the position of trainee should theoretically be considered as one of an apprentice, this relationship evolved during a time when training was for a very limited/finite period of time, and when the perception of students and fellows as "cheap labor" was not as widespread. A potential solution, then, should incorporate the need for a more flexible type of training that will enable students and fellows to enter a wide range of careers upon the completion of their apprenticeship.

The presentation by Dr. Cassman was followed by a discussion involving Dr. Ed Stryker, of the Association of Neuroscience Departments and Programs, as well as several members of Council. Dr. Stryker initially raised two issues including: 1) a perception among investigators that they are investing in trainees to become the next generation of researchers, and 2) a need for investigators to have students and postdoctoral fellows in the laboratory to generate a fresh perspective on ideas. Dr. Cassman expressed concern about the future of these fellows in a job market that will ultimately not allow many of them to pursue positions in academic research. Others discussed the length of time it currently takes to obtain a PhD, whether the increasing age of newly granted PhDs is truly a problem, and whether US over-production of PhDs in science is positive or negative for the country. It was also noted that the predictions of decreasing job markets in specific fields do not always hold true; thus, it would be inappropriate to scale back the numbers of PhDs that are being produced in response to events that may not transpire.

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IV. Report of the Acting Director, NINDS

Dr. Penn began her report with comments on the substantial increase in funding received by both NIH and NINDS in the FY 2001 budget; with NIH receiving a 14 percent increase from FY 2000, and NINDS receiving a 14.4 percent increase from last year. At present, it is anticipated that 79 percent of the FY 2001 budget will be spent on total Research Project Grants and Centers, with 2.1 percent of the budget being planned for training programs, and 9.4 percent of the total planned for intramural research. Career awards comprised 4 percent of the total budget. In most categories, success rates for applicants increased in FY 2000, with renewals of single-investigator projects being the only category to decrease.

Dr. Penn noted that the House Appropriations Subcommittee, last chaired by John Porter (R-IL), will now be chaired by Representative Ralph Regula (R-OH). Senator Arlen Specter (R-PA) will continue to chair the Senate Appropriations Subcommittee.

Regarding the development of the new National Institute of Biomedical Imaging and Bioengineering, Dr. Penn commented that the Institute has not appointed a director or staff as of yet, although a committee has been established to develop a mission statement, and begin the process. At present, the mission of the institute includes promoting basic research in bioengineering and related fields, partnering with other NIH institutes in translating this research into clinical applications, and planning the development of an intramural program.

The management of loan repayment provisions was also noted by Dr. Penn as an important activity for NIH in the coming year. Loan repayment capabilities have recently been expanded by the 106th Congress to include a number of new fields, including pediatric basic and clinical research, and patient-oriented research in the extramural program. Although the Office of the Director will take responsibility for making these payments to investigators, each Institute/Center will perform its own review of applications.

Dr. Penn noted that recruiting for new staff is still an important priority of the Institute, including the intramural clinical neuroscience program, and components of the intramural basic science research program.

Progress is still ongoing regarding the disease planning groups and their websites. The Parkinson's Disease Implementation Committee is planning a meeting for March 12, 2001, and completion of the NINDS Parkinson's disease website is expected in the next several months. The Brain Tumor Progress Review Group held a meeting on February 22, 2001, and the results of their earlier meeting are already available on the web. Regarding epilepsy planning, the benchmarks that were developed as a result of last year's White House-sponsored epilepsy meeting are also available on the web. Lastly, the stroke planning effort is in full swing, with a large conference anticipated in July of 2001. The extramural co-chairs of this planning effort are Drs. Michael Moskowitz and James Grotta.

Lastly, Dr. Penn noted that progress on the new National Neuroscience Research Center is now underway, and that both Mr. Porter and the neuroscientists across NIH have now had the opportunity to review the plans for the building.

Copies of the slides used in Dr. Penn's presentation are attached as Appendix 2.

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V. Presentation: "Novel Approaches Toward the Pathogenesis and Treatment of Multiple Sclerosis"

Dr. Roland Martin, Acting Chief, Cellular Immunology Section, Neuroimmunology Branch, Division of Intramural Research, NINDS, reported that multiple sclerosis (MS) is the most frequent inflammatory disease of the central nervous system (CNS) in the United States and Northern Europe. It primarily affects young adults, women about twice as often as men, and since it may lead to substantial disability at an early age, poses a significant burden to our socioeconomic system. The cause of MS is not known, but data from animal experiments as well as from human studies indicate that auto reactive T cells with specificity for myelin components are involved in its disease mechanism.

