Transcript
Speaker: Welcome to the Healthcare Theory Podcast. I'm your host, Nikhil Reddy, and every week we interview the entrepreneurs and thought leaders behind the future of healthcare care to see what's gone wrong with our system and how we can fix it.
Speaker: My guest today is Gadi Saroni, the CEO of Edvara, and he started his career at Prexel back when CROs were a nascent part of biotech and over nearly 17 years there at clinical research organizations, he went from leading strategy to running the company's entire clinical operation.
Speaker: And now he's the CEO of Edvara, roughly $5 billion dollars company that makes sure clinical trials are safe and ethical for the people in them. And every trial involving people, if you don't know, has to be approved by an independent ethics board.
Speaker: And Edvar runs one of the largest, reviewing thousands of active protocols, and he has now grown in technology and consulting business that connects sponsors, sites, and CROs. And in today's episode, we talk about why drug development still struggles with many of the problems it had struggled with 20 years ago, who should really own a clinical trial, and whether AI can finally close the gap between discovery and development.
Speaker: Hi, Gadi. Welcome to The Healthcare Theory. Thank you so much for joining. Thank you, Nikhil, for having me. asrian I'm looking forward to it. Yes, I'm looking forward to it too. And especially given your career, it's quite interesting to me. I mean it didn't start in clinical research. I saw that you started in strategy at E&Y. You joined a venture-backed startup.
Speaker: um And that was like right as the dot-com bubble was bursting. So you saw all these crazy evaluations. And eventually, a lot of these companies like disappeared in months. So this crazy time in technology. And at the same time, I mean, in 2003, you joined Parexel, which is now the largest CROs.
Speaker: But you joined, which is, in my opinion, like a sharp turn from software. You still have these big strategic questions, but going from software to what at the time was a regulated, slow-moving corner of healthcare, i imagine, was a big difference.
Speaker: What was going through your head? Like, what brought you from software into clinical trials? And was clinical research always part of the picture? Like, what really got you in there and what's kept you there since? Yeah, you know, Nikhil, partially it's, and i I say this to every young people, whenever you have, every young person, whenever you have an opportunity, take advantage of it. If it's an interesting one and it gives you sort of a new path, ah a new adventure. And to me, this was really, came to me opportunistically. If you really think about it, opportunity came up and I took it less because I was interested in clinical trials at the time and much more because
Speaker: To me, it was the confluence of things that really interested It was the confluence of policy, economics, science, technology, global reach. These things were things that were close to my heart and were interesting to me. um But actually stayed in the industry all these years, and it's now been...
Speaker: don't know, 26, 27 years that I've been in it, um because very few industries really combine such a level of operational complexity and strategic complexity with a meaningful human purpose. And to me, the problems were difficult, consequential.
Speaker: um They were never completely solved. And that made it interesting. I stayed because it was really meaningful. Yeah, I think healthcare is one of the few areas we have just inherent mission-driven nature. I think a lot of people in healthcare are mission-driven, which I've loved a lot. But then every single facet of healthcare, care from healthcare care ai to drug discovery, like the operation, clinical side, delivery side, so complex from a strategic and delivery perspective.
Speaker: um So many different questions, and there are none of them are solved industries either or far from getting to perfect efficiency, which I think is part of why many people love it. And it also makes sense to join when you did. I mean, at the time, Big Pharma was still running a lot of their clinical development in-house.
Speaker: And I think at the time, I mean, CROs are a much smaller part of this industry than they are today. i think within that decade, they basically tripled in size and sponsors realized that they could handle and handle. hand that entire execution off CROs like Parexel. So I wonder, I mean, you had a front row seat of that for this entire decade.
Speaker: We suddenly start to outsource all the clinical trial infrastructure and how that's done. CROs became way more involved. Was that something that you hadn't been expecting or was this something that you thought was more permanent? Like, what was that like at the time joining a CRO as the entire space started to evolve and these companies became bigger than ever?
Speaker: and Look, you know, it's actually really interesting. When I joined, I'm not even sure the CRO category existed. When you look at simply from the financial markets perspective, but you would talk to analysts and what is a CRO? Where does it fit? What's the segment? So the evolution of that industry has been remarkably fast from something that didn't exist into something that's so institutionalized and so important to what is a huge part of the economy, which is business. healthcare, clinical research, et cetera. So to me, that was really interesting. But look, I would say this, unfortunately, and this is to a point that you made to have seen the evolution. I've seen the evolution of an an industry in the CRO. I've seen the evolution of the science and by the way, the science is advancing remarkably fast.
Speaker: Unfortunately, I haven't seen enough of an evolution in how we do development. I will tell you that today i have the same conversations I had 20 years ago.
Speaker: It's about slow study startup. It's about enrollment is never hitting targets. It's about the bottlenecks, the inefficiencies in the system. So on the one hand, you know, I would say, yes, a lot of advancement. Certainly, we've thrown a lot of technology at things.
