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<span>NAEC Meeting Minutes - June 12, 2020</span>
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<div class="c-jump-menu__intro">On this page:</div>
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<a class="c-jump-menu__item" href="#section-id-15807">Council, Staff, and General Public Present</a>
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<a class="c-jump-menu__item" href="#section-id-15813">Opening Remarks</a>
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<a class="c-jump-menu__item" href="#section-id-15817">Administrative Details</a>
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<a class="c-jump-menu__item" href="#section-id-15819">Budget Update</a>
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<a class="c-jump-menu__item" href="#section-id-15821">Council of Councils Debrief </a>
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National Eye Institute
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<p>National Advisory Eye Council<br>
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One Hundred Fifty-Fifth Meeting<br>
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June 12, 2020</p>
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<ul>
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<li><strong><a href="https://youtu.be/-qfN7AQtqto">Videocast</a></strong></li>
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<p>The National Advisory Eye Council (NAEC) convened for its one hundred and fifty-fifth meeting at 10:00 am on Friday, June 12, 2020. The meeting was conducted via a ZOOM Webinar. Santa Tumminia, PhD, Acting Director of the National Eye Institute (NEI), presided as Chair of the Council, Anne E. Schaffner, PhD, as Executive Secretary, and Michael Steinmetz, PhD, as Director of Extramural Science Programs. The meeting was open to the public from 10:00 am until 1:30 pm. The meeting was closed to the public for a session from 2:10 pm until 3:30 pm for the review of confidentiality and conflict of interest procedures, grant and cooperative agreement applications.</p>
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Council Members Present:
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<p>Dr. Eduardo Alfonso<br>Dr. Jose-Manuel Alonso<br>Dr. Tereté Borras<br>Dr. James Coughlan*<br>Dr. Katia Del Rio-Tsonis<br>Dr. Thomas Gardner*<br>Dr. Mary Elizabeth Hartnett<br>Dr. Renu Kowluru<br>Dr. Carol Ann Mason<br>Dr. Mary Ann Stepp<br>Dr. Benjamin Teller<br>Dr. Russell Van Gelder<br>Dr. Marco Zarbin<sup>t</sup></p><p>*<em>ad hoc</em> members<br><sup>t</sup>present for closed session only</p>
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Panelists
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<p>Dr. Houmam Araj<br>Dr. Neeraj Agarwal<br>Dr. Steven Becker<br>Dr. Sangeeta Bhargava<br>Dr. Brian Brooks<br>Ms. Karen Colbert<br>Dr. Mary Frances Cotch<br>Dr. Emily Chew<br>Dr. Martha Flanders<br>Dr. Shefa Gordon<br>Dr. Thomas Greenwell<br>Dr. Brian Hoshaw<br>Dr. George McKie<br>Dr. Sheldon Miller<br>Ms. Karen Robinson-Smith<br>Dr. Anne E. Schaffner<br>Dr. David Schneeweis<br>Dr. Michael Steinmetz<br>Mr. Brian Trent<br>Dr. Santa Tumminia<br>Dr. Michael Wright<br>Ms. Maria Zacharias</p>
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Members of the General Public Present as Panelists
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<p>Mr. James Jorkasky, Executive Director, NAEVR (National Alliance for Eye and Vision Research)</p><p><strong>OTHER NEI STAFF, NIH STAFF, AND MEMBERS OF THE PUBLIC WERE PRESENT AS ATTENDEES</strong></p><p><strong>CALL TO ORDER OF THE OPEN SESSION OF THE MEETING AT 10:00 AM</strong>–<br><em>Dr. Santa Tumminia, Acting NEI Director</em></p>
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Introductory Remarks
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<p><em>Dr. Anne E Schaffner, Acting DEA Director and Executive Secretary of the NAEC</em></p><p>Dr. Schaffner thanked all those present and reviewed Webinar etiquette regarding muting, turning off video to increase bandwidth and facilitate sign language interpretation, asking questions and voting. She then turned the meeting over to the Acting NEI Director.</p>
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Opening Remarks
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<p><em>Dr. Santa Tumminia, Acting NEI Director</em></p><p>Dr. Tumminia added her welcome and thanks to panelists and attendees. She introduced the four new Council members: Dr. <a>Terete Borrás</a>, Professor in the Department of Ophthalmology at the University of North Carolina, has expertise in the areas of the trabecular meshwork and gene therapy for glaucoma. Dr. James Coughlan, a Senior Scientist at Smith Kettlewell Institute in San Francisco, has expertise in the design and development of assistive technologies for the blind and visually impaired. Dr. Thomas Gardner, a clinician scientist and Professor at the Kellogg Eye Center at the University of Michigan, has expertise in retinal diseases and clinical trials. Dr. Renu Kowluru, Professor in the Department of Ophthalmology, Visual and Anatomical Sciences at Wayne State University, has expertise in diabetic retinopathy including the role of mitochondria and epigenetics.</p><p>Dr. Tumminia told the group that the appointment of a new, NEI Director is forthcoming. The appointment of a new Scientific Director is being put on hold until after the new NEI Director has been selected. Dr. David Schneeweis is currently serving as Acting Scientific Director. Several former NEI staff have retired or moved on to other jobs. Dr. Jerome Wujek, who managed the small business portfolio retired in May. Dr. Wai Wong, Senior Investigator and Chief of the Section on Neuron-Glia Interactions in Retinal Diseases, left the NEI in February to become Vice President for retinal diseases at the Janssen Pharmaceutical companies of Johnson and Johnson. Dr. Wong was well-known for elucidating basic physiological properties of innate immunity including how they contribute to degeneration of photoreceptors.</p><p>New employees included Dr. Paek Lee from CSR who will be assuming management of the small business portfolio, and Natalia Gordiyenko, also from CSR, who will be managing a retinal grant portfolio. A new Director of the Division of Extramural Activities (DEA) has been selected, but the name was being withheld until after they have completed the onboarding process. Dr. Tumminia thanked Dr. Schaffner for her job as Acting Director since January of 2019. In other news, Dr. Kapil Bharti, a Senior Investigator and Chief of the Ocular Stem Cell Translational Section, received IND approval for his novel, stem cell-derived, RPE replacement Phase I clinical trial. It involves a patient-derived stem cell therapy to replace and repair dying cells in the retina to treat geographic atrophy, the advanced dry form of AMD. Three of 12 subjects have been enrolled.