LARRY TABAK: Good afternoon, everybody. I want to thank you all for joining us today. This is the second of several important listening sessions on the Advanced Research Projects Agency for Health, or ARPA-H, that the NIH is organizing together with our colleagues from OSTP. We do appreciate your taking the time to attend today's session. We will have a live Q&A session after the formal presentations and so we encourage all of the attendees to submit your questions to us during this event. As you know, President Biden's budget has proposed the creation of a new entity, ARPA-H within the NIH. ARPA-H will be structured as a new division within the NIH but, with a radically different culture and organization. It will embrace a DARPA like model of innovation and accountability. And it will force their bold ideas that are largely use-driven research-- that is research directed at solving a practical problem. And that will result in the creation of platforms and capabilities and resources that could be applicable across many diseases and conditions. Importantly, ARPA-H will have a distinct focus on equity, making sure that there is diversity in funding recipients, as well as the patient populations that will benefit from its breakthroughs. The NIH Office of the Director is collaborating closely with the Office of Science, Technology, and Policy, OSTP, to establish ARPA-H. And during July and August, a number of stakeholder listening sessions will be held to gather feedback from important organizations such as yours. And these will contribute to the planning process. To set the stage for today, you'll be hearing from both NIH and OSTP leaders. You'll then hear from select speakers representing advocacy for research on eye disease and visual impairment, deafness and communication disorders, and dental craniofacial and autoimmune disease of the salivary gland this will be followed by a brief panel discussion before we close. And now, I would like to offer a brief welcome from Dr. Francis Collins, NIH director. FRANCIS COLLINS: Hello, everyone. It's a real pleasure today for me to launch this important listening session on the Advanced Research Project Agency for Health or ARPA-H. As you may know, we are working closely on this bold proposal with White House Science Advisor, Eric Lander and his staff at OSTP, the Office of Science and Technology Policy. We're grateful for your interest in ARPA-H and you're taking the time to attend this listening session organized by the NIH leadership. As you know, ARPA-H is a high priority for President Biden and his administration. ARPA-H is designed to capture ambitious ideas and approaches that will shape the future of Health and Medicine in the United States. Here in 2021, as we seek to find a path forward from the worst pandemic in more than a century, it's clear that science supported by NIH has been a critical ally for developing, testing, and implementing a better COVID-19 diagnostics, effective treatments, and most dramatic of all safe, and effective vaccines. Some are calling this our generation's Sputnik moment. While building on that moment, we are now hearing the full-throated commitment from the president to science, ensuring that science is at the helm of delivering real results on cancer, Alzheimer's, diabetes, and virtually all other diseases, as well as preventing future global pandemics. As designed ARPA-H a model built upon the DARPA experience, focused on high risk and high reward programs led by visionary program managers, recruiting research contributors who might otherwise never apply to NIH for support . and driven by explicit milestones. Well let me be clear-- this is not the way to support most of NIH's storied portfolio and investigator-initiated research, which must continue to be the main foundation of progress. But for particular areas where rapid translation can lead to real clinical advances, ARPA-H accelerate progress and cut in half the time needed for breakthroughs. This can help science reach new heights and harness the momentum from the rapid scientific progress we saw during the pandemic. But now, we can apply this approach to all diseases. We also have the opportunity to champion equity in science. By drawing on the top talent from across the country, we must ensure we're seeing diseases through all lenses and delivering benefits to those who are disproportionately affected by health inequities. We must enable and promote the effectiveness of scientific solutions for all. Located within NIH, ARPA-H will leverage its proposed $6 and 1/2 billion budget for the next fiscal year to build high risk, high reward capabilities, that will transform breakthroughs in biomedicine into tangible solutions for patients in our lifetime. Its focus will be broad, ranging from molecular to societal. And its partners will cover the spectrum from industry, academia, non-profits, and the federal government. Because we know breakthroughs are more likely to come from multiple domains and across disciplines. Ultimately, ARPA-H will strive to propel us towards one goal-- to directly improve the health of Americans faster than was ever imagined to be achievable. The Human Genome Project took 13 years, and that was radical at the time. I believe we are at a moment in time where such projects can go even faster. ARPA-H will embrace a high risk, high reward approach through engagement with all research sectors. And this is why we are here today, to hear from you. You are critical stakeholders in this endeavor as ARPA-H gets shaped. Today our leadership team therefore, wants to hear from you. We want to hear your feedback on the priorities, the structure, and the organization of ARPA-H. We're committed to listening and to keeping you up to date on the progress of the plans as we work with OSTP on its development. We are grateful for your support and are looking forward to developing these plans in partnership with you. So thank you for the chance to introduce this particular stakeholder meeting. And I'll now turn it over to those who are going to manage the discussion. Thanks very much. LARRY TABAK: It's now my pleasure to hand this over to Max Bronstein, Assistant Director for Health Innovation, Office of Science and Technology Policy. MAX BRONSTEIN: Thank you very much Dr. Tabak. And thank you, Dr. Collins. It was a tough act to follow. Let me also say thank you to those who have joined the meeting today. Very much appreciate you all being here, and we are looking forward to a thoughtful and lively discussion on all things ARPA-H. I'm excited to have the opportunity to share with you why I think ARPA-H is so important and why it can be transformative for a variety of disease areas and societal challenges relating to health. So I think as the folks on the line know, we have an incredible world class biomedical ecosystem here in the US, much of which is undergirded by the important fundamental research supported by NIH, work which is often leveraged by the vibrant biopharmaceutical industry, to create products for patients and a multitude of disease areas. NIH continues to be a keystone in the US biomedical enterprise. And the work that supports has made great and remarkable progress in uncovering the underlying mechanisms of health and disease. However, our current system primarily supports projects that tend to come into flavors-- those that are well-suited for public support and those that fit into privately funded projects. So there's a substantial gap here, and we can all imagine that some projects that hold a lot of potential and promise fall outside of these two categories. If those projects were funded, they could make meaningful and even disruptive improvements for human health. So basically, that was a really long winded way of saying we are missing out on some really exciting science that could make a meaningful difference in the lives of patients. And that is exactly the gap that ARPA-H can fill. It provides us with a totally new lens for thinking about exciting biomedical science and how to catalyze improvements for health. Imagine for example, if we could program mRNA to pre-vaccinate you against the top 50 or 100 most common forms