Speaker: But as I look at the evolution, you see an evolution of an an industry. You don't necessarily see an evolution of how the problem is getting solved. And that's a little disheartening, but I also have a lot of hope because I do think things are starting to change. I'll also add one other thing.
Speaker: Look, I believe that actually what the CROs have done is they've created an impetus to um solve some of these problems. I'm i'm a huge believer in CROs. I think they're an important part of the ecosystem.
Speaker: think if you look at um the arc or the pendulum of outsourcing, when I first started, outsourcing penetration was maybe, don't know, 25%, meaning 25% of the activity was outsourced. By the way, most of it was you know, we'll rent will vent people to do tasks for us.
Speaker: um But then the evolution moved to, okay, instead of renting people to do tasks for us, we'll give you a whole study. Then it evolved into, well, let's do strategic partnerships. We'll give you a portfolio and you do everything. um I think now the pendulum is swinging back a little bit towards more insourcing, but it's really interesting to see how that pendulum has swung and how the industry, the CRO industry has adapted to that, evolved and actually helped sort of direct how that pendulum is swinging.
Speaker: Yeah, I think it's really interesting you call it a pendulum because in other industries from consumer goods to watchmaking, you see this shift from like outsourcing to insourcing every few decades. But still, I mean, it's interesting. We probably never go back to that state where CROs are just handling a few things at once. Like now they're integral and part of how pharma does business. Like these trials are now, they provide a lot of real value.
Speaker: But then I almost wonder, like you talk about how, yes, CROs have gotten bigger, they've gotten more important. But it doesn't necessarily mean the system has changed and that the drug development process has changed drastically.
Speaker: But why do you think that is? Like, these are the smartest people in the world, many billions of dollars trying to answer these questions. Yet it's not just like changing, every though even though almost everyone wants it to. It's not like a huge stakeholder issue from what I understand. Like, what do you think is going on here that makes it so immovable in some ways?
Speaker: you know it's it's I ask myself this question a lot. Look, I think some some things are obvious, right? I think there is this is a highly regulated industry. And I think there is, by the way, i actually believe the regulators are pretty open-minded, pretty flexible, and want to hear back, and they want to interact, and they want to collaborate. But there is that fear of, these are the regulations, therefore, don't do anything stupid.
Speaker: um I think that's one. I think the second piece is if you actually look at the history, yeah it's it's a very interesting sort of picture. If you look at the history of the indices, if you look at the pharma index and if you look at the biotech index, life sciences has always actually been a safe haven for investors. It's actually always worked, right? So you didn't have to really make a lot of changes.
Speaker: From a financial perspective, at the end of the day, it actually always worked. Now, what I would claim is it worked from ah maybe from a capital markets perspective, but didn't really work from the perspective of you eking the most out of the research that you could with the dollars that you're spending. So I think part of it was also comfort that industry is doing well.
Speaker: But you know when you see an inflection point, every time there's a patent cliff, There's some sort of a panic. What do we need to do differently? How do we do differently? And part of the challenge is, and one I think one of the reasons why a lot of change hasn't happened is it takes so long to develop a drug.
Speaker: The failure rate is so high. Once you're on patent, you don't want to mess with anything because you need that revenue stream coming in. So I think there's a hesitancy to actually play with the system, a system that is inefficient but is working.
Speaker: I will also say that, look, at the end of the day, and my hope actually is that CROs can drive a lot of the um a allowed of the change. At the end of the day, pharma believes in the science very strongly.
Speaker: They're very competent, they're very strong at the science, they're actually very strong at the commercialization end as well. The more they let go of the development, the more they trust the CROs, the more you actually go and see the standardization. Even today, if you look at outsource penetration, I don't know the exact figure, but I think it's still roughly only, what, 55%, 65%. There's still a lot of activity that happens in pharma.
Speaker: I think the more you let... the core competent people in development do that work, I think the more you're going to see sort of the evolution and a faster sort of change in the system.
Speaker: It's a perspective. um But look, the other piece of it, we work in a very, very disconnected value chain. There are so many pieces. If you think about what we touch, we touch the site, touch the patient, we touch the science clearly, the regulators, there are systems for each component. There's a different system that does something.
Speaker: There's a different requirement. There's a different document. It's just so highly fragmented and there's so many pieces to it. And we haven't figured out yet how to connect all those pieces. And I will tell you, up until more recently, I'm not sure that there was sufficient incentive.
Speaker: All a sudden, you're seeing a lot more incentive. think the incentive is coming from two places. First place is, for sure, ai is helping this. The science is running so much faster than development.
Speaker: So you're going to have more and more bottlenecks. You're going to have to open that bottleneck to get more therapies to patients, to get more through the pipeline. I think the second piece is particularly here in the US, but I think it applies globally, the realization of how important clinical research is from two perspectives.
Speaker: One is an economic engine. The second perspective is as a mode of care, meaning the clinical research is a great way to give the population, particularly underserved population, access to the most innovative therapeutics.
