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Home » About NEI » The National Advisory Eye Council (NAEC), Minutes June 13, 2013

NAEC Meeting Minutes

National Institutes of Health
National Eye Institute
National Advisory Eye Council
One Hundred Thirty-fourth Meeting
June 13, 2013

The National Advisory Eye Council (NAEC) convened for its one hundred and thirty-fourth meeting at 8:30 am on Thursday, June 13, 2013, at the Natcher Conference Center, 9000 Rockville Pike, Bethesda, Maryland, 20892. Paul A. Sieving, M.D., Ph.D., the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 12:35 p.m. The meeting was closed to the public from 2:00 p.m. until adjournment at 5:00 p.m. for the review of grant and cooperative agreement applications and a review of a Report of the Board of Scientific Counselors. Attachment A provides a roster of Council Members.

COUNCIL MEMBERS PRESENT:
Dr. Hollis Cline
Dr. David Copenhagen
Dr. Laura Frishman
Dr. Bernard Godley
Dr. Jonathan Haines
Dr. John Morrison
Dr. Eric Pierce
Dr. Krishna Sharma
Dr. Jayne Weiss
Dr. Sheila West
Dr. Rafael Yuste
Dr. Marco Zarbin

COUNCIL MEMBER ABSENT:
Ms. Kathleen Petrillo

NEI STAFF PRESENT:
Dr. Houmam Araj
Dr. Neeraj Agarwal
Ms. Pamela Bobbitt
Ms. Sylvia Braxton
Dr. Deborah Carper
Ms. Janet L. Craigie
Mr. William Darby
Ms. Linda Dingle
Mr. Donald Everett
Dr. Frederick Ferris
Dr. Richard Fisher
Dr. Shefa Gordon
Dr. Thomas Greenwell
Mr. Dustin Hays
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Ms. Jean Horrigan
Mr. Kevin Keating
Ms. Marilyn Laurie
Dr. Ellen Liberman
Dr. Andrew Mariani
Dr. George McKie
Dr. Matthew McMahon
Dr. Loré Anne McNicol
Dr. Sheldon Miller
Ms. Kathleen Moy
Dr. Robert Nussenblatt
Dr. Lisa Neuhold
Mr. William O'Donnell
Dr. Steven Oversby
Dr. Gyan Prakash
Dr. Maryann Redford
Ms. Karen Robinson-Smith
Dr. John Paul SanGiovanni
Dr. Gale Saunders
Dr. Anne Schaffner
Dr. Eleanor Schron
Dr. Grace Shen
Dr. Paul Sieving
Dr. Michael Steinmetz
Dr. Daniel Stimson
Dr. Santa Tumminia
Ms. Jenny Wenger
Mr. David Whitmer
Dr. Cheri Wiggs
Dr. Louise Wideroff
Ms. Keturah Williams
Dr. Jerome Wujek

OTHER NIH STAFF PRESENT:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Rene Etcheberrigaray, CSR
Dr. Nataliya Gordiyenko, CSR
Dr. Paek Lee, CSR
Dr. Kirk Thompson, CSR
Dr. Maqsood Wani, CSR

MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Ms. Erica Froyd, Lewis Burke Associates
Dr. Israel Goldberg, Health Research Associates
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Dr. Michael Oberdorfer, American Optometric Association (AOA)
Mr. Rodney Peele, AOA
Ms. Kelli White, AOA

OPEN SESSION OF THE MEETING
08:30 am

DIRECTOR'S REPORT AND OPENING REMARKS
Dr. Paul Sieving, Director of the National Eye Institute (NEI) and Chairman, National Advisory Eye Council (NAEC), welcomed all attending the meeting and he specifically welcomed three newly-appointed Council Members, Dr. Laura J. Frishman, Professor, College of Optometry, University of Houston, Dr. Jayne Weiss, Professor and Chairman, Department of Ophthalmology, Louisiana State University, and Dr. Rafael Yuste, Professor, Department of Biological Sciences, Columbia University.

