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<span> NAEC Meeting Minutes - June 7, 2024</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-Eighth Meeting</strong><br><strong>June 7, 2024</strong></p><ul><li><a href="https://videocast.nih.gov/watch=54718"><strong>Videocast</strong></a></li></ul><p>The National Advisory Eye Council (NAEC) convened for its 168th meeting at 8:30 a.m. on Friday, June 7, 2024. 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 2:15 p.m. The meeting was closed to the public from 2:30 p.m. until 5:00 p.m. for the review of grant and cooperative agreement applications and the Board of Scientific Counselors Report.</p><h2>Council Members Present:</h2><p>Dr. Michael F. Chiang, Chair (in-person)<br>Dr. Kathleen Anderson, Executive Secretary (in-person)<br>Dr. Reza Dana (in-person)<br>Dr. Maria B. Grant (in-person)<br>Ms. Janice Lehrer-Stein (in-person)<br>Dr. Maureen Maguire (virtual)<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 (in-person)<br>Dr. Neeraj Agarwal (in-person)<br>Dr. Afrouz Anderson (in-person)<br>Lisa Applewhite (in-person)<br>Dr. Houmam Araj (in-person)<br>Dr. Sangeeta Bhargava (in-person)<br>Dr. Kapil Bharti (virtual)<br>Holly Blake (in-person)<br>Dr. Christopher Bradley (virtual)<br>Nathan Brown (in-person)<br>Dr. Emily Chew (virtual)<br>Dr. Ed Clayton (in-person)<br>Jay Colbert (virtual)<br>Karen Colbert (in-person)<br>Claudia Costabile (virtual)<br>Dr. Mary Francis Cotch (virtual)<br>Kevin Chu (virtual)<br>Kathryn DeMott (virtual)<br>Britt Dennis (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>Alexandra Gavrilovic (virtual)<br>Kerry Goetz (in-person)<br>Dr. Nataliya Gordiyenko (in-person)<br>Dr. Shefa Gordon (in-person)<br>Dr. Tony Gover (in-person)<br>Dr. Anna Han (in-person)<br>Dustin Hayes (in-person)<br>Lateefah Hill (virtual)<br>Dr. Brian Hoshaw (in-person)<br>Dan Ignaszewski (in-person)<br>Dr. Jimmy Le (in-person)<br>Dr. Paek Lee (in-person)<br>Dr. Richard Lee (in-person)<br>Renee Livshin (virtual)<br>Natanya Malcolm (virtual)<br>Dr. George McKie (in-person)<br>Dr. Lisa Neuhold (in-person)<br>Bobby Nonato (virtual)<br>William O’Donnell (virtual)<br>Dr. Bob O’Hagan (virtual)<br>Barbara Payne (virtual)<br>Dr. Mary Ann Redford (in-person)<br>Carissa Reilly-Weedon (virtual)<br>Holly Russo (virtual)<br>Dr. Jennifer Schiltz (in-person)<br>Dr. David Schneeweis (in-person)<br>Shauna Schwartz (virtual)<br>Dr. Grace Shen (in-person)<br>Dr. Azadeh Shoaibi (in-person)<br>Karen Robinson Smith (in-person)<br>Dr. Hongman Song (in-person)<br>Dr. Santa Tumminia (in-person)<br>Terry Vance (virtual)<br>Fausto Vela (virtual)<br>Leslie West-Bushby (virtual)<br>Dr. Cheri Wiggs (in-person)<br>Bronte Washington-Williams (in-person)<br>Keturah Williams (virtual)<br>Dr. Charles Wright (in-person)<br>Maria Zacharias (virtual)</p><h2>WELCOME AND INTRODUCTIONS</h2><p><strong>—Dr. Michael Chiang, Chair, NAEC, and Director, NEI</strong></p><p>Dr. Chiang called the 168th NAEC meeting to order. He introduced two guest speakers, Dr. Vinit Mahajan of Stanford University and Dr. Afrouz Anderson of the National Institute of Biomedical Imaging and Bioengineering. 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, colleagues from the Center for Scientific Review, invited speakers, and members of the public who were in attendance virtually and in person, and staff members who organized the meeting and provided technical support. She also made some logistical announcements regarding participation in the hybrid meeting.</p><p>She noted that future NAEC meetings are listed on the agenda and on the NEI website. The next in-person NAEC meeting will be held on Friday, October 11, 2024. Minutes of the February 2024 NAEC meeting were made available in the electronic council book (ECB) prior to the meeting. A motion to accept the February meeting minutes was made, seconded, and approved unanimously. Going forward, draft council minutes will be emailed to Council members for 3 168th National Advisory Eye Council Meeting, June 7, 2024 approval in advance of the meeting as under a new requirement to have final meeting minutes certified 120 days after the meeting.</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, @NEIDirector and @NatEyeInstitute.</p><p> </p><p><strong>NIH and NEI Leadership and Staff Updates</strong><br>Dr. Chiang announced that Dr. Kathleen M. Neuzil has been named director of the Fogarty International Center. He noted that Dr. Neuzil is an infectious disease specialist and a global health expert, and that she served as a vaccine policy advisor to both the World Health Organization and the US Centers for Disease Control and Prevention. He also noted that NEI has many touchpoints with the Fogarty Center though its global health focus.</p><p>Dr. Chiang also announced the departure of Dr. Joshua Gordon, Director of the National Institute of Mental Health, after serving during an especially important time for mental health in the US.</p><p>At NEI, Dr. Chiang welcomed Bronte Williams-Washington, who will serve as the new Operations Coordinator for the Division of Extramural Activities and the Division of Extramural Science Programs.</p><p><strong>Awards and Recognition</strong><br>Dr. Chiang congratulated Dr. Larissa Huryn, a pediatric ophthalmologist at NEI who received the 2024 Outstanding Emerging Leader Award from the American Association for Pediatric Ophthalmology and Strabismus (AAPOS). He also lauded Dr. Emily Chew for receiving the Proctor Medal and Dr. Anand Swaroop for receiving the Friedenwald Award from the Association for Research in Vision and Ophthalmology (ARVO).</p><p>Dr. Chiang also congratulated Dr. Carlos Ramon Ponce of Harvard Medical School for being one of 20 winners of the NIH Common Fund challenge competition for Complement Animal Research in Experimentation (Complement-ARIE). Dr. Ponce’s project investigates how neural networks use visual information processing for image recognition.</p><p><strong>NEI-funded Highlight</strong> –Dr. Chiang highlighted a research project funded by NEI and led by Drs. Jayshree Advani and Anand Swaroop. Their project investigated genotype, RNA expression, DNA structure and DNA methylation in 160 human donor retinas to identify genes involved in adult macular degeneration disease progression and pathology.</p><p><strong>Highlights of Innovative Research</strong> –Dr. Chiang noted that an element of NEI’s mission statement is to drive innovative research. He highlighted several innovative research projects in which NEI is involved.</p><p>One such project was a workshop on extracellular vesicles organized by Dr. Alissa Weaver of Vanderbilt University and Dr. Ali Djalilian of the University of Illinois. The workshop outlined opportunities for research on extracellular vesicles in the visual system. A white paper from the workshop summarizing these opportunities is forthcoming.