Transcription
Welcome to Note to File, a clinical research podcast, a collection of interviews, candid commentary, and general nonsense for the clinical research community. Check us out at notetofilepodcast.com. And now, without further ado, on to the show.
[Music]
All right, guys. Welcome to another Note to File podcast. It is July 30th, 2025. Uh, how's it going, Denali?
It's fine. It's rainy here.
Okay. How about you?
Better than the 100-degree weather. And uh, I just want to point out that I'm uh outnumbered by roses today uh on the show. And uh, go ahead and, you know, introduce our guest here. I'm gonna actually take you off mute, Josh. Sorry. Here we go.
Excellent. Josh, glad, glad to have you, man. How you doing?
It's an honor. You know, I was thinking about you guys like must be like in the doldrums of summer because you had Califon and a whole bunch of others. You're like, there's no meat left. So, I get it.
Well, we've been, we've been talking about this since was it Scope? It was. Yeah, I think so. I think it was Scope. So, like that's what I mean, Feb. That's that's been a while. We've been trying to get you for a while, is what we're saying.
Yeah, man. I've been talking to your agent and uh, you know, finally worked out all the pricing to get you on. So excited we could finally afford it.
Exactly. No, I'm really excited about it. Um, in general, I'd say follow you guys. You guys have a remarkable point of view. And, uh, this should be fun. I am in North Carolina. It is also really hot as well. Um, so I'm with you, Brad.
Yeah. Yeah. Summer. It's okay. Fall will be here someday. Before we know it.
Well, I mean, I can't believe it's already end of July.
I know. It's insane. Summer gets away from me quick.
I know. Yeah. The year gets away from you. What happened? Like, yeah. Yeah.
Well, now we're in like the whole swing of like the the fall conference seasons are coming up. So, it's like starting to think about and like making travel plans and it's like, this is making I'm not ready for this. Like, yeah. Yeah.
Not that this is a uh to make this about you, but in your new exciting role, do you do international or US only?
Yeah. It's a great question. So, Viva is obviously a global company. I think right now from a site solutions perspective, this year we're focusing more so domestically in the US, but we are a global company and the site solutions are across the globe. So we're in APAC, we're in EU. So we do travel internationally. Um, right now, most of my travel is domestic, but I think we have some stuff on the horizon where we're looking to do some more international site work.
I normally ask my guests on this call, sorry, that's not how this stuff goes, but where, like, if one country overseas or whatever exists that you were able to go to as far as your new world, which, what would it be?
Oh, so I, I, this is a hard one. I, I think right, it is. I know. So I think about this a lot because I love to travel. Um, and like, it depends on what region. So if you're talking about like the APAC region or EU, I think right now, I think Germany. I, I like my background heritage is very German and so I've never been, I've always wanted to go. That or the Czech Republic. So like doing some of that like in ancestral like stuff sounds fascinating. Um, I mean, I could list, I could just list off countries of where I want to go.
So that's not, not what I thought. I didn't think you're going to go that route, but that's interesting. What about you right now?
Um, so during COVID, when COVID happened, my wife and I had like a two-week trip planned to Japan. And when I was at ACU, we're going to get into my background a little bit, but I, you know, I would, I would travel for business there. And it's just a, it's a remarkable country and a whole bunch of different levels, kind of. It's an island, but highly developed, really deep culture, great food, great history. And so I think for now would be to, for us to, it got canceled, right? The whole thing got canceled. It would be to re-re-play that. Yeah, I think that's probably my top country in the APAC region right now. But again, it shifts. It depends on my mood. I feel like I'm so, I'm so varied. What about you, Brad? Where would you go?
Yeah, Brad, where'd you go?
I don't know. Do they do research in like Antarctica? We'll do it there. Yeah, I'm sure they do. There's probably a whole lot of research. Probably not clinical trials, but I know the same way. Actually, Japan sounds really interesting. There's a lot of cool stuff that, you know, I find fascinating about Japan. Uh, like that's where I want to go. Like this whole thing with, uh, with our administration focusing on expanding the, uh, you know, our greater presence in the world. I'd love to go there. I like plant a flag. We're gonna buy it. That would be, you got me thinking on that. That would be, I'd like to do that. Yeah, that would be cool. That would be very cool.
All right. Well, uh, Denali, I'm sure Viva has a fleet of private jets, so I'm sure you'll get to go to all kinds of cool places, right?
Yeah. Yeah. Like really good use of funds. Let's, let's do that. Actually, we're going to buy yachts and we're going to go to Asia, Southeast Asia, and just ride around in our sponsor-come-sponsored yachts.
Yeah. All right. We'll just keep this podcast money rolling in and see what we can, what we can do. First, we need a single sponsor, but we'll get there. We'll get there eventually.
Gosh. Yeah. Yeah, man. Everybody starts out kind of the same. Let me want to hear a little bit about, you know, your background and uh, what's brought you today to to Hawthorne. If you would, just to give us your story.