Dr. Sieving announced the forthcoming retirement of Dr. Deborah Carper, NEI Deputy Director after nearly 40 years of government service. Dr. Sieving thanked her for her dedicated work. He noted that a search committee has been formed to identify candidates for the post of Deputy Director and the committee includes Council member, Dr. Marco Zarbin.

Dr. Sieving thanked Dr. Sarah Sohraby for seven years of service of as Deputy Scientific Director and Acting Chief of the Ophthalmic Genetics and Visual Function Branch. Dr. Sohraby will be returning to Brussels, Belgium.

Dr. John Hooks, Chief of the Immunology and Virology Section, has retired and Dr. Louise Wideroff has joined the Division of Extramural Research as a Program Director for Collaborative Clinical Research.

Recipients of the NIH Director's award, Drs. Neeraj Agarwal, Rachel Bishop, Emily Chew, Hemin Chin, Robert Nussenblatt, Sarah Sohraby, Anand Swaroop, and Cheri Wiggs, were acknowledged.

Of general interest, Dr. Sieving noted that May was Healthy Vision Month, an event sponsored by the NEI. CVS drug stores, LA Fitness, and others displayed the Healthy Vision Month logo. Dr. Rachael Bishop is now head of the Clinical Consult Service in the Intramural Program. The Board of Scientific Counselors met from Sunday to Wednesday (June 9-12).

An important meeting will be held on June 24th sponsored by NEI in collaboration with a new NIH Center for Regenerative Medicine. The FDA gave clearance to proceed with a clinical trial for an investigational new drug (IND). NIH Director Dr. Francis Collins, has put $50 Million into stem cell research in the intramural research program and Dr. Sheldon Miller, Scientific Director of the NEI program has been very successful in competing for these funds. The 7th Sayer Research Vision Lecture will be by Dr. Wei Li. Dr. Li, an NEI intramural scientist, is recipient of the first "Young Intramural Investigator" award. A renewed interest in the brain has turned into the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) initiative. New Council Member, Dr. Rafael Yuste was a part of the group involved with initiating the Brain Activity Map (BAM) Project that has led to the BRAIN Initiative. AREDS II is completed and the results were announced at ARVO last month.

Dr. Copenhagen asked, "What is the NEI's role in the BRAIN Initiative?" Dr. Sieving replied that no institute has a specific role. A BRAIN Working Group of the NIH Advisory Committee to the Director has been charged with developing a rigorous plan for achieving the scientific mission of BRAIN. He stated that for the record, the NEI launched the Audacious Goals over a year before the Brain Initiative and it will be interesting to see what initiatives overlap. Dr. Yuste noted that the vision research community is well represented on the BRAIN Working Group.

CONSIDERATION OF JANUARY 2013 MINUTES
Dr. Loré Anne McNicol, Executive Secretary of the Council, requested approval of the minutes of the January 2013 Council Meeting. A motion for approval was made and the minutes were accepted.

BUDGET UPDATE
Ms. Marilyn Laurie, Chief, Financial Management Branch, presented an overview and update on the NEI Fiscal Year (FY) 2013 budget. She began by reviewing the appropriation history and grant funding success rates for the past 5 years.

The FY 2013 Budget narrative began on Feb 13, 2012 with the FY 2013 President's Budget (PB). On October 1, 2012 a six month Continuing Resolution (C.R.) through March 27, 2013 was enacted. The Sequestration law was postponed on January 2, 2013, but enacted on March 1, 2013. On March 26, 2013 a full-year Omnibus Bill was enacted for Labor-HHS for FY 2013. The FY 2014 President's Budget was released with FY 2013 levels that included a 0.6% funding increase on April 10, 2013 and the approved post sequestration operating budget was implemented on May 7, 2013.

The FY 2013 Post-sequestration Operating Budget is $662M amounting to a 5.7% or $40M reduction from the FY 2012 level. NEI shared reduction across all programs with Extramural Research at -6%, Research and Development Contracts at -5%, the Intramural Research Program at -4%, and Research Management and Support at -5%. FY 2013 funding distribution is Extramural at $569M, Intramural Research at $79M, and Research Management and Support at $23M.