of cancer, giving your body the ability to target and eliminate those cells before they can ever create a tumor. Think about the enormous impact of such an innovation could have on cancer rates. What if we could develop drugs that have very precise molecular zip codes that would allow for unprecedented targeting to specific cells in your body? We would be able to deliver a therapeutic with dramatic accuracy and greatly lift the efficacy of a drug, while mitigating or even eliminating side effects altogether. So these are just a couple of the examples of the types of capabilities and platforms that ARPA-H could develop. Doing so will require a novel approach to supporting biomedical research, which we have applied in other areas of R&D like at DARPA, ARPA-E and others. So ultimately, the goal is to create a distinct and bold entity where ARPA-H leadership and staff will have the autonomy independence and resources to tackle some of the biggest challenges facing health. So if we know this model works, it's about time we deployed it to lay the groundwork for disruptive innovation in health and health care. So let me conclude by saying thank you again for being here today. Really looking forward to hearing everyone's thoughts and input into today's discussion. At this point, let me turn it back over to Dr. Tabak. LARRY TABAK: OK, thanks very much. And it's now my pleasure to introduce the next three speakers-- Drs Chiang, Tucci, and D'Souza. Dr. Chiang? MICHAEL CHIANG: Larry, thanks. As Drs. Collins and Tabak had mentioned, with the COVID vaccines I mean, we've all seen the remarkable things that happened when an urgent public health threat mobilizes us to act together. And my hope is that through ARPA-H, we can bring that same level of focus to vision disease. Surveys have shown that blindness is really among those conditions that Americans fear the most. In terms of numbers, there are 7 million Americans who have blindness or uncorrectable low vision. And then there's 164 million Americans with glasses. And so if we live long enough, each of us is going to be at high risk for developing things like macular degeneration or glaucoma that are blinding disease. And so this is an enormous public health issue. And it's getting worse obviously, as the American population ages. And so vision impacts our ability to work, to get an education, to avoid accidents. And beyond that, it is how we experience the world. And so vision loss impacts things like mental health and accelerated dementia. And so this is why we at the National Eye Institute exist. There's been an enormous amount of research done in the visual system, because it's such an easily accessible model system to study. Andat the NEI, we're really proud to have funded the research of eight Nobel Prize winners during the past to two years. So how can we build on this foundation to develop those transformative solutions that are going to make a difference through ARPA-H? I think one possibility is by applying artificial intelligence to screening for eye disease. There's been a revolution in AI during the past 10 years, heavily driven by AI research. The first FDA approved autonomous AI system in any field of medicine was for diabetic eye disease. And we could use this to solve real world problems. For example, half of the diabetic patients in this country don't get the annual recommended eye exams to screen for retinopathy. So people are going blind, especially in medically underserved urban and rural areas. And we already have many of the AI and imaging technologies that are needed to address this, but we lack the ability to deploy it nationwide on a large scale. So I think ARPA-H could democratize eye care and allow us to screen or manage eye disease in drugstores, in community health centers, or primary care offices. And another possibility is that we've had a revolution in ocular imaging during the past 20 years, where we can get resolution that's comparable to that of histology. And that's fundamentally changed the way that we provide eye care. And it's also fueled the AI revolution by providing big data. But because of the risk, many of these imaging devices are only available in eye doctor's offices. And there really aren't many portable devices that can be used for telehealth, for home monitoring, or for improving access to eye care for underserved populations. And so ARPA-H can really help bridge that gap by bringing researchers, clinicians, engineers, and industry together to develop some of these portable ocular imaging devices. So really in summary, we at the NEI are really enthusiastic about the potential of ARPA-H. And we're really excited to open more dialogue about what we can do together to try to improve the vision care for all Americans. So thank you. And I'm going to hand off to Deb Tucci, Dr. Tucci DEBARA TUCCI: Thank you, Mike. The NIDCD mission is to support research on the normal and disordered processes of hearing balance, taste, smell, voice, speech, and language, with a vision to advance the science of communication to improve lives. The NIDCD supports innovative research to achieve this goal. And the establishment of ARPA-H would provide an unprecedented opportunity to fund high risk, high reward research in basic translational and clinical sciences that could spur discoveries and accelerate treatments. ARPA-H provides a unique opportunity to advance the development of targeted drug and cell-based therapies to treat sensory and communication disorders. For example, accelerating gene therapy research could potentially result in treatments for hereditary hearing loss in utero before the onset of degenerative changes take place in the inner ear. Second, advances in regenerative medicine could lead to restoration of function of the damaged sensory cells in the inner ear, and lead to recovery of hearing and balance function. The application of machine learning and other advances could improve the function of hearing aids and cochlear implants, to restore more normal hearing abilities with these devices. Ear infections are the number one reason that children visit the pediatrician each year. Chronic ear infections may cause hearing loss and then lead to deficits in speech, language acquisition, and learning. There's an opportunity to fast track our strong foundational knowledge into new clinical strategies for preventing and treating ear infections. Deficits in taste and smell can negatively affect overall health status and quality of life. Neurons in the olfactory system have a remarkable and unique capacity to regenerate throughout the lifetime of an individual. Accelerated and collaborative research programs could facilitate the understanding of the properties that enable stem cells to proliferate and differentiate, and provide insights not only for the treatment of these targeted disorders, but also for the treatment of other neurologic diseases. And finally, scientists have developed impressive assistive devices and brain computer interface technologies that can help restore communication ability for those who have lost the ability to speak, such as through neurologic disease or head and neck cancer. Investments that spur competition and drive down costs make these devices accessible and affordable to all members of our society, improving quality of life and public health for tens of millions of Americans and people around the world. I look forward to hearing from our stakeholder groups to understand the ways that you think ARPA-H can leverage these exciting opportunities in science and technology to improve public health outcomes for individuals with deafness and other communication disorders. Your input as input is critical to help us identify the opportunities that are most meaningful and impactful for you and the communities that we serve. Thank you. And now, Dr. D'Souza. Rena, you're muted. RENA D'SOUZA: OK, can you hear me? Thank you, Deb. Thank you, Michael. Thank you, Dr. Tabak. And welcome stakeholders. I want to say at the onset, that an NIDCR the Institute for Dental and Craniofacial Research, has an unflagging commitment in helping advance the mission and the goals of ARPA-H, which is to create a new