Research Confidential_Bari Kowal: Audio automatically transcribed by Sonix

Research Confidential_Bari Kowal: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Joseph Kim:
Welcome to Clinical Research Confidential. On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health, but it’s not for the faint of heart. And so on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
And today we have on the show Bari Kowal, who is the senior VP at Regeneron and Clinical Development and Portfolio Management. Did I get that right?

Bari Kowal:
Yes, you did.

Joseph Kim:
Okay, great. So, Bari, first of all, thanks for being on the show today. I can’t wait to talk to you about your own hardships in clinical research because I think people forget that research, while, yes, it’s happening at the sites and with patients, you have a whole different set of problems that you need to wrestle with, good or bad, but I think might take you a long way from your origin story in clinical research where you actually kind of started as a CRA, is that correct?

Bari Kowal:
That’s right. I did, my first job was as a CRA, but it wasn’t where I was expecting. I wasn’t looking to move into clinical research even, and, when I was a graduate student, I was actually thinking I was going to go into medical school and, at the time, I was looking for a role, looking to work while I was in graduate school and thinking about medical school and landed in clinical research because someone said to me, this is the best of both worlds. There’s a business aspect to it, you can be in the science, it’s really fascinating, and the story goes from there. I started out as a CRA, and within a year, though, I think what really prompted kind of my career trajectory was being able to work at a cutting-edge company. So I was offered a role at a gene therapy company. So imagine almost 30 years ago, I know that dates me, but almost 30 years ago there was a company that was doing gene therapy. And I thought, how fascinating, gene therapy, this is so cool. This is the cutting edge of science. This is really the kind of job that I want, how can I, you know, get involved in this and keep a career going and advance in clinical research? And so there it goes, I worked at a biotech company and I really learned the nuts and bolts of not only gene therapy in its early days, really early, because we’re seeing kind of the downstream impact of gene therapy only, you know, in the last few years, but just how drug development was done and how small companies really had to get involved in early on with regulators, understanding all the rules, figuring out how to operationalize trials, etc, etc. So that was my start and a little untraditional, but certainly was in line with what I thought I was going to do, it was a little different than what I ended up doing.

Joseph Kim:
Yeah, well, let’s contrast the CRA role and skill set of yesteryear to today, and I think there’s a lot of complaints around CRAs that some of them are too green or they don’t know the protocol well enough. So hearken back to your experience as a CRA, like, how expert were you in the studies you were monitoring? How deep into the science were you? Like, could you answer every question from the investigator?

Bari Kowal:
I could answer every question from the investigator, and if I didn’t, though, I wasn’t afraid to go to the person who did have a medical background to get those specific questions. But for the most part, I do think there’s been a very big change in the expectation. I don’t want to say CRAs are bad. I think at the end of the day we’ve changed the dynamic and the roles over time. A CRA has become more of a commodity, right? Someone who goes and checks data points, when that wasn’t the role when it started in this industry. The role, you owned the relationship with the site, you own the data that was being reported at the site, and you were the one who was managing the protocol, the expectations of it. And there weren’t people who handled contracts and people who handled the regulatory piece and people who ensured the CRF was appropriate, I did all of those things, right? So that’s actually how I learned some of the things that I know today. I really needed to be the jack of all trades to some degree with the knowledge that I had, and by the way, it was really limited back then, but at the end of the day, it forced you to learn a lot, but it did in fact force you to be somewhat of an expert on the protocol you were managing and the site you were working with, and those relationships were important too, and I think that’s not, it’s not the role that exists today.

Joseph Kim:
And, you know, I’m sort of focusing on this a little bit longer than it feels like we should because I want to, I wanted to roll up to eventually how you end up seeing the output of the CRA work as an executive. So one more question about the CRAs. As a CRA, in terms of supporting that site for execution of the study, right, what was the best way to support them? How did you see deviations or how did you remove guesswork? Because research is a complicated thing and not everyone can do it perfectly right away. So how did your relationship and your support system as a CRA at that time, how did that play out in the conduct of the study itself?

