NAEC Meeting Minutes
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute
NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting
January 18, 2007
The National Advisory Eye Council (NAEC) convened for its one hundred fifteenth meeting on Thursday, January 18, 2007, at the Montrose Hotel, 2430 Pennsylvania Avenue, NW, Washington, DC 20037. 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. Mae O. Gordon
Dr. Gunilla Haegerstrom-Portnoy
Dr. Barrett G. Haik
Dr. Lenworth N. Johnson
Dr. Douglas H. Johnson
Dr. Juan I. Korenbrot
Dr. Todd P. Margolis
Dr. Mary C. McGahan
Dr. Val C. Sheffield
Dr. Earl L. Smith, III
Dr. Mriganka Sur
Dr. Marco A. Zarbin
COUNCIL MEMBER ABSENT:
Dr. David E. Holck
NEI STAFF PRESENT:
Dr. Houmam Araj
Ms. Pamela Bobbit
Ms. Sylvia Braxton
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Janet Craigie
Mr. William W. Darby
Mr. Michael P. Davis
Dr. Peter A. Dudley
Mr. Donald F. Everett
Dr. Richard S. Fisher
Mr. Kenneth Frushour
Dr. Chyren Hunter
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
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Grace L. Shen
Dr. Annie E. Schaffner
Dr. Paul A. Sieving
Ms. Judith Stein
Mr. Arthur Stone
Dr. Santa Tumminia
Mr. David L. Whitmer
Ms. Romona Williams-Parker
Dr. Jerome R. Wujek
OTHER NIH STAFF PRESENT:
Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Dr. Gwynne Jenkins, Office of Extramural Research (OER), NIH
Dr. Norka Ruiz-Bravo, Deputy Director for Extramural Research, NIH
Dr. Michael Steinmetz, CSR
Dr. Jerry Taylor, CSR
Dr. Baio Tian, CSR
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Lori Methia, ARVO
Ms. Elaine Richman, Richman Associates
THURSDAY, JANUARY 19, 2007
CLOSED PORTION OF THE MEETING8:30 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.
REVIEW OF RESEARCH AND RESEARCH TRAINING APPLICATIONS
OPEN PORTION OF THE MEETING10:30 am
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 fifteenth session of the NAEC. Dr. Sieving discussed the role of Council, stressing that Council provides advice regarding all aspects of Institute business, and that the NEI staff does not function in a vacuum. He indicated that it is important to continue with portfolio analysis and to proceed with Phase II program planning.
Dr. Sieving introduced four ad hoc members present for this Council meeting:
- Mae O. Gordon, Ph.D.,
is a Professor in the Department of Ophthalmology and the Division of Biostatistics at the Washington University School of Medicine, St. Louis. She trained in Sociology and Psychometrics at the University of Wisconsin and has participated in a number of NEI-funded clinical trials, including the Collaborative Longitudinal Evaluation of Keratoconus Study and the Ocular Hypertension Treatment Trial. She has published extensively in the area of clinical trials biostatistics. - Douglas H. Johnson
received his M.D. from the Mayo Medical School where he pursued a residency in ophthalmology. Following a glaucoma fellowship at Harvard Medical School, he returned to the Mayo Clinic where he is now a Professor of Ophthalmology. His outstanding research in the cell biology of the human trabecular meshwork and its role in the pathogenesis of glaucoma has been recognized by numerous awards, including a Research to Prevent Blindness Foundation Lew Wasserman Mid-Career Scientist Award. - Mary C. McGahan, Ph.D.,
is Professor and Head of the Department of Pharmacology at the North Carolina State University, Raleigh. She trained at Mt. Sinai School of Medicine, did postdoctoral work in ophthalmology at Columbia University, and joined the NC State faculty. Her career has been distinguished by service as an NIH study section review, as the chair of the ARVO Advocacy committee and member of the International Society for Eye Research Council, representing North America. Her research focuses on trace element dynamics in the eye. - Val C. Sheffield,
received his M.D., Ph.D. from the University of Chicago and is now a Howard Hughes Medical Institute Investigator in the Department of Pediatrics, University of Iowa. His career has been marked by service on prestigious review panels and blue ribbon groups, providing advice in the area of human genetics. He has received numerous honors and citations, culminating in election to the National Academies of Science Institute of Medicine. His extensive publications have explored the molecular genetics of many ocular disorders, particularly primary open angle glaucoma and developmentally-expressed conditions.
