DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute
NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting
October 21, 2010
The National Advisory Eye Council (NAEC) convened for its one hundred twenty-sixth meeting at 8:30 am on Thursday, October 21, 2010, at The Melrose Hotel, 2430 Pennsylvania Avenue, NW, Washington, D.C. 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 October 21, 2010 from 1:15 pm until 2:30 pm, the meeting was open to the public. Attachment A provides a roster of Council members.
COUNCIL MEMBERS PRESENT:
Dr. Joseph Bonanno
Dr. James Chodosh
Dr. Scott W. Cousins
Dr. Donald A. Gagliano
Dr. Charles D. Gilbert
Dr. Bernard Godley
Dr. Mae O. Gordon
Ms. Alberta Orr
Dr. Val C. Sheffield
Dr. Richard Stone
Dr. Marco A. Zarbin
AD HOC COUNCIL MEMBER PRESENT:
Dr. Lawrence Friedman
COUNCIL MEMBERS ABSENT:
Dr. David Copenhagen
Mr. Ronald Gardner
Dr. Mary C. McGahan
NEI STAFF PRESENT:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin Chin
Ms. Janet Craigie
Ms. Linda Dingle
Dr. Richard Fisher
Ms. Jerusha Gittlen
Dr. Shefa Gordon
Dr. Tom Greenwell
Mr. Tom Hoglund
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Andrew Mariani
Dr. Loré Anne McNicol
Dr. Jennifer Mehren
Dr. Lisa Ann Neuhold
Dr. Samuel Rawlings
Dr. Maryann Redford
Dr. Merlyn Rodrigues
Dr. Annie Schaffner
Dr. Eleanor Schron
Dr. Grace Shen
Dr. Paul Sieving
Dr. Michael Steinmetz
Dr. Mark Stevens
Dr. Santa Tumminia
Mr. David Whitmer
Dr. Cheri Wiggs
Dr. Jerome Wujek
OTHER NIH STAFF PRESENT:
Ms. Jocelyn E. Baccus, Office of Logistics and Acquisition Operations, NIH Director’s Office (OD)
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Keith Crutcher, CSR
Dr. Mary Frances Deutsch, Office Extramural Research, OD
Dr. Rene Etcheberrigaray, CSR
Dr. George McKie, CSR
Dr. Joseph Rudolph, 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
Ms. Erica Froyd, Lewis-Burke Associates LLC
Ms. Rebecca Hyder, American Academy of Ophthalmology
Dr. Elaine Richman, Richman Associates
Dr. Stephen Rose, Foundation Fighting Blindness
Thursday, October 21, 2010
CLOSED PORTION OF THE MEETING- 8:30 am
The meeting was closed to the public at 8:30 a.m. in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix2).
CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST
Dr. 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
OPEN PORTION OF THE MEETING - 1:15 pm
DIRECTOR’S REPORT AND OPENING REMARKS
Dr. Paul Sieving welcomed the Council Members, NEI and NIH Staff, and members of the general public attending the meeting. He announced the end of the terms of appointment for Drs. Mae Gordon, M. Chris McGahan, Val Sheffield and Richard Stone on November 30, 2010 and thanked them for their service to the Council and to the National Eye Institute. They were presented with Certificates of Appreciation signed by the Secretary, Department of Health and Human Services.
Dr. Sieving reported that Dr. Joseph Bonanno, a member of the Council since January 2009, was very recently named Dean of the Indiana University School of Optometry. Dr. Sieving congratulated Dr. Bonanno on the appointment and noted that he will succeed Dr. Sarita Soni, who has been serving as interim Dean, and who is a former member of the Council.
Dr. Sieving welcomed Dr. Lawrence Friedman to Council as an Ad Hoc member for this meeting. Dr. Friedman received his medical degree from the University of Pittsburgh. From 1972 to 2005, he was at the National Heart, Lung, and Blood Institute. During that time, he served as Chief of the Clinical Trials Branch, Director of the Division of Epidemiology and Clinical Applications, Associate Director for Ethics and Clinical Research, and Acting Deputy Director. Dr. Friedman has been involved in, overseen, consulted on, and been a reviewer for many clinical trials. He has written numerous articles, co-authored books, and taught courses on clinical trials. Dr. Friedman is currently an Independent Consultant to several NIH institutes and other organizations, and has served on the National Advisory Council on Aging.
