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NAEC Meeting Minutes - June 15, 2017
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<h1>
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<span>NAEC Meeting Minutes - June 15, 2017</span>
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<div class="c-jump-menu__intro">On this page:</div>
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<a class="c-jump-menu__item" href="#section-id-14742">Council, Staff and General Public Present</a>
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<a class="c-jump-menu__item" href="#section-id-14752">Opening Remarks</a>
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<a class="c-jump-menu__item" href="#section-id-14757">Budget Update</a>
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<a class="c-jump-menu__item" href="#section-id-14759">Program Presentation</a>
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<a class="c-jump-menu__item" href="#section-id-14761">NIH Clinical Trials</a>
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<a class="c-jump-menu__item" href="#section-id-14880">Stem Cells and Organoids</a>
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<a class="c-jump-menu__item" href="#section-id-14882">AGI Update</a>
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<a class="c-jump-menu__item" href="#section-id-14884">AMD Pathobiology</a>
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<a class="c-jump-menu__item" href="#section-id-14886">NGRI</a>
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<a class="c-jump-menu__item" href="#section-id-14763">General Council Discussion</a>
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<a class="c-jump-menu__item" href="#section-id-14767">Attachment A: National Advisory Eye Council</a>
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National Eye Institute
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<p>National Advisory Eye Council<br>
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One Hundred Forty-Sixth Meeting<br>
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Thursday, June 15, 2017</p>
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<ul>
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<li><strong><a href="https://videocast.nih.gov/watch=22068">Videocast</a></strong></li>
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<p>The National Advisory Eye Council (NAEC) convened for its one hundred and forty- sixth meeting at 8:30 am on Thursday, June 15, 2017 at the T-Level Conference Center at 5635 Fishers Lane, Rockville, Maryland, 20852. Paul A. Sieving, M.D., Ph.D., the Director of the National Eye Institute (NEI), presided as Chair of the Council, Paul A. Sheehy, Ph.D., as Executive Secretary, and Michael A. Steinmetz, Ph.D., as Director of Extramural Science Programs. The meeting was open to the public from 08:30 am until I:00 pm when the meeting was closed to the public for a session from 2:00 pm until 4:00 pm for the reviews of confidentiality and conflict of interest procedures, the report of the Board of Scientific Counselors, and grant and cooperative agreement applications.</p>
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<h3 class="c-section__heading">
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Council Members Present:
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<p>Dr. Eduardo Alfonso<br>Dr. Thomas Glaser<br>Dr. Jane Gwiazda<br>Dr. Dennis Levi<br>Dr. Carol Mason<br>Dr. Stephen McLeod<br>Dr. Douglas Rhee<br>Dr. Sylvia Smith<br>Dr. Monica Vetter</p>
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<div class="c-section" id="section-id-14744">
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<h3 class="c-section__heading">
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NEI Staff Present:
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<p>Dr. Houmam Araj<br>Dr. Neeraj Agarwal<br>Dr. Sangeeta Bhargava<br>Dr. Steven Becker<br>Ms. Cindy Best<br>Ms. Pamela Bobbitt<br>Ms. Sylvia Braxton<br>Dr. Brian Brooks<br>Ms. Monique Clark<br>Mr. Jay Colbert<br>Dr. Mary Frances Cotch<br>Ms. Ashley Dash<br>Ms. Kathryn Demott<br>Ms. Linda Dingle<br>Ms. Courtney Dodson<br>Mr. Don Everett<br>Ms. Blair Feldman<br>Dr. Martha Flanders<br>Ms. Kerry Goetz<br>Dr. Shefa Gordon<br>Dr. Thomas Greenwell<br>Mr. Dustin Hays<br>Dr. Brian Hoshaw<br>Dr. Ellen S. Liberman<br>Dr. Jessica Mazerik<br>Dr. Anna Mazzucco<br>Dr. George McKie<br>Dr. Sheldon Miller<br>Dr. Lisa Ann Neuhold<br>Dr. Maryann Redford<br>Ms. Karen Robinson-Smith<br>Dr. Annie Schaffner<br>Dr. David Schneeweis<br>Dr. Belinda Seto<br>Dr. Paul A. Sheehy<br>Dr. Grace L. Shen<br>Dr. Paul A. Sieving<br>Dr. Michael Steinmetz<br>Ms. Chantelle Stevenson-Brown<br>Ms. Melissa Trinchet<br>Dr. Santa Tumminia</p>
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<div class="c-section" id="section-id-14746">
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<h3 class="c-section__heading">
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Other NIH Staff Present:
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<p>Dr. Jodi Black, OER<br>Dr. Michael Chaitin, CSR<br>Dr. Nataliya Gordiyenko, CSR<br>Dr. Paek Lee, CSR<br>Ms. Veronica Vanwagner<br>Dr. Cheri Wiggs<br>Ms. Keturah Williams<br>Dr. Charles Wright<br>Dr. Jerome R. Wujek<br>Dr. Kristin Kramer, CSR<br>Dr. Tara Schwetz, OD<br>Dr. Lawrence Tabak, OD<br>Dr. Maqsood Wani, CSR</p>
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<div class="c-section" id="section-id-14748">
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<h3 class="c-section__heading">
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Members of the General Public Present at the Open Session:
