FRANCIS COLLINS: Good afternoon, good morning to everybody. Thank you so much for taking the time to join us in this one in a series of listening sessions on ARPA-H, a new proposed component of NIH that has all kinds of exciting potential, and where we want to have the chance to hear from all of you about your views on this. We have a very full 75 minutes ahead of us, where we're going to hear from three institute directors, Drs. Rodgers, Cernich, and Langevin, about their perspectives from NIDDK, NICHD, and NCCIH. And then we're going to have stakeholders, quite a list of them, who are in this area of particular interest for today's conversation, and they will tell you their perspectives, four minutes each. And then we'll have time for a Q&A. Just a little heads up about that. Those of you listening, if you want to pose a question after we've heard these presentations, please use the Q&A feature in Zoom. Don't use the chat box, because not everybody will be able to see it. So Q&A feature is where I will try to be moderator and pick out questions as they come in. So that's the plan. That's what we're in for. Really looking forward to the chance to hear from all of you. It is a pleasure to tell you about this Advanced Research Project Agency for Health, or ARPA-H. As you know, we're working closely with White House science advisor Eric Lander, and his staff at the Office of Science and Technology Policy, OSTP, on this bold proposal. ARPA-H is a high priority for President Biden and his administration. It's designed to catalyze ambitious ideas and approaches that are use-driven and will shape the future of health and medicine for all Americans. As designed, ARPA-H aims to follow a model that's built upon the DARPA experience, built 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 and a willingness, when projects are not succeeding, to say so early. So if you're going to fail, fail early. Today, NIH and OSTP want to hear from you, our stakeholders. You are in one of no less than 15 of these outreach meetings. And we're learning a lot, and I know we will today, as well. To set the stage, you'll be hearing from several NIH and OSTP leaders. Then, we'll hear from those select speakers, in this case representing advocacy for research on diabetes, digestive disorders and kidney disease, child and maternal health, complementary and integrative medicine. I see now 175 participants have signed up. We will have a live Q&A session after the formal presentations. And encourage you to submit your questions during this event. You don't have to wait until the end. And again, please use the Q&A function if you have a question you want the group to address. Now, I would like to hand it over to Dr. Tara Schwetz, who is assistant director for Biomedical Science Initiatives at OSTP and has been working pretty much full time-- or in her case, twice full time on the ideas that are going to be necessary for effective launching ARPA-H. So Dr. Schwetz, over to you. TARA SCHWETZ: Thank you, Dr. Collins. And thank you everyone who has joined the meeting today. We very much appreciate you being here and look forward to a really thoughtful and lively discussion. I'm excited for the opportunity to share a bit today about the importance of ARPA-H and how it will aim to be transformative for a variety of diseases and conditions and societal challenges related to health. So as all of you know, we have an incredible biomedical ecosystem here in the US, much of which is bolstered by the important fundamental research supported by NIH, work which is often leveraged by the vibrant biopharmaceutical industry that we also have to create products for patients in a multitude of disease areas. And NIH continues to be a keystone in the biomedical enterprise, and the work it supports has made great progress in uncovering the underlying mechanisms of health and disease. However, our current system has some gaps, some blind spots, and we all know of ideas that fall into the gap between what can be and what is advanced through traditional public support mechanisms and industry. And these ideas have the potential to bring disruptive innovation to health and health care. And so that's exactly the gap that ARPA-H is trying to fill. While it's not the model that should be used for everything, it will provide us with a new lens for thinking about exciting biomedical science and how to improve human health. So if we imagine, just for a second, for example, if we could program mRNA to prevaccinate you against the top 50 most common mutations for cancer, giving your body the ability to target and eliminate those cells before they can ever even create a tumor. What if, for example, we could develop drugs that have very precise molecular "zip codes" that would allow for unprecedented targeting, even across the blood-brain barrier, to specific cells in your body? We would be able to deliver a therapeutic with dramatic accuracy that could greatly increase the efficacy of a drug while mitigating, or potentially even eliminating, side effects altogether. So these, of course, are just a few examples of the types of capabilities and platforms that ARPA-H could develop. And I know you all have some ideas as well, and likely ones that are even more ambitious and exciting than those. And so advancing these ideas is going to require a novel approach to supporting biomedical research. And this approach, this ARPA-like model, has been applied to other areas of R&D-- of course, DARPA, ARPA-E, IARPA, and others. And our goal is to create a distinct and bold entity, where ARPA-H leadership will have the autonomy, the independence, the resources to tackle some of the biggest challenges facing human health. It's not applicable for all types of research questions, but we do know that this ARPA-H model works and think it's about time we deploy it to lay the groundwork for disruptive innovation in health. So thank you again for being here today, and I look forward to hearing your input. So let me put it back to Dr. Collins. FRANCIS COLLINS: Thanks, Dr. Schwetz. By the way, I also want to express thanks to Dr. Rachael Fleurence, who's been very much in the middle of organizing these outreach sessions. Thanks to Rachael. So the next three speakers are IC directors or deputy directors, and I will introduce them only by their name and their particular institute. And I'll ask them to hand off to each other. So we're going to begin with Dr. Griff Rodgers, who's the director of the National Institute of Diabetes, Digestive, and Kidney Diseases. After he speaks for three minutes, he will be handing off to Dr. Alison Cernich, who is the deputy director of the National Institute of Child Health and Human Development. And then Alison will in turn hand this off to Dr. Helene Langevin, who is the director of the National Center of Complementary and Integrative Health. Dr. Rodgers, over to you. And I think you're muted. GRIFF RODGERS: 14 months later, I still can't get that mute button working. FRANCIS COLLINS: Well, we always have to have at least one of these in any session, so now you have checked the box. GRIFF RODGERS: All right. Good. Thank you. Well, thanks for the opportunity to speak and, even more importantly, to listen during today's session. The NIDDK's broad research responsibility includes some of the most common, debilitating, and costly conditions affecting Americans. And while NIDDK's research is actively addressing ways to reduce the burden of these diseases, ARPA-H could complement this work by taking on visionary research with the potential to revolutionize care for chronic diseases. These approaches might involve novel ways to rejuvenate, regenerate, and even replace some of the cells, tissues, and organs that show progressive loss of function in the diseases within NIDDK's mission. In addition, the development of new pharmacotherapies that are targeted, personalized, and that simplify care can also transform treatment for diabetes, inflammatory bowel diseases, liver disease, or end-stage renal disease, just to name a few of the conditions we battle at NIDDK. Like much of NIH, many of the diseases in NIDDK's mission have a disparate impact on minority and lower-income Americans. Therefore, like many of you, I feel it is critical to apply ARPA-H resources in ways that move our nation toward health equity. While we may think of ARPA-H as focused on technology development, finding new, innovative ways to engage stakeholders, perhaps through novel partnerships, may be another