June 21, 2023: Nina Tandon, CEO and Co-Founder at EpiBone joins Bill for the news. What is the background story of EpiBone and its technology? How do stem cells play a role in EpiBone's approach to tissue engineering? Is there a risk of rejection when using a patient's own stem cells for tissue regeneration? What are some applications of EpiBone's technology in clinical trials? How do healthcare entrepreneurs and consumer companies contribute to the development of personalized medicine?
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Today on This Week Health.
recruit a dream team and be really humble and ambitious and really interdisciplinary because like I said, we got this multi-stakeholder environment and your value proposition needs to resonate across the value chain or else you're dead in the water. (Intro) 📍
Welcome to Newsday A this week Health Newsroom Show. My name is Bill Russell. I'm a former C I O for a 16 hospital system and creator of this week health, A set of channels dedicated to keeping health IT staff current and engaged. For five years we've been making podcasts that amplify great thinking to propel healthcare forward.
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(Main) 📍 all right. It is Newsday. And today we have Dr. Nina Tandon, who is joining us. She is the c e o of EpiBone, is that correct? EpiBone.
EpiBone, that's right.
Wow. First of all, I watched your TED talk prior to this.
And I watched the video on the website about this. This is you guys are doing, I, we are gonna get to the news at some point, but we really have to delve into this. By the way, welcome to the show.
Thank you so much for having me.
Well, you've gotta tell me about this technology cuz it's interesting.
I'm watching the TED talk and you're talking about tissue engineering and those kinds of things. And then I imagine the business, the entrepreneur in you said, okay, this is amazing. This is gonna lead to some great breakthroughs, but there has to be a business or a funding mechanism behind this to keep this really moving forward.
So give us a little bit about the story in the background of this.
Yeah, I mean, so I gave my TED talks, I, there were two of them in 2011 and 2012, so it was quite some time ago. And it was around that time that I was a PhD student working in the lab, growing cardiac tissue, which was what I'm an electrical engineer by training, so I was really interested in the electrical signals that are extant in the body and drive things like embryonic development and wound healing.
And so I, gave these talks when I was a TED fellow over a decade ago outlining the promise of our field. And what's really interesting is that in the intervening decade, and I had the chance to give an update at this year's, Ted actually so this very point was that, many Tedsters, which is what Ted attendees are called, Colloquially, many Tedsters as well as folks from my M B A training and every other walk of life, because my friends and family round really did become every single person I know.
We started EpiBone. In 2014, with the help of Tedsters and many others, and in the intervening decade, we've now proven that our technology not only works in the bench and works in animals, but also now works in human because we are the first company green lit by f d a to take stem cells, grow them into tissue, and put those
those tissues into people. We did that for Jawbones in 20, starting in 2021. And we're hopefully within a very short time window between when we expect to be approved as well for cartilage. So we're starting to finally now a decade later. Start to make good on our promise to make the world a better place through replacing parts of our body.
Not with metal, not with plastic, not with parts cut out of ourselves or other people, but out of our own selves, which is kind of our own personal fountain of youth.
Yeah, I it really is. I'm down here in Naples, Florida, and the number of people, oh, the number of times I've heard the word cartilage referred
to, well, you're in Naples, Florida, so I know who some of your neighbors are.
And there's a really big company there that works with cartilage. So I'm sure it happens that those conversations come up.
Well, and when you get to that certain age, I mean, it's amazing how many former runners and that kind of stuff, they're just, they're getting shots to just try to extend.
Before they have to get a replacement, that's essentially, that's right. Car cartilage is gone. I know I'm gonna have to do it. I don't want to do it. I'm gonna extend as long as I possibly can. It it's amazing. So, I mean, it's, stem cell extraction from the individual. So we've gotten past the controversy of embryonic stem cells.
We're actually taking the stem cells out of people we're then we're growing them. Is that, is this the technology That's right
at this point? Yeah. Yeah. So embryonic stem cells exhibit a property called totipotentcy, meaning that they are, they have the potential to become any other type of cell in our body.
