Thanks to the speakers and Dr. Kim Sciarretta for really fascinating discussion of the, uh, investors and- and regulatory microcosm involved in developing these new health at home technologies. Our last session today is the government panel. Why is the government investing in health at home technologies? I want to reintroduce several speakers and moderators that you've met today. Dr. Kim Sciarretta is a branch chief here at the Launch Office in the Division of Research,
Innovation and Ventures at BARDA. Then we have Dr. Dana Plud, who is the Deputy Director of the Division of Behavioral and Social Research at the National Institute on Aging, National Institutes of Health. And of course we have Dr. Anne Bailey with us, who's the Director of the Clinical Tech
Innovation and Office of Healthcare Innovation and Learning at the Department of Veterans Affairs. So, considering that today's, summit is a really public outreach summit, we thought that the audience might be interested in learning why these various government agencies and government entities are so interested in health at home technologies. So rather than going through a list of our various funding announcements, we wanted to paint a different picture, a picture of why the government considers these tools so important for research and development. To begin that discussion, I'll ask here Kim Sciarretta to give us her view and BARDA's view towards health at home technologies and specifically what the DRIVE, the Division of Research, Innovation, and Ventures is doing. Thank you Šeila. BARDA's mission really is to respond to public health emergencies, so we're taking the perspective, when we think of these health at home technologies, we think of the patient.
The majority of patients are not going to see care in a hospital for the majority of diseases that we face, or common colds that we face. Most individuals will have a mild illness that can be cared for at home, although we may not know how sick they may become, or what their risk is. And then that's really important to think about for preparing for. the future potential series outcomes of those patients. But early intervention with these patients could really reduce those severe outcomes, reduce that hospital burden, the surges we saw early in COVID-19. And so there's this desire to think about the patients earlier in that care journey and how we can mitigate those outcomes and how we can overall respond to a public health emergency in terms of wanting to reduce the morbidity and mortality and economic burden of that disease, or the emergency that we're facing.
We're doing all that by thinking about technologies in that earlier space at the home. We're seeing a shift in patients wanting to seek that care, not going to hospitals, rural hospitals closing, patients not having primary care providers anymore And they want to be more in control of their care, they want to seek their care where they want to and when they want to, not on their healthcare provider's schedule, on their schedule. Because of that we are interested in DRIVe in developing technologies that can match that patient with what they're looking for and also help them and help in the time of emergency. So we have a couple programs that I'll highlight and you can find out more about these on our drive website, DRIVe.hhs.gov.
One is actually Dr. Selimović's program, DRIVe's Lab at Home program, and this program actually seeks to develop CLIA waivable tests that have performance and quality comparable to that of a central lab. So what you would get if you went to a hospital or clinic to get your blood drawn, can we replicate that in the at home setting to aid in clinical decision making? Then my Launch Office has a program called Host-Based Diagnostics, and this is really to harness our own bodies' response to infection to inform on our own infection risk, our trajectory of infection, if we're going to deteriorate, if we need to seek that escalated care. And then lastly we have a program called Digital Medical Countermeasures, or MCM program, and this is also Dr. Selimović's program. The goal of this is to leverage this power of digital health tools that are coming online to empower individuals. So not just the patient, but also providers and other stakeholders and being able to rapidly respond to health security threats.
And so these can be risk assessment tools or diagnostic tools that can aid in that decision making as well. Thanks. We're back to you.
Thank you. And just to put it in context for people on the call who may not be familiar with BARDA's mission, our mission here is to develop medical countermeasures. So vaccines, therapeutics, medical devices, diagnostics, etcetera, against things like chemical, biological, radiological and nuclear threats. And so we're charged with essentially developing tools that help keep people safe in those events.
And obviously COVID-19 was was an example where we had a lot to do and we were able to contribute to people's health. That's a somewhat specialized mission, but you can clearly see, as Dr. Sciarretta here described, that we have a really important interest in the health at home technologies that can be used in general for for human health monitoring, in any case, but also have very specific role to play in our much more narrow mission. Dana, would you tell us a little bit about the views of the National Institutes of Aging? Sure.
Thanks, Šeila. We featured in our session this morning three companies that we provided seed funding to support. And it's not just NIA, the Small Business Program cuts across all of NIH. And NIH's tagline is "turning discovery into health," and obviously NIH funds tons of basic research at all different levels, going from molecular up to societal, and in my division, the National Institute on Aging, Behavioral and Social Research, we fund researchers that investigate mechanisms of change at the individual level through population level, demography, epidemiological, kind of work, and so our interest in the digital technologies space centers and part on the idea that technology we think gives us potential for scaling up some of the interventions that are found to be effective in small laboratory type studies, but which for whatever reason can't seem to get traction for scaling up to widespread usage.