Hence, it is now well accepted that MS is an autoimmune disease. Similar to diabetes and rheumatoid arthritis, multiple genes are involved in disease susceptibility, and these are at least in part responsible for the clinical, immunological and pathological heterogeneity of the disease, i.e. some patients present with a relapsing-remitting course, others with a progressive disease from onset; in some patients disease is dominated by inflammation and hyperreactivity of the immune system, whereas in others the cells producing myelin and axons are more vulnerable, and the disease is characterized by profound demyelination or even axonal loss. Since Dr. Martin's and other laboratories developed a sound understanding of which areas of one of the myelin antigens, myelin basic protein (MBP), are immunodominant in humans and encephalitogenic in animals, Dr. Martin's laboratory has recently explored the safety and therapeutic efficacy of an altered peptide ligand (APL) based on the immunodominant MBP (83-99) peptide in a phase II clinical trial. Surprisingly, the high dose of APL that they had chosen induced disease exacerbations in two out of eight patients in their trial. While a large, multicenter phase II trial with three different doses and APL and placebo indicated that the lowest dose had some clinical benefit, this trial also had to be halted due to allergic reactions. These studies towards specific immune intervention have taught valuable lessons, including: a) that we need to carefully find the right dose and route of administration for such specific immune intervention, and b) that the basic principles about the induction of MS that had been deduced from animal and human studies have been correct, i.e. that at least one myelin antigen is indeed a target for the disease process in MS.

Current experiments in the Neuroimmunology Branch in collaboration with the Human Genome Research Institute and with NCI aim at capturing the disease heterogeneity in individual MS patients by using expression profiling with cDNA microarrays and quantitative PCR. The Branch has already used this strategy to define responder- and non-responder gene expression profiles in response to one of the established therapies, IFN-b. Their data indicate that an individual responder pattern can be established to such a treatment, and that this will hopefully allow identification of non-responders in the future prospectively before treatment is initiated.

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VI. Presentation: "On the Outside, Looking In and On the Inside, Looking Out: The Role of Experiential Learning About Chronic Illness and Disability in Medical Education"

Dr. Alicia M. Conill, Clinical Associate Professor of Medicine, University of Pennsylvania, is also Founder, Conill Institute for Chronic Illness, which is a non-profit, 501-c-3, organization committed to helping people living with chronic illness and disability as well as those who care for and about them.

Dr. Conill described that as a practicing clinician-educator and as a woman living with multiple sclerosis, she wondered whether the experience of being disabled or chronically ill could be taught to able-bodied people (specifically, to health care professionals), in an effective, realistic way. Review of the curriculum of medical schools in our country reveals that it has been only recently that information about the care of people living with disabilities is even mentioned. Frequently, it is mentioned only in passing, or as an afterthought. There are an estimated 54 million Americans who live with a disability (many involving neurological impairments) and approximately 100 million others have been diagnosed with a chronic illness. As medical educators, we need to impart a solid fund of basic medical knowledge about "disease"-and of course, encourage and support efforts in research to understand and hopefully, treat or cure these diseases.

However, there is a deficit in the training of future physicians about the experience of living with the disease- about the experience of "illness." There is a deficit in teaching them about the many variables that color an individual experience and in providing them with a real-life view. "The Disability Experience" seminar was created in an effort to begin to approach these issues. It was piloted in 1997 and the curriculum has been developed and adapted to become a requirement for all medical students at the University of Pennsylvania. The program has also been modified to target other audiences including nursing and psychology students as well as corporations and insurers.

Similarly, expansion of program design has allowed for provision of educational programs to patients and families. This increases awareness of options available and facilitates communication between all who are touched by the losses inherent in living with chronic illness. While continuing to search for the "cures," educational efforts such as these focus on the "care" and empowerment of the chronically ill and their families.

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VII. Council Subcommittee Reports

Dr. Henry Khachaturian, Training and Referral Officer, NINDS, reviewed the NINDS Training and Career Development Programs for Clinical Scientists. The guiding principles of the program are: to ensure the continued development of the clinician scientist research workforce in the neurological sciences; to encourage the interest of potential clinician scientists early in their education; to accelerate entry into independent research; to encourage translational research; and to foster research training by especially competent laboratories.