</p><p>Dr. Tumminia then gave a brief overview of the open session presentations, which included a budget report, a debrief from the Council representative on the Council of Councils, updates on program planning and regenerative medicine, and a presentation on the Anterior Segment Initiative also known as ASI. Topics that came up on a Fall 2019 RFI (Request for Information) for the ASI included inflammation, ocular pain, immunology, and the microbiome.</p><p>Dr. Tumminia presented an update on NIH’s policies for addressing sexual harassment related to NIH-funded research. She also commented on COVID-19 and the current societal unrest. She emphasized that the NEI is committed to establishing an inclusive and healthy work environment and supporting research that is diverse, inclusive, and supportive. All of NIH, including the NEI, have been involved in planning processes for the development of diagnostics, therapeutics, and a vaccine for COVID-19. Many pharmaceutical companies are also involved to gear towards speed and coordination of efforts. There are 4 RADx programs at NIH. RADx Tech is a 500-million-dollar, 3-phase challenge program, to find the best candidates for at home or point of care diagnostics and the development of easy to use testing technologies for SARS-Co-V-2. Out of 2200 applications, 58 are in phase 0 (selection phase) and 9 are in phase 1. Phase 2 will be clinical testing, regulatory approval and scale up. RADx ATP is an advanced testing, 230-million-dollar program. The third is RADx RAD for RADx Radical. It is a $200 million program to develop and advance novel nontraditional approaches for, or new applications of existing approaches, for diagnostic testing. The last program is RADx UP, short for RADx Underserved Populations. That is also a $500 million program focused on implementation strategies to enable and enhance testing of COVID-19 in underserved and vulnerable populations. Several NEI staff are involved in these programs. The NEI Intramural program is also participating in COVID-19 research. Dr. Tumminia acknowledged the anxieties in the grantee community due to COVID-19 related lab closures. The NEI is exercising maximum flexibilities within any allowable limits for currently funded NEI grants.</p><p>A Council member asked if funds for COVID-19 would compromise monies available for eye research. Dr. Tumminia said no; those were separate appropriations and shouldn’t impact our current appropriation or future appropriation</p>
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Administrative Details and Minutes from January Council
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<p><em>Dr. Anne E Schaffner, Acting DEA Director and Executive Secretary</em></p><p>The Executive Secretary called for and received approval of the January 2020 NAEC Minutes from Council members. Dr. Schaffner then mentioned the spreadsheet on the ECB of all NEI-supported and participating PARs and RFAs. Council approved the re-issue of NEI’s R24 PAR for translational research and the K12 for institutional clinical research training. A Council member asked a question of the NEI’s training officer, Dr. Neeraj Agarwal. Would the K12 program be de-emphasized, given the fact that trainees on individual K’s have better success at obtaining an R01 than trainees on institutional awards? Dr. Agarwal said that the K12 will be re-issued, and the program will be retained. Dr. Michael Steinmetz added that, while the NEI does not want to “pull the rug” out from under departments depending on a K12, the NEI would be migrating slots from both T32 and K12 institutional training grants to individual F and K awards. This decision was based on data from the National Academy of Medicine and an NEI analysis that indicated that trainees who held individual awards had higher success rates for subsequent R01s than those who were on institutional awards.</p>
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Budget Update
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<p><em>Ms. Karen Colbert, Budget Officer, Office of the Director</em></p><p>Ms. Colbert began her presentation showing the history of NIH and NEI success rates from 2013 through 2019. She explained that success rates are determined by dividing number of competing applications funded by the sum of the total number of competing applications reviewed and the number of funded carry-overs. Funded carryovers are those applications that were reviewed and not funded in the review year but were refunded in next year. Information indicated that the NEI’s success rate increased to 28% while NIH's success rate has remained constant at 20%. NEI operating levels versus buying power from 1999 through 2019 were also displayed and indicated that the buying power has been shrinking due to inflation and other recissions (money taken out of the NEI budget by NIH for specific programs). Ms. Colbert then gave a brief overview of the budget process. It begins in the early Fall with budget submissions by the Department of Health and Human Services (DHHS) to the Office of Management and Budget (OMB), which considers the request in light of the President’s budget/priorities. Initial decisions by OMB are passed back to the agency, which submits a final budget request to OMB. The President submits the budget request sometime in January, before his state of the union address. Congress weighs in on the budget in the Spring, first the Senate in April, and then the House in May. The House and Senate start markups in late June. Markup is the process by which Congressional committees and subcommittees debate, amend and rewrite proposed legislation. An official appropriation is due on October 1. However, sometimes the appropriation is stalled, and then the government is faced with a shutdown or a continuing resolution. There has been a history with the current administration requesting significant cuts to the NIH and NEI budgets. Congress, however, has prioritized NIH research and proposed budget increases. For 2020, the NIH budget could have been cut by 13% and the NEI budget by 14%. Ultimately, in FY2020, NIH received 6.7% or a 2.6-billion-dollar increase. NEI received 3.5% or a 27.6 million increase over FY2019. There is the expectation that funding increases will be followed by an increase in competing awards. However, the increases in the budget barely keep up with inflation.