DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute
NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting
January 14, 2010
The National Advisory Eye Council (NAEC) convened for its one hundred twenty-fourth meeting at 8:30 am on Thursday, January 14, 2010, at 5635 Fishers Lane, Rockville, 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. On Thursday January 14, 2010 from 1:00 pm until 4:30 pm, the meeting was open to the public.
COUNCIL MEMBERS PRESENT:
Dr. Joseph Bonanno
Dr. James Chodosh
Dr. Scott W. Cousins
Mr. Ronald J. Gardner
Dr. Charles D. Gilbert
Dr. Mae O. Gordon
Dr. Mary C. McGahan
Ms. Alberta Orr
Dr. Val C. Sheffield
Dr. Richard A. Stone
Dr. Marco A. Zarbin
AD HOC COUNCIL MEMBERS:
Dr. David Copenhagen
Dr. Bernard Godley
NEI STAFF PRESENT:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Monique Clark
Ms. Janet Craigie
Mr. William W. Darby
Ms. Linda Dingle
Mr. Donald Everett
Mr. Sean Finnegan
Dr. Richard Fisher
Ms. Jerusha Gittlen
Dr. Shefa Gordon
Dr. Thomas Greenwell
Mr. Thomas Hoglund
Ms. Tina Jones
Ms. Shara Kabak
Mr. J. Kevin Keating
Dr. Daniel Kenshalo
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Lisa Neuhold
Dr. Andrew Mariani
Dr. Loré Anne McNicol
Dr. Jennifer Mehren
Ms. Kathleen Moy
Dr. Lisa Neuhold
Ms. Jessica Perez
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Ms. Karen Robinson-Smith
Dr. Merlyn Rodrigues
Dr. Anne E. Schaffner
Dr. Eleanor Schron
Dr. Gordon Shefa
Dr. Grace L. Shen
Dr. Paul Sieving
Dr. Michael A. Steinmetz
Ms. Chantell Stevenson
Dr. Santa Tumminia
Ms. Keturah Williams
Mr. David Whitmer
Dr. Jerome R. Wujek
OTHER NIH STAFF PRESENT:
Ms. Alicia Barbieri, Center for Scientific Review (CSR)
Dr. Michael H. Chaitin, CSR
Ms. Mary Frances Deutsch, Office of the NIH Director (OD)
Dr. Della Hahn, Office of Extramural Research (OER), OD
Dr. Angela Hvitved, OER, OD
Ms. Donna Holland, OD
Dr. Judith Finkelstein, CSR
Dr. George McKie, CSR
Ms. Kristin McNamara, CSR
Dr. Luci Roberts, OER/OD
Dr. Antonio Scarpa, CSR
Dr. Jerry Taylor, CSR
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Dr. Bobbie Austin, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Joanne Angle, ARVO
Ms. Lauren Friend, General Dynamics Information Technology (GDIT)
Ms. Kelly Hipp, American Optometric Association
Ms. Rebecca Hyder, American Academy of Ophthalmology
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, ARVO
Mr. Winston McCarthy, GDIT
Ms. Elaine Richman, Richman Associates
Ms. Kathi Terlizzese, Tissue Banks International
Thursday, January 22, 2009
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).
CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST
Dr. Andrew Mariani, 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.
REVIEW OF RESEARCH, RESEARCH TRAINING, AND COOPERATIVE AGREEMENT APPLICATIONS
Following the review of applications, a Survey of Peer Review Enhancements developed for Special Government Employees, was administered to Council members by Drs. Della Hahn, Angela Hvitved, and Luci Roberts, Office of Extramural Research, Office of the NIH Director.
OPEN PORTION OF THE MEETING
CALL TO ORDER AND OPENING REMARKS
Dr. Sieving welcomed all attending and introduced Dr. Antonio (Toni) Scarpa, Director, the Center for Scientific Review (CSR). Dr. Sieving noted that Dr. Scarpa has been very busy with the NIH initiative, “Enhancing Peer Review” to look at the quality and processes of peer review.
CHALLENGES AND OPPORTUNITIES FACING PEER REVIEW: A VISION FOR ENSURING ITS STRATEGIC NATIONAL VALUE
Dr. Scarpa discussed the reorganization of CSR to improve Study Section alignment through input from the community, internal CSR reviews, open houses with stakeholder scientists, and, the Peer Review Advisory Committee (PRAC). CSR has shortened the review time and added additional review platforms to include an Editorial Board Review and College of CSR Reviewers.