We all started that life as one cell big. And that cell divided and divided again, and those cells differentiated and became all the various tissues in our body. Our brain, our heart, our liver, our skin, and so on. And so, our body, our adult bodies maintain a population of stem cells as well.
Those stem cells may not be totipotent, but they might be multi potent, meaning that they have the potential to become various tissues, but not necessarily every type. So, they're quite powerful. They live in our bodies every day, repairing our tissues. And our fat tissue is an important source of stem cells.
Fat gets a bad rep, but a lot of stem cells in there and also our bone marrow. So we can extract those. The thing about cells, and this is one thing that's quite metaphysical in a way, is that cells don't necessarily know if they're living inside a body or outside a body. So we can kind of. Take a cell, take stem cells and grow them in a one of our robots, a cell culture robot that we call a bioreactor.
And we can kind of trick them into thinking they're inside the body and emulate the natural conditions for tissue repair. And lo and behold, those stem cells lay down new matrix, they multiply and we can coax them using these controlled processes to turn into bone, turn into cartilage. And then this is the really cool part.
Put those tissues back into the person and
there you go. Is there a risk of rejection or because it,
if it's your own self? No,
It's your own cells, your own personal fountain of youth. Now this approach doesn't work for every tissue type because like I said, they're only multipotent. They're not totipotent.
So certain tissues, like cardiac tissue, like the heart just are not amenable to this approach. But skeletal tissues like bone, cartilage, or even adipose tissue or soft tissue or ligaments and tendons are amenable to this approach. And so, that's probably why we're seeing so many people.
Take on what I call a spray and pray approach where people are getting stem cell injections and kind of hoping for the best that the cells will just sort of figure out what to do. But we're really taking a very controlled engineering approach to controlling the cells environment so that they will make new tissues that then can serve as skeletal replacements like any other tissue we were born with.
this be the kind of technology that's available let's say at cer, like academic medical centers in your local community? Or will this be more prevalent in in most hospitals? Do you think?
In the future, if we have our way, we will be the future standard of care for everyone. Not just for the privileged view.
So we could walk into a room where there's essentially a bone being grown for different patients at the same time. I'm just picturing this room of little bioreactors, not what bioreactor looks like. Is it the size of
a, it looks like a little shoebox. Picture a shoebox that has a little pump that sort of feeds the bone or cartilage as it's growing.
And we have a 30,000 square foot laboratory here in in Jersey City, New Jersey. And we see ourselves as being the factory, but we can ship those phones anywhere throughout the country. And we've done that already for our clinical trial. We shipped bones to California, to Texas, to, all around the country, Louisiana.
interesting. So they can extract it locally, send that to
yes. Ship the cells. Yeah. Wow. We take two things from the patient, sample of cells and an image. And the image, which is like a CT scan, which is a three-dimensional x-ray. We can extract the 3D data out of that and make a perfectly designed piece of bone that'll fit your skeleton.
And we've had patients in our clinical trial that range from trauma, people who suffered from trauma due to say a car accident or folks who were born with congenital defect and facial asymmetry. For me, it's just a lot of fun. It's where engineering meets design meets medicine.
It's very fulfilling.
Do you enjoy the scientist aspect of it or the entrepreneur business aspect of it, or, yes. Yes, because it's not a, it's not a slam dunk that some, even though this is really interesting it's not a slam dunk that Oh, yeah, there's a business model here and we're gonna be able to make
No, I mean, It's of no, and that's what's fun.
And also the double-edged sword of being first is that everyone says, oh, it's impossible. It's never been done before. And then, And then, we have to go and make the impossible possible. And we were the first, and so far only biotechnology company green lit by f d a to take stem cells, turn those stem cells into tissues and put those tissues back into people.
I hope there will be more companies doing this in the future. But we've really, we saw that we had, we're able to connect those dots. We saw that like, hey, there's not a lot of people that understand how to grow tissues and. Not just how to get it to work in the lab and to get it, but to get it to work in the economy and to get it to work in society.
