NAEC Meeting Minutes - June 14, 2012

National Eye Institute
National Advisory Eye Council
One Hundred Thirty-first Meeting
June 14, 2012

The National Advisory Eye Council (NAEC) convened for its one hundred and thirty-first meeting at 8:30 am on Thursday, June 14, 2012, at 5635 Fishers Lane, Rockville, Maryland, 20852. Paul A. Sieving, M.D., PhD, the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 08:30 a.m. until 12:15 p.m. The meeting was closed to the public from 12:45 p.m. until adjournment for the review of grant and cooperative agreement applications. Attachment A provides a roster of Council Members.

COUNCIL MEMBERS PRESENT:

Dr. Joseph Bonanno

Dr. Hollis Cline

Dr. David Copenhagen

Dr. Donald Gagliano

Dr. Jonathan Haines

Dr. Eric Pierce

Dr. Krishna Sharma

Dr. Sheila West

Dr. Marco Zarbin

COUNCIL MEMBERS ABSENT:

Dr. James Chodosh

Dr. Bernard Godley

Dr. John Morrison

Ms. Kathleen Petrillo

Ms. Alberta Orr

NEI STAFF PRESENT:

Dr. Houmam Araj

Dr. Neeraj Agarwal

Ms. Pamela Bobbitt

Dr. Deborah Carper

Dr. Preethi Chander

Ms. Monique Clark

Ms. Janet Craigie

Mr. William Darby

Ms. Linda Dingle

Mr. Donald Everett

Dr. Richard Fisher

Dr. Shefa Gordon

Dr. Thomas Greenwell

Mr. Theodore Gutman

Mr. Dustin Hays

Ms. Jean Horrigan

Dr. Brian Hoshaw

Mr. Kevin Keating

Dr. Daniel Kenshalo

Dr. Natalie Kurinij

Dr. Ellen Liberman

Dr. Andrew Mariani

Dr. George McKie

Dr. Loré Anne McNicol

Dr. Jennifer Mehren

Dr. Sheldon Miller

Ms. Kathleen Moy

Dr. Lisa Neuhold

Dr. Steven Oversby

Dr. John Prakash

Dr. Maryann Redford

Ms. Karen Robinson-Smith

Dr. Gale Saunders

Dr. Anne Schaffner

Dr. Eleanor Schron

Dr. Grace Shen

Dr. Paul Sieving

Ms. Chantell Stevenson

Dr. Michael Steinmetz

Dr. Santa Tumminia

Dr. Cheri Wiggs

Mr. David Whitmer

Ms. Keturah Williams

Dr. Jerome Wujek

OTHER NIH/DHHS STAFF PRESENT:

Dr. Michael Chaitin, Center for Scientific Review (CSR)

Dr. Keith Crutcher, CSR

Dr. Samuel Edwards, CSR

Dr. Nataliya Gordiyenko, CSR

Dr. Peter Guthrie, CSR

Dr. Paek Lee, CSR

Ms. Teresa Shea, Center for Information Technology (CIT)

Dr. Kirk Thompson, CSR

MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:

Ms. Katie Cleffi, RTI International

Ms. Shannon Curtis, American Academy of Ophthalmology

Dr. Israel Goldberg, Health Research Associates

Mr. James Jorkasky, National Alliance for Eye and Vision Research

Mr. Stanley D. Maoury, Jr., ICF International

Ms. Joanne Olson, Association for Research in Vision and Ophthalmology

Dr. Stephen Rose, Foundation Fighting Blindness

Dr. Peter Soliz, VisionQuest Biomedical

Ms. Claudia Siervo, IQ Solutions

OPEN SESSION OF THE MEETING

08:30 am

CALL TO ORDER AND OPENING REMARKS

Dr. Paul Sieving, Director, NEI, and Chairman of the NAEC welcomed all attending the meeting. He introduced Dr. John Prakash as the newly-hired Associate Director for International Activities. Dr. Prakash has over 25 years’ experience in global health issues with Pfizer, NIAID, and the Department of Defense.

Dr. Sieving noted that the second year follow up of all patients in the Comparison of AMD Treatments Trials (CATT) comparing Lucentis and Avastin is completed and that the outcome is the same as after one year, Avastin is not inferior to Lucentis.

He reported on The 6th Sayer Vision Research Lecture and Award that was given in April by Yoshiki Sasai, M.D., Ph.D., laureate of the 2012 Inoue Prize for Science on “Self-Organization of Neural Structures in Three-Dimensional Stem Cell Cultures” as part of a symposium on stem cells and welcomed suggestions for future symposia.