In 2008, CSR received 15,000 applications, and used 8,000 reviewers. In 2009, the number of applications more than doubled to over 40,000 and there were 30,000 reviewers. He discussed some of the successful strategies to recruit the best reviewers such as moving one meeting a year to the West Coast, the implementation of additional review platforms, a national registry of volunteer reviewers, providing tangible rewards for reviewers such as no submission deadlinesand providing flexible service time for reviewers.
Dr. Scarpa then outlined CSR review of applications assigned to the NEI for funding consideration, stating that 78% of NEI applications were reviewed in three standing study sections, the other 22% were reviewed in 39 standing committees and 27 Special Emphasis Panels (SEPs). These three “captive” study sections are to be considered for reorganization with integration of the applications into other study sections. He noted that the review outcome of applications was nearly identical between those reviewed in the three main study sections and the remaining 22% reviewed elsewhere.
The Enhancing Peer Review Initiative, “to fund the best science, by the best scientists, with the least administrative burden,” was summarized, and included changes to the scoring system, the implementation of criterion scoring, the structured, template-based, critique, clustering of the review of new investigators, overall impact scoring for discussed applications, alignment of the order of review, and shortening of the applications.
Dr. Scarpa summarized the effect of “the stimulus” or the American Recovery and Reinvestment Act (ARRA) on the review workload at CSR that resulted in over 29,000 additional applications and the use of over 28,000 reviewers. Finally, he predicted that peer review at CSR would experience an increase above historical rates for the numbers of applications received and reviewed.
Council questions to Dr. Scarpa, and his responses included a discussion of recruitment of reviewers, increase in the number of applications, professional expertise of reviewers, technological enhancements used in review, the new scoring system, and the length of applications.
DIRECTOR’S REPORT, OPENING REMARKS AND INTRODUCTION OF NEW COUNCIL MEMBERS
Dr. Sieving introduced and welcomed two new members of the National Advisory Eye Council, Dr. David Copenhagen and Dr. Bernard Godley. Dr. Copenhagen received a Ph.D. in Bioengineering from the University of California, Berkeley and is Professor of Physiology and Ophthalmology at the University of California, San Francisco. Dr. Copenhagen is well known for his research on the neurophysiology of the retina.
Dr. Godley received a Ph.D. in Neuroscience from the Massachusetts Institute of Technology and an M.D. from Harvard Medical School. Dr. Godley is Professor and Chair of Ophthalmology at The University of Texas Medical Branch, Galveston. He is a vitreoretinal surgeon and conducts research on the molecular mechanisms of AMD including the role of antioxidants and the pigment epithelium.
Dr. Sieving thanked Drs. Copenhagen and Godley for agreeing to serve on Council.
Dr. Sieving noted the retirement of Dr. Michael Oberdorfer, a Program Director in the Division of Extramural Research after being with the NEI for over two and one-half decades and before that with the NIH. Dr. Oberdorfer will be missed as part of the neuroscience group of extramural program staff.
Dr. Eleanor Schron has joined the Division of Extramural Research as a Program Director for Clinical Trials and Epidemiology. She formerly was at the National Heart Lung and Blood Institute as a member of the Unites States Public Health Service, and a nurse, with experience in clinical trials, an understanding of quality of life assessment, and expertise in genetic epidemiology.
Dr. Tom Greenwell is a newly-hired Group Leader for the retinal neuroscience grants. He has a Ph.D. in Neuroscience from Tulane, followed by a postdoctoral fellowship at the Scripps Institute prior to his joining the NIH as a program director in the National Institute of Alcohol Abuse and Alcoholism. He will join four other Program Directors in the Division of Extramural Research who have expertise in neuroscience underlying vision and visual processing.
Dr. Sieving provided Council with the recent article “Opportunities for Research and NIH” (Science 327: 36, 2010) by NIH Director, Dr. Francis Collins, outlining five areas he perceives as ripe for major advances with potential and substantial benefits. These five areas are: High-throughput Technologies, Translational Medicine, Benefitting Health Care Reform, Global health, and Reinvigorating and Empowering the Biomedical Research Community. The role of the NEI in advancing vision research related to these areas was discussed.
The series of the 40th Anniversary Symposiums, past and future, were reviewed by Dr. Sieving in context of the very robust science represented in the vision research community. He also noted that Dr. Roger Tsien, recent Nobel Laureate, would be, in March, presenting the Annual Sayer Vision Research Lecture upon his receipt of the Sayer Award.
