K2 Medical Research and Populace Health on Winning in CNS

 In this episode of SCRS Talks, Jimmy Bechtel sits down with Sean Stanton, Founder and CEO of K2 Medical Research, and Christian Burns, Founder and President of Populus Health, to explore how their two organizations are working together to advance CNS drug development. With decades of combined experience across psychiatry, neurology, and neurodegeneration, Sean and Christian discuss what makes CNS trials uniquely challenging, what it takes to earn and maintain trust with sponsors and CROs, and why communication is just as critical as performance metrics. They also share their outlook on the future of the space, from biomarkers and precision health to the growing potential of psychedelics across therapeutic areas, and why CNS research feels less like a job and more like a mission. 

Transcript

Jimmy Bechtel 0:00

Hello, and welcome to SCRS Talks, provided by the Society for Clinical Research Sites. I'm Jimmy Bechtel, the chief site success officer with the society, and today I'm joined by Sean Stanton, the founder and CEO of K2 Medical Research, and Christian Burns, the founder and president of Populus Health, here to talk about how their collaboration is advancing work being done in the CNS therapeutic area space. Really excited to have the two of them here. Before we get into, learning about what they've done collaboratively here, we'll start with introductions, learn a little bit more about each of them and their organizations respectfully. So, Christian, why don't you start us off?

Christian Burns 0:35

Perfect. Everybody, nice to, speak with you and have you listen to us. Sean and I go way back. We've known each other for at least 20 years, at least since I've been in the space. So excited for this discussion today. But, I've been in the industry now for about 20 years. Populus Health is newer. We're about two and a half years in, and we specialize, by having a independently owned network of sites in three countries, and we do CNS among many other therapeutic areas.

Jimmy Bechtel 1:04

Thanks, Christian Sean, why don't you take It

Sean Stanton 1:06

from there? Sean Stanton. I've been in the industry for 32 years, I believe now. I started in academics. started a site network, which is still exists today, called CNS Healthcare, in 1998. I did that for about a decade. Specialized in psychiatry only when I was there, and then, built Compass Research, you know, which was a multi-therapeutic first in human, all the way through, phase three. that was acquired by Bioclinica in 2016, and I became part of a group that had 28 sites in 14 countries. Helped oversee operations in that capacity. Did that for... That was another 10 or 12 years. And then this new thing with K2 started in 2021, and right now it's on the eastern part of the US, but our goal is to be, a best in class US site network

Jimmy Bechtel 1:58

Excellent. So we know that your organizations individually play distinct but complementary roles in the CNS drug development space. So can you, maybe Sean, start us off and give us a quick snapshot of how your organization is specifically tackling some of the problems and what you're setting out to solve in that space.

Sean Stanton 2:16

I've always been involved with brain, you know, kind of looking at it as, like, almost, like, the last frontier. There's so many, diseases that don't have cures or treatments, so I've always been drawn to the brain. So there's therapeutic areas like psychiatry or mental health, Alzheimer's, anything that degenerates in the brain, and then pain. Those three areas we've been focusing on. I'm drawn to it because they're hard. It's not like, you know, vaccines or healthy populations. There's just an unmet need in finding treatments for all of these diseases. And there's not a really strong network in, neurodegeneration, and that's one of the things we're setting out to try to do, like, create a network of sites that can help speed drug development in the, in that neurodegenerative space.

Jimmy Bechtel 2:56

Excellent. Christian, you know, from your perspective as well, how does, Populus Health, distinctly, yet complementary in solving some of the challenges here?

Christian Burns 3:04

You know, it's funny though, based off what Sean even was just saying, CNS is, Especially psychiatry. It's like the cool thing to talk about now. I, like Sean, something continues to always draw me to CNS, in my last company, we always specialized in CNS, but the complexity, just all the staff you need. but it's also, like, really rewarding and a lot of fun. But today, you know, it's a, it's an exciting space to be in 'cause it's absolutely booming, specifically within psychiatry. And when I say that, I guess as I'm about to, take a flight down to obesity kind of conference, like, I know the three questions or four questions that sponsors are gonna wanna talk to me about. Psychiatry and neurology, it's just very different. It feels... It's, it's a lot. You know, you can't predict those same questions. but having said that, it's, it's just a special part of the industry to be in, and it's a great time. So now to specifically answer the question, Populus is in this, like, unique position to help a variety of different types of experience in sites. On one side, the problem in the industry is we don't have enough great, CNS sites, and I'm saying that broadly. It's mostly psychiatry sites in specific geographic areas. So Populus can help them implement a roadmap to be successful. And on the flip side, we have significant, experience at a lot of sites that have been doing research for a number of years, like the K2 sites, where, you know, they can leverage each other as a network should. so the experienced sites help the inexperienced sites, in just about everything to, to operationalize the study. So Populus kind of sits in the center of that, and hopefully is continuing to help bring in net new, staff that have been doing research for a while, but potentially not in CNS, along the same lines, doing significant research, and helping them get, better opportunities and be more successful.

