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NAEC Meeting Minutes - September 9-10, 2004

Department of Health and Human Services
National Institutes of Health

National Eye Institute

Minutes of Meeting

September 9-10, 2004

The National Advisory Eye Council (NAEC) convened for its one hundred eighth meeting at 8:30 a.m. on Thursday, September 9, 2004, in the Hyatt Regency Bethesda, Bethesda, Maryland. The Director of the National Eye Institute (NEI), Paul A. Sieving, M.D., Ph.D., presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 5:00 p.m. The meeting was closed for the review of grant applications on Friday, September 10, 2005, from 8:30 a.m. until adjournment at 12:00 p.m. Attachment A provides a roster of Council members.


Dr. Ruben Adler
Dr. Roy W. Beck
Dr. Suraj P. Bhat
Dr. Eileen E. Birch
Dr. Barrett G. Haik
Dr. Todd P. Margolis
Dr. Mildred M. G. Olivier
Mr. Richard J. Salem
Dr. Lois E. Smith
Dr. Mriganka Sur
Dr. Janey Wiggs
Dr. Karla Zadnik
Dr. Marco A. Zarbin (Ex Officio)


Lt. Col. J. Brian Reed (Ex Officio)


Ms. Louise M. Amburgey
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Janet Craigie
Mr. William W. Darby
Ms. Chris A. Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Mr. Donald F. Everett
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Dr. Ralph J. Helmsen
Dr. Chyren Hunter
Ms. Tina 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
Ms. Kathleen Moy
Dr. Michael D. Oberdorfer
Dr. Samuel Rawlings
Dr. Maryann Redford
Dr. Jean Paul SanGiovanni
Dr. Grace L. Shen
Ms. Karen Robinson Smith
Dr. Annie E. Schaffner
Dr. Paul Sieving
Ms. Karen Tolson
Dr. Santa Tumminia
Mr. John Whitaker


Dr. David Armstrong, Center for Scientific Review (CSR)
Dr. Michael Chaitin, CSR
Dr. Christine Livingston, CSR
Dr. Michael Steinmetz, CSR


Dr. Wylie Chambers, Food and Drug Administration


Dr. Israel Goldberg, Health Research Associates
Mr. James Jorkasky, Alliance for Eye and Vision Research
Ms. Nicole A. McPherson, Uniformed Services University of the Health Sciences
Ms. Kate Quinlan, Salem Law Group
Ms. Eileen Resnick, Society for Women’s Health Research
Ms. Hollie E. Stephenson, Association of Independent Research Institutes
Ms. Helen M. Viksnins, American Academy of Optometry
Dr. John Whitener, American Optometric Association




Dr. Paul A. Sieving, Director, NEI, and Chairman of the Council, called the meeting to order and welcomed the Council members to the one hundred eighth meeting of the National Advisory Eye Council.

Dr. Sieving provided Council members with an update on significant recent events at the NIH: The new NIH Clinical Research Center will be dedicated on September 22, 2004. This facility has been designed to place laboratories in close proximity to patients, in order to accelerate clinical research. The NEI Intramural Research Program will have some limited floor space in this new building for translational vision research.

Dr. Sieving noted that the NIH Institute and Center (IC) Directors recently had a retreat to discuss solutions to common concerns. The retreat was organized around three topic areas: In the area of clinical research, there is a tension between basic science and translational research. Dr. Sieving indicated that the NEI needs advice from Council to determine the proper balance. Regarding leadership, the ICs are being asked to provide models for the exemplary management of ideas. Dr. Sieving asked Council members to assist him in formulating explicit concepts for managing the vision research portfolio. The final retreat topic was that of portfolio analysis, which Dr. Sieving indicated should be an action item for Council members. He described the necessity for the NEI to develop measures of disease-adjusted life years and to estimate vision disease burden in the American population.

Dr. Sieving reviewed recent trans-NIH scientific initiatives in which the NEI has had a significant participation. These include the NIH Roadmap for Medical Research, where the NEI has taken the lead on the Nanomedicine initiative; the Neuroscience Blueprint, which will be rolled out at the fall meeting of the Society for Neuroscience; a symposium on ophthalmic genetics which the NEI is sponsoring at the October meeting of the American Society for Human Genetics; and a broad, national issue regarding research training programs. Dr. Adler recommended that Council members be asked to submit discussion topics for future meetings in order to present their ideas and suggestions.