important opportunity for ARPA-H and a way to ensure that medical breakthroughs developed through ARPA-H are accessible to all. With these considerations in mind, I look forward to hearing the views of the organizations who have joined us today whose support we greatly value as we work together to achieve an era of better health for all Americans. And with that, I'd like to turn the virtual microphone over to Dr. Alison Cernich, deputy director of NICHD. Alison. ALISON CERNICH: Thank you so much, Dr. Rodgers. And thanks, also, for the opportunity to participate and listen to this session, as I have to many of the others. NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. During our recent strategic planning process, we considered a number of aspirational goals that NICHD could pursue in partnership with other institutes that would impact not only our science but could have broader implications. Some of these goals could be accelerated by an entity like ARPA-H and serve as platform technologies to advance prevention, diagnosis, and therapeutics for several conditions on which NICHD focuses. For example, maternal morbidity and mortality is a public health crisis in the United States, with glaring structural inequities in access to care and greater rates of illness and death in women who are Black or African American and Native American and American Indian women. While many ICs across NIH are working together to address this crisis, the use of flexible funding mechanisms to include new partners in this effort, especially to address social determinants of health, could be addressed by ARPA-H. NICHD also aims to advance the ability to regenerate human limbs by using emerging technologies to activate the body's own growth pathways and processes, particularly among individuals born with structural birth defects and those who experience amputation. A targeted, accelerated effort in this research area could spur scientific progress in limb repair, neural regrowth, and vascular system repair. Another example is endometriosis, which affects 10% of women in the United States and results in chronic pain, infertility, and a higher risk of some cancers. ARPA-H could support novel platform development to prevent, diagnose, and treat this disease, which could also impact studies of tissue regeneration, wound healing, and immune function. And finally, our understanding of technology exposure and interaction with digital media on the development of children in the United States trails significantly behind the adoption and use of these technologies. This became particularly clear during the pandemic, when many children switched to online learning and it highlighted the potential inequities introduced by the digital divide. ARPA-H initiatives could help us better understand the impact of digital media on developmental trajectories, health and mental health outcomes, and cognitive development. At the heart of the aspirational goals we considered was the commitment to facilitating scientific discovery and the translation of research results into medical practice to help patients. NICHD sees the potential for ARPA-H to break new ground against the health challenges facing our world, and we're excited to be its partner moving forward. I will now turn to my colleague, Dr. Helene Langevin, the director of the National Center for Complementary and Integrative Health, for her remarks. Helene. HELENE LANGEVIN: Well, thank you, Dr. Cernich. It's my pleasure to present the perspective of NCCIH. ARPA-H will aim to develop transformative tools and platforms for the benefit of all patients, and this is very much aligned with NCCIH's focus on whole person health. Whole person health means empowering individuals to improve their health in multiple interconnected domains-- biological, behavioral, social, and environmental. One way that ARPA-H can catalyze this vision is by harnessing and integrating information from all the areas of life that can impact our health. We all know that health is multifactorial. It includes physiology and genetics, but also it's affected by environmental exposures, like air quality, water, crime, and noise. And it's impacted by modifiable behavior, such as poor diet and sedentary lifestyle that, combined with chronic stress and poor sleep, can lead to many chronic diseases, like type 2 diabetes, cardiovascular and degenerative joint disease, chronic pain, and depression. But rather than focusing on one disease at a time, whole person health is a cross-cutting concept that integrates all of these factors, and therefore requires new partnerships and platforms. Technology already provides so much information, and it's right at our fingertips-- fitness trackers, sleep sensors, genomic and geospatial data. But this technology is not uniformly available to all, and it's not integrated into health care. Our current electronic health records are designed primarily for health care providers and billing, not for the patient, and can be difficult to engage in research. There's also little incentive for health care systems to change from within to make health records universal and inclusive of the marginalized and uninsured. Some countries with national health care systems-- for example, the UK, Sweden, and Portugal-- are way ahead of the US in having health registries that include the entire population. While the US is lagging in this area, radical innovations could leapfrog over pitfalls of our established systems. Just imagine if you could track a person's health through their whole life, starting at birth, including every lab test, procedure, et cetera, whether this occurs in a hospital, clinic, school, or the person's home. Eventually, this would constitute the individual's unique, lifelong, person-centered health record that could be accessed by individuals themselves and, with appropriate deidentification, made available for research. By closing the loop back to the patient and via research to health care providers, such technology would lead to a true learning health care system that would engage patients in taking charge of their own health. This may seem far fetched, but it's exactly the kind of bold, transformative challenge that ARPA-H is made for. NIH by itself cannot fix the health care system, but with ARPA-H, it can motivate the private sector in tackling the most complex and pressing problems that are dragging down the health of the nation. We need your feedback and perspectives on how ARPA-H can transform important areas of medicine and health for the benefit of all. Thank you. And I will now hand it over back to Dr. Collins. FRANCIS COLLINS: Oh, thanks very much, Dr. Langevin. So we're now going to go to stakeholder comments. Each of our stakeholders, of whom there are nine, are being given four minutes to say what they think would most be relevant here for our discussion about ARPA-H. Just to remind you, if you're 30 seconds away from your four minutes, you might hear a bell ringing to remind you that there's a time limit here, because we want to hear from everybody, and we want to protect the time for Q&A after these presentations. I'm going to make my introductions extremely brief by simply giving name and the person's current professional title. So let's begin with Dr. Bishr Omary, who is past president of the American Gastroenterological Association. Dr. Omary. BISHR OMARY: Thank you so much, Dr. Collins, for the opportunity to provide comments on the development of the ARPA-H. I'm currently at Rutgers University, and I have the privilege to be here representing the American Gastroenterological Association, otherwise known as AGA, which is a trusted voice of the AGA community serving patients. AGA represents 16,000 members from around the globe who are involved in all aspects of the science, practice, and advancement of gastroenterology. AGA's mission is to empower clinicians and researchers to improve digestive health. And the vision-- to create a world free from digestive diseases. As a follow-up to what Dr. Rodgers mentioned, a 2019 analysis estimated health care expenditures for GI diseases were $136 billion, with over 240,000 GI cancer and non-cancer-related deaths. Given this health burden and AGA's mission and vision, we wholeheartedly support the creation of ARPA-H because it will no doubt drive transformational innovation and breakthroughs, as has been mentioned, and health-related research. I will very briefly share AGA's thoughts on structure, funding, and areas of focus for the proposed