era of use research that improves health for all. We intend to manage for results, challenge the status quo in our thinking, aim at the extraordinary, and always deliver the scientific and clinical evidence necessary to improve dental, oral, and craniofacial health for all. Now let me tell you why ARPA-H is so important to us. Oral health is at an inflection point with the World Health Organization, WHO, declaring that it is integral to general health and hence, should be part of the universal health coverage. The human face, as been look around this panel-- the skull, our smiles, our teeth, in fact, do impart to us, a sense of identity and well-being. So diseases and disorders that threaten the integrity of this craniofacial complex rank amongst the highest in terms of prevalence and incidence, and in fact, pose significant public health challenges, both within the US and globally. So just to give you an example-- so craniofacial disorders in general constitute 50% of all inherited disorders, both single gene and syndromic of humankind, our cleft palate ranking 1 in 700 live births, and requiring surgical intervention and lifelong management. We have untreated decay, the most common of childhood diseases, also the most common reason why kids miss school and the most common reason why folks land up in the ER. Periodontitis is ranked as sixth, the most prevalent condition. So we have caries and periodontal disease as one of the most common infectious diseases of mankind. Cancers of the lip and oral cavity, HPV especially now, are rising to one of the most dominant forms of cancer. We have dental and oral facial pain that is truly difficult to treat and often mismanaged through opioids. Sjogren's and other drug and radiation-induced dry mouth conditions continue to pose great threats to individuals. When you lose your teeth entirely, as seen in some of our aging population, that is associated with cognitive decline as well. And to compound these issues, oral health records are not integrated into electronic health records with either medical and pharmacy tied in. And so we stand here at data science opportunities to actually identify common risk factors that are shared with major systemic diseases. And oral health care is fraught with disparities and inequities of many of our citizens who have no dental coverage. Care is unaffordable, difficult to access, and disparate. So even those of us that have coverage and you need dental care, you're guaranteed to be out of pocket. For those that have no coverage, it is truly difficult and compromising general health. So that is my overview. And I feel it's wise to include hard-driving research that ARPA-H can facilitate for improving health for all, and specifically focusing on some of our needs. The opportunities abound, I think for transformation, and the way we actually prevent, diagnose, and treat these conditions that cause major public health threats to our nation and the world. So with that, I thank you for listening. And I welcome stakeholder comments. I guess Larry will take over. LARRY TABAK: Thank you, so much. And now I will in fact, introduce the various stakeholder members today. Just a reminder to the stakeholders-- when you are a minute away from your prescribed time, there'll be a bell to remind you that there's about a minute left. So if you could adhere to that, we'd really appreciate it. If I mangle the pronunciation of your name, please do correct me I hope I don't do that. But in case I do, please correct me. The first speaker will be Dr. Stephen McLeod, Editor in Chief, Ophthalmology and American Academy of Ophthalmology. STEPHEN MCLEOD: Well, thank you very much for giving me the opportunity to comment. I hope I've unmuted, and I will try to avoid the bell. So Thanks a lot for the opportunity to comment. I'll start by saying that the Academy of Ophthalmology represents the profession on the front lines of patient care. And so of course, we're extremely supportive of serious initiatives that really are trying to find solutions to the big intractable problems in health, which is clearly where this program is going now of course. These are significant issues in vision care as well. As Michael pointed out, from, the individual perspective patients do indeed rank vision loss as one of their greatest fears. And from a societal perspective, the cost of visual disorders are really enormous. When we think about cataract surgery is the single most commonly performed elective procedure here and worldwide. When you think about the cost of the irreversible causes of blindness beyond cataract, things like macular degeneration, diabetic retinopathy, and glaucoma, these are all really significant and take an enormous social toll, And. Yet have remained really high hanging fruit. So ophthalmology really has seen a number of really tremendous therapeutic successes. We think about the widespread use of anti-VEGF agents for macular degeneration and diabetes and even more recently, the gene therapy trials and implementation. And as those of you who follow the science, the pathway to each of these therapeutics and interventions is really emblematic of the heavy lift that I think ARPA-H is looking at, which is really that convergence of multidisciplinary research that by virtue of the novelty and the technical challenges is really high risk. It's costly and it's complex, but worthwhile because the stakes and the rewards are so high. Again, these advances really with the product of disease-oriented multidisciplinary teams that are working at the tail end of a pretty long translational pathway. And as I've alluded to, the next set of problems really is as complex. I think that the traditional work of the NEI a great job and really laying the bed, the pathway for our understanding the underlying biology. But now when you get to that final translational mile, that's really where this sort of organizing principle of multidisciplinary groups coming together with a very singular purpose could be extremely powerful. I'm not really suggesting that we lay out what the top therapeutic challenges should be right now. But but there's no question that we do recognize that these solutions are going to lie at that complex intersection of cell and molecular biology, medicinal chemistry, neuroscience, engineering, and then finally for us, very frequently surgical implementation. And so there's no question. We have a dynamic and collaborative community that would really benefit from the organization and funding stimulus that this would present. There's a lot of thought that would have to go into the right targets that balance risk, cost complexity, and impact. But that's a work that we're very pleased to contribute to. I will say one thing about organizing principles. Personally, I'm very pleased that this is going to reside within the NIH, at least within the vision science community. The NEI has been a really effective organizing force. And for ARPA-H to be successful, I think that many of us feel that collaboration and coordination and clear open line of communication with the NEI will be really critical and effective in success. So thank you for allowing me to share a few thoughts. LARRY TABAK: Thank you so much. Our next speaker, Dr. Timothy McMahon, American Academy of Optometry. TIMOTHY MCMAHON: Well, thank you for the invitation to be part of this presentation today and be part of the potential for the development of ARPA-H. Dr. McLeod made some excellent points, so I will not repeat those for the sake of brevity. What I will do is different from that, is actually I will suggest some actually topic areas, potentially as trial balloons that potentially might be very valuable to the ARPA-H vehicle as we go forward. The first would have to do with the visual impairment world. So patients with low vision have significant limitations due to their underlying disease or trauma. But the current technology that is not being employed for visually impaired potentially could be readily adapted. So that could involve university, industry, NIH, collaborations, to foster that particularly, in this age of artificial intelligence. The second one in a very exciting one