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</h3>
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<div class="c-text">
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<p>Mr. James Jorkasky, National Alliance for Eye and Vision Research</p>
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<div class="c-section" id="section-id-14750">
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<h3 class="c-section__heading">
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Open Session of the Meeting
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</h3>
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<p>08:30 am</p>
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<div class="c-section" id="section-id-14752">
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<h3 class="c-section__heading">
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Call to Order and Opening Remarks
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<p><em>Dr. Paul Sieving, NEI Director</em></p><p>Dr. Sieving welcomed the Council members and visitors.</p><p>New appointments include the renewal of Dr. Francis Collins as NIH Director. Dr. Sieving expressed appreciation for his leadership and interest in vision science and regenerative medicine. Norman E. Sharpless, M.D. has been nominated as the new director of the National Cancer Institute (NCI). Dr. Sharpless comes to NIH from the Lineberger Comprehensive Cancer Center at the University of North Carolina.</p><p>Dr. Sieving then gave a review of the 2017 NIH and NEI budget. He noted the various figures that can be used to describe the marginal budget changes due appropriations, taps, directed programs and changes in accounting policies. At this time, we have only the President's budget. Factors other than the initial budget proposal will also be important including sequestration and the debt ceiling limit. He cautioned Council to bear these considerations as we enter the process of formulating, appropriating and executing the FYI 8 budget. Despite cuts proposed by the White House, NIH continues to receive broad, bipartisan/bicameral support. Lawmakers have boosted NIH's budget by $2 billion each of the past 2 years.</p><p>On May 8th, the White House held a summit on federal research funding to consider what federal research can and cannot be picked up by the private sector. Attendees included President Trump, NIH Director Francis Collins, HHS Secretary Tom Price, FDA Commissioner Stephen Ostroff, and a dozen representatives from the biotech industry and academia. Notable topics addressed include</p><ul><li>Why private investment can't substitute for NIH's support for basic research at academic institutions</li><li>Effect of flat NIH budgets on early-career investigators</li><li>Effect of immigration policy on recruitment of research talent</li></ul><p>In the context of young investigators, Dr. Sieving gave an overview of the Diversity in Vision Research and Ophthalmology (DIVRO) Program. The program was launched in 2011 by the NEI intramural research program to increase the number of African-American, Latino, and Native American scientists in vision research. The program has mentored 47 interns ranging in educational status from high school to medical and graduate students. For those interested, the application window opens in late November and closes March 1 and the Point of Contact is Cesar Perez-Gonzalez. More information about DIVRO and other training opportunities are available on the NEI website.</p><p>The 3-D Retina Organoid Challenge is a novel NEI initiative with the goal of developing technology that will speed the discovery of treatments for retinal diseases. Such a tool will enable scientists to study how retinal cells interact under health and diseased conditions and test potential therapies. It is comprised of 2 stages with prizes totaling $1.2M. The first stage was launched on May I and responses are due by August 1. The second phase (developing a prototype) will be launched in the fall. NEI staff have been very successful in recruiting sponsors to join the challenge by providing support in the form of reagents, expertise, etc. The Challenge is further described by a letter in the June 15, 2017 edition of Nature magazine.</p><p>Dr. Sieving then gave an overview of the agenda of the open session of Council.</p><ul><li>Blair Feldman, Deputy Director of the NEI Financial Management Branch, will present a timeline of the budget process and explain specific relevant terminology that may help Council</li><li>Grace Shen, NEI Program Director, will provide an overview of the NEI Retinal Diseases Program.</li><li>Jodi Black, Deputy Director of the NIH Office of Extramural Research, will address Clinical Trial Stewardship activities, including how clinical trials are defined.</li><li>Lisa Neuhold, NEI Program Director, will give a summary of an Organoid and Stem Cell course held at the May ARVO meeting.</li><li>Steve Becker, NEI, will provide an update on recent and planned activities of the Audacious Goals Initiative.</li><li>James Handa, Johns Hopkins University, will provide an update from the AMD Pathobiology Working Group. This is a working group of Council charged with identifying biological causes of AMD disease and developing hypotheses for clinical study, including clinical trials.</li><li>Lawrence Tabak, Principal Deputy Director, NIH, will speak on new trans-NIH efforts to promote a stronger and more stable biomedical workforce.</li></ul>
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<div class="c-section" id="section-id-14754">
