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Bringing Clinical Trials Into the Neighborhood

Bringing Clinical Trials Into the Neighborhood

Released Thursday, 25th August 2022
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Bringing Clinical Trials Into the Neighborhood

Bringing Clinical Trials Into the Neighborhood

Bringing Clinical Trials Into the Neighborhood

Bringing Clinical Trials Into the Neighborhood

Thursday, 25th August 2022
Good episode? Give it some love!
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Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are proud of the amazing work that pharmacies do to support patient health and wellbeing. The need for innovation in the clinical trial ecosystem has challenged traditional pharmacies to rethink their strategy since they are the ones with the greatest access to a diverse and underserved population. On this episode of People Always, Patients Sometimes, we hear from a member of the clinical trials team at Walgreens that recently announced a corporate launch into providing clinical trial services at neighborhood store locations. Adam Sampson, head of clinical delivery operations for Walgreens is one of the team members tasked with managing the plan at clinical trial services to brick and mortar locations by the end of the year. I hope you enjoy this conversation on People Always, Patients Sometimes.

 

Janet Kennedy: (00:53)

Hi, I'm Janet Kennedy and a member of the Spencer Health Solutions team. I'm looking forward to speaking with today's podcast guest, Adam Samson on People Always, Patients Sometimes. Adam is the Head of Clinical Delivery Operations for Walgreens, and he has a really big project in front of him. Welcome to the podcast, Adam!

 

Adam Samson: (01:12)

Thanks so much, Janet. I really appreciate you having me on the show.

 

Janet Kennedy: (01:15)

Well, you know, we've heard a little bit about you from my CEO, Tom Rhoads, but I'd really like to figure out how you got where you are today, especially from your startup background. So do you mind giving us a little bit of a catch up with your career and how you ended up where you are today?

 

Adam Samson: (01:31)

Yeah, I'd be glad to. So I started my career in clinical trials as many people do, you know the cliches - to say that we kind of fell into the industry. I was a registered dietician out of undergrad and very quickly found my way into interacting directly with patients as part of clinical trials and worked as a clinical research coordinator for a few years and transitioned from there about 10 years ago into the more business side of our industry. So I worked at a couple mid-size CROs, took a very standard path. I was a regional monitor, worked in project management in line management. And then about seven years ago, my wife and I moved out here to North Carolina and I worked at Duke Clinical Research Institute for a few years. While at Duke, I did a lot of work in government funded trials in the pediatric space and completed a master's degree through George Washington in clinical trials.

 

Adam Samson: (02:28)

And then I moved to a large pharma company and was conducting global, late phase studies. And then the pandemic hit, like many of us, I was, scrambling to keep my study going. You know, it's a hundred sites in eight countries. And how do we, possibly kind of keep operations, running lots of challenges. It was an eye opening experience around how in this industry, we really are under utilizing technology. That's no surprise to anyone we've gotten a bit better, but especially at that time, the start of the pandemic, getting even things like e-consent and other things approved was very challenging. So I decided to kind of take a leap of faith and join a very small time startup that was in the decentralized clinical trial space and had a great software product, but wanted to really build out their services and operations.

 

Adam Samson: (03:22)

I joined the team when there were about 15 people and was with the team until series B and about 130 people. It was a really exciting couple years and enjoyed working in that space of how do we bring trials into patients homes and give them additional options to participate in trials? The one thing that remains a pervasive challenge when we're trying to do decentralized trials is that technology of course, is not enough. Sometimes patients there's a lack of trust. If things come through via email or they see them on the internet, not everybody wants somebody in their home. Sometimes people want to, go to a trusted healthcare provider, that's local to them. So when I saw this opportunity open up at Walgreens recently, where Walgreens was getting into the clinical trials business kind of light bulb went off, I'd been watching what's happening just overall in the retail pharmacy space.

 

Adam Samson: (04:16)

And, I saw this as just an incredible opportunity to be able to take what I had learned across my career and kind of running trials in the traditional site based model, as well as, more recently working in the decentralized trials model and saying, "What if, we can take the best of both?" And we've got the technology and Walgreens has 9,000 approximately stores in the US. So 78% of the, the us population is within five miles of the Walgreens. What if we can take and plug clinical trials into that, right? There's the existing trust within the Walgreens brand and with the pharmacists that these patients are seeing every day. And we can really build a model on a really strong foundation that Walgreens has started to build in the healthcare space. So I joined the team as Head of Clinical Delivery Operations, as you said. And my role here is really to operationalize our stores, our physical footprint. How do we make sure that we have the right people process and technologies to be able to start seeing clinical trial patients within some of Walgreen's locations?