Dr. Sieving announced that this is the last Council meeting for three Council members, Drs. Mildred Olivier and Karla Zadnik and Mr. Richard Salem. Dr. Sieving thanked them for their efforts on behalf of the NEI and of vision research. He indicated that the success of NEI programs is in very large measure due to the willingness of Council members, who not only spend many hours in preparation for our meetings and other activities, but also sacrifice their private interests to advise the NEI on the planning and operation of our programs. Dr. Sieving presented the outgoing members with certificates, letters of thanks, and tokens from the NEI, in recognition of their service.


Dr. Loré Anne McNicol, Director, Division of Extramural Research, NEI, and Executive Secretary of the Council, reviewed policies and procedures regarding confidentiality and 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. Dr. McNicol reminded members that applicants are not to call them directly regarding materials being considered by Council. Any such contacts should be forwarded to the appropriate NEI staff member.


The minutes of the June 10-11, 2004, NAEC meeting were considered and approved.


The following dates were previously agreed upon for future Council meetings:

February 28- March 1, 2005
June 9-10, 2005
September 22-23, 2005

Council members were asked to continue to keep these dates reserved as they make future plans and obligations, noting the unusual scheduling of a Monday to Tuesday meeting in February. Also, members were asked to bring their calendars to the February meeting, when meeting dates for calendar year 2006 will be determined.


Dr. McNicol indicated that this meeting will be the last for Ms. Carol Fivozinsky, the NEI Budget Officer. She is planning to retire on October 1, 2004. We have all thoroughly enjoyed working with Carol. She has always embodied the three Rs of management, responsiveness, reliability, and resilience. The staff will miss her.

Ms. Fivozinsky reviewed the NEI FY2005 budget, which is presently undergoing House mark up. The President’s budget and House mark is $671.6M. This represents a 2.9% increase over the NEI FY2004 budget, which was $652.7M. The NEI increase is slightly higher than the 2.6% increase for the NIH as a whole. The President’s Budget calls for $28.8B for the NIH, compared with $28.0B for FY2004. The Senate appropriations committee has not finished its mark up, and it is likely that there will be a Continuing Resolution. Ms. Fivozinsky reviewed particular areas of emphasis in the FY2005 House committee report language. These included research on the ocular complications of juvenile diabetes and ocular albinism.

Ms. Fivozinsky also provided an overview of the FY2006 budget process. The Department of Health and Human Services (DHHS) budget was submitted to the Office of Management and Budget in August, and the pass back is expected in November. In January or February, the budget will be transmitted to Congress.


Dr. McNicol provided an update of funding for the extramural research program in FY2004. The budget provided $570.5 M. Dr. McNicol reviewed the level of support for research project grants (RPGs). Both competing and total RPGs are expected to increase in FY2004 compared with FY2003. The NEI expects to make 331 competitive awards and 1220 total awards, historically the largest numbers ever supported. The success rate is anticipated to be 31%, down from 32.6% in FY2003. This decrease can be directly attributed to a continued large increase in the number of applications submitted. In FY2004 there were 1,094 RPGs submitted, compared to 948 in FY2003, marking a 15% increase. The average total cost of RPGs is expected to remain stable, at approximately $315,000.

Dr. McNicol reviewed a number of other funding categories. She noted that in the Center Core Grant program the total number of awards remained constant at 40, while the average total cost increased slightly from $581,000 to $600,000, a 3% increase. The NEI made 41 RPG supplements (minority scientist, bridging, equipment) for a total of $4,184,525. There were 75 Small Business Innovative Research and Small Business Technology Transfer grants, for a total of $16,362,484. Cooperative Clinical Research awards totaled $72.5M, compared to $68.1M in FY2003, a 6% increase.


Dr. McNicol introduced Dr. Deborah Carper, Head of the Section on Molecular Therapeutics and Special Assistant to the Director, NEI. Dr. Carper provided an overview of this symposium, which will be held on December 13-14, 2004, at the NIH Natcher Conference Center. The agenda is focused on describing training and research support mechanisms which are being developed to support the clinician scientist and on the status of the K-series Career Development Awards. Guests will include early career clinician scientists, current and past recipients of a Career Development Award, and experienced mentors. The program includes speakers, scientific poster sessions, and panel discussions of issues and concerns.