</p><p>Specifics regarding the NEI budget followed. Eighty-five percent or 698.8 million dollars of NEI’s FY 2020 operating budget was distributed to research activities including all grants and contract mechanisms. Eleven percent or 93.5 million dollars was estimated to be spent on intramural research. Remaining funds at 4% or 31.1 million dollars, will cover administrative, logistical, and scientific support for the NEI programs and includes administrative functions such as awarding grants and contracts, planning and evaluation and other management activities.</p><p>Ms. Colbert also addressed supplemental bills in 2020. As a result of coronavirus pandemic within the last few months, Congress has passed several supplemental appropriations bills. The first bill was the Coronavirus Preparedness and Response Supplemental Appropriations Act, which passed with near unanimous support in both the House and Senate. This bill provided $8.3 billion in emergency funding for federal agencies to respond to the coronavirus outbreak. Of that $8.3 billion, $6.7 billion is designated for domestic response, and $1.6 billion for international response. The majority of the funding for the domestic response, which was $6.2 billion, went to Department of Health and Human Services, 3.4 billion to the Public Health and Social Services Emergency Fund, $1.9 billion to the CDC, $836 million to the National Institute of Allergy and Infectious Diseases, which conducts research on therapies, vaccines, diagnostic and other health technologies here at NIH, and $61 million to the FDA for development and review of vaccines, therapeutics, medical devices, counter measures and to address potential supply chain interruptions. Later supplements included the Families First Coronavirus Response Act, the Coronavirus Aid Relief and Economic Security or CARES Act (with an additional $945 million for NIH to expand COVID-19 research plans), an Interim Coronavirus Relief Bill called the Paycheck Protection Program and Healthcare Enhancement Act. The latter bill included $1.8 billion for NIH to accelerate development of point of care and rapid diagnostic technologies, $306 million of which to be transferred to National Cancer Institute, $500 million to the National Institute of Biomedical Imaging and Bioengineering, and $1 billion to the NIH Office of the Director, with transfer authority to the accounts of the institutes and centers of the NIH. The last supplement passed was the Heroes Act, which was signed into law on May 15th provides an additional $500 million for National Institute of Allergy and Infectious Diseases, $200 million for the National Institute of Mental Health and $4.021 billion to the NIH Office of the Director to prevent, prepare for and respond to coronavirus domestically and internationally. Three billion dollars of the amount provided is designated for offsetting the costs related to reductions in lab productivity resulting from the coronavirus pandemic or public health measures related to the coronavirus pandemic, and $1.021 billion in transfer authority to the institutes and centers.</p><p>The outlook for 2021 to date indicated that the President, via OMB, proposed a 7% reduction to NIH budget, and a 9% reduction to NEI. If this budget request actually came to fruition, the NEI would have to cut approximately 125 awards across all grant activities except for NRSA training slots and cut approximately $63 million from the extramural research budget. Given that Congress controls final funding amounts and not the President, drastic cuts like this are not expected in 2021.</p><p>Ms. Colbert entertained questions. A Council member asked about the appropriation for loss of lab productivity and wondered if there was a plan for how that would be implemented. Ms. Colbert said that this has been a very fluid process, and she didn’t know what funds would be available.</p>
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Council of Councils Debrief
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<p><em>Dr. Russ Van Gelder, Council and Council of Councils member</em></p><p>Dr. Van Gelder gave a brief overview of the history and purpose of the Council of Councils. The Council of Councils is an arm of the Division of Program Coordination Planning and Strategic Initiatives (DPCPSI) that was established in 2006 in the NIH Reform Act of that year. It acts in an advisory capacity to the Director primarily regarding resources to coordinate across the NIH, i.e., the Common Fund, whose budget is just over $600 million a year. Members are made up of nominees from the 27 individual institutes and centers who hold 6-year terms. Jim Anderson, a Deputy Director of NIH, Chairs the Council of Councils, and Franziska Grieder, Director of the Office of Research Infrastructure Programs (ORIP) in the DPCPSI, is Executive Secretary. Dr. Van Gelder had attended 2 meetings. The Council of Councils has 2 main purposes. One is to serve in an advisory capacity to ORIP to administer the National Primate Centers, and the second is to review Common Fund initiatives. There was approval for the re-issue of several initiatives including the Pioneer Award, New Innovator Award, Transformative Research Award, Early Independence Award, and HIV Scholars Award through ORIP for K01’s and R21’s. Other activities included a Common Fund concept clearance in May on the design and use of Artificial Intelligence platforms, for biomedical and behavioral research to provide a common protocol for submitting data sets to ensure interoperability. There was also clearance of an Office of Dietary Supplements concept for administrative research on dietary supplements; obviously some NEI research on AREDS type vitamins falls under that umbrella. There are several working groups within the Council of Councils, including a new basic behavioral and social science research working group, and Dr. Van Gelder made the plea to include sensory deprivation diseases such as blindness and deafness in the area of behavioral research. There was discussion of strategic planning concept clearances for programs to improve gender and racial equity, and diversity and inclusion within NIH. There was a presentation by Dr. Hannah Valentine, the Director of the office for Scientific Workforce Diversity, on a concept clearance for faculty institutional recruitment for sustainable transformation. This would be a program to set up centers of excellence for the advancement of scientists from underrepresented minority backgrounds, and essentially create critical masses at specific institutions large enough to support a vibrant community. This was a bit controversial due to the amount of money it would cost ($250 million) and a concern that it may result in an actual decrease in diversity at other institutions if there is cross-institutional recruitment. Dr. Van Gelder shared some general concerns. He wanted to be sure that the NEI, even with its small budget that amounts to about 2% of the total NIH budget, still has a voice at the table, and the best mechanisms for coordination between this Council, and the Council of Councils to ensure that the NEI's voice is heard at that larger table. He also wanted to establish an open line of communication for any Council member and the Director of Extramural Activities.