Yeah. I'll try to keep it, you know, I'll try to keep it brief, but um, so my journey into clinical research started with uh, IQVIA. Uh, it was actually Quintiles at the time, you know, large CRO that then merged, uh, Quintiles merged with IMS became IQVIA, kind of became this very large contract research, health data technology company. And um, you know, that's kind of where I cut my teeth, so to speak, and I was fortunate enough to have a prosperous career there, you know, starting off in kind of strategic marketing, going up through chief of staff, strategy, etc. Ended up being head of strategy, corporate strategy, um, kind of M&A, tip of the spear and innovation at um, as reporting into the leadership on the CRO side. And it was a really good um, like for many of us, it was a really good training ground, just because, um, solid company, been around for a while, you know, essentially created in many ways the contract research space and evolved. And so, so I had a really kind of a good um, you know, it was good. I was there for 11, 12 years. And so it was a good opportunity, but sort of along, especially during COVID, it was busy. Every, like all of us, we were working 80 hours. And I was kind of, I was thinking, you know, I really wanted to do something different and I wanted to do something smaller and more entrepreneurial because when I was at IQVIA, I was fortunate enough to, you know, I had corporate strategy and M&A leadership, but then if there was something that we couldn't buy or or partner, then, you know, I'd appropriate funds and kind of build it myself. And it was actually in many ways, it was kind of like a dream job, right? Because, um, they were very good at that, like, okay, let's try to figure out how we can make this work and put money towards it and build it. So we'll come back to this a little bit later, I think, but, you know, I built a Cubist DCT business way before that concept even existed, like that term wasn't even there, like 20, early 2017, home research business, you know, connected devices, a lot of different things that I kind of, I'm really proud of that today, they're kind of self-sustaining, good businesses. But I wanted to do something different. Uh, as common in the in the CRO industry, I had a pretty stringent non-compete. And I was fortunate enough to be recruited by CVS Health to build a clinical trial delivery business there, which, I think you guys know about. We did that for a couple of years, actually. We can talk about it if you want. It was a very successful business, but didn't fit into um, like large multi-billion, multi-billion dollar companies like CVS, like Walgreens, maybe, um, you know, like Optum. Really, really complicated. They're really, really complicated for for smaller innovation priorities to give them enough time. So we did that successfully for a little bit, but then it didn't fit in with everything that's going on with like CVS. Yeah. Without going into details, right? Everything in the public domain. But it was good. It was a good opportunity. We did it for a couple of years. We had a phenomenal leadership team, which some of us are still not together at at Hawthorne. And then, um, the the board at Hawthorne was looking for somebody to take, kind of the foundation, which we can get into a little bit, that was really focused more on kind of a different, a differentiated way of doing clinical research in the patient's home, but figuring out how do you evolve that model and then create value from the, um, let's refer it to the machinery that the company had, know-how, expertise, technology, etc. So I've been there for a year and a half. It's been a great ride and it's a good spot for, I like, I like small venture-backed growth entrepreneurship, fast decision-making. It's, uh, I mean, you guys know this, you guys live this, but it's, it's an exhilarating and really rewarding place to be.
No, absolutely. I think that's, it's interesting. So I think it's a certain type of folks that like can excel in that background. Some folks like that big sort of like slow-moving being a cog in a wheel, but it takes a different type of f person to to really excel in that that sort of space. So it's cool you found. You got to like, you got to like risk.
Yeah. You have to be comfortable with your decision-making, good or bad. Do you know what I mean? You have to be comfortable because like, you're going to screw it up half of the time, at least. And you got to be okay to be okay. We got to do something different.
Yeah. There's a certain amount of accountability you have to be comfortable with, to your point.
Yeah. Yeah. Which I like it. And we're fortunate that a bunch of the folks at CVS, we all kind of went different ways, but slowly a handful of us are back together and they're just an excellent team. And, um, this isn't a cliche. Uh, you know, there's nothing more important than having the right team around you.
Yeah, absolutely. No matter how good the company is.
Yeah. Yeah. No, that's my background. I'm, I'm curious. Yes, I want to do, I want to talk, you know, about about Hawthorne, but if I can go back, I'm curious about, and not even, we don't have to talk about CVS specifically, but I think the concept of, I guess, clinical trial delivery within these sort of retail or especially retail pharmacy setting, I guess knowing what you know, and again, you don't get crazy into any details, but like, is this a, it was a big, it was a big um, point of, you know, popularity, I guess it was talked about a lot for a while there and it seemed like, you know, potentially the next big thing. We hear a little bit less about it now, or at least not quite the same way we heard about it then. Is it sort of inherently challenging or problematic in in this setting, do you think, or is it just something that hasn't been quite struck right? I mean, it sounds like to your points and, you know, to what it's publicly available out there, like it wasn't that it didn't, it wasn't by all accounts successful, but to your point, you're talking about these gigantic multi-billion, whatever dollar companies. Is it ever going to be, is the value ever really going to be there for them to run and scale that at a level that it ever even makes a dent in the bigger picture?