entity. First, some remarks on structure. During the development of this new division, hopefully within NIH, AGA recommends that ARPA-H leadership aim for transparency and collaboration-- transparency in the agency's selection criteria, decision-making process for its goals, and investment strategies, and collaboration with stakeholders, as is taking place here, to identify areas of focus and to ensure ARPA-H's goals result in maximum impact. Moreover, as ARPA-H's structure begins to take shape, AGA recommends that decision makers adopt similar approaches to DARPA, as nicely articulated in what I would consider a must-read commentary by Drs. Collins, Schwetz, Tabak, and Lander, which was published three weeks ago in Science. Moving onto funding, AGA recommends that ARPA-H be funded at a substantial level in its inception to ensure programs and initiatives have the necessary support. Consistent and sustainable increases in federal funding should be provided annually to ensure that ARPA-H can continue its mission. Importantly, ARPA-H funding should not impact the funding levels of other federally supported research efforts at NIH and other funding agencies. Regarding priorities, AGA recommends ARPA-H leaders and project managers focus on areas with significant impact on global communities, like GI diseases and cancers, diabetes, obesity, and other disorders. Several GI cancers are considered deadliest cancers and exemplify areas where medical practice and preventive care would dramatically be changed through technologies and platforms developed under ARPA-H. Specifically, we recommend that the principles ARPA-H uses to prioritize funding decisions incorporate a definition of need that includes mortality rates and areas where tools are lacking instead of solely focusing on incidence. Prime examples of this are colorectal, pancreatic, gastric, and esophageal cancers, which are impacting patients in lower age cohorts and broadening to patients in communities of color. Moreover, GI diseases like nonalcoholic fatty liver disease and inflammatory bowel disease are increasing in similar populations and further exacerbating the health disparities that plague underserved and underinsured populations and communities of color. Lastly, we suggest including with ARPA-H funding for career development. In this regard, the support for F, K, and T type NIH grants has not kept up percentage wise with the total NIH research support. So ARPA-H presents an opportunity to also invest in a future diverse group of researchers who would carry on NIH and ARPA-H's missions. In closing, thank you so much for this terrific opportunity to be among this distinguished group and provide brief remarks on behalf of AGA and the GI profession. FRANCIS COLLINS: Thank you very much, Dr. Omary, and for staying tightly within the four minutes. That was a good start of what I know is a challenging effort for people to try to say what they want to say in such a limited time frame. But next, we are going to hear from Melissa West, who is senior director of strategic relations and patient engagement at the American Society of Nephrology. BISHR OMARY: You might be on mute. FRANCIS COLLINS: Unfortunately, you're muted. [LAUGHS] MELISSA WEST: [LAUGHS] Thank you, Dr. Collins. The American Society of Nephrology is enthusiastic about ARPA-H's potential, as Dr. Rodgers mentioned, to complement efforts to bring new therapies to the 37 million Americans living with kidney diseases. Having a disproportionate impact on Black, Latinx, Asian, and Indigenous Americans, kidney diseases are costly to the public and associated with the highest risk of severe outcomes of COVID-19. Therapeutic options remain limited. Of the 100,000 Americans who start dialysis every year, more than 50% of them die within five years. Through federal partnerships, such as the Nephrologists Transforming Dialysis Safety, the Kidney Health Initiative, and KidneyX, ASN leads collaborations among patients, clinicians, researchers, industry, payers, regulators, and the private markets to promote kidney health and expand patient choice. ARPA-H could complement this growing ecosystem of patient-centered innovation, building on NIDDK's program, such as the Kidney Precision Medicine Project, to develop targeted molecular therapies for kidney diseases. There are many opportunities to accelerate innovation for people with kidney diseases. 1 in 3 Americans have some form of kidney disease, but 90% do not realize it until their disease has advanced to kidney failure with irreversible damage. Targeted kidney ARPA-H projects, as well as integration with other areas such as diabetes and cancers, could have a significant impact. Protecting kidney health should be integrated and prioritized within ARPA-H, especially with a nimble, flexible, risk-tolerant funding mechanism. I'm pleased to see so many of my kidney colleagues have joined this listening session. ASN welcomes further details about ARPA-H and looks forward to working with the administration, Congress, and the kidney community to accelerate innovation and promote kidney health. Dr. Collins, thank you again for the opportunity to participate in this listening session. FRANCIS COLLINS: Well, thank you very much, on behalf of my daughter who's a nephrologist, for everything you're doing for kidney disease. So now we're moving from nephrology to endocrinology. Dr. Carol Wysham, who is president of the Endocrine Society. Dr. Wysham. CAROL WYSHAM: Thank you. I am an endocrinologist at Rockwood MultiCare Health Systems in Spokane, Washington and clinical professor of medicine at the University of Washington. And as president of the Endocrine Society, I want to thank you for the opportunity to discuss the ARPA-H proposal. As you know, endocrinology is an all-encompassing discipline that has impact on and influences the health of all of our organ systems and in the development of many of the chronic diseases that afflict our citizens. The Endocrine Society is the world's oldest, largest, and most active organization of scientists and health care professionals dedicated to research on hormones and the clinical treatment of patients with endocrine-related diseases. Our field of medicine and research crosses boundaries and addresses many of the priorities important to the NIH. As a clinician, with relevance to the institutes here today, I work with our members and our patients in the front lines of the complex diabetes public health crisis. I also conduct clinical research in preventing and managing cardiovascular disease in people with diabetes. However, the Endocrine Society members also study the critical role of hormonal systems in reproductive biology, human development, amongst many other disciplines. We enthusiastically welcome the new use-driven approaches to drive transformational innovation that improves health, and we appreciate your early engagement with us as ARPA-H takes shape. Obviously, diabetes is an excellent example of a disease that's ripe for prioritization by ARPA-H. NIDDK-funded research has allowed the delivery of new products and solutions that allow real-time measurement of glucose and other parameters, and they are revolutionizing the treatment of diabetes. However, fully implementing these and related technologies into patient care is going to require funding outside of the scope of typical NIH grants. We can envision projects funded by ARPA-H that bring together scientists, engineers, the FDA, and industry. One of these things that could be developed is more accurate wearable devices that measure additional measures. We could also engage computer scientists to improve the mathematical equations driving the performance in patient outcomes and the electronic security of these increasing complex ecosystem of disease management devices. The benefits of technologies would not be exclusive to diabetes, but could also be applied to other conditions, such as frailty, infertility, lung and cardiovascular disease, where wearable technology can help us understand how lifestyle factors and integrated hormonal systems could be linked to improve outcomes in these high-risk patients. They could also be used to create platforms to study biology in new and more important ways to improve our biological understanding of transitions that are driven by hormones, such as puberty and menopause. And therefore, we could increase our understanding of these mechanisms that drive the complex changes in our life cycle. Crucially, these types of projects