Bari Kowal:
So by the way, you’re really testing my memory now in 30 years, but I will try my best. I know what I expect today, and actually doing what I did then really set me up to understand the roles and manage them over the years. At the end of the day, what I think worked best was I owned everything that was related to the site. So even if I wasn’t the expert in a contract or the expert from a data management perspective, we did have data managers back then too, I knew what was supposed to get done and I knew how they were supposed to fill out the information and what was right. I knew, I also looked at trends as well. I spent a lot of time with the coordinators at sites, understanding what wasn’t making sense, what they weren’t understanding, what they were relaying to us in terms of either whether it was data or issues they were having with carrying out the trial and managing those, whether it was going to the pharmacy and figuring out what the pharmacists, you know, the logistics of how they were getting the drug, how they were preparing it, or even the managing the budget, right? Things like that are payments. You know, I just cared about all of those things because it was part of my job at the time. I made sure, I was their one-stop shop to manage that trial, and there were some sites that had coordinators who had been there for 30 years. And so they, they knew the lay of the land. They may not have needed as much help from me, but there were some sites we had new people or people who just started as coordinators and they needed a little more help. And they were always really eager to say, how can we do this better? And I was always eager to say, here, look, this is what worked at other sites, let me share this with you. So I think that’s kind of the, when I talk about the relationship, if you’ve ever heard me talk before, I tell my staff I feel like I’m a little old school, but what I want to see is a very positive way. I thought that relationship and I still think that relationship between the sponsor, the CRA, whomever is the representative at the site, whether it’s from a CRO or from the sponsor, they manage the site and vice versa. Site managers, the CRA, and they have that very symbiotic relationship and they should count on each other. And I don’t, I think we’ve evolved to a place where that’s not always the expectation on both sides, and so it has some downstream impacts.

Joseph Kim:
Yeah, yeah, and so moving forward through your career, you worked for a CRO, which in large part is a CRA staffing organization, and then senior leadership positions at Pfizer, and now you’re at Regeneron. So as you’ve gone through both being a CRA working for a CRO, going to a very big pharma, and then landing at Regeneron, like, what have you learned along the way that has set you up to be an excellent leader in clinical development at Regeneron?

Bari Kowal:
Yeah, so I think a number of things. First, I do think the variety in my career from biotech CRO pharma has given me a unique perspective, right? I’ve seen the world from different lenses and been able to apply some of the things I’ve learned from the different business perspectives. At a CRO, you do learn the business aspect, I, you know, if I manage a budget better than others, it’s because I worked at a CRO, but I can also go toe to toe on the science and some of the analytics, and that I learned at a lot of the early biotech companies. And my background in understanding. Understanding is not meaning I’m an expert, right, in data management or regulatory, but I have a great understanding of what they do because I’ve had to work at startup companies. And actually, I was probably an N of two in an operations and regulatory group, we were one of each and we had to help each other and figure out what do we need to do next. And so that type of experience enabled me to see broadly, and that’s kind of where I moved purposefully later in my career. Early on, it was maybe a little about where I wanted to live and to what role seemed interesting, what science was great. Where I landed eventually was really getting a combination of the right experiences, whether it was the role or the company that then gave me that breadth, right? The understanding across the board so that I could not only understand the things that I talk about from a startup perspective, but different company, companies’ way of working and size and scale, right, how to scale up. And when I came to Regeneron, I came here because I thought, it goes without saying, Regeneron really does have unbelievable science. I don’t know that there’s another company that has the same level of scientific rigor that Regeneron has. However, and I’m not saying no, no other company is scientifically.

Joseph Kim:
You’re picking a fight here, right?

Bari Kowal:
I’m not saying that. I just am saying, you know, I can say there’s a tremendous amount of rigor here, and our true, you know, kind of true north is science. Science to medicine is not just our logo, it’s really what we’re about, it’s our ethos, but it’s partly why I came here. But I also saw opportunity, right? Because the science is so great, because of the rigor, because of the, kind of the meaning behind it, right? The science is not just about the science about helping patients. And so in the end, that’s what it’s always been about for me. And so I saw this as a, almost a means to an end. If I go somewhere that has amazing science, job security, first of all, but that’s not what I was exactly looking for. I wanted to do something meaningful for patients, and I really saw an opportunity at Regeneron to utilize some of the skill sets that I learned over time, some of that breadth of how do you go from a small company to do a big company? And look, that was seven years ago. Regeneron has been growing and been around for almost 35 years. I came in as we were really building up the drug development space and the Research and Discovery Unit has been innovating for many, many years before that. And at this point, I really felt that there was a lot of room to grow, and I have not been disappointed, and I hope I’ve made huge contributions to it as well. We have continued to deliver and we have continued to utilize science as kind of the background company led by physician-scientists, founded by them. So it’s no surprise that’s kind of the way we see the world, but at the end of the day, my role now is to kind of remove the bottlenecks. And you talked about it earlier, to go back to what you originally said, how do we make it easier, right? What are the hardships in drug development? How do I, you know, I can run trials, I can deploy lots of people, I can scale up and build parts of organizations. But how do I make it easier to develop drugs in the world today? And, you know, big part of it is our sites. I always say, and it’s why I go back to that CRA, you have to have good relationships with sites. Those are the people who treat the patients, who bring the patients in, who gain their trust, and who help us deliver.