Dr. McNicol introduced Dr. Peter Dudley, Retinal Diseases Program Director. Dr. Dudley reviewed the Special Statutory Funding Program for Type 1 Diabetes Research, which augments the regular DHHS appropriation. For the period FY2004 to FY2008, this special program provides $150M per year. These funds are administered through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), but are shared with those ICs which support research in support of the six goals of the special program. These goals are to identify genetic and environmental causes of Type 1 diabetes, prevent or reverse the disease, develop cell replacement therapy, prevent or reduce hypoglycemia, prevent or reduce complication, and attract new investigators to the field of Type 1 diabetes research.

The NEI has successfully participated in six different NIDDK Requests for Applications (RFA) for consortia, resources, and special multidisciplinary research projects under the Special Program. The NEI uses the ARVO alert system to notify the vision research community of possible funding opportunities.

The NEI has also used Special Program funds in developing the Diabetic Retinopathy Clinical Research Network. The network is a cooperative agreement dedicated to multicenter clinical research on new therapeutic approaches to diabetic retinopathy, macular edema, and associated disorders. It includes 120 sites at domestic universities and private practices.


Dr. McNicol introduced Dr. Richard Fisher, Corneal Diseases Program Director, and NEI liaison to the Nanomedicine Roadmap. Dr. Fisher gave an overview of NEI participation in the NIH Roadmap for Medical Research. The Roadmap is a trans-NIH scientific opportunity funded in concert by all ICs. The Roadmap is not focused on any particular disease, model system, or cell type, but rather is generalized across all areas of biomedical science. The NEI serves as the lead IC for Nanomedicine. The Nanomedicine vision is to characterize quantitatively the physical and chemical properties of molecules and nanomachinery in cells; to understand the engineering principles used as cells build molecules, molecular complexes, and organelles; and to use this knowledge to develop new technologies and engineer devices and structures for repairing tissues, as well as preventing and curing disease.

Dr. Fisher indicated that in FY2004, the Nanomedicine initiative provided $1.5M in funding for Concept Development Awards (CDA) to be used for center planning activities. In each of FY2005 and FY2006, an additional $6 will be invested in center grants. The initiative is funded using a Flexible Research Authority, which allows the NIH to enter into transactions other than grants, contracts, or cooperative agreements and to utilize appropriate procedures in lieu of standard peer review and advisory council review procedures. In FY2005, the CDA awardees will submit Concept Development Plans and attend an investigator meeting to assist in the preparation of a Nanomedicine Centers RFA.


Dr. McNicol introduced Dr. Ellen Liberman, who is Director of the Lens and Cataract and the Glaucoma and Optic Neuropathies Programs, and also serves as staff liaison for the NEI-sponsored summer course, Fundamental Aspects of Vision Research. Dr. Liberman reported that this biennial course was initiated in 1992 and is held at the Marine Biological Laboratory in Woods Hole, MA. This facility has the infrastructure and educational mission for hosting summer courses, as well as a long tradition of supporting vision research. The purpose of the course is to recruit the highest caliber of young scientists to vision research and to highlight the need for scientists trained in molecular genetics, cell biology, neuroscience, and immunology to apply their expertise to vision research. Dr. Liberman reviewed the nature of the student body, faculty, and structure of the course from 1992-2004. And she provided data regarding the subsequent career paths of alumni. To date, 27% of the students have received independent NIH funding, largely with the NEI. Two have received prestigious national-level research recognition awards: the ARVO Cogan Award and the Presidential Early Career Award for Scientists and Engineers. Council members expressed their enthusiasm for the high quality of the course and its success in training outstanding vision researchers.


Dr. McNicol noted that NEI staff member, Dr. Chyren Hunter, attended this year’s annual meeting of the National Medical Association (NMA). Dr. McNicol introduced Council member Dr. Mildred Olivier, who presented insights on recent NMA activities regarding vision health disparity research. Dr. Olivier reminded Council that the NMA was organized in 1895, and now supports over 20,000 African American physicians and the patients they serve. The organization membership includes over 400 ophthalmologists. In 2000, Dr. Olivier received the Rabb-Veneble Ophthalmology Award which gave her the opportunity to speak with Congress regarding health disparities. These efforts have contributed to the establishment of the Commission to End Health Care Disparities, a first time collaboration between the NMA and the American Medical Association centered on health disparity issues. Dr. Olivier encouraged the NEI to continue implementation of the recommendations of the NEI Strategic Plan on Reducing Health Disparities.


