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NAEC Meeting Minutes

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute

NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting

September 14, 2006

The National Advisory Eye Council (NAEC) convened for its one hundred fourteenth meeting at 8:30 am on Thursday, September 14, 2006, at the Terrace Level Conference Center, 5635 Fishers Lane, National Institutes of Health (NIH), Bethesda, MD. Paul A. Sieving. M.D., Ph.D, the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was closed to the public from 8:30 am until 12:00 pm for the review of grant and cooperative agreement applications. The meeting was open to the public from 1:30 pm until 5:00 pm. Attachment A provides a roster of Council members.

COUNCIL MEMBERS PRESENT:

Dr. Roy W. Beck
Dr. Suraj P. Bhat
Dr. Eileen E. Birch
Dr. Gunilla Haegerstrom-Portnoy
Dr. Barrett G. Haik
Dr. Lenworth N. Johnson
Dr. Juan I. Korenbrot
Dr. Todd P. Margolis
Dr. Earl L. Smith, III
Dr. Lois E. Smith
Dr. Mriganka Sur
Dr. Janey L. Wiggs
Dr. Marco A. Zarbin

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COUNCIL MEMBER ABSENT:

Dr. David E. Holck

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NEI STAFF PRESENT:

Ms. Louise M. Amburgey
Dr. Houmam Araj
Ms. Pamela Bobbit
Ms. Sylvia Braxton
Dr. Deborah Carper
Dr. Hemin R. Chin
Dr. Mary Frances Cotch
Ms. Janet Craigie
Mr. William W. Darby
Mr. Michael P. Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Dr. Leon Ellwein
Mr. Donald F. Everett
Dr. Richard S. Fisher
Mr. Kenneth Frushour
Dr. Chyren Hunter
Ms. Tina E. Jones
Mr. J. Kevin Keating
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Dr. Päivi H. Miskala
Ms. Kathleen L. Moy
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Ms. Karen Robinson Smith
Dr. Grace L. Shen
Dr. Annie E. Schaffner
Dr. Paul A. Sieving
Dr. Sarah Sohraby
Mr. Arthur Stone
Dr. Santa Tumminia
Mr. David L. Whitmer
Ms. Romona Williams-Parker
Dr. Jerome R. Wujek

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OTHER NIH STAFF PRESENT:

Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Ms. Mary Frances Deutsch, OPERA, OD
Dr. René Etcheberrigaray, CSR
Dr. George McKie
Dr. Christine Melchior, CSR

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MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, ARVO
Dr. Eric Pearlman, Case Western Reserve University
Ms. Elaine Richman, Richman Associates

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THURSDAY, SEPTEMBER 14, 2006

CLOSED PORTION OF THE MEETING

8:30 am

The meeting was closed to the public at 8:30 a.m. in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix2).

CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST

Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive Secretary of the Council, reviewed policies and procedures regarding confidentiality and the avoidance of conflict of interest situations. To avoid conflict of interest, members of federal advisory committees must not participate in the discussion of any application or proposal in which they, their spouse, minor child, close professional associate, or organization has a financial interest or affiliation. The Council members signed a statement certifying that they were absent during such discussions.

Council members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members signed a statement to this effect.

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REVIEW OF RESEARCH AND RESEARCH TRAINING APPLICATIONS

OPEN PORTION OF THE MEETING

1:30 pm

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CALL TO ORDER AND OPENING REMARKS

Dr. Paul A. Sieving, Director, NEI, and Chair of the Council welcomed Council members, staff, and guests to the one hundred fourteenth session of the NAEC. Dr. Sieving discussed the role of Council, stressing that Council provides advice regarding all aspects of Institute business. He indicated that it is important to continue with portfolio analysis and to proceed with Phase II program planning. He reviewed the portfolio analysis from the September, 2005, meeting and reported on the most recent evaluation of the human genome. Of the roughly 2,000 identified human disease-related genes, 400-500 are in the visual system.

Dr. Sieving introduced the new NEI Executive Officer, Mr. David Whitmer. Mr. Whitmer had previously been the Executive Officer of CSR.

Dr. Sieving next reported on recent NIH events, including budget development, electronic grant submission, and a new initiative to allow multiple co-Principal Investigators on grant applications. He reviewed the recent NIH Science Leadership Forum, stressing the rise in translational research and the increased importance of a team approach to science.

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RECOGNITION OF RETIRING COUNCIL MEMBERS

Dr. Sieving thanked the members of Council whose terms will end on November 31, 2006. He presented Drs. Roy Beck, Suraj Bhat, Lois E. Smith, and Janey L. Wiggs with certificates of appreciation and NEI tokens of respect for their dedicated service in support of the mission of the NEI.