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<h3 class="c-section__heading">
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Consideration of Preceeding Minutes
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<p><em>Dr. Paul Sheehy, Executive Secretary and Director, Division of Extramural Affairs</em></p><p>The Executive Secretary asked for comments and corrections to the January 2017 Council minutes. There were none, and the minutes were unanimously approved.</p>
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<div class="c-section" id="section-id-14757">
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<h3 class="c-section__heading">
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Budget Update
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<p><em>Ms. Blair Feldman, Deputy Budget Officer, Office of the Director</em></p><p>Ms. Feldman addressed the use of different terms during the budget timeline and that none of them correspond to the commonly understood term "funding level". The fiscal year often starts and operates for a variable time on a series of Continuing Resolutions. The Continuing Resolution ends when Congress passes an Appropriation. The Appropriation may increase or decrease due to transfers, adjustments, <em>etc.;</em> the net result is Budget Authority. The Budget Plan (derived from the Budget Authority) is subject to review by the Office of Management and Budget and cannot be publicly released without 0MB approval. Finally, data is reconciled at the end of the fiscal year to calculate our actual Obligations. Direct comparisons across fiscal years is further complicated by changes in accounting methods.</p><p>NEI allocates its operating funds according to 4 goals:</p><ol><li>funding investigator-initiated research;</li><li>building a robust intramural program;</li><li>training the next generation of scientists; and</li><li>expanding data resources.</li></ol><p>About 80% goes to extramural grants, the bulk of which (63% in 2016) goes to non-SBIR RPGs (the mechanisms most used by universities and independent research institutions). Since different grant mechanisms have different costs (U0ls on average cost almost as much as 6 R21s or 3RO1s) direct comparison of the number of awards is not valid if the mix of mechanisms has changed. As such, NEI considers the most informative statistic to be the percentage non-SBIR RPGs comprise of the total extramural award allocation. Historically this has been 61-62% but was 63% in 2016. Because these awards incur future commitments, any increase in this percentage decreases the funds available for new awards in future years. Note that this effect would be exacerbated if the future year appropriation also declined. As such, NEI has set the goal of returning to the historic level.</p><p><strong>Council Discussion:</strong> Council members noted that the balance of R01s and R21s has changed over the years and asked if the drivers of this change are known. Dr. Steinmetz said that the changes reflect increased numbers of R21s in the application pool. He noted that while the overall NEI success rate (# awarded over # received) was 26%, the success rate for R0ls was 28% but 19% for R21s. Council members asked about training. Staff noted that NIH has approved a both a stipend increase and a slot increase for training grants that will require an increase in this budget category. As for K series awards, NEI's strategy is to move to more individual Ks and fewer slots on Kl2s.</p>
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<div class="c-section" id="section-id-14759">
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<h3 class="c-section__heading">
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NEI Retina Diseases Program
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</h3>
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<p><em>Dr. Grace Shen</em></p><p>Dr. Shen led off with an overview showing that the Retina Program accounts for just about half of total NEI Extramural awards. Grants are managed by four Program Directors (Dr. Grace Shen</p><p>-Retinal Diseases; Dr. George McKie - Immunology, Infection, Inflammation; Dr. Lisa Neuhold-Fundamental Retinal Processes and Cancer; and Dr. Tom Greenwell-Retinal Neuroscience and Early Retina Development). Drs. Neuhold and Greenwell will present their programs at subsequent Council meetings.</p><p>The retinal diseases program is very broad, including Retinopathy, Age-Related Macular Degeneration, Retinitis Pigmentosa, inherited eye diseases, retinal detachment & vitreous disorders, angiogenesis, and genetics. Three prominent crosscutting topics in these areas are Model Systems, Basic research and Bench to Bedside research.</p><p>Model Systems are versions of human conditions that are some way more experimentally tractable and/or less complex. The Retinal Diseases Program includes the full spectrum of models from in vitro (cell lines) through invertebrates and mammals to non-human primates.</p><p>Basic research supported by the program has important activities in technology development, angiogenesis, cellular processes, and genetics.</p><p>Dr. Shen provided highlights in Bench to Beside research, including noninvasive in vivo imaging technology (in coordination with AGI efforts); molecular therapeutics directed at neovascularization in Diabetic Retinopathy, and gene/stem cell therapy.