complement and build upon the work by the NIH and should not compete with investigator-initiated research that will remain necessary for discovery of new opportunities and to improve our overall understanding of human biology. We expect that the solutions advanced by ARPA-H will be technologically advanced. And perhaps unlike security solutions funded by DARPA, ARPA-H will need to ensure that health care systems are equitably delivered across communities and demographics. The selection of projects must reflect scientific and community needs, and the project managers and partners will need to include diverse voices across the depth and breadth of projects. And to maximize the benefit of society, projects should include populations typically underrepresented in clinical research, including women, pediatric, pregnant and lactating patients, and, importantly, underrepresented populations. Thank you for involving us in this important session, and I look forward to hearing from the other stakeholders. FRANCIS COLLINS: Thank you very much. I'm glad you mentioned health equity. That is something which is going to be absolutely fundamentally written into everything that ARPA-H strives to do. So I appreciate you raising that point. Next, we go to Dr. James Graham, who is a professor at Colorado State University representing the American Congress of Rehabilitation Medicine. JAMES GRAHAM: Thank you. Yes, and as I was trying to think about how to represent the ACRM and the larger disability and rehabilitation field, I jotted down four ideas, four thought fragments, really, to try to get in here. And I'll start with reminding us of the obvious, and that is that individuals with disabilities experience extraordinary health disparities in terms of both access and outcomes. Further, they often share other marginalized identities, including lower SES, lower education and employment rates, and racial and ethnic minority status, all of which are associated with poor health outcomes. And I was pleased to see, Dr. Collins, that you and your colleagues did list disability in the equity discussion in your recent Science article when you were introducing the ARPA-H. However, I will point out that that attention has largely been missing from prior NIH and other federal agency language and priorities when related to diversity, equity, and inclusion. So I just encourage you to maintain that disability status as an explicit demographic in the ARPA-H priorities. And I also urge the ARPA-H architects to take advantage of the collective intellect in existing rehabilitation networks, both within federal funding agencies and in the trenches. For example, the Interagency Committee on Disability Research needs to be included. The ICDR is already charged with promoting coordination and collaboration among federal departments and agencies that fund or administer disability, independent living, and rehabilitation research. And thus, there is inherent representation, not just from across NIH, but you have the National Science Foundation. You've got the National Institute on Disability, Independent Living, and Rehabilitation Research. You've got the Department of Defense, the Veterans Administration, Health and Human Services, Indian Health Services. All these are already at the table and are a great resource for, again, expanding the scope of this program. Another example is the Disability and Rehabilitation Research Coalition, which is a coordinating body for a group of more than 20 national professional and scientific organizations committed to improving the science of disability, independent living, and rehabilitation. Among these are the ACRN, which I'm representing today, the American Physical Therapy Association, the American Occupational Therapy Association, the Brain Injury Association of America, the Association of Academic Physiatrists. And each of these have tens of thousands of members that they're representing, so dissemination is magnified exponentially with a single communication or a single point of contact. Similarly, when you get input from the DRRC, for example, you can be assured that it represents the vetted and shared ideas of countless health researchers and health care providers. And another thing I'd like to point out is doubling down on the data sharing expectations and opportunities for research data that originates from the ARPA-H-funded projects. This will include revisiting the timelines and investing in infrastructure to facilitate the novel and near real-time analysis, which can expedite breakthroughs and confirmatory findings. I truly believe that the efficiency and cost effectiveness of data sharing and secondary analysis are inarguable, and I think they align well with the ARPA-H goals. But I also believe that this has been underutilized in current funding mechanisms. Lastly, I'll just point out that the pandemic has broadened the scope and enhanced efficiencies in ways to engage stakeholders and the public, and this forum today is a great example of that. And so I can't say I'm trendy enough to understand crowdsourcing, but there are people who do understand that. And I think we have the technology, so I think it really is worth considering in this venture, in terms of expanding both the speed and the depth with which we address emerging issues. So I will leave it at that. And I look forward to the discussion. So thank you again for the platform and giving me a few minutes to share my thoughts. And I wish you good luck and godspeed in this. This is great. FRANCIS COLLINS: Thank you very much, Dr. Graham. Now we move to Lindsey Horan, who is the chief advocacy officer for the Society for Women's Health Research. LINDSEY HORAN: Director Collins and esteemed NIH and OSTP colleagues, on behalf of the Society for Women's Health Research and our president and CEO, Kathryn Schubert, thank you for the opportunity to comment on the ARPA-H proposal. SWHR's mission is to promote research on biological sex differences and to improve women's health through science, policy, and education. We appreciate the opportunity to explore new approaches to research and look forward to seeing the promise of this transformational new research realized. The establishment of ARPA-H presents myriad opportunities for scientific advancement and for ensuring equity in health outcomes and health care access and use. As NIH, OSTP, and other stakeholders endeavor to build ARPA-H, SWHR offers the following for consideration. We believe that ARPA-H has the potential to benefit areas of health and disease that have not historically received robust funding, including many conditions unique to or more common in women. We applaud NIH's vast research portfolio and its implementation of its Sex as a Biological Variable, or SABV, policy. However, significant gaps remain in our understanding of health conditions both specific to women or that disproportionately or differently affect women. According to a July 2021 article in the Journal of Women's Health, a disproportionate share of NIH resources is applied to diseases that affect primarily men. ARPA-H presents an opportunity to adopt, implement, and build on the NIH's policies on SABV and to prioritize use-driven research related to women's health. Given the current research and knowledge gaps, and in rising public health crises where women are the focal point, such as uterine fibroids, maternal mortality, and Alzheimer's disease, more must be done to prioritize women's health. The NIH's institute and center model, while driving important discoveries that are protecting and improving the health of the nation, tend to provide greater benefits for high visibility diseases and conditions. To capitalize on ARPA-H's potential as a hub for generating bold advances in medicine and health, it should incorporate a life span approach that is complementary and additive to NIH research. Beyond the scientific and research opportunities in women's health, we would also propose some logistical considerations to help ensure ARPA-H's long-term success. First, ARPA-H should prioritize diversity, including more women, historically underrepresented populations, disability status and other diverse populations, both in the institution's leadership and among grant recipients. NIH and OSTP should work directly with organizations at the community, public health, and academic levels who can disseminate information to their respective networks. Additionally, SWHR encourages offering trainings for researchers, including training on