Dr. Robert Nussenblatt, NEI, and Dr. Richard Lee of Bristol Eye Hospital in the United Kingdom have launched a consortium agreement to promote human ocular immunology, ease collaboration, and standardize clinical protocols.

Dr. Sieving reminded Council that at the last meeting he proposed taking a broader look at research opportunities that would go beyond the six panel reports on “Vision Research: Needs, Gaps, and Opportunities” and to engage other government agencies outside of the NEI as well as private foundations. A subgroup of Council met on April 26 to discuss how to proceed and a draft document on the process and from this meeting will be presented by Dr. Eric Pierce.

PROVOCATIVE QUESTIONS
Dr. Sieving introduced Dr. Edward Harlow from Harvard University who has worked with Dr. Harold Varmus, Director, NCI, on the Provocative Questions Project. Dr. Harlow stated that the Provocative Questions Project was intended to challenge NCI’s scientific community to ask and frame important but non-obvious questions and to stimulate NCI’s research communities to use
laboratory, clinical, and population research in especially effective and imaginative ways. The questions would not be simple restatements of long-term goals of the National Cancer Program, which are to improve the prevention, detection, diagnosis, and treatment of all forms of cancer. Instead they should build on specific advances in our understanding of cancer and cancer control; address broad issues in the biology of cancer that have proven difficult to resolve; take into consideration the likelihood of progress in the foreseeable future (e.g. 5 to 10 years); and address ways to overcome obstacles to achieving long-term goals.

A total of 24 Provocative Questions posed during the nationwide Provocative Questions workshops and from website submissions were selected for inclusion in a Funding Opportunity Announcement (FOA) “Research Answers to NCI’s Provocative Questions”. About 750 applications were received in response to the FOA. The review is complete and a funding plan is being developed.

Dr. Harlow then gave some examples of the questions. How does obesity contribute to cancer risk? Given the evidence that some drugs commonly and chronically used for other indications, such as an anti-inflammatory drug, can protect against cancer incidence and mortality, can we determine the mechanism by which any of these drugs work? Given the appearance of resistance in response to cell killing therapies, can we extend survival by using approaches that keep tumors static? Why are certain disseminated cancers cured by chemotherapy alone?

Continued participation in the process of Provocative Questions Project is available by suggesting new questions and commenting on posted questions in the ‘Community Dialog’ section of the website.

Dr. Harlow commented that as an experiment the Provocative Questions Project was engaging and fruitful; the quality of the questions submitted reached a level beyond expectations and they are expected to expand the portfolio into new research areas. A repeat of the process is currently in the planning stages.

The Council had many questions and comments concerning the size of the meetings, the selection of meeting participants, the breadth of participation of the community, the review process, the initiation of new program areas, and the collection of information through the web.

NEI CHALLENGES AND PRIZES TO PROMOTE OPEN GOVERNMENT

Dr. Matthew McMahon stated that monetary prizes are often offered as a way to achieve an answer to a challenging problem, or to provide a product such as a logo or software. He gave the example of the 1714 Longitude Prize offered by the British Government. While latitude was relatively easy to determine, longitude was of paramount importance in ocean navigation. Although the major prizes were never awarded, many small awards were made for work that laid the foundation towards the goal.

Under the America Competes Act, all Federal Agencies now have the authority to offer prizes and prizes are another tool to attack a problem. There are several examples of prizes offered by Federal entities which are relevant to the biomedical sciences. These include the DHHS Office of the National Coordinator for Health IT, which has issued national competitions toward the creation of easy-to-use, web-based tools, and the Design by Biomedical Undergraduate Teams Challenge where the NIH National Institute of Biomedical Imaging and Bioengineering has challenged teams of undergraduate students to compete in a design competition for Diagnostic Devices/Methods, Therapeutic Devices/Methods, and Technology to Aid Underserved Populations and Individuals with Disabilities. The winning team in each category will receive a $10,000 prize and be honored at an award ceremony during the 2012 Annual Meeting of the Biomedical Engineering Society in Atlanta, GA.

Council members asked whether there didn’t need to be a relationship between the monetary value of the prize and the capital cost of doing the work. Surprisingly not, was the reply. Recognition for winning the prize is often more important and can be used to leverage the goals of the prize winner.

