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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

January 19-20, 2006

The National Advisory Eye Council (NAEC) convened for its one hundred twelfth meeting at 8:30 am on Thursday, January 19, 2006, at the Madison Hotel, 15th and M Streets, NW, Washington, DC 20005. Paul A. Sieving. M.D., Ph.D, the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 8:30 am until 5:00 pm. On Friday, January 20, the meeting was closed for the review of the report of the Board of Scientific Counselors and the review of grant and cooperative agreement applications from 8:30 pm until adjournment at 12:00 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. 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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AD HOC COUNCIL MEMBERS PRESENT:

Dr. Juan I. Korenbrot
Dr. J. Mark Petrash

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NEI STAFF PRESENT:

Dr. Houmam Araj
Ms. Sylvia Braxton
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Janet L. Craigie
Mr. Michael P. Davis
Dr. Peter A. Dudley
Dr. Leon Ellwein
Mr. Donald F. Everett
Ms. Janelle Everett
Mr. Kenneth Frushour
Dr. Ralph J. Helmsen
Mr. Tom Hoglund
Ms. Regina Horrigan
Dr. Chyren Hunter
Ms. Rosemary Janiszewski
Mr. J. Kevin Keating
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Xuri Li
Dr. Ellen S. Liberman
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Ms. Angelia Neal
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Grace L. Shen
Dr. Annie E. Schaffner
Dr. Paul A. Sieving
Ms. Sylvia Speight
Ms. Judith Stein
Mr. Arthur Stone
Dr. Santa Tumminia
Mr. John Whitaker

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OTHER NIH STAFF PRESENT:

Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Dr. Alan E. Guttmacher, National Human Genome Research Institute (NHGRI)
Dr. Christine Livingston, CSR
Dr. Jerome R. Wujek, CSR

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FOOD AND DRUG ADMINISTRATION REPRESENTATIVE PRESENT:

Dr. Wylie Chambers

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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)
Dr. Elizabeth C. Engle, Children's Hospital, Boston
Dr. Israel Goldberg, Health Research Associates
Dr. Eve J. Higginbotham, University of Maryland
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, ARVO
Ms. Lois Schoenbrun, American Academy of Optometry
Dr. John Whitener, American Optometric Association

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THURSDAY, JANUARY 19, 2006

OPEN PORTION OF THE MEETING

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 twelfth session of the NAEC. 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 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. Dr. Sieving discussed the role of Council, stressing that Council provides advice regarding all aspects of Institute business.

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COUNCIL OPERATING PROCEDURES

Mr. J. Kevin Keating, Grants Management Specialist presented the annual overview of Council Operating Procedures. He indicated that NEI staff was recommending a change to the actions which must be brought to the attention of Council. For the Institutional Training Grants (T32 and T35), Institutional Career Development Awards (K12), and Center Core Grants (P30), Council review of the entire program will no longer be mandatory. Instead, Council members and staff are encouraged to raise for discussion any issues affecting individual grants within these portfolios. Council members voted to accept the revised Council Operating Procedures.

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INTRAMURAL PROGRAM REPORT

Dr. Sheldon Miller, NEI Scientific Director, gave an overview of recent activities in the Intramural Research Program (IRP). Dr. Miller reviewed the mission, organization, and budget of the IRP. He indicated that the NIH Clinical Center is a unique resource for carrying out clinical research, and that it carries global responsibilities for pursing clinical research. Dr. Miller summarized staffing patterns within the IRP, recruiting efforts for three open positions, and recent progress towards such goals. He also described resource development, the status of the US-Indo Collaborative Agreement, and the NEI IRP Overseas Scholars Program.

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ANGIOGENIC GROWTH FACTORS FOR THE EYE: NEW PLAYERS IN AN OLD GAME

Dr. Xuri Li, a newly recruited tenure-track IRP Principal Investigator in the OSD/URNVB reported on her research regarding new angiogenic growth factors in the eye. Her work focuses on PDGF-C and D and VEGF-B (a homologue of VEGF). Her goal is to understand the physiologic role of these factors in the eye and to determine whether they can be exploited for therapy or neural regeneration using an antibody approach. She indicated that several ocular diseases, including Age-related Macular Degeneration (AMD), Diabetic Retinopathy, Retinopathy of Prematurity, Familiar Exudative Vitreoretinopathy, Retinal Vein Occlusion, Sickle Cell Retinopathy, and Trauma involve retinal neovascularization

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STATE-OF-THE-ART IN HUMAN GENETICS