the intellectual property and commercialization process, legal and paperwork processes, and, more specifically, on incorporating and conducting data analysis on SABV and clinically relevant research studies. This training will help ensure both that the researchers develop science in an intentional, inclusive way and that research can be scaled up and impactful. Finally, SWHR encourages NIH and OSTP to consider how to best leverage the knowledge and expertise within NIH and how to most effectively and efficiently collaborate with other key agencies and stakeholders. The NICHD, in particular, uses a research network model for pregnancy and women's health that can be built on or leveraged to improve and explore women's health across the lifespan. Other models to explore include incubators or convenings that allow researchers to build networks, enlist mentors, and share information across disciplines and sectors. Director Collins, thank you again for involving us in this important session and for your consideration of our recommendations. We look forward to continuing the discussion. FRANCIS COLLINS: Thank you very much. Appreciate those comments. Next, we go to Dr. Michael Cabana, who is chair of the Committee on Pediatric Research and senior director for the American Academy of Pediatrics. Dr. Cabana. MICHAEL CABANA: Thanks. I am a general pediatrician and a researcher. I also serve as physician in chief for the Children's Hospital at Montefiore, as well as the Albert Einstein College of Medicine in the Bronx. I'm also chair of the Committee on Pediatric Research for the American Academy of Pediatrics, who I'm representing here today. I want to start by thanking the NIH for the chance to comment on ARPA-H. It's a very exciting project and an important opportunity to share the thoughts of the pediatric research community on this proposal. Of the initial examples suggested-- or conditions that ARPA-H could affect that were shared by the administration, asthma and cancer are both diseases that could greatly benefit from expanded pediatric research. Innovative asthma and cancer therapies tested specifically for children could reduce the harm caused by these diseases during childhood. But there's also tremendous opportunity to advance pediatric health by advancing prevention. At its core, pediatrics is about prevention. Many of the costly diseases of adulthood have their origins in childhood. And therefore, pediatricians try to give children their best shot at a healthy adulthood by preventing conditions like obesity and mental health issues. But we are in need of more research to better understand how we can impact these diseases early to prevent their long-term outcomes. We would therefore urge ARPA-H make child health a major research priority. The big issue is to consider your perspective and your time frame for ARPA-H. Advances in pediatric medicine can have important near-term benefits for children, but most often, their most important effects are in the longer term. For a number of reasons, medical care for children is, on average, inexpensive compared to that for adults, so there's less opportunity to reduce near-term medical costs through pediatric research. Addressing the childhood antecedents of adult disease, however, can address the benefits well into the future and pay dividends throughout the lifespan. The value, then, of pediatric research is really only fully recognized when the return on investment is considered over the long term. Pediatric research is undervalued if research decisions are made on the basis of current disease burden. Therefore, on behalf of the pediatric research community and the children of the United States, two suggestions. Number one, we would urge that ARPA-H ensure research decisions be made by considering both the short-term and the long-term benefits of potential research. And number two, we'd caution ARPA-H against overly prioritizing projects based on their potential to be commercially successful, as this could potentially lead to a deprioritization of projects relevant to children. Because children need tend to be healthy, there's less of a need for therapeutics. There's also fewer children than adults, so the market is smaller, and advances in prevention don't often result in commercially viable products. Thank you for the opportunity to speak to you about ARPA-H, and we look forward to continued partnership to advance child health. FRANCIS COLLINS: Thanks much, Dr. Cabana. Now, Dr. Catherine Collings, who's president of the American College of Lifestyle Medicine. Dr. Collings. I'm not sure I'm seeing Dr. Collings. Well, OK. Maybe we've had a loss of connection. We'll go on and see if that person returns. So that means we can now jump to Dr. Brian Berman, who is president of the Institute for Integrative Health. BRIAN BERMAN: Thank you, Dr. Collins. I'm honored to be participating today. I commend you on the vision for ARPA-H. It promises to be a very timely and impactful initiative, and the Institute for Integrative Health is very enthusiastic about this proposed entity. I'm also professor emeritus of Family and Community Medicine at the University of Maryland School of Medicine. Over the past 30 years, I have been an NIH-funded principal investigator under a number of clinical trials and five research centers of excellence focused on the treatment of complex, multifaceted, chronic diseases, particularly pain-related disorders. While this work remains essential, it has also felt like putting a finger in the proverbial dam. The upstream drivers of the crisis of noncommunicable chronic diseases remain at the sidelines of solutions-oriented discourse, and thus are not fully comprehended and addressed. The COVID-19 pandemic has illuminated the inadequacy of our current disease-centric approach to health care. Of course, the incredible biomedical advances, like the development and approval of a vaccine in less than a year, should be heralded. However, if we look at the grand, interconnected challenges of our times-- the unequal burden of disease, poor nutritional quality of the food system, racial, social, and economic injustice, some of which played a role in pandemic severity and mortality-- we see the urgency for taking a more upstream and integrative approach that will ultimately promote well-being and flourishing. The challenges can seem daunting. However, ARPA-H provides a golden opportunity to think creatively, dispense with fragmented, siloed approaches, and foster an interdisciplinary, integrated approach that helps us better understand the interwoven connections that impact health at the scales of people, places, and planet. With this background, there are areas at the Institute for Integrative Health that I run is involved with or interested in that I think could help advance ARPA-H's goals. First, prioritizing projects that study the person in the context of their total lived experience over time. Advances in omics technologies have allowed us to begin to comprehend the health implications of the biologically relevant microbial ecosystems on and within each of us. These are some of the building blocks of precision medicine. Now is the time to examine the environmental, psychological, social, and economic factors and fully explore their integrated impact on the biophysiology, and thus the health or "dis-ease" of individuals and communities. Over time, this work will likely have broader impact for flourishing of whole societies. Diabetes provides an example. The effects of pharmaceuticals may be modified by the individual's unique microbiome. The microbiome is, in turn, influenced by numerous environmental factors-- limited access to healthy foods, exercise, and clean air in an urban food desert with high crime, no green space, and air high in particulate matter. Studies of the exposome, in other words, will enhance the quest for personalized precision medicine and ensure equity in health care and health outcomes for all people, also giving greater emphasis and access to the positive protective factors that buffer adversity. My second suggestion is the creation of a responsive integrative health observatory. This would provide infrastructure and be a living laboratory that leverages advances in technology and data science to illuminate connections between factors at many scales and levels, from genome to geography. Through interdisciplinary partnerships and cross-sectoral collaboration, including schools, environmental monitors, connected devices, apps, health