Speaker: So to me, there's a much greater, and by the way, the cost of healthcare care is increasing so much. The population that's not getting the best care is actually, even though we're getting much better care than we've gotten decades ago, a century ago, we're actually seeing greater gaps in care.
Speaker: And I think all of that is actually going to drive the need for more efficiency, for more speed, for more connectivity, for all the parties coming together closer. Yeah, it's interesting because you have on one side the pharma companies that want really high biotechs and CROs, really high patient enrollment. And then you have the other side, the patients who want to be in trials and see frontier research and do things that will help them get to the place that they need. Yet these two often don't connect because the patients are like...
Speaker: aren't really in areas like New York with as much of academic medical centers than rural areas under certain populations. So it's almost like an infrastructure problem of it connecting the dots together, which I imagine CROs are like a huge part in helping with.
Speaker: But I do wonder, i mean, if you, with the CRO, the value add is that they can outsource clinical trials, but could you really maybe for us like prepare like the the bull and the bear case for that. Like, why should and shouldn't CROs take care of clinical trials? Because I think we're moving in that direction, but then there's still arguments that CROs leave a lot of the responsibility to pharma too. Like, to what extent do you think they should own the drug development process? And what are like the caveats of doing so? How do you see those two kind of comparing together? Yeah, maybe I'll parse out a little bit. And so far as, you know, ownership...
Speaker: is a loaded of word because look at the end of the day, um oversight still belongs to the sponsor, right? It's their trial, it's their science, it's their protocol. um They might delegate the oversight and the authority to the CRO, but ultimately the accountable party is the sponsor and it's the sponsor who ultimately has to um file and take the product to market, right? So I want to maybe parse that out a little bit.
Speaker: I do think that the sponsor should have their hand in the trial, understand what's going on have some oversights, um interact closely, by the way, not just with the CROs, but with the sites and to the extent where it's logical with a patient as well, because that very much should inform the science as well. um If you don't understand what the site is going through,
Speaker: you don't understand what the patient is going through, you're going to design a protocol that neither site nor patient want to participate in. So I want to make sure that we sort of parse that ownership versus connectivity a little bit. um i actually believe that, look, think about it this way.
Speaker: More and more clinical trials are run, particularly if you look at the phase two, three trials, although more and more you see it in phase one as well, they're they're much more global, right? I think the capacity of sponsors to stand up teams and to stand up operations in, some trials have 30 countries. In 30 countries is very difficult, is very inefficient, and it's not a core competency of pharma.
Speaker: Nor do I think that process is a core competency of pharma. um Take any biotech or any pharma. Let's say they do 100 trials. yeah The largest do 100 trials a year.
Speaker: CRO at any one time has 800, large CRO at least 800 trials running. um thousand trials running, they have expertise in scaling processes, um in achieving economies of scale, and leveraging geographic um advantages, in labor arbitrage, et cetera, et cetera, et cetera. So I think at the end of the day, the CROs are just a much better process machine than pharma can be. I also think that because of the volume of
Speaker: sites that CROs touch and the volume of patients and the volume of trials that they touch, their ability to actually deploy technology at scale across the standardized technology at scale across multiple sites and studies is much greater than what a farmer could do.
Speaker: Now that of course requires CROs to align and agree to have connected technologies and connect their own silos because I will tell you, having come from from a CRO, the CRAs did what the CRAs did and the data managers did what the data managers did and the regulatory folks what they did.
Speaker: And I'm not sure that they ever really spoke to each other or connected to each other. They certainly didn't sit next to each other. So I think the CROs should be the first ones to connect the systems and to figure out a way by which to connect, meet the sites where they are, um collaborate with the sponsors in a way that gives the sponsors access and visibility into what's going on at the trials in a real-time basis. I think that solves for some of the problems.
Speaker: Yeah, so your thesis is almost that like its clinical trials and drug developments are process. So it's really a process game. And then the core competencies of CROs is process, but pharma companies should still stay involved. But like the most of the development will be handled. The process will be all handled by the CROs, but then the drug, the pharma companies are still should have oversight over the trials and drugs itself.
Speaker: or so done Yeah, and look, to a certain extent, and I hear this from pharma a lot and I don't disagree with it. There's some competencies that pharma has that they don't want to outsource.
Speaker: um And I get it, for sure I get it. Look, this is their, by the way, particularly if you think about it, where ultimately it has to go into the FDA or to MHRA, EMA, whichever for for approval, you wanna be close enough to it and you wanna be responsible enough for it to be able to answer the questions, to be able to defend, to be able to actually stand behind what what was done and how it was done.
Speaker: I completely get that. And I think there's some functions where you'll never see them outsourced. But there are certain set which is why, by the way, you see more and more and more FSP. I think the mistake that pharma can make um And by the way, I'm a huge fan of what pharma does in terms of the innovation, the thinking, um how to sort of advance the science, etc. But I think the challenge that pharma has and the mistake that pharma can make is to parse out the activity so much that that disconnects them even more.