</p><p>In response, Dr. Schaffner said that Dr. Van Gelder was welcome to present Council of Council deliberations at future Council meetings to remain an active liaison with that group. There were no other questions.</p>
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NEI Strategic Planning Update
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<p><em>Dr. Shefa Gordon, Director, Office of Program Planning and Analysis and Associate Director for Science Policy and Legislation, Office of the Director</em></p><p>Dr. Shefa Gordon presented an update of the NEI Strategic Plan entitled, “2020 Vision for the Future.” The first step was an RFI that generated over 250 responses that were used to further develop the plan. Three domains and 7 areas of emphasis were defined: Visual System in Health and Disease (Genes to Disease Mechanisms, Biology and Neuroscience of Vision, Immune System and Eye Health), Capitalizing on Emerging Fields (Regenerative Medicine and Data Science), and Preventing Vision Loss and Enhancing Well-Being (Individual Quality of Life and Public Health and Disparities Research). Each panel will meet 3 times (virtually) for about 90-minute sessions. Each panel has 12-13 experts plus 2-5 NEI program or planning staff. The panels are very diverse with respect to gender, race/ethnicity, age, geography, area of expertise, degree (MD, PhD, OD). Panelists are blind, partially vision impaired or fully sighted.</p><p>The Gene to Disease Mechanisms panel had experts in rare diseases and gene therapy. A past (Lou Pasquale) and current Council member (Renu Kowluru) are on the panel. Highlights included 7 main topics: databases (standardization and harmonization), new model systems, aging, angiogenesis, sex hormones, redox biology, and collaborations/talent pool (to expand interactions beyond ophthalmology and vision research departments). This panel has met 3 times.</p><p>The Biology and Neuroscience panel has met twice, and the Council representative is Jose-Manuel Alonso. Highlights included the BRAIN Initiative, visual circuit dissection, molecular responses, plasticity, CVI and visual decision making. An emphasis in all areas was the application of newly developed technologies and tools to questions involving the nervous system. The development of functional assays for CVI was also a priority.</p><p>The Immune System and Eye Health panel has also met twice, and the Council representative is Russ Van Gelder. Panel highlights included 1) the gut microbiome, 2) infectious eye diseases such as herpes, uveitis, Ebola and SARS-CoV-2, 3) AMD/chronic degenerative diseases, 4) immunotherapy, 5) alternatives to steroids, 6) immunosenescence, 7) functional mapping of genes in the immune pathway, 8) neuroimmunology and “immune privilege” (lymphocytes and cytokines), and 9) live quantitative imaging of ocular immune responses.</p><p>Regenerative Medicine has 2 Council representatives, Marco Zarbin and Katia Del Rio-Tsonis. There are also industry members and bioengineers on board. Highlights were the 1) human immune response, 2) material transfer after transplantation, 3) automation and AI to improve cell manufacturing and quality, 4) direct reprogramming of cell types such as Muller cells into rods and RPE into retinal neurons, and 5) recent advances in retinal organoids, extracellular vesicles and biomaterials.</p><p>Data Science was a new and more unique area. This panel has met once and has a mix of expertise including academic data scientists, data generators, industry, and a bioethicist from the Patient-Centered Outcomes Research Institute (PCORI) to look at the bioethics concerns of data science. Dennis Levi is the Council representative. NIH recently put out an NIH-wide data science plan, and the NEI will build off that when planning its own data strategies. The main topics included big data and concerns with privacy, data sharing incentives and standardization of de-identification procedures, storage, and formats. Other topics were artificial intelligence, computational advances, the challenges of training a future workforce, and an NAEC idea of creating centers of expertise to bring together data generators and data scientists.</p><p>The panel on Individual Quality of Life is co-Chaired by Lofti Merabet and Ava Bittner. Mary Elizabeth Hartnett and James Coughlan are the Council representatives. Expertise on the panel ranges from rehabilitation to mental health and assistive device developers, to low vision educators and epidemiologists. Veterans Affairs and the American Federation of the Blind are represented on the panel. Topics of interest for this group were brain-related visual impairment due to CVI, TBI and stroke, telemedicine, comorbidities, strategies to improve mental health/wellness, technology/communications (better access to mobile- and internet-based applications), rehabilitation and navigators for the visually impaired, educational tools, barriers to employment of the visually impaired, and promoting independence through the development of driving and navigational tools.</p><p>The Public Health and Disparities Research panel had members with expertise in the areas of epidemiology, community health and clinical trials, health economy, and biostatistics. The 2016 NASEM [<a href="https://www.ncbi.nlm.nih.gov/books/NBK385157/%20">https://www.ncbi.nlm.nih.gov/books/NBK385157/</a>] report provided a foundation for the group discussion. Topics included obtaining improved epidemiological data, especially in pediatric and underserved populations, behavioral economics, cost-effectiveness research to look at cost savings and improved health outcomes, development of tools to increase access to care such as telemedicine, harmonization of study designs and outcome measures, health behavior research and health care delivery models, diversity of NEI-supported researchers, and community engagement and social determinants of health and health literacy.</p><p>Dr. Gordon presented a timeline and next steps for the planning process. There were 4 more panel meetings following the Council meeting, after which a draft of the plan would be ready to present at the October Council meeting. The new NEI Director will also have input into the planned direction with a final document completed by the end of 2020. The floor was then open for questions. There were none.</p>