</p><p>Another effort Dr. Chiang noted was the NIH Regenerative Medicine Innovation Project (RMIP), one of four innovative projects created through the 21st Century Cures Act. Of the 20 funded RMIP projects, five are related to vision. NEI Deputy Director, Dr. Santa Tumminia, is now working with her counterpart Dr. Robert Carter at the National Institute of Arthritis and Musculoskeletal and Skin Diseases to establish the next steps for RMIP – including creating public private partnerships for developing cell-based therapies. After a workshop hosted in November 2023, they expect to produce a research plan this year.</p><p><strong>Highlights of Innovative Research (2)</strong> –Another innovative project that Dr. Chiang described was Stage 3 of EyeGENE, a long-running effort to study rare inherited eye diseases. Stage 3 aims to collect large genomic datasets to target diagnoses that are currently underrepresented in the program, including Aniridia, Best disease, Blue-cone monochromacy, and corneal dystrophy. The project is now re-opening enrollment with a new data collection protocol in place. Efforts are underway to pilot the use of electronic consent forms and mailed DNA collection kits.</p><p><strong>Highlights of Innovative Research (3)</strong> –Another innovative project that Dr. Chiang described was Stage 3 of EyeGENE, a long-running effort to study rare inherited eye diseases. Stage 3 aims to collect large genomic datasets to target diagnoses that are currently underrepresented in the program, including Aniridia, Best disease, Blue-cone monochromacy, and corneal dystrophy. The project is now re-opening enrollment with a new data collection protocol in place. Efforts are underway to pilot the use of electronic consent forms and mailed DNA collection kits.</p><p><strong>Discussion</strong><br>Dr. Maria Grant suggested tapping into departmental or university-wide announcements to post this opportunity. Dr. Reza Dana suggested ways to disseminate the tools that emerge from such research efforts – for example, taking a mass marketing approach, or in a more focused manner, working with nonprofit organizations that serve affected communities, or through professional organizations such as the American Academy of Ophthalmology. Dr. Pradeep Ramulu said that there was already strong interest in this topic within the low vision community and that he has talked to many researchers who plan to submit an application. Because the deadline is short, he suggested that the effort needs a longer launchpad to bring new people into the field. That could help lure experts such as engineers, behavioral change architects, interventional specialists and others who are not necessarily low vision specialists.</p><p>Dr. Chiang agreed on the importance of tapping into expertise beyond the vision research community. He noted that a recent World Health Organization report on accessibility noted the wheelchair and the hearing aid as key accessibility tools. He wondered what the low vision community’s equivalent of that would be—whether it might be glasses, or a white cane, or something that has not yet been invented. Dr. Janice Lehrer-Stein noted that her own version of a low-vision accessibility tool was a service dog, but that he has no thumbs, cannot drive, and is not great with smart phones and the internet. She said there is a huge interest in improvements to tools for navigating in physical space but also for accessing documents, handling currency, and other daily activities. Most rehabilitative work is done by nonprofits, she said, though companies like Microsoft are creating some powerful products. She suggested public-private partnerships as well as challenges or hackathons to engage engineers.</p><p><strong>Highlights of Innovative Research (4)</strong> –Dr. Chiang described an initiative on Oculomics and imaging supported by the Common Fund at the NIH. Launched last year, it aims to develop novel non-invasive ocular imaging technologies as well as machine algorithms to build better tools for identifying biomarkers for systemic diseases. A Research Opportunity Announcement (ROA) for $1.6 million total costs per year for up to three years was announced in March, with a deadline in late May. Applications are currently being reviewed.</p><p>Another ongoing Common Fund project called Bridge2AI funded a team from the University of Washington headed by Drs. Aaron Lee and Cecilia Lee. That work gathered data from 4000 people with diabetes at different disease stages and used artificial intelligence (AI) to examine saludogenesis – progression from disease to health. The researchers have now released the first dataset from this project, with data from 204 participants, and it can be accessed at <a href="https://aireadi.org">https://aireadi.org</a>.</p><p>A third Common Fund project that Dr. Chiang described has been a signature initiative of NIH Director Monica Bertagnolli, and was just announced yesterday in a press release and an editorial in Science magazine. It addresses the overall decline in health among the US population, particularly in underserved populations, and its goal is to establish primary care focused networks that integrate research into routine clinical care. The budget will be $5 million for FY24 and will ramp up in future years. Dr. Chiang asked Council members for their thoughts on how to better connect eye care to primary care.</p><p><strong>Discussion</strong><br>Dr. Victor Perez noted that many physicians are afraid of addressing eye issues and prefer leaving that to specialists. Education and outreach to primary care providers can enable them to integrate elements of eye care into common disease treatment such as diabetes and hypertension, he said, and maybe this can serve as a platform to demonstrate that they can integrate the use of imaging and other tools for eye care in a user-friendly manner.</p><p>Dr. Dana agreed and noted that few medical schools have a required ophthalmology curriculum. He also said that it will be important to look beyond diabetic retinopathy into aspects of eye care that may be less familiar to primary care physicians. Invited speaker Dr. Vinit Mahajan noted that some practices across northern California have been making imaging widely accessible by deploying cameras and combining AI and humans to screen patients. Originally, ophthalmologists feared that adding these tools to primary care would cause specialists to lose patients, but the increased screening enabled primary care practices to correctly refer patients to ophthalmologists.