National Institutes of Health
National Eye Institute
National Advisory Eye Council
One Hundred Thirty-seventh Meeting
June 12, 2014
The National Advisory Eye Council (NAEC) convened for its one hundred and thirty-seventh meeting at 8:30 a.m. on Thursday, June 12, 2014, at 6701 Rockledge Drive, Rockville, Maryland, 20852. 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 12:45 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. Attachment A provides a roster of Council Members.
COUNCIL MEMBERS PRESENT:
Dr. Hollis Cline
Dr. Laura Frishman
Dr. Stephen McLeod
Dr. John Morrison
Dr. Eric Pierce
Dr. Krishna Sharma
Dr. Monica Vetter
Dr. Jayne Weiss
Dr. Sheila West
Dr. Rafael Yuste
Dr. Marco Zarbin
COUNCIL MEMBER ABSENT:
Dr. Jonathan Haines
Ms. Kathleen Petrillo
NEI STAFF PRESENT:
Dr. Houmam Araj
Dr. Neeraj Agarwal
Ms. Pamela Bobbitt
Ms. Sylvia Braxton
Ms. Vicki Buckley
Dr. Preethi Chander
Dr. Hemin Chin
Ms. Monique Clark
Mr. William Darby
Ms. Linda Dingle
Mr. Donald Everett
Dr. Richard Fisher
Dr. Shefa Gordon
Dr. Thomas Greenwell
Mr. Dustin Hays
Dr. Fielding Hejtmancik
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Mr. Kurt John
Ms. Tina Jones
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. Lisa Neuhold
Dr. Gyan Prakash
Dr. Maryann Redford
Ms. Karen Robinson-Smith
Dr. Gale Saunders
Dr. Anne Schaffner
Dr. David Schneeweis
Dr. Eleanor Schron
Dr. Grace Shen
Dr. Paul Sieving
Dr. Michael Steinmetz
Dr. Daniel Stimson
Dr. Santa Tumminia
Dr. Jennifer Wenger
Dr. Louise Wideroff
Dr. Cheri Wiggs
Ms. Keturah Williams
Mr. Michael Wright
Dr. Jerome Wujek
OTHER NIH STAFF PRESENT:
Dr. Steven Becker, National Cancer Institute
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Nataliya Gordiyenko, CSR
Dr. Paek Lee, CSR
Dr. Leah Miller, Office of Research on Women’s Health
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Ms. Shannon Curtis, American Academy of Ophthalmology
Dr. Israel Goldberg, Health Research Associates
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Dr. Michael Oberdorfer, Consultant
Ms. Kelli White, AOA
Dr. Matthew Windsor, Association for Research in Vision and Ophthalmology
OPEN SESSION OF THE MEETING
The webcast of the open session of the Council meeting can be viewed online at:
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. He announced the appointment of two new members to Council, Drs. Stephen McLeod and Monica Vetter.
Dr. Vetter received a Ph.D. in Neuroscience from the University of California, San Francisco with Dr. Michael Bishop. After postdoctoral work in developmental biology she joined the faculty at the University of Utah, where she is now Professor and Chair of the Department of Neurobiology and Anatomy.
Dr. McLeod received an M.D. from Johns Hopkins University School of Medicine, then held an internship at Beth Israel Medical Center, a residency at the Illinois Eye and Ear Infirmary, and a fellowship at the Doheny Eye Institute of the University of Southern California. He is currently Professor and Chairman of the Department of Ophthalmology, University of California, San Francisco, School of Medicine.
Dr. Sieving then announced a number of staff changes at the NEI:
Dr. Deborah Carper retired after 40 years at NIH, mostly at the NEI. For the past four years she served as NEI Deputy Director. He acknowledged her considerable help with a number of issues involving the NEI.
After a national search, Dr. Belinda Seto was appointed Deputy Director. Dr. Seto has a Ph.D. in Biochemistry from Purdue University, and spent her career at NIH and other federal agencies. For the past ten years she was Deputy Director of the National Institute of Biomedical Imaging and Bioengineering.
