Enhancing Trial Agility: Inside Elixia's Innovative Approach to Clinical Research

Join Dustin Owen, CEO of Elixia, as he discusses the company's unique Clinical Site Organization (CSO) model and its role in successful clinical trials. With a focus on enhancing patient recruitment and delivering quality data, Elixia is reshaping how trials are managed in complex therapeutic areas like nephrology and psychiatry. Discover their innovative strategies for boosting trial efficiency and overcoming common enrollment challenges with agile site management.

Transcript

Jimmy Bechtel: 0:01

Welcome to SCRS Talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. Today, I'm joined by Dustin Owen, the CEO of Elixia, here to share with us a little bit about their organization and their partnership with SCRS. Dustin, it's great to have you. Really excited to learn a little bit more about Elixia and what you guys do in the industry. So if you wouldn't mind, I'd love to start us off for our listeners, learning a little bit more about you and Elixia.

Dustin Owen: 0:38

Jimmy, it's pleasure to be here. Happy to share. Thank you so much. And so Dustin Owen, CEO of Elixia been in the role for almost 2 years. Prior to this, I was at PPD Thermo Fisher for about 9 years running a number of executive roles clinical operations across Asia-Pacific and then last role was leading Accelerated Enrollment Solutions, or AES. Where we had arguably at the time, 65 sites across 9 countries, a whole slew of additional affiliated sites and a very large patient recruitment arm. And so, you know, I've seen sites on scale and also know where, you know, I believe the opportunities and needs are in the industry. And that's what we're doing with Elixia. We've paired, you know, 12 sites in six states focused on specific therapeutic areas challenging therapeutic areas with a top tier patient recruitment engine that can support global trials in a number of different tactics. Ultimately, what we tried to put together is solution for sponsors and CROs to deliver on trials. And that's ultimately to get the patients into the trials to stay and generate the data necessary for the trials. I'm based in Chapel Hill, North Carolina, and we're going to continue to grow the business. We have aspirations, but we're going to try to stay very focused on our mission and what we're doing. And again, a lot of that relates to therapeutic area focus.

Jimmy Bechtel: 2:13

That's great. Thanks for sharing that, Dustin, and really excited to talk with you because I know that Elixia takes a little bit of a different approach, right? A novel approach to how you all are structured and your approach to clinical trials, because rather than a CRO, which is a familiar term you refer to yourselves as a CSO or clinical site organization. Can you dive into that term specifically? Explain to our listeners what that means. Then how that affects your role in the research ecosystem.

Dustin Owen: 2:45

Sure, I mean, clinical site organization, you know, heard various terms, SMO, what have you out there, but there's just not very many organizations that combine both site networks with then robust patient recruitment capabilities that are beyond the 4 walls and regions that your sites deal with. And so let me start with the site side. I mean, we're a little bit different on that side as well. You know, we have a combination of wholly owned independent sites, and then we have embedded sites. Our focus on specific therapeutic areas, complex metabolic, think MASH, diabetes, obesity, then going over to psychiatric studies and neurology studies, and then finally, nephrology studies. All these areas are pretty darn hard, and we have models that focus specifically on these, being able to leverage electronic medical records at the practices we embed in, and ultimately deliver a very high number of patients in very challenging trials. Now, on the flip side, we've got a patient recruitment business that is more global in nature, beyond the 48 states of the lower U. S., and able to take on phase 3 trials and in many ways agnostic to therapeutic areas. I mean, why does this all work together? I mean, number 1, we do eat our own cooking, so to speak. Our patient recruitment business does support our sites when needed. Beyond that, I mean, we're ultimately looking to go to sponsors and give them options for solutions when they've got challenges with enrollment. We've got quality sites. We've got patient recruitment that can be at the beginning of the study. It could be later in the study. I mean, we all want trials to ultimately be delivered on time, but we know approximately 50 of them run behind. And so again, depending upon the need, we have a solution to go in there. And again, Yeah. Not everybody has this breadth of service to deliver. And so our patient recruitment business doesn't just support our sites. They support oncology trials and other complex trials. And again, across the globe. So hopefully that answered that question, Jimmy.

Jimmy Bechtel: 5:06

It did. Yes. That's excellent. And I want to dive in and take a closer look, I guess, at that enrollment solution, because I know that you all have consistently been excellent enrollers on the trials that you guys have done across your various therapeutic areas. And you really kind of knocking it out of the park in a lot of different ways, which is great. So, can you share a little bit more about that recruitment solution and how you might have accomplished some of the great work that you guys have been able to do on those trials?

Dustin Owen: 5:39

Sure. Happy to. I mean, I'll focus on a few different areas because we have different models based on the therapeutic area. For our nephrology business, again, we're embedded in very large nephrology practices with 10, 20, 25 different practitioners. And therefore we're tapping into a very large patient database to go after. And we take kind of two different approaches where we're looking at the patients that are coming in on a weekly basis, daily basis. We're also looking to interrogate the EMR records for more rare diseases. And then that's for both kind of an outpatient pre in stage renal disease approach. And then we also have the ability to go into dialysis clinics, which are supported by by our sites. And so, you know, being able to, again, tackle these areas, having the expertise and then the insight work with the providers, the EMRs to identify these patients. And ultimately, we're trying to take a lot of the risk out of delivering on these clinical trials and hit the targets in the numbers that we've shared in feasibilities to ultimately meet and exceed the expectations from our sponsors and CROs. In other areas, we do, again, have different databases to tap into, but we're also very active in the surrounding areas around our sites, and so we leverage again, some of our patient recruitment expertise, and that can come in multiple ways. I mean, there's a lot of companies that can do advertising out there, social media, TV, radio, print, you name it, but we also leverage our local enrollment specialists. These are former coordinators that can either embed and help our sites, or they could be out in the community, talking to referring physicians and other types of outreach, you know specific fairs, could be assisted living facilities, what have you. And so we really take this multi pronged approach to ultimately reach and exceed our numbers for enrollment. And I mean, it takes a lot of effort. You got to have plan A, B, C to make that happen.