</p><p>Dr. Ramulu noted that the aim of the proposal is not to get primary care doctors more involved in ophthalmology, but to create a research connection between the two. Algorithms for ophthalmological imaging that can improve screening for diseases such as hypertension or diabetic retinopathy should help do that. Dr. Mutti said that one factor limiting efforts to improve services to the underserved was the fact that young trainees were hesitant to move to underserved areas. Incentivizing a public service career might move the needle, he added.</p><p>Dr. Grant noted that even within academic communities, experts like pulmonologists, cardiologists and hematologists do not appreciate how important the eye can be for diagnosing other diseases. Making data that shows this more mainstream may help convince clinicians, she said. Also, she suggested tapping into state-wide efforts on earlier disease diagnosis by educating patients. Dr. Chiang summarized the discussion by noting that both technology and policy are at play in this issue.</p><p><strong>Highlights of Collaborative Research (1)</strong> –Dr. Chiang described several ongoing projects that relate to another element of NEI’s mission statement, to foster collaboration. He mentioned that Amber Reed and Kerry Goetz in the NEI Office of Data Science and Health Informatics have been working on a resource that can generate synthetic patient data. The tool they developed is called Synthea and it is freely accessible and available at https://synthetichealth.github.io. One of the applications for this is people trying to test the interoperability of new electronic health record systems.</p><p>There are also efforts to standardize ocular imaging, and NEI has been pushing the adoption of standards by commercial devices. On May 3, 2024, NEI published a new guide notice strongly encouraging the use of common formats like DICOM, both for clinical and nonclinical imaging. Researchers whose grants score highly may not be prioritized for funding if they are not using devices that produce data in these common formats.</p><p><strong>Discussion</strong><br>Dr. Ramulu asked Dr. Chiang how synthetic data might be useful for research capacity. Dr. Chiang responded that retinal images are one example of how synthetic data could be used. There are a lot of concerns about privacy and whether or not retinal images are deidentified, with different institutions having different policies. Accessing them through synthetic EHR data could offer a solution.</p><p>Dr. Goetz added that Synthea does not just include eye-related information but also diabetic and primary care information, so it could be used to study the relationship between the three areas. But she and her colleagues still have to validate the system further before it can be useful for research, she says. But she noted that in addition to synthetic clinical information, the program aims to generate synthetic images and is trying to create a use case for research and development of tools that bridge the imaging to electronic health record link.</p><p><strong>Fostering Collaborations and Improving Quality of Life</strong> –Dr. Chiang next spoke about an effort to quantify vision-related quality of life. A questionnaire called the Visual Function Questionnaire 25, developed in the 1990s, is the most common instrument for doing this, but it has some limitations and is somewhat outdated. On September 29, 2023, NEI hosted a workshop with the FDA and the Patient Centered Outcomes Research Institute (PCORI) to develop a new generation of tools for measuring quality of life. Participants are preparing a white paper from the workshop. One key idea was the creation of a disease agnostic tool that tests multiple domains and that uses a database managed by NEI.</p><p>In honor of May being Healthy Vision Month, Dr. Chiang discussed components of another effort to address vision-related quality of life, the National Eye Help Education Program (NEHEP). One social media campaign called Reframe your Vision, focuses on the relationship between vision and mental health.</p><p><strong>Highlights of Collaborative Research (2)</strong> –Dr. Chiang gave an update on the NASEM Myopia Study, a study group cosponsored by NEI and chaired by Dr. Kevin Frick at Johns Hopkins University and Dr. Terry Young at the University of Wisconsin. The group is conducting a consensus study to assess the mechanistic understanding of myopia and propose a research agenda. Participants will produce a final report by the end of the year. In the meantime, Dr. Chiang said, a symposium held at ARVO’s annual meeting in May aimed to build a group of people interested in myopia.</p><p><strong>Highlights of Collaborative Research (3)</strong> –Collaboration is also building on the small business front, Dr. Chiang said. NEI has a Small Business Innovation Research (SBIR) cooperative agreement for early-stage trials with greater than minimal risk. Researchers conducting early-stage commercialization-oriented trials can apply for three years of funding, with budget requests at $1 million per year and total costs of up to $2 million. Another opportunity is the Small Business Transition Grant for New Entrepreneurs, which is meant to support early career scientists transitioning to entrepreneurship. This grant will have a training component. A Pre-Application Technical Assistance Webinar was held on Tuesday June 11.</p><p><strong>Highlights of Collaborative Research (4)</strong> —Dr. Chiang described a collaboration with the NIH Center for Alzheimer’s and Related Dementias (CARD). NEI will share space in the CARD clinic and conduct testing on its patients including deep retina phenotyping and central visual pathway testing and will also generate induced pluripotent stem cells from CARD patients. The aim is to develop tools for risk assessment and determining diagnosis and prognosis of dementias, and to learn how the pathophysiology of the eye and brain are related to each other.</p><p><strong>Highlights of Collaborative Research (5)</strong> —Dr. Chiang discussed efforts to develop ways that NEI can collaborate with NIBIB and the All of Us study. After a workshop held last year, efforts are now in the concept development stage and NEI representatives will give a presentation in July to All of Us leadership.</p><p><strong>Recruit, Inspire, Train: Career Development</strong>—Dr. Chiang described a funding opportunity that NEI recently joined, Stimulating Access to Research in Residency (StARR) R38 award. NEI is one of four NIH institutes participating in this initiative which aims to attract ophthalmology residents to research. Dr. Chiang also noted an effort called the Council for Vision Editors, which launched in April with an initial cohort and aims to provide editorial opportunities for 14 early faculty members. In this program, the cohort meets a few times per year with Dr. Chiang and Editors-in-Chief of some of the major vision journals to discuss how to advance the field. Young faculty members are matched with journals and mentored as junior editorial board members, creating career development experiences.