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<span>NAEC Meeting Minutes - October 13, 2023</span>
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<p><strong>National Institutes of Health</strong></p><p><strong>National Eye Institute</strong><br><strong>Minutes of the National Advisory Eye Council</strong><br><strong>One Hundred Sixty-Sixth Meeting</strong><br><strong>October 13, 2023</strong></p><ul><li><a href="https://videocast.nih.gov/watch=52408"><strong>Videocast</strong></a></li></ul><p>The National Advisory Eye Council (NAEC) convened for its 166th meeting at 8:30 a.m. on Friday, October 13, 2023. The meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended either virtually or in-person. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 8:30 a.m. until 3:00 p.m. The meeting was closed to the public from 3:30 p.m. until 5:00 p.m. for the review of grant and cooperative agreement applications.</p><h2>Council Members Present:</h2><p>Dr. Michael F. Chiang, Chair (in-person)<br>Dr. Kathleen Anderson, Executive Secretary (in-person)<br>Dr. Terete Borrás (in-person)<br>Dr. James Coughlan (in-person)<br>Dr. Reza Dana (in-person)<br>Dr. Thomas Gardner (virtual)<br>Dr. Maria B. Grant (in-person)<br>Dr. Renu Kowluru (in-person)<br>Ms. Janice Lehrer-Stein (in-person)<br>Dr. Maureen Maguire (in-person)<br>Dr. Tirin Moore (in-person)<br>Dr. Donald Mutti (in-person)<br>Dr. Victor Perez Quinones (in-person)<br>Dr. Pradeep Ramulu (in-person)</p><h3>NIH Staff Members Present:</h3><p>Shawn Adolphus (virtual)<br>Dr. Neeraj Agarwal (in-person)<br>Lisa Applewhite (in-person)<br>Dr. Houmam Araj (in-person)<br>Dr. Kapil Bharti (in-person)<br>Dr. S. Patricia Becerra (virtual)<br>Dr. Sangeeta Bhargava (in-person)<br>Holly Blake (virtual)<br>Nathan Brown (in-person)<br>Leslie West-Bushby (virtual)<br>Alysia Champagne (virtual)<br>Faith Chen (virtual)<br>Dr. Emily Chew (virtual)<br>Monique Clark (virtual)<br>Dr. Ed Clayton (in-person)<br>Jay Colbert (virtual)<br>Karen Colbert (virtual)<br>Dr. Mary Frances Cotch (virtual)<br>Kathryn DeMott (virtual)<br>Britt Dennis (virtual)<br>Joshua Denny (in-person)<br>Mala Dutta (virtual)<br>Donald Everett (in-person)<br>Dr. Martha Flanders (in-person)<br>Dr. Ashley Fortress (in-person)<br>Dr. James Gao (in-person)<br>Dr. Susan Gillmor (virtual)<br>Dr. Kerry Goetz (in-person)<br>Dr. Nataliya Gordiyenko (in-person)<br>Dr. Shefa Gordon (in-person)<br>Dr. Tony Gover (in-person)<br>Dr. Thomas Greenwell (in-person)<br>Lateefah Hill (in-person)<br>Dr. Brian Hoshaw (in-person)<br>Dr. Michelle Hribar (in-person)<br>Koray Dogan Kaya (virtual)<br>Dr. Alicia Kerr (virtual)<br>Dr. Jimmy Le (in-person)<br>Dr. Paek Lee (in-person)<br>Renee Livshin (virtual)<br>Dr. Barbara Mallon (virtual)<br>Dr. George McKie (in-person)<br>Dr. Sheldon Miller (virtual)<br>Archana Mohale (virtual)<br>Dr. Lisa Neuhold (in-person)<br>William “Russ” O’Donnell (virtual)<br>Shaun Patton (in-person)<br>Barbara Payne (virtual)<br>Dr. Zepeng Qu (virtual)<br>Dr. Mary Ann Redford (in-person)<br>Melissa Reeves (virtual)<br>Carissa Reilly-Weedon (virtual)<br>Holly Russo (virtual)<br>Dr. Delia Olufokunbi Sam (virtual)<br>Dr. Jennifer Schiltz (in-person)<br>Dr. David Schneeweis (virtual)<br>Dr. Shauna Schwartz (virtual)<br>Dr. Grace Shen (in-person)<br>Dr. Azadeh Shoaibi (in-person)<br>Rugie Sillah (virtual)<br>Karen Robinson Smith (virtual)<br>Dr. Hongman Song (in-person)<br>Dr. Afia Sultana (virtual)<br>Dr. Xun Sun (virtual)<br>Dr. Ginger Tansey (virtual)<br>Dr. Santa Tumminia (in-person)<br>Fausto Vela (virtual)<br>Dr. Cheri Wiggs (in-person)<br>Mary Wiles (virtual)<br>Keturah Williams (virtual)<br>Dr. Charles Wright (in-person)</p><h3><strong>Others Present Virtually:</strong></h3><p>Dr. Monica Hooper (virtual), Guest Speaker<br>Dr. Stephen McLeod (virtual), Guest Speaker<br>Television Operations</p><p>NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.</p><h2>WELCOME AND INTRODUCTIONS</h2><p><strong>—Dr. Michael Chiang, Chair, NAEC, and Director, NEI</strong></p><p>Dr. Chiang called the 166th NAEC meeting to order. He welcomed invited speakers, Ms. Kerry Goetz, Associate Director of the NEI Office of Data Science and Health Informatics and Dr. Michelle Hribar, an NIH Data Scholar at NEI. All Council members briefly introduced themselves.</p><h2>COUNCIL PROCEDURES AND RELATED MATTERS</h2><p><strong>—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)</strong></p><p>Dr. Anderson welcomed the NEI research and advocacy community, NEI and NIH staff, invited speakers, and members of the public who were in attendance virtually and in person, and staff members who organized and provided technical support. She also thanked Drs. Coughlan, Gardner, Kowluru, and Borrás who agreed to extend their terms through the February 2024 3 166th National Advisory Eye Council Meeting, October 13, 2023 meeting. She also made some logistical announcements regarding participation in the hybrid meeting.</p><p>She noted that future NAEC meetings are listed on the open agenda and on the <a href="https://www.nei.nih.gov/about/advisory-committees/national-advisory-eye-council-naec/national-advisory-eye-council-naec-meetings">NEI website</a>. The next in-person NAEC meeting will be held on Friday, February 16, 2024. Minutes of the June 2023 NAEC meeting were made available in electronic council book (ECB) prior to the meeting. A motion to accept the June meeting minutes was made, seconded, and approved unanimously.</p><p> </p><h2>NEI DIRECTOR’S REPORT</h2><p><strong>NEI DIRECTOR’S REPORT</strong> —Dr. Michael F. Chiang<br>Dr. Chiang began by noting the value of social media in disseminating news about scientific and research activities taking place at NIH and NEI. He encouraged attendees to follow NEI’s social media accounts.</p><p><strong>NIH and NEI Leadership Updates</strong><br>In NEI’s intramural research program, Dr. Richard Lee has come onboard as NEI’s Clinical Director. In the Office of the Director, Jessica Ryan was promoted to Deputy Executive Officer. In the extramural science programs division, Dr. Ed Clayton was hired to work with Dr. Neeraj Agrawal to run the NEI research training portfolio, and Dr. Azadeh Shoaibi was hired as a program officer in the collaborative clinical research group. Dr. Ellen Liberman, who served as the glaucoma program director, retired in July 2023. Linda Dingle has returned to her position as a grant specialist in the grants management branch. Recruitment is ongoing for the position of Director of Extramural Science Programs.</p><p><strong>NEI Updates</strong> –Dr. Chiang congratulated several NEI investigators who received major awards.</p><p>Dr. Gordon Legge of the University of Minnesota received the APS James McKeen Cattell Fellow Award for his foundational research on low vision.</p><p>Within Health and Human Services (HHS), Dr. Mary Ann Redford, received the HHS Career Achievement Award for the multidisciplinary research she conducted and supported over the course of her career, spanning multiple topics including vision, dental, HIV, and women’s health. Dr. Cynthia Jaworski received the 50 Year Length of Service Award for her work in the Laboratory of Retinal Cell and Molecular Biology.</p><p>The 2023 Lasker-DeBakey Clinical Medical Research Award went to a trio of researchers from the vision community. Dr. David Huang from Oregon Health & Science University, and Drs. James Fujimoto and Eric Swanson from the Massachusetts Institute of Technology received the award for inventing optical coherence tomography, a retinal imaging technology that has revolutionized patient care.