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NEI BUDGET OVERVIEW

The NEI Budget Officer, Marilyn Laurie, provided an update of the FY2007 President's Budget. The NIH received a 0.1% decrease compared with the FY2006 appropriation, while the NEI decrease was 0.7%. Central budget guidance has calls for all NIH ICs to reduce FY2007 competing Research Project Grant (RPG) commitments by 2.35%. For competing RPGs, there will be no average total cost increase over the FY2005 competing level ($345,000). She also discussed the provisions of the NIH Reform Act of 2006, which provides the Director, NIH, with new authorities to improve agency coordination and collaboration.

Mr. James Jorkasky, Executive Director, NAEVR, summarized citizens' activities in support of the vision research budget. These included an ARVO lobby day, and a NAEVR and Juvenile Diabetes Research Foundation joint congressional briefing on current research into care for diabetic retinopathy on December 7, 2005. Mr. Jorkasky also described the NAEVR Special Report to the White Conference on Aging. This briefing focused on four conditions: AMD, Glaucoma, Diabetic Retinopathy, and Cataracts.

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NEI EXTRAMURAL ACTIVITIES UPDATE

Dr. Loré Anne McNicol provided an overview of recent extramural activities. She introduced Dr. Jerome R. Wujek, the new NEI Research Resources Officer, who is replacing Dr. Ralph J. Helmsen. Dr. Wujek received his Ph.D. in neurobiology from Case Western Reserve University, and did postdoctoral work at the University of Maryland School of Medicine. After independent research as a Senior Staff Fellow at the National Institute of Neurological Disorders and Stroke, he joined a start-up biotechnology firm, Gliatech Incorporated. He received an NIH Small Business Innovative Research grant to support his work on peripheral nerve regeneration, and worked on technology transfer in this field at Edison Biotechnology and the Cleveland Clinic Foundation. Dr. Wujek joined the NIH CSR, where he managed two Small Business study sections in the areas of visual systems and neuropharmacology. Dr. Wujek will carry responsibility for the NEI portfolio of small business grants, and he will provide coordination activities for resources and initiatives when span the programmatic areas within DER.

Dr. McNicol gave an update regarding FY2006 extramural grant budget operations. She described NEI participation in three major trans-NIH programmatic initiatives, the Roadmap for Medical Research, the Neuroscience Blueprint, and the NIH Countermeasures Against Chemical Threats (CounterAct) Research Network. And she described the two pilot award mechanisms, R03 Small Grant and R21 Exploratory/Developmental Grant, employed by the NEI. The NEI-specific balance for the 2006 extramural budget is $550M. This will allow for the funding of approximately 267 competing Research Project Grants (RPGs)-compared to 289 in FY2005. The number of applications submitted has remained stable (1,102 in FY2005 compared to 1,103 in FY 2006), so the award rate is anticipated to decline from 26.3% to 24.2%.

Dr. McNicol gave an overview of anticipated NIH grants initiatives. These included a pilot permitting multiple co-Principal Investigators on research grants, a pilot testing the feasibility of providing a one month turn-around from review to summary statement for new investigators (the R01* initiative), and electronic submission at Grants.gov using the new government-wide Standard Form 424 (Research & Resources) in place of the PHS SF398.

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FUTURE COUNCIL MEETING DATES

Dr. McNicol noted that future meetings are scheduled for a day and a half, and asked that everyone keep those times free on his or her calendar. The following dates have been agreed upon:

January 18-19, 2007
June 7-8, 2007
September 27-28, 2007

She reminded members that at the January, 2007, meeting Council will determine meeting dates for calendar year 2008. Staff will identify possible times and email these to members in advance. Members are asked to come to the January, 2007, meeting with their personal calendars. In addition, on the day before the January, 2007, meeting, staff will hold another Council Orientation session for newly appointed members, as well as any experienced members who like to have a refresher.

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POPULATION-BASED STUDIES

Dr. McNicol introduced Dr. Natalie Kurinij, Program Director for Collaborative Clinical Research. Dr. Kurinij gave an update of the status of the Fourth US Symposium on Ocular Epidemiology. This meeting is to be held in Sarasota, FL, on January 29-31, 2007. The purpose of the meeting is to assess progress and future research needs in the areas of genetic epidemiology; measurement and classification of ocular disease; identification of novel risk factors; and prevalence, incidence, and progress of eye disease in special populations. Dr. Kurinij described the program outline, a combination of overview talks, contributed papers, and panel discussions. The symposium proceedings will be published in the summer of 2007.