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<div class="c-section" id="section-id-15825">
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<h3 class="c-section__heading">
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AGI and RMIP Updates
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<p><em>Dr. Steven Becker, Associate Director, NEI Office of Regenerative Medicine (ORM), Office of the Director</em></p><p>Dr. Becker went through a brief history of the NEI’s Audacious Goals Initiative (AGI) that began in 2013 with a prize competition and a 200-person meeting. The established goal was to regenerate retinal neurons and their connections lost or damaged due to disease. Three consortia have been funded: Functional Imaging, Discovery (factors) and Translational Models. Several workshops were also held, the latest on “Understanding Human Retina Biology and Perception.” Due to the pandemic, 2 consortium meetings and an ARVO Town Hall were postponed or canceled. Workshop members are working on several issues raised during the meeting including areas where information is lacking including disease processes and the microenvironment of the retina. A white paper is being written. The next virtual workshop planned will be on immunology of retinal transplants.</p><p>A second program is the NEI’s 3-D Retina Organoid Challenge, a prize competition to improved retinal models for disease modeling and drug development. Final submissions are due October 1, 2020 and an informational webinar will be held June 30, 2020.</p><p>Another program is the AMD Integrative Biology Initiative. There are now available 11 pluripotent cell lines generated from AMD patients who were part of the AREDS2 study. Additional cell lines will become available by the end of the summer from the New York Stem Cell Foundation (NYSCF). Cell lines will be available to both academic and commercial entities, and isogenic controls, where risk alleles have been corrected, will also be available. Requests should be made to <a href="mailto:repository@nyscf.org">repository@nyscf.org</a>. A list of lines is also available on their web site. The lines also have accompanying clinical, imaging, and genetic data available for the patients from whom the cells were derived. This data will be housed on the NIH Biomedical Research Informatics Computing System (BRICS).</p><p>The NEI Office of Regenerative Medicine launched several new resources including a virtual seminar series, monthly newsletters via listservs, information on their web site and materials at the virtual NIH ISSCR (International Society for Stem Cell Research) annual meeting.</p><p>Dr. Becker gave some background on the NIH Regenerative Medicine Innovation Project (RMIP) that was established by the 21<sup>st</sup> Century Cures Act, which authorized $30 million in federal awards over a 4-year period from 2017-2020. Recipients must provide matching non-federal funds and make their adult stem cells available for independent characterization through a program called the RM Innovation Catalyst (RMIC). A recent RMIP funding announcement was for a clinical trial (UG3/UH3) using products already developed in pre-clinical studies where successful applicants will obtain an investigational new drug (IND) authorization or an investigational new device exemption (IDE) to administer the products to humans.</p><p>Dr. Becker expressed a desire to further develop concepts for one or several FOAs related to: promoting characterization of IPSC lines from AMD patients, development of protocols and assays for functional tests, and correlating genetic variants with mechanisms driving disease progression. Council members present unanimously approved the further development of the FOAs. There were no further questions.</p>
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<div class="c-section" id="section-id-15827">
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<h3 class="c-section__heading">
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Concept Clearance for Re-issue of the AGI U24 FOA on Translational Enabling Models
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</h3>
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<p><em>Dr. Thomas Greenwell, Program Officer for Retinal Neuroscience, and Development and Regeneration, and a member of the NEI’s AGI Working Group</em></p><p>Dr. Greenwell shared that previous workshops and a portfolio analysis had emphasized the importance of a team approach to generate improved animal models to better understand the fundamental biology of regenerative processes. An initial FOA was released in December 2017, and 5 projects were funded proposing the development of animal models including tree shrew, ground squirrel and non-human primates. Reviewers commented that other, nonfunded projects had needed additional development and preliminary data. The NEI thus issued an FOA for an R21 in December 2018 to allow investigators to generate preliminary data in anticipation of a U24 re-issue. Nine R21 projects were funded, several of which are currently in no-cost extensions due to the pandemic. The new U24 will focus on NHP models that recapitulate human disease and are amenable to stem cell approaches. The proposed funding for 3-5 grants will be in the range of $4-5 million. Dr. Schaffner called for a vote of approval on the re-issue of the U24 mechanism for model development. Council members present were unanimous in their approval.</p>
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<div class="c-section" id="section-id-15829">
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<h3 class="c-section__heading">
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Concept Clearance for Possible Re-issue of the BRAIN Initiative R21 FOA on New Concepts and Early Stage Research for Large-scale Recording and Modulation of the Nervous System