Speaker: Imagine you are doing an FSB model. So you're outsourcing CRAs to one organization, you're outsourcing data managers to another organization, you are keeping in-house the biostatisticians.
Speaker: Now you've created even more disconnect, right? Because that's parties that don't actually interact with each other regularly or talk to each other regularly. So I think the modality really matters. And I think farmers should just be cautious not to over fragment things um and make sure that whatever it is they do in house connects to what is done out of house with the CROs. I think that whatever it is that they outsource, they should do so in such a way that at a minimum, they insist on a single system and a single way of operating so they all have the same visibility.
Speaker: Yeah, that makes sense. it's It's like a weird trade-off in some ways, and each organization is making their own trade-off, so sure it's hard to come to a common solution. And, i mean, within your role there, like, how did your role at Parexel evolve over time? And especially, I think, the industry evolved in terms of size and how much, how often, and how...
Speaker: involved the CROs were in this process, but within your role, I mean, you kind of stepped up and you were there for almost 17 years. um What did that look like towards the end of your tenure there? um What kind of questions were you asking? What was the role in the organization? And how did that um and what was really your your mission? How did that evolve over that time at Forexel?
Speaker: You know I would say, look, first first of all, from the arc of my career, I started out in strategy, then I ran the consulting business there at Parxel, and then I moved to run a segment of the CRO and then the totality of all the CRO from phase one to phase four, inclusive link clinical logistics, our phase one units. So there was an evolution in my role, which by definition meant I saw things from different angles and different perspectives.
Speaker: I will tell you that the one big difference, if I just take the CRO portion of my sort of run over there, the biggest difference was initially it was all about how do I deploy resources in the most efficient and effective way. It was really a resource management activity and a project management activity.
Speaker: the Toward the end of the um journey at ParXL, the conversation revolved more around, how do we get involved earlier on in the decision making of pharma such that, for example, we help inform what does the protocol really look like?
Speaker: So feasibility. um The second piece was how do we look at things much more strategically? How do we understand the totality of your pipeline and how to actually organize the trials in such a way that we um both resource them correctly, right? But also are really thoughtful about country selection, site selection. um It became much more part of the strategy.
Speaker: um Initially, it used to be the sponsor came to us said, here's the site, here's what I want you to do, where I want you to do it. Toward the end, we were the ones who were driving country site selection, um much more of the portfolio strategy, although at the end of the day the decision always laid with the sponsor, but it was much more of a strategic conversation.
Speaker: I will tell you what's fascinating is at the end of the day, by the way, I was on the leadership team. I was C-suite and all that stuff. At the end of the day, when something went wrong on the trial, it doesn't matter if it was a top five pharma or small biotech, I would still get the phone call and it would get the question of how come the first site initiated has been initiated?
Speaker: How come... The first patient enrolled is not enrolled yet. The target was yesterday. So at the end of the day, yeah the strategic as we've become, the tactics never left.
Speaker: Yeah, that's so interesting. And like within, I mean, you're and you were at that time, you were at the C-suite seeing the strategic side, the consulting side, the operational side, basically every lens and every hat you could take. um But I'm curious in terms of like part of the time, time especially when you're on the consulting side and at the C-suite level is like trying to differentiate pro-exile And how did you see when you had a pharma company that wants to run a flagship trial, a large deal?
Speaker: How did you see the different CROs differentiating themselves? Like, what were they winning on? Because I'm assuming they're not just winning on price anymore. These are much like, these are strong value ads that each one of them had. Is it, would you say they're truly differentiated? Were this, did some of them offer speed? Like, how did you differentiate yourself and Proxel as a business when trying to win clients and position the business?
Speaker: No, Nikhil, it's a great question because even that has evolved, right? In the very early days, there's a limited universe of CROs. So the differentiation, as important as it was, it wasn't as important as it is today. Now it's a pretty crowded space. If you think about it, you just look at the landscape of CROs, you know, have the top whatever, six large ones.
Speaker: Then you have in the middle tier a bunch and then you have very small ones. So even differentiation today is different from what it was back then. I will tell you that in some respects ParkSale was actually ahead of its time, maybe too far ahead of its time. Our differentiation was um twofold.
Speaker: One oh maybe threefold um one was scale. right So we had the capacity to take on very large trials, much the same way you could argue that the QVIA did and ICON did at the time and some of these other folks. But scale mattered.
Speaker: um The second one was globality. We realized, by the way, one of the reasons I was brought on to lead strategy over at ParExcel was the thought of how do we grow the company? How do we grow the organization in such way that we can differentiate ourselves at scale?
Speaker: And one of the conclusions we came to were the first ones were truly global. then we need to become even more global. now By the time I left, I had 53 countries under my remit. That's a huge difference because more and more trials are conducted globally, one. Two, from a patient access perspective, it's really, really important. And three, from a regulatory submission, where you do the trials matters as well. So that was the second differentiator. But we were, i think, probably first, with the QVIA as well, sort of first to the line.