Joseph Kim:
Yeah, so let’s start connecting those dots now. So perfect, thank you for all this sort of context. And by the way, you are absolutely right. Your reputation of Regeneron is very good. I know many friends who’ve gone to Regeneron whom I respect very highly in clinical operations. So you’re recruiting excellent people and for good reason, obviously. At your level now, how do you, it is all about the site and the relationships happening there, but as a senior VP, you can’t know that by looking at a spreadsheet, right? So how do you start to think about performance on studies vis a vis the site performance, how CRAs might be doing? Like how do you trace back good things and bad things back to that kind of relationship? It’s hard, isn’t it?

Bari Kowal:
It’s really hard, but I will say part of what kind of enabled me early on in my career was, I had a leader I worked for at a company who was very data-driven, and she worked with a number of reports, and this is back in the late 90s when we didn’t have the technology we have today. And there were lots of reports that she threw on a table and said, you need to look at all of these because it’s going to help you manage your trials and really understand what’s happening. And, you know, it was overwhelming at the time, and thought, okay, I need to look at all these. But translate that many years later, part of what I did when I first came to Regeneron was build out a operational analytics group, because what we had to do, and build systems around it as well. So we built our data lake, we built systems to enable data to really understand performance and understand ways in which we weren’t performing, and even at the level of a site, at the level of the data we see at a site, at the information coming in from logistics, from our vendors. So there’s a lot of ways to go about it. Some of them are around the data and analytics that you can derive and really manage performance by, but you have to know what you’re looking for. You can have tons of systems and tons of reports, but they have to be very directed. And I will say, you know, I’ve hired a number of really smart people who are very analytical and so they can help us think through what’s going to tell us, you know, where things are not working well, what is going to give us the most information on risks or ways in which we can improve and what can we tangibly do about that? And so I’d say data is a big piece of how we manage.

Joseph Kim:
And so, I mean, is it fair to say there weren’t enough systems in place so you actually couldn’t even tell how good or bad you were doing? This was years ago, right?

Bari Kowal:
No, some of it’s anecdotal, right? I mean, sometimes you have to go with, and that’s probably why even earlier it was, you know, the relationship was key. You had to have that communication. You had to understand what was going on on the ground in order to have a sense of how things were going. You could you know, at the time, yes, we, I would say, we had paper CRFs when I first started, but it did go into a system, right? It did go into a system. You know, you could read out some of it, but it was very hard to tease through. And I think we’re incredibly lucky now. I mean, the fact that we have technology that really gives us the clues that we didn’t have then, it was very manual.

Joseph Kim:
Yeah, give me one example of like something you can detect now, either as a leading indicator like, oh, this is wrong versus like, gosh, five, six years ago, we would never know that this was a problem until it was too late.

Bari Kowal:
Yeah, I mean, we’ve seen this, right? We’ve had trials where we look over time and see whether it’s a drug dose calculation was wrong or some logistical part of our IRT wasn’t working, or even our compliance data on, you know, our devices that are reading out on the electronic reported outcomes. You can look at that data and say, you know what, this compliance isn’t right, but it’s because half the devices didn’t work. But we didn’t know that, you wouldn’t know that at the time, and you wouldn’t have been able to see that if people were just filling it out on paper. But now in real time, I know if devices aren’t working, if people aren’t collecting them, I could be at the end of a trial, and by the way, I think we were when I got here, we were at towards the end of a trial only to find out, this was a real-life example, that we had devices that weren’t working and we didn’t collect the data early enough, and that was a big learning. We’ve never done that since. Lucky enough, our drug was so great, really was in this case, and it could have gone either way that we were able to see a difference for fewer time points than what we originally anticipated. But realistically, that kind of thing, and we do, now we track it. We know where it’s not working, if it’s not working, we fix it on the spot or within a day. Those are things you just wouldn’t know, and it leads to real outcomes, and that whole trial could have been worthless if didn’t have that data, which was a pretty big endpoint.

Joseph Kim:
Yeah, for sure, great examples. Understanding how to course correct in real-time or knowing where your problem is today, that’s kind of like being in Google Maps. Like if you just had a paper map, you wouldn’t know that you’re off track until you were off track, but Google Maps will tell you right away like, oh, turn left, you’re off.