for me is, we know from certain imaging characteristics, in particular OCT imaging, that the ability with employing AI to actually investigate things that the human eye actually couldn't see, potentially allows the opportunity for the human eye to act as a biomarker for a number of neurodegenerative diseases in terms of risk factor calculations, early disease discovery, and a potentially therapeutic management effectiveness. So that is an area that I would put out as a trial balloon to think about. The third one is, as been mentioned earlier, and that is the notion of vision screening. This would involve children as well as adults. And in particular, in underserved areas, it's hard to do vision screenings if you don't have a fair degree of expertise and get accurate information. And this would be primarily for refractive error, but it could also be applied towards a variety of different diseases, particularly diabetes. And with the advent of appropriate technology, again, partnering between academic world, industry and NIH, the ability to potentially have individuals that are not very well trained to accurately perform these screening activities, would be very helpful for the underserved areas that don't have access or understanding of the need for vision screenings. And the last one-- and this is a real trial balloon that I'm not sure is within the realm of ARPA-H-- and that has to do with the paucity of minorities in health care professions. If you look at all of the various different professions in almost all circumstances-- so Blacks, Latinx, you name it, are underrepresented in most professions, relative to their population within North America, for example. And there are a number of reasons why that has happened. And some of it is the cost of that education. And the other is a lack of mentorship, because individuals in these underserved areas really don't have the mentorship to be able to say, hey, I want to be a doctor. And so this is something that would be a long term effort, but potentially might be within the realm of ARPA-H. So as I said, I'll keep my comments brief. And I would like to pass the next session on to Dr. Benjamin Yerxa, the CEO from the Foundation for Fighting Blindness. Thank you. BENJAMIN YERXA: Hey, everyone. I'm Ben Yerxa, CEO of Foundation Fighting Blindness and its venture philanthropy fund, the RD Fund. I spent 25 years in the biotech industry prior to moving to the foundation, where we are driving the discovery of treatments and cures for inherited and age-related retinal blindness. There are millions of people in the US and around the world that are going blind. So thanks for the opportunity to make some comments on President Joe Biden's ARPA-H plans today and to participate in the discussion. Foundation Fighting Blindness fully supports these efforts because we believe funding translational science is complementary to the NIH's basic science programs, especially the National Eye Institute. We see enormous opportunities in funding, cross-cutting, translational projects around neuroprotection and regeneration, that have high impact, not only in the retina, but also in all of neuroscience and brain research. Neural systems like the retina have been found to be amazingly plastic. If salamanders can regrow their eyes, why can't we? And by the way, what about a whole eye transplant? We hear about advances in whole hand transplants. Why not think about other areas of the body, like the eye? We know there are immense hurdles in getting it to hook back up to the brain. But imagine the impact with science and the need required to solve this problem. One of the biggest gaps in our field right now is in gene therapy is gene therapy manufacturing, including the testing that goes with it. I imagine a future state where genetic therapies are available in a sort of library, frozen and stable for a decade or more. This leads to affordability and access for all. Now NCATS and the PaVe-GT program are a really good start here. But we need something more ambitious in order to keep up. Another gap is simply the speed and cost of genetic testing. Despite the amazing advances achieved by the Human Genome Project, the speed and cost is still not where we need it to be. There should be no disparity between who gets a definitive genetic diagnosis and who doesn't. Now if discoveries don't go, don't do humankind any good if they're not useful products. So I know I'm stating the obvious. But this part is almost universally underestimated in terms of how hard expensive and time consuming it is to actually translate the discoveries into usable products. In my experience, is not just who's on the team, but how they're funded, not how much. It needs to be time bound and milestone-based, focus on applied, work not hypotheses, and have insane amounts of accountability. But it sounds like you already know this based on the DARPA experience. But just don't underestimate what it takes to achieve this type of culture and performance when you're building it from scratch. I've seen this [INAUDIBLE] work well back in the early '90s when I worked on novel HIV therapies, where the goal was simply to accelerate high priority projects. Now in Foundation Fighting Blindness with 50 years of funding experience, we pretty much pivoted all of our programs to be early to late translational grants. However, this often not enough. And we constantly face this proverbial valley of death. Our projects are almost there. We even create a non-profit venture philanthropy fund to pull projects from academia into the hands of industry entrepreneurs. And finally realizing that we also need alternatives to venture capital, we've helped to develop new legislation that could be very complementary to ARPA-H called Loan for Biomedical Research Act or HR-3437, that's also growing support broadly, and authorizes up to $30 billion in loans, bio-bonds, things like well-established, $270 billion green bond market. In this case, the [INAUDIBLE] is via new innovative funding [INAUDIBLE] backstopped, that is importantly not funded by the government, and not impacting NIH funding at all, but rather it's funded by risk averse capital like pension funds and insurance companies. So check it out. This broad funding mechanism across the spectrum of disease and disability could be very complementary to ARPA-H. Thanks for listening. LARRY TABAK: Thank you very much. Our next speaker, Dr. James Denneny Executive Vice President and CEO, American Academy of Otolaryngology Head and Neck Surgeons. JAMES DENNENY: Thank you. I'm Jim Denneny, representing the otolaryngologists, and I appreciate the agency for letting us speak on this critical topic. The first question that was asked was identifying scientific and research opportunities that a different approach might be helpful for in our specialty. Looking at the ways we determine that we wanted something that would affect broad populations, and a positive result would increase access, quality of everyday life and function, positive effect on interrelated problems, and also applicability to other unrelated diseases. Hearing imbalance disorder fits one of those areas. One of the key things for us in sensorineural hearing loss is to increase the subclassification for more specific treatments. With that, improving inner ear imaging with AI would be helpful. Our hearing aid technology-- we would love to have on a common platform with better devices. Nerve and hair cell regeneration that produce better discrimination, better hearing-- it makes devices more effective, and is also a critical area, as is the nerve protection, both from noise and from medications and chemical substances. I'd also like to add in immune related disease. For us, it affects many things in the head and neck-- allergic and chronic rhinosinusitis, asthma, hearing loss, balance disorders, dermatitis, Sjogren's, and thyroiditis as well as head and neck cancer. The rise in food allergies, which have caused multisystem issues increasingly over the last 10 years, is also something critical to us. What are the gaps in the R&D that are slowing and impeding progress? From our perspective, lack of comprehensive approach and