</p><p>Another notable awardee was Dr. Shiela Angeles-Han from Cincinnati Children’s Hospital Medical Center. Dr. Angles-Han received a Team Science Leadership Scholars Program award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the Office of Research on Women’s Health for her project, “Towards personalized use of methotrexate for the treatment of juvenile idiopathic arthritis-associated uveitis.”</p><p>The National Academy of Medicine announced its newly elected members, which included four people from the vision research community. Dr. Justin Hanes, at Johns Hopkins University, was honored for his discoveries and inventions of drug delivery technology targeting the mucosal ocular nervous system. Dr. Hongkui Zeng, from the Allen Institute for Brain Science, was honored for her investigations of cell types and connections in the mammalian brain. Dr. Eric D. Green, the director of National Human Genome Research Institute (NHGRI), was honored for his work on incorporating genomics into clinical car. Finally, Dr. Chiang himself was also elected to the Academy for his research on retinopathy of prematurity.</p><p><strong>Highlights of Collaborative Research</strong>—Dr. Chiang noted that an element of NEI’s mission statement is fostering collaboration. He highlighted two collaborative projects in which NEI is involved.</p><p>NEI’s strategic plan identified plasticity as a topic for which scientific exploration can advance therapies for diseases such as amblyopia, traumatic brain injury or stroke. To foster collaborations between vision research and neuroscience, an open virtual workshop to explore gaps in knowledge about visual neuroplasticity will be held on January 10, 2024. The meeting will focus on four scientific areas: cortical cellular mechanisms, functional reorganization, subcortical mechanisms, and retinal remodeling.</p><p>Another collaborative project is a trans-NIH project on regenerative medicine that includes NEI and NIAMS. A recent AMP (Accelerated Medicines Partnership) public-private partnership project involving gene therapies, awarded three out of eight clinical trials for vision-related diseases. A workshop in November 2023 funded by Food and Drug Administration (FDA) and Foundation for the National Institutes of Health (FNIH) will explore the possibility of establishing an AMP initiative for cell-based therapies. NEI Deputy Director Dr. Santa Tumminia, who has been spearheading this effort, said that if this project goes forward, the vision community is poised to do well.</p><p><strong>Highlights of Innovative Research</strong>—Dr. Chiang noted that driving innovative research is another pillar of NEI’s mission statement</p><p>NEI has focused on developing novel quantum technology imaging systems and quantum computer algorithms for disease diagnosis. That work aligns closely with NIH efforts, exemplified by a Notice of Special Interest (NOSI) published in September 2023 for using quantum sensing in biomedical applications. NEI is also actively supporting translational research, with applications for two types of awards – R61 (exploratory) and R33 (developmental) due in February 2024.</p><p><strong>Highlights of Innovative Research, Health Disparities (1)</strong>—Dr. Chiang highlighted two efforts addressing health disparities research, which has been a key focus for NEI.</p><p>Dr. Chiang described one Notice of Funding Opportunity (NOFO) called Understanding and Mitigating Health Disparities experienced by People with Disabilities caused by Ableism, for which applications are due November 29, 2023. This <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-24-007.html">NOFO</a> aims to understand the impact and mechanisms of ableism on health outcomes, and to look at interventions at the system and community levels.</p><p>Dr. Chiang also noted that NIH is seeking public comments to a change in its use of the word “disability” in its mission statement. The current mission as stated, is “to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life and reduce illness and disability.” The proposed revision, on which comments are open until November 24, 2023, would change the last clause so that it says “… to apply that knowledge to optimize health and prevent or reduce illness for all people.”</p><p>Dr. Chiang then asked council members and attendees for their thoughts on this proposed change.</p><p><strong>Discussion</strong><br>Council member, Jenny Lehrer-Stein, thanked Dr. Chiang for noting this change. She noted the enormous diversity encompassed by the term disability and said that many in the disability community consider the term to be descriptive, and not negative. She added that the proposed change helps advance this concept.</p><p><strong>Highlights of Innovative Research, Health Disparities (2)</strong>—Dr. Chiang highlighted several other efforts addressing health disparities research.</p><p>A predoctoral training program called ADVANCE aims to train pre-doctoral students from diverse backgrounds to conduct health disparities and health equity research and to develop, implement and evaluate preventative interventions.</p><p>A <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-23-309.html">NOFO</a> called Health and Healthcare Disparities among Persons Living with Disabilities aims to fund research on novel and innovative applications and interventions that address the intersecting impact of disability, race, ethnicity and socioeconomic status on healthcare access and health outcomes. First applications for the program are due on February 5, 2024.</p><p>Dr. Chiang asked council members and attendees whether they knew of projects that would benefit from this opportunity or have thoughts about how to encourage investigators to apply for such a program.</p><p><strong>Discussion</strong><br>Dr. Dana asked when the new program announced, noting that something so new, that differs from the usual investigator-initiated research, requires time to be planned, and if the application process is rushed the NIH may feel compelled to grant applications at a level that may not normally be competitive.</p><p>Dr. Anderson replied that the health and health care disparities among persons living with disabilities Funding Opportunity Announcement was published a couple of weeks ago, but the program is going to be active for three years, through October 2026, leaving plenty of time to develop and revise projects and pull together collaborative teams.</p><p>Dr. Grant noted sickle cell retinopathy as a possible area of research under this funding program. Patients often cycle through repeated trips to the emergency room while in great pain, and clinicians often crack down on medications. Changes in vision can be an early predictor of a severe sickle cell episode, so studying the ocular component of the disease might be a way to investigate the intersection of ethnicity, race, disability, socio economic issues, and eye disease.</p><p>Ms. Lehrer-Stein noted that President Biden has discussed the designation of disability as a health disparity, and the disability community and others have noted the lack of available data that impacts quality of life. It is also an area of tremendous uncertainty with respect to women's rights. Abortion bans in 21 states affect more than 35 million women, 3 million of whom are women with disabilities. Furthermore, 35 states presume that a person like her – a mother of three and grandmother of one – is unfit to parent because of a disability. The question, she said, is how to match the scientific and the lay community on this topic.</p><p>Dr. Coughlin underscored the need to push for collecting more data that tracks how different factors like race and socioeconomic status impact disability.