NAEC Meeting Minutes
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute
NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting
September 12, 2008
The National Advisory Eye Council (NAEC) convened for its one hundred twentieth meeting at 8:30 am on Friday, September 12, 2008, at the Marriott at Metro Center Hotel, Washington, DC. 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 10:00 am for the review of grant and cooperative agreement applications. On Friday, September 12, 2008, from 10:30 am until 5:00 pm, the meeting was open to the public. Attachment A provides a roster of Council members.
COUNCIL MEMBERS PRESENT:
Dr. Scott W. Cousins
Dr. Lenworth N. Johnson
Dr. Ronald J. Gardner
Dr. Todd P. Margolis
Dr. Charles D. Gilbert
Dr. Mary C. McGahan
Dr. Mae O. Gordon
Dr. Richard A. Stone
Dr. Gunilla Haegerstrom-Portnoy
Dr. Marco A. Zarbin
COUNCIL MEMBER ABSENT:
Dr. David Holck, Dr. Juan I. Korenbrot, Dr. Val C. Sheffield and Dr. Earl Smith
AD HOC COUNCIL MEMBER PRESENT:
Dr. David R. Copenhagen
NEI STAFF PRESENT:
Dr. Neeraj Agarwal
Dr. Ellen S. Liberman
Dr. Houmam Araj
Dr. Andrew P. Mariani
Dr. Brian Brooks
Dr. Loré Anne McNicol
Dr. Deborah Carper
Dr. Sheldon S. Miller
Dr. Hemin R. Chin
Dr. Michael D. Oberdorfer
Ms. Janet Craigie
Dr. Samuel C. Rawlings
Mr. William W. Darby
Dr. Maryann Redford
Mr. Donald Everett
Dr. Grace L. Shen
Dr. Richard Fisher
Dr. Anne E. Schaffner
Mr. Kenneth Frushour
Dr. Paul A. Sieving
Ms. Jerusha Gittlen
Dr. Sarah Sohraby
Dr. Shefa Gordon
Dr. Michael A. Steinmetz
Mr. Tom Hoglund
Dr. Anand Swaroop
Dr. Karl John
Dr. Santa Tumminia
Dr. Natalie Kurinij
Dr. Jerome R. Wujek
Ms. Marilyn Laurie
OTHER NIH STAFF PRESENT:
Ms. Sylvia Braxton, Division of Extramural Activities Support (DEAS)
Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Ms. Melanie Gray, Office of Federal Advisory Committee Policy,
Office of the Director (OD), NIH
Ms. Jeanette Gordon, Division of Grants Compliance and Oversight, OD, NIH
Dr. Holly Krull, National Heart Lung and Blood Institute (NHLBI)
Dr. George McKie, CSR
Dr. Keith Mintzer, NHLBI
Ms. Marilyn Smith, DEAS
Ms. Jennifer Spaeth, Office of Federal Advisory Committee Policy, OD, NIH
Dr. Jerry Taylor, CSR
Ms. Romona Williams-Parker, DEAS
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Dr. Bobbie Austin, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Adrianne Drollette, American Optometric Association (AOA)
Ms. Jan Gardner
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, ARVO
Ms. Jodi Mitchell, AOA
Ms. Elaine Richman, Richman Associates
Dr. Jerome Rotter, Cedars Sinai Medical Center
FRIDAY, SEPTEMBER 12, 2008
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. Appendix 2).
CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST
Dr. Andrew Mariani, Acting 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 twentieth session of the NAEC. He announced that this would be the last meeting for four of the Council members whose terms of service were ending, Lt. Col David Holck, Dr. Lenworth Johnson, Dr. Todd Margolis, and Dr. Earl Smith. Drs. Holck and Smith were unable to attend the meeting due to emergency preparations in Texas for the hurricane. Drs. Margolis and Johnson were presented plaques in recognition of their service on the Council. Dr. Johnson thanked Dr. Sieving, the NEI Staff, and the other Council members, and stated that he hoped a diverse council would continue. Dr. Sieving agreed that a diverse council was important. Dr. Johnson commented on the role of the Council of Councils, of which he is a member.
Dr. Sieving discussed the recently held NIH Leadership Retreat as a thoughtful and deliberative process. One particular issue discussed at the retreat was comparative effectiveness research due to its recent emphasis by the Congressional Budget Office (CBO) because of increasing federal spending on health care particularly through the Centers for Medicare and Medicaid Services (CMS).