Jimmy Bechtel 4:55

It's great points, guys, and, we know CNS is challenging, right? It's, it's a pretty tough, therapeutic area for a lot of the reasons that you guys mentioned, but probably a lot of other reasons as well. We know the nature of the conditions in which need to be treated here are much less straightforward than other therapeutic areas, and there's a lot of ambiguity and challenge that comes along with that. So, you know, Christian, what drew you to that? You mentioned that you continue to go back to, CNS, and it, it just always has drawn you back regardless of where you've been in your career. So what continues to draw that space, and, and what makes you believe that there's, there can be a difference that's made there?

Christian Burns 5:30

Well, if I start with being fairly broad, as I get older, I continue to think like, "What do I really like to do just regardless?" And one of those things I think is just connecting, like being a connector of people and connector of things. And the CNS team... the, I'll say the CNS teams, whether it's the sites or the sponsors or the CROs, they tend to leave one company and go to another company within the space. Sean, I'm sure you've always, seen that. Like, the relationships you build in the space, they tend to be forever lasting because you don't really tend to leave. there is something special within CNS, probably like there would be in oncology. and because of that complexity and the business that has to be set up, I was just saying actually to someone this morning who's getting into CNS, and they are a site. And when you, when you train someone to think CNS, they're thinking like tho- those types of therapeutic areas where they might not have to put as much, into the infrastructure like, like you would for something else. So like even the investment, the team, the experience of the team, um, the recruitment strategy, among many things. But, the point is, it's incredibly rewarding. And then the other side, Sean and I, and K2, they, they tend to be the group that we use when we need one, two sites for like an Alzheimer's trial, could be Parkinson's. Sean and his team have great, personnel that can speak the weeds of trials, to say the least, and tend to be very good executors of those studies. so when I, when I'm kind of talking about the various experience here, I always see Sean, especially in neuro. He knows his material

Jimmy Bechtel 7:02

Sean, how about your perspective on that? I mean, what keeps you going in the CNS beyond maybe some of the tr- trauma bonding that Christian kind of mentions?

Sean Stanton 7:09

My family's personally touched too, just by, like, the Alzheimer's space. So just to me, there's, there's a personal element and then I think we're on the brink of discovery. Some great things are gonna happen in this space where we might be able to not cure, but really find really, really solid solutions in neurodegeneration. mental health, you know, I'd say, like, with the wave of these psychedelics that are coming in, we're seeing incredible response. So I think we're actually gonna see some really great things, and there's nothing better than seeing that happen for patients. And especially when your families are touched by it, you know, you're kind of even equally... You have this, like, bigger push to it. So there's that, I think. and I think what Christian's saying is, like, it's, clinical trials since it- my first job. So it's like I love everything that I do. And, Christian and I, have known each other for at least two decades, maybe more, and, that common group trying to solve problems, you know, in this, these therapeutic spaces are incredibly rewarding. It's, like, becomes, like, part of who you are, not, like, a job.

Jimmy Bechtel 8:10

Yeah. It becomes such an intimate, relationship that you build because of, you know, the, the challenges that you face and the uniqueness of it and the camaraderie and the, the relationships. It's really, really great to see. we know that sponsors and CROs have a lot of options when it comes to the different partners that they work with and the different organizations and the directions that they wanna take with their portfolio. So Sean, maybe start us off talking about what types of things you had to get right to earn trust in this space.

Sean Stanton 8:36

So I'd say the number one thing when I, I read that or see that is, what did we get right? you're only as good as your last study, so if you don't perform, you know, you're probably not gonna get the work. And honestly, you learn pretty quickly that when you don't do well, you own it. You own it, you come back with solutions. You don't come back with complaints and problems. and then an element of this too is, like, we're the people that we have in our offices that are fighting these diseases are usually touched and connected to it. So when you find a group of people that are trying to find a cure or a cause to help stop these diseases, it becomes like a force. So, it will stop at nothing to try to help people with these diseases, and it's beyond just, you know, a business. it's a mission.