So I think it's really interdisciplinary when we think about societal change and changing the paradigm for how people are healed. We can't ignore society. When I think back about. And there's so many beautiful historical examples of this, but the, but I guess blood transfusion has only been around for about a hundred years.
Around the time of the telegraph, that era. And there was a lot of societal debate about whether or not, this was okay. Are you transferring someone's soul? Because many people believe that the soul is part of the blood, and and I think some analogous to kind of some of the questions that come up now in terms of who am I?
Am I myself, where are the boundaries of the body, when I die, Does my entire body die, or only parts of my body die? And what does that mean for things like organ donation? I mean, I think as a society we metabolize some of these very deep questions when we have disruptive technologies that come about like this.
I think we're seeing this a lot with AI right now. And I think it's it's, it behooves us as scientists. And as entrepreneurs, and especially as healthcare entrepreneurs to, to try and educate ourselves with The societal impact, positive or potentially negative that could come about from our inventions and to be really proactive about addressing them.
And I loved your question about, if we, I think the subtext to your question was, if we can't afford general medicine, how can we afford personalized medicine? Is this gonna be available for everyone or just a few people? I think implicit in that is a value that you and I think would share if I had to guess that healthcare is something that should be.
Belong to everybody, yeah. And how do we make sure that happens?
Absolutely. I mean, this is so fascinating to me. That you can take. Well, you take a picture, you take you do the extraction, you grow it, you place it back in. The human body to me, is just so amazing that, isn't it? Yeah. It then takes that, but I think of like some of the toys I had as a kid, and I would put that thing there and it would just fall off.
But in this case, you put it there and the body says, Oh no, we've gotta, it just connects it up. Let's integrate it like it's always been there. That's just it's just amazing. Yeah. Before we go to an article, and we may never get to an article based on this conversation, personalized medicine.
So we've been talking about personalized medicine for. Oh gosh. I can't even put a date on it. It's been a long time. Yeah. We've been talking about this. I think ever since, at least since we've mapped the genome, we've been saying, oh, we're gonna have, yeah. Drugs that are very specific to you. And, even though we've done the clinical trials on a large population and we had to turn that drug away because it was only effective on 60% and 40% was not.
So we just, away it goes. The reality was it was effective on 60%. And there's a promise there of getting more granular with that type of approach of, what does this specific individual, because it was interesting. When I was cio I was talking about developing the whole patient profile and I sat down with mm-hmm.
Mm-hmm. some doctors and they're like, do you realize what you're asking? You realize what you're saying. And what I was essentially saying is there's more to medicine than just what happens in the hospital. And they're saying, Hey, there's more to medicine than just what's happening in the hospital, but beyond, it's like the genome and there's things we don't even know yet.
And they were saying to me, the record could get massive on each individual person. And I was just saying, I want to know where they live. Do they live in a food desert? Can we assist them there? And they're like, yeah, there's this whole other side as well. Where are we at in this, do you think we're at, in this journey?
And what might we see over the next couple of years?
Well, it's really interesting in that I think healthcare entrepreneurs are driving some innovation here. But so are a lot of consumer companies consumer companies where you can, spit in a vial and give samples of all kinds and get personalized recommendations for nutrition.
New tropics and even, Consult with physicians about, possible medical interventions around, biomarkers like cholesterol or your weight and so on. And I think it demonstrates a real demand. On the part of consumers a convergence of what technologies like genome mapping and AI in terms of uncovering insights that can be available to providers to then make recommendations.
But it's all on the consumer side. It's not, these are not innovations that are being driven by, IBM or like the IBMs of the world. It's people. It's startups and so I think that kind of personalized medicine from a kind of holistic point of view, I'm seeing that happen.
My husband is really into this and also now gamifying for him. Some of these biomarkers, and I think that's fantastic to give people motivation and real time data to help improve their health outcomes. I think that's just one side of the story. Obviously, I love where I sit in terms of the future of medicine and being able to repair the body using new modalities.