I really like the question and I think, um, I think it, it, it's layered. The answer is layered, but the fact that you're, it's really easy, I think, to jump to conclusions. People say, oh, you know, clinical research can only be done at like a dedicated site. That's the easy answer, but it's an incorrect one. Um, because it, it, it's layered. And I'll share a little bit of what was like the pros and then why I think it still is problematic and why it, you know, for some of those that are still playing with it, while it's still, if, if you don't change the mindset, then it, it won't work. Okay. The pros are like unbelievable brand, really, really strong brand. And, and I'm not talking about a brand like on a commercial, um, you know, consumer marketing. It's a brand that's trusted. It's a brand that's trusted. Pharmacies are trusted. Pharmacies are trusted almost as much, and sometimes more than primary care, than doctors. Um, great physical presence, so kind of, you know, pervasive, uh, coverage across the US. Unbelievable healthcare data. Um, and I think that CVS in particular is maybe second to none if you think about, you know, claims on the insurance side, pharmacy data, ability to pull in, you know, labs. Um, so really, really good, rich, which allows you to solve really the fundamental problem of clinical research, which was access to patients. So it's this combination of trusted brand to a certain extent, right? Um, trusted brand, unbelievable data, good footprint in theory makes for an unbelievable success, right? And like I mentioned, we did that, that business grew. That business grew really, really, I mean, we're growing 30, 40% a year. Um, but now the cons, the cons are is that, you know, as a, I'm not going to say the actual number because then I'm not disclosed to say, but let's just say a multiple of tens of millions. So, sizable business, uh, in a $320 billion company that is fighting margins, you know, all this stuff's in the public domain. PBM issues. Sure. Um, insurance with Medicare coverage, um, on the, you know, on the insurance side. And I just think that in order to, for, for you guys know this, right? Businesses take time. Small business takes, you need patience. It's what we were talking about. You need to give it time to justate and grow and distill and kind of turn into something special. And the con is, I think that a lot of these organizations, we'll see what happens with the players that are still out there, kind of, we'll see if there's organizational patience.
Yeah. Well, and yeah, I'm curious. I mean, obviously the big one out there is Walgreens still, but we've seen, you know, they're going private, or does that, is that a good or a bad thing, do you think, in terms of their, uh, the patients they may have with a clinical trial business? Um, what do you think? I don't know. I mean, again, I'm, I'll be the first to admit, I often, you know, speak out of turn on these things. I mean, to me, it seems perhaps less likely, but, you know, I'm willing to be willing to be wrong.
Yeah. So, I'll give you my answer, and then if you want to jump in, please. Um, but, um, here, here's my take. I hope I'm wrong because I think there's a real place for retail pharmacy in and retail healthcare, right? Not retail in general. Kind of Best Buy was in it. Best Buy, Walmart, Kroger, all of them. Yeah. Yeah, Best Buy in particular, kind of they went deep, right? They spent hundreds of millions, um, and have recently kind of, I, I think in their recent, they may be pulling out of it, but I think retail, any, any kind of retail pharmacy, including Walmart, by the way, they got a very, very big retail pharmacy presence. So, I put them in that category of they should be able to succeed, and I'd love for them to, because there are so many patients that are just in healthcare deserts, research deserts, don't have access, and they don't want access through the traditional channels. So, I think it can work. That all being said, since you asked me the question, I think the private equity thing is potentially a risk. So, I don't know. I mean, fingers crossed because because we really love what those guys are doing.
Yeah. Yeah. I mean, everything I know about them is, you know, sounds great. So, yeah, I, I, but I do, I mean, you, I have my, uh, sort of, you know, pre-judged thoughts about private equity and what they, you know, what their goal is, and it doesn't necessarily seem to, you know, align well with something that's going to take time and patience to grow to something that, you know, is never probably, and I know there's a question, probably relates to some questions that you want to ask later, but like, I don't know, the list, I got my list, be prepared.
Yeah. Right. Right. And again, at least traditionally, and, you know, I do want to agree, I want to go back to and agree with you that like, I don't think sites, sites don't have to run in traditional research sites, and I think we're moving away from that. I think it's a good thing overall. I don't know yet. Again, is retail pharmacy in these big, big companies the way to do it? I don't know. And again, me, natural cynic sometimes to a fault. But yeah, I, I, when I first heard the private equity involvement, I was like, "Oh, this can't be good for their their research unit." But again, could be, could be entirely wrong. I hope we're wrong, right? I hope we're wrong.
Sure. Sure. Yeah, that would be great. There, we all, we all want the same thing here. So, yeah, it's, it's not written against them by any means, but
Well, and I think that it all depends on what the private equity's priorities are and who the private equity firm is and who's on the board and who's calling the shots, because I mean, I think, you've probably heard me talk about that generally. I'm also fairly skeptical of VC, PE, some how the impacts, especially in clinical trial sites, but I think fundamentally the model could support it if the decision makers have the same priorities. I think it just go well, time will tell what they, what they do with it.
I see your comment, John Campbell. You're next. Oh, here, here in a few weeks, we'll get you on next to hear your opinion on this. Now you're going back to the A-list. I got it on. Good question. John, we're rooting for you guys for sure. Hey, um, a distinction on comment that you just made, yes, that I think is important, which I feel there's a real big difference between VC and PE because you kind of lump them in together. I, I actually would love. So today, in the site space, kind of dominated by PE dollars. We've all seen it, right? Yep. I'd love to see more VC money going in because VCs kind of are, you know, are in it for the long haul. They want to grow. They want to, they're dedicated to growth as opposed to, I'm buying something that has really good EBITDA. How do I make it more EBITDA ticket? Yep. Yeah. So, I, I would, I would like to see that happen.