Ms. Laurie reviewed the FY 2013 Operating Plan including the post-sequestration operating policy that would keep the average of RPG awards to FY2012 levels; issue non-competing awards at 95% of the previously committed level; eliminate annual out-year inflationary increases; and implement the President's Executive Order directives for conferences, travel, printing, employee IT, and supplies.

The impact would be for NEI to fund approximately 1068 new and non-competing Research project Grants (RPGs), a decrease of 28 awards compared to FY 2012; and maintain relatively the same numbers of Small Business, Center Core Grant, Career Development, Training, Translational, and Cooperative Clinical research awards. Thus there will be a slight decrease in the RPG success rate from 30% in FY 2012 to 26% in FY 2013.

For FY 2014, the House Budget Resolutions moved all sequestration cuts to discretionary programs; the Senate Budget Resolutions does not include sequestration cuts. Therefore the DHHS distribution and final NEI budget level are uncertain. The next fiscal year is likely to begin under a C.R.

Dr. Sieving thanked Ms. Laurie, Dr. McNicol, and Mr. Whitmer for managing in these difficult fiscal times and described how the balance was reached between cuts in the number of grants and percentage cut.

Council had questions on how the R21s figure into the success rate, and the decision process for determining percentage cuts.

UVEITIS CONSORTIUM UPDATE
Dr. Robert Nussenblatt, Chief, Laboratory of Immunology, NEI, described the US-UK Collaborative Research-UNITE Program, The Human Ocular Immunology Consortium that emphasizes human disease and the normal state, and establishes a new paradigm for studying ocular disease. UNITE wishes to globalize their endeavor to use global expertise to help patients worldwide. The aim is to unite clinics and laboratories to investigate ocular inflammatory disease such as uveitis, Age-related Macular Degeneration (AMD), diabetes, and genetically-driven immune diseases.

The Human Ocular Immunology Consortium will emphasize understanding immune alterations and how to apply these observations to therapy. He reviewed uveitis incidence and prevalence, and the relationship of genetic and environmental factors to the immune system and AMD. He spoke about the involvement at the NIH and also worldwide through the NIH Center for Human Immunology and the Federation of Clinical Immunology Societies.

UNITE achievements on the personnel level and in clinical trials was emphasized. Dr. Nussenblatt summarized by stating that UNITE is not a collaboration in the standard use of the term. We wish to globalize our endeavor in order to use global expertise and also to investigate (and help) patients worldwide. The aim is to literally "unite" the clinics and laboratories to investigate ocular inflammatory disease in the broadest sense of the word, to include uveitis, AMD, diabetes, genetically driven immune diseases, etc. The template still is developing and growing and it may be a useful template in other areas of ocular research.

Council raised questions about the nature of and utility of "immune platforms" that Dr. Nussenblatt elaborated on.

NEW PEER REVIEW SCORING SYSTEM
Dr. Anne Schaffner, Chief, Scientific Review Branch, NEI, reviewed the new NIH scoring guidance and score recalibration that was recently implemented. The reasons for revisiting the scoring of applications by the Center for Scientific Review (CSR) were score compression in the one-to-three range and the perceived difficulty identifying truly meritorious applications as percentiles rise in that range, too many tied scores which complicates funding decisions, concern that score compression negatively affects R01s reviewed in CSR Special Emphasis Panels (SEP), concern that the entire available scoring range is not being used, and concern that priority scores were based on lack of weaknesses (usually in the Approach) and not on overall impact of project.

Interventions implemented by CSR for May 2013 Council meetings were to provide educational material for SROs and reviewers that describe the problem (compression) and its consequences; education on percentiling; emphasis on five as a score which should apply to good, medium-impact applications; and the importance of the significance criterion score in relation to the overall impact score. Also, new scoring charts for Overall Impact of research applications, Individual Fellowships and Career awards, and Institutional Training applications were introduced along with a "new" set of descriptors for criterion scores.