Dr. McNicol introduced the NEI Training Officer, Dr. Chyren Hunter. Dr. McNicol explained that Dr. Hunter administers the NEI Loan Repayment Program (LRP). This is a mandatory trans-NIH program which administers contracts awarded through a process which does not require Council review. Nevertheless, staff gives Council an annual overview of how the program is running to solicit feedback regarding its goals and performance.

Dr. Hunter provided an overview of the program, which was designed to assist in the recruitment and retention of clinical researchers by providing repayment of educational loans. The LRP awards up to $35,000/yr for two years, in a renewable contract to repay qualified education loan debt. In return, the awardee commits to a 50% effort, year-for-year research career. Dr. Hunter indicated that in FY2004, the NEI provided $1.7M to fund 30 LRP awards. She indicated the need for better communication regarding the program in order to help increase the number of vision clinician scientists. Council members indicated their strong support for the LRP program, and recommended advertising to university-level pre-med counselors in order to give students information about the possibility of LRP support as they decide between a clinical and a research career.


Dr. McNicol introduced Dr. Hemin Chin, Director of the Ocular Genetics Program. Dr. Chin indicated that he is responsible for coordinating the extramural research aspects of the operation of the NEIBank, a visual system web-supported database of genes and proteins expressed in the eye and visual system. Dr. Chin reviewed the history that led to establishment of the bank, and described its current features. Dr. Chin indicated that he has recently established a NEIBank Executive Advisory Committee. The six members met in April, 2004, and developed a set of recommendations for the future operation of the database. In the near-term, the Committee recommended that current information be made more broadly available to the vision research community, by providing new data in a more timely and open manner and by developing a central hub for accessing annotated genomic, genetic, and cell biological data. In the longer term, the Committee recommended generating new information and resources such as developmental gene expression patterns, high quality antibodies reactive against selected proteins of interest to vision researchers, yeast two-hybrid libraries from ocular tissues, ocular tissue gene arrays, and RNAi reagents. Dr. Chin indicated that he proposes to begin implementation of these recommendations through contract support of annotation, linkage to other public databases, and collection and distribution of antibodies.

Council members expressed their strong support for these endeavors, noting that these resources are crucial for progress in translational research. Members also recommended including a vision-specific hybridoma bank, the full transcriptosome, and a SNIP repository. They voted unanimously in support of the concept.


Dr. McNicol introduced Dr. Michael Oberdorfer, Director, Strabismus, Amblyopia, and Vision Processing and Low Blindness and Blindness Rehabilitation Programs. Dr. Oberdorfer reviewed the background of this initiative and indicated that its goals were to foster collaboration and cooperation among the NIH neuroscience ICs. The 14 Blueprint ICs have produced an inventory of neuroscience research at the NIH; in FY2004 this was funded at a level of $4.9B. Future Blueprint activities will focus on four topics: neural development, plasticity, neurodegeneration, and behavior. Council members indicated some frustration that this activity has a time frame which is too short to produce a comprehensive blueprint when the visual system could be employed to achieve considerable depth. Members noted that there is no doubt that the collaboration and coordination will be tremendously fruitful.


Dr. Fisher reviewed previous trans-NIH bioengineering initiatives, including the Bioengineering Consortium (BECON), the annual BECON Symposia, and the development of several joint RFAs and Program Announcements. He described the Bioengineering Research Partnership (BRP) initiative, which encourages multidisciplinary research teams to apply integrative, systems approaches to develop knowledge and/or methods to prevent, detect, diagnose, or treat disease or to understand health and behavior. The NEI has actively participated in the BRP program over the past three years, funding ten at an overall level of $12.7M annual total cost. Dr. Fisher reviewed these projects and noted that half of the NEI BRPs focus on medical imaging technology. Now that the National Institute of Biomedical Imaging and Bioengineering has been established, Dr. Fisher asked Council for their advice as to whether the NEI should continue to participate in the BRP program. Council members indicated their strong support for this program, noting that imaging technology development is very mission-related and that advances in imaging technology are central to our progress in understanding vision. Council approved the concept of continued NEI collaboration in the BRP initiative.