Yeah. No, and I, I, I, I would agree with that. I think I tend to be skeptical across the board, but I, I do do appreciate the difference in the variation in risk and growth strategy and all of that, for sure. I, but would like to see more of that as well. But totally. Yeah. Also, I want to touch too on something else you mentioned about, um, your role at IQVIA and the, uh, DCT. Um, is it fair to say like when you were working on, you know, the sort of early, how much has things changed in the DCT space between, you know, when you were working directly in them to now, or is it essentially the same? I mean, I'm sort of curious the evolution. I mean, I feel like it was sort of a, another thing that at least the talk and marketing about it sprung up very quickly and then sort of has subsided to a large degree. Now, obviously, we're still doing things that are DCT, and again, we talk about Hawthorne, which I fits right in nicely to probably what we're talking about in terms of DCT, but I mean, how has that shifted, um, from then to now, do you think?
Yeah, I'm totally resisting right now temptation for self-promotion around Hawthorne, but you're, you're fine. You're fine. We, we'll get there. We'll get you. You gave some time to plug a little bit. It's okay.
No, because it's related to this conversation about retail pharmacy. It was like a nice jump off, but I don't want to break, uh, I don't want to break the flow. So, let's talk about DCT, which is not what we do, by the way. We're not a DCT company in any way, but we'll come back to it. Um, and kind of the Hawthorne expanded services and what we're trying to address in the marketplace. Um, you know, it's interesting. Um, DCT used to be called virtual trials way back when, when it first started, and, um, it's an enigma to me. It's an enigma. Um, it's, it's an enigma because, uh, you know, when I, when I first built the capabilities at, uh, at IQVIA, it's very new. Nobody knew about it. Nobody was talking about it. This concept of doing just using remote and using digital and using an alternative to physically interacting with the patient and physically writing things down on paper. This is 2017, 2016, right? This is, I mean, you always talk about, you know, in on LinkedIn and other things about e-consent and ePRO and this e-that, and it's today it's common nature, but it's amazing that, you know, eight years ago, it wasn't. And so I think there was a real, there was a ton of promise and opportunity for the industry to be able to say, you know, just like these big transformations that happen in other industries, right now we're seeing it in AI, go back x numbers of years, we saw it in, you know, like 20 years ago in the internet, electric vehicles. I'm trying to think about the big, like transformative things that move the industry. I think this was an, this was an opportunity for the industry, collective pharma, regulators to be able to say, there's a, there's a good channel over here that we can put in that, that is doesn't have a tremendous amount of risk, doesn't have where where it's pro. And I think we, pre-COVID, it was, it was rough. Like we were, I was across the globe, proselytizing on places like Japan and China, all over the place, like, hey, why wouldn't you do this? Why, why for studies where you don't physically need, they're not highly invasive, you don't necessarily need very specialized, you know, specific instruments, thinking about certain neurological studies. Why wouldn't you do this, right? I mean, it's used in other industries. Relatively slow adoption. Along came COVID, as you guys know, it was kind of like, now we don't have a choice, and everybody fell in love with it. And I think the everybody falling in love with it included some of the folks on Denali's not very like list, DC, VCs, and PEs. And I think I think that actually ended up potentially kind of souring. What I mean by that is there was just so much of this kind of financial exuberance, uh, that, um, oh, this is amazing, this is going to completely supersede. Let's pour 500, 600, 700 million into it without necessarily thinking about, okay, but COVID's going to end at some point, and as humans, we regress towards the mean. Happened. And now everybody was stuck in. People started like, honestly, um, kind of giving it a bad rep just because it didn't have the expected return on investment, which is unrealistic in the first place. Full circle back and then to you guys, because I think I'm talking too much. But I, I think the issue is it just, we just played it wrong. And we played it wrong because we didn't say, "Hey, this is good. Now we got this, you know, whatever this opening, and let's just go and nurture it, but do it in a way that allows us to grow." Instead, everybody got on board, everybody excited, and then everybody kind of like, I don't want to date that person anymore. Almost like they got sold. It seems like people got sold on something, right? Where it's like they, they did it for, to your point, financial reasons, not necessarily because we're going to make this industry-changing swing. We're going to invent the electric car. We're going to invent the internet. We're going to do this thing. It wasn't maybe it wasn't for innovation. It was for finances, is what it seems like. And so that's not going to be long-term sustainable. What are you guys seeing? You, I mean, you're close to it. And what's, what's your take? I know that there's still a bunch of players in it. Um, I, I think pharma is still doing it's, kind of now it's becoming more organic in there, but it's so that's what I was going to say is I, I think we're talking about it less, but I think it's happening the same amount. It's just now part of the norm of what folks are doing. And I mean, I would say I think AI is going to be similar, right? Like we, we're talking about it all the time. We talked about DCT for years, and now we're talking about it less, but I don't think it went anywhere. Or we're just now saying, this is, we have absorbed it into the status quo, and I think we're going to see AI going the same way.
Brad, what do you think?
Yeah, I'd say that's fair. Um, and I think agree with the general sentiment and where I think I've, you know, I'm not anti-DCT. I think I probably come across that way in many instances, but it was more of the, again, like you're not anti-DCT.