Anecdotal results to date seem to indicate that the quality of discussion has changed to more strength-based, with greater focus on overall impact. Although actual recalibration is done infrequently, the active attempt to use the entire scale is ongoing. Any major shifts in a standing study section's scoring patterns will be assessed post-meeting prior to releasing scores.

In response to a question from Council, it was stated that there is an ongoing effort to recalibrate but there has not been a big shift.

CONCEPT CLEARANCE: INTERNATIONAL ADVISORY COMMITTEE
Dr. John Prakash, Associate Director, International Programs, NEI, presented a Proposal of a Meeting of International Consultants to develop NEI International Program Goals. The purpose of the meeting is assessing the elements to develop the NEI program agenda for the next ten years to include areas of basic, translational and clinical research where international collaborations offer unique advantages and opportunities, and to mobilize unique resources on the international scene (patients, disease pockets for study, unique diseases, genetic resources) that would accelerate some elements of vision research.

The proposed agenda of the meeting is to develop an international research agenda for the NEI to include the following elements: How the NEI research goals could be harmonized with the NIH-wide international collaboration and translational research goals; NEI's responsibilities towards fostering relationships with the international research community, non-government organizations (NGOs), WHO and foreign governments and professional societies; roles in fostering international collaborations and cooperation; areas of basic, translational and clinical vision research where international collaborations offer unique advantages and opportunities; and what resources will be needed to meet the stated goals in the next ten years.

Proposed participants to be invited for the event/meeting are the following experts (or professionals of similar caliber) in the area of vision research and international programs; Sheila West (USA), Al Sommer (USA), Hugh Taylor (Australia), Tom Lietman (USA), Pawan Sinha (USA), Bruce Spivey (USA), Serge Resnikoff (Switzerland), G. Nag Rao (India), and Tien Wong (Singapore).

The meeting would be held for one day in September 2013 on the NIH Campus. The expected outcome of the meeting is that the international consultants will use their knowledge to make assessments of the areas of basic, translational and clinical vision research where international collaborations offer unique advantages and opportunities. The team will identify the areas of major need in addressing international vision disease for which NEI can provide leadership, and develop an international research agenda for the NEI to include the following elements: NEI's responsibilities towards fostering relationships with the international research community, Non-Government Organizations (NGOs), the World Health Organization, foreign governments, professional societies and towards fostering international collaborations and cooperation. The team will also identify the resources that will be needed for meeting the NEI's international goals in the next ten years, and will help determine how NIH-wide international collaborations could support the NEI's research goals, and the NEI role in international training. The meeting will generate a strategic document that will be posted on the NEI website for future guidance and be utilized in development of operational agenda for the NEI international programs.

Council noted that Latin America and Africa were not included and stated that we need to have someone there who is on that panel from Latin America or Africa even if it is more challenging because it's important to say they were represented. Dr. Prakash replied that he was open to this suggestion to strike a better balance on representation as the idea moved forward. Council inquired about the types of training envisioned and had suggestions on how to implement the training to enhance international collaborations.

A motion was raised and seconded to consider the concept of the meeting of the international advisory committee and all were in favor.

UPDATE ON THE AUDACIOUS GOALS INITIATIVE
Dr. Paul Sieving reviewed the outcome of the Audacious Goals Development Meeting that was held February 24 through February 26, 2013 and presented a video that captured highlights from the meeting. Given the remarkable, new tools of biology developed during the last decade, there is now an opportunity to leverage our collective action to accomplish something big and remarkable over the next 10-15 years. He announced that there was one Audacious Goal, and two High Priority Research Areas.

The Audacious Goal is to "Regenerate Neurons and Neural Connections in the Eye and Visual System." Establishing functional neural connections would be a pinnacle achievement for regenerative medicine in the eye. It would be a paradigm shift to create a new understanding of plasticity and regeneration. It addresses the pathogenesis of many ocular and vision diseases and it provides a model for regenerative therapies beyond vision, for treating CNS disease and spinal cord injury.

