Part Pharmacist, Part Business Leader....All About that Data!

Brian Urban:
Yes, this is the Healthcare Rethink Podcast. I'm your host, Brian Urban. Today, we have an interesting guest from Parexel. The US Regional Head-Scientific Data Strategy Director, Stacy Charlerie, has joined our show. Stacy, welcome to our little show.

Stacy Charlerie:
Thank you. Happy to be here, Brian.

Brian Urban:
This is going to be a little fun. We used to share a background, and we know each other to a good degree, so it's just like a real treat. We wanted to have you on the show for a long time. And I think it's really fun to be able to explore some of the other facets of Stacy. And we're going to do that to kick things off our conversation. So let's go back a bit to have our audience get to know you a little bit more. Let's go back before the PharmD, before Howard, before a lot of your different projects in the community and even in the corporate level. Bring us up to speed. How did you get into your line of work, and what's going on in Stacy's world today?

Stacy Charlerie:
So you're going to take me way, way back. You're going to date me here. You're asking me to dig way, way deep. But the truth is, I am really just simple, a simple island girl. That's my humble beginnings, and that's probably still true today. I'm a pretty simple, simple person, but I moved to the US when I was about 12. I moved from Trinidad, and it is a typical story. I moved and wanted to fulfill my parents' dream to give me and my siblings more opportunities. So that's how I got into this realm of academics. When you are an immigrant and you move and you're moving for opportunities, my parents have instilled in me that academics was the way to go. And so that really has been the center of my life by the time I was 12 and still is. It's something I enjoy doing, learning, and that's really made me who I am today and led me down this path as a pharmacist and into this wonderful world of tech and data.

Brian Urban:
I think your story connects with a lot of other interesting leaders and leaders that are emerging in different spaces. It comes back to your upbringing, comes back to your family influences. And it's a story that I love to hear because it talks about who you are and then really why you're doing what you're doing, which is more the interesting side of a lot of our conversations we have.
I want to get into a couple things. Your work as a pharmacist, you saw a lot of people one-on-one. You saw families, you saw needs that were beyond just a pharmacological or a medicinal or other clinical needs. And you've touched a lot of different projects around addressing social determinants and identifying those needs. So I want to look across your different experiences here and understand from that, what have you seen in the healthcare society overall that we're missing, that's not connected, aside from some of the cliche things of care coordination or data systems not talking to each other? But what are we missing from the ground up that you've seen in all different experiences?

Stacy Charlerie:
Yeah, no, it's a good question. You're right. I've seen a couple of different areas in pharmacy. So I went into Howard University, which is an HBCU in Washington DC. And so my core education as a pharmacist really was in a community where there was, there still is a lot of social terms of health aspects. We saw that every single day, and we saw that on the streets outside of the Howard University Hospital and all the way now to where I sit behind the scenes in analytics and research. But I've really seen quite a bit, and I think that has shaped my sort of values as being a healthcare professional and a pharmacist and what that means to me. But I think what it's really taught me is that we've got a lot of work to do. Regardless of how you look at it, we've got a lot of work to do.
I think one of the things, and going back to your question as what we're missing, and [inaudible 00:04:50], we find many conversations about this, it is the fact that it's a person there, it's a patient. I would say it's not a patient. It's a person. And that person has a lot to unpack with them. And you can't really just treat a symptom or disease. You have to treat the entire patient. And the better we get at doing that, understanding how we do that, I think we will actually start to make some good progress. But I think that the headline there is, what I've learned is that we've made progress, but there's still a lot we need to do to get this right.