</p><p>The non-invasive in vivo imaging program has three major goals:</p><ul><li>To produce histological quality images at the cellular level</li><li>To identify visual stimuli-induced retinal changes, and</li><li>To enable longitudinal cellular imaging of cells and structures during development, disease progression and therapeutic intervention</li></ul><p>The development of Optical Coherence Tomography (OCT) for ophthalmic and clinical applications represents one of the most remarkable stories of Bench to Bedside research. It was first proposed in a 1971 by Michael Duguay, a scientist at Bell Labs, that high speed detection of an object (photographing light in flight) could be used to see inside the body. Twenty years later, David Huang, a MD/PhD student in the laboratory of Dr. James Fujimoto developed an OCT device to image the ex vivo bovine eye. Many generations of clinical devices have subsequently been developed with improved resolution. The technology, initially developed for ophthalmology, is now also used in cardiology, dermatology and gastroenterology with well over 100 million procedures performed globally. Work currently supported in the portfolio supports development of other technologies to image cells in the retina that are currently not readily detectable (ganglion cells, amacrine cells, horizontal cells, Muller cells, and bipolar cells).</p><p>Drugs directed against Vascular Endothelial Growth Factor (anti-VEGF) have become the standard of care for neovascular eye diseases but many patients do not respond to anti-VEGF treatment. Current research strategies focus on identification of key molecules in signaling pathways and the development of microRNAs or drugs to target these molecules.</p><p>Retinal diseases historically have been at the leading edge of clinical innovation. Over the past two decades the discovery of retinal disease genes has increased ten-fold, each of which is a potential target for a gene-based therapy. At the same time, advances in our understanding of stem cell biology have brought stem cell-based therapies into consideration for clinical use.</p><p>Nonetheless, many challenges remain including delivery, when to intervene, how to control the magnitude and longevity of therapeutic effect, potential adverse effects (<em>e.g., </em>"off target," tumors), restoration of functional connections.</p><p><strong>Council Discussion:</strong> Council members noted that Dry AMD afflicts a large population and wondered how it is represented in the Retinal Diseases portfolio. Dr. Shen noted that this is a major area of emphasis with numerous groups working in areas such as oxidative stress and complement dysfunction.</p>
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NIH Clinical Trial Stewardship Reform
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<p><em>Dr. Jodi Black</em></p><p>Dr. Black opened her talk by noting that underreporting of clinical trials, including NIH-funded trials, is a longstanding and widely recognized problem. Recent legislation and regulation impose important requirements for investigators proposing clinical trials and for sponsors to accept, manage, monitor and report clinical trials. As the largest public funder of clinical trials in the US, the NIH has a responsibility for instituting reforms. To that end, NIH is collaborating with the FDA and Clinical Trials.gov to make it more straightforward to meet these requirements. The term "Clinical Trial" has been defined and incorporated into the Common Rule and NIH has decided that the definition of clinical trial should be broadened to encompass all biomedical and behavioral outcomes.</p><p>To determine whether a study is a trial under the NIH definition, applicants should consider the following questions:</p><ol><li>Does the study involve human participants?</li><li>Are the participants prospectively assigned to an intervention?</li><li>Is the study designed to evaluate the effect of the intervention on the participants?</li><li>Is the effect being evaluated a health-related biomedical or behavioral outcome?</li></ol><p>If the answer to all four questions is "yes," then the study would be considered a clinical trial according to the NIH definition and the Common Rule. All clinical trial applications submitted to NIH for due dates on or after January 25, 2018 must be in response to Funding Opportunity Announcements specifically designed for Clinical Trials.</p><p>Dr. Black then presented a series of case studies to illustrate how the four-question algorithm would be used by an applicant.</p><p><strong>Council Discussion:</strong> Council members presented examples relevant to the NEI scientific program and asked whether they would meet the definition of clinical trial. Dr. Black noted that this is a very important issue and that NIH leadership has developed a set of case studies that will soon be posted to the Office of Science Policy website.</p><p>Council members noted many of the projects conducted by students, fellows, and residents, largely for heuristic purposes, would be problematic with these requirements. Dr. Black noted that one NIH's goals is to ensure that studies are meaningful and thus the mentor has the responsibility to ensure that the studies are properly designed. Council members noted that this would both greatly increase the bureaucratic workload and that registration of such studies in ClinicalTrials.gov would introduce many studies that might be misinform the public. Dr. Black acknowledged this concern but noted that the law is quite clear and imposes significant penalties for non-compliance. We collectively will have to work to educate the public about how to use ClinicalTrials.gov.</p><p>Council members asked about studies incidental to the patient's normal clinical care (with informed consent). If the purpose of the collection was to inform clinical care, the study would be a clinical trial. If the purpose is to collect generalizable information, it is not a clinical trial.</p><p>Council members noted that it would be useful for ClinicalTrials.gov to indicate sponsorship (NIH, other Federal, Pharma, other).</p>