The overall program consists of new and ongoing programs at all stages of clinician scientists careers: medical school, post-MD, intra-residency, and post-residency.

During medical school, NINDS offers:

• a medical student summer research program (T35), which provides brief intensive research experiences during the summers or "off" quarters of medical school.
• a medical student scholars program (F31), which provides for 2-3 years of research experience beginning in the third year of medical school.
• individual NRSA pre-doctoral fellowships (F30), leading to either combined MD/PhD or MD/MPH degrees.
• a Medical Scientist Training Program (T32), leading to a combined MD/PhD degree (this is modeled on a similar NIGMS program).

During residency, NINDS offers a career transition award (K22), in which individuals begin their training in the Intramural program before leaving for positions in extramural programs as independent researchers. In addition, NINDS offers individual postdoctoral NRSA fellowship (F32) both pre-residency, during residency, and after residency.

After residency, NINDS continues to offer:

• Mentored Clinical Scientist Development Award (K08)
• Mentored Patient-oriented Development Award ((K23)
• Independent Scientist Award ((K02)
• Mid-career Investigator Patient-oriented Research Award (K24)

Clinical Trials Subcommittee

Dr. Atwell presented the deliberations of the first meeting of the NANDS Council's Clinical Trials Subcommittee as Dr. Lowenstein's illness had forced him to participate via telephone conference call, and Dr. McKhann was temporarily absent from the afternoon session of Council.

The subcommittee will address policy issues involving the Institute's support of large scale clinical trials and epidemiology studies, particularly priority-setting of clinical trials vis-à-vis each other and within the overall mission of the NINDS. Dr. Atwell summarized the existing procedure covering large grants, i.e., those greater than $500,000 are required to be formally accepted by the Institute before review; the Institute's Clinical Trial Planning Grant and the opportunity this mechanism would allow to assess program interest in the study's objective before a large commitment is made; and the efforts of the NINDS Clinical Trials Group to have pre-submission meetings with investigators developing a clinical trial application to discuss program interest and priorities as well as some design issues. For the pre-submission meetings, potential applicants must submit a "Clinical Project Summary Outline" - the equivalent of a letter of intent.

The Subcommittee members will be provided with a list of all the clinical trials NINDS is currently supporting in order to provide a framework for their discussions, as well as a list of all the clinical trials applications being recommended for assignment to the NINDS. The Subcommittee will review these on a regular receipt cycle to avoid delays in the funding process. Decisions to consider supporting a particular clinical trial proposal will probably be based on a cost versus public health benefit analysis. Those for which there is enthusiastic support will be approved for acceptance via telephone conference call; the others will be discussed at the next meeting of the Subcommittee held in conjunction with the NANDS Council meeting.

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VIII. Overview, Division of Intramural Research, NINDS

Dr. Story Landis, Director, Division of Intramural Research, NINDS, described the state of the Intramural research program, now in the 5^th year of a major revitalization effort, as in better shape and still improving. Although the Intramural budget has increased in real dollars, the percentage Intramural received of the total NINDS budget during that period has gone down from about 13 percent to 9.4 percent. The Intramural program has approximately 60 independent investigators covering a very broad spectrum of research, from studies of the molecular structure of ion channels to clinical research such as the multiple sclerosis studies presented at this Council meeting.

The revitalization effort has relied not only on new dollars but also the reallocation of funds from less to more excellent researchers. The program has recruited outstanding senior scientists. Dr. Kurt Fischbeck has created a neurogenetics program. While continuing his more fundamental studies of disease mechanisms, his efforts illustrate how the advantages of the Intramural program can expedite clinical trials, such as idebenone for Friedreich's ataxia and gentamicin for Duchenne muscular dystrophy, that might then expand to the extramural community. Dr. Steven Warach is applying his expertise in imaging toward improving stroke therapy. Dr. Alan Koretsky is doing pioneering work in high field strength MRI imaging of animals and people. Eight tenure track investigators have also been recruited. Three searches are underway in areas of basic research, translational and clinical research. Following successful experimentation providing physicians in service positions with small independent research efforts, the program is extending its efforts in more flexible positions, including the extramural-intramural crossover by recently recruited Dr. Katrina Gwynn-Hardy.

