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NAEC Meeting Minutes

Department of Health and Human Services
National Institutes of Health
National Eye Institute

NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting

September 24, 2009

The National Advisory Eye Council (NAEC) convened for its one hundred twenty-third meeting at 8:30 am on Thursday, September 24, 2009 at The Natcher Conference Center, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 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 closed to the public from 8:30 am until 12:00 pm for the review of grant and cooperative agreement applications and the report of the Board of Scientific Counselors. On Thursday September 24, 2009 from 1:00 pm until 3:00 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
Mr. Ronald Gardner
Dr. Charles D. Gilbert
Dr. Mae O. Gordon
Dr. Mary C. McGahan
Ms. Alberta Orr
Dr. Gunilla Hagerstrom-Portnoy
Dr. Val C. Sheffield
Dr. Richard Stone
Dr. Marco A. Zarbin

AD HOC COUNCIL MEMBER PRESENT

Dr. David Copenhagen

COUNCIL MEMBER ABSENT:

Dr. Juan Korenbrot

NEI STAFF PRESENT

Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Janet L. Craigie
Dr. Mary Francis Cotch
Mr. William Darby
Mr. Donald Everett
Dr. Richard Fisher
Dr. Shefa Gordon
Ms. Denise Huttenlocker
Dr. Shara Kabak
Dr. Dan Kenshalo
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Andrew Mariani
Ms. Juanita Marner
Dr. Lorť Anne McNicol
Dr. Jenny Mehren
Dr. Lisa Ann Neuhold
Dr. Michael Oberdorfer
Dr. Maryann Redford
Dr. Merlyn Rodrigues
Dr. Annie E. Schaffner
Dr. Eleanor Schron
Dr. Grace L. Shen
Dr. Paul A. Sieving
Dr. Michael Steinmetz
Mr. Mark Stevens
Dr. Santa Tumminia
Mr. David Whitmer
Dr. J. R. Wujek

OTHER NIH STAFF PRESENT

Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Mary Frances Deutsch, Office of the NIH Director (OD)
Dr. George McKie, 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)
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Ms. Lori Methia, ARVO
Dr. Elaine Richman, Richman Associates
Dr. Dwight Stambolian, University of Pennsylvania

Thursday, September 21, 2009
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 wasconcerned 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

REVIEW OF BOARD OF SCIENTIFIC COUNSELORS REPORT, LABORATORY OF IMMUNOLOGY AND UNIT ON RETINAL VASCULAR NEUROBIOLOGY

OPEN PORTION OF THE MEETING

1:00 pm

DIRECTORíS REPORT AND OPENING REMARKS

Dr. Sieving welcomed the all attending to the One Hundred and Twenty-third Meeting of the National Advisory Eye Council. He thanked Drs. Juan Korenbrot and Gunilla Haegerstrom-Portnoy, whose terms of appointment to Council expire November 30, for their service on Council and to the NEI, and presented them with certificates of appreciation signed by the Secretary, Health and Human Services.

Dr. Sieving introduced the new book on the history of the NEI by Dr. Carl Kupfer, former Director, NEI. He commented that there were many interesting and historical pictures, novel, for the time, ideas, and an emphasis on clinical trials and epidemiology as important ways to understand diseases.

He noted that all of the Division of Extramural Research Staff has been very busy making grant awards with the additional funds appropriated by the American Recovery and Reinvestment Act (ARRA). Dr. Sieving observed that the Financial Management Branch under Ms. Marilyn Laurie would spend the NEIís appropriation to a balance of less than one dollar by the end of the fiscal year and he thanked all NEI staff for their efforts in handling the extra work due to the stimulus.

Dr. Sieving acknowledged the appointment of the new NIH Director, Dr. Francis Collins, and stated that a replacement for Dr. Collins as Director of The National Human Genome Research Institute is underway.

Dr. Sieving then reflected on Dr. Collinsí 5 ideas or critical pathways for biomedical research at NIH. The first is to apply unprecedented opportunities in genomics and other high through put technologies to understand fundamental biology and to uncover the causes of specific diseases.

The second is to translate basic science discoveries into new and better treatments. Research all too often stops at the basic science discovery and does not move into translation. It is necessary to provide the tools to make the move from science to treatment possible.

Thirdly, the development of the science of healthcare reform will be critical to provide the evidence necessary for our healthcare system to focus more effectively on good outcomes and reduced costs. This can mean focusing on everything from comparative effectiveness to personalized medicine and pharmaco-genetics.

Encouraging a greater focus on global health, or ďHealth DiplomacyĒ is a fourth priority. We understand the basic nature of certain pathogens that cause illness for hundreds of millions worldwide, yet a lack of economic incentives has resulted in few developed therapeutics for these conditions.

Lastly, to reinvigorate and empower the biomedical research community is important so that so they can chase after innovative ideas and recruit the next generation of investigators. We must foster innovation and interest in the sciences by sustaining funding, encouraging young scientists, and facilitating innovative research.

LABORATORY OF COMPUTATIONAL MEDICINE

Dr. Sheldon Miller, Director, Division of Intramural Research, addressed the need to apply unprecedented opportunities in genomics and other high throughput technologies to understand fundamental biology and to uncover the causes of specific diseases. He posed the following question, ďIs there any systematic way to unravel that complexity toward understanding diseases?Ē He then discussed the approach to systems biology and the practical details of a computational medicine laboratory. In order to develop this type of program, one needs to analyze a large number of high quality datasets from many different sources allowing harmonization between different data sets. He stated that the NEI is recruiting for computational medicine. He noted that there are strong efforts in the extramural program that are coincident with the efforts of the Intramural Program. The NEI is interested in recruiting a group who is extremely multidisciplinary and who can interact in team science.