Brian Urban:
I love that you said that, it's progress. I think a lot of different organizations across the ecosystem are trying to nail it all and try to have programmatic level solutions everywhere. This doesn't make sense. There was a conference I attended recently, the Medicaid Health Plan Association of America, MHPA, and a lot of great sessions there. One session was talking about behavioral health substance use disorder. And they were finding that if they just did surveys, the PHQ-9, if they just did this traditional old survey, more persistent than just throwing it out and hoping someone does it through a social worker or through a survey that might land on their door or through email, they actually followed through with the surveys. And they found by just doing the surveys and then learning a little bit more, they were able to reduce a lot of the pharmaceutical spend in terms of just right-sizing the drugs and utilization, which is an obvious measure.
But I like what you said, aside from that type of measure, it's the person, and it's the person, the household, the community. So I love what you said, and it just connected right in my brain there. So your work in some of the pharmacy retail spaces is actually really interesting. You're not just behind the counter, but from a strategic level, from a data insights level, real world data, that's a lot of what you're touching now and not just real world data, but SDOH data, socioeconomic data. So what is Parexel up to these dates? What's exciting you about these different huge data sets that are highly valuable and fills your research bucket in a lot of ways? So what're some exciting things happening?

Stacy Charlerie:
Yeah, I think it's a lot. I stepped into this clinical research industry or space less than a year ago. And as we were talking before, I've seen quite a few sides of healthcare, and I think right now it's an exciting time to be in a clinical research organization as we learn to understand how to apply the data that's out there, so what we call real world data. Big data isn't a concept anymore. It isn't a theory. It's here, and we're using it. We're finding ways to use it. And I think in the clinical research industry, that's a long-standing industry that did things very specific based on regulations, very traditional clinical trials, really haven't had much innovation over the past 50 years.
And so we are at a time now, where you're seeing the FDA encourage research to embrace data. And there's really been a shift in how people feel that they can use data in clinical trials as opposed to maybe 5, 10 years ago. In fact, the Commissioner, Robert Califf, was quoted in an interview just a couple, I'd say a couple months ago, a couple weeks ago, early September, really saying that he's optimistic this year that the FDA and other federal agencies will really make a run this this year and really try to practically use data in clinical trials. There's a lot of opportunity. So getting back to Parexel, I think what excites me most in my role is really trying to be at this foundational moment in the industry to try to transform. And I think the hope in doing that is that clinical trials will become more diverse.
And we talked about social determinants of health. It's an area where we really haven't put focus on diversity. And now we are, and that's led by the FDA and others and some of the really good work that SDOH has brought to life. But Parexel has taken that on head first and really made strategic investments in trying to understand how we can leverage this data in clinical research. And a big focus of that is diversity. That's what excites me most about this current role. I was able to bring in some of my past experiences, and I really tackle an industry that needs the innovation and needs to progress into using data to create more diverse clinical trials.

Brian Urban:
Let's go into that maybe a little bit more. I find it really interesting. A lot of these huge retail pharmacies that now have extensions in the primary care, et cetera, are trying to do it in-house. Some have pulled out of this attempt, and some have really invested more into it. But clinical resource organizations, this is your IQ. I mean, this is what you have the highest contribution towards. So I see you all continuing to have more and more of an impact because you've been there and you've done that. And now there's regulation from FDA that a lot of new drugs going through pipeline have to have a more diverse cohort for more drug effectiveness. It just seems like a no-brainer. It should have been done 50 years ago, but for now, it seems like the sweet spot of growth.

Stacy Charlerie:
Yeah, no, it is. And you're right. I mean, this industry is ripe for change. It's ripe for the innovation. And it's definitely what we're looking at. On my remit, my focus is on the data and the partnerships. But really we partner closely with .... We've got an incredible chief patient officer, Clare Grace, and her team in patient innovation and patient recruitment really try to apply strategies to engage patients and get them into clinical trials. And some of these are life-saving clinical trials for people. So there is a bridge if you want more of a pathway to get from SDOH data or data itself and the application of it in clinical trials. And one of the things about Parexel that I think we are really embracing is looking at that full roadmap and the full picture of the patient. And it's really the end point of the patient. How do we meet them where they are, get them the information they need about the clinical trial, and get them enrolled, and then hopefully really make an impact in their lives?

Brian Urban:
And that's the ultimate goal. I think that's your pharmacist at [inaudible 00:12:16] as well that I think a lot of other ends of this business continuum and clinical trial diversity can often miss or I think maybe even higher up can often miss from an industry level. So it has to be still person-focused. So I love that that's always in your brain.