I mean, bone is the most transplanted human material after blood. And as a society, we are replacing millions of joints per year, oftentimes because of just a couple millimeters of damaged cartilage. So the fact that our cells grew our bodies in the first place and repair our bodies every day, and we're replacing whole parts of our bodies because of like tiny pieces of tissue, makes me bananas.
And so I'm glad that, in the future, I think we're gonna be able to repair the body using much more organic approaches. I think we're starting to uncover, COVID made it very clear to people that our immune systems are like, A Reprogrammable computer. And so I'm so excited to see companies like Moderna and others making customized vaccines that are programmable.
The Pfizer vaccine for COVID was only designed over a weekend because the data, our ability to translate between data and antibodies or proteins, the kind of relationship between those various large molecules has been more and more understood in the past two decades since the advent of the Human genome project.
So there are so many examples of how I think medicine is just transforming. And that's even. Ignoring the non-human element. I mean, we have so many non-human cells living in our bodies, and I think we're starting to understand the role of our non-human neighbors in our gut, for example, all those little microbes that are involved in our metabolism that aren't, or in our mood, that aren't even human at all.
So I think this is just such an exciting time for healthcare and the convergence of these. Of technologies coming together, I think will I, of course I'm supposed to be optimistic. I'm an entrepreneur. But I hope that my reality distortion field will help make some of this, help some of this come to pass, you
know as an entrepreneur, if you don't start out optimistic it doesn't, that's what you gonna do, doesn't
Yeah, you're probably gonna be a short seller instead of an entrepreneur, right? Yeah. It's jobs for pessimists.
We'll get back to our show in just a minute as we celebrate our fifth anniversary At this week, health, we've partnered with Alex's Lemonade Stand of Foundation, combating Childhood Cancer. And I've just been floored by the generosity of our community. We set a goal to raise $50,000 this year, I wasn't sure how we were gonna hit it.
And we are already up over $34,000 for the year, and we want to thank you for being a part of that. This June, as you know, we've been doing drives all year, and we're gonna do something a little different in June. We have 2 29 groups where we bring together healthcare leaders, about 10 to 15 of 'em in a round table format.
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Well, let me ask you this. I mean, what's it gonna take? For this technology, your specific technology to be prevalent, to be widely under, widely understood across healthcare, widely available across healthcare, and for it to become the norm in terms of care that we would receive at our local hospital.
Yeah, I think there, if there's gonna be a few innovations that have to happen in tandem we're gonna have to prove that the modality works. Okay. And then, but that is gonna have to happen probably before we figure out how to scalably manufacture these technologies, which will help address the point you brought up earlier around making this affordable for everyone.
So I think bio-manufacturing is a really important. Sister field. And I'm glad that the White House has acknowledged this and actually allocated some real dollars towards addressing this issue because that's not for any one company to solve on their own. Then I think there's a regulatory framework component that comes up because the F D A is wonderful at I think it is the world's envy in terms of helping to keep people safe from medicines
that, that may be dangerous. I think, sometimes they can be they can over correct and make it difficult for innovations to get through. So I would love to see the f D a continue to move in the right direction towards viewing technologies like ours as what they truly are, which is platform technologies.
Right now we can grow the body's 207 bones and 360 joints and the FDA would regulate us as, 270 different products potentially. Oh, wow. So, so I think that's, that type of thinking about a platform type of cure. I would love to see the f D a kind of revise their thinking as other types of platform technologies also start to mature.
And then finally, I think we need to also consider, How our payment systems work. We work in a healthcare system where the key decision makers are the surgeons who are not the end users, who are the patients, and are also not the people writing checks, who are the insurance providers and governments. So when we think about products like ours that might have a high upfront cost, but whose true economic value added comes from prevented or forced stalled?
Surgeries, like a knee that needs to be replaced every five years because you're under 40 and you're gonna wear it out. That type of prevention. And I think by extension, I think our healthcare systems don't necessarily I. Reward preventative care in general. So I think there's, it's gonna be a multi-pronged approach, but this is absolutely the direction everyone's moving.