</p><p>Dr. Ramulu noted that to truly conduct interventional work that can improve healthcare access and outcomes, it will be crucial to collaborate with researchers who have experience going into the community and who have connections with groups that experience health disparities. That is especially true for people with visual disabilities, who may have difficulty accessing other healthcare services because of those disabilities.</p><p>Dr. Chiang noted that the concept of the eye being a window to the body is especially true today because of advances in ocular imaging technologies – work which received a Lasker Award. It is an exciting time to be exploring these issues, he said.</p><p>Dr. Dana suggested reaching out for collaborators to schools of public health, where these topics have arguably gained more traction than in most medical schools.</p><p><strong>Fostering Collaborations: Data Sharing Challenge</strong>—Dr. Chiang noted that data sharing requirements have caused some angst and frustration in the community. Metaphorically speaking, he said the White House Guidance and NIH requirements to come up with a data sharing plan are essentially sticks, but the community also needs carrots. A validated quantitative data sharing index could serve as a carrot.</p><p>The goal is to develop and validate such an index, which is being called an S-index (paralleling the H index) to identify and reward exemplar data sharers. This mechanism could be used to identify and sustain quality data sets. Tthe idea would be to conduct a challenge, judged by a collaborative group, essentially as a carrot to incentivize self-directed change. This could be done in collaboration with universities, publishers, or data indexers, and it would propel cultural change by creating good datasets as stand-alone products of studies. NEI staff presented this idea to the leadership at NIH, and currently a group of partners including National Institute of Neurological Disorders and Stroke (NINDS), National Library of Medicine, NCBI (The National Center for Biotechnology Information) BRAIN Initiative, Office of Data Science, and others are on board. The first step, ongoing now, is to do a landscape analysis, then conduct some workshops for interested people and the general public to design the challenge and flesh out the judging criteria, with the aim of launching the challenge in 2024.</p><p>Dr. Goetz said she would be extremely interested in hearing input or feedback about the proposed index, what the hurdles to doing this might be, and considerations on how make this a more equitable measure.</p><p><strong>Foster Collaboration: Cortical Visual Impairment</strong>—Dr. Chiang described a workshop on cortical visual impairment (CVI) that will take place in December 2023. CVI emerged as an interest for NEI in its strategic planning process because there are so many unanswered questions and fundamental unknowns about it. CVI is now the leading cause of childhood blindness in the US, and pediatricians, neurologists and eye doctors tend to pass patients back and forth between them. The two-day workshop, which has been a year and a half in the making, will bring together experts from many disciplines with the goal of drafting definitions and determining criteria for diagnosis, as well as moving toward building a registry for CVI.</p><p><strong>Foster Collaboration: Quality of Life (1)</strong>—Dr. Chiang described another workshop, held in September 2023, on patient reported outcomes and vision related quality of life questionnaires. Instruments for measuring vision-related quality of life need to be improved, so the intent of this workshop was to highlight the importance of patient perspectives and patient reported outcomes, and to think about opportunities and challenges for creating new instruments.</p><p><strong>Discussion</strong><br>Dr. Perez said that one of the challenges is to have a consensus about which measurements are needed. For the ocular surface, the problem is to understand what to look for and how to put it in a way that is cohesive and easy to communicate. Also, he congratulated the workshop organizers for involving the US Food and Drug Administration to underscore to that agency how important quality of life endpoints are.</p><p>Dr. Ramulu said it was a great workshop, and he noted that it is challenging to pin down which measures to select, and whether an array of different measures or one integrated measure would be most useful. Additionally, there are difficulties with measurement science, such as reproducibility and accuracy, speed, ability to adapt the measurements to people with vision or hearing deficits. He expressed hope that the summary of the workshop would lead to calls for proposals that move the science forward.</p><p>Dr. Maguire noted that this area is very complicated, and one important thing noted during the workshop was the importance of asking the patient, “What are you having difficulty with?” and “What is important to you?” -- thereby personalizing the measure to the patient.</p><p>Dr. Dana concurred with the importance of demonstrating the importance of quality-of-life measures to the FDA in ophthalmic research. There are many examples in ophthalmology where patients’ quality of life and quality of vision can be improved without impacting vision in a direct way.</p><p><strong>Foster Collaboration: Quality of Life (2) </strong>—Dr. Chiang described an NEI-funded project called Project Prakash, based in India, that aims to understand brain plasticity in children with congenital blindness. The project has been funded for 15 years and is based at Dr. Schroff’s Charity Eye Hospital, which provides surgeries for children with cataracts and other reversible forms of blindness. A long-held assumption has been that past a certain critical period, the brain lacks plasticity and intervention would not be effective. But more recent data reveals that sight recovery surgery induces significant white matter plasticity, suggesting that treatment for children past the critical period may be effective. It also suggested the need to rethink how we think about critical periods. Dr. Chiang traveled to India to see this project in action.</p><p><strong>Foster Collaboration: Complement-ARIE Concept Prize Competition </strong>—Dr. Chiang called attention to a Common Fund research program for the development, standardization, validation, and use of methods that complement, make more efficient, or in some cases replace traditional animal models. These methods can be in vitro methodologies, in silico or some type of artificial intelligence system or organoid model. The planning for this program has been ongoing for some time, and the <a href="https://www.herox.com/Complement-ARIE">Challenge announcement</a> was published in November 2023. The submission deadline is January 11, 2024.</p><p><strong>“Recruit talented and diverse individuals” </strong>—Dr. Chiang highlighted two recruitment programs. He said that NEI has officially signed on to the StARR program – Stimulating Access to Research and Residency – which aims to facilitate a path for clinician scientists by supporting institutional programs in research during their residency. For residents interested in research, Dr. Chiang hopes to make people know that the vision field is very welcoming to physician scientists. Another program he described was the NIH administrative supplements to promote diversity in health-related research funding opportunity. This <a href="https://grants.nih.gov/grants/guide/pa-files/PA-23-189.html">funding opportunity</a> is applicable for PIs of active grants to support and provide research training to candidates from high school students through faculty researchers.</p><p>Another example of diversity-related recruitment efforts is an NEI video contest called Eye on the Future. The purpose is to identify high school students from around the United States and get them interested in health care and vision. There were 60+ submissions in the contest’s second year, and the 13 winners came to Bethesda for a day to engage with NEI scientists and networked with scientists and clinicians.