An area of opportunity for furthering translational research, mentioned by Dr. Sieving, is the Clinical Translational Science Award (CTSA) as something the NEI, as an institute, and the vision community in general, needs to be aware of and participate in.
Dr. Sieving spoke about “workforce” issues and the average age of a first time NIH grantee rising to 44 years. He related the NIH’s efforts to deal with this issue, and the establishment of the identification of Early Stage Investigators as distinct from “new” investigators.
NIH/NEI BUDGET OVERVIEW
Ms. Marilyn Laurie, Chief, NEI Financial Management Branch, spoke about the timeline of the NIH budget faces and the overlap of the prospects of a continuing resolution and the transition of a new administration and Congress. She reported that the NIH received a $158 Million Dollar supplemental appropriation and the NEI portion of that was $3.5 Million. The NEI’s current budget is $670M.
The success rate of the NEI for extramural grants has been high compared to other institutes. While the number of applications had continued to climb after the doubling period, now the success rate is back up to 29.4%. There is no way to estimate a 5-yr. trend. Ms. Laurie reported that the NEI is very active within the NIH community in Trans NIH activities. NEI is the lead institute on the Nanomedicine grants and very involved in the NIH Blueprint for Neuroscience Research.
A Senate appropriation committee meeting was held on July 16 which was very late for that event. A looming issue is the transition to a new administration. There are not any appropriations bills on the Hill. Stop-gap funding in the form of a continuing resolution will be the same as FY 2008 funding. This is to our advantage because the 2008 budget is higher than the President’s 2009 bill. The NEI and the NIH are building a 2010 budget based on the 2008 budget. There will be no new numbers to report at the January Council meeting since the 2010 budget will not be released until February.
NEI EXTRAMURAL BUDGET UPDATE
Dr. Ellen Liberman, Acting Director, Vision Research Program, Division of Extramural Research, NEI, presented an unfinished retrospective of 2008 pointing out that everything is an estimate, but, the Division of Extramural Research is getting close to closing out the fiscal year. Solid, final numbers would be available at the January 2009 Council meeting.
Dr. Liberman reported that Extramural spends approximately 75% of its total funds on the Research Project Grants (RPG’s). RPG’s include the Small Business Innovative Research (SBIR) grants, about 3% of the extramural budget that is a set aside and counted as part of the RPG line. NIH central guidance was followed in managing RPG’s to achieve the totals number of awards and average costs. Other grants include large clinical trials and epidemiological studies, and the R24 Therapy program. Training includes individual fellowship and large institutional training grants as well as K Awards.
A council member asked if the NEI tracked the consequences of the R21 developmental/exploratory research grants. Dr. Liberman noted that the intent of the R21 developmental/exploratory research grant is to develop something new, to take a risk.
Dr. Liberman then spoke about strategies for funding new investigator where training takes precedence over track record, preliminary data are not as heavily weighed and the level of commitment of the institution in start up funds for the new investigator are considered. For fiscal year 2008, the NEI will have funded 39 new investigators.
A Council Member asked if the greater road to success for a new investigator is an R01 first, or an R21 and then in two years an R01. Dr. Liberman replied that it depends on the circumstances, and research proposed. If the person has a good institutional backing and a good start up package usually the NEI advises an R01 because of the funds needed to do research and the longer time period to set up and stabilize a lab effort. Conversely, the R21 is a two-year grant with a much smaller budget. A new investigator would have to put in another grant application almost immediately in order to sustain support.
Current initiatives the NEI is involved in are the NIH Roadmap for Biomedical Research, the NIH Neuroscience Blueprint, the NIH Genes and Environment Initiative, NIH Counterterrorism Research, and the NIH Director’s Bridge Award (NDBA). The NDBA allows established labs that missed funding to keep stay in operation for one year to resubmit an amended application. It’s an NIH-wide program and the funds come directly from the NIH OD Common Fund.
Planned initiatives the NEI will undertake or participate in are an RFA to solicit SBIR/STTR applications for screening for diabetic retinopathy, and the NIH Roadmap Transformative R01 Program.
UPDATE ON NEI LOAN REPAYMENT PROGRAM
Dr. Neeraj Agarwal, the NEI Research Training Officer, gave the annual update on the NIH Loan Repayment Program (LRP). He noted that this is an NIH-wide initiative. The purpose is to attract health professionals to careers in research by helping repay their educational loans. NEI specifically participates in pediatric and clinical research. He reviewed data on rises in tuition costs and indebtedness of young physicians, the types of eligible educational loans, NEI spending on the LRP since 2002, the funding rate, and the timeline for the LRP for 2009.