Dr. Sieving expressed his appreciation that such distinguished scientists would participate in this NAEC meeting.
Dr. Sieving next announced the retirement of Ms. Judith Stein, NEI Associate Director for Communication, Health Education, and Public Liaison. Ms. Stein’s long career included initiation of the National Eye Health Education Program, establishment of the Vision Network, and the production of many award-winning public service announcements. Dr. Sieving also noted the retirement of Dr. Leon B. Ellwein, Associate Director for Applications of Vision Research, who most notably established the Statement of Intent on Indo-US collaboration on Expansion of Vision Research.
DIRECTOR’S REPORT
Dr. Sieving provided members with an overview of the NIH Reform Act of 2006, which was recently passed as part of the NIH reauthorization. The bill authorizes new processes to facilitate trans-NIH research. Dr. Sieving discussed several of these initiatives in which the NEI participates:
- NIH Roadmap (RM) for Biomedical Research.
This initiative presents broad themes of science which are in need of special emphasis. NEI is the lead Institute for the on-going RM Nanomedicine Center Network. One of the six centers, “Optical Control of Biological Structure”, encompasses vision research. The current process to identify the next round of funding, Roadmap 1.5, began this spring. A series of national-level consultants’ meetings generated 342 proposals which were reviewed by the NIH Institute and Center (IC) Directors. Four proposals were selected for future funding: the Human Phenome, the Immune Basis of Chronic Disease, The Microbial Biome, and Epigenetics. - NIH Neurosciences Blueprint.
This consortium of 16 ICs includes the NEI; each participant contributes funds in proportion to its neurosciences grant portfolio. Currently-funded opportunities are in the areas of neurodegeneration, neurodevelopment, and neuroplasticity. Future steps include a planning meeting to be held this August, and a proposal to transition the Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program in the Neurosciences (T32) into the Blueprint funding umbrella. - The Foundation for the NIH (FNIH) Biomarkers Consortium.
This partnership among industry, Food and Drug Administration, NIH, and other key stakeholders is designed to promote the discovery, development, and qualification of biomarkers. The FNIH provides fiscal and administrative management of the consortium, the NIH provides program staff effort, and industry provides intellectual and financial contributions. - The Genes, Environment, and Health Initiative (GEI).
This NIH-wide activity is administered by the National Human Genome Research Institute and the National Institute of Environmental Health Sciences. It supports research that will lead to the understanding of genetic contributions and gene-environment interactions in common disease. GEI is one of several trans-NIH activities that help support the DHHS Secretary’s goal of personalized health care. The NEI held a meeting at Twinbrook to assist vision researchers interested in applying for GEI funding.
COUNCIL OPERATING PROCEDURES
Mr. William W. Darby, Grants Management Officer, presented the annual overview of Council Operating Procedures. He indicated that NEI staff was not recommending any change to the actions which must be brought to the attention of Council. Council members voted to continue to function under the Council Operating Procedures.
BIENNIAL ADVISORY COUNCIL REPORT CERTIFYING COMPLIANCE WITH THE NIH POLICY ON INCLUSIONS GUIDELINES
Dr. Päivi H. Miskala, Director, Collaborative Clinical Research Program, presented a two year overview regarding NEI compliance with the NIH policy on the inclusion of women and minorities in sponsored research. She reviewed the legal and ethical background to the NIH policies in this matter. In 1990, a Government Accounting Office study found less than optimal compliance regarding inclusion. Therefore, in the 1993 NIH Revitalization Act, Congress mandated that advisory councils provide biennial oversight. PL 103-43 noted the ethnical principal of justice and the importance of balancing research burdens and benefits. The law mandates that women and minorities be included in all clinical research studies, and that Phase III clinical trials be designed to permit valid analysis of gender and ethnic subgroups. The NIH is enjoined to support outreach efforts to recruit and retain women, minorities, and their subpopulations in clinical studies. Dr. Miskala presented the strategies NEI has put in place to encourage compliance with these guidelines. These activities include public education efforts on the NEI web site and in all published funding initiatives; staff training; documentation of grant files; maintenance of a population tracking system, and collaboration with various NIH Offices to secure funds to recruit additional special populations to NEI-funded Phase III clinical trials.