LOAN REPAYMENT PROGRAM

Dr. Neeraj Agarwal reported on the NIH Loan Repayment Program at NEI for fiscal year 2009. 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.

He presented data on the number of loans repaid by NIH from 2002 to the present. He also presented data on the award rate of the NEIís loan repayment from 2002 through 2009. Questions about the success of the program and how to measure success were raised by Council. Dr. Agarwal replied that would examine this issue and report back to Council.

EMERGING ROLE OF GENETICS IN VISION RESEARCH

Dr. Hemin Chin identified the goals of genetics research to fully dissect inherited component of diseases, i.e., both common diseases and Mendelian diseases, to identify high risk populations, and to develop specific preventive and therapeutic measures applicable to individualized medicine. Gene discovery for common diseases can take a hypothesis-based approach in candidate gene discovery or a hypothesis-independent approach using linkage scans (families) or genome-wide association studies (GWAS). GWAS gene discovery should lead to hypothesis-based investigations into biological pathways, pharmacogenomics, studies on natural history and disease progression, and which populations are more likely to respond to therapies.

Dr. Chin discussed discoveries for genes in common diseases by GWAS studies from 2005 through 2009 when over 400 GWAS studies were published. He stated that what is being looked at today is changing interactions, and at less common variants associated with large-scale diseases. Sample size really does matter in the search for less common variants. There is an enormous amount of data being generated begging the need for computational genomics. The initiatives of other Institutes including NHLBI and NIA were reviewed.

The NEI currently intends to support GWAS studies and to make data sets available through the database of Genotype and Phenotype (dbGaP). The NEI also recently held a workshop to identify gaps, needs, and opportunities in ophthalmic genetics (June 4-5, 2009) and recognizes the need to develop strategic plans and implement initiatives on ophthalmic genetics. Current NEI GWAS data sets in dbGaP include AREDS 1, AMD-MMAP Cohort Study (2009), and the Whole Genome Association Twin Study of Myopia and Glaucoma risk factors (2009). The NEIís most recent genetic initiative is NEIGHBOR (NEI Glaucoma Human genetics collaBORation). It is a model for collaborative efforts with 22 investigator groups from 12 institutions pooling samples of 2400 POAG cases and 2400 controls, harmonizing phenotypes and combining analysis with GENEVA GLAUGEN (1200 cases and 1200 controls from NHS and HPFS) and CARE. There will be public access through dbGaP (2010).

The next steps for the NEI will be meta-analysis, large-scale fine mapping, re-sequencing of regions of interest, large cohort genetic epidemiology studies, wide sharing of data through public data repositories, dbGaP, and SRA (Sequence Read Archives).

Issues to consider for the future are how best to utilize existing cohorts and epidemiology data, how to harmonize phenotypic ascertainments and incorporate new diagnostic tools, the need for prospective epidemiology studies, genomic resources, both data and biorepository, a data sharing policy, and a training program in computational biology and statistical genetics.

PROGRAM PLANNING

Dr. Richard Fisher discussed the process of strategic planning currently being considered. There would be two main parts to the strategic plan. First of all, an Overarching Framework would be a document to be posted on the web as an umbrella for all of the plans to follow. This would be formulated with input from the vision science community as well as NEI Staff. Secondly, panels in each of the six program areas will be convened to describe program highlights, needs and opportunities, and goals that should be addressed in the next 4-5 years.

It will also be important for the NEI to stay active in having up to three workshops per year directed at emerging areas or topics not addressed in the past. Input would come from the scientific community and NEI Program Staff. The topics would be prioritized and approved by Council and could lead to targeted funding opportunities. The planning and workshop process is a collaboration between DER and the Office of Program Planning and analysis.

INSTITUTIONAL CLINICAL SCIENTIST DEVELOPMENT PROGRAM (K12)

Dr. Neeraj Agarwal reviewed the NEIís K12 Mentored Clinician Scientist Development Program and compared specifics of the NEIís program to other NIH Institutes and Centers (ICís).

The purpose of the NEI Mentored Clinical Scientist Development Program Award (K12) is to facilitate and support the career development of clinical vision scientists who have made a commitment to independent research careers. This award is made to an institutional program accommodating a number of candidates with varying levels of research experience who require an individualized, mentored career development experience.

The NEI, unlike some other ICís has no salary cap for candidates (other than the Legislatively-mandated salary cap). No Institute allows salary for mentors, other than a small amount (5%) for the PI.

Council asked why there was no support for mentors. Dr. Agarwal relied that it was a money issue and that the Institute wanted to be sure there were enough funds to support the trainees. Council agreed that support for the candidates was important.

Council asked about the success of the program. Dr. Agarwal observed that while not enough data are yet available to draw a firm conclusion, the Institute is optimistic about the success of the program and the potential to develop a pool of well-trained, clinician scientists.

GENERAL COUNCIL DISCUSSION

Council brought forth several issues concerning recent changes in peer review including the newly implemented scoring system and how this was working and being perceived by the Program Staff and the applicants.

Dr. Carper reported that the scoring system was currently being evaluated by CSR. Dr. Mariani suggested that a representative from CSR be invited to the next Council meeting in January to report on the changes.

ADJOURNMENT

Dr. Sieving adjourned the meeting at 3:00 pm

CERTIFICATION

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.
Executive Secretary
National Advisory Eye Council
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

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