No, not, not at all. Look, I mean, again, I do what I do, audience, it's on the record. I do. Exactly. Clip this. Clip this and you know, put it out there. I mean, you know, ultimately, I do what I do because I, I want there to be more opportunity for more people, period. So whatever gets to that goal is something I want to get behind. And I think where, again, I took some umbrage is that I felt like it was something being, yeah, co-opted specifically for money, not being implemented in a sustainable way that's actually going to be helpful. And so instead, you got a people wanting to cash in, which to me was upsetting because I'm like, hey, no, no, no, this is a good opportunity to actually make it happen, and you're screwing it up because, you know, you're, yeah. So that, that's where I felt a lot of frustration around it and why, you know, maybe it was sometimes like sort of misdirected, but, um, at least my, my frustration with it, but I think that's where, you know, it felt, I have a follow-on question, please.
Um, no, it's interesting. Um, so, so I think that your perspective was that there was a lot of large money that was co-opting and maybe kind of taking over a little bit. Do you think that the traditional sites voiced a bunch of structured concern in order to protect their status quo?
It's hard to say. I mean, they're probably, that probably did happen to some degree. And I think, you know, also because I think if you wanted DCT to be successful, you probably needed the buy-in of sites to some degree. And I don't think sites felt like they were being involved in that, which then of course, but you, I mean, I don't know. I, I feel like that was part of it. Or was it more maybe just wanted to protect financial interests?
That's possible, too. I mean, that, that certainly is possible. Yeah. I'm, I'm, I'm not, uh, I'm not willing to say that that wasn't at least a reasonable chunk of it. Um, but yeah, that could well be. I mean, obviously when, to your point, like at first it was all virtual trials, siteless trials, of course. Yeah, if you're a site and you're siteless trials, like, well, [ __ ] I'm a site. What am I, what am I supposed to do? Of course, I don't like this.
That's a, that's a great point. That's a good. It was an unfortunate, I think virtual and siteless were kind of unfortunate names.
Yeah. And it pivoted. I mean, even companies like, you know, Science 37 was a good example, like you go look, like that was their first, like tagline was like siteless trials. Um, so, yeah, of course, you're going to get sites like, hey, wait a minute, I'm a site. What are you, why, what are you doing? Don't do this to us, please. But, you know, then you, again, DCT has become so ambiguous now to me. Yeah. We can talk about things like e-consent or ePRO. Are those, do those count as DCT elements?
They're not. Yeah, sort of. Maybe. Yeah. We want those. We don't want someone filling out a paper paper diary. We want to be able to talk to them asynchronously and work with our patients as much as possible. We want to offer home health visits if that's a thing that makes sense and can be done according to a protocol. Um, so a lot of the elements, I'm, you know, are there less, less so now than than COVID. Uh, I haven't seen a study in a long time with a home health offering. Um, which, why do you think that is?
I don't know. I mean, I, I honestly don't. I mean, I've, it's hard to say. I don't know if it's a cost thing or, you know, that's another thing is like from the site level, a lot of that stuff is, those decisions are like completely opaque. We have no idea why or why not. Sometimes these things are included. Um, you just kind of notice the, the trend is that for a while, every study was like, we have home health, we have nurses, we have phlebotomists that can go, we have all this stuff. Now it feels like nobody offers that. And actually, I had an instance recently where I was like, I have a patient who lives like two hours away, they can't make the visits. Can we send somebody out? Like, no, no, we don't do that. You said that the pharma, the pharma company. This is, and this is a, wow, top five, like big, big boy pharma. So I was a little bit surprised that they couldn't help.
Comment. What was the, was it, was it protocol or study specific related, or was it just in general?
It, it seemed to be just in general. Um, but yeah, I mean, I think you asked the question, what, what happened? We can get into a little bit into Hawthorne whenever you guys want to, but that's, um, that's where the company's core was.
Well, I was going to say, my, my understanding of Hawthorne is that it used to be called Hawthorne Effect, I believe. Yes. Originally, and I, my understanding was that they were, yeah, traveling nurse, home health type, type offering.
Yeah. And my understanding is you guys have evolved like since then, or maybe the offering is different. So, yeah, please.
We, we've definitely kind of diversified a little bit along the lines of what Denali was talking about, kind of. It was,
Do you want me to go into it?
Yeah. Yeah. Love to go for.