coordination of projects, sharing of key existing resources for repurposing, similar to the platform for mRNA last year. In hearing aids, the multiple competing platforms with no incentive to collaborate-- also, we're not happy that the FDA has still not released the over-the-counter hearing regulations, which would have been helpful. The nerve and hair cell regeneration, genetic modification has been slower than we'd hoped with obstacles. AI may help in that. Hair cell regeneration with trans tympanic treatments and various products has no co-ordination and really hit and miss on the products that could be improved. Finally, immune diseases-- there are many isolated projects on many specialty areas that could benefit from a central design. The challenges that we see from advancing commercialization would include the long timeline from initiation of a grant to completion, uncertain ROI, hard to fund, peer review delays, and product liability concerns. Our organization has had a couple of things that have worked well for us in this, in starting out with partnerships with industry and federal agencies to begin work at the very initial part of study design and all the way through the project. Our clinical research through the clinical data registry of our networks increases real world data, more rapid accumulation, and lesser researcher conflict of interest. It's critical that experts in the subject matter are leading these projects that will move quicker and more efficiently from initial idea to completion. The related beneficiaries to these and caught along with our specialty would be neurologic diseases-- Alzheimer's and dementia, olfaction, peripheral and cranial nerve deficits, and multisystem autoimmune disease. Thank you very much. LARRY TABAK: Thank you. Our next speaker, Jeffrey Reagan, Director of Government Affairs and Public Policy, American Speech Language Hearing Association. JEFFREY REGAN: Thank you, Dr. Tabak. Good afternoon. On behalf of the American Speech Language Hearing Association, I thank NIH and OSTP and appreciate the opportunity to provide comments during today's listening session. ASHA is the national, professional, scientific, and credentialing association for 218,000 members and affiliates, who are audiologists, speech language pathologists, speech language and hearing scientists, support personnel, and students. Audiologists specialize in preventing and assessing hearing and balancing disorders, as well as providing audiologic treatment. Speech language pathologists identify, assess, and treat speech language and swallowing disorders. ASHA is strongly supportive of ARPA-H. We agree that the use driven research model offers promising opportunities to solve practical problems and create platforms, capabilities, and resources with multidisciplinary applications. This discussion is especially timely, as the House of Representatives is currently considering legislation to establish ARPA-H, so to accelerate the pace of scientific breakthroughs for diseases such as ALS and Alzheimer's that significantly impact the ability of individuals to communicate effectively. The need for a use driven research model within NIH is significant for communication disorders. ASHA acknowledges an ever-growing body of literature that indicates adults with disabilities face poorer health and medical outcomes. This remains true for people with communication disorders. A seminal study conducted by Stransky, Jensen, and Morris in 2018 concluded that adults with speech language and voice disabilities face greater challenges accessing health care. These challenges include, but are not limited to, locating medical providers, receiving high quality emergency and routine care, and foregoing medical care due to cost or availability of services. Solving practical problems and developing meaningful solutions, particularly in the area of health and health care equity and communication disorders, is one of ASHA's top research priorities. ASHA is currently supporting a number of critical research initiatives in this field. These initiatives are related to a number of challenges, including, first, disparities in care between minority and non-minority patients with communication disorders due to factors such as unrecognized clinical needs, systemic racism inherent in health care systems, and provider bias, second, provider attitudes and skills when communicating with people with communication disorders and the impact provided communication has on health outcomes, third, the need for diverse stakeholder input to address disparities experienced by persons with communication disorders, and fourth, health care systems that are poorly equipped to serve people with hearing loss and the impact that miscommunication, inaccessible health information, and reduced awareness has on health outcomes ASHA'S current engagement in health and health equity research leads me to make the following three main points this afternoon. First, a use driven research model indeed offers promising opportunities to solve practical problems and develop solutions with multiple applications. A better understanding of effective dissemination and implementation strategies is also needed to accelerate the uptake of research findings so that health and health care equity may be improved among underrepresented minorities and those living with a communication disorder. Second, while ARPA-H should be properly focused on supporting research initiatives that lead to practical solutions and more equitable and positive health outcomes, greater support is also needed to expand the research workforce, especially with individuals from underrepresented populations. The current shortage of scientists and researchers focused on communication disorders is impeding progress and a large challenge to advancing equitable health care delivery for those with communication disorders. And third and finally, transparent collaboration and coordination with diverse public and private stakeholders is absolutely critical to success. Again, I thank you for this opportunity to comment today. LARRY TABAK: Thank you very much. Our next speaker, Barbara Kelly, Executive Director, Hearing Loss Association of America. DEBARA TUCCI: Barbara, you're muted. BARBARA KELLEY: Hi, again. Thank you. The Hearing Loss Association of America is strongly supportive of ARPA-H, and I'm very happy to be here. We are a national organization for people with hearing loss who want to stay in the hearing world with technology, with anything available to treat hearing loss, mitigate hearing loss. Hearing loss is a great disrupter to life, and we know that one in 3 people in the ages of 65 to 74 have hearing loss. So we need more research to show that hearing testing in people 50 and over should be mandatory. What scientific research and opportunities maybe have a different approach is perhaps funding for research from departments that enjoy the benefits of technology. For example, if cochlear implants save education dollars, then Department of Education should contribute to the research. Similarly, funding sources for co-morbidities should contribute to hearing research, such as those that fund dementia and depression. With all the communication data on a relatively small number of video conferencing platforms, there could be informative data that help diagnose hearing loss or communication problems from analyzing communication interactions. There are a lot of privacy issues here, but if an individual owns their data, then perhaps they could consent for the research of it. I'm so happy to hear about translational science because patient involvement is a critical feature in all stages of translational science. And my hope and our hope is that the research being done will truly benefit people with hearing loss. When it comes to advancing research through to commercialization, implementation-- I was happy to hear Dr. Collins talk about including companies along with academic research. I believe that the interface between commercial and academic research is sometimes hampered on the academic side by individualistic, IRBs, onerous contracting procedures, licensing and patenting policies, conflict