Jimmy Bechtel: 7:56

Thanks, Dustin. And, you know, I'd say that that's a pretty consistent and arguably a common theme around success in our industry. Not only having this multifaceted approach, which it sounds like you guys do specifically in the nephrology area, right? You're not just kind of going to one place. You're tackling it from different angles and providing kind of this suite of services to be able to meet the needs of that patient population. But you're also approaching all of these things with backup plans, right? And, and having quick nimble course correction should plan A not go. Like you said, you have plan B and plan C to be able to institute when something may not go exactly as expected, which we all know those with experience, in the industry know that it rarely goes to plan, right? I'm sure plan a happens and is executed from start to finish, maybe 10 percent of the time. So having those plan Bs and those plan Cs in place, you're ready to rock and roll, I think is probably a feather in the cap and attributed to the success you all have seen.

Dustin Owen: 8:57

It definitely is. And it could be something that has worked previously. It just doesn't work as well. Now. I mean, there's different behaviors from from patients out there. There are different therapies coming to market and there's other competing trials. And so you have to be flexible and nimble and that's the approach we espouse. I mean, there's the other side of it where there may be one of those surprise amendments that comes across and that inclusion exclusion criteria that you were depending upon. Now, has been tightened in some way that unfortunately all the time, and all of a sudden, you know, we have to then be pivoting to what we're going to do. And that, yeah, that's where you're having to tap into those backup plans to make sure that, ultimately, the patient funnel is yielding what you need and again, having that multi faceted approach being ready for it is what allows us to to succeed.

Jimmy Bechtel: 9:52

Excellent. And I know, speaking to that point, it's clear that you pride yourself on enhancing trial agility and efficiency and using approaches like that to enable such things to come to fruition. Can you share a little bit more, maybe beyond the recruitment aspect, some of the innovations that Elixia has implemented and how they have ultimately affected the trial processes and brought about some of those agilities and efficiencies.

Dustin Owen: 10:21

Yeah, I mean, a lot of them are on the front end, but just being able to sufficiently support a multi state site network. I mean, we've got a lot of groundbreaking site networks, mature site networks out there, but, I don't take it necessarily for granted that all the steps in the process. Patient recruitment is part of the process, but, having a fast startup approach, having a consistent regulatory approach, having sufficient quality behind the scenes to ensure that we're doing things right the 1st time. I don't take these things for granted, given, you know, as you get to 12 sites, we'll be going to 15, 18, 24, you name it. And we have to have all of that behind us so that our teams ultimately can be delivering, driving delight with the patients that we're seeing, keeping them enrolled and engaged, and then ultimately generating the high quality data that's expected of us.

Jimmy Bechtel: 11:22

It's as easy as that, right?

Dustin Owen: 11:25

Yeah, I wish it was as easy as numbers in a spreadsheet.

Jimmy Bechtel: 11:29

Exactly. I hear you there. You know, Dustin, it's been great to talk with you here. And I do have one final question that I want to tackle here. What role does Elixia local enrollment specialists play in supporting sites? I know this is again, something relatively unique to your organization, or I guess we should say not tremendously common in the industry. And how does this also then affect and contribute to the success of your clinical trials?

Dustin Owen: 11:56

Sure, our local enrollment specialists are different because a lot of the time we can see and identify patient referrals. A number of companies can do that, but ultimately the challenge is qualifying those referrals, getting the patients to understand exactly what they're signing up for and getting them to make an appointment to show up at the site. Our local enrollment specialists, I'll say in one way, increase the efficiency of the inbound funnel. And that's one approach that we take. The other approach I mentioned a little while ago is just, filling in a number of different ways at the site. Again, not every site needs this level of support. And I'm talking about independent sites here, not under the Elixia umbrella, but, they can be an incredibly busy site, enrolling lots of patients, lots of trials, and there's a lot of things they want to do. You know, maybe they're not able to give as much attention to one of their trials. They've got a database that is ripe for again, interrogation. And, you know, the CRCs or infrastructure at the site can't handle it. There could be that long list of referring physicians or sources of patients that the site would love to tap into, but they just don't have the time to do it. That could be, pediatricians, daycares, it could be assisted living facilities, pharmacy, houses of faith, you name it. These are the types of things that our local enrollment specialists again, they're former coordinators, they can do a number of things. And these are the options that we provide. And so they work closely with the site to determine what they need and ultimately how they can get more highly qualified patients in the door so that the site team can do what they do best and that's taking good care of those patients.

Jimmy Bechtel: 13:51

Well, Dustin, that's an excellent place to end our conversation. I want to thank you for sharing your insights and thank Elixia for the contributions that they're bringing to the industry. I hope we have more opportunities to share and talk about, you know, unique approaches, unique models, ways for others to glean potential efficiencies in a way they approach their clinical trials. I think there's a lot for even sites that are completely different from how you guys function. There's a lot for them to understand and to glean from you guys. Because ultimately we're all in the business of finding and enrolling patients and treating them with the highest quality care that we can and helping bring new medicines to market. So thank you again for your contributions and for the conversation today.

Dustin Owen: 14:35

Thanks, Jimmy. Really appreciate the time.

Jimmy Bechtel: 14:39

Well, for those listening, we want to make sure that you don't forget to explore other site focused resources made available to you, like various publications and webinar opportunities on our website, myscrs. org. You'll also find a wealth of content there and details about upcoming engagement and connection opportunities like our Site Solutions Summits being held throughout our calendar year. Thanks again for listening and tuning in, and until next time.