Dr. Landis noted a few recent highlights from the Intramural research program. Dr. Thomas Reese continues his noteworthy efforts on the molecular architecture of the synapse, working on both the presynaptic side and more recently the post-synaptic density. Stem cell research continues to be active, with notable papers from Dr. Ronald McKay and others on generation of neurons from bone marrow precursor cells, on the efficient production of dopamine neurons from ES cells, and on the effects of manipulating oxygen tension on dopamine fate. Dr. David Goldstein has a series of findings on the effects of Parkinson's disease on the sympathetic innervation of the heart, which may have important implications for understanding the non-dopaminergic effects of Parkinson's. Dr. John Hallenbeck is continuing to pursue a hypothesis that immunization against certain cell adhesion molecules might reduce stroke incidence. Promising preclinical studies in rats are leading to a phase I clinical trial. Dr. Roscoe Brady's lab has cloned the gene responsible for mucolipidosis type IV and is continuing the path breaking work on enzyme replacement therapy with successful trials in Fabry's disease.

Finally, Dr. Landis discussed the importance of the National Neuroscience Research Center. The NIH Bethesda campus has an extraordinary collection of neuroscience researchers at several institutes. Several efforts, planned or underway, aim to develop a more cohesive neuroscience community. These include cross-institute interest groups, common retreats, seminar series, and, in July, a common website. But all of these produce incremental effects. The new facility promises a more dramatic impact, especially given the innovative and suitably beautiful architecture designed to provide flexibility and facilitate interaction. The new building also presents challenges, such as overcoming the traditional allocation of space by affiliation rather than research, but the hope is that a sense of community will grow.

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IX. Report of the Former Director, NINDS

Dr. Gerald Fischbach, Vice President for Health and Biomedical Sciences, Columbia University, and former Director, NINDS, came back to express his gratitude to Council and NINDS staff for three wonderful years as Director of NINDS. He noted that he had spent 11 years total at NIH, including 8 years as a staff scientist. Everything he became as a scientist was grounded in those years at NIH, which shaped his ideas about what scientific questions were important. The last three years were equally important, setting a pattern on a different scale on issues of policy, the relationship of science to disorders, and translating basic findings to the clinic.

Dr. Fischbach noted his pride in three aspects of his time as Director. First, the planning process, which began on his first day. The process involved more than 100 extramural scientists, intramural researchers, NINDS staff, and advocates, and set the tone for everything that followed. A second activity was the reorganization of the extramural program that followed the major themes of the planning effort, forcing the Institute to think about what is common to the hundreds of disorders within our mission. The change invigorated people and set new courses for interaction, including increased participation of NINDS staff from offices of policy and planning, from communication and public liaison, and from review. The third highlight is the National Neuroscience Research Center, which is also a symbol of the planning theme reflecting the need for all people who work on the brain to search out what is in common.

Dr. Fischbach noted his confidence in the NINDS staff and his hope to stay involved with the Institute.

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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 laboratories/units during 2000 of the Division of Intramural Research. The Council discussed the reports of the Board and accepted them.

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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 applications for which there were concerns about human subjects, including appropriate representation of women and minority subjects, or laboratory animals.

Research Training and Career Development Programs

The Council reviewed a total of 101 research career development and institutional training grant applications; of this total, 78 applications had primary assignment to NINDS, and 60 of them (76.9 percent) were recommended for support in the amount of $2.6 million first-year direct costs. It is anticipated that, of the research career development grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $8.6 million.

Research Grant Awards

The Council reviewed a total of 1,093 research grant applications; of this total, 779 applications had primary assignment to NINDS, and 531 of them (68.2 percent) were recommended for support in the amount of $147.7 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 $47.8 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 five investigators as Javits awardees.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 131 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 67 applications had primary assignment to NINDS and 47 of them (70.1 percent) were recommended for support in the amount of $7.1 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 $2.3 million.

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XII. Adjournment

The meeting was adjourned at 11:10 a.m. on Friday, February 16

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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A complete, printed copy of the Council minutes, including attachments, may be obtained by contacting:

Mrs. Ruth Linn
Committee Management Specialist
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Suite 3309
6001 Executive Boulevard, MSC 9531
Rockville, MD 20852-9531
(301) 496-9248
(301) 402-4370 (FAX)
linnr@ninds.nih.gov