of interest policies. And I think that companies struggle to do multi-site research trials if each research site requires their own nuances. So companies look to less academic research partners who use centralized IRBs, so I'm really happy that this might be an opportunity that the commercial side and academic side come together. Again, I would just like, on the big picture, to say that it's imperative that you include people who live with hearing loss daily in the research. Thank you for being here. LARRY TABAK: Thank you very much. Our next speaker will be Dr. Jamie Perry, Board of Directors, American Cleft Palate Association. JAMIE PERRY: Thank you very much. I appreciate the invitation to be here on behalf of the American Cleft Palate Craniofacial Association. ACPA is an association of health care professionals who are interested in the clinical care and research advances for those individuals who are affected by cleft and craniofacial conditions. We are home of the primary journal. That's our interdisciplinary journal called the Cleft Palate Craniofacial Journal, where I serve as editor in chief. Cleft palate in general is the most common birth defect in the United States. Research demonstrates that between 20% and 35% of children born with cleft lip and palate will continue to have nasal speech, and that hypernasal speech leads to the continual need for speech therapy, often, and repeated-- multiple surgeries. And those surgeries often have negative consequences related to psychosocial development and also just the continued burden of care. These children also have increased burden of care. They have an increased cost to the patient. And as I mentioned, not to mention the psychosocial impacts of these things. Unfortunately, what we find is that, that rate, that 20% to 35% that I mentioned has not really been improving over the past 25 years. So our numbers continue to remain the same. And I think what this demonstrates is that there is a great need for our discipline to have transformative research that really accelerates these advances. So I was really excited to see this because I really feel that this addresses and will allow us to move several of these areas forward at a pace that we have not yet seen. And also, another particular thing that's unique to ACPA is that in the area of cleft care, one of the major issues that we have is the burden of limited access. And in our area, one of the primary ways of providing cleft care is through interdisciplinary team collaborations, and these are mainly found in urban areas and not found in our rural communities. But as with most rural communities, health disparities limit that access to those teams, and our research funding opportunities that might focus on bridging those gaps to provide specialized team care and services would be of great benefit to address some of these needs. But I do think that we have to be very creative to make sure we don't just stimulate research that focuses on teleservice. While this is definitely an area that we've seen, particularly with COVID and the pandemic, has been beneficial in providing care, I think what I love about the mission with this is the idea to really get outside of the box and think beyond those kinds of things which have been great-- but what can we do that's even better? I think that there needs to be more advanced models and approaches to expanding access to care in all regions. And additionally, while health disparities is certainly expanding in the area of cleft craniofacial, there's just limited research into what are the factors that change and alter the way that we provide care and that service being equitable across all patients. So targeted RAs or PARs that identify some of a impacts and create really innovative solutions would be very transformative in cleft care. Also, because of the interdisciplinary nature of ACPA, it would be really difficult for me to identify just a few key areas. But in my last minute here, I wanted to just say that some broad goals for ACPA are really to advance research that transforms how we treat patients, and this could include advancing sophisticated pre-surgical planning tools to improve surgical outcomes and also the need, as I mentioned, to reduce some of these barriers in cleft care. So thank you again for the opportunity to contribute, and I look forward to what will be coming forth from this initiative. Thank you. LARRY TABAK: Thank you. Our next speaker, Dr. Christopher Fox, CEO American Association for Dental Oral, and Craniofacial Research. CHRISTOPHER FOX: Thank you, Dr. Tabak. I am now the CEO of the American Association for Dental, Oral, and Craniofacial Research. Our association recently expanded its name to reflect the full breadth of the science in which our members are engaged. We represent over 3,000 individual members, and our parent international association represents over 10,000 members worldwide. AADOCR's mission is to drive dental, oral, and craniofacial research to advance health and well-being. We are very enthusiastic about the administration's proposal to establish ARPA-H, as we believe it's bold, transformative approach can complement the successes of NIDCR and address several intractable problems within dental, oral, and craniofacial research to improve health for all Americans. In my allotted time, I would like to highlight just five areas. One is cleft lip and palate, which we just heard from Dr. Perry. But we believe that a better understanding of the basic biologic mechanisms, genetic pathways, and environmental influence can lead to gene based therapeutic approaches. Indeed, this line of research has been a passion of our own NIDCR director. But progress needs to advance further and faster within a bioethical framework. Two, while this country has made great advances in reducing the prevalence of cancer, oral cancer and oropharyngeal cancer is increasing in prevalence. HPV related oropharyngeal cancer is now more prevalent than HPV related cervical cancer. While vaccines need broader uptake amongst girls and particularly boys, earlier detection is critical. Molecular testing of tumor sites augmented with artificial intelligence and machine learning can lead to earlier detection, personalized treatments, and improved survival and quality of life. Three, dental caries and periodontal disease are highly prevalent, ranking number one in prevalence in the global burden of disease studies from 1990 to 2019. Dental caries and periodontal disease are both complex multifactorial diseases. In addition, health disparities are first manifested in the oral cavity and are a bellwether for future health disparities. Bold and innovative approaches are needed to disrupt these diseases using deeper knowledge of biologic pathways, environmental and societal influences, and social and commercial determinants. A systems biology approach using multiple omics technologies, bioinformatics, data acquisition, and analysis is in its infancy with oral diseases. AI and ML applied to integrated electronic health records will lead to deeper understanding of the relationships between oral and other diseases. Four, the current COVID pandemic and earlier AIDS epidemic have highlighted the importance of mucosal defenses, including physical barriers, secretions from associated glands, and mucosal immunity. A better understanding of these defenses could be gleaned by establishing a molecular map of mucosal tissues throughout the body with their similarities and differences. Lastly, disruptive advancements in dental materials are needed. The profession still uses dental amalgam, a product that has been available for 150 years. While a very effective clinical material, the US has pledged as a signatory to the Minimata Convention on Mercury to phase down its use for environmental reasons. Dental composite restorations have been around since the 1960s. And while there have been continual incremental improvements, there have been no dramatic innovative restorative material advancements. The development of new smart materials and enhanced systems for digital dentistry and 3D printing have the potential to deliver improved dental restorations with