Dr. Sieving announced the appointment of Dr. Cheri Wiggs as a Program Director for the Perception and Psychophysics portfolio and the Low Vision and Blindness Rehabilitation portfolio. She completed a Master’s degree and Ph.D. in Cognitive Psychology at Georgetown University examining the influence of age on different memory systems. Dr. Wiggs worked at the NIMH as a Senior Staff Fellow in the Laboratory of Brain and Cognition, pursuing basic behavioral, neuroimaging, and clinical research while also serving as adjunct faculty at George Washington, Marymount, and Catholic Universities. In 1998, Dr. Wiggs moved to NIH’s Center for Scientific Review (CSR) where she was involved in the reorganization of behavioral science study sections, eventually becoming the Scientific Review Officer for the Cognition and Perception Study Section.
Dr. Sieving then introduced Dr. Neil Bressler, The James P. Gills Professor of Ophthalmology and Chief of the Retina Division in the Department of Ophthalmology, Johns Hopkins University School of Medicine. Dr. Bressler is currently the Chair of the Diabetic Retinopathy Clinical Research Network (DRCRN) and Principal Investigator of the Network’s operation center.
DIABETIC RETINOPATHY CLINICAL RESEARCH NETWORK PROTOCOL I
Dr. Neil Bressler reviewed the DRCRN, a collaborative network to facilitate multicenter clinical research on diabetic retinopathy, diabetic macular edema and associated conditions. Funding is from a Cooperative Clinical Research Agreement (U10 Award) with the National Eye Institute, now in its second 5-year cycle: 2009 to 2013, from the NIDDK through Type 1 Diabetes Research funding, Foundations such as the Juvenile Diabetes Research Foundation (JDRF), and there are industry collaborations.
He presented data on the Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema. The study rationale was to determine if anti-VEGF therapy alone or in combination with laser, or if triamcinolone in combination with laser, might result in improved outcomes compared with laser alone for treatment of DME, the DRCR.net designed a clinical trial to evaluate 3 treatment modalities for DME in comparison with focal/grid laser
Intravitreal ranibizumab with prompt or deferred (=24 weeks) focal/grid laser had superior VA (visual acuity) and OCT (ocular coherence tomography) outcomes compared with focal/grid laser treatment alone. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial.
CONCEPT CLEARANCE: BIOMEDICAL INFORMATICS RESEARCH CONTRACT
Dr. Hemin Chin, Associate Director for Ophthalmic Genetics, talked about the usefulness of biomedical informatics infrastructure as an integrated bioinformatics research resource for multi-disciplinary, large-scale collaborative vision research, and as a portal into a shared unique research resource extending and complementing existing National Center for Biotechnology Information (NCBI) resources and NEI genetics/genomics initiatives.
The purpose of the Contract would be to establish a bioinformatics resource for widely sharing diverse sets of biological data and research tools for vision research. The scope of the Contract would be to create a data-sharing infrastructure optimized for the work flows associated with vision research, develop databases and populate them with relevant sharable data sets, receive, archive, store, and distribute data sets of various forms and modalities, which exist in the vision research community, and maintain core computational/bioinformatics facilities.
Specifics of the Contract are to issue a solicitation, a Request for Proposal (RFP) in 2011 for a 5-year research and development (R&D) contract, and to issue the Contract in September 2011. The significance of the Contract is to support diverse needs and activities by enabling collaborative vision research and it would represent research resources critical for accomplishing the missions of NEI. Council concurred with the concept.
REPORT OF OCULAR PAIN WORKSHOP
Dr. Jennifer Mehren of the Office of Program Planning and Analysis (OPPA), presented a summary of the Workshop on Ocular Pain and Sensitivity, held September 30-October 1, 2010, at the Airlie Conference Center in Warrenton, Virginia. The NAEC approved the concept for the workshop in January 2010. The purpose of the workshop was to identify gaps and opportunities in ocular pain and sensitivity research.
The NEI staff attending included the Director and Deputy Director, and staff from the Division of Extramural Research and the Office of Program Planning and Analysis. A multidisciplinary group of 18 invited participants from outside of NEI participated and included expertise in ocular surface or ocular pain (e.g., dry eye; corneal wound healing; photophobia) and pain and sensitivity in non-ocular tissues (e.g., itch; migraine; burning mouth). Drs. Todd Margolis (University of California, San Francisco) and Carlos Belmonte (Universidad Miguel Hernandez, Instituto de Neurosciencias, Alicante, Spain) co-chaired the meeting.
The agenda for the workshop included clinical issues and characteristics of ocular pain and sensitivity, classification of pain, neural basis of ocular pain (peripheral and central mechanisms), pharmacology, treatment, and management of ocular pain, and a concluding discussion during which high priority gaps and opportunities were identified. The workshop participants identified several important needs including a formal classification of ocular pain and sensitivity; molecular and cellular mechanisms of desensitization/hyperalgesia of the ocular surface; cortical representation of ocular sensation and pain; the roles that neurons play in the health, healing, scarring, and immunology of the cornea.