Dr. Kurinij also described program planning activities in the area of Ocular Epidemiology. The NEI will convene an expert panel in March of 2007, with the charge of developing a strategic plan of the research needs and opportunities in this field. The panel will present a draft plan to the Council at its June 7, 2007, meeting. After consideration of Council comments, the recommendations of the panel will be presented to the Council and the NEI in September, 2007.

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REPORT ON THE NIH GENES AND ENVIRONMENT INITIATIVE

Dr. Hemin R. Chin, Director, Ocular Genetics Program, gave an overview of this NIH-wide initiative proposed in the President's budget for FY2007. The project aims to accelerate understanding of the genetic and environmental contributions to health and disease. The initiative will involve two components: the genotyping of case-control studies of common diseases and the development of innovative technologies to measure environmental exposures, diet, physical activity, psychosocial stress, and addictive substances. Funds for this five year activity will be committed to a common pool to be managed by an NIH-wide coordinating committee. The $40M annual commitment will be divided between $26M for genotyping and $14M for studies of exposure biology.

The GEI genotyping program will give priority to selecting studies for genome-wide association studies (GWAS), such as the NEI-supported work identifying complement factor H as a risk factor for Age-related Macular Degeneration. The dataset from the Age-related Eye Disease Study (AREDS) will be released into a public database.

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OCULAR IMMUNOLOGY, INFLAMMATION, AND INFECTION PROGRAM PORTFOLIO ANALYSIS

PROCESS OVERVIEW

Dr. Sieving thanked members for their support for the NEI plan for a regular cycle of review and analysis of the individual NEI portfolios. These activities include scientific presentations by members of the vision research community as well as an administrative description by the appropriate Program Director. Portfolio analysis is designed to provide staff an opportunity for self-assessment, to give Council members a broad over-view, and to set the frame for specific Council actions in the future.

Dr. Sieving introduced Dr. Eric Pearlman, Ph.D., Professor and Director of Research, Department of Ophthalmology, Case Western Reserve University, Cleveland OH. Dr. Pearlman received his B.Sc. degree in Zoology from the University of Glasgow, a M.Sc. in Microbiology from the Hebrew University of Jerusalem, and his Ph.D. in Microbiology from the University of Texas at San Antonio. He then moved to Case Western Reserve University where he has studied the immunobiology of T-cell responses in murine models of lymphatic filariasis and ocular onchocerciasis (river blindness). Dr. Pearlman's research includes a landmark study demonstrating a critical role for endosymbiotic Wolbachia bacteria in the development of oncocercal keratitis He has also been involved in efforts to control river blindness in West Africa. His numerous awards include a Senior Scientist award from the Research to Prevent Blindness Foundation.

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NEW DEVELOPMENTS IN INFECTIOUS AND INFLAMMATORY EYE DISEASE

Dr. Pearlman identified the four most exciting current scientific opportunities in infectious and inflammatory eye disease: 1. new pathogens such as Fusarium solani, 2. the role of toll-like receptors as pathogen recognition molecules and mediators of corneal inflammation, 3. the role of complement and innate immunity in the pathogenesis of acute macular degeneration, and 4. the recognition of diabetic retinopathy as a chronic inflammatory disease. He described the most recent work on these topics, and then pointed to inflammatory responses in other ocular diseases as emerging areas worthy of emphasis and support. These included inflammation in a mouse model of glaucoma, T-cell mediation of lachrymal gland keratoconjunctivitis in Sjögren's Syndrome, and the roles of Decay Accelerating Factor and CD59 in modulating experimental myasthenia.

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PORTFOLIO OVERVIEW

Dr. McNicol indicated that members had been sent a package of summary materials regarding grants in the Ocular Immunology, Inflammation, and Infection Program. This included a snapshot of grants funded in FY2005, the appropriate portion of the National Plan for Eye and Vision Research, a set of grant summaries which included the abstract and administrative information, and longitudinal data on numbers of grants and on dollars awarded.

Dr. McNicol introduced Dr. Grace L. Shen, Director, Ocular Immunology, Inflammation, and Infection Program. Dr. Shen described the sub-program areas in the portfolio and identified the major diseases and conditions associated with each. She described NEI's participation in trans-NIH cross-cutting committees involved with immunology and inflammation. These include the Autoimmune Disease Coordinating Committee, NIH AIDS Coordinators Committee, tee Lymphatic Disease Coordinating Committee, Transplantation Coordinating Committee, and Sjögren's Registry. Dr. Shen reviewed historic trends in the portfolio sub-program structure and gave a snap shot of the FY2005 budget ($33,416,215) and grant mechanism distribution. Most studies employed the R01 research project grant mechanism. In FY2005, 36% of the portfolio was in Immunology, 27% Inflammation, and 42% Infectious Diseases. She identified three recent advances funded by the NEI: the role of complement and innate immunity in AMD, the role of endogenous antigen-presenting cells and immune cells in local ocular tissue responses, and the role of angiogenesis and Lymphangiogenesis in ocular immune responses.