Technology gives us an opportunity to explore whether some of these interventions, some of which you heard about today, can actually be done at scale and in the home. I'm emphasizing right now our contribution in the small business space because the Small Business Program was actually instituted 3 decades ago by Congress and it calls for a certain percentage of our budget to be set aside to support research and development by small businesses, which are defined as companies with fewer than 500 employees. And these companies have difficulty - they don't have the research and development divisions that the large companies do. And it's a way of us being able to provide seed funding to developthese ideas, and for these companies to get traction and investors supporting their work once it's gone past that initial seed stage. The NIH Office of Small Business Research was actually rebranded, and it's now called SEED, S-E-E-D, which is "Small Business Education and Entrepreneurial Development Program." So if you wanted information about what sorts of resources are available to support small businesses, you could dial up the SEED program at NIH and you'll find out about it there.
Each of our institutes has a small business program that supports these kinds of initiatives.Two of the talks from the session earlier this morning on the patient and caregiver perspective were projects that have been supported by NIA, and then another project was supported by another one of the Institutes, General Medical Sciences if I remember correctly, our interest is really trying to promote technologies that will help folks, in our case aging in place. But more broadly the theme of the Summit is to try to have more healthcare in the home, and in the context of aging, the aging in place idea you heard several times today. I think that's where our interests lie, in terms of trying to facilitate the development of technology that can accomplish that end, and also alleviate the burden on caregivers in those situations. So in a nutshell, I would say that summarizes it, and I have lists of funding announcements which you've said we're not supposed to talk about, so... No, no, no.
You can! Thank you, Dana. Is it fair to say, then, that some of these technologies might have the promise to actually delay people from having to move to a nursing home, and the longer they can stay safe and protected in their own home with their own health care providers- Yes. Absolutely.
And actually that's one of our goals is to support that kind of work that allows people to age, but age healthfully. It's one thing to increase lifespan. But we're about increasing health span. So what you want is a safe environment that people can live in and continue to thrive within, but not be a burden to the people that are responsible for caring for them. Not only a burden, but there was a nice example given earlier today about how having certain kinds of systems in one's home as an older adult alleviates anxiety on the part of children who can't be taking care of their parents but from a distance keep track of what's going on. I think all of these things can help delay those kinds of moves whether it's to a nursing facility or skilled care.
Yes, thank you Dana. And so, Anne, you represent the Department of Veteran's Affairs, so very specific part of our population. Can you talk a little about that population's specific interest in some of these technologies? Sure, I'll talk a little bit about our office, and then some of the things we're doing that are in specific focuses.
I think one of the things that's unique about VA is that we do represent the end user, the healthcare system that can actually test and pilot and scale, some of these things, the largest integrated health care systems serving one million veterans and a swarm of staff. And then in the pandemic we had the infrastructure to shift to that strong telehealth, telemedicine, remote monitoring, that type of thing. But certainly our place is where we were also recognize additional opportunities - we talked about that some earlier in the provider perspective.
Our Office of Healthcare Innovation and Learning has three areas of focus, one of those being the staff and veteran approach - human-centered design, understanding the problem, really diving into supporting the field, and that is the VHA Innovation Ecosystem, so how do we think differently about how we do things, and then once we identify opportunities - are there ways that we need to provide stimulation and education and training, evaluation to put things into practice and that's our SimLEARN program. And then also long term, we know that we have stakeholders. People talk about how "it takes an act of Congress" to do something; well for us it sometimes literally does. And so we have to think about our stakeholders both in the field and all the way up to the top of the federal government and leadership.
One of the programs we have focused on that in is our Center for Care and Payment Innovation. That's really thinking about transformational business and care models and care pathways, and certainly health at home fits into each of those programs. We want to make sure that the end user - the veteran - and that the clinician understand or recognize the problem and understand the problem and are able to articulate that so that we can innovate around what the actual problem is. I love what you're saying, Kim, about expanding the footprint of the healthcare system right into the home, augmenting our clinicians; we've talked about that. It's what patients - it's what people, not even as patients - and it's what we've all come to expect in our own personal lives. We touch a button and we get what we need and we know where it is in the process of coming to us or where we are given push notifications to remind us to try a new restaurant or all these different things that have become a part of our daily life.
It makes a lot of sense. Thank you. And question for for Dana and you, do you think that there might be some overlaps in your two constituencies? For example, individuals with mobility difficulties, maybe amputees as well as somebody who might be elderly.