Okay, but this is kind of just for every, for the audience, this is like, we're jumping off your comments about, um, the adoption of home as a viable option and why it's not happening. And I think before I go into, I think it's a combination of, um, I don't think that we've completely figured out the economics yet, right? I think that the pricing that carried in COVID doesn't carry now, and so there needs to be some kind of adjustment on how we do things and the way to make it more seamless, synergistic, so that the optionality is really option and not necessarily, oh, now we got to figure out how do we add options, how do you handle data collection, how do you handle oversight? I, I think, I think there's some structural issues they're preventing, because I mean, to the point of your patient who's two hours away. I mean, I, I live in kind of somewhat rural North Carolina, but, you know, let's just say I'm an hour from Raleigh, right? If, God forbid, I needed to participate in clinical research, as much as I love the industry, that hour would like weigh on me. Yeah. But if somebody said, "Hey, somebody you're going to take a call with these great two folks like right now, and then afterwards, somebody's going to come and do a clinical visit," I'll be like, "Sure, I'm in." So, I don't think we got it right. And I'm hoping that we will. Um, Hawthorne Health today, uh, is the roots of the company were focused on kind of a better way of doing clinical research in the patient's home. Kind of an Uberized way of doing clinical research. Think about two-sided markets. Got a giant bolus of riders and a giant bolus of drivers. This is an Uber model. And you'll essentially create technology in order to optimize, make more efficient, streamline basically a service, right? Uber is not a tech company. It's a service company. They just leverage technology in a really, really great way. That was the kind of, that's the, when I talked about machinery at Hawthorne, that's our machinery. Like we have technology that allows us to connect networks. The core was, was research, you know. So we have a, we still have a very, very large, maybe the US's largest fleet, if you will, of contract healthcare professionals, primarily nurses, RNs, PAs, phlebotomists, sonographers, some doctors, and we have technology that allows us to schedule for clinical research and collect, collect electronic data, adjudicate it, make sure that there's good PI oversight and hybrid model, etc., etc. That was the core, but Denali, it's, there's just not enough growth there, right? We figured out it's good. We got great customers, you know, but we want to grow. We want to continue growing. And so, as a company, we kind of took a step back and said, what's the machinery that we have? And machinery that we have is we know community really well because we, you know, we've done 50,000 home visits. Yeah. We know how to manage networks really well. Thousands of, you know, contractors with various credentials and schedule them. And then we said, well, where is there, where is there an opportunity in the market that the market really wants to go to, but it's not solving it today? Enter community health. Enter community pharmacies, as opposed to in, uh, retail pharmacies. There's a difference between them, right? They're very, very different animals. So,
Go ahead.
No, I was going to say that's what I, that's what I want to kind of dig into because we talked a lot about retail pharmacy earlier when we talked about the big dogs and the, you know, Walmarts and Walgreens and CVS and the place and their square into research and, you know, what that looks like and where they could be really successful, but I think there's a big distinction between retail pharmacy and community pharmacy, and I would love to sort of hear what you guys are doing at Hawthorne about that.
Brad, you were writing stuff down. Was that a tough question you're going to pop?
No, I'm just taking notes for for any potential follow-ups. Go ahead.
Gotcha. I'll keep on going though. So, so you're right. There's a huge difference between retail, which we talked about a lot of pros, cons, we've already got out of the way, but community locations, community pharmacies, including, we have a really good strategic relationship with LabCorp, and they have a bunch of these PSCs, they're called PSCs, like patient service centers that are in community that do stuff. But these are, let's just focus on the community pharmacies. They're like the bedrock of healthcare provision for a disproportionate number of patients in the US. There are patients that are uninsured, underinsured, not necessarily in rural communities, but in urban communities, maybe not metro, but in urban that just don't necessarily have good access to healthcare, can't afford healthcare, can't like, and, and independent community pharmacies play that role for them. And so when you go into a community pharmacy, you're not going through all, like, no disrespect in saying this, but you're not going through milk and and candy and electronics and, you know, you're going into healthcare. And many of them, just because they need to survive because of competition from the bigs, they have expanded their service line. Many of them are providing diabetes management, uh, you know, healthcare, uh, just they've added a lot of, uh, benefits. So from our perspective, enabling community pharmacies now to plug this gap in access to clinical trials in clinical trial deserts is kind of our mission and what we're focused on. And we really like it because it's solving the fundamental problem for pharma. You know, reality is sites are saturated. They'll tell you that themselves. They go to the same ones. They have competition for studies. They, they have or don't have access to patients, which is why pharma spends millions and millions of dollars on patient growing. Where they're not going, you know, are places like, uh, um, you know, like Diamond Head, Mississippi, right? Right. Diamond Head, Mississippi has hundreds of thousands of patients, potential patients, but, and they have independent pharmacies, but they don't have any traditional sites. So what we do is we strategically look for locations that are providing great healthcare in their own right. They're not just doing meds, but they're doing other services. Some of these places do like 10,000 vaccines a year, 20,000 vaccines a year, diabetes management, kind of long-term care help, and, and also have the right infrastructure. So they have visitor rooms, and we essentially bring our machinery, networks, tech, the ability to mobilize in community, and, and it's a super symbiotic relationship because we bring studies. We allow them to expand and grow their revenue, which ultimately leads to kind of long-term survival for what I believe is really, really important in our industry. Does that help?
Yeah. And I think it's, it's interesting because when I remember when I first heard about this whole concept of, you know, pharmacies and using the pharmacist as that sort of trusted resource, I was admittedly very skeptical, but I think if I'm thinking about my, my personal lived experience, right? Like I'm fortunate enough to be a healthy, fairly unmedicated individual, and I go to Walgreens when I need my antibiotic, and I don't know my pharmacist. So to me, when I first heard, I was like, oh, that doesn't track. But it's so fundamentally different. And I've talked to some of these pharmacies and some other past life work that I was doing, and it's so strikingly different. It, it is, it's it's fascinating. So I think it's a fascinating way to increase access. Again, one of the fundamental problems we have is how do we increase access to folks who aren't at these research hubs? And I, I mean, I, I think it's a great approach. I'm excited to see what kind of success are you guys seeing? Like, how is that working so far?