Dr. Alan E. Guttmacher, Deputy Director of the National Human Genome Research Institute, discussed the current state-of-the art in human genetics research in the post-genome era. Dr. Guttmacher reviewed the steps leading up to the completion of the human genome sequence. He then described future collaborative initiatives. These include: a trans-NIH Roadmap initiative, Molecular Libraries, with a screening center network; Chemical Genomics, using small molecules to perturb biological systems with genomic readouts; Comparative Sequencing opportunities, including the chimpanzee and the dog genome; the Knockout Mouse Project, an international effort to produce and phenotype knockouts for all mouse genes and place these resources into the public domain; the Whole Genome Association approach to common diseases, using genotyping of all DNA for all SNPs; and the International HapMap Project. Dr. Guttmacher next described the ways in which NEI-supported research has been a leader in state-of-the-art genetics: For example, the first HapMap success story is the association of AMD with a Complement Factor H Polymorphism. Dr. Guttmacher ended his presentation with a discussion of the major policy issues for genomic medicine in the future. These include protection of the public from genetic discrimination, reimbursement for new genetic tests, and education of the public and health care professionals.

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NATIONAL EYE HEALTH EDUCATION PROGRAM (NEHEP) STRATEGIC PLANNING

Dr. Eve J. Higginbotham, Chair, Department of Ophthalmology, University of Maryland School of Medicine, reported on the process for developing a new 5-Year Agenda for the NEI's NEHEP Program. NEHEP is a Congressionally-mandated program instituted in 1988, coordinated by NEI staff in conjunction with a Planning Committee and the NEHEP Partnership of 66 public and private organizations concerned with eye health education. The Partnership organizations collaborate on the development of eye health education programs targeted to a variety of high-risk audiences that can be implemented through their chapters/affiliates at the local level. The focus of these program areas is on glaucoma, diabetic eye disease, and low vision.

Dr. Higginbotham shared a draft of the NEHEP 5-Year Agenda with Council members. This plan is designed to provide strategic objectives to guide future program efforts. It will be built upon best practices, current research, and the scientific literature. Dr. Higginbotham reviewed the goals, objectives, and priority areas for the strategic plan and discussed the cross-0cutting issues that will be evaluated. She provided a time table for the final steps in the development process. The Agenda concept will be presented to the NEHEP Partnership at their March, 2006 meeting. The group will then convene subcommittees and working groups to establish work plans to complete the document. The final draft plan will be presented to Council for their consideration at either the June or September meeting.

Council members expressed their enthusiasm for the planning process, and recommended a web-based format. They indicated that it would be extremely valuable for the plan to document areas of research where scientific evidence is not available.

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BUDGET OVERIEW

The NEI Budget Officer, Marilyn Laurie, provided an update of the finalized FY2006 budget. The NIH received a 0.1% decrease compared with the FY2005 appropriation, while the NEI decrease was 0.3%. Central budget guidance has called for all NIH ICs to reducing FY2006 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 indicated that the FY2007 President's Budget is scheduled for release on February 6, 2006, in time for appropriation hearings in March

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 OPERATING STRATEGY

Dr. Loré Anne McNicol, Director, Division of Extramural Research and Executive Secretary of the Council, provided an overview of recent extramural activities. She noted that Dr. Ralph Helmsen, the NEI Research Resources Officer, is retiring after 40 years of government service. Dr. Helmsen has agreed to return as a contractor Extramural Program Analyst for six months in order to expedite the transition for his replacement. Dr. McNicol also mentioned that staff member Mr. Donald Everett, Program Director for Collaborative Clinical Research, had recently received a significant award from the NIH Office of Research on Women's Health. This award recognized his efforts in making the NEI one of only three ICs with complete and consistent reporting data on the inclusion of women and minorities in research for the past fiscal year.

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.

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:

June 8-9, 2006
September 14-15, 2006
January 18-19, 2007
June 7-8, 2007
September 27-28, 2007

She reminded members that at the January, 2007, meeting we will determine Council 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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NIH BRIDGE TO INDEPENDENCE PROGRAM

Dr. Chyren Hunter, NEI Training Officer, gave Council members an overview of the new trans-NIH career catalyst award program (K99/R00). This program was established in responses to the National Academies of Science report, "Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research". NIH data has established that the average age of a first time R01 Principal Investigator has risen to 42 yrs for a Ph.D. and 44 yrs for an MD, MD/PhD. The goals of the new program are to foster an earlier transition of postdoctoral scientists from mentored environments to stable, independent research positions and to maintain a cohort of new and talented NIH-supported independent investigators. The K99/R00 is a phased award for US citizens and non-citizens who have less than five years of postdoctoral training. The first two years are characterized by mentored support up to $90,000 total cost, with an 8% F&A. The last three years are an independent investigator phase. The R00 provides three years of independent research support up to $294,000 direct costs with full F&A. The R00 is contingent upon the candidate securing an independent research position and being approved through an administrative review process. The NIH intends to fund 171 K99/R00 awards annually, beginning in FY2007. The NEI is expected to fund four awards each year, a level proportionate to our budget.