</p><p><strong>Educate about vision research advances: OCT </strong>—Dr. Chiang described a White House educational event scheduled for November 2023 that will showcase advances in nature, energy, national security, IT, AI, industries of the future and health that improve the lives of Americans. NEI was selected to demo an Optical Coherence Tomography (OCT) device. This was timely as developers of this technology were honored with a Lasker award in 2023.</p><p><strong>NAEC Budget Update</strong> —Ms. Karen Colbert, NEI Budget Officer, summarized the budget for the last fiscal year, 2023, and shared what’s currently known about the budget for the current fiscal year, which began on October 1, 2023.</p><p>NEI’s 2023 budget was $896.1 million, which was a 3.8% increase over NEI’s 2022 budget. Official spending totals for 2023 are not yet available. In fiscal year 2022, NEI spent 83% of its budget on extramural research, 12% on intramural research and 5% on research support – figures that closely align with historical trends.</p><p>A couple weeks before the NAEC October 2023 meeting, the government avoided a shutdown by Congress passing and the President signing a continuing resolution that allowed the government to operate for 48 days, from October 1 to November 17. Funding during this period is determined by calculating a daily budget based on last year’s appropriation – approximately $2.5 million per day – and multiplying that by the 48 days for which the resolution holds. These funds cover most nuts and bolts of operation, with grant awards making up the largest percentage of costs. An NIH Guide notice was released in early October and gave NIH institutes and centers the discretion to reduce certain awards, providing a temporary mechanism for spending flexibility.</p><p>Ms. Colbert predicted that in the best outcome, NEI’s FY2024 budget will be same as FY2023, though a budget cut was still possible. A budget with no increase is essentially a funding cut because the cost of doing business increases each year, she noted, but NEI staff are confident in their abilities to manage within the resources they are afforded.</p><p>The budget picture for NIH overall is a bit different, Ms. Colbert said. The House bill reduces the total NIH funding by $3.7 billion, which would mean targeted cuts while most institutes and centers are held flat. The House bill also reduces the Cures Act funding, without replacing it with non-Cures money. The Senate bill, meanwhile, backfills the Cures Act funding and proposes a net increase to NIH of $265 million. Ms. Colbert speculated that there would be one more continuing resolution before the FY2024 budget was finalized.</p><p><strong>NEI-All of Us Collaboration on Vision Health</strong> —Dr. Joshua Denny, CEO of All of Us, NIH; Kerry Goetz, NEI; Dr. Michelle Hribar, NEI and Oregon Health Sciences University</p><p><strong>All of Us Program Overview</strong> —Dr. Joshua Denny, MD, MS, CEO of All of Us</p><p>Dr. Denny broadly described the aims and approach of All of Us, a study announced in 2015 by then-President Barack Obama and launched nationally in 2018. The study aims to enroll at least 1 million participants and to assemble a massive dataset that will accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for a broad population representative of the diversity of the US.</p><p>All of Us has recruited more than 700,000 participants so far, hailing from all 50 states. Of these, close to 5000 have completed all the initial surveys, donated DNA, and agreed to share their electronic health records. More than 80% of participants are underrepresented in biomedical research. The study collects five basic types of data – electronic health records, participant surveys, physical measurements, biosamples, and wearables data – though people choose not to submit some of these data types.</p><p>Returning value to participants is a big part of the program. In a survey asking people why they might join, the prospect of accessing their genetic information was the biggest draw. Another was simply altruism – the ability to make a difference in the future health of their communities. In terms of the genomics, participants can receive information about their hereditary disease risk, based on whether they carry a disease-causing variant in 59 genes associated with serious health conditions; their bodies’ ability to metabolize medicines, based on 7 genes; and their genetic ancestry. People who have been found to have an elevated genetic risk for diseases can meet with a genetic counselor to discuss their results.</p><p>All of Us data is longitudinal, with some information from electronic health records dating back to the 1980s. Researchers can access these data at different tiers. Basic summary statistics and aggregate counts are available publicly, to anyone, and beyond that, access works on a passport data model, meaning that once individual researchers receive approval, they can create workspaces for their projects. The data is available to academic and not-for-profit organizations, and institutions can sign a master agreement that enables access for their researchers. Dr. Denny noted that he and his team have tried to focus on diversity in the institutions and researchers that use the data; currently, 40 Historically Black Colleges and Universities (HBCUs), 57 Hispanic Serving Institutions are using AoU data, and outreach is ongoing to other minority-serving institutions, including tribal colleges and universities.</p><p>The first paper to come out of All of Us, published in 2021, showed that multisite All of Us data fed into an artificial intelligence algorithm can accurately predict who needs glaucoma surgery based on electronic health records variables. All of Us aims to build a large set of core data including DNA sequencing, electronic health records and surveys that researchers can use, Dr. Denny said, but there are lots of opportunities for ancillary studies, too. He mentioned a few that are ongoing, including one about serology relating to COVID, one investigating quantitative cognitive behavioral trait modules, and one looking at nutrition for precision health.</p><p> </p><p><strong>Discussion</strong><br>Dr. Maria Grant asked Dr. Denny to elaborate on the nutritional questionnaires used in the nutrition precision health study, and specifically how researchers were capturing accurate diet information considering that about 25% of the population is low income. Dr. Denny responded that this study includes a subset of the All of Us population and uses a couple different types of questionnaires. A subset of the study group will receive take-home diets to measure biomarkers before and after intake, and a subset of that smaller group will do a feeding study at a clinical research center. The aim will be to adopt some of the questionnaires into the larger All of Us cohort and to enable participants to submit photos of their food as well.</p><p>Dr. Dana asked what the formal definition of the term “underrepresented” was in relation to All of Us. Dr. Denny responded that the participants of All of Us do not constitute a representative population because the study specifically sought to over-enroll people who are underrepresented in biomedical research. This is defined based on groups that are absent or unexplored in most existing studies. For example, it’s not known whether sexual or gender minorities are underrepresented in research because often, no questions are asked that would identify them. Meanwhile, with genetics, 95% of all GWAS (genome-wide association studies) focus on people of European ancestry, so All of Us seeks to enroll others. Dr. Denny noted that a paper exists that explains the definition used in the study.