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</h3>
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<div class="c-text">
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<p><em>Dr. Martha Flanders, Program Officer for Central Visual Processing, and Director of the NIH’s BRAIN Initiative New Concepts R21 Program</em></p><p>Dr. Flanders began with a description of the R21 (RFA-EY-18-001), which supports small, innovative projects for large-scale recording in the nervous system. The R21 is the first stage in a pipeline that would eventually lead to larger and more translational grants such as the R01 and U24. The grant supports $300,000 in direct costs over 2 years. About half the applicants are early stage or new investigators. Applicants have varied backgrounds that include physics, material science and engineering. The techniques proposed include development of optical, biosensory, and electrical modalities. She then described two funded applications, one brain and one vision-related, to emphasize both the range of the science and the multi-disciplinary nature of the teams. The grants are funded through BRAIN, but these R21 grants are reviewed and managed administratively by the NEI. Dr. Schaffner asked if the “possibility” of re-issue was due to a lack of funds or if the BRAIN group felt that the best ideas had already been funded, since the RFA has been out for 5 years. Dr. Flanders said that with the arrival of a new BRAIN Initiative Director, the trans-NIH working group wants to allow him to make decisions about the RFAs going forward. There were no other questions, so Dr. Schaffner asked for Council’s approval of the re-issue. All Council members present approved the re-issue.</p>
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</div>
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<div class="c-section" id="section-id-15831">
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<h3 class="c-section__heading">
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Anterior Segment Initiative (ASI) Update
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</h3>
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<p><strong>Dr. Sangeeta Bhargava, Collaborative Clinical Group, and Dr. George McKie, Program Officer for Cornea with an introduction by Dr. Michael Steinmetz, Director of the Division of Extramural Science Programs (DESP)</strong></p><p>Dr. Steinmetz reminded the audience that Dr. Houmam Araj had presented an introduction to the ASI<strong> </strong>at the previous Council meeting. He credited Dr. Araj for assembling a group of Program Officers, Review Officers and staff members in the Office of the Director with the purpose of distilling ideas for future RFAs in possible areas of ocular pain, dry eye, and involvement of the microbiome in ocular diseases. The public face of the initiative began with a Request for Information (RFI) and internally, there were several portfolio analyses done. The NEI decided, initially, to focus on the area of ocular inflammation, since it had generated a large number of comments from the RFI and appeared to be an area of need within several portfolios.</p><p>Dr. Bhargava stated that the ASI used the AGI as a prototype and gave a brief history of the ASI. The RFI was out in late 2019 and received 52 responses from over 200 stakeholders (several responses had multiple signatories). Over half of the respondents wanted NEI to support more work in inflammation. Specific topics were a basic understanding of inflammation, the involvement of the immune system and delivery of immunotherapies, cross talk between different mucosal sites, and the need for new and better model systems, technology (imaging), and data banks for clinical samples. Development of the ASI occurred simultaneously with program planning, and both Drs. Bhargava and McKie were members of Immunology and Eye Health panel. Inflammation received significant attention from the program planning group with discussion of the need to capitalize on new technologies to understand inflammation, the need for novel treatments, whether inflammation is a risk factor for eye disease, regulation of host immunity, and the mechanism of intestinal microbiota-induced immunomodulation. Analyses of the NEI portfolios in both basic immunology and clinical trials were conducted. The basic science portfolio has about 65 active grants focused on AS inflammation, notably drug treatments, and only 20 involve immune components of disease. On the clinical side, an examination of ClinicalTrials.gov revealed a large number of studies on the AS (cornea, eye infection, uveitis, or keratitis for example) conducted by the NIH and both extramural and intramural components of the NEI. Three general themes were apparent: the normal/homeostatic state, the disease state, and resolution of inflammation. Both the RFI and program planning analysis revealed a perceived need for multidisciplinary teams to address problems in these 3 areas.</p><p>Dr. McKie followed with a short presentation on more specific questions related to the 3 thematic areas. For the normal/homeostatic state the main questions involved the nature of the resident immune cells, their interactions with other cells in the AS, the contribution of cell signaling of non-immune cells and the role of cells of innate and adaptive immunity to homeostasis, and the need for better animal and human model systems. The disease state also generated several topics of interest including the need for better animal models that recapitulate human disease, the role of inflammasomes, changes in neuroimmune cross-talk that lead to disease, the need for biomarkers, obstacles to therapy, and the alteration in the biofilm caused by contact lenses and sutures. The last theme was resolution of inflammation, a very complex problem. Previous research targeted anti-inflammatories like corticosteroids, but there is a need to move beyond that class of drugs. There is a need to understand whether resolution is a general or eye-specific process, and there is a need for human clinical samples and again, more animal models that recapitulate the inflammatory process in human eyes. Three possible topics for further development emerged: dynamic neuroimmune interactions from normal to disease states, immunosenescence and its role in inflammation and resolution of inflammation. The plan will be to take all the information garnered from the RFI, portfolio analyses and program planning and have targeted workshops, NOSIs (Notice of Scientific Interest) and FOAs. Concept clearance from Council will be sought for future workshops and FOAs.