Dr. McNicol had been asked by council members to provide an overview of the participation of women in the NEI extramural programs. She indicated that starting from 1970, when only 12 women submitted any type of application, the number of female applicants has risen steadily to 303 in FY2003. This represents 25% of the total number of applicants, a percentage which is identical to that of the NIH as a whole for FY2003. Although the number of women is lower than that of their male colleagues, women face no discrimination in the rate at which their proposals are funded. Both genders have had essentially equivalent award rates since 1975. Unfortunately, there is evidence for a “glass ceiling” in the role of women in NEI programs (and in NIH as a whole). Women are less likely to be the Principal Investigator (PI) for complex grant mechanisms, such as the institutional training grants or center core grants. Women are also under-represented as PI for large budget, collaborative grant activities such as Phase III clinical trials, Bioengineering Research Partnerships, or Collaborative Research on Therapy for Visual Disorders. Council members indicated that they were gratified to see no evidence for discrimination in award rates for women, and urged NEI staff to monitor policies which lead to equity. Council urged NEI to explore outreach programs that might increase the number of women who apply for funding. To break through the glass ceiling, Council noted that the vision research community as a whole needs to do more to promote women to higher leadership positions.


Dr. Dudley reviewed the background and history of this program announcement, and indicated that it would soon expire. He described the specific research projects which had been funded under this program and indicated it’s utility in providing multidisciplinary clinical resources which could be focused on a single disease. Council members enthusiastically indicated their support for the continuation of the program.


Dr. Fisher reviewed the background and history of this program announcement, and indicated that it would soon expire. He described the characteristics of the R03 Pilot Grant and compared the Pilot Grants to other NEI and NIH-wide small grant programs. Council members expressed mixed feelings regarding the future of this mechanism. All agreed that it has clearly attracted a significant number of applications. Some felt it has been quite successful, others felt there was not much basis to determine how successful it has been. All agreed that there is a confusing mixture of available mechanisms and that the NIH Exploratory/Developmental Grants (R21) are quite similar to the NEI Pilot Grants.



The meeting was closed to the public 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. Appendix 2).



Dr. McNicol introduced Scientific Review Administrators from the CSR: Dr. Michael Chaitin, Biology and Diseases of the Posterior Eye, Dr. Christine Livingston, Anterior Eye Disease, and Dr. Michael Steinmetz, Central Visual Processing.


Council considered research and research training grants. 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.


Dr. Sieving adjourned the meeting at 12:00 p.m. on September 10, 2004.


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.
National Advisory Eye Council
National Eye Institute

These minutes will be submitted for the approval of the Council at the February 28-March 1, 2005 meeting. Any corrections or notations will be incorporated into the minutes of that meeting. 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


Attachment A


(Terms end 11/30 of the designated year)

Ruben Adler, M.D. (05)
Department of Ophthalmology
600 N Wolfe St Maumenee 519
Johns Hopkins University School Med.
Baltimore MD 21287-9257

Roy W. Beck, M.D., Ph. D. (06)
Jaeb Center for Health Research
Suite 350, 15310 Amberly Drive
Tampa FL 33647

Suraj P. Bhat, Ph.D. (06)
Department of Ophthalmology
Jules Stein Eye Institute
100 Stein Plaza, BH623
Los Angeles CA 90095-7000

Eileen E. Birch, Ph.D. (07)
Retina Foundation of the Southwest
9900 N Central Expressway, Suite 400
Dallas TX 75231

Barrett G. Haik, M.D. (07)
Department of Ophthalmology
University of Tennessee
Health Science Center
930 Madison Avenue, Suite 100
Memphis, TN 38163

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

Mildred M. G. Olivier, M.D. (04)
President and CEO
Midwest Glaucoma Center, P.C.
1575 N Barrington Road, Suite 105
Hoffman Estates, IL 60194

Richard J. Salem, J.D. (04)
Senior Partner
Salem Law Group, P.A.
101 East Kennedy Blvd, Suite 3220
Tampa, FL 33602

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 and Cognitive Sci.
Massachusetts Institute of Technology
45 Carleton Street, E25-235
Cambridge, MA 02139

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

Karla Zadnik, O.D., Ph.D. (04)
Professor, College of Optometry
Ohio State University
Columbus OH 43210-1240

Department of Defense Representative
Lt. Col. J. Brian Reed, M.D.
Chief, Vitreoretinal and Uveitis Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Department of Veterans Affairs Representative
Marco Z. Zarbin, M.D., Ph.D.
New Jersey Veterans Administration Hospital
Newark, NJ 07103

Ex Officio Members

Tommy G. Thompson
Department of Health & Human Services
Washington, DC 20201

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

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

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