</p><p><strong>NEI-All of Us Workshop Highlights</strong> —Kerry Goetz, Associate Director of NEI Office of Data Science and Health Informatics</p><p>Dr. Goetz discussed how NEI’s strategic plan, which says the agency must invest in resources to pursue technological advancements, positions NEI to work with All of Us to create a data source for clinical research using ocular imaging, genomics, and biospecimens. Ocular imaging is now common in eye care. And what’s more, data analysis and image processing tools have advanced to allow artificial intelligence, machine learning and deep learning methods to be applied to research and clinical decision support tools, and to lay the groundwork in a new area of science called oculomics. This new field might include things like the study of risk factors for systemic disease or investigations into social or biomedical causes for disease disparity, but its development has been hampered by a lack of publicly available, disease agnostic cohorts and by limitations in data quality and standardization.</p><p>At a workshop held in April 2023, NEI, National Institute of Biomedical Imaging and Bioengineering (NIBIB) and All of Us researchers met to discuss these issues. Attendees were subject matter experts in AI and vision science, ophthalmology, diagnostics, retinal imaging technologies, analysis platforms, public health, biomarkers. privacy, data security, and health disparities, and they explored the current state of science and opportunities to expand research with large retinal imaging cohorts. The workshop summary, called Opportunities for Ophthalmology Research in Large Research Cohorts, was posted in November 2023, and as of this meeting had already been downloaded more than 200 times.</p><p>Dr. Goetz noted that the eye is often called the window into the soul, as well to overall health. If the metadata associated with ocular images can be captured in a fast, cost-effective way, she said, the dataset of disease agnostic images such as those in All of Us coupled to biometric, clinical, genomic, and survey data from a large, diverse population could push forward research on ocular health, as well as research on neurodegenerative and cardiovascular health, aging and inherited conditions. She described an NEI proposal for a pilot study that would place four high quality, low cost easy to use devices in four existing All of Us locations. Participants could consent to ocular imaging, and these images would then be linked with their other All of Us data. Participants would also have access to these data, potentially contributing to the early detection of disease. An ancillary study proposal describing the pilot study has been submitted to All of Us for review.</p><p> </p><p><strong>Discussion</strong><br>Dr. Grant asked whether blood samples of these patients would be available to investigators. Dr. Goetz said that the ocular imaging samples will become part of the All of Us research project and investigators will be approved to access data based on their permission level.</p><p>Dr. Teresa Borrás noted the need to promote the All of Us data within the research community, and Dr. Goetz noted that All of Us communicates widely with the public and that NEI will make sure to promote any vision-specific datasets.</p><p>Dr. Victor Perez asked whether there were plans to collect functional data, like vision, and whether there is the worry of collecting tests for which experts have no agreed-upon interpretation. Dr. Goetz said that according to the proposal, the data to be collected will be clearly labeled for research, to limit issues with interpretation.</p><p>Dr. Donald Mutti asked whether other eye-specific measurements are also made during the assessment. Dr. Goertz said that the project also hopes to capture standard Snellen visual acuity, and possibly other measures such as intraocular pressure. Across the board, eye measures are inconsistent, she said.</p><p><strong>Common Data Models for Ophthalmology Research Collaboration</strong> —Dr. Michelle Hribar, NEI and Oregon Health Sciences University</p><p>Dr. Hribar, who is in her second year as a NIH data scholar at NEI, talked about the importance of common data models – otherwise called data standardization. One key to a rich, diverse dataset is sourcing it from multiple locations. But data that originates in electronic health records tends to be siloed because different institutions use different systems for electronic health records and implement them in different ways. That’s where data standardization comes in, she said.</p><p>One approach for standardizing data is to pull it into a single registry. Having everything available at a single site is a big benefit, but this approach can require extensive legal, privacy and security agreements. It also may have limits in scalability because each site must do a lot of work to contribute data into the shared repository. A second, newer approach involves each site keeping their own data. Here, researchers use various bioinformatics tools to share their code and their models between sites. This approach is much more scalable, and it means large data components such as imaging do not have to be pulled out and send to a different location. It does, however, require data standardization and harmonization up front, and partners need to be available at each site to run models at researchers’ request.</p><p>One widely used data model is the OMOP (which stands for observable outcomes data partnership) common data model, which All of Us datasets use. This data model was originally developed with the aim of using observational health data to do surveillance of treatments and products. It is simply a standardized scheme for organizing and naming data and compiling it into a database. Ophthalmic functional and imaging data is currently not officially part of OMOP. Imaging data can be especially tricky to share. The OHDSI (Observational Health Data Sciences and Informatics) Eye Care and Vision Research Workgroup, a multidisciplinary group of researchers in eye care and vision research co-led by Dr. Goetz, Dr. Hribar, and Dr. Sally Baxter, is working to harmonize ophthalmic data and add it to OMOP.</p><p>The resulting OHDSI Ophthalmic Data Network would consist of data distributed across multiple institutions that could be accessed through a data coordinating center. One way of using this data might be to look beyond a clinical trial to investigate longer timeframes or broader patient cohorts for an intervention, said Dr. Hribar. Another opportunity would be validating artificial intelligence models on additional data besides that on which the models were trained.</p><p><strong>Discussion</strong><br>Dr. Maguire asked how the American Academy of Ophthalmology’s IRIS Registry might interface with this system. Dr. Hribar replied that her team has been speaking with IRIS and it would be wonderful if IRIS could essentially be a node on this ophthalmic data network, if the data were standardized the same way.</p><p>Dr. Dana noted that this work will require lots of resources and attention over many years, a difficult thing to maintain in academia, and asked whether there exists a centralized superstructure at the NIH for allocating these resources. Dr. Hribar noted that the OHDSI community has been in existence for over a decade and that a significant number of people within it were from pharma.