 

Janet Kennedy: (05:26)

All right. So let's go back a little bit to joining Walgreens in clinical trials. This is very new for them and you are in a very new group at Walgreens, are you not?

 

Adam Samson: (05:37)

Absolutely. Yeah, you're correct. So about seven months ago, actually I might even take a step farther back than that and say spring of last year, we had our new - no longer new, I guess - CEO, Roz Brewer, joined. And Roz, very quickly - I believe it was by, by fall of last year - announced that we were moving into the healthcare space with the offering of Walgreen's Health. As part of that vision that she had, right? Overall moving to a more interoperable health type framework to ensure for our patients, our main constituents here at Walgreens, that we were not decoupling them from their healthcare providers, but really helping to bridge that care continuum. Part of that offering, they realized clinical trials could be part of this, right? So about seven months ago, my boss, Ramita Tandon, our Chief Clinical Trials Officer, joined the team, joined Walgreens Health, and she began to lay the framework for what this clinical trial business would look like. What services we might offer to begin with, what are the key roles that we needed leadership to get going?

 

Adam Samson: (06:50)

And then Ramita, a couple months ago started bringing on other folks like myself. So I've been with Walgreens - I believe this is the end of week six for me - we've had some folks on a couple weeks longer, or a couple weeks less than me, but we're coming from different backgrounds. We have folks on the product side, we have folks who are really accustomed on digital optimization and how do we engage with patients in a meaningful way, making sure that we leverage our footprint to engage with folks in diverse communities. so really exciting to be part of this new and growing team.

 

Janet Kennedy: (07:29)

I am both thrilled and awestruck for a huge company like that to make such a big move is amazing. And I keep thinking, you're trying to move a tank when the industry needs to be on motorcycles. That might be a horrible analogy, but it's a huge company you said over what, 7,000 locations within five miles of individuals. So how do you do that? Are you cherry picking certain markets or certain states where you already have some of those type of services in play or is this literally you're starting from a blackboard and you're just starting from the very beginning.

 

Adam Samson: (08:09)

Yeah, it's a really good question. And honestly kind of going back to when I first saw the opportunity open up here for a position with Walgreens, my first thought similar to years I think was how could this possibly happen as a company so big, right? how could you possibly get something this big done, and after a call with Ramita, it was quite clear to me that Walgreens was very much invested in this, but also that they had the leadership team Ramita included to really make this happen. I've been blown away since I've joined at not just our small core group that is starting, but outside of that, in the Walgreens ecosystem, just a lot of excitement around Walgreen's health and clinical trials in particular. So obviously we're part of this larger company, but we are somewhat entrepreneurs, right?

 

Adam Samson: (08:54)

We are being given the opportunity to start something new within a very large business and allowing some flexibility around how we might be able to make sure that we can do that in a way that is both effective and compliant, but also nimble. Now 9,000 stores - obviously we're not gonna try and open them all at once and, and activate them as clinical trial sites. The biggest thing on my mind right now is I'm traveling to a number of different locations. We have other folks on our team who are as well meeting with stores, understanding capabilities. We have identified already a number of stores that really are the ideal kind of first step, if you will, to be clinical trial sites. So we have a few investments, key investments that we've made, and some companies that I'll talk about that will really support that.

 

Adam Samson: (09:47)

And also, I will say that Walgreens has, we've started building out what we call health corners. So this has already been happening for a year. Plus health corners are a place where there are a small physical footprint within a Walgreen store. That's staffed with a registered nurse or a registered pharmacist. They have private health rooms and they have places to interact with technology. And it's a place where our patients can go and they can have deep discussions that can help them with chronic care. They can have blood pressure drawn, maybe they could have, blood taken, these type of things to help with chronic disease management and others questions that might come up. Our idea first is to leverage these existing capabilities, as you can probably draw the connection there, right? We've already got nurses, we've got a private health space.

 

Adam Samson: (10:39)

So we're gonna use that and make sure that we put trained clinical research professionals in place to support these activities within these spaces and support them with centralized staff as well. Now we don't wanna stop there. we don't wanna be limited. Now we are somewhere in the range of 200 health corners. I believe by the end of the year, we don't wanna only focus there. As I mentioned, we have some, some other key partners. One is village me medical or village MD. So village MD is actually a primary care offering in a community based setting. And these will be co-located with Walgreen. So this is actually 3,200 square feet of a Walgreen store that will be dedicated to primary care staffed with physicians and other clinicians. So this is another great opportunity for us to be able to leverage the existing Walgreens Health enterprise, to be able to plug clinical trials in make sure that we're doing it in compliant way, but utilizing the existing infrastructure.

