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CHARLES RHYEE: Hello. My name is Charles Rhyee, TD Cowen's Health Care Technology and Distribution Analyst. And welcome to a special edition of the TD Cowen FutureHealth podcast. We're recording this at TD Cowen's 9th Annual FutureHealth Conference on September 10. And I'm joined by Ramita Tandon, Walgreens' Chief Clinical Trial Officer who we're hosting at a fireside chat later this afternoon. Ramita, thanks for joining us today.
RAMITA TANDON: Thanks, Charles, for having me today.
CHARLES RHYEE: Maybe to start, talk through Walgreens' decision to get into the clinical trials business, and why do you think that makes sense now to leverage a retail pharmacy footprint for clinical trials?
RAMITA TANDON: You know, I've been in the industry for a very long time, over 25 years. And some of the issues around clinical trials has been around lack of access, patient access, lack of representation in clinical research.
So as we think about the Walgreens assets and our ecosystem, particularly our direct access to patient populations, our national footprint, and just the trust and brand and scale that we have across the nation, it becomes a natural partner for the pharma industry to be able to leverage this ecosystem to help solve some of their own pain gaps that they're facing in their R&D portfolio, particularly around trying to find patients and patients in communities that have been underrepresented in clinical research or just socially vulnerable areas that they've never tapped into in the past.
CHARLES RHYEE: Yeah. So then what is Walgreens doing? What are the main offerings that Walgreens is providing to the biopharma community?
RAMITA TANDON: Yeah, great question. We launched the clinical trials business in June of 2022 with the aim to redefine the patient experience and really start to focus on tackling the issues around increasing patient access and improving representation. And so as we came together and we spoke to a number of our pharma partners, the idea is, how do we solve some of the pain points that they're facing?
So we built a business model to focus in three service areas, the first being around an insight-driven patient recruitment offering where we're leveraging our direct access to patient populations and help pharma to find those patients and match them to trials. What's unique about Walgreens is that we can actually outreach. So once we find the patients, we're able to then outreach to those patients to gain interest and then get them as part of the drug development process.
The second area is really around trial conduct. How do we bring trials closer to where the patients are in the communities? And so in this area, we've actually created a flexible set of options and modalities, where the first one being we've got pharmacy locations where we've got private health rooms anywhere from 500 square feet to 5,000 square feet, multiple exam rooms, and really using that as an opportunity for patients to really come in, first and foremost, to be educated about a clinical trial.
Believe it or not, Charles, we've got a number of folks who don't even know what a clinical trial is. But once they get educated and they've expressed interest, we can go ahead and consent those patients to participate. And as they consent, we then are offering low-acuity services on site, whether it's screening, diagnostics, blood draws, anything to make sure that a patient's experience is positive and accessible.
The second format is really around the hybrid of clinical trials. And that's really digitizing aspects of the workflow to make sure that we can make it convenient while they can come into the store. And then finally, the opportunity to go at-home. So today we have a trial where we're actually delivering clinical trial services at patients' homes. So that's the second vertical, our service line.
And the third one is really around real-world evidence and informatics. And that's really using the insights that we have on our consumers and patients help our biopharmaceutical partners to really start to answer some of the questions they have as they look at evidence generation planning for their pre- and post-product launches.
CHARLES RHYEE: That's great. You mentioned a little bit before the ability-- leveraging this network to get to particularly underserved communities. Maybe talk about that because obviously, the FDA has made a big push, ensuring that clinical research includes diverse and representative populations for the medicines that would be delivered in the future. How is Walgreens unique in that capability? And what have you seen so far in your ability to bring these populations into the clinical trials process?
RAMITA TANDON: Yeah, it's a great question. Look, just from a statistics perspective, less than 5% of this nation participates in clinical research. And those that participate, 3/4 of the participation are folks that identify themselves as white. So we know that this is no longer a nice-to-have. It's a must. We're starting to obviously see the push from our lawmakers, from the agency, and other parts of the health care ecosystem, like payers, patients.
And pharma's getting more intentional about how they're designing and executing these trials. And they want to make sure that they're enriching their sample size so that when they are able to bring their products or their therapies into the marketplace, it benefits all the patient populations. And so this is where Walgreens is in a very unique position to lead in this effort to help support pharma as they look to find enriched populations.
Just the sheer fact that we have a diverse patient population across the nationwide locations that we serve today, so our ability to canvas our ecosystem, identify those patients by race, gender, ethnicity, social determinants of health information, that becomes a powerful foundation for pharma to leverage and help them find those patients that are hard to reach and they're underrepresentative.
We've got some great case studies today. We've just finished a phase 3 vaccination program where we were able to enroll patients much earlier. We referred within 16 weeks of study start all the patients that were required for that particular trial. And then within that trial, we were able to generate a diverse patient population, double the industry, the FDA standards.
So for today in the Black and Hispanic population, it can be anywhere from 6% to 8%. We were at 15% of Black and African-American patients to participate. And then with the Hispanic population, it's, again, in the single digits. We were able to bring 18% of patients into that particular study. So what we're seeing as we're within the two-year readout is that the capabilities in our ecosystem is allowing pharma to really leverage those assets and go find patients that are in these diverse patient communities.
CHARLES RHYEE: Yeah. And not only interest from pharma, right? I think you recently announced a strategic partnership with BARDA to drive innovation in decentralized clinical trials. Maybe talk a little bit about that. And I think it includes a project on COVID-19 as well. Maybe explain the partnership first. And then what do you think that partnership represents for Walgreens? And why do you think BARDA selected Walgreens in the end?