</p><p>Dr. Grant said that billing codes in electronic medical records can often paint an incomplete or inaccurate picture of patients’ medical condition, so she worried about the accuracy of this database. Dr. Hribar agreed that billing codes are not necessarily accurate, and that data experts working on this dataset have instead been using natural language processing to identify clinical information from progress notes.</p><p>Dr. Ramulu asked whether IRBs (institutional review boards) handled access to information stored at their institution in different ways, and whether standards were emerging for this. Dr. Hribar said that there were individual institutional review board protocols that had to go through approval, but there was some sharing between different sites in this respect. She speculated that in some cases, an umbrella institutional review board approval would be needed, while for others separate approvals for each study would be required.</p><p><strong>Discussion</strong><br>Ms. Lehrer-Stein encouraged Dr. Wiggs and her colleagues to explore current pending legislation called the Websites and Software Application Accessibility Act, which highlights universal design as accessibility devices are increasingly keyed to the internet. She also relayed her recent travel experience when a tour guide in Bologna, Italy had purchased statues of monuments to allow her to experience them tactilely.</p><p>Dr. Coughlan underscored the importance of universal design. In the past, assistive technology was stigmatized and treated as something to be used as a last resort, he said. It is important to normalize these types of tools, and it is possible to create them to be broadly useful and pleasing. Dr. Coughlan also asked whether grants for the research Dr. Wiggs proposed might be devised to specifically incentivize scientists with vision impairments to apply. Dr. Wiggs thanked him for the suggestion and agreed that writing this into the description of the funding opportunity was important.</p><p>Dr. Ramulu said that in designing accessibility technology it is important to place the focus on systems-based change. Instead of people with visual disabilities shouldering the burden, businesses, hospitals, and other institutions should have tools that enable them serve people with a variety of needs – from those with visual impairment to those who simply forgot their glasses.</p><p>Dr. Mutti said that as the design of these tools gets increasingly high-tech it is important to avoid creating disparities in who can afford to access them. Dr. Wiggs agreed, noting that the cost of 3D printing has gone down considerably and that a similar decrease in price point would hopefully increase access to other technologies.</p><p>Kerry Goetz noted that accessing current assistive technologies often requires visiting a low vision specialist, and because there are so few such providers, patients experience a long wait. She highlighted the importance of adding capacity to provide access more widely to assistive technology.</p><p>Dr. Anderson asked for a motion to approve this concept for potential development into a future funding opportunity, which passed unanimously.</p><p><strong>NEI-India Collaborative Research Program Renewal</strong>—Dr. Charles Wright, NEI</p><p>Dr. Wright described this collaborative research program, which was launched in 2005 with the goal of ending the burden of blinding disease for citizens of India and the United States. There are many touchstones for collaboration. For example, diabetes prevalence has risen dramatically in both countries and is the primary risk factor for diabetic retinopathy. Climate change is also increasing the disease burden in both countries. The program has long had a board scope from basic to translational research, and this will continue with the program’s renewal. Some of the health topics to be explored include the link between climate change-related pollutants and ocular disease risks and outcomes, as well as genetic markers that predict the risk or impact of eye disease.</p><p>Dr. Wright highlighted two projects that were funded since this program was last re-issued. The first is a basic science project that uses cryoEM to resolve the structures of protein complexes spanning the first visual synapse that are implicated in conditional stationary night blindness. The second is more translational – it involves sequencing the genome of patients with microphthalmia, anophthalmia and coloboma and identifying variants in vitamin A metabolism genes.</p><p><strong>Discussion</strong><br>Dr. Dana asked how many grants had been funded so far, to which Dr. Wright replied four.</p><p>Dr. Maguire asked whether those grants could have been funded through other mechanisms. Dr. Wright said they could have, but the advantage of this program is that it does not involve transfer of funds to India so projects can start as soon as a grant is awarded.</p><p>In response to a question from Dr. Perez, Dr. Wright described the process of grant evaluation. The US-based collaborator applies to the NIH at the same time as the Indian collaborator applies to the Indian equivalent of the NIH. Both need to score favorably for the project to be funded. Dr. Wright said that estimated that 17 or 18 grants have been submitted.</p><p>Dr. Ramulu asked why clinical trials were not allowed as part of this program. Dr. Wright said that is how the project was originally conceived. Dr. Anderson added that NEI’s clinical trials portfolio does have clinical trials sites in India, so such trials can occur. They are just done in a different way that gives a little more oversight and budget flexibility.</p><p>Dr. Mutti noted that many of the health topics Dr. Wright had mentioned referred to environmental pollution and climate change, and asked whether he envisioned increased interest in these areas. Dr. Wright explained that at a section on global health at ARVO, there seemed to be an increase in interest among the community to move in this direction. He added that this an area NEI is looking to grow.</p><p>Dr. Ramulu suggested including rare diseases as a point of focus as well.</p><p>Dr. Anderson asked for a motion to approve this concept for reissue, which passed unanimously.</p><p><strong>NEI Loan Repayment Program Update</strong> —Dr. Neeraj Agrawal, NEI<br>Dr. Agrawal gave an annual update on NEI’s participation in the NIH loan repayment program, which aims to attract health professionals to a career in research by paying their educational debt.</p><p>The program is open to US citizens and residents and re-pays up to $50,000 plus accrued US taxes. Participants must spend 50% of their time on research, which must be overseen by a mentor. The grant is renewable multiple times and NIH grant support is not required. NIH intramural program researchers are also eligible to apply. NEI participates in five different types of research programs; one added this year is Diversity (L34), which is open to anyone from an underrepresented minority or other diverse group. This year NEI received 13 renewals and 13 new applications. They renewed 10 out of the 13 and funded 6 out of the 13 new applications. NEI’s success rate for new applications is slightly lower than in previous years because of changes in funding rules.</p><p><strong>Discussion</strong></p><p>Dr. Gardner noted that the people he knows who have successfully applied have found the program very helpful. He asked whether the number of applications was optimal, and Dr. Agrawal said that although the numbers have dropped a bit, they are currently stable at about 30 applications per year.</p><p>Dr. Dana asked for clarification about whether the program supports basic research, as Dr. Agrawal had not mentioned basic research in the list of supported research programs. Dr. Agrawal said it does, but specific basic research projects get classified as part the other programs – for example, any research that uses human tissue falls under the category of clinical research.