Bari Kowal:
Well, speaking of Google Maps, though, when you were a CRA back in the early 90s, you also had to have a map, right? You had to go to sites with a map. So technology has made everything a little bit easier and sometimes harder.

Joseph Kim:
Yeah, let’s focus a little bit on things like site selection, right? As a CRA, you knew how to select your 1 to 5 or 10 sites, like you did that a certain way. At your level, you’re talking about site selection in a very different scale. Like you’re talking about country allocation across many molecules and many studies. And you know, this idea of like which site to select isn’t your problem anymore. You have other level problems of like, are we putting too much in Spain? Or give us a sense of like the struggle you need to think through around what site selection means as it rolls up to your decisions, right? You’re not deciding on site A, B, or C, you’re making much bigger decisions. Talk to us about that.

Bari Kowal:
That’s fair. So the decisions that I’m making are, where do I put in-country resources where we don’t have an office where I have to actually place people because we have a trial there? And it may be, we use CROs, but it may be because I have to oversee them, right? Or oversee them from a nearby country. So I have to think about resourcing for trials like that, or sites, in fact, like that. And we do a fair amount of rare disease, so we have one-off countries that we work with or sites that we work with that, that’s we go where the patients are. So we do have to think about the resourcing, we have to think about the local regulations, we have to think about the local requirements, we have to think about the cultural diversity there and what are the things, how are we writing our study in a way that aligns to the standard of care? So when I think about site selection, it has to go back to the protocol, it goes to staffing, it goes to the budget that you have. And, you know, every time we go to another country it’s exponential, in terms of the cost because whether you’re running a trial of 100 patients in a country or two, a lot of the costs are the same. So cost weighs heavily on me because it’s not that I am looking to get things done cheaper, it’s that I, the more we can do with the money we have, the more studies we can run, the more patients we can treat, the more medicines we can get to the market. And costs of trials are significant, it’s just hard to get studies up and running, pay sites, pay staff across the world. Those are the things that weigh on me as an executive is, how do I, you know, how do I select the right sites? At the end of the day, all of that aside, all of that is nothing if I don’t have the right site. So it doesn’t, none of that matters, I’ll make all of that work. I’ll find the money, I’ll make it work, we’ll get the people, if we find the right sites who are really capable, have the patients, who can do the outreach, who think the science is interesting, who, you know, do all the right things, we’ll make it work.

Joseph Kim:
Yeah, and how much do you get countries kind of jockeying for your attention to, say, put more research here? Does that all sort of fall on you? I know you’re triangulating a lot of other stuff, but every country wants to do more research, right? That’s probably a true statement. How do you?

Bari Kowal:
… Interesting, I don’t, you know, look, I think Regeneron is still building our global brand. And even when I was at Pfizer, I don’t know that we had countries jockeying per se. I think it’s more around the areas you’re working in and the key opinion leaders. And so if they do exist primarily in a country, they are looking to work on the most exciting thing or the nearest to reading out sometimes or, you know, when you have some proven efficacy, things like that, that does. You know, we spend a fair amount of time really thinking about the competitive landscape and how sites can perform across the board on multiple studies with multiple sponsors, deliver, have the right staff to deliver, really understand capabilities and even help them with staffing or help them with some of the things that we require. You know, I think part of what I have to think about is, how do we continue to build our global brand? How do we ensure we have people in the right countries? How do we, have all those things that I talked to you about before that I need to understand whether I can work in a country? You know, when I first got to Regeneron, we set up a steering committee to understand our capabilities and capacity as a company to work in all these countries. And we still have it today because there are some, you know, just whether it’s legal or otherwise, regulatory, other reasons. We talk about countries that we work in and ensure we can do the right thing.

Joseph Kim:
I remember stories of, you know, you wanted to use this comparator at this dose, but, you know, France didn’t offer it that way in standard of care. And these little things can just like derail the whole country selection process. So I feel for you for sure.

Bari Kowal:
Yeah, no, I mean, just imagine, you know, unfortunately, we were working in the Ukraine and in Russia and that was part of our plan. And ultimately, whether it’s things that are happening around the world, that is a huge impact, too. And you have to change your strategy and you have to really adapt to the environment as well, especially over the last few years. I think, you know, COVID has given us a special way of looking at how to make things work in a unique environment.