The "New Enabling Biology" for this Goal builds on the biological discoveries, advances and tools of the last decade such as stem cell biology (ESC, iPSC), cell and systems biology and pathophysiology of disease, neurotrophic factors, glial biology, neural plasticity, comprehensive signaling pathways, and production of 3-D organized neural retina tissue in culture. There are also enabling technologies such as optogenetics, multiphoton microscopy, single cell functional imaging, multi-unit electrophysiology techniques, and nanotechnology.

The ocular disease implications of this Goal are for neurodegenerative diseases such as glaucoma, AMD, and others, in order to regrow and reconnect functional axons in the optic nerve targeted to specific location in the brain, to regenerate photoreceptors with functional integration with RPE and connectivity to bipolar cells and for corneal neuropathy to regrow and reconnect corneal nerves after LASIK, wounding, or ocular surface disease. There are also implications for neural plasticity in order to develop and translate the basic science of plasticity into effective treatments for strabismus, amblyopia, and other disorders involving central visual processes.

What will we need to know to accomplish this Goal? What trophic factors will stimulate and guide axons to specific targets in the brain? How do synapses form in an adult? What steps are required for exogenous repair? Can we activate latent endogenous cells to replace lost host neurons? How do we control immune responses and ensure safety and efficacy? How do we monitor in vivo for functional success?

Dr. Sieving then noted that the two Audacious Goals High Priority Research Areas are "Molecular Therapy for Eye Disease" and the "Intersection of Aging & Biological Mechanisms of Eye Disease":

Implementation of the Audacious Goals Initiative will start this summer with the convening of expert workshops to define the needs and approaches to move the projects forward. The charge will be to build on the new biology, to identify and prioritize the first steps to set direction, to anticipate challenges and potential roadblocks and to consider measures of successful outcomes. The guiding principles for implementation are to support the science trajectory, evaluate progress toward goals yearly, and make course adjustments as the science evolves. An independent Scientific Leadership Committee (SLC) with rotating membership using the broad community base will be formed and the processes will be open throughout. There will be close participation with NAEC, and the process will involve the vision community as a whole and remain flexible as the science changes.

The initial AG Development Group of 7-11 members, an NAEC sub-group including a few from the research community, will report to NAEC on AG target identification, development and refinement. This group, at a one-time meeting, will identify needs, challenges/barriers, identify first steps, and recommend the configuration, the agenda and the experts for an AG Initiation Workshop in the fall of 2013.

An ongoing AG Science Leadership Oversight Group would be an NAEC Working Group (WG) of 5-7 members of the research community. The WG will report to the NAEC, meet several times a year, be staffed through NEI with a mission to monitor overall progress and to provide continuing guidance, re-examine milestones, barriers and outcome measures; and have a rotating membership as needed to address evolving AG needs.

The first steps for maintaining momentum are to publish an NIH Guide Notice announcing Audacious Goals Initiative outcomes; establish an NEI Website as the central site for all matters related to Audacious Goals Initiative to include the ARVO location webcast, initiative development, advances related to the Goal and 2 High Priority Areas; and the NEI Director's column in ARVO newsletter. Another first step is to have an analysis of current NEI/NIH portfolio to identify baseline for implementation and document global progress toward our goal.

Council had questions and suggestions with regard to the AGs concerning communications, membership for the workgroups, focusing of the AGs, and leadership. These topics were discussed with Drs. Sieving, McNicol, and Fisher. Council members additionally discussed leveraging resources, accountability, alignment with the BRAIN Initiative, and the role of the NEI Intramural Program.