</p><p><strong>Recruit, Inspire, Train: Workforce Diversity</strong>—Dr. Chiang described a trio of efforts to provide mentorship to trainees at multiple levels. An ongoing program in the Office of the Chief Officer for Scientific Workforce Diversity (COSWD) offers mentorship supplement awards for investigators who are outstanding mentors in the area of Diversity, Equity, Inclusion and Accessibility (DEIA). NEI’s Diversity in Vision Research and Ophthalmology summer program brought in 7 students (5 college, 1 medical school, 1 veterinary school) from underrepresented backgrounds in 2024. Finally, a high school video contest, which has run for the past three years, has students submit videos about vision science and/or projects they have developed. The winners receive $2000 and are brought to the NIH campus in Bethesda for a day to tour NEI labs and attend networking events. This year, NIH Principal Deputy Director Larry Tabak will be speaking with the students.</p><p><strong>ARVO 2024: NEI and Research to Prevent Blindness (RPB) Career Development Symposium</strong>—A symposium held at ARVO this year brought together early career researchers who have received NEI mentored career grants and/or RBP career development awards. The symposium included keynote talks, roundtable symposia, and panel discussions on career development issues. Dr. Chiang noted that this event has not happened since 2005, the year Dr. Chiang had attended and found it extremely valuable.</p><p><strong>Education Resources</strong>— Dr. Chiang provided QR codes for educational resources. These included a link to information about a seminar series hosted by the <a href="https://www.nei.nih.gov/about/goals-and-accomplishments/nei-research-initiatives/data-science-and-health-informatics">NEI Office of Data Science and Health Informatics</a>, and to the NEI extramural research newsletter (<a href="https://list.nih.gov/cgi-bin/wa.exe?SUBED1=NEI-EXTRAMURAL-RESEARCH&A=1">Subscribe here</a>) which provides updates on funding opportunities, policies, and events.</p><p><strong>NAEC Budget Update</strong> —Ms. Karen Colbert, NEI Budget Officer, recapped the current fiscal year and shared her expectations for the new 2025 fiscal year, which begins October 1, 2024.</p><p>The FY2024 NIH budget remained flat with FY2023 enacted levels, which is effectively a budget cut because of increased costs and inflation. During periods of flat or reduced budgets, the agency reviews commitments in all areas and prioritizes training and support for early career investigators. NEI proposed spending for the year invests $742 million, or 83% of the total budget, into extramural research; $111 million or 12% of the budget into intramural research, and $43 million, or 5% of the budget into research support.</p><p>How the NIH budget will change in FY2025 is still unknown. This is an election year, which always has an impact on the budget process. It is unlikely that Congress will pass appropriations before FY2025 begins in October, and instead the NIH will likely start the year under a continuing resolution. Continuing resolutions avoid costly and difficult government shutdowns but can also delay some funding decisions. The president’s budget request for FY2025 is $898.8 million, which is $2.3 million above the current year.</p><p>In recent House and Senate activity, Kay Granger (R-Texas) announced in March she was stepping down as chair of the House Full Appropriations Committee, and the chair is now Tom Cole (R-Oklahoma). Tom Cole has historically been supportive of NIH so there is hope that this is a good sign for the budget process. He released his markup schedule for FY2025 appropriations bills; there is currently no expectation for a House Appropriations Subcommittee hearing for NIH. However, the Senate held their hearings in March, during which several areas were raised as funding priorities. These include continued investment in better diagnostics, precision care for mental health patients, targeted investments for research on women’s health, reducing the cancer death rate, data science and data sharing, Alzheimer’s Disease, Diabetes, and other areas.</p><p><strong>Discussion</strong><br>Dr. Dana asked how much variance there generally is in the relative intramural to extramural expenditures. Ms. Colbert said the number has been consistent, with the intramural program representing approximately 12% of the total NEI budget. Dr. Dana also asked about the number of laboratories or PIs supported by the intramural and extramural funding. Dr. Chiang said the number of intramural investigators was smaller, with 26 laboratories and six core facilities.</p><p><strong>Translational Opportunities for Multi-Omic Research Approaches</strong>— Dr. Vinit Mahajan, Stanford University; Dr. Afrouz Anderson, NIBIB</p><p><strong>TEMPO: A multi-omic approach to identifying disease mechanisms in living humans</strong>— Dr. Vinit Mahajan, Stanford University</p><p>Dr. Mahajan directs the Molecular Surgery Program at Stanford, and he noted that ophthalmologists and vision scientists can deliver any molecule anywhere in and around the eye – and that they can essentially operate on cells. For example, the first FDA-approved gene therapy involves injecting a needle just below the retina to deliver a gene therapy vector that treats retinal pigment epithelial cells to prevent vision loss. But he added that they do not take advantage of this procedure to remove fluid from the eye. Cataract surgery, the most common surgery in the world, involves removing fluid from the eye, but this fluid is thrown away. He and his colleagues instead save and freeze it, and then use it to develop molecular diagnostic technologies, including a method called TEMPO, which stands for “Tracing the Expression of Multiple Protein Origins” and was described in a recent publication in the journal Cell.</p><p>For TEMPO, they extract 50 microliters of eye fluid and use DNA array technology to measure about 6,000 proteins. They then traced protein signatures to specific types of cells, such as different types of immune cells, retinal cells, or blood vessel cells. These signatures were robust, containing more than 50 proteins each. TEMPO also reveals protein signatures of disease. Eye fluid samples taken from people with retinitis pigmentosa were missing the signature from rod cells, as the disease’s pathology would predict. Diabetic retinopathy also showed a distinctive molecular signature that changed over the course of disease progression. TEMPO could also identify and reveal molecular insights about Parkinson’s disease.