Joseph Kim:
Yeah, so let’s turn our lens inward now. So now you also have a large staff of study managers and other operations folks who are here to execute the portfolio. And let’s be honest, I’ve worked at three different pharma companies like you, and there’s always more work than can be executed, and so you have to place your bet. And more than that, no one likes to say this, but the priority of developing certain drugs can get very foggy. And the worst case scenario is that it’s too conspicuous that Drug X is the most important thing, or that there’s maybe equally bad is like nobody knows what has priority. And so everyone thinks their study is priority, and when resources are finite, you have to decide who’s robbing Peter and who’s paying Paul. How do you manage some of that prioritization internally when it comes to clinical operations and drug development?

Bari Kowal:
That’s a trick question because it’s a really hard one.

Joseph Kim:
It’s all right ….

Bari Kowal:
At Regeneron, we, I would say, purposefully choose as much as we can to not prioritize, right? We have great science and no one wants to let that science go unviewed and, you know, tested, right? So we try not to prioritize. And I wouldn’t say that that means we don’t at all, right? We do have, when COVID hit, we looked at how do we, in record time, developed an antibody and really hard trials to run for antibodies. How do we make this happen? And you know, in a world that is a challenge and deliver and manufacture and do all of that, and what we ended up doing as a company was deploying our resources to one space, right? We said, you know, we’ll keep everything going, but we’ll make sure this gets the most attention and that we really deliver on this because, you know, we did really feel like the world was counting on us and others, so that’s the extreme. I think in other ways we try to lead with the science and follow the data, and so if things are important and if it requires more resource, we put more resources on it. And it may take a little longer to get that resource, we don’t just have people ready to deploy all the time, but if we think there’s important things, we’ll say, let’s go do the work. If we think there’s data that supports the science behind it, we’ll put more effort there. And so, yes, I think things do ultimately, some things come first because they may be at the, you know, at the edge of something that is going into phase three versus something early, that if it takes a little more time and we get a little more data, that may be helpful even. But, you know, I think that’s generally how it works itself out. But we are not limited by, we have this much resource, so this is actually what we’re going to be able to deliver on. We usually say, we have this much work and we’re going to get more resource.

Joseph Kim:
Yeah, that’s a great answer, actually. It’s, well done. Related to that, as you think about talent development, you know, your more seasoned professionals, top-tier talent versus junior entry-level folks, Like clearly, you want to give them great opportunities, you want to give everyone great opportunities. But as things get prioritized to some degree, right, because you’re still a little bit of a, you know, back, you know, more important than this, I could put more here and wait here. How do you think about talent development and applying those to specific kinds of high-profile projects?

Bari Kowal:
Yeah, look, I would say my job related to talent development has been easy. And I say that because Regeneron, at least my time here, and certain prior to when I joined, the trajectory and our growth has been so significant that opportunity abounds. There’s more science, there’s more work, there’s more development. Our attrition rate is great, right? So a lot of our drugs that we are testing early, we spend a lot of time in targeting of molecules and early science, preclinical, and so much time, in fact, that, you know, it gives us a little never, it’s never certainty in anything, but it gives us more certainty than otherwise we would have had. And so we see a lot of things growing. It’s not to say not everything, it will end up, you know, as a molecule or approved drug, but for the most part, we’ve had a upwards trajectory and so opportunity just comes with that. We’ve had to create new roles, new groups, new opportunities. As it relates to priority projects versus non-priority, we don’t really have nonpriority. I think it’s, you know, I think people get invested in the work they do and there’s no science that’s better than other science, so they get invested in this is the molecule. I’ve learned the physicians that are working here around the world, I know the patients, even those that you know, we have rare diseases where there’s some that are ultra rare, that there’s maybe 30 patients in the world or 100, maybe even 30 that we treated, I have people most vested in that, it may not be our biggest profile drug, but they’re most vested because the community is vested there. So I think everyone finds purpose and half the people are not always working directly on one of our molecules. They may be behind the scenes running the data we talked about working across the portfolio. You know, I think there’s just a tremendous amount of meaning in seeing that the way we deliver on drug development and have amazing research that leads to that.

Joseph Kim:
One final question about sort of personnel and talent development. What kind of person does best at Regeneron in your oversight?

Bari Kowal:
Yeah, it’s a company of doers. I would say we all are really vested in what we’re doing and everybody, you know, any idea is a good idea. And so people who have, who are thinking big, who, you know, want to change the world, who, you know, are go-getters and really want to be involved, those people really thrive here. I think it’s, on the flip side, you have to be okay with ambiguity, right? Not there’s not a clear path, it’s not all black and white, there’s some gray. We deal with the gray and we deal with it really well, but we need that to be nimble, and so that doesn’t resonate with everyone. But for the most part, for the most part, I think people who are challenged to really inherently want to do the right thing that are vested in the science and the patients, this is a really rewarding place for people for that reason.