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<h3 class="c-section__heading">
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Stem Cells and Organoids as Models of Tissue Differentiation and Eye Diseases
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</h3>
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<div class="c-text">
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<p><em>Dr. Lisa Neuhold</em></p><p>Dr. Neuhold presented an overview of a course she organized in conjunction with ARVO and held immediately prior to the annual meeting with 150 participants. The course covered all areas of the eye and addressed topics such as 1) how 3D cultures differ from 2D stem cell-derived tissues; 2) organoid culture methods; and 3) the use of 3D cultures for model development, diseases, drug screening, and as tissue sources for transplantation. The morning session started with a plenary talk followed by a session devoted first to the anterior segment and then to the posterior segment. The afternoon session was similarly structured with the first half focused on niches and scaffolds and the second half focused on modeling eye development and diseases.</p><p>Three main themes emerged: 1) recent findings that the mechanism of action may be microvesicle-mediated transfer of material (protein and nucleic acid) from the donor stem cells to the host tissues rather than integration of the donor cells into host tissue; 2) the use of endogenous stem cells; 3) the use of scaffolds to support and direct growth and differentiation.</p>
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<div class="c-section" id="section-id-14882">
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<h3 class="c-section__heading">
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An Update on the NEI Audacious Goals Initiative
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</h3>
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<div class="c-text">
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<p><em>Dr. Steve Becker</em></p><p>Dr. Becker reviewed the history, structure and activities of the Audacious Goals Initiative. It started with a challenge competition soliciting ideas from the vision community that led in 2013 to selection of the Audacious Goal of regenerating neurons and neural connections in the eye and visual system, targeting photoreceptors and retinal ganglion cells. Activities to date include:</p><ul><li>Two RFAs, the first focused on functional imaging and the second on regeneration factors. The investigators meet annually and share data extensively using standardized formats to promote cross-validation.</li><li>Workshops and "Town Hall" meetings on specific themes held annually at SfN and ARVO. Published White Papers resulting from five of these meetings have been presented to Council with the others still in preparation.</li><li>Seminar series held on the NIH Campus.</li></ul><p>Recent efforts have focused on identifying researchers with the necessary expertise, promoting collaboration and dissemination of critical tools and resources. Following a suggestion from Council, staff have developed a course entitled "Regeneration Methods for the Visual System that is directed at trainees. The course will be held in the late summer and will use intramural laboratories to provide hands-on experience.</p><p>The next meeting of the PIs and External Oversight Committee members from the first AGI Imaging Consortium will be held in August 2017 and that for the second RFA will be held in December 2017.</p><p>Dr. Becker reviewed the AGI overall strategy including knowledge areas to be incorporated into the AGI for successful translation to disease treatment. He closed by requesting approval of a future FOA on improved animal model systems. The objectives of the FOA are to:</p><ul><li>Generate models that more closely recapitulate human disease and are amenable to regenerative medicine approaches.</li><li>Create models that more closely resemble the human anatomy and physiology of the retina.</li><li>Test models with appropriate functional assays for integration and assess visual improvement.</li></ul><p><strong>Council Discussion:</strong> More closely recapitulating human disease is a worthy objective but it is not clear how this will be evaluated. Getting axons to grow to the right place remains a challenge, particularly in pathological settings. Techniques to provide or enhance guidance would be very valuable.</p>
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<div class="c-section" id="section-id-14884">
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<h3 class="c-section__heading">
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AMD Pathobiology Working Group Report
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</h3>
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<div class="c-text">