superior clinical properties and at a reduced cost improve access to care and reduce health inequities. AADOCR looks forward to future opportunities to contribute to the success of ARPA-H. Thank you very much. LARRY TABAK: Thank you very much. And finally, our last speaker from the stakeholder group, Kathy Hammit, Vice President of Medical and Scientific Affairs, Sjogren's Foundation. KATHY HAMMIT: Thank you so much, Dr. Tabak, and hi, everyone. I am also a longtime Sjogren's patient in addition to my role with the Sjogren's Foundation. Sjogren's is the second most common autoimmune rheumatic disease affecting the entire body. It causes extensive dryness along with profound fatigue, chronic pain, major organ involvement, neuropathies, and lymphomas, especially of the salivary glands. I'm excited about the idea of transforming our approach to disease such as Sjogren's with ARPA-H and how this could complement the already great work of the NIH. I have personally struggled with Sjogren's for a very long time. And during that time, while I've seen some important strides, it's not enough. So seeing what was done with COVID in such a short time is phenomenal. So the ARPA-H concept, instead of looking at single diseases from a vantage point in which science defines them in a given moment, it's awe inspiring to think about an approach of diving into cross-cutting themes for disease and looking at what, why, and how of those. This brings the opportunity to discover the unexpected for our diseases. So cross-cutting themes that excite us at the Sjogren's Foundation-- well, first, COVID has brought to light intriguing areas that are ripe for investigation across many disease fronts. We saw the use of mRNA vaccines surge dramatically, so they're being investigated now as a treatment for cancer. And we could and should tap into this growing body of knowledge to make substantial progress in the treatment of autoimmune disease. Long term COVID morbidity has increased recognition dysautonomia and the role it might play in a number of diseases, including Sjogren's. Can we analyze its role in fatigue, in depression, in oral and ocular dryness, brain fog, a major problem with long term COVID that also occurs in autoimmune and other diseases? These all point to how multiple diverse pathophysiological pathways involving, well, the brain and also the nervous, endocrine, and immune systems are all converging to lead to disease. Another area-- how might we speed development of gene therapy and gene transfer? If we can learn how to safely regenerate damaged glands, just imagine how many lives could change dramatically. In Sjogren's alone, we have damaged and dysfunctional salivary and lacrimal glands, leading to a major burden on quality of life. Could this also help other gland and organ damage that occur in multiple conditions? The concept of wearable devices-- other symptoms beyond those mentioned could be monitored and disease repercussions recorded by patients to improve clinical management and clinical trial success. On Friday, Bob Carter mentioned skin sensors that might monitor inflammation. Wow. We will absolutely need consistency in these measures so that those that cross diseases can be compared, patients have the ease of tracking specific data for more accurate and easier recording to their doctors, and clinicians can learn just one system instead of becoming confused by many. And only the NIH or a single agency can streamline this field. Finally, I mentioned biomarkers in the microbiome. They should be highlighted as critical overarching themes. So I want to thank you for the opportunity to dream big, expand our thinking about what might be possible under the umbrella of ARPA-H. We'll want to make sure that a wide variety of stakeholders have input into this agency because, together, we can unlock so much potential and advance our communities forward through this collaborative approach. Thank you. LARRY TABAK: Thank you, and I want to thank all of the stakeholder representatives for very broad and cross-cutting themes-- really very, very helpful. We now have some time for questions. We are joined by Dr. Tara Schwetz from OSTP, whom we're going to give all the tough questions to. But I'll chime in as needed. So Max, I'm going to turn it back to you, please, to moderate. MAX BRONSTEIN: Thank you very much, Dr. Tabak. I'm happy to help moderate today's session, and I'm going to ask a few questions, just to kick us off here. And while I'm doing that, I hope folks will use that Q&A function and please chime in with any questions you may have. So just to get us started here, when it comes to priority setting, obviously there's a lot of stakeholders involved. There's a lot of diseases that ARPA-H could work on. There's just almost an overwhelming number of needs in sort of the health and health care community and certainly an overwhelming number of needs from patients in a post-COVID world. So how do you anticipate ARPA-H will set priorities? How will they decide what to work on and what to work on first? TARA SCHWETZ: All right, I can jump in on that one, Larry, and feel free to fill in. Priority setting for ARPA-H is going to come from multiple different directions. We do feel like it is a great opportunity to engage stakeholders in the process, and so we envision that there will be some mechanism by which stakeholders-- and I'll use that term broadly. So when we say stakeholders, we mean folks from patient groups, from academia, industry, other areas that support science, et cetera-- but an opportunity for all of them to weigh in and provide input and ideas. What exactly that process is going to look like is still being developed, but we do think that will be an important component. Importantly, ideas can also be generated through the program managers themselves. So for example, the model that DARPA uses is that the program managers are hired based on the idea that they bring with them to the organization and how well in alignment it fits with the vision of the organization that is brought forward by the ARPA-H director. So the ARPA-H director obviously will have an opportunity to shape the vision and direction of the organization, and that will on some level determine some of the priorities. But we hope that the ideas will be coming from multiple directions and they will be informed by multiple sources. MAX BRONSTEIN: OK, thank you. Dr. Tabak, did you want to take a swing at that as well? LARRY TABAK: Oh, no, I thought that was great. Why don't we go to the next question, please? MAX BRONSTEIN: OK, great. I'll pose one more question, and this is a question that comes up very frequently. We have lots of agencies in the federal government that get involved in R&D and doing science. How do you see ARPA-H as sort of coordinating and collaborating? I mean, how do we do that in a way that would prevent the inadvertent creation of silos and ensure that the best ideas from the federal government are being brought to bear on the challenges that ARPA-H is working on? LARRY TABAK: OK, well, I'm going to-- TARA SCHWETZ: I can take part of that, Larry, and then I think I'll add another piece to that, which I hope, Larry, you can answer more fully, is how ARPA-H will coordinate with the NIH institutes and centers. So in terms of the rest of the federal government-- the broader agency, that is a critical partner for ARPA-H and will be moving forward. We have already convened a group internally, composed of a variety of different agencies from across the federal government-- across HHS but also agencies like DARPA and ARPA-E, DOE, and others that have joined an inter-agency working group to help work out some of the challenges that we think we might face as we're planning to do this-- but also to really help us establish some clear mechanisms for collaboration across the federal government because it will be so critical to this effort. LARRY TABAK: Yeah. So similarly, we have convened a small group of institute and center directors to work through similar questions within the NIH. Ultimately, of course, whatever this group comes up with will be thoroughly discussed and vetted with all of NIH leadership, all institute