</p><p>Dr. McKie opened the floor for questions. One Council member thanked the presenters for the summary and said that input from town halls (workshops) is enormous. The field is vulcanized and granular in terms on interests and it would be important to find common ground best suited for an FOA to move the field forward. He went on to say that this area has not received a lot of attention and support but is a major source of blindness and disability. Another Council member also applauded the focus on inflammation. A third member commented on the studies on clinicaltrials.gov and wanted to take a more granular look to see if the NEI can partner with industry to share costs of trials, especially given the current state of the economy in the pandemic. Dr. Bhargava commented on the public partner aspect and said that our trials do partner with pharmaceutical companies to provide drugs or devices. Dr. Steinmetz said that the NEI should take a deeper look and direct our basic science approaches to identify druggable targets that pharma might have an interest in.</p>
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</div>
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</div>
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<div class="c-section" id="section-id-15833">
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<h2 class="c-section__heading">
|
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General Council Discussion
|
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</h2>
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<div class="c-text">
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<p>Dr. Tumminia thanked the presenters and Dr. Van Gelder for relaying information on the Council of Councils. She emphasized the need for communication between that NIH Council and ours to ensure that the NEI has a voice at the table. She then opened the floor for general Council discussion.</p><p>A member complimented Dr. Shefa Gordon for his leadership in the program planning process. His one concern, as a member of a program planning panel, was the limited time people will be able to devote to the process. He felt that the next stage, the final distillation of topics and writing/editing of related documents, would require a lot of attention. It would also be important to clearly communicate to the panels what would be expected regarding concrete deliverables, such as what topics are within the bandwidth of the NEI (due to limited resources) and what the priorities should be. Dr. Gordon reminded the audience that a considerable amount of work goes on behind the scenes, not just the 3-4-hour panel sessions. He acknowledged that the work ahead will be daunting, but a 50 page, public-facing document could be a “2 for 1” and include a document to be presented to Congress. There will also be an implementation document that will include details not found in the public document for the benefit of staff and the new NEI Director. Some panels have already been asked to rank or prioritize areas they discussed. The same Council member said that a “3 for 1” might be possible if the Chair(s) were given the opportunity to write up the results as a white paper (e.g., The State of Computational Ophthalmology) to be published in the peer-reviewed literature, in journals such as IOVS. Another member echoed the previous remarks and said that she would welcome short papers on each topic. Dr. Tumminia agreed and commented that this had been a much more forward-looking process and recognized the enthusiasm and engagement on the part of both staff and members of the community who were on the panels. The Council member then mentioned that version 2 of the BRAIN 2025 document went through a similar process. Another Council member said that all the work that went into the process would be appreciated by the new NEI Director, who would be receiving an updated plan going forward that would jump-start what happens in the upcoming year. She also added her thanks for the time and hard work that went into program planning.</p><p>A Council member asked Dr. Van Gelder to say something more about the Centers of Excellence. Dr. Van Gelder answered that the Centers were meant to improve the success of underrepresented groups in science. A Blue-Ribbon panel met to review progress in that domain. Their conclusion was that while individual institutions have successfully recruited individuals these groups, the rates are not what the NIH would like to see. The root cause might have been that many institutions were recruiting from a small pool of individuals, and the support structure within any given institution was insufficient to help foster their careers, including the availability of peer mentors. The Centers, with funds available from the program, would give competitive institutions the ability to recruit outstanding URMs and provide a local, deep support network of peer faculty as well as a career development plan specific for that institution. Despite enthusiasm for such a program, two counter arguments arose. This approach would effectively give a small number of institutions (~ 12-24) tremendous resources (the total was ~ $25 million), and might also attract faculty away from other institutions, thus countering their efforts to attract minority faculty and reduce their diversity. The Council of Councils did give approval for concept clearance of this idea, but there has been no FOA at this point. Dr. Van Gelder did mention that this would not result in a “winner take all” situation where large, already well-funded institutions would be the only recipients. Any FOA would be coming from the NIH Director’s Common Fund Initiative. Dr. Tumminia emphasized the awareness of the issues around the perceived advantage that larger institutions would have. Dr. Tumminia also mentioned the lower success rates of URMs for NIH funding, which appeared to be related to the types of studies that were favored by URMs, notably in the social, community and behavioral sciences, which don’t tend to score as well in study sections. The NIH recognized that those are important areas and is looking at ways to increase the success of those types of applications in the review process. Another Council member expressed some concern about the NEI’s 2% portion of the NIH budget and how that might affect getting our voice heard. She wondered if there were other small institutes in a similar situation, and what they might be doing to be heard at the larger table. Dr. Van Gelder agreed that this is a challenge. He felt the key was to use the forum effectively and speak out when there are issues that affect the NEI or where the NEI has something to contribute. As an example, in the area of data science, the vision community has a leadership position. We have the first FDA-approved deep learning system for the diagnosis of diabetic retinopathy. Other areas would be gene therapy and regenerative medicine. Dr. Van Gelder was hoping to have something to contribute to the big data format. He emphasized his desire to have open communication between the Council of Councils and the NAEC through the DEA Director, perhaps by sharing Council of Councils material with NAEC members before a Council meeting to get their feedback.