Jimmy Bechtel 9:20

yeah. Well, I mean, that mentality, right, you know, I want... Christian, I want your perspective on this as well, but that mentality most certainly directly translates into the operation and the execution of that clinical trial as a result. That, like you said, Sean, that personal investment into the outcome of what's happening carries a different connotation than someone who's treating it like, simply like a business. So I think that's an important distinction.

Sean Stanton 9:43

It's their baby, and we're trying to take their baby across the line. I always say, we're their first stop at, like, babysitting their child. And They're dropping them off at our house. And it's like we try to take care of it just like it's our own child.

Jimmy Bechtel 9:57

And then give them the report card of all the data at the end of the day, right? Exactly.

Sean Stanton 10:01

Yes.

Jimmy Bechtel 10:02

Christian, how about you? I mean, what kinds of things from your perspective have earned trust, and then what needs to be done right in order to maintain that?

Christian Burns 10:09

To piggyback off of even what Sean said is the, the studies are complex. you know, anxiety is like a 90% screen fail rate, in some of these trials right now. Alzheimer's, what do they say, Sean? It's like 2% of patients that have Alzheimer's actually qualify for Alzheimer's so the difficulty is immense. so even when there... As Sean said, it's you're only good as your last trial, which, makes sense. But sometimes I always wish, especially on the site side, like if you can communicate yourself, if you can communicate through the ups and downs of these trials, you will You will come out successful even if you don't meet exactly what you thought because of the difficulty. So ultimately- to me is if you're good at communication, you, you understand enough about, how to operationalize these things, and where staff and recruitment strategies, whatever it is, you know, you, you will tend to do really well. Having said that, because I talked about earlier how the space is very tight-knit, people stay in the space, they don't forget. So if you do make some of those mistakes, They'll follow you because they don't forget. They'll follow you much closer.

Sean Stanton 11:13

Yeah. I think he's right though. Like investigator communication and engagement, it means as much as the numbers you promise. It's like when they're communicating, you know, what goes, right and goes wrong, it's like it's super valuable.

Jimmy Bechtel 11:27

Yeah. Excellent points. Well, I wanna kind of continue that thread a little bit here. As you guys both articulated it, we do feel like we're at this inflection point, this culmination of work in the CNS space now with a lot of really interesting approvals and strategies and momentum across all these various indications that fall into the CNS bucket. But Christian, what does that mean to you? Right? I mean, both you guys have been in this space long enough to have seen, where all the work that it's taken to get here. So what does that mean, and how is it shaping where you take your organization and the work that you're, you guys are doing?

Christian Burns 12:02

I think if you look at each CNS as a, as a global kind of term, and then you, you break it into psychiatry and neurology, for us, we are trying to foster good clinical trials, through sites that need some support and infrastructure. But to do really well in CNS, whether it's a psychiatrist first or a neurologist kind of first site, we are trying to help sites be successful. I mean, you can be good at both, but, you tend to be good at one before you're good at another. Psychiatry, you can do Alzheimer's, maybe the late-stage Alzheimer's, and then neurologist is gonna do maybe more of the early side, and of course they're not gonna They might not get a shot at some of the psychiatry indications like psychedelics, even though they, they do have the opportunity to. but yeah, for us, we're gonna continue to focus on how do we centralize data, how do we get the right team members that understand CNS, that are kind of project managing across the site, solving the problems, talking to the CROs, talking to the sponsors, making sure sites have what they need. And, we put into our post, so I'm gonna stop with this even though everybody's throwing AI so much in every conversation, and I love AI as well. But Sean, I don't know about you, but since we just came out of ASCP last week, every sponsor and CRO, in our meetings, they came in, they're like, "Yeah, we wanna get back to trying to get closer to the sites." I just thought that was interesting. Everybody said that- in their own way. but they did not say the AI thing in cNS,

Jimmy Bechtel 13:25

Sean, how about your perspective on that? I mean, how is it shaping the direction that you're taking K2?