Dr. Loré Anne McNicol, Director, Division of Extramural Research, will retire on September 30, 2014. She has a Ph.D. in Medical Sciences from the Boston University School of Medicine. Dr. McNicol came to the NIH in 1985 to the National Institute of Allergy and Infectious Disease, Laboratory of Parasitic Diseases, then joined the NEI in 1989 as the Corneal Diseases Program Director. She has held many positions at the NEI including Acting Deputy Director. Dr. Sieving thanked Dr. McNicol for many years of superb service to the NEI.
Dr. Richard Fisher, Director, Office of Program Planning and Analysis will retire at the end of the month. Dr. Fisher came to the NEI in 1999 as Director of the Corneal Diseases Program, and has worked closely with Dr. Sieving on the Nanomedicine Roadmap Initiative, which is in its final year. Dr. Sieving considers this a significant departure for the NEI, especially with regard to the Audacious Goals that Dr. Fisher was instrumental in leading.
Mr. David Whitmer, Executive Officer, left a few weeks ago to become Chief Operations Officer at the VA Sunshine Health Network in St. Petersburg, FL. Ms. Vicki Buckley, Deputy Executive Officer has assumed the role of Acting Executive Officer.
Ms. Jennifer Wenger, Associate Director, Office of Science Communications, Public Liaison, and Education, will retire after a year and a half in that position. She has served very well and made many key hires in the reorganized office. Dr. Daniel Stimson will assume the duties of Acting Director.
Dr. Sieving then reported that Dr. Cheri Wiggs, Director of the Low vision and Blindness Rehabilitation Program, has been named NIH Super Hero Cyclist of the year.
Dr. Sieving reported on the ups and downs of the budget over the past several years and noted the prospect of a $10M increase this year. He reported that the Brain Research through Advancing innovative Neurotechnologies (BRAIN) Initiative.
CONSIDERATION OF JUNE 2014 MINUTES
Dr. Loré Anne McNicol, Executive Secretary of the Council and Director, Division of Extramural Research, requested approval of the minutes of the January 2014 Council Meetings. A motion for approval was made and the minutes were accepted.
Dr. McNicol began an update on the budget by reviewing post-sequestration budget appropriations from 2010 through 2014, relating the appropriation to buying power with FY2000 as the baseline. She presented a financial summary for FY2013 that included a 5.68% reduction for all NIH Institutes and Centers. All NEI functional areas were affected. In FY2013 NEI funded 31 fewer Research Project grants, while protecting training positions.
Dr. McNicol noted that in FY2014 the NEI received $673.5M, which was 2.5% above the FY2013 post-sequestration level. All areas shared the budget increase: extramural +2.6%, intramural +2.0%, and Research Management Support +2.5%. Non-competing Research Project Grants (RPG) are being funded at 98% of the committed level to enable continued support for new awards. The average cost of new RPGs will remain flat at $404K, and the number of awards will decrease slightly. She presented the history of NEI RPG success rates since 2010, estimating 25% for the current year.
PROGRAMMATIC UPDATE ON THE NEI OFFICE OF INTERNATIONAL PROGRAM ACTIVITIES
Dr. Gyan Prakash, Director, Office of International Program Activities, reported on the outcomes of the International Consultants Meeting which took place on September 23, 2013. The purpose of this meeting was to make recommendations on the NEI’s involvement in international research and training, to develop strategic goals, and to identify unique opportunities for NEI to partner with international groups to help support the NEI mission. The consultants included Drs. Sally Atherton, Roger Glass, Thomas Lietman, G. Nag Rao, Pawan Sinha, Alfred Sommer, and Hugh Taylor. Dr. Sieving and other senior NEI staff members also attended.