</p><p>Dr. Bruce Reed, Deputy Director at the Center for Scientific Review offered some comments on the observation of the differences in award rates among different scientific topics. He said that the simple conclusion of a recent study, published in Science Advances [<a href="https://advances.sciencemag.org/content/5/10/eaaw7238">https://advances.sciencemag.org/content/5/10/eaaw7238</a>], was that reviewers do not favor them. However, he emphasized that the picture was more complicated, and that another factor was the priorities of different ICs and whether they fund that type of science. Those ICs that do support social science and behavioral research, like the Office of Minority Health and the Nursing Institute (NINR), tend to have very low award rates. The NEI has one of the highest award rates but does not tend to fund research in those areas. One Council member agreed with the complexity of the issue but also made the point that the NEI has certainly paid a lot of attention to issues of health care disparity and health care delivery among underrepresented groups. He gave the example of the Latino Eye Disease study, an enormous, multi-center study that looks at the special needs of that community. He did not think that it was the impression of the outside community that the NEI was somehow lacking in their attention to health care disparities. There were no other comments.</p><p>Dr. Schaffner thanked the panelists, attendees, cart writer, interpreters, and Mr. Michael Wright, who helped set up the ZOOM Webinar. The open session of the Council meeting was adjourned at 1:30 PM.</p>
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</div>
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</div>
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<div class="c-section" id="section-id-15835">
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<h3 class="c-section__heading">
|
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|
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Attachment A: National Advisory Eye Council 2020
|
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</h3>
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<div class="c-text">
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<p>Eduardo C. Alfonso, M.D. (2020)<br>Chairman, Department of Ophthalmology and<br>Director, Bascom Palmer Eye Institute<br>University of Miami Miller School of Medicine<br>Miami, FL 33136</p><p>Jose-Manuel Alonso, M.D., Ph.D. (2021)<br>Professor of Biological and Vision Sciences<br>State University of New York, College of Optometry<br>New York, NY 10036</p><p>Terete Borrás, Ph.D. (2023)<br>Professor and Director of Research<br>Department of Ophthalmology<br>University of North Carolina School of Medicine<br>Chapel Hill, NC 27599</p><p>James Coughlin, Ph.D. (2023)<br>Senior Scientist<br>Smith-Kettlewell Eye Research Institute<br>San Francisco, CA 94115</p><p>Katia Del Rio-Tsonis, Ph.D. (2022)<br>Professor<br>Department of Biology<br>Miami University<br>Oxford, OH 45056</p><p>Thomas W. Gardner, M.D. (2023)<br>Professor<br>Department of Ophthalmology and Visual Science<br>University of Michigan, School of Medicine and Kellogg Eye Center<br>Ann Arbor, MI 48105</p><p>Mary Elizabeth Hartnett, M.D., Ph.D. (2022)<br>Professor<br>Department of Ophthalmology and John Moran Eye Center<br>University of Utah<br>Salt Lake City, UT 84132</p><p>Renu Kowluru, Ph.D. (2023)<br>Professor<br>Department of Ophthalmology, Visual and Anatomical Sciences<br>Wayne State University<br>Detroit, MI 48201</p><p>Carol Ann Mason, Ph.D. (2020)<br>Professor<br>Department of Pathology and Cell Biology, Neuroscience, and the Zuckerman Institute<br>Columbia University<br>New York, NY 10027</p><p>Mary Ann Stepp, Ph.D. (2021)<br>Professor<br>Department of Anatomy and Regenerative Biology<br>The George Washington University<br>School of Medicine and Health Sciences<br>Washington, DC 20037</p><p>Benjamin Teller, O.D. (2022)<br>CEO<br>Eye Rx<br>Chevy Chase, MD 20815</p><p>Russell Van Gelder, M.D., Ph.D. (2020)<br>Professor and Chairman<br>Department of Ophthalmology<br>Director, UW Medicine Eye Institute<br>University of Washington<br>Seattle, WA 98104</p><p><strong>Ex Officio</strong></p><p>Marco A. Zarbin, M.D., Ph.D.<br>Professor and Chair<br>Department of Ophthalmology<br>UMDNJ-New Jersey Medical School<br>Newark, NJ 07103</p><p>DoD Representative position is vacant</p>
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</div>
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</div>
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<div class="c-section" id="section-id-15837">
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<h3 class="c-section__heading">
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|
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|
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|
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Certification
|
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</h3>
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<div class="c-text">
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<p>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.</p><p><strong>Anne E Schaffner, Ph.D.</strong><br>Executive Secretary, National Advisory Eye Council<br>National Eye Institute</p><p><strong>Santa J Tumminia, Ph.D.</strong><br>Chairman, National Advisory Eye Council<br>Acting Director, National Eye Institute</p>
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<p class="views-element-container c-last-updated" id="block-views-block-nei-last-updated-block-1"><strong>Last updated:</strong> January 8, 2025</p>
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