Everyone. Like, if you were about to get your knee replaced, would you rather it be made out of living tissue or out of metal? Oh, no doubt. I know my answer to that question. Yeah. I,
I've heard the rehab on it alone is so, arduous. Yeah. That people wanna avoid it. At all costs. At all costs. Yeah.
So you're talking about these TED Talks a long time ago. Yeah. I mean, from the point at which you say, okay, you and your you have a co-founder as well. Yes. You're sitting in there going, yeah, we can make a business outta this. We're gonna do this.
From that point until you get f d a approval to actually put this in a human body is, what, is that a decade? How long is that? It
was for us. I mean, it was we started the company in 2013. We got our first funding in 2014, and we got approved to go into Human in 2019 then, so that was five years and then Covid happened.
We didn't implant our first patient until 2021. And then we're likely that trial is coming to an end now, and if we're lucky, we're gonna be approved in about 2026 to go to start selling products. So that would be 12 years. But I mean, we started working on this. I started working on this 20 years ago, so this is absolutely a long haul.
It's a relay race. And that's part of why we wanted to work on bone and cartilage, huge unmet need. The bone and joint reconstruction industry is vast and growing and we wanted to make a difference in our lifetime, which meant, 10 years ago we thought, oh, we can probably make a dent in 15, in 10, 15 years.
And now here we are. And it's like, ok, we gotta keep pushing, gotta keep pushing
it. It really is amazing. So it, yeah, if you get that FDA approval, will you have that much of a lead over anybody else who's,
oh my gosh. Just think about it. The poor souls who wanna, it's so much effort. And a lot of academic groups are doing great work.
That makes me very sad that we'll never see the light of day in terms of translating towards the clinic because the skillset for being a good scientist are, it's very different than the skillset for being a good entrepreneur. At the early stage, at the growth stage, and at the.
Scaled like the yeah. So it's just, it it, you have to be, I like to think that, we have to be really humble and ambitious to have that right mix of humility and ambition to say, you know what? I have a big goal, and I know I don't have all the skills to get there, but I'm gonna convene the brightest minds.
I'm looking at this Einstein picture behind you. Like, who is the Einstein of regulatory, who is the Einstein of orthopedic surgery? And you just to try and recruit a dream team and be really humble and ambitious and really interdisciplinary because like I said, we got this multi-stakeholder environment and your value proposition needs to resonate across the value chain or else you're dead in the water.
So, yeah, I don't know. I don't know. Say, well, you, we haven't succeeded
yet. I was gonna say, you say ambitiousness, the other word I'd throw in there is patient. I mean, there's, it just it, it seems like it, it takes that long. So, yeah, we're not gonna get to a story. But let me ask you this FDA standpoint, if I put you in charge of the fda, I mean, you gave us one thing you, this whole idea of platform.
And, not having 260 or 290 different products, but having a platform that like gets certified by the fda are there any other things that you would look at? I realize it's the envy and it's a great system and you can't say anything negative cuz you have to deal with them every day. But is there any other changes that you're looking at going, there might be more things that go from.
The research and the university setting to to products that can really benefit humanity if we tweak a couple of things here.
Well, thank you
for bringing that up. I mean, if I could wave my magic wand, certainly I used my 90 seconds that I was given at the White House to talk about what I, we've already talked about, which is this kind of platform approach towards platform technologies.
But I think if I were to also wave my magic wand I might take a page from Japan's playbook, For example, we have three phases of clinical trials, and only after the third phase is complete. Can we sell product here in the us? The first trial phase one is meant to demonstrate safety, and then we in phase two and three, demonstrate efficacy.
What I would love to see is something closer to what you can do in Japan, which is that once you've proven safety, You can start to recoup not for profit, but at cost, you can start to sell your product as you prove efficacy and you have a certain window of time in order to prove efficacy, after which if you don't, you can no longer sell your product.