Is there a potential to utilize or codevelop some of the same technologies? I will say yes. So that's one of the things that we are really interested in, is recognizing that. I totally agree with that and we support a lot of research on mobility and the environment and its impact on people in terms of the their living space and how it affects them personally and socially. And there's a growing concern about social isolation and older age that again I think provides an opportunity for a technological solution. Well, maybe not a total solution but there's at least an opportunity for exploring whether keeping in touch remotely can help alleviate some of the loneliness and social isolation that's often experienced by older adults. Mobility limitations are huge; part of my own portfolio has to do with aging and driving, and part of aging and driving is figuring out when not to drive and when to cease driving, and for sure, having other options for mobility.
besides one's personal vehicle is important in making and informing those kind of decisions. So I think there's plenty of opportunity to compare notes about what seems to be working and how we might partner up to explore some of these kinds of opportunities for examining technological and other solutions to those kind of challenges. Thank you.
Taking that concept of shared needs or common needs among different constituencies, I wanted to ask Kim here a question about offering solutions for involving different types of demographics in clinical trials. The idea of decentralized clinical trials, can you talk a little bit about how that could help with various needs for different population groups and what role BARDA and DRIVe are playing there? Sure. As Dr. Selimović mentioned, our agency was highly involved in COVID-19 and remains involved, and DRIVe ran a program called Rapidly Deployable Capabilities where we were trying to take technologies that existed today or were in late stage development and put them out in an environment that we would hope would support care of patients that needed it. And this was mainly in these nontraditional settings.
So before they went to the hospital, I'm hoping that we could inform on their risk of infection or their health if they were deteriorating and needed escalated care. The challenge is when conducting clinical research in that kind of setting - in a setting where that type of technology would be utilized, and that would be the at-home type of environment, traditional CRO's are not adept at handling that type of environment rapidly and responding to that. And there has been a trend towards trying to become more decentralized, but there are challenges with that. And also, at least during COVID, there was a challenge, that the priority for much of the clinical research being conducted was on the critical medical countermeasures, the vaccines and therapeutics.
And so it was difficult to test some of these more novel technologies like an at-home diagnostic or physiological monitor in the settings that they were meant to be utilized in, as well as collect that longitudinal data that you may need from a patient. For instance, if you're conducting a study on the value of these tools and informing on risk outcomes of a patient, then you're not just engaging with that patient for a single event. You're engaging with that patient through their care journey. And so you need to collect data longitudinally. We've seen, as we were discussing throughout this meeting today, this shift in healthcare practices mainly demanded by COVID, but also by this desire by patients to seek that care, because of the fact that patients have to travel distances to a clinical site or they're hesitant in enrolling in a study because of the time involved, or of those individual events that are needed for patient engagement - versus, as I was stating before, the longitudinal time.
Also there are challenges with special groups even getting to those clinical sites and pediatrics studies, for instance, where you need the care provider or the parent with the children. And if we move these clinical studies closer to the home and then we may be able to be more efficient in how we think about clinical trial design and also be able to assess some of these technologies more rapidly when we need to. And so the desire is that if we start thinking about this, how we're conducting and engaging in decentralized healthcare right now, and that's seeking care at home, going to a community clinic or retail clinic, or a retail pharmacy or using telemedicine, could these types of settings and interactions with the healthcare system be leveraged for clinical trials? And we have an initiative around this decentralized clinical trial that we're currently conducting market research on. But these types of technologies that we discussed today would be critical for the success of that type of model, so we could monitor the patient in these settingsand collect that data To be useful for the clinical trials, if we didn't have these technologies, that would create a gap and this wouldn't really be feasible. But with these technologies and the fact that we're already seeking care in these settings, I really think this positions us for success of launching more decentralized studies. Thank you.
I wanted to just touch on a little bit more on that topic - and I think it's extremely important - you just raised about involvement or inclusion of this decentralized healthcare model. How would you take this further to ensure that we also have insights into real world data beyond the clinical study, beyond the clinical trial? And alternatively, do you see a way for any at home technology to be used to reinvent how clinical studies are done? Or are there novel insights that may be available to researchers by employing those technologies that maybe researchers just haven't been able to get otherwise? I think I touched on some of this, but just to be a little bit more specific, with just telemedicine capabilities right now, we're able to engage with patients on the onset of any sort of concern about infection that can enable early enrollment in this virtual enrollment capability - recruitment and enrollment of patients. And the second piece is, with any clinical study, we don't just want to understand the patient at time zero, it's also some time period down the road, whether it's the benefit of the therapeutic or breakthrough infections occurring from a vaccine. That requires longitudinal engagement with the patient.