Stacy Charlerie:
Yeah. It really always is. And one of the things about Parexel is a lot of organizations say it, but they are really patient-first. And that's kind of embedded in all of our values and what we do. And so they're really trying to make that, keep that as our North Star. And so something that can be so sometimes boring and it's a data set and you're looking at data variables and you're trying to figure out who has what variable, you can get lost in the bigger picture. And that's something that hopefully I don't get lost. And I keep that true to myself that I really try to impact the patient. I'm really trying to impact someone's life and really get us to the application of it. And I'll say it again. I think a lot of people miss that. It's not about the data. It's not about how much you can bring in and how much you can find out about the patient. It's how do you actually use that to make a difference in that patient's life? And again, we've got a great team that is behind that.

Brian Urban:
And the most interesting part is, and I've known you for a little while, even before the COVID-19 pandemic, there were a lot of leaders trying to say this, but that voice was a lot softer than other things in the industry. Remote patient monitoring, virtual care was starting to grow a little bit bigger through consumption of MDLIVE and other really cool great new things. But the actual philosophy that architecture is built around as person-first is finally now being listened to, having seen the pandemic having such dramatic impacts on more vulnerable populations from an economic standpoint. So it's just finally our society has woken up to this voice now it's being heard. So your voice has never changed, though. It's been like that.

Stacy Charlerie:
Yeah, but I've been singing the same song for a while and I'll keep singing it because it's the right thing to do. One of the things that was, as a pharmacist or really a physician or a nurse, and this is kind of my take on it, I almost feel like as a clinician in healthcare, you cannot separate yourself from social injustice because you take an oath. You don't see many clinicians, not that there are not bad apples, but when you take that oath and you're really here to help people, you don't see that. You see a patient. And I think now what we've learned from the pandemic and what we've learned from the SDOH research is that there are social barriers, and that's what the SDOH shows us is these constructs that actually prevent us from making the impact that we want to make. And so it's really bridging these two things together. It's the data, it's the policy, and it's really still the clinician that's at the center. They have to take the vested interest and somehow get past. You could only go so far.
So one of the things in the pharmacy I used to see all the time is, it broke my heart then and it breaks my heart now, when someone comes to your counter and they cannot afford their medication. You say, okay, and you put it back on the shelf and they walk out the door. And so as a person who wants to help someone, you're kind of like, can you pay for it yourself? Well, probably no. There're probably policies against you paying for it yourself. Can you call someone? What can you do?
And so I think a lot of this is again, going back to the practical application of social determinants of health is creating these programs, these proven programs in a community, where you, as a clinician, can have access or a roadmap or an option to help this person if it's through a referral. I think in the past you really are strapped with no options except you go home at night and you feel for that person. So I think now with, again, a lot of the visibility from the pandemic, people are understanding the importance of this and actually investing into programs and policies to make a difference.

Brian Urban:
It's great that you said the program side of it. There're a lot of anchor community health services that have existed for a long time across the US. And now more than ever, I think a lot of health plans, pharmacy, healthcare organizations just bring in the partnerships. You don't have to do it all yourself. It's obviously great press and marketing for whenever a large organization can pump out an initiative and show some successful measurements from that and they scale some impact. But it's even better when you, as a responsible party, can bring in others that have done this type of grassroots work long before you and are experts in building trust and sort of unlocking access. So it's happening. It's not happening everywhere. It's definitely siloed, and there's probably some competitive nature to doing some of these things now, but I love how you said the program side of it, that's where we need to start allowing partners to contribute toward it. And you don't have to do it all on your own.