The question was asked by a council member why some applications were not funded. Dr. Agarwal explained it was because they usually did not meet the criteria set forth for funding. However, the number of applications is increasing and the success rate is declining.
A council member asked if there are any outcome data for this program from NEI or NIH on people who have their loans partially repaid and if this program tracks how many enter academia or incorporate research into their careers. Dr. Agarwal relied that these data are not yet available.
BRIEFING ON THE ROLE OF NIH IC ADVISORY COUNCILS
Ms. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy, OD, NIH, stated that NIH has more Federal Advisory Committees than any other organization in the government. She reviewed the legal basis for national advisory councils including the Public Health Service Act and the Federal Advisory Committee Act and detailed the regulations and policies for councils.
The Secretary of the Department of Health and Human Services (DHHS) appoints National Advisory Council members and there are sources outside of the NIH that have input. The White House Personnel Office also approves the appointment. The key roles of federal personnel in the council function were reviewed.
Ms. Spaeth noted that national advisory councils are the second level of peer review. They may bring up applications for special consideration. After councils provide advice and recommendations, only the government has the right to follow through. The advisory council has the responsibility to make good faith recommendations but the legal responsibility for decision making is incumbent upon the Institute. Activities outside the scope of the council listed.
A council member then opined that they, council members, are consultants, give opinions, and, advise. It is then up to the NEI to implement. What if the council decided not going to give en bloc approval?
Dr. McNicol replied that without council en bloc approval, the NEI would not be able to fund any grants.
PROGRAM PLANNING
Dr. Richard Fisher, Director, Office of Program Planning and Analysis, discussed the role of program planning relative to scientific merit as determined by peer review, and the availability of funds. He presented an historical review of Program Planning (where we are and where we are going) progress, goals, objectives and vision research. Plans were based on the programs of the institute such as Retina, Cornea, Lens, Glaucoma, SAVP, and Low Vision. When Dr. Sieving arrived at the NEI, he added genetics and immunology to the already established cross cutting myopia and refractive error, and applied clinical research programs. The current NEI interest is in a Phase 2 of Program Planning, which is an on-going planning process that consists of conferences, workshops, reports.
The National Plan for Eye and Vision research is going to be updated with overarching goals, challenges and objectives. Panel reports will result from existing and future meetings. Much of the future advancement will need to be developed. The implementation of the national plan will be a road map-like process, ideas that lead to a workshop, programs, etc.
Roadmap is the trans-NIH approach. Dr Fisher noted that Dr. Zerhouni spoke on the hill recently and he emphasized transparency, not just for scientists but in planning, for the public as well.
One of the council members responded to Dr. Fisher that the opportunity lies in translational research. To make translational research work, a multi-disciplinary effort is needed. What if the NEI makes a process that provides some semblance of structure? Dr. Fisher stated that the intention is to have an inclusive, open and transparent process so that there are no questions where this is coming from. In the end, it all filters to the NEI to make a decision, then to Council, and finally to Dr. Sieving who makes the decision which of these initiatives to go forward with. Like the NIH common fund, they should represent a very small percentage of our budget.
A Council Member asked that with the increasing complexity of overlapping programs with the NEI, is any thought being given to restructuring the overall programs at the NEI. Dr. Fisher replied that these are all the sorts of questions that need to be answered. This is the right time to take a look.
REPORT ON THE INTRAMURAL RESEARCH PROGRAM
Dr. Sheldon Miller, Director, Division of Intramural Research, NEI, discussed the intramural research program (IRP) mission: to significantly improve Public Health in the 21st century. He posed the questions, “What distinguishes the intramural program from other research programs?” What do they do that is any different from what anyone else in extramural research does? Congress has mandated the existence of the intramural programs. The intramural program is not limited to research that can only be done in one institute. Examples are the human genome projects that span many different NIH institutes. A key distinguishing element of the intramural research program is the ability to recruit scientists with research programs that are widely multidisciplinary. This makes an extremely powerful Intramural program.
