The Power of Proximity - Nick Bruggeman

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HANNAH LIPPITT: Hello

and welcome to the Totally Clinical podcast brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges, and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and most importantly, the people benefiting from clinical research. So, tune in, settle back and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT:

Today, I'm joined by Nick Bruggeman. Nick is a founder and Vice President at CCT Research, a company that offers an innovative approach to conducting clinical trials by bringing a clinical research platform directly to senior living communities. Nick's here to tell us about his journey, starting with explaining more about his background as a second-generation clinical research company founder.

NICK BRUGGEMAN: So I will start off – I always make the joke, my father, David Bregman, didn't actually start from scratch, and with the research company, he, him and his business partner purchased a company called Clinical Research Advantage back in 2007. Clinical Research Advantage at that point in time had four research sites across the valley – the Phoenix Valley – and what they did was actually embed their clinical trials into physician offices, and most of these offices were primary care general medicine, family practice offices where, like I said, they had they would staff the research staff and they would utilize the EMR system to recruit patients, but they would also utilize the physicians to oversee the research. So he grew that pretty quickly here in the states, I think grew it to about 30 locations across six or seven states if I'm recalling correctly and then purchased a company called Radiant Research.

Radiant Research had a little bit different of a model. They actually had a standalone research model where they would utilize outside recruitment efforts to drive patients into their site. So that was, I think, back and that was in 2011. If if I recall correctly. But I actually it's really funny. I worked for my dad all the way from and I know it says, you know, I was 22, that's when I actually stopped working for it. But when I was 18, I was coming into the office from nine to two, helping the regulatory division out. I called myself a regulatory assistant. I make the joke that I was just scanning papers and building source documents from a printer. I also did a lot of the inclusion and exclusion type ups and was building rate binders.

So that's what I did as a regulatory assistant. And I actually would come into work for my dad wearing flip-flops and shorts, and everybody would, you know, make jokes about the whole wardrobe that I wore. I think looking back on it, if I knew where I am today, I probably would have taken that role a little more seriously. But it was exciting to see and be a part of research at that time. I believe that's when the H1N1 vaccine was coming out, and that was the big craze. It was interesting to see some of these higher volume studies coming through. But I was a part of that from a very small section of the business. But it was great working with a lot of these different people. And I mentioned before they purchased Radiant Research, which then led to a purchase from PPD. And that's when my father

got out of clinical research, which was about six or seven years ago.

HANNAH LIPPITT: So you've got a lot of experience in the industry from a young age, and you were then inspired to set up CCT Research. I know that you initially chose to focus on patients with Alzheimer's. Why was that?

NICK BRUGGEMAN: It's a great question. So CCT Research technically stands for cognitive clinical trials. About early 2017, we had the thought of running Alzheimer's studies and site senior living communities. Myself, CJ Anderson – who's the president – and Alex Knobbe – who's our CFO – us three founders really have a passion for Alzheimer's research. We've all been affected by it in some way.

So, the idea of running research inside of a senior living community really brought the patient focus to research, right, where the goal was. If a patient that's – or a resident – is in our study, they could go down the hall and knock on our door and talk to the coordinator. And that was the idea that we had because a lot of times Alzheimer's and dementia research is not accessible to patients. They may have to drive hours just to be a part of a study.

Our goal was to bring multiple senior living communities to light by embedding research into the community across the whole valley. So we had sites in the west valley, we had sites in downtown Phoenix, we had sites in Scottsdale, we had sites in the east valley, and the goal would be: “If you qualify for a study, we're going to do whatever we can to get you in and be involved.” Right? And it was extremely easy for the residents to be a part of it.

But the one great thing that – not the one – but one of the great things the senior living communities did for us, is they gave us a great point to operationalize a site, right? The communities really understood the value that research is bringing to the community, because there's – especially here in Arizona – there are senior living communities going up daily and to be able to offer clinical trials as a hope to cure Alzheimer's was something that the neighbor wasn't doing, right? Every time you went to the community, every time you heard what great... hair salon they had or movie theater or the cafeteria and the food they eat, which is all great, but you didn't really hear people talking about the problem of Alzheimer's and memory loss, and that's what we were set out to do.

So, yeah, that was kind of our goal and our mission early on with CCT.

HANNAH LIPPITT: We've seen so many breakthroughs with other diseases, but not so much with Alzheimer's. Why do you think this is?

NICK BRUGGEMAN: It's a really tough question. I think there's, you know, a few different reasons and this is all what I believe in being in the Alzheimer's industry. So really, it's an elderly disease, right? As you get older, these things happen. And I think one thing is we're still figuring it out, right? Brains are evolving and you know, things are changing every day where I think, you know, 50, 40, 50 years ago, people were not living to the ages of 80 or 90 years old. And now they are and they're not being diagnosed until they're 80 or 90, right? So they’re a little bit past the time that they need to catch Alzheimer's right? And go to a neurologist or an Alzheimer's specialist to really figure out what's going on. You know, that's one kind of main reason why I believe there hasn't been any cure for Alzheimer's.