 

Adam Samson: (11:38)

There are some other exciting partnerships we have with Shields Health and specialty pharmacy, as well as CareCentrix in post-acute and, and home care. But as far as the physical space and building that out, that's where my focus is right now. How do we activate existing health corners and Village MD, but also looking at our our physical footprint that's out there that has private health rooms because of the immunizations. We administered approximately 63 million COVID vaccines. These spaces are already being used for healthcare purposes. How can we staff those stores and make sure that they are compliant to do certain clinical trial procedures, lots to think about long winded answer there, but really, really kind of cool work to start conceptualizing.

 

Janet Kennedy: (12:27)

I've spent a little bit of time in the shopping center industry. So I feel like I've got a grasp of retail space issues and questions. And let me ask you this. A lot of the Walgreens, I would imagine in more rural or suburban areas have lots of space, but not necessarily in downtown Atlanta or downtown Raleigh or downtown New York city, are you gonna be able to find the space you need in those urban populations, which also are in areas that wouldn't be dealing with underserved populations?

 

Adam Samson: (12:58)

Yeah. And I'm glad you mentioned that too, because this is as we've been very public about in our announcement, one of our biggest focuses right now is making sure that as we are opening up these type of health corners for healthcare purposes, but also our clinical trial purposes. So more than 50% of Walgreens stores are in socially vulnerable areas. And right now there is a huge push in industry and for very good reason to increase, diversity and inclusion within clinical trials, as we're looking at potential locations of where do we start doing this? We're not making it easy on ourselves. We're not, yeah. Let's, to your point, right, go to just the stores with the highest volume or anything. We're very much focused on going into places where there is not as much access to clinical trials or healthcare overall, and areas that are in communities that are overall just underserved. We have already started having these discussions with the the regional managers to identify those stores where, to your point there's only so much retail space or pharmacy space, and this is another thing that we're bringing into stores.

 

Janet Kennedy: (14:08)

Well, you know, I'm wondering about how you're finding out what the needs are. Have you been in communication with some of the larger pharmaceutical companies in a, a, what if scenario, you know, if this were available, what kind of things could we bring to the table? What would you need to get from us? Obviously, patient records are a big part of what you have and also from the geographic location. I mean, so often now clinical trials are done where the principal investigators are. And a lot of the principal investigators are in larger city centers where there are medical centers and universities. How do you balance those needs with what do you actually have to have for the space to conduct a clinical trial?

 

Adam Samson: (14:51)

Great question. And so, yeah, when it comes down to it and what I've spent a lot of the past two years prior to coming to Walgreens doing is trying to figure out how can we leverage some of these new models, right? So how can we leverage, not necessarily even fully decentralized hybrid type models. And we're looking at that with Walgreens too, right? How can we potentially have something at something like a Village MD where there's primary care and physicians and have kind of a hub and spoke model potentially right. Where we would have a PI within a certain region that might be conducting activities within a larger clinical type site, but then have within perhaps a 40 or 50 mile radius, we have X number of Walgreens locations and patients are able to go there for perhaps some of the follow up, right? They can meet with coordinators and have their blood drawn. They can have assessments done, and then if need be, they could come into the to the larger, location for certain procedures throughout the course of that trial. So looking at it in a very broad way and saying, we need to make sure that there's that PI oversight. How can we enable that though over a bit of a larger distance through centralized administrative support, as well as really best in class technology,

 

Janet Kennedy: (16:07)

As I think about a Walgreen's on every street corner, what about the idea of the local Walgreen staff actually going to the patient to their home? Is that something you've discussed?

 

Adam Samson: (16:18)

So we are absolutely looking at also as an option, not just in store, but also bringing this at home, in a doctor's office via mobile app. So we will be in addition to the existing Walgreen staff, which we very well are looking at opportunities for folks to be upskilled into clinical trials. We will be partnering with folks like, those that we have potentially over at CareCentrix and others that are accustomed to working within patients homes so that we can offer that as a service as well, where we could if it's permitted by the protocol, be able to, rather than have patients come all the way into a larger clinic or even to have to drive 10 minutes down the road to a Walgreens that we could potentially go out for certain things like blood draws and other things, and be able to see patients in their home, especially for those type of conditions patients might have where it makes access to clinical trials has decreased because of decreased mobility.

 

Janet Kennedy: (17:16)

Now, the patient is obviously an important part of what we're talking about because that's one of the reasons that clinical trials do struggle that it isn't wrapped around what the patient needs, what the patient expects and how to support them best. Have patients been involved in these kinds of conversations, has Walgreen committed to any kind of patient advocacy committee group or focus group or anything of that sort?