Dr. Shen closed by discussing some of the immediate challenges for the Immunology, Inflammation, and Infection portfolio. There is a need to understand the role of inflammation in infection, angiogenic and lymphangiogenic responses, inflammatory disease, degenerative diseases, and transplant rejection in the eye. There is a need to develop animal models that mimic the human eye disease conditions that involve the immune response. And there is a need to attract outstanding students to be trained to serve in the next generation of vision researchers to study Ocular Immunology, Inflammation, and Infection.

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GENERAL COUNCIL DISCUSSION

Council members expressed their enthusiasm for the scientific presentations and for Dr. Shen's stewardship of the program. They initiated an open discussion regarding novel scientific opportunities, concerns about the academic environment that affect progress in vision research, and suggestions to the NEI regarding the management of the program. Members noted that research in this area is not published exclusively in vision journals, but also can be found in the broader scientific press. They also mentioned future needs which include studies of the role of trauma and secondary infection in the development of keratitis, studies of the role of inflammation in the pathogenesis of uveitis, and the role of rubella virus infection in Fuchs Heterochromic Cyclitis.

Council members next expressed their concern regarding recent activities of the Animal Liberation Front in personalizing their protest against studies of neurophysiology in higher animals. They urged the NEI to protect investigators performing legitimate work in this area. Dr. Sieving indicated that he would take this issue to the NIH Neurosciences Blueprint Directors.

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ADJOURNMENT

Dr. Sieving adjourned the meeting at 5:00 p.m.

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CERTIFICATION

I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Dr. Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute

Paul A. Sieving, M.D., Ph.D.
Chair
National Advisory Eye Council
Director
National Eye Institute

These minutes were submitted for the approval of the Council; all corrections or notations were incorporated. A complete, printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Janet L. Craigie
National Eye Institute
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: craigiej@nei.nih.gov

06/25/2007


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Attachment A

NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE

ROSTER

(Terms end 11/30 of the designated year)

Roy W. Beck, M.D., Ph. D. (06)
Jaeb Center for Health Research
Tampa FL 33647

Suraj P. Bhat, Ph.D. (06)
Department of Ophthalmology
Jules Stein Eye Institute
University of California
Los Angeles CA 90095-7000

Eileen E. Birch, Ph.D. (07)
Retina Foundation of the Southwest
Dallas TX 75231

Gunilla Haegerstrom-Portnoy,OD, Ph.D.
Associate Dean for Academic Affairs
School of Optometry (05)
University of California
Berkeley, CA 94720

Barrett G. Haik, M.D. (07)
Department of Ophthalmology
College of Medicine
University of Tennessee Health Science Ctr
Memphis TN 38163

Lenworth N. Johnson, M.D. (08)
Professor of Ophthalmology & Neurology
University of Missouri
Columbia, MO 65212

Juan I. Korenbrot, Ph.D. (09)
Department of Physiology
University of California, San Francisco
San Francisco, DA 94143

Todd P. Margolis, M.D., Ph.D. (08)
Professor of Ophthalmology
Director, F. I. Proctor Foundation
San Francisco, CA 94122

Earl L. Smith, III, O.D., Ph.D. (08)
Dean, College of Optometry
University of Houston
Houston, TX 77204

Lois E. H. Smith, M.D., Ph.D. (06)
Department of Ophthalmology
Harvard Medical School
300 Longwood Ave
Boston MA 02115

Mriganka Sur, Ph.D. (07)
Department of Brain & Cognitive Sciences
Massachusetts Institute of Technology
Cambridge MA 02139

Janey L. Wiggs, M.D., Ph.D. (06)
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
Boston MA 02114

Department of Defense Representative
Lt. Col. David E. Holck M.D.
Chief, Reconstructive, Orbit, and Ocular Oncology Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Dept .of Veterans Affairs Representative
Marco A. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103

Ex Officio Members
Michael O. Leavitt
Secretary
Department of Health & Human Services
Washington, DC 20201

Elias A. Zerhouni, M.D.
Director
National Institutes of Health
Bethesda, MD 20892

Chair
Paul A. Sieving, M.D., Ph.D.
Director
National Eye Institute
National Institutes of Health
Bethesda MD 20892

Executive Secretary
Loré Anne McNicol, Ph.D.
Director
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892

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