Stacy Charlerie:
Yeah. I think it's really important in clinical research. When you mentioned trust, I mean, there's a lot of mistrust all over the healthcare system, but it's pronounced in clinical trials in minority groups. And so we have a lot there to do to overcome that trust. It's one thing to say yes, you need to be able to recruit and ensure an active plan to have more diverse clinical trials. But on the other side, even if you can reach them, there's this level of mistrust, where people do not want to participate in it. So you may get to them using the most innovative strategies of all the data-driven approaches, but they may not want to participate. And so that's where the programs come in and that's where the partnerships come in to really look at root causes for some of these issues and structural issues and try to address them.
But I think the partnerships are key. That's something I saw coming from prior experiences and even here at Parexel. We often have one perspective, and that makes sense. You are a company. You've got your own goals, and you see one side of the patient. And this is not an issue where we need to try to be overly competitive. And I say that with a smile because I know that is coming from the product background of business development. I know we have to differentiate ourselves, but this particular issue really requires collaboration. It really requires us to break down some of our own ways of doing business to address it. And it's not just organizations. Again, it's across all the stakeholders in healthcare. It's the health system leaders, it's the health plans, it's the CROs, it's the data providers, it's the clinicians. It's everyone really taking a step back and saying, how can we actually partner together?
And I know it's a silly idea to think everyone's going to come together and work together, be this kumbaya moment, but looking for partners that share your values. I think in my role as the US head, one of my major roles is to identify data partners. And what I look for a lot is, does that company [inaudible 00:20:35] their values? So we share the same values. Are we trying to do this for the right reason? Where are there synergies? Where are my blind spots that you can help me uncover and the reverse? And so that's going to be key to solving the partnerships.

Brian Urban:
I love that you touched on that. I think yourself and a lot of other high-impact leaders across the ecosystem are thinking beyond just transaction, having more of a deep understanding of not just data, but the application, the whole end-to-end process. And then how do you continue to progress even forward after that and also sharing your message. It's incredibly important to share what you're doing. That's kind of the collaborative piece I think maybe you're touching on to a degree, is you're sharing things that can be shared that will help advance the rest of the industry. And that's a really cool competitive way of saying, hey, we're doing really well. You can do better. And I love that approach. That gets me pumped up in a lot of ways.
So I love your philosophy in terms of business, but also how you brought in your personal philosophy toward tackling a lot of things here, too. With that kind of philosophy, health equity is always on the table, I think, in a lot of our past conversations. So what's your approach to health equity? And you touch on data partners, et cetera. Your CRO angle is a bit different than other angles that you've had in the past in terms of product behind the counter as a pharmacist. So what's been your philosophy with health equity? Has it changed, I guess, as the way you've seen health equity changed over the last five years?

Stacy Charlerie:
Yeah. I would say yes and no. I think that given my experience and where the CRO industry is today, where Parexel is today, I think a lot of my philosophies and my approach remains the same. And we talked about the collaboration. There's just an education component to it, and that remains to be true, I think, across the board, even educating within my own department, educating within the company, bringing that message forward. I think it is easier at Parexel or companies that do have a patient-first approach. But I would say yes and no in that it's slightly different in the clinical research space because traditionally clinical trials are done at large academic centers. There was not a diversity approach to it. It was more of a numbers game. You need to be able to have X number of patients enrolled in your study. And studies were taking place in these larger centers. And so your demographic was almost sort of controlled for you.
I think now when we think about health equity in clinical trials and clinical research, the only shift in my philosophy remains is seeing the shift in their approach is this data approach. How can we now use the data to inform you on that patient or that population or inform your tactics on how to recruit? Because again, we talked about this earlier. I mentioned it's not about knowing where these patients are and who they are. It is about what would you do different to attract these patients and educate them on the benefits of clinical trials. That's, I think, the part that's a little bit different, but in terms of my approach to health equity, it is the same. It has to happen. It is taking the blinders off. It is removing some of these injustices and policies that prevented us from really making an impact in someone's life as a clinician. And that all remains the same. And we talked about collaboration as well.

Brian Urban:
I like what you mentioned in terms of a couple of things, education, internal and external. What's the culture at Parexel in terms of learning a little bit more about what these data sets mean? Have the words that you use changed? Has the viewpoint on the person as a deeper cut to the data become more visible to people? Because this is not just research, like you pointed out many times. It's being able to say, hey, here's how you can recruit a pharmaceutical manufacturer in your cohort. Here are some methodologies and here's what we're seeing. So I guess with all of that, what's the culture like in Parexel in terms of the actual now vision of what health equity is connected to clinical trial diversity?