The second one is as trials go through the phases of research, right? Pre-clinical, Phase I, Phase II, Phase III, Phase IV. I do believe as they go through the Phase II and Phase III – when they're trying to meet endpoints – they don't really match up and the data is not there. So they have to scratch the whole protocol and get back to the drawing board. I will say in the Alzheimer's industry, we like to say bad data is still good data, right? We know that this didn't work. Now let's scratch that and start with something new and something fresh, right? Why didn't this work? Let's work on a new medication or try some other neurological stimulation type study where... let's see if we can push that forward. So, I believe that's another part.

And then kind of the last part is there's a lot of studies out there that some, some sponsors and crows are looking for 100 sites, right? And if they go to 100 different sites, that's 100 different companies working on the research, right? And I like to believe everybody is following the protocol and everybody's following the regulations and things like that, which I do believe people are. But you know, there's always different people working these studies and there could be different data coming back because they are working with a hundred different types of sites, right? So, there's probably not consistent data across the board to keep moving these medications through the phases of research.

I will say that I think we are setting ourselves up in the next 10 plus years to really see some advancements with the technology that's come about. So, I'm excited. I think if we're

going to a place that's going to really see some positive feedback moving forward.

HANNAH LIPPITT: So COVID-19 has changed the way a lot of companies operate. How has the pandemic changed your focus as a company?

NICK BRUGGEMAN: Our business was built around senior living communities for the first year, year and a half. We were strictly running Alzheimer's and dementia studies from these communities. COVID hit, and we were pretty much locked out of our communities. Not because, you know, they wanted us not to be there. It was because we had to not be there. And the regulations are actually still changing daily inside of our communities that we were in. We actually had to pick up and move our studies to neurology offices because we did not know how long this was going to last and we were not able to step foot back in these communities unless we were a resident.

But what that did for us was we can now open up the range of CNS indications. We now run migraine studies, we now run Parkinson's, MS, ALS, you know, still running MCI and Alzheimer's studies, but we can now run the whole array of CNS trials – which is great. Now we can offer more hopeful medications to patients and all different types of neurology indications.

So that took place. And we realized we couldn't put all of our eggs in that basket. These studies are very difficult. All neuro studies are difficult. It's not... you will not find an easy neuro study, but my background, you know – being involved in my dad's company – was family med and internal med of primary care studies. So I knew a lot of physicians in that space. And I actually had physicians reaching out to me and they said, “Hey, Nick, I heard you starting a research company. Can you... is there any way that we can get involved?” And that kind of opened up the door for our ...sites. And with COVID, we also believe that that's where the research was kind of shifting as you... if you speak to a lot of sponsors and CROs in the industry, a lot of their other studies and protocols were put on pause due to COVID.

So we knew we can run vaccine studies. We knew we'd be able to run treatment studies, and even diagnostic studies, and we kind of pivoted to that and it actually catapulted our growth. I think when March of 2020 hit and the world kind of shut down, and CJ Anderson – our president – got everybody on a Zoom call and said, “Hey, we either have two options. We can either, you know, kind of pack up and weather the storm or we can flourish in this environment.” And we kind of did. We jumped

into a growth mode of opening new sites and running

COVID studies out of there.

HANNAH LIPPITT: And I imagine you faced some challenges doing that.

NICK BRUGGEMAN: Oh yeah, we definitely did. So, a few of the challenges, obviously, with people coming into our offices. We had to use more virtual. So, we had virtual visits. We utilize vendors for virtual visits. We also had a lot of our physicians saying that they didn't know if they wanted research to be there at that time. What we actually did at a few of our sites, we set up trailers in the parking lots where we could see sick patients if we were doing COVID treatment studies. But we can also, you know, see the healthy patients for our vaccines inside the practice.

So, we definitely were molding ourselves around the environment and what we needed to do. And to be honest, our sponsors were OK with it. They were happy that we were figuring this out during a tough time. But it's kind of... it’s giving us the confidence that we can run these types of studies. And I mean, I hope this, you know – a global pandemic – does not happen again, but I think we – all in the research industry – have realized what we need to do to excel during this time.

HANNAH LIPPITT: At CCT you're paving the way in a data-driven approach to trials. Why do you think the industry has been so slow to adapt to the changing digital landscape?

NICK BRUGGEMAN: My background and the other founders and some of the executives in this company's background has been all paper-driven research. I mean, it probably four years ago, people just started realizing or companies started realizing that we can do things digitally and electronic. And now we don't need pharmaceutical companies to send CRAs out to a site where we can do it virtually, which is amazing.