It's difficult for patients, sometimes, to keep coming back to the same clinical site. If we have technologies to provide information on the patient's health status at home, then they wouldn't have to keep traveling back to these sites, so that could be telemedicine versus a wearable physiological monitor just measuring vital signs. There are also technologies that can draw blood at home. I think we're moving in that direction where many of the lab-based requirements that were needed for clinical studies are shifting to the home and that can be leveraged to make these types of studies feasible. So I'm glad you mentioned real #NAME? out a funding opportunity announcement in the Alzheimer's disease and Alzheimer's disease- related dementia space on using real-world data platform to facilitate that kind of work that you were just talking about, and capitalizing on existing databases and forming public- private partnerships in order to have access to data that would otherwise not be available for helping to support those kinds of initiatives, whether it's helping caregivers or people with dementia themselves utilizing these existing data that are there for harvesting, but are just not available currently.
So I think that the idea of accessing real world data is important and it fits right into this idea of promoting health at home, and it also ties in with a talk earlier today on the use of artificial intelligence to put together, and analyze data - the huge amounts of data - to help us better understand the circumstances that influence people living healthfully at home. And there are some resources available through various agencies, but we have something called the A2 Collective which is a set of institutions that focus on artificial intelligence and machine learning, and they have resources for businesses and other to avail themselves of in terms of developing and utilizing AI for promoting health, in a nutshell. So real world data is huge, and I think combined with some of the tools that are coming into existence or already exist, has great potential for answering many of these questions. Thanks.
Thanks Dana - a quick follow-up question of personal interest: are some of these digital solutions that NIA might be supporting, are they are at this point on par with neurological tests, for example, to determine early onset dementia, Alzheimer's, etc.? That's a really good question, and the short answer is no, they're not on par yet, but that's the idea, to see if there may be some signals that that might be picked up on early, that may be indicative of later development of dementia or other kinds of problems. It makes me think of Robert's talk earlier about sepsis detection, and then the algorithms that his company developed, too, to catch this 39 hours before the symptoms emerged and would require an emergency room visit. That is the paralle, only trying to do it months, weeks, years in advance rather than hours. We're supporting a lot of that kind of work.
It's really still in its infancy. And one of the big challenges - and it comes back to the point you were just talking about with regard to diverse populations - is that a lot of the gold standards that exist for determining whether someone has dementia or not are predicated on non- representative samples. The data in those gold standards may not apply to underrepresented populations that didn't have certain experiences. There's a challenge in that space, trying to identify what are the gold standards that should be used now that you're moving away from some from a formal testing laboratory situation into using real-world data that are occurring in everyday life. Really interesting and important. Thank you so much.
And we have time for just one quick question. And so I'll ask Anne here to close up the session with this. We've heard earlier from Jen Goldsack, one example of a tool, I believe, was a smart toothbrush that was tested with a group of veterans - I believe they were diabetes patients. Could you leave us here with one or two other examples of health at home technologies that the VA is currently interested in? Yes, absolutely. One of the things that we're looking at is remote temperature monitoring.
We have been evaluating that for a few years now and are in the process of scaling it and making it more the standard of care to help with monitoring for diabetic foot ulcers, and ultimately prevention of amputation, which is an incredible goal to pursue. When you come into a hospital for veterans and you think that the amputees are related to the combat, they may be, but it also may be related to to diabetic closer. SWe want to pay attention to those kinds of things and remote temperature monitoring is one of the ways that we can do that. Another one that I get really excited about - you guys know this, and I could talk about it for hours and hours - it's virtual reality and the ability to extend the healthcare system into the home, whether it be for at home physical and occupational therapy, or the patient is able to be assigned exercises and then do them side-by-side with an avatar, or have very objective measures that can then be sent back to the provider and then dashboard could be done in real time with the provider picture in picture or looking like they're across the table when actually obviously they're in the click space far away. But also mindfulness, relaxation, pain management, things like that that we know that we can do remotely by providing these devices. So those are some things that we're really excited about.
This is some really exciting important work, really fascinating. I wish we had more time to talk about it, but at last we're at time to conclude this session and this summit. And I really wish to to thank all of the speakers today.
Really fantastic contributions today, especially Dr. Disbrow and Dr. Vega and Dr. Patel for their opening remarks. Thank you so much, everybody in the audience for your interest today and for sticking with us through and for your engagement; we received a lot of inquiries in our resource inbox, which I think is a great indicator of how important this topic is to you.
So we really appreciate that. And last but certainly not least, I wish to thank my organizers who are still here on the panel: Dana Plude from NIA, Kim Sciarretta here from BARDA DRIVe, and Anne Bailey from the VA. This was truly an interagency federal event. And I'm very, very grateful for your agency support. So with that, thank you so much for your attention.
If anybody has any further questions about the event or any of the speakers, feel free to e-mail us again at fed.summit@hhs.gov. And with that, we'll conclude today's meeting. Thank you so much.
2023-05-22