Dr. Miller introduced the next few speakers, Drs. Swaroop, Brooks and Sohraby, all from the NEI’s Intramural Program
GENESIS OF A MAMMALIAN PHOTORECEPTOR
Dr. Anand Swaroop, Chief, Neurobiology, Neurodegeneration and Repair Laboratory, spoke on the use of basic biology to identify new genes that are the underlying causes of many untreatable forms of blindness. He noted that a single mutation in the same family can lead to multiple phenotypes. To understand the disease process, one needs to understand the normal gene process along with other basic fundamental mechanisms.
He described how his work on the development of photoreceptors, and that of his laboratory and their collaborators, hopes to bridge basic research in biology to develop novel therapeutic strategies such as small molecule drug therapy, stem cell therapy, and gene therapy, to treat retinal degenerative diseases.
NATIONAL OPHTHALMIC DISEASE GENOTYPING NETWORK UPDATE
Dr. Brian Brooks, MD, PhD, tenure track investigator in the NEI Ophthalmic Genetics Visual Function Branch, provided an overview of the current state of the National Ophthalmic Disease Genotyping Network (eyeGENE). Dr. Brooks indicated that this is a nation-wide collaborative effort that was initiated by the NEI in 2004. It currently involves more than 20 investigators and research institutions across the United States. This Network provides a novel approach of coupling a genetics research database and repository with a program which provides genetic diagnostic information for physicians and patients with Mendelian disorders involving the eye and vision. Clinicians outside the network may also participate and submit samples to the network.
Dr. Brooks stressed that the eyeGENE is not a multi-center clinical trial—it is a multi-center genetic network that can be shared and utilized across the community. The Network is currently in its second phase, operating under a protocol that has been reviewed by the NIH Institutional Review Board (IRB). At this point more than 600 samples have been received and are being processed. The next phase of project development involves design and IRB review of a protocol whereby a registered investigator can submit a short written request for quality review and then obtain samples for investigation. The database is being developed to be fully searchable. The eyeGENE is now at a stage of delivering results while at the same time providing opportunity for growth and enhancement of genetics research in the future by the broad vision community.
Council asked if thought had been given on tracking research that resulted from samples or on information provided by eyeGENE. Dr. Brooks noted that publications are expected to acknowledge data retrieved from eyeGENE.
Dr. Brooks reviewed the operating procedures employed by eyeGENE since 2004, when the original set of CLIA-certified extramural laboratories began to participate in this collaborative network. In order to enhance the national capacity for CLIA-certified genotyping, the NEI solicited applications to supplement existing grants, using standard policies. Oversight and further development activities are periodically reviewed by an eyeGENE steering committee. Dr. Brooks described how clinicians wishing to submit a patient’s sample for testing must provide approximately ten disease-related pieces of clinical information about the patient and the state of pathology. Dr. Brooks noted that current CLIA laboratory activity is supported through a standard contract mechanism.
Council asked why the NEI had registered a trademark for the name eyeGENE. Dr. Sieving replied the registration of a trademark was not done for commercial purposes but rather reserves and protects the name eyeGENE for the intended use.
A council member asked about the costs of gene testing within the Network. Dr. Brooks replied that costs vary with the size of the gene and the type of mutation screening that is performed. The reimbursed cost to the individual CLIA laboratory for mutation screening of any particular gene was determined by a competitive contract process, and the costs were internally consistent across many laboratories who submitted. The range is from a few hundred to a few thousand dollars per test. He indicated that laboratories receive a fixed yearly base support amount, and then the cost for mutation screening of each particular gene is determined by the contract. The Network maintains a fixed level of genotyping funds for each year, and therefore this amount determines the number of tests that may be done in a year. If the Network expends all of its funds before the end of a year, any unprocessed samples will be held until the next year.
Dr. Sieving noted that Michael Leavitt, Secretary, Department of Health and Human Services, has publicly committed to working toward a health care system for the future that will incorporate an individual subject’s genomic information within that person’s medical record. eyeGENE is at the forefront of this movement.
Dr. Jerome Rotter, MD, Professor and Director of the Medical Genetics Institute, Cedars-Sinai Medical Center, Los Angeles, California, also addressed the Council. Dr. Rotter directs and participates in a number of genetic epidemiology programs outside the field of vision research. He also served as a member of the eyeGENE Steering Committee. His presentation noted that identifying disease genes is important not only to those individuals at risk, but also to scientists determining future directions of biological research. Dr. Rotter stated that eyeGENE is an important model for personalized medicine and for research in eye diseases. The outcomes of eyeGENE will lead to improved diagnosis and will affect prognosis, therapy and preventive measures. As genetic knowledge accumulates about diseases, patients will seek access to that knowledge, and thus will help to accelerate the future of medical research. He commented that the eyeGene approach is a unique solution to that problem, and that the broader medical research community can well learn from the model that is being developed. He foresees the replication of this resource internationally and noted that it will be a significant source of participants for clinical trials. Lastly, he noted that the network is also ultimately an economical source of research material.