Dr. Miskala presented aggregate data regarding the inclusion of women in NEI funded research. In FY2005, 54% of study subjects were women. In FY2006 this rose to 56%. In Phase III clinical trials, in FY2005 57% of subjects were female, and in FY2006 50% were female. She also presented data regarding the inclusion of ethnic subpopulations. African Americans comprised 25% of the individuals in NEI-sponsored clinical research in FY2005, and 23% in FY2006. Other groups were represented at levels comparable to their proportion in the America population. In NEI-sponsored Phase III clinical trials for FY2005 and FY2006, African Americans were 44% and 65% of the totals. This over-representation correlates with the frequency of African American patients in NEI trials studying various aspects of glaucoma and diabetic retinopathy, as well as the initiation of a foreign phase III trial.
Council members indicated their opinion that the NEI has demonstrated a strong effort in staff training and in outreach activities; members voted to accept the report as being in compliance.
BUDGET OVERVIEW
The NEI Budget Officer, Marilyn Laurie, gave an update on the development of the President’s Budget, which is scheduled to be released on February 5, 2007.. And she reviewed the details of the current Continuing Resolution (CR). It calls for the NIH to receive a 0.1% decrease compared with the FY2006 appropriation, while the NEI decrease is 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). For the NEI Intramural Research program, the budget is flat, $67.0M. But the salary raise will be 2.64%, and this will have a negative impact on intramural research activities.
Ms. Laurie reviewed the trans-NIH initiatives for FY2007. All ICs will continue to participate in the Roadmap (NEI contribution of $8.0M), Genes & Environment (NEI contribution $1.1M), and Pathway to Independence K99/R00 (NEI contribution $360K). Council members asked what portion of the RM funds come back to vision researchers. Dr. Sieving answered that there are a number of individual grants, and that the initiative provides tools and resources which are available generally. One example is that one of the large roadmap Clinical Translational Science Awards went to a vision research group.
NEI EXTRAMURAL OPERATING STRATEGY
Dr. Loré Anne McNicol provided an overview of recent extramural activities. She noted that Dr. Houmam Araj, who has been one of the NEI Scientific Review Administrators since 2004, has taken the additional position of Program Director for the Lens and cataract grant program. Dr. Araj is replacing Dr. Ellen Liberman who has taken a senior leadership position within the NEI.
Dr. McNicol gave an update regarding the FY2007 operating strategy under the continuing Resolution. The present CR will be effective until February 16, 2007. Under this bill, non-competing research project grants will be awarded at 80% of the previously-committed level. When the final appropriation is enact, the NEI intends to make upward adjustments, but no inflationary increases will be allowed. For competing RPGs, the average total cost will remain at the FY2005/2006 level of $360,000, for a success rate of approximately 25%. The NEI intends to fund 43 first-time R01 grants to new investigators. For non-RPG grant mechanisms, funding will be done according to scientific and programmatic imperatives. The NEI anticipates a 4.4% decrease in the Center Core Grant program, no change to Research Training, a 2.0% increase to Other Research, and a 33.3% increase to the Roadmap. Other NEI changes anticipated for this fiscal year include an expansion of electronic submission, creation of multiple PI R01s, shortening of the grant review cycle, changes in application receipt dates, and no further funding of the R03 grant mechanism.