Dr. Prakash indicated that the meeting discussions and outcomes were considered in light of the NIH and NEI missions and goals. Given the limits inherent in these in the context of international funding and limited resources, the outcomes centered on identification of unique opportunities in scientific research, not in international aid or vision health care delivery.
Dr. Prakash explained that the participants provided their opinions on three selected research topics: the ocular complications of diabetes, anterior segment inflammatory and infectious eye diseases, and genetic diversity and unique gene pools around the world. He noted that the consultants recommended development of a science-based research agenda, concentration on unique international opportunities for NEI, formation of partnerships within NIH and with external organizations, and leverage to enhance limited resources. The consultants also recommended a unique role that NEI can play in meeting these scientific mandates: training the next generation of internal vision researchers.
At Dr. Prakash’s invitation, Dr. Fielding Hejtmancik, Chief, Ophthalmic Molecular Genetics Section, Division of Intramural Research, NEI, described his establishment of international collaborations in India. He began with an emphasis on pooling clinical data, which led to a formal epidemiological study followed by a genetic epidemiological study of risk factors for diabetic retinopathy.
Council members noted that there has been an absence of involvement with other populations with known genetic risk factors, such as the Arab countries and Mexico. Members also commented on the differences between science and health care and noted areas where health care and science converge. Council members also requested that the proposed international research plan be further refined to add the key components of population science and service delivery like mobile health. An updated and more fully developed plan should be presented at a future Council meeting.
UPDATE ON THE BRAIN INITIATIVE
Dr. Michael A. Steinmetz, Director of the Strabismus, Amblyopia, and Visual Processing Program reviewed the NIH BRAIN Initiative timeline and the membership of the Working Group of the Advisory Committee to the Director (ADC) on the BRAIN Initiative. The charge to the Committee was to review recent scientific advances, articulate goals, develop a plan, recommend principles and appropriate structures for achieving the goals, identify areas of collaboration with public and private partners, make specific recommendations regarding timelines and milestones, and provide cost estimates.
For FY2014 funding, six Funding Opportunity Announcements (FOA) have been issued for the Brain Initiative:
Transformative Approaches for Cell-type Classification in the Brain
Development and Validation of Novel Tools to Analyze Cell-specific and Circuit-specific Processes in the Brain
New Technologies and Novel Approaches for Large-scale Recording and Modulation in the Nervous System
Optimization of Transformative Technologies for Large-scale Recording and Modulation in the Nervous system
Integrated Approaches to Understanding Circuit Function in the Nervous System
Planning for Next Generation Human Brain Imaging.
In a final report to the ADC, the Working Group articulated a ten year plan for 2016-2025, a $4.5B budget, core principles, and a plan for action. The core principles are to pursue human and non-human studies in parallel, to cross boundaries in interdisciplinary collaborations, to integrate spatial and temporal scales, to establish platforms for preserving and sharing data, to validate and disseminate technology, and to consider ethical implications of neuroscience research. Dr. Steinmetz ended his presentation with a video demonstrating the activity of single cells in the whole brain of intact zebrafish.
Council members posed questions regarding overlap between the NIH BRAIN Initiative and the NEI Audacious Goals Initiative. The ensuing discussion, which included members of the NEI senior staff, concluded that the two initiatives were synergistic. Dr. Sieving asked Dr. Steinmetz how the NEI could best leverage the BRAIN Initiative. Dr. Steinmetz answered that without doubt investigators who are working on the retina and higher areas of the visual system have an advantage over virtually all other circuits that are being analyzed in the brain.
Dr. Loré Anne McNicol provided an update on activities in the NEI Division of Extramural Research and an overview of future trans-NIH extramural funding programs. She highlighted the publication of the first Audacious Goals RFA and noted that applications would be received next month. And she stressed that in FY2014 the NEI continues to follow the NIH new investigator funding policy: to have an equivalent award rate to established investigators seeking a new R01, with over half of the new investigators being early-stage investigators. And she reminded Council that the NEI-sponsored Woods Hole Vision Research Course will be held again this summer.