</p><p>Dr. Mahajan and his colleagues also applied AI modeling to groups of proteins identified with TEMPO to identify a molecular signature of aging overall, predicting study participants’ birthdays with some accuracy. They also used the approach to identify molecular signatures of aging for multiple eye-related diseases, identifying which cell types contributed most strongly. These signatures could reveal signs of advanced aging even when a patient’s disease was controlled, suggesting aging may be a separate biological pathway.</p><p>Dr. Mahajan also described studies using TEMPO to investigate eye cancer, identifying protein profiles that help classify a tumor without a biopsy. The technique identified characteristics in patients’ samples that suggest whether specific cancer therapies are likely to be effective. That is especially powerful in uveal melanoma, a rare but deadly cancer. Testing patients’ cells in this way can be used to identify whether they carry a particular drug target and therefore whether they would be candidates for a specific therapy or clinical trial.</p><p>Dr. Mahajan summarized his talk by underscoring the power of combining proteomics with single cell sequencing, as TEMPO does, and noting that some of his colleagues are also applying the technique to samples taken outside the eye to look at conditions such as inflammatory bowel disease, neurological diseases and other cancers, as well as aging and menopause. He is currently trying to encourage industry to include such eye samples as they enroll patients in studies of molecular therapies. He also suggested that NEI support a multicenter fluid collection effort to power further studies.</p><p><strong>Discussion</strong><br>Dr. Dana noted with interest that TEMPO pinpointed macrophages as players in in diabetic retinopathy, saying that this aligns with his observations of macrophages as the chief source of pro-angiogenic molecules in several of the disorders presented. He noted he will send a paper that captures what macrophages do in regard to the expression of both ligands and receptors to drive that process.</p><p>Dr. Grant asked whether Dr. Mahajan’s team had compared the aging profiles observed in eye fluid with blood samples. She also asked what he makes of the presence of B cells in the fluid samples. Dr. Mahajan replied that he expects eye fluid to be strongly enriched for relevant proteins because it is local and close, and because blood is generally less important for eye disease markers because proteins get diluted out of it and may not be reflected in blood. As for the B cells, he noted that there was substantial subclinical inflammation in the eye, and that although it is an immune privileged area, it is not “immune zero.” These different cells may have contributions that have not been clinically characterized, he added.</p><p>Dr. Perez asked whether the work had characterized pediatric aqueous fluid, and Dr. Mahajan said that they had collected some samples from pediatric uveitis but that it was more complicated to characterize and there was no comparative control.</p><p><strong>Integrating biomedical imaging with multi-omics analysis for diagnosis of ocular and systemic diseases— Dr. Afrouz Anderson, NIBIB</strong></p><p>Dr. Anderson focused on the intersection of imaging and Artificial Intelligence (AI), noting that efforts to enable imaging technologies through AI have grown by 3.7 times ($1.1B) at NIH over the past five years, along with an enormous market growth in the use of AI and machine learning in imaging technologies. NIBIB is disease agnostic and does a lot of work in the early stages of tool development. The aim of these tools is to optimize the information that can be obtained from the imaging data and to be able to explain its clinical relevance.</p><p>Preparing data for AI analysis requires intensive work including curation, quality control, annotation, and harmonization, she noted. It is also crucial to understand bias and diversity in the data, she added. A major actor in data resources for AI and imaging is a multi-institutional collaboration called the MIDRC – Medical Imaging and Data Resource Center. Its goal is to create an open discovery data common for creating patient data sets and using machine learning for creating clinically relevant tools. MIDRC contains sequestered data that is still being validated in collaboration with the FDA, as well as public facing data.</p><p>Due to a 2023 executive order to build a national research infrastructure for AI, NIH has participated in NAIRR, the National AI Research Resource pilot program to deploy these resources to early users. MIDRC is also part of the ARPA-H Biomedical Data Fabric Toolbox. This is a national infrastructure for industrial data curation and discovery and visualization of AI in healthcare, Dr. Anderson said.</p><p>Dr. Anderson described some examples of NIBIB’s AI imaging portfolio. What is most exciting, said Dr. Anderson, is the growing overall capability in noninvasive optical imaging technology. This growing suite of tools can image at all scales, from macro to nano and both structurally and functionally. Multimodal imaging can reveal multiple biomarkers for ocular and systemic disease. Longitudinal data can be captured in all these different ways. These multidimensional capabilities enable scientists to study more complex diseases and disease processes, and partnerships have been crucial for these advances.</p><p>Harnessing AI for ocular imaging, both for research and for point of care use, is an exciting prospect, though it comes with challenges, she said. These include access to large usable datasets, developing the best algorithms, addressing bias, and creating trustworthy and explainable AI that yields standardized outcome measures, as well as challenges in regulatory clearance and clinical adaptation. But the solution lies in building engineering and medical partnerships and using the type of data repository and federated networks that MIDRC has created, she said. Building on these models and working together across different societies and stakeholders can help push these tools’ utility beyond a single disease.