NEI PROGRAM PLANNING STATUS REPORT
Dr. Richard Fisher, Director of OPPA, reported on the current status of program planning. Each of the six program areas will be represented by co-chairs, whose names were announced, at a meeting on December 1, 2010 in Rockville, MD to help determine the structure of the plan. The full program planning panels will convene just prior to the annual Association for Research in Vision and Ophthalmology (ARVO) meeting at the end of April 2011 in Ft. Lauderdale, Fl. Dr. Fisher also announced that periodic workshops would be convened to supplement the planning process and that concepts for workshops would be presented to Council beginning in January 2011.
TRANS-NIH SUPPORT FOR VISION RESEARCH UNDER ARRA
Dr. Loré Anne McNicol, Director, Division of Extramural Research, presented an overview of the American Recovery and Reinvestment Act (ARRA) relative to the NIH and the “stimulus” funding for biomedical research. In addition to stimulating the nation’s economy and creating and/or retaining jobs, ARRA as implemented by the NIH had a goal of accelerating scientific progress.
NIH Extramural funding of $9.9 billion dollars was distributed as follows: Individual Institutes and Centers (ICs) received $7.3billion.; NEI received $168 million, the National Center for Research Resources received $1billion for construction, repairs, and alterations and $300 million for shared instrumentation and other capital equipment. The NIH Office of the Director received $930 million and $400 million for comparative effectiveness research (CER) from the Agency for Healthcare Research and Quality (AHRQ).
The NIH Director’s Common Fund ARRA programs for individual grants went to Challenge Grants. In the RC1 category, 6 of 200 awards were for vision research for a total of, $5.7 million. One application was the highest rated application at NIH out of over 20,000 applications submitted. Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3) made two awards, out of a total of ten, for vision research totaling $6 million. There were 850 applications.
For the NIH Director’s Opportunity for Research in Five Thematic Areas (RC4) Competition, 1 of 25 awards made out of 2070 applications was to an NEI grantee for $4.0 million. Administrative supplements for Summer Research Experiences Students/Science Educators went to 53 NEI grantees for $510,848. Academic Research Enhancement Award (AREA) grants made by the Common Fund under ARRA totaled 50 and 3 of these were for NEI grants for a total amount of $1.1 million. There were over 1100 applications submitted.
Small Business Catalyst Awards for Accelerating Innovative Research (R43) awarded $399,735 in 2 of 20 awards for vision research. One of these applications was the highest rated application at NIH out of 780 applications.
Recovery Act Funds for Competitive Revision Applications through the NIH Basic Behavioral and Social Science Opportunity Network (OppNet) of $217,500 went to an NEI grantee. This was one of twenty awards and it was the highest rated application received. NEI Grantees and vision research received $17.9M from the Director’s Common Fund under ARRA.
NEI LOAN REPAYMENT PROGRAM FOR FY2010
Dr. Neeraj Agarwal reported on the NIH Loan Repayment Program at NEI for fiscal year 2010. He noted that the NIH Loan Repayment Program (LRP) is intended to attract health professionals to careers in research. NIH Grant support not required. The program is for two years and up to $35,000 payback of qualified educational debt is allowed, plus tax payments at 39%. They are renewable, if eligibility criteria are met. The candidates must perform patient-oriented clinical research, devote a minimum of 50% effort for 2 years, be a United States citizen, U.S. national, or, permanent resident. The application is available online. The NIH will repay educational loans backed by the U.S. Government and Educational loans from accredited U.S. academic institutions and commercial lenders. The NIH will not repay home equity loans, loans consolidated with another individual (i.e. spouse, child), PLUS loans, delinquent loans, loans in default; or loans not current in repayment.
Dr. Agarwal presented data on the number of loans repaid by NIH for the fiscal year 2010. A total of 30 applications were funded for a 94% success rate. He reported that 54% of successful applicants for the LRP already had NIH Grant support, and that 13% were subsequently successful in achieving NIH Grant support. Thirty-three percent of successful LRP awardees have not applied for NIH Grant support.
GENERAL COUNCIL DISCUSSION
Council expressed concerns about recent enhancement to the peer review process, specifically the length of the application, the scoring system, and the summary statement format. The Council was surveyed on these issues at the January 2010 NAEC Meeting. The results of that survey will be presented to the Council at a future Council meeting presenting an opportunity for discussion of the issues.
Dr. Sieving adjourned the meeting at 2:30 pm
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
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
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Bethesda, MD 20892-9300
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