Council members expressed their strong endorsement of the eyeGENE network, particularly the innovation of its start-up and implementation, and its open accessibility.
MENTORING IN THE NEI INTRAMURAL RESEARCH PROGRAM
Dr. Sarah Sohraby, Deputy Director, Division of Intramural Research, NEI, NIH, described efforts to provide mentoring and training to the 58 postdoctoral fellows in the intramural research labs. These efforts are also extended to the senior scientists, the mentors, to help them improve their mentoring. The basis for this effort was her perception of the dwindling role of mentoring in the scientific enterprise. She discussed the training opportunities available on the NIH Campus such as the NIH Office of Intramural Training and Education (OITE), English as a Second Language (ESL), MEDIA training, individual meetings within the Office of the Scientific Director (1/year), small group meetings (2/year), plenary meetings (3/year), and a Web site http://neinet.nei.nih.gov/training/. It was also noted that the NEI’s intramural labs are scattered and separated and this makes it difficult to provide a cohesive environment where the fellows feel that they are truly a part of the Institute. Dr. Sohraby has originated a yearly event, the second annual installment of which will be held next month, titled “Focus on Fellows” that brings together all NEI postdoctoral fellows, students, and trainees, along with the senior scientists and mentors for two days of scientific presentations in a retreat-like social environment.
The NEI has established an Overseas Scholars Program aimed at fostering international research collaborations in the home countries of the foreign fellows to create research opportunities by participating in the Global Health Research Initiative Program (GRIP), and exchange programs such as the NEI/NIH South China Initiative with Sun Yat-Sen University.
Dr. Sieving thanked Dr. Sohraby for her contributions to this program and noted that having this strong effort to improve mentoring provides a very valuable service to both the postdoctoral fellows and the Institute.
GENERAL COUNCIL DISCUSSION
Dr. Todd Margolis stated that he had great time working with everyone on council and with the NEI Staff and he offered several suggestions to maximize the efforts of the council members including reminding the council members that they are consultants, briefer power point presentations, avoiding abbreviations and acronyms, providing council with direct contact information for NEI staff members, feedback on council actions and discussions, and, a clearer overview of the intramural research program. Dr. Margolis also suggested that the Council become more involved in strategic planning.
Dr. Lenworth Johnson reminded the council and the NEI staff to keep in mind that the Council of Councils on the science of science management may end up changing the way the NIH conducts its mission. Perhaps that would depend on the successor to Dr. Zerhouni. How to manage science will have political and social ramifications, and this is something to consider for future discussions.
ADJOURNMENT
Dr. Sieving adjourned the meeting at 5:00 pm
CERTIFICATION
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.
Acting 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
06/26/2008
Attachment A
NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE
Meeting Roster
National Advisory Eye Council
National Eye Institute
September 12, 2008
|
Scott W. Cousins, M.D. Ronald J. Gardner, J.D. Charles D. Gilbert, M.D., Ph.D. Mae O. Gordon, Ph.D. Gunilla Haegerstrom-Portnoy, OD, Ph.D. Lenworth N. Johnson, M.D. Todd P. Margolis, M.D., Ph.D. |
Mary C. McGahan, Ph.D. Richard A. Stone, M.D. |
Ad Hoc
David R. Copenhagen, Ph.D.
Professor
Department of Ophthalmology & Physiology
University of California at San Francisco
School of Medicine
San Francisco, CA 94143
Executive Secretary
Andrew P. Mariani, Ph.D.
Acting Executive Secretary, National Advisory
Eye Council
Division of Extramural Research
National Eye Institute
Rockville, MD 20852
Ex Officio
Paul A. Sieving, M.D., Ph.D.
Director
National Eye Institute
National Institutes of Health
Bethesda, MD 20892
Marco A. Zarbin, M.D., Ph.D.
Professor & Chairman
Staff Physician
New Jersey Veterans Administration Hospital
East Orange, NJ 07018