</p><p><strong>Discussion</strong><br>Dr. Mahajan asked whether ophthalmology led the way in terms of AI imaging. Dr. Anderson said it did, and she described the power of multidimensional data in ophthalmology. Dr. Chiang also noted that ophthalmology is often said to have the first FDA approved autonomous AI system, but in terms of FDA-approved AI imaging systems currently available, radiology leads the way. He asked what that field is doing that the vision field is not doing. Dr. Anderson stressed that connection with different societies, and a true community driven approach, is crucial. Vision researchers are poorly connected to physicians and other medical practitioners and do not necessarily understand their needs, she said. She added that the establishment of an imaging standard is crucial, but something the field is still working on.</p><p>Dr. Dana noted that any AI system relies on access to large amounts of reliable, normative data. That is a challenge because there is so much variation even within the “normal” population. Efforts to develop AI tools will have to deal with the fact that ophthalmologists, in particular, tend to image clear-cut disease states, whereas many other fields have a lot more information on control populations, he said.</p><p>Dr. Maguire referred to a discussion earlier in the day about the challenges of getting eye care into primary care. She asked how far off we might be from a primary care physician ordering a lipid panel to also be able to order a battery of tests on a single machine that would offer wide-ranging information on systemic conditions. Dr. Anderson replied that although regulatory issues can extend the timeline, technologically such a scenario is perhaps five years away. She added another five for clinical approval – so, optimistically, she estimated a total of 10. Already, point of care diagnostics can detect biomarkers from both an imaging and a molecular perspective. She said partnerships between people who understand the needs for applications and those who have technological expertise will be key.</p><p><strong>BRAIN Multi-Council Working Group Update</strong>—Dr. Tirin Moore, Stanford University</p><p>At the May 2024 meeting, Dr. Moore reported, the BRAIN Director summarized the status of the BRAIN Initiative’s budget. Since its launch in 2014, the BRAIN Initiative has enjoyed robust funding, with a peak in its total budget for Fiscal Year 2023 due to a large but temporary increase in funds derived from the Cures Act. That temporary increase was reduced to previous years’ levels for the current year, resulting in a $280 million reduction in funding. Nevertheless, the Director stressed that the initiative planned to be a good steward of the funds allocated to the BRAIN initiative, and to fund the best science. It is hoped that some funds will be restored in future years. The BRAIN initiative is still committed to funding ongoing commitments with some slight adjustments to out-year costs for projects. The reduction also means the BRAIN initiative may need to reduce the number of awards made this year and likely next year and cancel some initiatives.</p><p>The BRAIN Director also announced recent honors and awards received by investigators involved in BRAIN Initiative projects, including Dr. Larry Abbot of Columbia University, Terry Sejnowski at the Salk Institute for Biological Studies, and Haim Sompolinsky at Harvard University, who won the 2024 BRAIN Prize. He also summarized recent BRAIN Initiative events, including requests to participating ICs on the impact of the BRAIN the ICs initiatives. There have been several articles published on these perspectives, which have been inspiring and encouraging about the impact the BRAIN has had on the mission of the ICs. The BRAIN recently held a workshop on “Advancing Human Neuroscience Through Neurostimulation and Recording” at the end of May. He also mentioned the10th Annual Brain Initiative conference, held on June 16, 2024, provides a forum for discussing new developments and bringing BRAIN investigators together. The BRAIN Director provided some updates on recent awards, including the distribution of BRAIN funded investigators across the United States (36 states have BRAIN awards), as well as challenges in diversifying the pool of BRAIN-funded investigators and scholars.</p><p>Another major source of discussion was how the initiative plans to handle the substantial decrease in budget and which priorities, under the circumstances, should be emphasized, Dr. Moore said. The BRAIN Multi-council Workgroup meeting was recorded and can be viewed <a href="https://videocast.nih.gov/watch=54568">here</a>.</p><p><strong>Concept Clearance: NEI New Innovator Award</strong>— Dr. Sangeeta Bhargava, NEI</p><p>The goal of this concept is to support postdoctoral researchers and other early-stage investigators who show exceptional creativity, propose especially novel or insightful work, and address important issues in vision research. The concept is driven by two observations. First is that NEI’s F32 postdoctoral program, has seen a dramatic drop in applications of more than 50% in the last five years. Other institutes across the NIH have observed a similar trend. The second observation is that an NIH advisory committee established in 2022 to re-envision postdoctoral training provided recommendations to address this decline. These recommendations included increased pay and benefits, create and expand mechanisms to support postdoctoral scholars to transition into independent careers, support safe and diverse perspectives, and promote training and development.</p><p>This new concept aims to incorporate all of these recommendations. It would be open to both US citizens and noncitizens based at US institutions who have either a research or a clinical doctorate. The concept is both research and person focused. Applicants are encouraged to emphasize innovation and creativity. The review process will emphasize the individual’s creativity, innovation of the research proposal, and the impact on the mission of NEI. Ultimately the goal is to support promising early-stage researchers to move into independent positions.</p><p> </p><p><strong>Discussion</strong><br>The assigned discussants for this concept clearance were Drs. Dana and Moore. Dr. Dana noted that the drop in postdoctoral scholars is alarming but not surprising, with many moving into industry given limitations in federal funds. Any measure with a meaningful impact on the decline should be supported, but if there are not enough people being funded then the award will become a prize but will not change the trend. Dr. Dana would prefer more awards given for less money, but overall, he thinks this is a good idea. He asked, though, whether other institutes have similar mechanisms, and how many awards NEI hopes to disburse.</p><p>Dr. Bhargava responded that the NIH Common Fund has a similar program started in 2014. NIAID launched a similar program in 2019 that has succeeded in getting postdoctoral fellows into more independent positions and supporting early-stage-investigators who have then gone on to get R01 grants. The number of NEI awards depends on the budget, but the aim is to support as many meritorious applications as possible.