Dr. McNicol noted that FOA’s are time limited and need to be reissued every three years. This year the NEI reissued the R24 translational research FOA, and the NEI center core grant (P30) announcement moved to electronic submission for the first time. For clinical trials, U10 and UG1 FOA’s have just been released, and a new K12 institutional mentored clinical scientist development award FOA is expected to be out soon.
She mentioned that in FY2014 the NEI has been involved in co-funding several multi-institute and trans-NIH scientific initiatives:
Research Resource for Human Organs and Tissues
Brain Disorders in the Developing World: Research Across the Lifespan
U.S.-India Bilateral Collaborative Research Partnerships on Diabetes Research
High Throughput Screening to Discover Chemical Probes
Discovery of in vivo Chemical probes
Limited Competition for NIH-Industry Program: Discovering Pediatric New Therapeutic Uses for Existing Molecules
NIH Neurosciences blueprint
Big Data to Knowledge
The Basic Behavioral and Social Sciences Opportunity Network
She also mentioned that in a recent policy article in the journal Nature, NIH Director Francis Collins and NIH Office of Research on Women’s Health Director Janine Clayton discussed ways that NIH is addressing sex difference in research findings by requiring grantees to address inclusion of both sexes in preclinical research.
Dr. McNicol summarized several FY2014 administrative issues. There is a change in the eligibility criteria for applicants to the K99 Pathway to Independence Program. No more than five years of post-doctoral experience is now allowed, up from four. The NIH extramural community has held prolonged and heated discussion on the topic of raising the modular grant budget cap. No action was taken. A change in the Biosketch for grant applications now allows two extra pages to describe a person’s five most important scientific contributions and the role he/she played. The idea of “person” grants, rather than project-specific grants has been widely discussed. This concept grew out of the National Cancer Institute’s Outstanding Investigator Award, and other NIH ICs have been considering similar programs. NIH has also changed the resubmission policy. Following an unsuccessful resubmission (A1) application, a applicants may now submit the same idea as a new (A0) application for the next appropriate due date.
In budget news, Dr. McNicol mentioned that training stipends increased 2% for pre- and 4% for post-doctoral fellows, with the overall numbers of funded trainees held steady. The salary cap limit for investigators supported on NIH grants was raised 1%. And NIH established the policy that each IC’s K99 (Pathway to Independence) program will achieve a 30% award rate.
Council members commented on the highly negative reaction in the scientific community to the revised biosketch policy. They also posed questions regarding the implementation of equivalent gender/sex requirements to achieve reproducibility in preclinical and basic science studies involving animals, tissues, and cells.
UPDATE ON THE AUDACIOUS GOALS INITIATIVE (AGI)
Dr. Paul Sieving reviewed a “decade of remarkable biology’ which began in 2001 with the sequencing of the human genome. This led to the discovery of small interfering RNA, microRNA, the genetics of common complex diseases, induced pluripotent stem cells, human gene therapy, 3-D organogenesis. This led into a new decade with human stem cell therapy for age related macular degeneration and Stargardt’s disease, and CRISPR/CAS9 gene editing. This enabling biology and technology will allow us to build new discoveries and advances in the AGI.
The NEI Audacious Goal is “Regenerate Neurons and Neural Connections in the Eye and Visual System”. Its focus is on photoreceptor loss and ganglion cell injury. Many questions will need attention: What trophic factors 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 explained that implementation principles for the AGI include the leadership of a Scientific Steering Committee. It will be composed of five members, with rotating terms, drawn from a broad community base. Their charge is to support the science trajectory; evaluate yearly progress; make course adjustments as the science evolves; remain flexible and nimble as science changes; use transparent processes throughout; and insure collaborative, integrative, and cross-disciplinary science.
Dr. Sieving noted that the first Audacious Goal FOA, “Addressing Technical Needs and Opportunities for Imaging the Visual System”, has been issued. The NEI intends to commit a total of $5-6M in FY2015 to fund 4-6 awards to support the development of transformative imaging technology. He asked: again how do we monitor in vivo for functional success?