And I think the, you know, over the last, however many years, the reason why it was so difficult to change this landscape was because the technology just wasn't there. I think what we have done, especially during the times of COVID, is be able to produce technology that allows for people to, you know, do visits or do things from afar, which is great. And I think that technology wasn't here five, six, seven years ago. Now I think we are moving forward and while technology wasn't always there, it was something that was always thought about. And I think I remember... I go back... I'm going to bring up my father a lot in this... I remember when I first started CCT and I told him we were doing a eRegulatory – so electronic regulatory and electronic source – and he said, “I don't think the sponsors are going to like that.” And I had to tell him. I was like, “I think it's a new time, and I think they have to get behind it.” And that was four years ago.

So, I really believe it's just because the technology at that time was not there to really help push this for it. So, it was always needed research. I'm sure, you know, a lot of people that are listening to this will understand that patients are the most valuable part of research and having and getting technology in place – which I don't even think is there yet, it's something that I think... we're still moving forward – but figuring out how to get patients in studies, figuring out how to get patients involved when it comes to education and material for clinical research trials, I think is still something that needs to, you know, get better and improve.

I think right now, patients still don't know research studies are out there and when people call internal recruitment team or internal recruitment team calls, they're very caught off guard. So figuring out ways from a technology standpoint to get more patients involved is something that I still believe is going to be up and coming, but

I think before is all about the technology and what we didn't have access to at our fingertips.

HANNAH LIPPITT: Yeah, that's incredible. The story from your father. You know the discussion with your father because I think that in so many other industries, things are so much more advanced.

NICK BRUGGEMAN: Exactly I have a funny story. We just hired here at CCT a VP of data and analytics, and he comes from the EMR space. He worked for Cerner and Epic for a very long time. He didn't have any research experience, but... high-level person... and we brought him in and, you know, kind of the first month he was here, we were talking about the feasibility process. And CCT, here we already do a great job at the feasibility side of things because we have access into our EMRs and our databases where we can run these reports to figure out what patients fit our trials, but there's still a sense of like, “OK, even though we have access to 200 patients, how many patients will actually qualify? How many patients will actually say ‘yes’ to a study and how many patients will actually show up for their visit?” Right? It breaks that down, and those are a lot of, you know, things that we can't really measure, right? So there's still some sort of guessing factor in regards to how many people we actually believe were going to enroll in this study. And I think his name is Kyle McAllister. I think that's kind of been the backbone of... what we're trying to accomplish here is figuring out how to take the guesswork out of, you know, the operation, right? And I think that's something that he's embarking on and we are going to be building over this next six to eight months. And I think, you know, his lack of knowledge in the research space is actually a positive where he's looking at it from a different lens, figuring out how do we get this feasibility process so, you know, particularly, where we aren't guessing and when we tell you “We can enroll

200 patients, we believe we can enroll 200 patients and this is why. We’ll show you.” So, It's exciting.

HANNAH LIPPITT: And looking to the future. How do you see the clinical research industry changing over the next five years?

NICK BRUGGEMAN: So one – and it's something that we've discussed over the last few minutes – it's the technology. I think there will be better technology, you know, artificial intelligence and things like that that're going to be incorporated into research that I think is going to help pinpoint patients enrolling patients into a study, selecting the studies that qualify best for sites – I think that's going to come up – but I also believe a big, you know, thing that's going to be changing in the future is moving more to a decentralized approach.

So, I know there are studies that we will need to have a brick-and-mortar building – I hope there is because we would be out of business without brick-and-mortar buildings – but we are also moving to a decentralized area where we can do half the visits from home or half the visits virtually. And I think it's something that probably will help enrollment where we can tell a patient “You don't have to come in for your visit at six because we will call you virtually,” or “We will send a nurse out to your house to do the visit.” Right? I think that's something that is going to be growing in the future and hopefully looking in the future – I mentioned this as well as access to patients – how do we bring patients to these studies?

We already... my company itself already has access to hundreds of thousands, and we're partnering with some large health care data companies, which could potentially give us access to millions of patients. But how do we get those patients in the door? And what do we need to do to have them feel comfortable with being a part of a study because we aren't going to be able to drive trials throughout the phases of research if we don't get patients interested and knowledgeable in research

in the first place? So those are the things I think are going to be the way of the future.

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HANNAH LIPPITT: And that's your dose of Totally Clinical. For all the listeners out there, you can follow Teckro on Twitter – the handle is @TeckroOfficial – LinkedIn, and Facebook, and subscribe to our YouTube channel. And of course, download the Totally Clinical podcast on Apple, Spotify and Google. See you on your next visit and remember to bring your friends. Thanks for listening. Goodbye.

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