Speaker: The third one, where I would argue we were... perhaps too far ahead of our time, we tried to differentiate through technology. We actually made a um an acquisition or a number of acquisitions where we bought technologies, CTMS, IVRS, imaging technologies, and we tried to bundle the technologies with the work that we were doing. um The operational work, the hands on the on the street kind of, or the feet on the street kind of work. I think that was a huge differentiation, but it was a bit ahead of the time because I am not sure at the time that a lot of people were willing to buy in that sort of a bundle.
Speaker: But those were the key differentiations. Look, some differentiate by therapeutic areas. Some, for example, specialize in rare disease disease and oncology. Some differentiate by we only do early phase work.
Speaker: um So some differentiate by we're only FSB. So I think the differentiation has shifted and changed and evolved. um And I will tell you, price still matters. um At the end of the day, particularly now, there is a lot of pricing pressure for the CRO industry. I say this a little bit from an outsider because I'm no longer in it, but i certainly hear about it Yeah, it's interesting because when you joined the industry, it was a little bit more nascent, less scaled, um and ultimately just a lot less a little less competitive than it is today. And now when you've seen this level of efficiency, competition, and scale, I think price compression or price competition is somewhat inevitable. But I mean, you hint towards the fact that you're not necessarily at a CRO today. And what Advara does is a little bit different. But
Speaker: Before we get into that, I think it would be good to get a picture on like what is an IRB. And for many listeners listening, like every trial involving a human must be approved by an independent ethics committee called an IRB. And from our research, I mean, this is needed by like those real abuses in the 70s and 80s that made this almost necessary that we could have an ethics committee with diverse individuals that could understand, should this be in humans?
Speaker: is Are the risks necessary? And like does this make sense? i even in your early years in Prexel, I saw... TGN 1412 was um a big thing in London that there is there was a lot of um really critical responses and healthy volunteers suffered life-thotting reactions. And this is like decades after those landmark issues in the 70s and 80s. So, I mean, IRBs are extremely important and the role they have, they can serve almost as a gatekeeper in what gets into clinical trials, but they're also there to help strategically get companies in the right position. um So you're in the CRO space, like actually helping these struggles happen. IRBs are probably one of the first steps there. But maybe I think you can describe this better than I do. Like, what did you initially think about IRBs when you first got into CROs? And now knowing what you know today, like, what do you think, like maybe pitch me like the value proposition? why why are they so important? Can you give the context for why they even exist in the first place?
Speaker: Yeah, and maybe for the for the listeners to make sure that there's really an understanding of what an IRB does, what the review boards do. um So if you think about it, really an independent body that's responsible for, help protect the the the rights, the safety, the welfare of research participants. That's truly the mission of an IRB.
Speaker: By the way, overseen ultimately, but it's it's also in in Europe, you have the In other places, you have ethics committees. Here in the US, it's called an IRB. um And it's over it's under the remit, ultimately, of HHS from a regulatory perspective. But if you think about that, there's this independent body responsible for helping protect the rights of the with the participant. um What we really do is, look, we review whether the risks um over clinical trials are reasonable relative to the potential benefits and the knowledge that the study may produce, right? So we don't adjudicate um is the compound going to be
Speaker: effective? Is the compound safe from once it goes into the human interaction? You didn't know it yet. That's why you're running in the experiment, right? So it's really around the risks relative to the potential benefits um based on the protocol for intents and purposes. We evaluate the informed consent form. um As you know, every participant has to consent to participate. um We want to make sure that they are reasonably articulated and the participants can actually understand information.
Speaker: We examine the participant selection, you know, the inclusion exclusion criteria, whether it makes sense, whether there's privacy confidentiality or all the other protections. um And then look, we ultimately independently judge um separate from the commercial and scientific interest of the sponsor.
Speaker: all these elements, right? We are by definition independent. So that's number one. When I first got to know IRBs, as you said, I was at Rxl and typically the IRB is and a very important step and you can't go beyond a certain step unless you have the IRB approval. um I always saw the IRB as something that I didn't fully understand. It's something that's very important, clearly for the protection of the participant. um But in reality, we need to just get it done so we can start, know, essentially because we can start enrolling. We can initiate the site and and then start enrolling.
Speaker: And what I've learned to come to appreciate, what I've come to appreciate over the years is just what an important role an IRB plays, not only in the protection, but also in actually making sure that the research can be done more efficiently.
Speaker: can be done more thoughtfully. You know, as an IRB, I will tell you at any one point, i think right now we have about 10,000 active protocols going. our Our review boards have seen everything.
Speaker: They've seen everything. It's not our job to tell you how to write the protocol, but it is our job to tell you this won't work. Now, it's not ethical.