I, I have a question for Brad first, and then I'll answer. Okay. Brad, how often do you see your PCP? No PHI, just like how often do you do him or her?
Yeah, I think I've seen a PCP twice in the last 10 years.
Wow, you're healthy. Um, so it's interesting. On average, we Americans see our PCP around twice. Um, on average, in community pharmacies, they see the pharmacy 20, 25 times. Yeah. So, D, it gets to the point that you made is when you go in there, and we've seen it. We've, you know, obviously conducting studies there, I'm always amazed at how much healthcare interaction and the role that, um, these community locations play for for patients. So we're, we're pretty excited about that. To answer, no, back to your question, we're relatively early in the process, right? This is a, uh, you know, when I was brought on to Hawthorne a year and a half ago, the idea was, okay, you got this like Uberized home business and make it work, and, and we grew it, and it's good, but it didn't have the growth that I wanted, that our investors wanted, and, and it was solving, I felt it was solving the problem that was already sold, right? COVID kind of, there's a lot of folks that entered the space, sure, and so we wanted to do something different. And, and so me and, you know, the excellent leaders that are now on at Hawthorne with me, we kind of took our experience from the retail pharmacy side and said, we know it, we know what we like, and we know it didn't work. Why don't we find a model where we think it's optimal? And, um, we're seeing good success. We're seeing good pharma adoption. There, listen, there's a normal skepticism of, wait a second, it's not a traditional site. Yes, you're right. It is not a traditional site, right? But brick and mortar stores, it, we got physical trained people, and so we're starting to see kind of really, really good interest into PSVs and CTS.
Yeah. Yeah, that's interesting. Are, are you able, so are your, is your model based, like, are you embedding or training like coordinators there and physically doing the trials there versus sort of a still using some of that virtual model there as well, or like a combination of the both of both maybe?
Currently, um, we are very focused on physical locations. Yeah. Nice. And think about this, I refer to it as our kind of like our, our unique machinery is that it's really easy for us to build networks. So if I need to build a network of sub-PIs, like we built thousands of nurses, we can build a lot of sub-PIs. That's like our core capability is how do we build networks? We have technology and now we're kind of augmenting that with the physical network. Brad, I think for here's my strategy. Let me know what you guys think. Ready? It's only us. Um, my strategy is that we have two service lines right now, and we're growing both of them. One of them is growing a lot faster. This community pharmacy for us has a lot of really good adoption because it's, there's a need, and pharma gets it, and they're smart, and they does it do X, Y, and Z? Yes. Yes. Yes. Yes. Yes. Good. Let's talk. Um, ultimately, I'd like to see a future where pharma says, we want to enable this seamless hybrid model, but we don't necessarily want to use a different partner here, a different partner there. We just want the patient to say, I'm going into pharmacy for physical visits, or I'm not. I want to do it at home, and then it's the same machinery that takes care of it. Yeah. But that's kind of where we're playing that out. We're not doing it today, but that's kind of where we want to go. What do you guys think?
Yeah, I mean, I bet that's makes perfect sense to me. Yeah, you get the best, get the best of both worlds because right now it's hard, right? Because right now a pharmacist, to your back to your both of your guys' questions about why we're not seeing better adoption in something that kind of like the Amazon of clinical research. People like things at home. People don't necessarily like going all the place. Many do, and we should all continue doing that, but sometimes you don't. But like your top pharma, they said we don't do that. Well, that's unfortunate because maybe maybe you should, maybe you should figure out how to make it work. We're hoping that this is a way to unlock it and solve some of the too many partners. The economics don't work, and let's just make it seamless. That's kind of where we're going. But I think it's like a 12, 18-month journey.
Yeah, I could see that. No, I like it. And yeah, that's, um, I mean, it makes perfect sense to me and not dis, not inherently dissimilar from what we're seeing with a lot of the more embedded models across, I guess, more traditional, but like embedding in physician community physician offices or, you know, community hospitals or whatever the case may be. He's just taking a different approach, and maybe it's a smarter approach in many ways. Um, listen, I don't want to, in many ways, I think it is because we, there's a lot of conflict of interest with, um, conflict of focus, not interest, when you talk about, uh, physician offices, right? It's not conflict of interest at all. Physicians can do clinical research all day if they wanted.
To the problem is that they run a business, right? They run a business. They got tons of patients that make a lot of money doing it. So, in order to get there, that's why I mean, it's conflict of resour of like focus and resource. It's hard. What we honestly, what we like about our model is that, um, it, it's they're hungry for additional revenue streams and they're going down that path. You know, as I mentioned, I'm kind of repeating myself now, so sorry, but like diabetes management or, you know, cardiovascular management, and now you're just adding on service offerings that are providing value to the community. It's very synergistic.
Hey Brad, we got to the point in this podcast where I actually ask you guys questions. Okay, this is now the Josh Rose show. You guys ready? Ready. Okay, but then take charge because it's your timeline. Ready? Okay, here we go. So, this is to both of you. Little kind of like speed questions out there. Um, whoever wants to take it. We got a bunch of these. Yes.