Joseph Kim:
Yeah, great, fantastic. Well, I know you’ve continued to hire some friends of mine in the industry and it’s great to see them, you know, landing at Regeneron as well. Let’s go to this topic called decentralized clinical trials. There’s been a lot of talk and I’ve done a lot of these podcasts just this year. And I always ask this question because my suspicion, which is turning out to be correct, is everyone has a different definition of DCTs. I would love Bari Kowal’s definition of DCTs.

Bari Kowal:
So I actually think DCTs is the wrong term, to be honest, just to start. They’re really, you know, I’ve heard people often say decentralized trials are really centralized trials. It’s a way of decentralizing. I just saw you a couple of weeks ago at the … conference, and we did a panel on modernizing clinical trials. And it was pretty purposeful because I think that’s what we’re talking about, right? We’re talking about taking some of the opportunities we have in clinical development and modernizing them, using technology, thinking about different ways to do things remotely, digital health. I could throw in so many different terms in this, but there’s so many aspects of, and I’ll call it DCT because it’s the popular term, but realistically, you know, I do think there are ways to look at clinical trials in, differently than we have in the past, but there’s no such thing as a, I mean there is, but not in my world, a truly decentralized trial. We don’t have any, it’s very difficult to run our studies in a way where you have no centralization of patients at sites or with all the different technologies included. I think for the most part, decentralized trials ultimately are a makeup of various parts of technology, of different types of sites, utilizing mobile sites, utilizing non-traditional sites, utilizing a virtual site, utilizing epro. There’s just so many different ways of defining what a decentralized trial is, but when you really dig in, there are companies who say, we’re going 50% decentralized. I have no idea what that means. I don’t know how you could do that because I don’t, I really don’t know. No one has one definition, and if there was one definition, we should align on that, but I just think it’s a bad moniker. The underlying pieces of it I think are amazing, right? think if we could utilize wearables and digital technologies more to actually get information on patients, there’s endpoints that we didn’t we never thought about or utilized that are incredibly meaningful, and my group is spending a lot of time there. If I can make it easier on the patient and the site in terms of a site or patient burden, I’m ready to do that. Some of the things that we think are great, I know, jury for me is out on e-consent. Some people say, you know, e-consent, it’s such an easy thing, that’s so easy in the background, and not everybody loves it. So we use it, we have it. Some sites have their own. I think all of these various ways that we’re envisioning decentralized trials all have their own pieces that I think add value. It’s just a matter of what, for me, it’s very specific. So what on a given trial, would work best to meet all the things you need to meet, to meet the scientific rigor, to make it easier on patients. I’ve mentioned in the past protocol. Let’s start with the protocol. How do I design a protocol that can adapt to this and vice versa, not just apply some of this to a protocol. So in a nutshell, that’s my thought on DCTs, but don’t know that there’s one way to look at it.

Joseph Kim:
You’re right, and it’s always funny when you overnight you see every single vendor all of a sudden become a DCT vendor and say they’ve run 600 studies in DCT. I’m like, you’re lying. It’s just, you’re just lying.

Bari Kowal:
It doesn’t make sense, and no one knows that …

Joseph Kim:
No one, exactly. And it’s one reason why, you know, a company like ours, ProofPilot, we’ve stayed far away from using that term. Really, it’s not where we want to go because, like you, don’t even know what it means, so why would I start saying it? So when you think about sponsors who say, I want to do X percent, what, to you, would count as a DCT, such that you would say, oh yeah, it’s probably decentralized, it’s decentralized? You say with a straight face, like what has to be there.

Bari Kowal:
For a decentralized trial, I’d have to have some of the components that I mentioned. You have to have variation on the theme of traditionally visiting a site for every visit and not utilizing either a lab or a mobile vendor or a van. Just had a van outside the other day that does clinical trials so people could actually see what we’re talking about. We try to get very real with what we’re going to do this, let’s test it out, right? Let’s see what it looks like. What are patient’s experience? So some element of not your traditional go to a site and have every visited a site would be incorporated into DCT. I would also say broad potential for various technologies, whether it’s digital health devices or different types of epros or incorporating real-world evidence into your trial, you know, different ways of advancing a particular trial that, and again, that’s why don’t know what it means when you say a decentralized trial. It’s utilizing kind of a modernized way of looking at how can I effectively run this trial with some of the levers I can pull that I couldn’t in the past.