COUNCIL OPERATING PROCEDURES
Mr. William Darby, Chief, Grants Management Branch, Division of Extramural Research reviewed the proposed Council Operating Procedures (COP) for the 2010 Calendar Year (CY). A motion was made and seconded to accept the recommended COP and ther vote indicated all were in favor of the motion.
2011 COUNCIL DATES
Dr. Mariani proposed the following dates in 2011 for Meetings of the National Advisory Eye Council: January 20-21, June 16-17, and October 13-14, 2011
Ms. Marilyn Laurie, Chief, Financial Management Branch, presented an overview of the NEI’s budget, as of January 14, 2010. The presentation included NEI’s appropriation/budget History, Research Project Grants (RPGs) and RPGs’ Success Rate, FY 2010 appropriation, ARRA funding status update, and other relevant Trans-NIH initiatives.
Over the last 10 years, NEI’s budget increased by $257 million, from $450 to $707 million; however, NEI’s true buying power of the budget only increased by $97 million when adjusted for inflation. During this period, NEI’s budget experienced annual percentage changes ranging from as high as 13.8% to a low as -1.4%, funded approximately 1,100 RPGs each years, and maintained a 30% average RPGs success rate.
NEI’s Budget for FY 2010 is $707 million, which represents a 2.7% increase over FY 2009. NEI allocated $611.7 million to Extramural Research, $71.5 million to Intramural Research, and $23.9 million to Research Management and Support. In FY 2009, NEI also received $174 million from the American Recovery and Reinvestment Act (ARRA), with legislative policy requiring that all funds must be obligated (awarded) by September 30 2010. $98 million have been obligated and the remaining $76 million will be obligated in FY 2010.
The NEI also participates in several trans-NIH initiatives. This includes the NIH’s: Neuroscience Blueprint, Genes and Environment, Pathway to Independence K99/R00, Therapeutics for Rare and Neglected Diseases, and Basic Behavioral, and Social Science Opportunity Network (OppNet) which are funded by the institutes. OppNet was initiated using $10 million of the OD’s ARRA funds. In FY 2011, OppNet will be transitioning from the OD ARRA funds to co-funding across all institutes; the institutes will be funding OppNet from 2011 -2014. NEI also participates in the NIH’s Pioneer Awards, New Innovator, and Roadmap Program which are funded by the NIH Office of the Director’s (OD) Common Fund. Additional information on NEI’s funding is available on NEI’s website.
NEIGHBOR GLAUCOMA CONSORTIUM PROGRESS
Dr. Hemin Chin updated Council on the genetics of Primary Open Angle Glaucoma (POAG) and the, NEI Glaucoma Human genetics collaBORation (NEIGHBOR). He outlined the goals, progress, lessons learned, and future timeline of the project. The overall goal is to find the full complement of genetic and environmental factors operative in primary open-angle glaucoma at the whole genome level.
Dr. Chin summarized the NEI’s genetics and genomics initiatives as intended to establish and expand collaborative research resource to enhance the value of NEI-funded studies through Collaborative Networks, harmonizing phenotypic definition across samples, incorporating new diagnostic tools, new analytic methods to integrate the large volume of data, collection of biological samples for genetic studies and genomic investigations for gene-gene and gene-environment interactions and changes in gene functions, and, as a resource for wide access to information and computational tools (consistent with participant informed consent).
VETERINARY RESOURCES FOR TRANSLATIONAL RESEARCH
Dr. Lisa Neuhold gave a presentation on large animal models that have been generated over the years, and discussed new ways to use these resources and evaluate opportunities and needs. One major area of opportunity that our new NIH Director, Dr. Francis Collins addressed is the “translation of NIH science into practice.” During the presentation, she described how large animal models have played a significant role in developing diagnostics and therapeutics including gene therapy approaches for many eye diseases. For example, results from a study showing replacement of the RPE65 gene in a dog model of LCA2 has led to clinical trials. Given the value these large animal models in translating new knowledge and strategies to humans and well as their use as in basic research, Council members recommended that NEI provide information regarding NEI-supported resources on our web site to encourage sharing.