Stacy Charlerie:
Yeah. I think we've got a really good culture. I mentioned a few times being patient-first. So our chief patient officer, we actually recently hired. She started about the same time I did. Her name is Stacy Hurt. She's a patient ambassador, an incredible, incredible person. She really speaks to her own personal experiences. She's had some healthcare issues herself. And she brings this incredible drive to the organization. And so I think we have this culture that understands that we're dealing with patients, which is great. I think in my department, which is the real world data department, as we're trying to make our data approach also centered on the patient and inclusive of social determinants of health data to broaden what we can find about the patient, we've got two things going for us.
And so the middle of the company, if you would say that, what's the culture, the end? Those are the folks we've got to change their minds and their hearts and educate them on the possibilities. But it's taking the data-driven approach that I think our team is leading. And then we've got this patient-first culture with a patient innovation team that they're leading. And together, we're hoping to bring really the organization along and so everyone understands not just the data and of the patient, but bringing it all together. So it's encouraging that the culture is here. It's not there everywhere. And it does make it more difficult to impact or to really be a changemaker when the culture isn't there. I think luckily for Parexel, that is central to who the company is.

Brian Urban:
And that's good to know because I think the work that you're doing, it has to be mirrored on that other side, too. It can't be just, hey, this is the work that we do. You have to be invested as a person into that work as well, not just an employee. So I wanted to touch on that and I think it's incredibly, incredibly difficult to recruit these future heroes that are these clinical trial patients. I think you can't just do it with a brand in a store. I think that will work maybe in some places. There're incentives, but it's definitely a movement. And I think you have to have some of that connect to a person and to a household in a community like on the streets. I am curious of your thoughts in how this can be, I don't even want to say the word scaled, but how can this be modeled and slightly replicated across the US? What's the best way to recruit clinical trial diversity patients to actually be engaged in these types of trials?

Stacy Charlerie:
Yeah. I mean, that's the million-dollar question. I wish I had the answer to it. I wouldn't be sitting here today with you. No, but it's a great question. I think the more we share, the more impact we can make across the US in a scalable fashion.
So these conferences, sometimes you overlook them. Sometimes you go through the back and forth on is it worth a company investing in people attending conferences, that whole thing? But that's really where a lot of the learning happens, organically. And that's when people walk away with, oh, exactly the story you just shared with me from your recent conference. That's how we can actually educate people in masses. And they take it back and they say, huh, this was interesting. Can we do this with this work here, with this? Did we need to tweak it to make it applicable to us? But I think sharing information is going to be key. I wouldn't be doing my job if I also don't mention that in terms of real world data in clinical trials, what we're also trying to push the boundaries of is, there are trials where we can use real world data as opposed to the person coming in to collect information.
So in traditional trials you have .... Let's just say you're doing a trial. It's for a drug. It's double-blind. It's a placebo. You have to come into the center. You have to get your followup here. We document everything. What side effects are you having? What are the outcomes? A lot of that can be done using data. So can we actually use real world data to replicate a trial? And that's where I think Parexel is sitting here at the intersection of how do we push the boundaries of that?
There's a lot of doubt in the industry from a scientific perspective. Are we controlling for biases? What's the methodology? What type of statistics are you going to use? Can you actually do it? And that's where I think the FDA is saying, yes, there are opportunities here. Let's figure out how to do it. And that's, I think, where our department at Parexel and where Parexel is going in the future is really trying to, yes, we still need to have traditional clinical trials in that sense and we need to recruit the patients, a live body, but can we also use the data to replicate that trial or even to get a control group? Can you have a control group from the data, use EHR data or claims data or SDOH data? Can you find a match for that control group so that you don't have to recruit that patient? That's actually going to theoretically reduce the cost of the trial. It should get the drug to market faster. That will reduce overall probably healthier costs back and really progress medicine in the US.
So there's a lot there as well, in addition to the diversity of recruiting live body patients. There's a lot there we can do in the data, and that's part of what we're looking at as well.