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GENERAL COUNCIL DISCUSSION

Council members 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 Council. Members felt that the issue of providing additional funding opportunities for first time investigators was a serious need. They questioned whether the Bridge to Independence Program would be sufficient, and requested that NEI staff pay attention to this problem when developing pay plans.

Members also discussed the Portfolio Analysis presentation at last September's Council meeting which focused on the Low Vision and Blindness Rehabilitation Program. Members indicated that they found such presentations valuable and recommended that they continue. Upon further consideration, several members wished to express their view that the program should highlight prevention research as well as research on the preservation of vision. They asked staff to consider whether the program title should have the phrase "visual preservation" in place of the word "rehabilitation".

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OCULAR GENETICS PROGRAM PORTFOLIO ANALYSIS

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PROCESS OVERVIEW

Dr. Sieving thanked members for their support for the new NEI initiative of a regular cycle of review and analysis of the individual NEI portfolios. These activities will continue to include scientific presentation(s) 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. McNicol indicated that members had been sent a package of summary materials regarding grants in the Ocular Genetics 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.

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UNDERSTANDING THE GENETIC BASIS OF OCULOMOTOR DISEASES: LESSONS FROM FAMILY-BASED STUDIES

Dr. Elizabeth C. Engle, Program in Genomics and Department of Neurology, Children's Hospital Boston, Harvard Medical School, presented her research employing a genomics approach to the study of the genetic basis of strabismus. Strabismus occurs in both common (esotropia, exotropia) and rare complex phenotypic forms. Dr. Engle's group has explored the Mendelian genetics of such complex strabismus disorders as congenital cranial dysinnervation and the "general fibrosis syndrome", using positional cloning techniques. They have discovered a novel autosomal recessive syndrome that includes abnormal ocular motility. This work has lead to the identification of genetic loci involved in the neuro-biologic basis of complex strabismus.

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PORTFOLIO OVERVIEW

Dr. Hemin R. Chin, Director, Ocular Genetics Program, described the background and history of the Program and provided data on its goals, funding, and research areas. Nearly 500 human ocular disease genes have been discovered since 1983, and the number of grants in the ocular genetics portfolio has risen concomitantly. Dr. Chin reviewed the numbers of grants and the levels of funding for genetics grants in various grant mechanism categories, and in various NEI programmatic areas through time. Most studies have employed the R01 grant mechanism and have involved family studies. In recent years, large-scale population-based association studies have become more prevalent, and they are found across the matrix of NEI extramural programs. Dr. Chin reviewed both NEI- and NIH-supported genetics and genomics resources. NEI specific initiatives include the National Ophthalmic Genotyping Network, a pilot study of the use of AREDS genotyped samples for Whole Genome Association Studies, NEIBank, and individual projects using model organisms. NEI also is an active participant is several large, trans-NIH genetics studies. These include the Mammalian Gene Collection, Human ORFeome Collaboration, the Knockout Mouse Project (KOMP), ENU Mouse Mutagenesis neurosciences initiative, and the NIH Neuroscience Microarray Consortium.

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COUNCIL DISCUSSION

Council members expressed their enthusiasm for the scientific presentations and for Dr. Chin's stewardship of the program. They remarked that ocular genetics has moved beyond the state of a cottage industry. And they recommended that the portfolio be broadened in order to achieve an equal balance between family studies and population-based studies. They noted the particular need for population-based studies in cataract.

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ADJOURNMENT

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

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FRIDAY, JANUARY 20, 2006

CLOSED PORTION OF THE MEETING

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).

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CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST

Dr. McNicol 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 THE REPORT OF THE BOARD OF SCIENTIFIC COUNSELORS

REVIEW OF RESEARCH AND RESEARCH TRAINING APPLICATIONS

ADJOURNMENT

Dr. Sieving adjourned the meeting at 12:00 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

09/26/2006


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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

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

Ad Hoc Members
Juan I. Korenbrot, Ph.D.
Department of Physiology
University of California, San Francisco
San Francisco, DA 94143

J. Mark Petrash, Ph.D.
Department of Ophthalmology and Visual Sciences
Washington University
St. Louis, MO 63310

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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