RAMITA TANDON: Yeah. This is a very exciting partnership for us at Walgreens. Bringing together public and private partnerships together to really start to solve some of these core issues that we've been seeing in the clinical trials industry is significant. And the goals that BARDA has aligns with what we have at Walgreens in really trying to improve representation and increase access of clinical research across the communities that we serve.
So by bringing these two entities together, it really starts to move the needle in how we can bring trials into communities that never have had access before. So we're very excited about this partnership. It's an investment. It's a recognition of the work that we're doing at Walgreens, the effectiveness of leveraging our physical footprint as ways to really tackle the issues around accessibility and make trials more convenient and, more importantly, bringing those diverse patient populations that historically have been left behind or not represented in clinical research an opportunity for them to be part of the drug development process.
So we're very excited about the architect of this partnership and just what it means as we start to execute not only their vaccine trial but as they start to build the infrastructure with us to start to bring more of these trials into the ecosystem.
CHARLES RHYEE: You know, I think when people talk about decentralized clinical trials, I think this concept that DCT originally was more like, hey, we're going to use some virtual care, we're going to use some technology. But I think more broadly, it being decentralized means you don't have to be at the academic medical center or at the investigator site per se. How do you envision what-- what does DCT look like in the future?
Obviously, you look at the IQVIAs of the world or the ICONs, all of them will talk about having DCT type capabilities. I know PPD talks about it a lot, right? So in that sense, how does Walgreens then fit into the broader CRO landscape as the capabilities that you bring-- right now, you're partnering directly with pharma. Maybe we think the broader outsourced market, how do you see Walgreens fitting into that?
RAMITA TANDON: Yeah, that's a great question. I would say, Charles, as we think about the future and the momentum that we're seeing around decentralization of clinical research, we look at it very differently. We think about, how do we bring trials into the communities? That's really what it's all about, right? How do we get more patients across this nation that have never participated an opportunity to participate and also bring in communities that have been left behind part of the drug development process?
So as we think about decentralization, it's about looking at alternative sites of care, like pharmacy, looking at different modalities in how we engage patients, whether they're digital modalities or other tech-enabled solutions. But ultimately, we believe, how do we build that right highway so trials can get closer to where the patients are so that it's convenient and accessible?
And so we continue going down this path. It puts us in a very unique position because we have the scale. We have locations that are very convenient to our patient populations to be able to come in to a Walgreens location that is a designated clinical trial center and participate in clinical research. We certainly have partnered with a number of tech-enabled organizations that have platforms that allow us to digitize aspects of our workflow so it can be convenient for some of our patient populations who use technology as a means to engage with their providers or other health care services.
So we believe at Walgreens the future of decentralization of clinical research will continue to be the focus, particularly as agencies and entities like BARDA want to continue to build infrastructure to make it easier for patients to participate. So we're excited about the movement. We're excited about the momentum. And we'll continue to invest as we leverage our full ecosystem and the assets to support that.
CHARLES RHYEE: And I guess if you think about in the broader context of Walgreens, how big do you think this opportunity is? Should we be looking at market estimates for the CRO industry as an oppor-- obviously, that's not everything you'll do but sort of an upper ceiling, and there's a portion of that that's available. How do you guys size the market then for what you guys are focused on?
RAMITA TANDON: Yeah. As we look at the addressable market, it's growing, and it's healthy, right? As we think about just generally the types of services that we're providing to pharma continues to grow, I think in the latest IQVIA report in 2023, we saw the growth in these services around 18%, right? And with the R&D investments around $150 million, and 50% of that is being outsourced, we believe that that's a tremendous opportunity for Walgreens to continue to grow in this space and continue down the path of strong growth and strong momentum.
CHARLES RHYEE: Great. And then maybe we touched on it briefly just now. Ultimately, what does the clinical trials industry look like in 5, 10 years?
RAMITA TANDON: Yeah. We just touched on the notion of decentralization, of clinical research. I do believe that that's going to be the continued momentum. It's all about just building the right highway so we can enable patients to be able to access these novel treatment options. And one of the things that's important for us is that as we have these conversations with patients, it's about changing that narrative so people see this as a care option.
So if you're in a chronic disease condition, and you're on standard-of-care of therapy that's not working, yet there's a life-saving treatment that could be an option, we want to make sure that people understand this is going to be part of the care option and their care journey.
And the other piece, I think, is continuing focus on improving representation. We are very excited when we work with our pharma partners that are looking at ways to enrich their patient populations. And so they reach out to pharma-- they reach out to Walgreens to help support in those efforts. I think that's going to continue to push ahead.
And for us at Walgreens, the role of pharmacy and the pharmacist is absolutely critical. We're intensely focused to make sure that pharmacy is seen as the practice setting of care. We've deployed national clinical trials training programs so pharmacists can become clinical research pharmacists to be able to advance their own professional endeavors. And we believe that the role of pharmacy is going to be quite critical as we continue to unlock some of the access issues and the representation issues that we see still within the industry.
CHARLES RHYEE: Great that's really great to hear. And I appreciate all your thoughts there. Ramita, thanks for joining us today.
RAMITA TANDON: Thanks for having me, Charles.
SPEAKER: Thanks for joining us. Stay tuned for the next episode of TD Cowen Insights.