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 7-8, 2007
- September 27-28, 2007
- January 25-25, 2008
- June 19-20, 2008
- September 11-12, 2008
UPDATE ON TRANS-NIH ISSUES
Dr. McNicol introduced Dr. Norka Ruiz-Bravo, the Deputy Director for Extramural Research, Office of the Director, NIH. Dr. Ruiz-Bravo described the NIH’s evolving response to change over the past decade. She reviewed the history of overall NIH funding, and discussed the changes introduced by the NIH Reform Act which was passed by Congress on December 9, 2006. This law establishes new processes to facilitate trans-NIH research, through an enlarged Common Fund administered by the new Division of Program Coordination, Planning, and Strategic Initiatives. When the Common Fund reaches 5% of the NIH budget, there will be an evaluation review of its function and performance. The Reform Act also creates a Scientific Management Review Board (SMRB) to conduct periodic organizational reviews of the NIH and make recommendations on the use of NIH organizational authorities.
Council members asked Dr. Ruiz-Bravo whether the SMRB could recommend consolidation of NIH Institutes and Centers. She indicated that such a recommendation would be within the purview of the committee. She said that the structure and procedural functioning of the SMRB had not yet been determined, but added that any reorganization of NIH program would require a public process.
Dr. Ruiz-Bravo next discussed the evolution in animal welfare and animal care and use issues. She noted that societal views of animals have been changing. Clearly, progress in biomedical research depends upon studies using good model systems. Much recent scientific knowledge leading to improved treatment and diagnosis of both animal and human disease has come from the study of animal systems. NIH policy stresses the use of non-human model systems before experimental work on humans, but requires that all animal research be justified and be performed under regulated, humane conditions. Increasingly, biomedical research is striving to refine, reduce, and replace live vertebrates. There has been an increasingly vocal minority in society opposed to all use of animals in research. Dr. Ruiz-Bravo asked for help from all research scientists to help educate and inform the public regarding the need for animal experimentation and to help enforce and improve on NIH guidelines for the appropriate care and use of laboratory animals.
EPIDEMIOLOGY PROGRAM PLANNING ACTIVITIES
Dr. McNicol introduced Mr. Michael Davis, Director, Office of Program Planning and Analysis, NEI. He outlined the future steps for developing a strategic plan for Ocular Epidemiology research. Overall, the process will be similar to that used for the current strategic plan:
- expert panel will receive input on content from the vision research community
- panel will prepare draft report focusing on accomplishments, needs & opportunities, recommendations
- review by the community and by the Council
- final report published on the NEI website
Mr. Davis indicated that the selection and invitation of panel experts is underway, and he anticipates that community input regarding priorities, needs, and opportunities will be solicited in time for a panel meeting in March/April. A draft report will be ready for Council review at the June, 2007 meeting with final editing and publication by August, 2007.
GENERAL COUNCIL DISCUSSION
Council members expressed their dismay over recent acts of violence against vision scientists using animals in research. They hoped that the NEI and NIH could find ways to protect investigators, now that the Animal Enterprise Terrorism Act has been passed into law.
GLAUCOMA AND OPTIC NEUROPATHIES 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 Nicholas A. Delamere, Ph.D. Dr. Delamere completed his graduate studies in physiology at the University of East Anglia, England, in 1976, and began postdoctoral studies in ocular physiology at the University of Colorado Department of Ophthalmology. He rose to the rank of Associate Professor before joining the University of Louisville in 1986. There, he helped shape the Kentucky Lions Eye research Institute into a group that grew to become one of the most productive research centers in the university. He was promoted to full Professor and became a Distinguished University Scholar. In 2006 he moved to become Head of the Department of Physiology at the University of Arizona.
INS AND OUTS OF GLAUCOMA
Dr. Delamere gave an overview of the incidence and economic burden of glaucoma and described the problematic relationship between increased intraocular pressure and the pathogenesis/diagnosis/treatment of glaucoma. It appears that “glaucoma” is a group of individual diseases in which damage to the optic nerve can result in vision loss and blindness. Clearly, in some individuals, increased intraocular pressure (IOP) can result in optic nerve degeneration. But normotensive patients may have glaucoma, and not all ocular hypertensives develop the disease. Nevertheless, the NEI-sponsored Advanced Glaucoma Intervention Study demonstrated that patients with advanced glaucoma have a decreased rate of neurodegeneration if their IOP is lowered sufficiently. So until a clinically relevant “neuroprotectant” is devised, IOP remains the sole modifiable risk factor for the development and progression of glaucomatous optic neuropathy.