 

Adam Samson: (17:41)

Yeah, I mean, it's very early days, I will say, right. So we did launch just last month, but I am thrilled that we have on board, some folks like Kendal Whitlock who comes with just vast experience in this area, right? Working with patient groups and ensuring that we get that type of representative voice within our research program. we're also talking some other organizations right now that I can't share publicly just yet. but really positioning ourselves very early on. Like I said, we're only a month or so in since our launch to make sure that we are not assuming what our constituents and what our patients want, but making sure that we're hearing directly from people within the communities. Another thing just to kind of bridge off of that is we're looking at not just how do we inform Walgreen's patients and customers about clinical trials that, that might qualify for them, but also how do we kind of help the industry and our patients with this grassroots basic general clinical research, understanding and education, because as you well know, the barriers in a lot of these communities to clinical trials is either a lack of understanding or a lack of trust.

 

Adam Samson: (18:56)

And if we just go in and, and start advertising clinical trials and every single Walgreens, I don't think that that's really gonna solve the problem. So we wanna be able to do some of that foundational clinical trial education through our pharmacist, through, through other staff to really start to build those connections with patients and hear from them so that that can help us inform our strategy.

 

Janet Kennedy: (19:21)

Well, that's really exciting because aside from the two things you already mentioned, just awareness that a patient could be eligible for a clinical trial is a real challenge. So I think the opportunity that you have to make folks aware that it's happening on my street corner is a lot different than, you know, what a lot of patients experience. And certainly if there is at all, a silver lining to the pandemic is that I believe people became aware that clinical trials are an essential part of forwarding health and forwarding the learning about drugs and new ways to deal with illnesses and diseases. So hopefully people have also understood that it is a process that while doesn't happen overnight, we were able to escalate that during the pandemic, but that it's essential that we have patients a part of the process.

 

Adam Samson: (20:16)

Absolutely. Yeah. And this idea of trying to assume what patients might want or to kind of do those checkbox activities of like, oh, well, we talked to a patient. I think, as an industry we're, we're moving past that. We're understanding that this is more than that, that we really need to engage in a meaningful way and that it's not a one and done kind thing. And I've been really glad to see that Walgreens very much is taking that approach to everything. And across the Walgreens health platform we have 160 million approximately lives that we service through Walgreens. And the trust that we have with those customers and those patients is something that is really first and foremost to Walgreen. So as we look at things like supporting, recruitment, as part of clinical trials, looking at insights gained through real world evidence, we have a really robust foundation around regulatory and privacy to make sure that we're not in any way violating that trust. And we're giving our patients, our customer the opportunity to opt in and opt out of these type of things. So that it's again seen as something that we can engage with them on, in a way that works for them, get their feedback. But if they're not interested also be able to not push the issue beyond the point where it should.

 

Janet Kennedy: (21:44)

Absolutely. I think that should be the tenant of any healthcare organization patient first and what are they going to be comfortable with? Well, I'm really excited that I was able to capture you so early and fresh in your experience with Walgreens and at the very beginning of your more public announcements related to getting involved in clinical trials. And I'm not gonna put you on the spot per se, or hold you to this, but what does it really mean? What's it gonna take to get you up and running? And, and when will the first clinical trials be supported at a local Walgreens

 

Adam Samson: (22:19)

We're shooting for this year, right. We, we want this to take months, not years to get off the ground. There's already, as I mentioned, been some groundwork done even before this initial team has started, there's been some really great work done by folks here at Walgreens to make sure that we're gonna be able to roll this thing out in a very compliant way. And now we got the folks on board that are needed to really start executing. And we're not starting from zero as well because we have as I mentioned, some physical locations that are very well staffed and set up to be able to support clinical trials. So we don't wanna rush, we do wanna walk before we run, but we anticipate that this year we will enroll patients within, a small number of clinical trials and start to get the wheels moving on this and then learn and, and build over time to be able to offer an increasing number of services and to be able to, service protocols of increasing complexity. So yeah, I would say, and expect by the end of the year to hear that we've had our first patient in store and certainly even before then, that we're, supporting recruitment in different ways as well.

 

Janet Kennedy: (23:27)

Oh, that is very exciting. Well, I look forward to not only catching up with you in six months, or a year and finding out how things rolled out, but also speaking to other members of your team, hearing maybe a little bit more about how real world data and real world evidence will be incorporated into the programs; how patient engagement is going. So let's continue the conversation and thank you very much for being a part of People Always, Patients Sometimes.

 

Adam Samson: (23:54)

Absolutely. Thanks so much, Janet for the opportunity. I look forward to reconnecting, and thanks so much everybody who listens.

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