</p><p>Dr. Moore said the drop in postdoctoral applications is striking and asked whether the reason for it was known. Dr. Bhargava said both salary issues and the Covid epidemic likely played a role. Salary drives postdocs into industry instead of academia. Other factors were mentioned in the report. Dr. Moore said he believed the concept was a good idea and especially liked that it is open to non-US citizens. Dr. Anderson noted that NEI is not limited on how many awards can be made under this program. If many meritorious applications come in NEI will prioritize them with other projects from early-stage investigators.</p><p>Dr. Maguire said she likes the recommendations for improving the overall postdoc experience. She asked if the decrease in postdocs was leading to a shortage causing independent jobs not to be filled, or if there were simply too many postdocs before. Dr. Bhargava replied that the number of graduate students had increased while the number of postdocs decreased – seemingly because they chose a different path. Dr. Dana noted a third option – that because investigators’ budgets have been kept constant, and at many institutions, postdoctoral salaries have increased, the number of postdocs that could be funded has decreased.</p><p>Dr. Perez said he thinks the concept would be a great program and asked how the review process would differ from other awards. Dr. Bhargava said that rather than focusing on data and publications, this award would focus on how creative or innovative the proposal was and whether it brings something new to the field. The review will also emphasize the potential of the person to make novel scientific contributions.</p><p>Dr. Moore noted that it will be difficult to evaluate newly independent investigators from postdoctoral applications during the review.</p><p>Dr. Dana suggested that the name of this award – NEI Innovator – sounds very high level. He suggested changing the name to something like NEI Early Investigator, or NEI Early Career Innovator Award, to prevent people from being misled by the title.</p><p>Dr. Anderson asked for a motion to approve this concept, which passed unanimously.</p><p> </p><p><strong>Concept Clearance: A Community Driven Research Approach to Achieving Vision Health Equity</strong>—Dr. Jimmy Le, NEI</p><p>This concept clearance emerged for the NEI Strategic Plan and from a workshop held last year with the National Institute on Minority Health and Health Disparities, on vision and health equity, Dr. Le said. The goal of this concept is to advance vision health equity by supporting community engaged research on multi-level interventions that simultaneously address vision health conditions and social determinants of health – which include nonmedical factors shaping daily life, such as housing, education, employment, and transportation. The concept aims to support research that prioritize populations with health disparities, focuses on multi-level interventions, demonstrates meaningful engagement with community partners to ensure that the interventions under investigation are responsive to the needs of the community and can achieve sustainable improvements once the research ends.</p><p>Dr. Le laid out the concept’s rationale: Vision health equity research is an important strategic priority for NEI. The Covid pandemic and other current events, laid bare the impact of inequities in the prevention, treatment, and management of diseases among health disparity populations, he said. Vision health disparities are addressable, best driven by the community, and the vision field is ready to lead large-scale projects addressing health equities, he added. Community engaged science is a gap in NEI’s current research portfolio. For example, refractive error and vision screening sounds like an obvious solution, Dr. Le said, but what happens after to address issues identified through screening matters a lot, and there need to be interventions at multiple levels, engaging many different types of community partners. Another example would be how mobile health might increase access to vision health services in rural settings. In what ways could collaboration with faith-based organizations or other businesses or services could expand the delivery of vision health interventions? How could culturally informed health promotion strategies improve vision health literacy? How might peer support programs and navigators connect patients to resources and other vision services? In what ways could AI enhance detection and referral processes in low resource settings? He ended by recapping the objectives and scope of this initiative which include:</p><ul><li>Catalyze, develop, and evaluate community-engaged, multilevel interventions that address health disparities to advance vision health equity.</li><li>Evidence of meaningful community engagement include but are not limited to community partners holding roles as key personnel on research projects.</li><li>Transdisciplinary collaborations with researchers outside the vision field such as health services, health disparities, education, behavioral science, and social science.</li></ul><p>He then thanked his collaborators at NEI and NIMHD asked for council feedback on this concept.</p><p><strong>General Discussion</strong></p><p>Dr. Grant opened the discussion by asking for clarification about the R38 grant mechanism. Dr. Chiang explained that is this program funds departments to support clinical residents to do research during their residency years. The R38 funds the years that are devoted to research. He noted that three other institutes besides NEI also participate in this program. Dr. Anderson clarified that the R38 is an institutional award, while the F32 is an individual fellowship award.</p><p>Dr. Grant noted that a common problem in ophthalmology is that students who want to get into the field but do not get accepted into a residency program end up taking a gap year. This is a great time to introduce physicians to science, Dr. Grant said. She suggested some hybrid version of the R38 could help enable that. Dr. Chiang agreed, and noted another common scenario, in which a medical student who wants to take time off to do research but cannot access a funding mechanism to do that. NEI would like to inspire people to get into research and he sees this as one way to do this. He asked what else can the vision community be doing to inspire someone to go into research?