Question number one. Go. Let's go. Okay. If you were the head of the FDA for one day, what single thing would you change? Um, all right. Well, so honest and honestly for me, I mean, obviously my my perspective is very much painted by the site side. Is I would just clarify the guidance that's out there for research, frankly, might not change. Well, I guess both, I bet. But I mean, even then, you said one thing, true. I'm just saying, even then, like it's not clear enough to even know what the hell you're trying to say anyway. So, like as sites, we're oftentimes frozen by the demands of the CRO and sponsors we work with, even though that's not necessarily what's borne out directly in guidance, but we can't hardly use guidance to build defensible positions because it's not [ __ ] clear enough. So, and so we're stuck constantly. I would say not just guidance. I want things to be written in just like layman's clear terms. I think everything tries to be so fancy and jargon filled that it's like policies and contractual. It's like, just write it in plain English because that's how folks are going to understand what's going on across the board. Why was a drug approved? Why was it not? Anything? Write it in plain English.
Question number two. Great answers, I guess. Question number two. If you were like the head of the large CRO for a day, what one thing would you do for the industry? I would change the entire CRO billing model so it was based on performance and not services because I think it's, I think you have a business model in the middle where sites and and sponsors are incentivized to have milestone based success, and I think you have a services CRO in the middle that's that's incented to bill hours, and I think that's creating an icky dynamic that is conflating interests. It's a good one. I would make my executives all visit research sites on a regular basis, spend time at research sites. I like those.
So, related to that, question number three, is there a conflict of interest with CROs owning sites? Yeah, Brad, that's the shortest I've ever heard you answer a question. I think there is. Even even if it's simply perceived, it's a, there's a, there's a conflict of interest. I don't know how you could argue that there's not. Yep. You think so? How many more do I have before you guys cut me off? I got like four or five more. Give me three. Three. Okay.
Um, is AI a threat for the site industry? And if so, how? No, I don't, I don't think it is either. No, I think not at all. It's not clear yet the impact it will have, but like again, if it, I don't want people to get like get twisted. Like again, I want whatever makes things better. I don't care what that is. If it's AI, and look, if frankly, if I become obsolete in what I'm doing, then [ __ ] it, man. I'll figure out something else to do that contributes, you know, to the greater good of what we're doing. Like, so I don't see it as a threat. threat. You know, if anything, it helps us do things better, then it's, it's a net positive. That's right. I would agree. I think like any big innovation, it will change it, but I don't think it's a threat.
Okay, two last ones. I'll give one to each of you. Um, Brad, what makes a site a site? That's number one. I have no idea. I have no idea. Hold on. I know you can. You got to give me an answer. Hold on. Denali, this is for you, but Brad, you can weigh in. If you look back in history in in our space, if there was any one idea innovation in our industry that you look back and you're like, "God, I wish I came up with that." What would it be? [Music] Um, EDC because I would have done it better. Interesting. Yeah, I guess mine would be similar. It might be CT. It might be CTMS, especially on the site side, because it's a great idea. Well, and you know what? Let me change my answer. It's SIP, but a version of SIP that is not terrible because conceptually, the idea, the shared investigator platform, I think is a great idea. It's a great, great, great idea executed in a way that almost no, you'll find nobody who will sing the praises of SIP. But I think the idea and the intent behind it is, you know, elegant. I think it's good. Uh, yeah.
Okay. And you want to do you want to dodge the, what's a site? What makes a site? No, I guess I would call at this point a site is, I mean, a, it's almost nothing more than a, a, a PI. A PI alone can be a site. I think remote PI can be a site. Oh, stop it. I knew you were going to do that. Let's stay friends. I don't know. I'm with you. I'm with you in that like the, the idea and the concept of a site is evolving and it doesn't have to be what has traditionally been known. Now, I don't know that I can give you a better answer in this time too, where like there are so many models of what a site is. I think it's partly what's fascinating, uh, about this, but I really have a hard time being pinned down. People even will ask me like, how many sites do you have? Well, I don't know. Where I have a clinic in a hospital and we serve 40 physicians. Is that one site or is each individual thing that I find the concept hard to nail down? I think so for our, for the business that I'm in, right? That we're in at in Hawthorne, it's a, it's a, it's a, it's a good question, right? And that's kind of where we're trying to educate the industry on how you think about a site as being this traditional brick and mortar and address somewhere out in the suburbs that people go to. Sorry, I don't know if your location is a sub. That's not what I meant, but it's different. It's there's a different construct. Um, and that, thank you for allowing me to answer to ask my questions. Yeah, of course. Very good, dude. Thank you so much for coming on. Where can people learn more about Hawthorne? No. Amazing. You guys do a great job. Continue like pushing evolving challenge in the industry. Have a great rest of your summer. Yeah, thanks.
Donali, who do we got next week? Oh, I've not prepared. Um, yeah, you're fired. Josh is proposed. I'll let you know who's coming next week after. Okay. Well, we'll be back next week and, uh, thank you everyone and, uh, we'll be back. Thanks for listening to Note to File. We're committed to continuing to bring you independent and unfiltered coverage of the clinical trial industry. We want to talk about what you want to hear. So if you have something on your mind, hit us up at notetofilepodcast.com. [Music]