But I think changing. Shifting the economics of the business models around drug discovery and development, I think might help us down the line with drug prices because what ends up happening right now is that we have to spend, depending who you ask billions of dollars to develop a product just to prove that you can sell it, and then you have to sell it in order to recoup all of those sunk costs from the past.
But wouldn't it be nice. And wouldn't it be good for innovation if that value of depth was which is what that gap in feasibility and funding is called colloquially. If we could sell product not necessarily for profit as we're proving efficacy, I think it would change the dynamics there and maybe allow fewer good technologies to die on the vine.
Yeah, it's a, it's amazing. We don't normally go down this path at this depth, so I really appreciate you coming the show and having this discussion. And we are actually giving $1 to Alex's Lemonade Stand for Childhood Cancer when the word ChatGPT or generative AI are mentioned.
So I just wanted to mention 'em at least twice so that there would be some money given because most chat,
chat, g, PT G, PT gt,
so, so many of our episodes, that's where we have lived and had so many conversations around. So I really appreciate this discussion. It it's really exciting to see.
What's possible with technology and I, I have seen little tweaks and, just the fact that you're at the White House, having conversations and, that's, that bodes well for the future of, Hey, how are we looking at this? Can we accelerate these kinds of advancements and discoveries and turn them into turn them into cures potentially.
I mean, that's what the 21st Century Cures Act was. Yeah. So exciting stuff. Well
preaching to the choir.
I appreciate, one last question. So I've talked to a bunch of people who have given TED Talks, give an idea of. Of what that's like to give your first Ted talk?
Well, I'm glad that I had no idea what I was getting into cause I didn't just shut down. There's a big red dot on the stage and you're not allowed to move outside of it. And I like to say, for me, my TED experience was like a mixture of pixie dust and rocket fuel for my career.
Pixie dust because it had a way of creating. I think there was a direct path from there to here, for example, because it really helped me, it gave some magic to magical, help by allowing more people to know about what we did. Right. A community form around the talk.
That's right. And it helps the people learn about our ideas and disseminate those ideas. And Rocket fuel because it also helped me connect with folks who could, who had the means to help make those creative ideas feasible in the world. I had, you have to practice a lot that, there's a saying.
I didn't have time to write a short letter, so I wrote a long letter. They're very tightly timed. The longest TED talks are 18 minutes. Mine we're all around five to eight minutes. By the way, there's gonna be a third one. Coming out this fall the kind of tenure update that I mentioned earlier in our conversation that's gonna be coming out this fall.
And so it's a real gift. I'm so glad that organization exists because I think they really invented a format of sharing ideas. And I think the world many folks have now copied it in the intervening, couple decades. But it's a magical place and it's still, Ted still is a magical conference.
I was so glad to return to it
this year. Fantastic. I believe you can tell a lot about a person by what's behind them on their. Desk and whatnot. And for the people who are listening on the podcast, you have all sorts of skeletal structures in both. Yes, we do. It seems to be a passion of yours, not just a job.
It's absolutely a passion.
It's, I you know, you said it takes patience. I don't think of myself as a patient person. In fact, I feel impatient all the time, however, I think this work has just, I've found it so captivating. When you look at cells under a microscope and realize that they're powering our thoughts, our breath it's every moment of our life, is powered by these little cellular beings.
And it makes me grateful to be alive, but also it keeps me continually engaged and present in the work. So, I would say maybe patience is side effect. Yeah. But I, I really do love, I love this work and I hope that our products become the future standard of care.
But I also hope that as society that we appreciate. The living homes that our our bodies provide us every day. It's a miracle to just take a
Well, no, no pressure. But I'm counting on you. I'm 55. I think by the time I'm 65, I'm gonna need some of that cartilage. So you got about 10 years to, to get it readily available in these hospitals down here, so I can I can avoid getting a knee replacement.
Yeah. Thank you very much. I hope that's true. I hope you never need what we're making.
Absolutely. Hey Nina. Thank you. Okay. Thank you for your time. Appreciate it.
Thank you. Take good care.
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