THE NEI SMALL BUSINESS RESEARCH GRANT PORTFOLIO
An overview of the Small Business Research Portfolio was presented by Dr. Jerome Wujek. The portfolio includes two Congressionally-mandated programs: Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR). Both programs have the goal of stimulating private sector commercialization and technological innovation. The two major differences are: 1) STTR requires collaboration between the small business and a non-profit research institution, thus stimulating technology transfer; and 2) SBIR has a budget set-aside of 2.5% of the Federal agency budget versus a 0.3% budget set-aside for STTR.
Examples of Commercial Success were cited: Bioptigen, Inc. (ophthalmic instruments); TissueTech, Inc. (amniotic membrane for corneal wound healing); Chadwick Optical (high power prism eyeglasses for hemianopia); and ViewPlus Technologies (accessible tactile (graphics/Braille) printing). The general success of the Small Business Program has been substantiated in a 2009 report by the National Research Council: “…SBIR Program is sound in concept and effective in practice.”
Dr. Richard Fisher, Director of Program Planning and Analysis, discussed the future of the NEI’s strategic planning and program planning. Traditionally, NEI has had a five-year plan and a new NEI Strategic Plan is being developed. This process will involve assembling panels of scientific experts in the different program areas to discuss needs and opportunities for the future. In addition, we plan to organize workshops in areas of scientific opportunity and will communicate the results to the vision research community. We hope to develop new ideas through the program staff, Council, the stakeholder community, and ARVO trustees. The NEI Planning Office will then present these ideas to senior staff for approval by Dr. Sieving and Council. Two workshops are planned for the next fiscal year and an email list serve called The Pipeline is being prepared. Anyone funded by the NEI will be placed on the list serve, and announcements and planning ideas will be circulated. The two workshops are 1) Ocular sensitivity and recurring pain, that will be discussed by Dr. Jennifer Mehren. She recently joined the Office of Planning and is a neuroscientist by training. 2) The structural biology of the lens workshop will be presented by Dr. Houmam Araj.
OCULAR SURFACE PAIN PROGRAM PLANNING WORKSHOP: CONCEPT CLEARANCE
Dr. Jennifer Mehren presented the intention to convene a workshop on ocular pain since the cornea has the highest density of nociceptive nerve endings in the body. This understudied area needs attention because of the clinical implications. The Co-Chairs are Dr. Todd Margolis, Professor of Ophthalmology at UCSF, and Dr. Carlos Belmonte, Professor at Universidad Miguel Hernandez. The meeting will be held on Sept 30-Oct 1, 2010 in Washington DC. Panelists will have expertise in a variety of areas of pain research, including dry eye, post-surgical corneal pain, ocular surface pain, other types of mucosal surface pain (mouth, throat), co-morbid pain (TMJ, migraine) and therapeutics.
Council discussion of the proposal focused on the breadth of the topic and whether it should be broadened to neurogenic mechanisms in general or more narrowly focused on ocular pain. A motion was made to endorse the concept presented and to allow the organizers to decide the focus of the workshop. The motion was seconded and unanimously approved by Council.
STRUCTURAL BIOLOGY OF THE LENS CIRCULATORY SYSTEM PROGRAM PLANNING WORKSHOP: CONCEPT CLEARANCE
Dr. Houmam Araj presented Council with the concept of a workshop focused on the Structural Biology of the Lens Circulatory System as part of the Phase II Program Planning process. The idea was to convene a panel of scientists from both the lens and outside-lens field for a one-day meeting to evaluate the progress of this area of research, as well as to identify any gaps and/or future opportunities. Council felt that it would be preferable to better identify and emphasize clinical and/or translational aspects of lens circulation.
GENERAL COUNCIL DISCUSSION
The Council was concerned about the issue of the vision study sections reorganization mentioned by Dr. Scarpa earlier in the meeting and questioned why this was being considered. Drs. Sieving and McNicol replied that it was CSR’s intention to periodically look at the organization of study sections to determine if the organization reflected the needs of continually changing science. They noted that they would be meeting with Dr. Scarpa at the end of the month when he would present his plan on the reorganization of the three largely vision study sections but until that plan was presented, it was not known what reorganization Dr. Scarpa had in mind.
Council expressed support for the NEI and the NEI’s stake in study section reorganization
Dr. Sieving adjourned the meeting at 4:30 pm
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Dr. Andrew P. Mariani, Ph.D.
National Advisory Eye Council
Division of Extramural Research
National Eye Institute
Paul A. Sieving, M.D., Ph.D.
National Advisory Eye Council
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
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
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