</p><p>Dr. Dana noted that many candidates are not that interested in research, but they want to get into a good residency and research experience helps them to do this. It is not possible to identify in advance who will choose to follow which path (academia or private practice), Dr. Dana said. He did say that it is our job to create opportunities for them, even if you cannot control their career choice. Dr. Perez noted that it will be up to individuals to push themselves into research opportunities in ophthalmology and vision and take advantage of these types of mechanisms.</p><p>Dr. Ramulu noted that they recruit faculty who have already been through this type of program which inspired his institution to apply for this program.</p><p>Dr. Maguire said that in finding ways to deliver eye care to underserved populations, a common consideration is manpower, and one option raised earlier in the day was training programs sponsored by journals that help awardees be good reviewers and get them involved in the editorial process. Dr. Maguire noted that it would be good to extend this effort to biostatisticians, considering there is a severe shortage of them.</p><p>Dr. Mutti asked for a clarification on what to call the Early-Stage Innovator Award. He also sought clarification on how applicants should think through whether to apply for it as a sort of pre-R01, or to cast their lot as a new investigator with an R01. Dr. Bhargava explained that if the researcher does not have a lot of data but perhaps a clever paradigm shifting idea, then you could go for the Innovator program. If you have multiple ideas and supporting data, a new investigator could apply for both, as the NIH does permit applicants to submit two distinct applications at the same time.</p><p>Dr. Mutti asked whether Dr. Bhargava had some feedback on encouraging early-stage investigators who do not have the reputation of a senior person. Dr. Brian Hoshaw, Chief of the Review Branch at NEI, addressed this question. He explained that all NEI R01s are reviewed at the Center for Scientific Review (CSR) and all early-stage investigator applications are clustered together during the review meeting – separate from applications from more senior investigators. Dr. Anderson added that institutes are encouraged to prioritize early-stage investigators and these applications might get a (virtual) 5% bump to their application scores. NEI prioritizes applications from early stage and new investigators when developing funding recommendations.</p><p>Dr. Ramulu said that what all these concept proposals illustrate is that science done at the NEI is changing. So young investigators who are developing proposals on topics relating to AI or big data or health equity often ask what study sections they should be submitting them beyond the typical ones that review NEI R01s. It is definitely creating anxiety in people working in these new areas, Dr. Ramulu said. It is not clear how to message that people who submit grant proposals on such topics are going to get a fair review, he said.</p><p>Dr. Chiang said that these are all great questions and noted that one big job of NEI is to stimulate the science that is best going to position us to achieve our mission moving forward. In the face of that, the field will have to evolve, he added. It may be challenging to find the most appropriate reviewers in a world that is changing rapidly. Dr. Anderson noted that submitted applications to an NEI RFA or initiative do not get reviewed by CSR review but are reviewed by NEI review staff who put together a panel with reviewers with the appropriate expertise for those specific applications. She also noted that CSR updates the make-up of and can create new study sections as science changes. They have a very established process for doing this. Dr. Hoshaw added that for CSR reviews, applicants can use tools that will match their application with the appropriate study section. Applicants should also get in touch with program officers to discuss their research as they can give advice about appropriate review panels based on their experiences. Dr. Bhargava added that for applications that are going to be reviewed in CSR, applicants can describe the expertise needed for the application in their cover letter. It is also possible to see the full membership of CSR standing study sections to ensure that the panel has the appropriate expertise and ask for additional expertise that is not represented on the panel.</p><p>Dr. Chiang thanked the council members for their engagement and feedback during the open session and noted that staff take their comments and recommendations very seriously and use them to develop new ideas. He adjourned the meeting and said that the closed portion would continue after a 15-minute break.</p><p><strong>CLOSED SESSION</strong></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 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). 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></p><p>NAEC members considered 597 grant and cooperative agreement applications on which NEI was the primary Institute; these applications requested a total of $198,463,603 (direct costs year 01). The Council also considered 360 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $224,829,511 (direct costs year 21 168th National Advisory Eye Council Meeting, June 7, 2024 01). The Council concurred with the Institutional Review Group recommendations on these 957 applications.</p><p><strong>ADJOURNMENT</strong><br>The 168th meeting of the National Advisory Eye Council was adjourned at 5:00 p.m. on June 7, 2024.</p><p> </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. Reza Dana (in-person)<br>Dr. Maria B. Grant (in-person)<br>Ms. Janice Lehrer-Stein (in-person)<br>Dr. Maureen Maguire (virtual)<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>Shawn Adolphus (in-person)<br>Dr. Neeraj Agarwal (in-person)<br>Lisa Applewhite (in-person)<br>Dr. Houmam Araj (in-person)<br>Holly Blake (in-person)<br>Nathan Brown (in-person)<br>Dr. Sangeeta Bhargava (in-person)<br>Dr. Kapil Bharti (virtual)<br>Nathan Brown (in-person)<br>Dr. Ed Clayton (in-person)<br>Jay Colbert (virtual)<br>Karen Colbert (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>Alexandra Gavrilovic (virtual)<br>Dr. Nataliya Gordiyenko (in-person)<br>Dr. Shefa Gordon (in-person)<br>Dr. Tony Gover (in-person)<br>Dr. Brian Hoshaw (in-person)<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. Bob O’Hagan (virtual)<br>Dr. Mary Ann Redford (in-person)<br>Dr. Jennifer Schiltz (in-person)<br>Dr. Grace Shen (in-person)<br>Dr. Azadeh Shoaibi (in-person)<br>Karen Robinson Smith (in-person)<br>Dr. Hongman Song (in-person)<br>Dr. Afia Sultana (virtual)<br>Dr. Santa Tumminia (in-person)<br>Dr. Cheri Wiggs (in-person)<br>Bronte Williams-Washington (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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