facilities, and businesses, data on social determinants of health, disease, and risk behaviors can be fed into the observatory, analyzed, and synthesized. And observing could thus monitor health, well-being, and disease trends, highlight areas of action, advise on methods for health inequality impact assessment, and address sticky, multiscale problems. Ultimately, the observatory can inform policy and provide accessible, timely, and relevant information to multiple users. Thank you very much. I look forward to the development of ARPA-H. FRANCIS COLLINS: Thanks, Dr. Berman. I think Dr. Collings was not able to join us, so I'm going to keep going to our final presenter of stakeholders here. This is Dr. Ben Kligler, who is the executive director in the Office of Patient Centered Care and Cultural Transformation at the Veterans Affairs. BENJAMIN KLIGLER: Thank you, Dr. Collins. And I assume that means I get eight minutes, so I'll just go ahead. FRANCIS COLLINS: [LAUGHS] No, no. Nice try. The bell will still go off. BENJAMIN KLIGLER: All right. Got it. Well, thank you for having me today. And I am actually really excited that I get to go last in this really interesting assortment of opinions on this, and particularly that I get to follow Dr. Berman. I wanted to just say two words about what we're doing at the VA and how it pertains to, I think, one of the greatest potentials of ARPA-H, which is the last subject Dr. Berman mentioned, as far as integrating inputs around health. So whole health is what my office is charged with pursuing at the VA. Whole health is an approach to care that looks to go beyond the disease-oriented model and really look at what's most important to the individual and how we can support them in moving towards that in their life. So the key principles of whole health are that it has to integrate everything that goes into a person's health and well-being, including structural determinants of health and health equity, as well as measure things that are potentially important beyond just disease-oriented outcomes. And we've been working closely with NCCIH, for example, on the notion of how do you measure things like well-being, and how do we measure that in the context of clinical care and routine practice. So what I think is so exciting about this opportunity with ARPA-H is that the idea of bringing artificial intelligence, machine learning, really advanced technological solutions to the challenge of understanding the complexity of the systems that go into making people well or not well I think is really, I mean, obviously, an extremely daunting challenge. And in some measure, we have not tackled it. And as one of the previous presenters said, I think the disease-oriented structure in which our research tends to be funded, although it's wonderful for furthering disease-oriented treatments, it doesn't really tackle this question of how do we understand how the whole person becomes more healthy, and how do we incorporate the concept of self-management and self-care. Because as we know, and as Brian was emphasizing, a huge proportion of what makes someone healthy or not healthy, what advances well-being, is not the interaction with the health care system, it isn't the new treatments that we have for our diseases, but it's the things that are happening in their environment-- social, environmental, family, spiritual, all these things that go into really shaping people's health. And we have yet to tackle the question of how do you understand a system that's that complex. And I want to reference back, also, to something Dr. Langevin said about a learning health care system. We can be a learning health care system where the individual has the chance to receive and integrate that information, and we can be a learning health care system on a large level, where we then tailor our implementation of the services we're delivering to really incorporate that into the work. And I want to put forward that if ARPA-H does move into that area and tackle some of those issues of understanding and measuring that kind of complexity that VA already has implemented, or is implementing a health care delivery system, that ultimately will become a perfect place to test that and how it actually applies in practice to a given individual or set of individuals. So thank you for having me. I'm really excited to see what comes out of this initiative. Thank you. FRANCIS COLLINS: Thanks very much. And thanks to all of our stakeholder presentations. Those were very thoughtful and covered a lot of territory. Let me just say, because in some early presentations about ARPA-H, there was some suggestion that the focus was going to be on cancer, diabetes, and Alzheimer's disease. That was intended to be examples of the opportunities, but not at all a limiting list. And so I think basically all of the things you all are talking about, including prevention, everything from molecules to society, is potentially on the table. But it has to be formed in such a way that it fits this use-driven concept and also fits a niche that ARPA-H aims to try to inhabit that is not otherwise being taken care of. You don't want to have ARPA-H step in and start competing with things that are already being addressed. So all of that just to reassure everybody. The landscape of opportunity here is intended to be quite broad, indeed. So we can now go to Q&A. We've got about 20 minutes to discuss the questions that are being proposed by the over 200 participants who I see have been listening to the presentation so far. And Dr. Schwetz and I will attempt to try to serve as moderators in this setting. And so pulling up the Q&A. First of all, there was, earlier on, a question about how stakeholders can submit comments that maybe don't fit neatly into this Q&A session. Let me just say, ARPAHcomments-- that's all one word with no spaces or periods-- ARPAHcomments@nih.gov is an email where you can send comments if you have things you want to say that didn't fit conveniently into today's discussion. We are monitoring that and paying a lot of attention to what stakeholders are sending to us. ARPAHcomments@nih.gov. So maybe, Tara, do you want to sort of alternate you and me here, in terms of how we tackle this? TARA SCHWETZ: Sure. FRANCIS COLLINS: I see seven questions, and we can probably get through most of those in the next 20 minutes, and maybe others will appear. So first question is, existing research funding can often concentrate around high visibility diseases at the expense of others. And the writer is concerned about women's health and research on sexual health, postmenopausal health underfunded, and certain cancers, like cervical cancer, underfunded. What is ARPA-H going to do to try to prioritize underfunded research in areas such as this? Well, it sort of fits with the comment I made a minute ago, which is the landscape is very wide here. And certainly, in considering the kinds of projects that ARPA-H might most be likely to take on, you want to identify areas that are opportunities, that are ready for this kind of large-scale, rapidly moving, high-risk, high-reward effort that aren't already happening. And that certainly means neglected areas ought to be particularly of interest. And as was made a point by one of the speakers a little bit ago, you also want to be sure that rare diseases, or diseases they don't have necessarily a great deal of commercial interest, are very much also on ARPA-H's list to be considered. And of course, all of this is going to come down to a lot of input from the public, a director who's going to have ultimate authority to decide what projects to start, and all of these program managers that are going to be brought in, perhaps as many as a hundred of them in the first year, who will be passionate about identifying the projects that are most likely to give exciting results in a reasonable time period. So Tara, over to you. Do you want to tackle the next one? TARA SCHWETZ: Sure. Well, there's a general question that maybe-- FRANCIS COLLINS: Oh, please. Yeah. TARA SCHWETZ: --we start with, because it's an easy one, too, or at least one that is sort of setting the stage. And it's a question about where ARPA-H staff will be housed. I assume that that's talking about organizationally [LAUGHS] and not physically, but maybe we can comment on both a little bit here. Is that one that you want to take, or you want me to take that one? FRANCIS COLLINS: No. Take it, Tara. You've been spending a lot of time thinking about these things. TARA