GENERAL COUNCIL DISCUSSION
Dr. Pierce again raised the issue of informatics and data and the value of large scale genomic data. Dr. McNicol responded by pointing out the NIH Big Data to Knowledge (BD2K) initiative which is designed to enable biomedical scientists to capitalize more fully on the Big Data being generated by the research community. She indicated that the NEI would be taking part in this initiative. Dr. Haines noted that big data goes beyond just genomic data; there are large clinical data bases emerging. Dr. Sieving wanted to further explore the extent, nature, the costs, and approaches to informatics and big data.

Dr. West noted that the earlier discussion of the budget problems created by multiple continuing resolutions and the effects on funding of grants was sobering. However the decision to keep clinical trials on hold has lead the clinical trials research community to conclude that money for trials was being shifted into other grant mechanisms and that this was an unusual and undesirable way to do business.

Dr. McNicol replied that the pool of funds for clinical trials was limited. Additional applications pending review later in the fiscal year could have higher scientific and technical merit than applications reviewed in earlier rounds. Therefore, NEI has felt it desirable to avoid spending too large a proportion of the available funds in the early rounds. Dr. West said that it was unconscionable to hold trials since this could result in the trial being nine months or more into operation before funding is received. Dr. Copenhagen indicated that a similar problem occurred when basic science applications are placed in a hold status and then funded later in the fiscal year; this policy is very damaging to laboratories.

Council, Dr. Sieving and Dr. McNicol discussed various solutions to the dilemma including once a year submission for clinical trials but no consensus on this approach was achieved. NEI will alter its operating culture and stop the policy of placing applications in a "hold" status.

CLOSED SESSION OF THE MEETING - 2:00 pm
The meeting was closed to the public at 2:00 p.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 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

REVIEW OF THE REPORT OF THE BOARD OF SCIENTIFIC COUNSELORS: DIVISION OF EPIDEMIOLOGY AND CLINICAL APPLICATIONS

ADJOURNMENT
The meeting was adjourned at 5:00 pm


CERTIFICATION
These minutes were submitted for the approval of the Council; all corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
National Eye Institute

Paul A. Sieving, M.D., Ph.D.
Chairman, National Advisory Eye Council
Director, National Eye Institute

ATTACHMENT A: NATIONAL ADVISORY EYE COUNCIL MEMBERS

Hollis T. Cline, Ph.D.
Professor
Departments of Molecular and Cellular Neuroscience and Chemical Physiology
The Scripps Research Institute
La Jolla, CA

David R. Copenhagen, Ph.D.
Professor
Departments of Ophthalmology and Physiology
University of California, San Francisco
School of Medicine
San Francisco, CA

Bernard F. Godley, M.D., Ph.D.
Professor and Chair
Department of Ophthalmology and Visual Sciences
University of Texas Medical Branch
Galveston, TX

Jonathan L. Haines, Ph.D.
Professor
Department of Molecular Physiology and Biophysics
Center for Human Genetics Research
Vanderbilt University School of Medicine
Nashville, TN

John C. Morrison, M.D.
Professor
Department of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
Portland, OR

Kathleen M. Petrillo, J.D.
Partner
Senniger Powers, LLP
St. Louis, MO

Eric A. Pierce, Ph.D, M.D.
Director
Ocular Genomics Institute
Massachusetts Eye and Ear Infirmary
Harvard Medical School
Boston, MA

Krishna K. Sharma, Ph.D.
Professor
Departments of Ophthalmology and Biochemistry
Mason Eye Institute
Unviersity of Missouri-Columbia
Columbia, MO

Jayne S. Weiss, M.D.
Chairman and Professor
Department of Ophthalmology
Louisiana State University
School of Medicine
New Orleans, LA

Sheila K. West, Ph.D.
Professor
Department of Ophthalmology
Wilmer Eye Institute
Johns Hopkins University
Baltimore, MD

Rafael Yuste, M.D., Ph.D.
Professor
Departments of Biological Sciences and Neuroscience
Columbia University
New York, NY

Ex Officio
Marco A. Zarbin, M.D., Ph.D.
Professor and Chair
Institute of Ophthalmology and Visual Science
UNDNJ-New Jersey Medical School
Newark, NJ

Last Updated: February 2014

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