Speaker: That's one thing. But the other thing is it's ethical, but do you really want to do this? It's ethical to do this, but you do this one extra thing. Do you really think that that's going to incentivize a patient to want to participate? Do you really think it's going to get you to your end result faster, better? So we take it upon ourselves. and We take this responsibility very seriously to give insights to the folks are writing those protocols. I will also tell you that as it evolved, I've come to the realization that we're so unique in so far CROs work with sponsors and with sites.
Speaker: And the reality is they are working at the behest of the sponsor um and they have to push the sites to do what they need to do. um sites work for the sponsor and the CRO.
Speaker: We're unique in so far as we work with sponsors, with sites, and with CROs independently. We're in the middle of it all and we are a great connector for that entire ecosystem.
Speaker: Something that I did not realize before i actually started working here. Yeah, that's ah really interesting because like the last thing you want is pharma companies to think about IRB as a check the box. Instead, you want to really provide real value and show them that this is not some commoditized service or we're just getting your trial approved. You're actually a strategic thought partner in some ways and also a gatekeeper in other ways, too.
Speaker: And I think though blending those two together is very important. um And I mean, joining Advaro, so two questions here. Like, first of all, what led you to join Advaro from a great position you had at Parexel? And the other is, I mean, within weeks after you joined, um trials are around the world were stalling, COVID happened, and then you were on the Operation Warp Speed. And you're new to the, I mean, every playbook is, every every CEO is rewriting their playbook, but you might not even had much of a playbook in the first place. You're a new CEO leading people you really never met in person, I assume. Absolutely.
Speaker: So two questions, what made you join? And when you did join, like, what were you thinking about the company? was your like thought process and first principles about how you'll navigate the company through this and position themselves in the years coming out of it?
Speaker: um Walk me through those early years at Edvara joining and then getting them through COVID. And I mean, they had a great few years in COVID, I assume. oh it's Look, it's been it's been a phenomenal run. i love what I do and I love where I am.
Speaker: in part because I love the industry, but in large part because I love this company and I was not wrong about the choice I made. And look, the choice was driven by, but would say three things.
Speaker: um The truth the matter is, had a hugely successful run at Park Cell. At the time I was...
Speaker: And I came at a point in my career where if I didn't take the opportunity that came my way now, the likelihood is I will never change. But you get to a certain point in time where, okay, it is yeah I was very comfortable doing very well.
Speaker: And I wanted to be uncomfortable. um So that was really important to me. to try something new in a place, and this is the second piece, where the reality is, remember how I mentioned that CROs are a lot about process, they're a lot about how do we make sure we find efficiency, deploy resources in the most effective way. Certainly there's strategic opportunities, I mentioned those as well, but I wanted to come to a place where I could actually have a relatively blank slate to build something.
Speaker: on top of a foundation that's incredibly strong. And when I got into the conversations with the owners, the private equity owners of Advara, their whole idea was, look, we are an IRB and we need to stay in IRB. It's core to who we are. It's in our DNA.
Speaker: But how do we leverage that position to do even more good, to remove bottlenecks, to improve the efficiency in clinical research? What else can we do? And that's probably the thing that compelled me the most because I saw where we sat at the time where Advar sat, the assets that it had, connectivity that it could make. And I was determined that if we can change the industry, probably from this seat, I could do it a lot better than I could do it from the CRO seat.
Speaker: That was the second piece. The third piece is probably more of a personal piece. um Look, I and i mean told you I had 53 countries under my remate. I was spending half my time in airplanes anywhere from Argentina all the way to China and in between.
Speaker: Right. I adore my wife and I adore my kids. and I was not spending enough time with them. And by the way, it was I always made it a point to be home on weekends. So there were times when i would fly to China, come home for the weekend and then fly to Japan because it was that important to me to be home.
Speaker: And this gave me the opportunity to be home now. And I know that COVID was coming and I'd be home now for that. Maybe I still don't think it would have changed my calculus, but it's certainly yeah um part of the calculus. So that's really what compelled me to move. I will tell you, having worked with Advara as part Paraccel,
Speaker: I held them in the highest regard. An organization that clearly was mission-driven, an organization that cared deeply about their clients, an organization that had very smart people who did very good work.
Speaker: um That was important to me. Having investors whose first principle, in in their case, it was a completely different orientation. You think private equity and you think it's all about profit. and so How do you grow a great company? And by the way, I'm now on my second, but i would actually third in my career, but second in the Advara Hold private equity. And it's still the same story.
Speaker: How do you grow a great company? And when the investors told me, Gatti, you have the 51st vote. And by the way, proved to be true, never vetoed any decision of mine.
Speaker: I realized that this is the place where I want to be. Yeah, and that you're making the right decisions. I mean, that Edvara had... Linden, of course, is like a great sponsor before you got there. And then Blackstones obviously knows what they're doing to some extent.
Speaker: But these are like sophisticated sponsors who have... um want to see growth, but also like... Growth means can mean like really good things for the company, too. And I think part of that is that Advara had their core competency of staying within IRBs. M&A got them there like really strongly to build such a good, um profitable and also like strong position in that market. And now is this if really just a few big players left.