</p><p>Dr. Ramulu asked whether the program pays up to the full amount of somebody’s loans. Dr. Agrawal said the program pays the full percent, including undergraduate studies, and that people often reapply until all their loans are paid off.</p><p>Dr. Perez lauded the program, saying that it helps clinician scientists stay in the vision field.</p><p><strong>NIH Simplifying Review Framework Initiative and Center for Scientific Review Updates</strong> —Dr. Noni Byrnes, Director of CSR</p><p>Dr. Burns began with an overview of CSR activities and then described multiple initiatives to strengthen peer review. In fulfilling its mission to conduct fair, independent, expert, and timely review for NIH grant applications, CSR reviews about 60,000 applications annually. The Center’s work is conducted with the assistance of about 275 scientific review officers and 19,000 reviewers in over 1200 meetings every year. CSR maintains a large number of standing study sections and also reviews many special initiatives. CSR works under a 3-domain framework for optimizing peer review. One domain focuses on fine-tuning study sections; another on training, evaluating and diversifying reviewers; and a third on establishing a solid process for things like criteria, scoring system and mechanisms for transparency.</p><p>Dr. Byrnes described ENQUIRE– which is a tortured acronym for Evaluating Panel Quality in Review. This is a systematic, data driven 12–18-month process for evaluating study sections. Each year 20% of all study sections undergo the process, with the aim of ensuring that every study section gets an external look every five years. For example, late-stage preclinical drug discovery was seen as a gap area, so CSR created a study section. The Center also took research on social determinants of health out of a single study section and distributed it into multiple study sections related to specific research areas.</p><p>CSR has also overhauled how it evaluates NIH research project grant applications. The aim for simplifying this process was to remove some administrative burden to allow reviewers to focus on science. Another concern was mitigating reputational bias in grant proposal evaluation of the project. One major change is to swap out the current five review criteria for three review factors – importance of the research, rigor and feasibility, and expertise and resources – that contribute to the overall score. Starting in January 2020, CSR sought and received a tremendous amount of input from the research community through avenues such as informal comments on blog posts as well as working groups. Between July 2021 and September 2022, NIH internally examined and approved the new framework. Public comment, solicited through a Request for Information open from December 2022 and March 2023, was largely supportive, Dr. Byrne said. The aim is to implement the changes beginning with applications received in January 2025. Between then and now, CSR will be holding webinars for the public and for staff describing the changes, refining grant application instructions, conducting trainings and doing outreach to socialize the change for reviewers, applicants, and others.</p><p>A third focus was improving the review of fellowship applications, with the goal of ensuring that peer review is identifying the most promising researchers of the next generation. A frequently voiced concern was that an over representative number of awards was going to trainees at elite institutions and with well-known sponsors. An analysis of 6000 applications confirmed this anecdotal worry, showing that a large number of awards went to a small number of institutions.</p><p>Input from working groups yielded two recommendations. The first was to change the review criteria to allow the application to present themselves, their research and their specific training needs rather than more boilerplate material. The second was to revise the application to better map on to the new review criteria – for example, eliminate undergraduate grades, which do not predict future success but can sway reviewers. After community input and internal review process similar to the one conducted for the review of criteria grant applications, an RFI has now been published and implementation will begin with applications received in January 2025.</p><p>Dr. Byrne also described other initiatives to promote fairness in review. CSR developed an online orientation for study section chairs focused on how to foster a strong study section culture. They also developed targeted bias awareness training for reviewers, which has been well received – people refer to the training when they find themselves having to intervene with colleagues. To date, 24,000 CSR reviewers have taken the training, which will be required beginning with May 2024 council review meetings. There is also a training module for review integrity, which has been completed by 17,000 CSR reviewers since its launch in Fall 2022, and it will be required beginning with February/March 2024 review meetings. CSR has a direct bias reporting mechanism, included in every email from any CSR staff member. The contact for that, Dr. Gabriel Fosu, CSR’s chief diversity officer, will ensure that all reports get investigated.</p><p>Finally, Dr. Byrne discussed efforts to diversify review panels. CSR has created a reviewer finder tool to identify lesser-known qualified reviewers. and one category is funded but underutilized investigators. Agencies and societies can recommend reviewers through the portal. The goal is to broaden the pool of potential reviewers but achieving it will require active culture change. CSR has focused on emphasizing the importance of reviewer diversity from above and is also committed to moving beyond demographic and geographic diversity to also capture a spread of topic, laboratories, and career stages. CSR’s data shows that interventions made over the past few years have significantly increased the number of women and underrepresented minorities of its reviewers.</p><p><strong>Discussion</strong></p><p>Dr. Dana said that as research gets more specialized, reviewers often do not have the depth needed to evaluate a body of grants. Vision related R01 grant applications generally go to two study sections which are designed to cover the same body of work, he said, and so reviewers have breadth but not necessarily depth. Dr. Byrnes replied that depth of expertise is subjective. Achieving the level of depth that Dr. Dana was seeking was likely impossible, she said, and for a five-year project breadth is also very important.</p><p>Dr. Borrás noted her frustration with the grant applications that do not get scored. These applications often have conflicting comments from reviewers, and although reviewers are supposed to discuss these differences and distill them into useful feedback, that rarely happens. She wondered whether it was possible to put some kind of number on non-scored submissions to help applicants figure out what to change. Another issue she raised is that many study sessions do not have standing members, so resubmitting a grant yields a whole new set of critiques. Dr. Byrnes noted that scoring is not an exact science and disagreed that adding a score to unscored applications would be useful. The summary statement is intended to provide the feedback Dr. Borrás is seeking, and researchers can discuss this with their program officers to gain clarity about the weaknesses in the proposal.</p><p>Dr. Borrás also noted that science has changed a lot: previously, to be funded, grants had to be hypothesis driven but that is not the case anymore. Today’s work is instead data driven. And yet reviewers still often make the comment that the work is not sufficiently hypothesis driven. Dr. Byrnes said that should not be happening – and if this comment is coming up, it should be brought to someone’s attention.