and center directors, as well as the NIH director and his executive team. But that integration and awareness of what else is going on so that we make the very best use of precious resources will certainly be very much on everybody's mind. TARA SCHWETZ: And let me just make one additional point too. We do hope to convene a group-- once our ARPA-H is established, a higher level inter-agency committee that the ARPA-H director, the NIH director, the HHS Secretary and many others-- and the leadership across a variety of different agencies within the federal government will participate in as well. So the initial group is sort of helping us work through all the details. And then once this thing gets kicked off, we hope to have a higher level group to work through the really sticky issues that are going to come up as this thing is implemented. MAX BRONSTEIN: OK, thank you for those responses. So I'm going to turn over to the Q&A that we've gotten in the chat box here. We got a question from Teresa Barnes, and she asks, how can dentists become a more integral part of the medical community via ARPA-H to help patients, including those with complex medical issues? So I'm going to editorialize a little bit on this, but this question sounds like, with dentist being sort of part of the front line response for a lot of patients, especially in parts of the country where access to specialists and others might be challenging, what role-- what larger role do you think dentists could play, and is there some specific way they could collaborate with the new ARPA-H initiative? Let me start with Dr. Tabak. LARRY TABAK: Well, actually, I'm going to ask Dr. D'Souza to comment. RENA D'SOUZA: [LAUGHS] From one fellow dentist to the next. But honestly, this is a multifaceted issue, complex and needs a multi-pronged approach, Max. Clearly, in terms of overall structure, the structural barriers are pretty obvious. I think creating integrated health records that allow any health care provider to see a patient as a whole is a very important way to actually prevent and diagnose conditions. So that would be taking advantage of emergent opportunities, right? There's also social determinants of health and structural barriers in our society that need to be addressed. And someone did ask later on in the questions whether prevention would be a theme for ARPA-H. And I don't know that. I don't know what the answer is. But I'm hoping prevention is considered in the overall scheme of using our technologies wisely to reach populations that have difficulty accessing care. So that's just the beginning, and there's lots of scientific arenas that one could cross with common risk factors and looking at molecules and mechanisms that are shared in common between genital, oral, and systemic diseases. So that's my answer in a nutshell. I hope it was focused enough. MAX BRONSTEIN: OK, thank you for that. So we have another question here about-- well, really, this question is about the agency head, the person who would lead ARPA-H, which is, I think, a really critical question for a number of reasons. So Dr. Schwetz and Dr. Tabak, maybe you could walk us through how you envision that person being sort of nominated in terms of the actual process itself. But more importantly, what do you see as the top characteristics that we would want in this new leader? LARRY TABAK: Dr. Schwetz? I told you. You're going to take the tough ones. Go ahead. TARA SCHWETZ: [LAUGHS] Oh, I was going to ask if you wanted to take that one. Sure. In terms of the appointment process, we're still working through who will appoint the director of ARPA-H. So that one doesn't have a clear answer at the moment. Obviously, there's at least two possible approaches, which would be presidential appointment or something more akin to how all of the institutes center directors, except for NCI, are appointed, which would be through appointment by the HHS Secretary. Those are two options that we're still discussing. In terms of the type of person, which I agree, this is a more poignant question here because the person that we bring on initially in this role is really going to set the stage for how this organization is going to play out over the course of the next several years. And they're also going to set the stage for the culture, which as I think most people recognize, culture is really difficult to change. And it's a really critical piece of developing this organization. So we want to find someone who is a really thoughtful and bold leader, someone who has maybe spent some time in industry academia, in a DARPA or ARPA-like environment so that they understand the model and approach, someone who's a really well-rounded expert, basically, and someone who can be an inspiring leader but also really empower their employees-- their staff to do their jobs most effectively. Because the program managers will have a fair amount of autonomy and flexibility, and we want to make sure that the director is able to support them as they move forward with their responsibilities as well. MAX BRONSTEIN: Great, thank you for that. Let's see. There was one question that came in. This relates to some of the remarks that Dr. Chiang was making at the start of the presentation today. And in his remarks, he talked a little bit about a technology, well, future technology, for portable ocular imaging device. And when I heard you speaking about this, it sort of got me thinking about it-- how important having Something like that would be, how transformative it could potentially be for patients, if we had those types of tools and technologies. I was hoping you could talk a little bit about why having that type of platform would be meaningful in the ocular space and what it could mean for patients, if we did have that type of technology. Maybe there's a role for ARPA-H here too. MICHAEL CHIANG: Max, thanks for asking about that. I think that imaging technologies-- and this gets into the question that was asked about biophotonics-- they have really transformed the way that we do eye care. The problem is that these devices are all in eye doctors' offices. And that's an issue that, from the perspective of the people who make these devices-- eye doctors use them. But we're moving to a world where things are shifting toward the home, and I view that as a little bit inevitable. And the problem is that we don't have a home based infrastructure for care, and there's a little bit of a chicken egg thing. Vendors don't-- these technologies can be made into home devices, but there's a chicken egg that vendors don't necessarily want to do it unless there's a market for it. And so I think that a really potentially transformative technology-- home based telehealth, remote monitoring, screening in urban and rural places, and that's the potential that I see for it. MAX BRONSTEIN: Excellent. Thank you for commenting on that. Let me turn it back over to Dr. Tabak at this time. I think we've run out of time for our Q&A session. So let me turn it back over to Dr. Tabak, who can close this out and bring us home here. LARRY TABAK: Well, thanks so very much, Max, and I want to thank everybody for your interest in ARPA-H. We're really grateful for the input and the perspectives that you shared with us today. I do want to remind everybody that this is just one way to engage with us. There are other opportunities to remain engaged during this planning process. The NIH and OSTP will be holding more listening sessions over the next weeks that will be publicly broadcast, and you can find that information on the sessions upcoming on the NIH website page. Additionally, the ARPA-H comment box remains open, and you are certainly welcome to add in your thoughts and comments over and above those that you heard today. We certainly look forward to engaging with the community as we continue to develop ARPA-H. And so with that, I want to thank my colleagues from OSTP, my colleagues from NIH, and especially the various groups that were represented here and all of you who attended this session. Thank you all very much. DEBARA TUCCI: Thank you. AUDIENCE: Thank you, Dr. Tabak. BENJAMIN YERXA: Thank you. AUDIENCE: Thanks so much. AUDIENCE: Thank you.