SCHWETZ: Sure. So what was included in the president's budget request for FY22 is that ARPA-H be housed within NIH. And I think you've heard today, and probably through other fora, the importance of having tight connections and coupling with NIH. There's a tremendous amount of expertise and knowledge and experience, and infrastructure, too, that exists within NIH. And we think that it will be really important to leverage that as we're developing this new agency. It also will, in kind of a practical way, give us a leg up because we don't have to create some of the existing infrastructure from scratch. So that's sort of the general gist of where we think it will go. And in terms of organizationally where it will be located within NIH, I think that it will be important to have this be a distinct organization with NIH with a lot of autonomy and independence, of course keeping the connections and the collaborations as appropriate. But that distinction will be important. And terminology aside, I don't know if we've quite settled on what we're going to call it, but I think the important points I just indicated. And then the question about if this was also talking about where it will physically be located, I think that that is still an open discussion. Obviously, there's a lot of pros for keeping it within the DC area, just because of the robust environment that is here. But there are potential opportunities elsewhere that may be worth being considered. FRANCIS COLLINS: So as long as you have the floor, the same questioner, Elliot Levine, is also asking how soon might solicitations go out. And maybe, Tara, you could explain. This is not the typical, OK, we're going to put out an RFA, and people are going to write their R01s, and a year later we might fund something. That's not the plan here. This is a totally different ballgame, for rapid-fire solicitation of interest. And NIH, in the form of ARPA-H, able to actually go out and find partners who might never contemplate writing a grant. So can you say a little bit more? How is this going to work? TARA SCHWETZ: Yeah. And that last point is really crucial in thinking about how we can attract and partner with entities and organizations and researchers that traditionally may be not engaged or as actively engaged in biomedical research. So if you just think about this idea of convergence, about bringing in the physicists and the mathematicians and all these other folks that can bring a novel perspective to solving problems that we have in the biomedical research space. But in terms of the kind of process for putting out an award, the idea would be that there would be a solicitation that would go out. A program manager would develop an idea for a program. They would pitch that program to the ARPA-H director and get approval very rapidly on whether or not the program can move forward. And very quickly, they would put out a solicitation for applications. And we likely will include some component of-- think about a concept letter or an abstract that could be approved, that just very quickly says, yes, this is the type of idea we're interested in, or no, this isn't really a good fit for the proposal. And then larger applications would be received. And so once that would happen, there would be a very robust review process. It would be a peer review, but that's different from the NIH peer-review process. FRANCIS COLLINS: Very different. TARA SCHWETZ: It would be internally driven by experts across the entire federal government. And then a decision would be made to either support or not support a specific project. And there would be-- the approach that DARPA takes, and it's one that we're considering for ARPA-H, is there's no ranking of applications. It's just, this is supportable. It meets all of the criteria that are put forth in the announcement. And this is not supportable because it doesn't mesh with what we had put out in the announcement. And then the program manager would propose a portfolio of projects to the ARPA-H director, who would give it the thumbs up or thumbs down, and it would move forward. And this would be a very rapid process that could occur in a matter of months and move forward. So we're optimistic, especially if we receive resources in FY22, that we could get awards out in FY22. So before the end of September next year. FRANCIS COLLINS: Thanks, Tara. You know, I think it might be helpful, as people are trying to figure out what's the right kind of project for ARPA-H-- again, we are looking a lot at the success of DARPA, which, after all, gave us the internet and GPS and self-driving cars and a few other useful things. And the way in which they have used, over decades, a certain set of questions to help decide whether a project is right or not are very general questions. And it's called the Heilmeier Catechism, based on the ideas put forward by DARPA director George Heilmeier back in the 1970s. So listen to these eight questions. They're very simple, but you ought to be able to answer this if you're proposing a project that would fit this model. First, what are you trying to do? Articulate your objectives using absolutely no jargon. Second, how is it done today, and what are the limits of current practice? Third, what is new in your approach, and why do you think it will be successful? Next, who cares? If you're successful, what difference will it make? Next, what are the risks? Next, how much will it cost? Almost at the end. How long will it take? And last question, what are the midterm and final exams to check for success? Those are basically your milestones. And you want those midterm ones, because if you miss the midterm, well, you flunk the course and the project has to be terminated. And we do expect that if ARPA-H is doing its job properly, there will be a pretty high failure rate. Otherwise, we're not taking the appropriate risks that this kind of entity allows us to. So maybe that's a little bit helpful, just in terms of the way in which projects are going to be sized up. Tara, do you see another question that you think we ought to grab? There's a lot of them now appearing, and they're all excellent, and we won't be able to get through them all. TARA SCHWETZ: Yes. So there was a question about just setting priorities for the organization. And I don't know if you want to talk a little bit about that and how the priority development will be decided upon and managed. FRANCIS COLLINS: Well, it is going to be very much driven by project opportunities. Again, maybe I could be a little bit more clear about the structure of this. So the most important thing that will happen when ARPA-H becomes a reality is to recruit the right director. The director will need to be somebody who is an entrepreneur, who is not afraid of risks, who is a visionary, who has a broad grasp of what's happening in biomedicine, all the way from basic to clinical, who appreciates the broad sense of the things that you all have been talking about that really are integral to any major portfolio of projects. And with the kind of funds that are available, this should be the kind of project mechanism that could support as many as a hundred or more projects. So that kind of vision. Also needs to be somebody who's really good at communicating, getting that vision to excite other people and recruit these hundred or so program managers who are going to come in. The managers will all arrive with their own ideas about what they think is particularly exciting, but they'll have to pitch those to the director. And if the director says go, then that starts the clock of what Tara was talking about in terms of trying to find out who's out there that can do this and then doing a very quick peer review. But keep in mind, the goal is, from start to actually having a project going is not a year. It's more like three months, which means everything is going to have to go really quickly. I do think-- there was a question, also, in here about how is it that we can build upon the fact that stakeholders have lots of interest oftentimes in areas within their own domains. I think a lot of the things that will be most productive for ARPA-H may likely be platforms that have applications not to a single disease but across different disorders, things like what Tara was talking about, if we came up with a zip coding that would allow you to send any drug or any gene therapy to a precise cell in the body. Think about how that would apply to rare diseases, to common diseases, to cancer, and so on. Those kinds of