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<p><em>Dr. James Handa</em></p><p>In recognition of the public health impact of Age-Related Macular Degeneration (AMD) the National Advisory Eye Council formed a Working Group focused on AMD Pathobiology. The goals of the group are to identify the biological causes and disease mechanisms of AMD disease (short-term) and to develop hypotheses for clinical study, including clinical trials founded on high impact preclinical evidence (long term). The group has met twice; Dr. Handa, a member of the group, reported the discussions of the most recent meeting.</p><p>The group was charged with the question of "How do we leverage genetic associations to causative, mechanistic biology-based clinical studies?" The many clues to AMD pathogenesis resulting from the identification of dozens of candidate genes have led to the picture of AMD as several diseases involving a variety of components (photoreceptors, RPE, Bruch's membrane, choroidal capillaries), each with alterations in one or more pathobiological processes (lipid recycling, mitochondrial dysfunction, stress response, autophagy, ECM remodeling, inflammation, complement activation) that result in pathological findings (abnormal RPE pigmentation, drusen deposits, microvascular changes, Bruch's membrane thickening and breakdown) which ultimately manifest as dry or wet AMD. It remains unclear how these processes relate to other factors (e.g. aging, environment), how they interact and how to prioritize their study.</p><p>The Working group's discussions at the April meeting were framed by a set of three questions:</p><ul><li>What are the gaps in knowledge and barriers to progress which prevent us from understanding the interplay between implicated biological pathways as well as the influence of genetic predisposition in AMD?</li><li>How would understanding earlier events in the AMD disease process alter patient care?</li><li>Are pathways that cause early disease the same as those that induce late events?</li><li>Are there diagnostic/imaging strategies for early diagnosis that warrant further development?</li><li>What do we want AMD diagnosis and treatment to look like in 10 years?</li><li>What candidate biomarkers warrant development?</li></ul><p>It is important to consider the interplay of pathways; different pathways may dominate in different individuals. Better understanding of which pathways and regulatory elements are affected may lead to biologically-informed biomarkers or treatments, possibly directed to AMD subtypes or to different points in the temporal progression. The need to better understand early events came up repeatedly.</p><p>Rather than recommending higher priority any of the existing hypotheses or investigative approaches, the Group discussed adding a systems approach to inform and direct reductionist approaches. Large-scale, unbiased approaches have the advantage of offering the opportunity to uncover novel events (but depend on the availability of high quality human AMD tissue). Other advantages include the potential to synthesize different datasets (omic, in vitro, animal models, human) that could identify new connections or patterns.</p><p>At the end of a long and productive discussion, the Working Group decided to develop a White Paper giving a high-level perspective on gaps in both mechanistic understanding and clinical treatment of the disease and point to the need future directions for the AMD research community. This paper would include a current overview of 1) AMD from a clinical perspective, 2) our current understanding of AMD Pathobiology, 3) the strategies employed in AMD research; 4) what a systems approach could bring to our understanding of AMD Pathobiology; and 5) the importance of interfacing AMD pathobiology with clinical understanding of AMD.</p><p><strong>Council Discussion:</strong> One of the unresolved issues about using metabolomics is variability. Dr. Handa noted that bioinformatics and animal models have potential to reduce this concern but it still exists.</p><p>Animal models have largely used young mice but the relevance to a late onset disorder is a concern.</p>
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<div class="c-section" id="section-id-14886">
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<h3 class="c-section__heading">
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The Next Generation Researchers Initiative
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</h3>
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<div class="c-text">
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<p><em>Dr. Lawrence Tabak</em></p><p>Dr. Tabak noted that NIH has a responsibility for ensuring a robust biomedical workforce. He noted that many observers of the biomedical enterprise have asserted that it has become hypercompetitive and this in tum discourages even the best students from entering research. The 21<sup>st</sup> Century Cures Act addresses this concern by directing the NIH Director to promote policies that will promote earlier independence and increased funding for new investigators. The data is clear- early stage and mid-career investigators (ESI and MCI) are declining as a fraction of the NIH scientific workforce. This is not a simple reflection of general population dynamics but also reflects increased resiliency of older investigators due to the availability of other support. The data also show that there are substantial numbers of early stage and mid-career investigators with meritorious applications that go unfunded. In many cases MCI have no other support so that failure to receive an award means they may have to leave the scientific workforce. Thus, the biomedical workforce has fewer researchers entering the pipeline and is losing more from the pipeline. NIH therefore proposes to create the Next Generation Researchers Initiative (NGRI) to support ESIs and MCIs at risk of leaving the workforce. Using an eligibility criterion of percentile <25 or priority score <35 would create an overall success rate of 25%, well within NIH historical norms. Modeling indicates that the NGRI could reach an annual cost of $1.1B at steady state. The NIH Office of the Director will create an inventory of early stage and mid career investigators within the funding range and track IC funding decisions. Dr. Tabak noted that ICs will be able to use a variety of funding strategies.