Sean Stanton 13:29

You're hitting a point that, like at the, on the neuro side too, like when you look at the biomarkers and the digital ways to identify patients, I've never seen studies in some of these spaces go as fast as they're going. So sites that I think that were less good at clinical diagnostics are performing at higher clips. So for us, we have to get faster, we have to get bigger, we have to get smarter, and so we're constantly thinking about how to change our recruitment efforts. and then now that you don't have a 12-month enrollment period, you have six months, it just changes the whole dynamic of how the offices are running. So for us, it's like I keep calling it, like you gotta flex or pivot, you know, constantly because the trials are fairly unpredictable on how fast they go. so it just means it's more of a challenge. I think you just need to have, you know, you gotta staff up, you gotta, you gotta get really creative on the recruitment. Basically, you gotta create cohorts that are ready before the trials actually begin, and those are the sorts of things that we're kind of preparing for, like for these disease states. Less in psychiatry, I think, than it is in like neuro, but it is happening there too.

Jimmy Bechtel 14:35

Thank you, Sean. Thank you, Christian. I think that's a, a great place for us to start to kind of, move into closing out the conversation here. But, you know, piggybacking on that, Sean, when we look 5 or 10 years out how does some of those things translate into success for your organization or even just for CNS, research as a enterprise?

Sean Stanton 14:52

I personally believe that, this biomarker, this precision health will emerge at a, a way that we haven't seen ever before. And I think that we'll be looking at, patients without disease that have risk factors to disease or genetic vulnerability, and we'll be utilizing cell and gene therapy or therapies before the disease hits

Jimmy Bechtel 15:13

It's, pretty exciting. I'm, to be able to not even have to wait for a patient to, to come in with presenting disease and be able to shape, alter their, the course of their lives before they even have to have anything to worry about is pretty, pretty exciting. Christian, anything to add? You know, what is your perspective on the 5 to 10-year outlook for your organization or, or CNS research?

Christian Burns 15:32

There's gonna be 5 to 50 different Seans, but they're AI versions of Sean. Well, since he, you know, Sean hit the neuro side, I... on the psychiatry side, I honestly think the psychedelics, And just so you know, like, not even my data, Sightline, I'll quote on, on a source here, it's like for the first year in, like, 20 years, oncology, studies are down, and CNS studies are up. you know, so you, you basically have the pendulum for CNS kind of moving faster than oncology right now, which is interesting. but just to- Yeah to get back to my point, the, psychedelics are starting to crawl into other therapeutic areas. We tend to think of them right now for psychiatry. the end result of psychedelics is you basically take people off drugs, which psychiatry has never had treatment that, you know, they basically had a similar type of result. and then you're starting to see it in women's health now. You're starting to see it in pain. So I think five years out, because I find myself talking about CNS so much for people, especially for good sites that need something like that have the potential to get into something like this to be better. I find myself always talking about it because I think they're just getting started. I think it's gonna be around a long time. It seems like the runway just started. and I think that the, the window of opportunity is immense. and it's kind of like a, like a GLP-1 is the, is the cure. It seems like it's, it's used for everything- you know, or it's going to be used for everything. Sure. That's whether we like it or, or not. But psychedelics is kind of like the sleeper that's gonna come out of nowhere that, that's gonna have a similar type of result, for many things dealing with the brain. I'm excited to continue to watch it and hopefully see, 15 to 50 different AI versions of Sean by the time I'm done. What do you think the buzzword will be in five years? not virtual or AI or diversity, what's it gonna be in five years? What's the word?

Sean Stanton 17:17

Robot.

Christian Burns 17:18

Come on, you gotta guess. This is like a time capsule.

Jimmy Bechtel 17:20

I mean, I couldn't have even guessed what's happening now, y- a year ago, let alone five years from now. Gene therapy.

Christian Burns 17:26

Prevention. Yeah. It's preventative health now, not disease.

Sean Stanton 17:30

Something with aging, right? 'Cause e- if we're all gonna not age anymore soon, I mean, that's the-

Christian Burns 17:34

longevity.

Sean Stanton 17:35

Yeah. longevity, better word.

Jimmy Bechtel 17:37

Well, well, thank you, guys. thank you both. it was great to have this conversation and learn about, you know, what your organizations are doing kinda collaboratively and the future direction of, treating r- a really, really complex, therapeutic area. So thank you guys both for the conversation today.

Christian Burns 17:52

Appreciate it. Thanks. Thanks for the time, Jimmy.

Jimmy Bechtel 17:53

and for those listening, we look forward to continuing discussions like this, highlighting other important pieces of information and industry-changing initiatives through other avenues within SCRS, like our site-facing publications, as well as our events that are available on myscrs.org. I look forward to having more conversations like this in the future, but for now, thanks for listening, tuning in, and until next time.