Speaker: But how do you decide on like how far Advara should go? in terms of like capturing wallet share and adding value because in theory, Advaro's at a really good position and you guys have added trial management tools, data tools, research tools to really expand like how much Advar can help and also expand how much WallShare Advar can capture. But the further you go, the less you are to your core competencies, unless you can keep building new ones. Like it's kind of a weird trade off here. You don't want to like grow your way out of business, but you also want to grow. You want to be able to expand more and and have help your customers more in some ways.
Speaker: What did that look like for you? How did you think about this? And what were those conversations like now and even back then? So Nikhil, I wanna, and I can tie these two things together in a second, but I wanna also go back to the the question you asked previously, because your follow on question was around the COVID piece, which I didn't answer, and around the playbook.
Speaker: I will tell you, there was no playbook. Nobody had a playbook. um You would typically do what every CEO tells you, new CEO tells you, come in and you're going to spend, you're going to do sort of 90 days of talking to employees and talking to clients.
Speaker: yeah I didn't have that luxury. I came in, um i didn't even come in. I sat in my home office, not knowing anyone, not meeting anyone. And immediately I had to figure out, one, how do we deploy technologies internally and processes internally so boards can still meet?
Speaker: 20, 21 times a week, boards can still meet, do their work, such that we don't stop or slow down research. So number one focus was, what technologies do we need to have in place? Now, luckily, we're already a technology-enabled IRB. A lot of their submissions were done in any event um through technology. But how do we finesse that? How do we connect all the employees? We sent them all home.
Speaker: How do we connect all those employees together? How do we set up the, by the way, but it used to be office based. How do we now change that posture? How do we very quickly assess what projects are in flight and how do we make sure that we close the loop with those clients?
Speaker: Now, there's another complication, which by the way, the CIOs had to deal with, the spouses had to deal with. of a sudden you stop enrollment. All a sudden you have to stop visits. You have to notify the patients. You have to notify the participants.
Speaker: Investigators come in. Procedures had to, some of them had to be removed remotely. That has a change to the protocol. That has an amendment. We had to figure out how to do all of those things. So that was order number one. And that was focus number one. In a perverse sort of way, that was a baptism by fire.
Speaker: One. But it got me to get to know the employees that much better because, man, we had to deal with each other on a crisis basis versus on a it's nice to get to know you kind of basis. right It also got me to understand what efficiencies we can put in place to operate better and more effectively, not because and wanted to find those efficiencies because I had no choice.
Speaker: So in many respects, it set the tone for the rest of my career. yeah How it ties back to your other question, it also opened my eyes to what are the other things that we can do and should do and what we should never move away from. So to answer your question around you know the the wallet share and you know how do you how you sort of do it not indiscriminately, um look, first and forst and foremost, IRB remains foundational to our identity, to our trust, to our mission. I will tell you, you can't do anything else if you're not a trusted IRB.
Speaker: yeah I think part of the reason why on the technology front, clients work with us, particularly the sites, is because they know we have their best interests in mind. When we say we're site-centric, we're truly site-centric because we understand what the site goes through.
Speaker: When we tell the sponsor we understand how to connect you to the site because we understand how the site works, and by the way, because we really understand your protocol, We really understand it.
Speaker: Right. So to me, without the IRB, we don't do anything else. We don't grow the business. We don't exist. So IRB, it's our DNA.
Speaker: It's our core competency. It is in many respects, the spine that runs through the organization. Okay. But there opportunities to expand and and get I would say not only more value for us, but also more value for our clients.
Speaker: So the boundaries that I typically set are, first and foremost, do we have the right to play in this space? If you look at our expertise, if you look at what we touch in the IRB on a day-to-day basis, do we have the right to also touch this other thing, also do this other thing?
Speaker: The second question that I always ask is, if we do so, are actually going to create more noise in the system, or are actually going to find a way by which we better connect the system and find more efficiencies.
Speaker: I will tell you, I don't believe in a closed system. I believe in the closed loop where everything runs through that loop. But I believe that we should connect the ecosystem. So my next question is always, will this thing enable a connection to the ecosystem?
Speaker: Or is this going to exclude somebody who's critical to what we're doing, to research? The third piece is i don't really want to compete with CROs. I don't want to compete with, one, they're a very important channel to us.
Speaker: Two, their core competency around process, their core competency around deployment of resources worldwide is different from ours. I think that what we need to do is supplement them, enable them, help them. So that goes into the calculus. And the final thing is,
Speaker: whether M&A or whether organic, if I can't be number one or number two, um why do it? I'll give you me an example. I'm not so interested in going into um sponsor EDC.
Speaker: That's been played out, right? There are big players out there, they're doing it, they're doing it very well. It's more of a standard in the industry. That's great.
Speaker: We will connect to it. I don't need to replace it. So that's kind of the way look at it. And look, capital deployment is a very important consideration. But at the end of the day, do I have the right to play there?