things will be particularly appealing. So I guess if I could, I'd want to appeal to our stakeholders, as you look at ARPA-H, also think about ways that what you're dreaming of can be a shared dream with other stakeholders so that we can make the most of those kinds of synergies. Let's see. There was a question about whether this is going to end up causing delays because of multiple cycles of submissions and rejections. I think ARPA-H aims to blow away those kinds of delay processes in the name of making rapid progress, but also recognizing that sometimes that's going to lead to failures. But we would rather see an exciting project get started and fail early than go through three rounds of revisions and ultimately fail anyway. So I think this is a somewhat different view than what many of you maybe associate with NIH's somewhat more careful, and appropriately so for a lot of the science, approaches to medical research. And having said that, let me just say, there is nothing about what I'm saying or what Tara is saying, what anybody is saying about ARPA-H, that should be seen in any way as a putdown of what NIH's absolutely fundamentally amazingly successful efforts have been over the decades. We want that to flourish. We do not want ARPA-H, if it comes into reality, to in any way detract from the rest of what the 27 institutes and all the rest of the NIH amazing biomedical community has been doing and must continue doing. I just want to be really clear about that. TARA SCHWETZ: And I'll add to that just a little bit, in that the fundamental research that NIH supports will help to really build that foundation that ARPA-H can then leverage and continue. And I think sort of similar parallels exist with DARPA and ARPA-E as well, with NSF and the DOE Office of Science, respectively. So this is a similar approach. This is nothing that I think is brand new. And it has shown to be effective. And the folks at both of those agencies, DARPA and ARPA-E, will tell you that they can't do what they do without the work of their partners who are supporting that really fundamental research. FRANCIS COLLINS: I want to address a question from an anonymous attendee about health disparities. The question-- for communities with health disparities, particularly those in the lower income groups, novel treatments and technologies may not be that helpful. Their main problem is access to even existing treatments and therapies. What will ARPA-H do to address these massive issues in access? Well, that's going to be, as I said a little earlier today, a critical part of everything that ARPA-H aims to do, is to address health equities, or more specifically, health inequities that we all know are quite serious at the present time. In the Science article that a couple people referred to that Tara and Eric Lander and Larry Tabak and I wrote, when we gave examples of things that ARPA-H might do, one that was there, which I'm kind of excited about, but of course it has to pass muster, is to really test the idea of having community health workers as an outreach to circumstances where health disparities are particularly significant. We've seen how that has worked in some communities in small scale, but it's not been particularly organized in a rigorous, research-oriented way. The promotores, for instance, that reach out in Latino communities and I think have been a really interesting and often very successful model for dealing with prevention and also helping to manage chronic illnesses, like diabetes. What if we really were serious about testing that model in a much broader way for health disparities, where you provide to individuals who are in those communities access to people who are like them and know them and can provide the kind of advice about health management that currently just isn't going to be available? And maybe even do so in concert with some new technologies like wearables, which was already brought up by one of our stakeholders today. That seems like a pretty bold thing, but if you did it on a large enough scale that you could assess the outcomes and then see whether it, in fact, reduced long-term illnesses and became, therefore, a benefit both to health and to economics, that might be a way to try to transform the way in which we take care of patients today. So that would be one possible example. There are probably many others. Again, if you haven't seen the Science paper, the last page of it just gives a bunch of ideas, none of which are intended to be at the top of the list when ARPA-H gets started, but they're to kind of get your brain going. And some of you have also offered some others today. And we are really interested in that kind of brainstorming. It's actually a lot of fun to think about what would be a project that would really fit this that's just not possible right now, but with this mechanism could be. TARA SCHWETZ: Yeah. That's one of the most fun and exciting points of this, right? Is to do that sort of imagination exercise, the "what if," the "but for X, Y, and Z, we could accomplish A, B, and C." And so that's where I think we would encourage you all to continue doing those exercises as well. There are a couple questions about collaboration and partnerships, mentioning other fields, industry, and interagency efforts. I don't know if we want to try to tackle that in one question or-- [CHUCKLES] FRANCIS COLLINS: Yeah, maybe just merge it all together. Because I think-- well, you give the answer, but I think I know what I would want to say. Go ahead, Tara. TARA SCHWETZ: All right. I'll start, and you can add. I'm sure I'll forget some element. So starting with the interagency piece, this is really critical to the success of ARPA-H, as all, I think, partnerships are going to be with this organization. And we currently have an interagency working group or committee within the federal government that is thinking about how we as a federal government and a series of agencies can work better together to achieve some common goals and promote the mission of ARPA-H and have these symbiotic relationships. And so we expect to enhance and to continue that moving forward. The other thing is that partnerships with industry are going to be critical, because, I mean, ARPA-H isn't going to be, for instance, manufacturing a drug that might come out of its support. So we will need to partner with those in industry to be able to help set those things up so that they can be then picked up by industry and carried forward to commercialization and beyond. And then in terms of-- and we kind of already touched on it earlier, but in terms of bringing on stakeholders from various fields that are interested in collaborating with ARPA-H, I mean, I think that's where we're going to get some really exciting ideas. You're going to have a physicist who-- I'm biased. I'm a biophysicist. But you know, you're going to have maybe a physicist who will come in and look at a problem and say, hey, actually, we have a very similar problem in astrophysics, and we solved it through this approach, and we can apply that to biology and to human physiology in this really unique way and work with the biomedical researchers to do so. So I think there's really a lot of opportunity there. FRANCIS COLLINS: Well, I see we have reached our deadline here of 75 minutes, and I don't want to take more time than people have already dedicated to this. But really appreciate the excellent questions we've gotten in the Q&A, as well as the wonderful statements from our stakeholders and from our three institute leaders, Dr. Rodgers, Cernich, and Langevin. I think with that, just, again, we will do what we can to try to answer questions that we didn't get to. One more time, if you are looking for a way to pose other questions, it's ARPAHcomments@nih.gov. You're welcome to send those to that email address. And I just want to thank all of you. This has been a very illuminating and helpful discussion for Tara and me and for the institute directors. We want to be sure, as we're shaping what could be the most significant new enterprise at NIH in a long time, that it captures all of the great ideas that can make it even better. So thank you for that, and we'll continue to try to do what we're doing here to stay really closely in touch with all of the stakeholders that have a real commitment, as we do, to trying to make the world a better place through biomedical research. So with that, thank you all very much. And we can, at this point, say have a wonderful Tuesday, and we are adjourned.