</p><p>An important aspect of NIH's stewardship of the biomedical research enterprise is its responsibility to make funding decisions that will support the most impactful projects. There are many ways to assess the impact of NIH research (e.g. paradigm disruption, patents & licenses, innovative technologies and medical interventions, changes in medical practice, improvements in public health) but their utility is limited because it takes decades for these outcomes to be realized. NIH is developing tools based on validated measures of research support. For example, Relative Citation Ratio (available at <a href="https://icite.od.nih.gov/">https://icite.od.nih.gov</a>) is a tool recently developed by NIH scientists that produces a time-independent, field-normalized metric that measures the influence of publications in PubMed.</p><p>In summary,</p><ul><li>Beginning immediately, NIH is committed to redistributing an estimated $210M/year, reaching a steady-state of ~$1.1B, over the next 5 years, to support additional meritorious Early Stage and Mid-Career Investigators</li><li>NIH will encourage independent analyses of metrics that can be used to assess the impact of the NIH portfolio</li><li>Analyses will be reviewed by a working group of the Advisory Committee to the NIH Director (ACD), and will be fully discussed at future ACD meetings</li><li>All actions will continue to be informed by stakeholder input</li></ul><p><strong>Council Discussion:</strong> Paylines vary across ICs, so that the 25<sup>th</sup> percentile means very different things in different ICs; how will NIH address this? Dr. Tabak answered that these are averages and that IC-specific aspects of the policy will be worked out soon.</p><p>At one time there was discussion of a "Last" award in which a senior investigator who is stepping down is paired with a mentee to whom the grant would eventually be transferred; what is its status? Dr. Tabak replied that this idea got a strongly unfavorable reception and is no longer under consideration.</p><p>What about individuals that want to stay in science but not necessarily as Principal Investigators (aka "Staff Scientists")? Dr. Tabak acknowledged that there are certainly many such individuals but the issue is complicated. However, there is considerable support for the idea of a stable workforce. At present, there does not seem to be overwhelming support for this idea. NCI is supporting a pilot and NIH will continue to track the issue.</p><p>What was the nature of the feedback that led to the withdrawal of the Grant Support Index policy proposal? Dr. Tabak replied that there were two major elements. First, the initial framework laid out for the OSI was not sensitive enough to team science and training. Second, the OSI did not consider investigators on case by case basis to identify and accommodate extraordinary individuals.</p><p>The NORI addresses the consolidation of NIH funds among certain age cohorts; what is being done about the consolidation of NIH funds among institutions? Dr. Tabak noted that by increasing the number of investigators, NORI will increase the distribution among institutions.</p><p>More information on the Initiative can be found at: <a href="https://grants.nih.gov/ngri.htm">https://grants.nih.gov/ngri.htm</a>.</p>
|
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|
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</div>
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|
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</div>
|
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|
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<div class="c-section" id="section-id-14763">
|
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<h2 class="c-section__heading">
|
||
|
||
|
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|
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|
||
General Council Discussion
|
||
|
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|
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</h2>
|
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<div class="c-text">
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|
||
<p><em>Dr. Paul A. Sieving</em></p><p>Many ophthalmology trials as currently conducted involve retinal and OCT imaging centers, functional assessment, reading centers, etc. that can be quite costly. Council noted that recent developments in technology offer opportunities to reduce the cost of randomized clinical trials (e.g., telemedicine, artificial intelligence). Artificial intelligence may in the near term be able to read images equal to highly trained specialists at a greatly reduced cost. Another example is that visual field assessments are being developed for cell phones; this has the possibility of eliminating both the technician and the reader. NEI could contribute to lowering the cost of large clinical trials by validating these new methodologies.</p><p>Council expressed thanks for Dr. Tabak's thoughtful and pragmatic presentation on a very difficult matter. Ultimately, the choice of output metrics is critical and Council supports continued experiments in this direction.</p><p>Dr. Steinmetz spoke to NEI's position on this issue and noted that workforce has always been an important consideration for NEI. The institute has never missed the ESI goal set by NIH. We also have a longstanding practice of using end of year funds to bridge MCIs.