Dr. Sieving next reviewed the AGI Emphasis Areas. The first is “Molecular Therapies for Eye Disease”. The genetic and cellular basis of many eye diseases is known. Proof of concept has been demonstrated for human ocular gene therapy. New technologies are available for precise gene correction in vivo, and molecular design of light-sensitive molecules is feasible.
The second AGI Emphasis Area is “Explore the Intersection of Aging and Biological Mechanisms of Eye Disease”. Advanced age is the greatest risk factor for vision loss. How does the biology of aging contribute to vision disease? How does failure of homeostasis cause a transition from aging to disease? Biological staging of disease is required to understand clinical pathophysiology towards therapy.
Dr. Sieving stressed that the NEI remains committed to funding investigator-initiated research project grants. Discovery research will continue to be supported. In parallel with that, the AGI provides to opportunity to develop a concerted line of research across any laboratories in regenerative and developmental neurobiology and ultimately foster development of therapeutics for human disease.
Council members raised questions regarding how many funded grants already fall under the science areas covered by the AGI. Staff from the NEI Office of Program Planning and Analysis provided answers for retina and optic nerve, but noted that this was a difficult question to answer precisely because each grant may not be totally focused on the AG.
Members also asked if the applications for the AGI, which have a potentially higher premium on and innovation and a little more tolerance for risk, will have these characteristics considered in the process of their evaluation. Dr. McNicol replied that RFAs have specific review criteria that can address these issues. Council discussed the review process and the role of the AGI Steering Committee in achieving the goal and keeping the trajectory of the initiative on track. Council discussed the relative value of Program Announcements versus RFAs and asked why mechanisms other than U01s, such as Exploratory/Developmental R21s, weren’t being utilized. Dr. McNicol answered that U01s permit additional levels of oversight to ensure that milestones are met, and this mechanism allows greater flexibility in responding to emerging scientific findings. Council also asked what factors limit the number of applications which would be funded under the AGI FOAs. Dr. McNicol said the availability funds and the number of highly meritorious applications.
CLOSED SESSION OF THE MEETING
The meeting was closed to the public at 1:30 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
The meeting was adjourned at 5:00 p.m.
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.
Anne E Schaffner, Ph.D.
Interim 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.
Departments of Molecular and Cellular Neuroscience and Chemical Physiology
The Scripps Research Institute
La Jolla, CA
Laura J. Frishman, Ph.D.
College of Optometry
University of Houston
Jonathan L. Haines, Ph.D.
Professor and Chair
Department of Epidemiology and Biostatistics
Case Western Reserve University
Stephen McLeod, M.D.
Professor and Chair
Department of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
John C. Morrison, M.D.
Department of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
Kathleen M. Petrillo, J.D.
Senniger Powers, LLP
St. Louis, MO
Eric A. Pierce, Ph.D., M.D.
Ocular Genomics Institute
Massachusetts Eye and Ear Infirmary
Harvard Medical School
Krishna K. Sharma, Ph.D.
Departments of Ophthalmology and Biochemistry
Mason Eye Institute
University of Missouri-Columbia
Monica L. Vetter, Ph.D.
Department of Neurobiology and Anatomy
University of Utah
Medical Research and Education Building
Salt Lake City, UT
Jayne S. Weiss, M.D.
Professor and Chairman
Department of Ophthalmology
Louisiana State University
School of Medicine
New Orleans, LA
Sheila K. West, Ph.D.
Department of Ophthalmology
Wilmer Eye Institute
Johns Hopkins University
Rafael Yuste, M.D., Ph.D.
Departments of Biological Sciences and Neuroscience
New York, NY
Marco A. Zarbin, M.D., Ph.D.
Professor and Chair
Institute of Ophthalmology and Visual Science
UNDNJ-New Jersey Medical School