Joseph Kim:
Yeah, and so let’s now level it up to how you’re seeing it as an executive. If you see someone who wants to offer these different solutions or technologies in order to quote-unquote, make it better, what does that actually mean in terms of some economic or time value? Because it’s probably going to be more expensive, let’s face it, and then should there be a time savings on the back end? And are you going to fairly set that goal and they better hit it? Or the last thing you want to do is throw more money at it and then it takes longer like, or the same like, what have you gotten like? So as these projects roll up, how do you start to look at them from a portfolio execution resource management at your executive level?

Bari Kowal:
So I’ve had to make some hard decisions there. Sometimes you have to try things and you have to pilot and you have to really see if things work in order to get a good answer. So I have potentially thrown good money after bad, right? I’ve looked at, let’s do, let’s try this, with the knowledge that I have something to lose, but it might get me something really beneficial in the long run, but I have to be really discriminatory about what makes sense. And if vendors are coming forward with good solutions, we’re always listening, right? But it has to be backed up by data. You know, I said it probably more than enough times. Regeneron is a very data-driven company and there’s a lot of analytical people and we like to test and retest our hypotheses. All of that considered, that leaks into everything we do operationally, too. And so if vendors come and say, We’ve done this great thing, we’ve just never tried it anywhere, or, you know, we think it has a lot of possibility, I might be willing to try it. I love when it’s been tried and you can show me some data, that’s even more useful, but I’m also willing to partner on things that have a lot of potential. And so we’re pretty open in terms of being innovative, I think it just has to make sense, fit with some of the things we’re doing, have a real business case behind it. To your point, DCTs, for all I just said, are more expensive today. They are, and there’s you know, we’re not finding easy ways around that, so I have to be really careful around what components we include in trials. The idea down the road is that it does become more streamlined, like the big screen TV years ago spent $5,000, now I can get one for $700 now. I hope that the way we DCTs follows that path, right? We’ve got to make it easier and more affordable because ultimately it has a lot of potential. I believe in the potential, but also I’m not always convinced that the bottom line is just that, what are you going to save me? If I save time, opportunity cost is tremendous. It’s hard to quantify, but as a leader, that’s what I look at. Is there an opportunity cost at the end of the day that has the potential to save a lot of time and, you know, speed, as well as quality, can get us there? It’s something worth looking at.

Joseph Kim:
Yeah, I mean back to your point about the science and the molecules, time gives you more resources to do more molecules, right? So time is certainly a big lever to think about, but it also can’t just be three months, you know, like that’s not, I’m not going to spend an extra 10 million to get three months. Like, really?

Bari Kowal:
That’s right.

Joseph Kim:
So I’ve thought about this a lot as a sponsor side too, when I was there. And when the math doesn’t add up, it just, it doesn’t add up. And yeah, one final question.

Bari Kowal:
I’ve convinced people too. I can make a significant number of decisions about things that we should be doing and I can make a business case, but you got to be able to sell it to me in order for me to sell it to others and say this is really value add, so your point is well made.

Joseph Kim:
Yeah, real quick anecdote. When I was at Lilly, we did a very easy decentralized trial and put it head-to-head against brick-and-mortar. And I, listen, I bet the wrong way. I thought the decentralized would enroll more, they were middle of the pack and they were very expensive. And I was like, I learned.

Bari Kowal:
That’s not even surprising to me from what we’ve seen, just the way it’s, the way we have to cost it out, the way we have to do it, it is more expensive today. I still believe in some of the benefits of it, but they have to be proven over time and they have to be additive, really, at the end of the day. And I don’t see that today, I think there’s potential.

Joseph Kim:
Yeah, and you know, if they were the fastest enroller, I would say, okay, well, now we’re everything is headed in the right direction. But the fact that they weren’t the most, that’s where I started to really question when something like this actually makes sense. Not if, but when it does.

Bari Kowal:
Yeah, and I will tell you just an important, other anecdote on decentralized trials, my group has been focused on, one part of them has been focused on digital biomarkers and patient experience in general, and they’ve spent a lot of time over the last year getting a lot of feedback from sites and patients, and we’ve done that in the past, but not in the robust, with the robustness that we’re doing today. And we’re hearing what you just said. We’re hearing not everybody wants a decentralized trial, not every patient is interested in that, not every site is interested in that, not everybody knows even what it is. So it’s one of those shiny, flashy, nice, great things that we talk about. But, you know, to me, it’s what just makes sense to do, what might have potential, and then what do we apply?