</p><p>Dr. Perez asked Dr. Byrnes to explain how CSR determines what level of diversity of experience the review panels should contain. Dr. Byrnes said that there are no specific benchmarks. Currently about 45% are full professors, 45% are associate professors, and 10% are assistant professors, which she thinks is a good mix.</p><p>Dr. Anderson also noted that CSR has an early career reviewer program on which NEI modeled a very similar program that aims to introduce early career researchers to the review process. NEI’s program allows early career researchers to dip their toes into reviewing by having them serve as secondary or tertiary reviewers. Seeing the review process up close also helps them develop their own grant-writing skills.</p><p>Dr. Kowluru noted that she especially appreciates CSR’s changes to the review process because they allow researchers to focus on deepening existing science rather than just chasing innovation.</p><p>Dr. Chiang said that several clinicians have told him that they have noticed the number of clinicians on study sections has been decreasing. However, he said, they have a unique role to play in addressing the question of whether the study should be done. He expressed concern that if just one or two clinicians are present, their perspectives are too easily diluted or drowned out. Dr. Byrne said this was an interesting notion. She noted that CSR does monitor the participation of clinicians on committees, and she encouraged societies and similar organizations to submit names of clinicians targeted to different panels.</p><p> </p><p><strong>General Discussion</strong><br>Dr. Grant asked if there might be an opportunity to centralize IRB submissions. Her experience is that we spend a tremendous amount of time getting relatively simple protocols approved – often due to back and forth between the main and the supplemental institution. She stated, sometimes we are inundated with a lot of stuff that is not important in getting the science done – and we should try to make that better for everyone as a community.</p><p>Dr. Redford said she agrees – and that NIH thinks that in concept, the single IRB framework is meant to facilitate review and approval. Still, she said, even though there is a single IRB of record, individual institutions require their own review and approval – that is problematic. But those are institutional issues that need to be dealt with.</p><p>Dr. Mutti said that this is an important issue, and that institutions have not caught up with the idea of a single IRB, and that very few groups can perform the single IRB review, and it is exorbitantly expensive in terms of cost and investigator time.</p><p>Dr. Everett echoed these concerns, noting the cost is becoming a huge problem. Many institutions seek approval from private IRBs, which charge for every modification. Dr. Mutti noted that just recently, he saw IRB costs go from $2000 to over $15,000 with the majority of resources going to get the study approved, not do the work.</p><p>Dr. Maguire noted that this also affects study design. Once an investigator gets a clinical trial through multiple IRBs there is great resistance to any change, even if it would be better for the patients and for the trial.</p><p>Dr. Coughlan asked about the S index challenge, which he found very interesting. In the context of the H index for publications, a publication must pass some bar. He wondered whether there was some bar like that for the S index – whether anyone has reviewed the the data is sensible or the metadata is needed – and what kinds of ideas there are to ensure the quality of data.</p><p>Dr. Goetz noted that she and her colleagues are just starting to lead this effort and that they are currently reaching out to a broad swathe of individuals who have experience with this. Some have mentioned that they have created metrics that pull in components of quality or other factors that aren’t just linked to publication. There are many approaches, a workshop discussing this issue will hopefully emerge in the late summer or early fall of 2024.</p><p>Dr. Chiang noted that one of the themes from earlier in the day is that what’s discussed in Bethesda needs to be disseminated – through social media, or through news. Council members are primary gateways to the real world, so whatever they can do to speak about these conversations to the community. Dr. Tumminia underscored this point, noting that council members are NEI’s conduit to the community and they represent a variety of different stakeholder groups, so their efforts to get the message out would be of great benefit to NEI.</p><p>Dr. Chiang officially adjourned the open session.</p><p> </p><p><strong>CLOSED SESSION</strong></p><p> </p><p> </p><p>This portion of the meeting was closed to the public in accordance with the determination that this session concerned 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, USC Appendix 2). 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 were asked to sign a statement to this effect.</p><p><strong>REVIEW OF APPLICATIONS</strong><br>NAEC members considered 473 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $154,189,301 (direct costs year 01). The Council also considered 234 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $210,966,817 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 707 applications.</p><p><strong>ADJOURNMENT</strong><br>The 166th meeting of the National Advisory Eye Council was adjourned at 5:00 p.m. on October 13, 2023.</p><p><strong>CLOSED SESSION ATTENDEES</strong></p><p><strong>Council Members Present:</strong><br>Dr. Michael F. Chiang, Chair (in-person)<br>Dr. Kathleen Anderson, Executive Secretary (in-person)<br>Dr. Terete Borrás (in-person)<br>Dr. James Coughlan (in-person)<br>Dr. Reza Dana (in-person)<br>Dr. Maria B. Grant (in-person)</p><p>Dr. Renu Kowluru (in-person)<br>Ms. Janice Lehrer-Stein (in-person)<br>Dr. Maureen Maguire (in-person)<br>Dr. Tirin Moore (in-person)<br>Dr. Donald Mutti (in-person)<br>Dr. Victor Perez Quinones (in-person)<br>Dr. Pradeep Ramulu (in-person)</p><p><strong>NIH Staff Members Present:</strong></p><p>Dr. Neeraj Agarwal (in-person)<br>Lisa Applewhite (in-person)<br>Dr. Houmam Araj (in-person)<br>Dr. Sangeeta Bhargava (in-person)<br>Nathan Brown (in-person)<br>Dr. Ed Clayton (in-person)<br>Donald Everett (in-person)<br>Lateefah Hill (in-person)<br>Dr. Brian Hoshaw (in-person)<br>Dr. Alicia Kerr (virtual)<br>Dr. Jimmy Le (in-person)<br>Dr. Paek Lee (in-person)<br>Dr. Barbara Mallon (virtual)<br>Dr. George McKie (in-person)<br>Dr. Lisa Neuhold (in-person)<br>Dr. Mary Ann Redford (in-person)<br>Dr. Jennifer Schiltz (in-person)<br>Dr. Martha Flanders (in-person)<br>Dr. Ashley Fortress (in-person)<br>Dr. James Gao (in-person)<br>Dr. Nataliya Gordiyenko (in-person)<br>Dr. Shefa Gordon (in-person)<br>Dr. Tony Gover (in-person)<br>Dr. Thomas Greenwell (in-person)<br>Dr. David Schneeweis (virtual)<br>Dr. Grace Shen (in-person)<br>Dr. Azadeh Shoaibi (in-person)<br>Karen Robinson Smith (virtual)<br>Dr. Hongman Song (in-person)<br>Dr. Afia Sultana (virtual)<br>Dr. Santa Tumminia (in-person)<br>Dr. Cheri Wiggs (in-person)<br>Keturah Williams (virtual)<br>Dr. Charles Wright (in-person)</p><p><strong>CERTIFICATION</strong><br>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> </p><p>______________________________________<br>Michael F. Chiang, MD<br>Chair<br>National Advisory Eye Council</p><p> </p><p>______________________________________<br>Kathleen C. Anderson, PhD<br>Executive Secretary<br>National Advisory Eye Council</p>
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