Brian Urban:
That, right there, I think is helpful. It's not an answer, but it's a strategy in terms of modeling, finding the right profile persona, if you will, and being able to map that across a bunch of different geographies. And then how do you thoughtfully recruit? How do you thoughtfully engage? And it's not purely raw data. I think a lot of this has to be modeled just like where you were going. And then from there we continue to maintain it and tweak it based on different physical areas. So that's exciting.
And you started to go into the future. I want to go into the future here for a moment. So let's talk about Parexel several years down the road here. What's the impact you envision making personally? Or what do you think your organization's going to contribute toward the ecosystem, whether it's research or beyond? Really curious of what you think is coming down the rail here in a few years.

Stacy Charlerie:
No. I mean, I hope to really make an impact and transform the industry. That's why I joined the organization and this position really excited me is that, we are sitting at this moment in clinical research where we have to transform. We cannot ignore the real world data and we cannot ignore the fact that our trials are not diverse. And if we do nothing, you're essentially going to be left out of the pack. So for me, personally, it's exciting to be in this position to transform. So if I think about the future, I want to see that transformation happen. I want us to have more clinical trials that are using real world data. I want us to not just necessarily be more diverse, but each drug, if we think about it, and we haven't ....
I know we're probably going to run out of time and this is a whole other topic, but from the genetics, yeah, from the genomics standpoint, once we get into genomics and the genetic data and use that, we can really tailor the drugs and really produce and make drugs that work for an individual person based on their biomarker results on their testing. And so that's a whole other angle that we're starting to bring into Parexel into our strategy is bringing in genomics data in addition to social determinants of health data and looking at it together and really try to see how we can, again, transform the industry.
We've got a brilliant team of epidemiologists, data scientists and informaticists. I mean, we've got the foundation here. And so I really think we're primed to make that impact. And hopefully in two, three, four, five years from now, if we have this conversation again, we'll talk about how the industry has changed and evolved. And maybe 99% of clinical trials are done this traditional way. And we'll be able to talk about the fact that maybe 50% or less and we're using the data and we've changed the policies and the FDA has opened and allowed this type of research to happen. So yeah, that will be my hope for the future. Maybe I'm ambitious at five. Maybe it's 10 years. But I mean, I think that the takeaway is the [inaudible 00:35:15] research industry is primed to have innovative approaches and transform. And Parexel is, I think, ahead of that curve and understands the task at hand and really puts together a team or department with experienced folks that are trying to solve this problem for the industry, which is really exciting to be part of.

Brian Urban:
The genomics piece that you hit on is extremely .... It's intriguing. I could probably come up with five different questions on it. All this different merging data from a trove of different sources and you eventually come to even the payment assistance side upstream once you come down to the very specific need and the effectiveness of a drug, that whole supply chain of data that really at the end of it has a better person outcome, a better person health journey, this is just a world of excitement. I can see why you went to Parexel. I can see that you're excited in what you're doing.
And I'll tell you, policy change is definitely possible. Allison says so, of RIP Medical Debt. She changed policy in the White House with Kamala Harris. She's also changed the credit bureaus being able to now wipe away the visibility of someone's medical debt on their credit score. So it's absolutely possible. And why couldn't it be possible now through the side of the FDA with Parexel? Let me pause here. I feel a follow-up conversation coming. I'm just excited to see what's happening now in the next 6, 12, 18 plus months ahead, Stacy. So I wanted to stop here and thank you very much for joining our little show. Extremely insightful and I'm very excited to see the impact that you're going to make.

Stacy Charlerie:
Yeah, no. Thank you so much for having me. And I think the work that you're doing here, even in your podcast lineup, you've got an incredible amount of real leaders and changemakers. So I love the fact that this podcast exists. Love the conversation and I think you're doing great work as well. I'm happy to come back again and dig into some other issues. And I can see where we land in a couple of years. So thank you again for having me.

Brian Urban:
You're a part of that, Stacy, now. It's just a great library of content and leaders speaking their voice on the show. So thank you for that. And for more exciting excerpts and insights, please visit us at finthrive.com.