Joseph Kim:
Yeah, I mean, at least we stopped talking about blockchain for a little bit. One final question, I know we’re, we’ve talked a lot and I can keep going, but I know, want to be respectful of yours. Talk to us about diversity, inclusion, and equity. And I don’t want to hear like what you’ve done necessarily, although I do, but I’d love to hear like how hard it is to actually enact, make sense of, and see results of things you’ve done. Like it’s hard, everyone’s struggling. Why is it hard?

Bari Kowal:
Well, it’s hard for a number of reasons. I know, let me go back, rewind a moment, and then I’ll talk about why it’s hard. I’m not going to talk about what we’ve done. I’ll just say the way we’ve approached this, even with a lot more intent now than we may have had years past, we go where the patients are, right? We go where the sites are, we go where the patients are. We use data to find out where patients are, what the right populations are. We spend a lot of time on epidemiology and that’s where the science comes in and is so important. We spend time on what scientifically could this mean for different populations. You know, Regeneron has a genetic center that was built, you know, several years ago for the sheer purpose of using genetic information to help us to create molecules that are more targeted. So if you’re talking about, you know, for Regeneron, that’s really at the base of what we want to do is really find the right things for the right people, whether it’s diversity in race or ethnicity or age or gender, anything, right? It’s, that kind of genetic medicine is one of the things that has been at the core of how we’re trying to develop medicine, right? So that’s one thing that I think will purposefully, but also in an underlying way, really facilitate the place for diversity in how we run trials. But what’s made it difficult is ultimately, you know, that just in the sphere of clinical development, the way that we communicate and how we involve sites. We’re usually going out to, we do it just like everyone else academic medical centers, places that have run trials before. We don’t spend a lot of time because it’s hard, right? It’s hard to find investigators who’ve never worked on trials and train them. It’s hard to go into communities that don’t standardly, and it just propagates the issue, standardly enroll in trials and try to get enrollment in trials because it’s all of those things. It’s more expensive, it’s more time, it’s a lot of things, and we don’t purposefully not go there. We just are working with data on here’s trials that deliver, here’s some sites that we know have good quality. And so if you just work that way, again, if you go where the patients are, you’ll tend to deliver, but it’s not as purposeful as it should be, and so I think we have to change the core messaging around it. And I do think, and I think this for drug development in general, diversity, as one major component of it, but COVID has really given us an opportunity. People did not know about clinical trials. My children said to me, I think I know what you do. And my kids are not five, they’re 18 and 20. But finally said to me, yeah, they finally said, I think I know what you do. And I thought, oh, she took a pandemic to get here. But it really resonated with me if my kids are finally understanding what drug development is and what clinical trials are and what it takes to get science and what the basis of science is, and all the discussions, for good or bad, that occurred during the pandemic, I think that gave us a platform that we can’t soon lose, right? We have to utilize that to build upon and talk about clinical trials and what they can deliver and how people can get involved and how important it is and even make the information we have more robust. What do we know about populations and their differences in terms of diseases? And we study that pretty intrinsically here. And, you know, it’s just about sharing that information. So I think that’s, the hardship is just where is the country, and the United States and maybe other countries we’ve been and how trials have been done, but I think we have a basis to go forward that might look a little different.

Joseph Kim:
Yeah, all well stated. I mean, a lot of it is structural. And let’s be honest, a lot of these problems are so much bigger than pharma and drug development.

Bari Kowal:
That’s true.

Joseph Kim:
Enterprise that, we can’t fix that alone. You know, to your point, you do have to go with the patients are, and if you always follow that, you’ll almost always succeed.

Bari Kowal:
I agree with that. I think that’s what we’ve seen. You know, I think and with more purposeful intent, we’ll do even better. It’s just a matter of paying more attention.

Joseph Kim:
Yeah, yeah. Bari, I’ve known you for a bunch of years. This is, like, the best conversation I’ve ever had with you. It’s so, I should, you know, I’m sad I didn’t do this before.

Bari Kowal:
Podcast!

Joseph Kim:
Even, yeah, exactly. Anyway, thank you so much for coming on the show today. It’s been a real pleasure. And I can’t, I look forward to seeing you in person at something soon.

Bari Kowal:
Yeah, absolutely. Thank you for having me. It was an incredibly easy conversation, which had no doubt it would be, and looking forward to talking to you soon.

Joseph Kim:
Yeah, thank you.

Bari Kowal:
Thanks.

Joseph Kim:
Thank you for tuning into Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some war stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com. This show is presented by ProofPilot and is powered by Outcomes Rocket.

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