Dr. Delamere next discussed the present research environment for glaucoma research. Given the state of our knowledge, one major goal is to develop techniques to improve early diagnosis. These center on work to understand IOP, improve imaging of the optic nerve, improve ocular electrophysiology, identify blood-borne markers of IOP, and analyze genetic factors associated with the disease. Genetic studies have been met with several recent successes. Four genetic loci have been associated with various glaucoma syndromes, and further work may help develop strategies for risk assessment as well as early diagnosis.
Another goal pursued by glaucoma researchers is understanding the causes of retinal ganglion cell degeneration, with the hope of applying this knowledge to the development of neuroprotectives agents. One particularly promising area of research has identified nitric oxide as substance which damages the optic nerve in glaucoma. In certain animal models, inhibition of nitric oxide synthetase by aminoguaunidine prevents the loss of retinal ganglion cells due to elevated IOP.
A third goal is research to better understand the formation of aqueous humor and the pathways by which it exits the ciliary processes. This work has led some to speculate that glaucomatous changes in the outflow pathway may represent an accelerated aging process.
Dr. Delamere closed by reviewing the many hurdles in the field: aging-related diseases are complex; glaucoma patients take several different drugs; laboratory animals have a different optic nerve structure; drug delivery to the optic nerve is difficult; and no single model system can address all the needs. He speculated that progress will most likely require an integrated, whole eye approach—one that examines messaging between the ciliary body and the aqueous humor outflow pathways and messaging between the ciliary body and retinal ganglion cells.
PORTFOLIO OVERVIEW
Dr. McNicol indicated that members had been sent a package of summary materials regarding grants in the Glaucoma and Optic Neuropathies Program. This included a snapshot of grants funded in FY2006, 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. Ellen S. Liberman, Director, Glaucoma and Optic Neuropathies Program. Dr. Liberman reviewed the diseases and conditions subsumed by the Program and presented data on the burden of disease. Overall, in the US 1.9% of the population has glaucoma and 120,000 individuals are blind. Prevalence of the disease is over two-fold early in certain minority populations such as African-Americans and Latinos. She gave a snapshot of the NEI investment in the Program for FY2006: it accounts for 10% of the NEI research project grants, both in numbers and in dollars.
Recent scientific highlights of the Program include results from three Phase III treatment trials: the Collaborative Initial Glaucoma Treatment Study, Early Manifest Glaucoma Trial, and the Ocular Hypertension Treatment Study. These have demonstrated that early treatment delays, and in some cases prevents, vision loss. Diagnostic trials such as the African Descent and Glaucoma Evaluation Study and the Quantitative Analysis of Optic Disc/Ocular Hypertension study have developed new ocular coherence tomography approaches to optic nerve imaging.
COUNCIL DISCUSSION
Council members expressed their enthusiasm for the scientific presentations and for Dr. Liberman’s stewardship of the program. They discussed the scientific opportunities, particularly intriguing studies that suggest some role for autoimmune factors in the pathogenesis of the disease.
ADJOURNMENT
Dr. Sieving adjourned the meeting at 5:00 p.m.
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
Attachment A
NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE
ROSTER
(Terms end 11/30 of the designated year)
|
Eileen E. Birch, Ph.D. (07) Mae O. Gordon, Ph.D. (10) Gunilla Haegerstrom-Portnoy,OD, Ph.D. Barrett G. Haik, M.D. (07) Douglas H. Johnson, M.D. (10) Lenworth N. Johnson, M.D. (08) Juan I. Korenbrot, Ph.D. (09) |
Todd P. Margolis, M.D., Ph.D.(08) Mary C. McGahan, Ph.D. (10) Earl L. Smith, III, O.D., Ph.D.(08) Val C. Sheffield, M.D., Ph.D. (10) Mriganka Sur, Ph.D. (07) |
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