</p><p>Council wondered about what analysis has been done to identify and control for other factors that might lead to the increased success of senior investigators. Council members were directed to a recent peer-reviewed paper that lays out the analysis approach.</p><p>Council noted that non-NIH tenure track positions are in many cases dependent on philanthropy and this is not a secure line of support. Similarly, institutional bridge support is dependent on philanthropy.</p><p>The discussion turned to scientific issues and Council noted that with respect to the AGI and the approved concept clearance, the nature of the material transferred from one cell to another to mediate the regenerative effect of stem cell transplantation is an open and important question. Dr. Steinmetz noted that the importance of this question is recognized across NIH and is an important component of two initiatives currently in development to study the nature and actions of exosomes.</p><p>Council suggested that there may be a place for FOAs for smaller-scale (R21-based) animal model development?</p><p>The Open Session adjourned at 1:00 PM.</p>
|
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</div>
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</div>
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<div class="c-section" id="section-id-14767">
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<h2 class="c-section__heading">
|
||
|
||
|
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|
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|
||
Attachment A: National Advisory Eye Council – January 2017
|
||
|
||
|
||
</h2>
|
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|
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|
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|
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<div class="c-text">
|
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|
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<p>Eduardo Alfonso, M.D.*<br>Kathleen and Stanley J. Glaser Chair in Ophthalmology<br>Director of the Bascom Palmer Eye Institute<br>University of Miami Miller School of Medicine<br>Miami, FL 33136-1134</p><p>Steven Bassnett, Ph.D. (2019)<br>Professor of Ophthalmology and Visual Sciences<br>Washington University School of Medicine<br>St. Louis, MO 63117</p><p>Thomas M. Glaser, M.D., Ph.D. (2019)<br>Department of Cell Biology and Human Anatomy<br>University of California, Davis<br>School of Medicine<br>Davis, CA 95616</p><p>Jane Gwiazda, Ph.D. (2019)<br>Professor of Vision Science<br>New England College of Optometry<br>Boston, MA 02115</p><p>Dennis M. Levi, O.D., Ph.D. (2019)<br>Professor of Optometry and Vision Science<br>University of California, Berkeley<br>Berkeley, CA 94720-2020</p><p>Carol Ann Mason, Ph.D.*<br>Professor of Pathology and Cell Biology, Neuroscience, and Ophthalmic Science<br>Columbia University College of Physicians and Surgeons<br>New York, NY 10032</p><p>Stephen D. McLeod, M.D. (2018)<br>Professor and Chair<br>Department of Ophthalmology<br>University of California, San Francisco<br>San Francisco, CA 94143</p><p>Louis R. Pasquale, M.D. (2019)<br>Director of Mass. Eye & Ear Glaucoma Service<br>and Ophthalmology Telemedicine<br>Massachusetts Eye and Ear Infirmary<br>Boston, MA 02114</p><p>Douglas Rhee, M.D. (2019)<br>Professor and Chair, Department of Ophthalmology and Visual Sciences<br>Case Western Reserve University Hospitals<br>Cleveland, OH 44106</p><p>Sylvia B. Smith, Ph.D., FARVO (2019)<br>Professor and Chair<br>Department of Cellular Biology/Anatomy<br>Medical College of Georgia<br>Augusta, Georgia 30912</p><p>Monica L. Vetter, Ph.D. (2018)<br>Professor and Chair<br>Department of Neurobiology & Anatomy<br>University of Utah<br>Salt Lake City, Utah 84132</p><p>Jayne S. Weiss, M.D. (2016)<br>Professor and Chair<br>Department of Ophthalmology<br>Louisiana State University<br>Health Sciences Center<br>New Orleans, LA 70112</p><p>Rafael Yuste, M.D., Ph.D. (2017)<br>Professor<br>Department of Biological Sciences<br>Columbia University<br>New York, NY 10017</p>
|
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|
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</div>
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</div>
|
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|
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<div class="c-section" id="section-id-14888">
|
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<h3 class="c-section__heading">
|
||
|
||
|
||
|
||
|
||
Ex Officio
|
||
|
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|
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</h3>
|
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|
||
|
||
|
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|
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<div class="c-text">
|
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|
||
<p>Marco A. Zarbin, M.D., Ph.D.<br>Professor and Chair<br>Department of Ophthalmology<br>UMDNJ-New Jersey Medical School<br>Newark, NJ 07103</p><p>DoD Representative position is vacant</p><p>* Ad hoc member</p>
|
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|
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</div>
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</article>
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|
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</div>
|
||
|
||
<p class="views-element-container c-last-updated" id="block-views-block-nei-last-updated-block-1"><strong>Last updated:</strong> January 8, 2025</p>
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<h2 class="o-footer__title">For NEI Employees</h2>
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