A member of the general public attending the meeting stated that in biomedicine, one needs money to do the prize work and outside of the NIH, there is little chance of support. A Council member commented that universities may offer seed money to investigators in order to pursue a prize competition.

REPORT OF THE NAEC PROGRAM PLANNING WORKING GROUP

Dr. Eric Pierce spoke about the NEI Challenge to Identify Audacious Goals and to establish a National Vision Research Agenda. Audacious was defined as bold or daring; extremely original; without restriction to prior ideas; highly inventive. This challenge originated at the NAEC Meeting on February 2 2012 when the process for developing an NEI National Vision Research Agenda was discussed and it represents an additional planning process beyond Vision Research: Needs, Gaps, and Opportunities. The NEI Challenge is offered to stimulate innovative thinking toward developing a National Vision Research Agenda. The intent is to widely advertise this challenge, select Audacious Goals in early 2013, and help set vision research priorities.

The overall process in identifying Audacious Goals begins by casting a wide net to capture ideas from vision researchers and beyond, and to widely publicize the NEI Challenge with public notices, direct contacts, etc. A one page Audacious Concept paper would be submitted in mid-September 2012. By December, 2012, the concept papers would be triaged, reviewed, and up to 20 would be selected for further consideration. Cash prizes are to be awarded to authors of selected concepts, which will be discussed at an NEI Audacious Goals meeting in February 2013 by 200 participants. This meeting will report the most compelling Audacious Goals with explanations of their strengths and rationale for selection. These will then be published on the NEI website to complement Vision Research: Needs, Gaps and Opportunities. Authors must be willing to participate in the Audacious Goals Meeting in February, 2013, permit their idea to be posted on the NEI website, and co-chair break-out discussion session(s) on concept. The concepts will be de-identified before judging. The NAEC will consider the Audacious Goals in the spring of 2013.

Issues brought to Council for discussion by the Council Working Group included the public strategy for the Audacious Goals process, publicity, the format, organization of the meeting, and final steps after selection. Council also discussed the page limitations, qualifications and selections of reviewers (judges), how best to engage the community, and implementation.

PROGRAM PLANNING

Dr. Richard Fisher outlined the next steps in the process of initiating the Audacious Goals concept. The first is getting the process and prizes approved by NIH, next is publication in the Federal Register followed by posting on the DHHS Challenge Website.

Council had concerns about the proposed timeline. Was it too ambitious? Was September realistic for a submission deadline? Council also discussed strategies for publicizing the Challenge including interactive web casts, announcements at scientific meetings, and letters to all in the vision research community.

TRANSLATING OPHTHALMIC RESEARCH AND DEVELOPMENT INTO CLINICAL APPLICATIONS

Dr. Loré Anne McNicol introduced Dr. Peter Soliz, President and CEO of VisionQuest Biomedical, LLC. Dr. Soliz described VisionQuest’s eye disease screening program funded by an NEI Phase I SBIR through the process to eventual commercialization. The mission of this program is to develop low-cost medical diagnostic systems and to transition advanced technologies into the clinic. He reviewed the path to implementation of an automated retinal screening process for diabetic retinopathy that included commercial activities and the regulatory process. Future NIH grant-funded products by VisionQuest include a low-cost retinal camera, educational material, and peripheral neuropathy screening for diabetes with infra-red technology for the detection of microvascular changes.

Questions to Dr. Soliz were about the use of mobile technology, benchmarking against databases, and exploration of international markets.

REMAINDER OF FY 2012 BUDGET

Dr. Sieving observed that the enacted budget for the NEI is just under $702m and that with the number of applications received and the anticipated number of awards, the success rate for grants will be about 30% this fiscal year. He noted that the President has signed an Executive Order promoting efficient spending that will affect spending on conferences, travel, etc. Targets for FY2013 include an additional 20% reduction in these categories and all of NIH is scrambling to figure out how travel and conferences will be paid for. He also stated that unless Congress agrees to some mix of spending cuts and tax increases to close a budget gap of $1.2T a mandatory sequestration would result in January 2013 resulting in an 8 to 12% budget cut which would necessitate either a decrease in the number of awards or a decrease in the amount of awards made by NIH.

CLOSED SESSION OF THE MEETING – 12:45 pm

The meeting was closed to the public at 12:45 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, 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

ADJOURNMENT

The meeting was adjourned at 1:30 pm

CERTIFICATION

I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Loré Anne McNicol, 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