Speaker: Do I have the competency? And do I actually enable the entire ecosystem or is doing this? By the way, enablement can also be disruption. but is my disruption going to create disruption that that's unnecessary or a disruption that's going to accelerate clinical research?
Speaker: Yeah, I think that's really interesting. Because lot of people like look for other adjacent areas where they have core competencies, but very few expect to be excelling in those areas like they do in their core areas like IRB. And I think that is an important standard to keep a standard of like excellence throughout the organization. And I'll keep this last question very brief. um But I mean, every few years, a new technology kind of gets sold about transforming clinical trials, youre like electronic data capture, decentralized trials, real world data. And every few years, something happens. And now it's AI and the promises are bigger than ever. Sites picked by algorithms, patients match the trials automatically.
Speaker: And you've watched redta several of these ways come and go. um But I'll keep this brief. AI is a big question. You can tell you talk about this for an hour, but what keeps you up at night, whether it's something you're excited about or worried about? um What keeps you up at night regarding AI and clinical trials and where clinical trials and all this stuff goes in the future that we've talked about? i Love to hear your thoughts.
Speaker: Yeah, you know, it's it's funny. Sometimes leaders are asked what keeps you up at night and they're like, oh, nothing. And I will tell you, unfortunately, everything keeps me up at night. um First and foremost, and it ties back to the to the previous question, my clients keep me up at night.
Speaker: How do I make sure that we do right by our clients? Why do I care so deeply about our clients? Because at the end of the day, they're the ones who are gonna bring those therapies that are also important to patients. By way, all of us included are the beneficiaries of clinical research. So to me, are we doing the right things for our clients? Whenever there's a client issue, I will tell you, I am on it. I know about it.
Speaker: um doesn't mean that i I don't micromanage, I let the team manage it, but I think about it, I ask about it, and I want to make sure it's resolved. So client issues, and by the way, we're very fortunate we don't have a lot of them, but what the client cares about matters to me a lot. It's not only in terms of what problems they're having,
Speaker: But what solutions are they seeking? So the other thing that keeps me up at night is what should we develop? To your previous question, what should we go into, what should we not go into? um That keeps me up at night. And then the third thing that always keeps me up at night is just the employee base. Look, it's really, really important to me that what can we do.
Speaker: No question about it. But how we do it is really important to me. And to how to me is culture. So to make sure that we build the right culture on that once where employees want to come here and work here and want to stay here and want to give it their best. And the point you made in their your very opening remarks, this is is the industry that really attracts um people with a mission, people with a North Star. And I want to make sure we continue to do that.
Speaker: Now, I will tell you to your ai point. a lot of questions from pharma but also from our employees is what does AI mean for me? From the employee base is how is AI going to impact my job? What does it really mean?
Speaker: From pharma perspective is what tools should I deploy? How should I deploy it Do I trust it? Etc. I actually have seen AI work pretty effectively in the discovery space I think we need to figure out how to deploy effectively in the development space. And to me, what does that mean to our technology and services? For example, are you really going to need um
Speaker: an operating system where everything flows through? or know can pharma have their sort of agentic that their agent, and I can have my agent, and the agents talk to each other and they exchange the documents and exchange the task, et cetera, and actually you can surpass some of the systems. you know I think that's a consideration. I think a second consideration to me is how do we actually, when we look at AI in particular, how do we make sure that that data interoperability, um how do we make sure that communications between systems, that agentic piece, um
Speaker: is really thought out, meaning how do we move at the speed of trust that human in the loop? You're talking about clinical research. You're talking about patients at the end of the line. How do we make sure that what we're doing is thoughtful, what we're doing is vetted out, and what we're doing ultimately is in the best interest of the patient who's going to be the recipient of the therapy. So AI to me, i think about it less in terms of day to day how it impacts me.
Speaker: And I'm thinking about more from an industry perspective, how can we all come together and leverage it in a trusted, confident, compliant way that accelerates what we do and allows us to better collaborate, but at the same time, allow us all to maintain our competitive edge, to continue to find new streams of growth.
Speaker: And to me, AI is a huge enabler for that. Yeah. And the interesting thing there is the only answer you're to get, like comes with time. Like we actually have no idea to some extent, but we can still put ourselves in a position to hopefully capture like a lot of value and add a lot of value um within that, as you say, but um Really appreciate the time today, Gadi. I think we've talked about so much from like clinical trials, your time at Parexel, and to where like also IRB and like these companies' strategic microeconomic decisions fit into this whole ecosystem. I think it's really cool, and I'm really excited, especially if to see if we can really cut down that development window down. like Maybe we can, um and I hope we do. But really appreciate the time. Thank you again for coming on The Healthcare Theory. It's been great to have you.
Speaker: And Nikhil, thank you. And one, thoughtful questions. Two, thank you for being interested in the space and creating interest in the space. This is so, so important. And by the way, I do believe we can find ways to truncate the time, get more productive, get more dollars, therefore flowing back into research so we can get more products out to the market that really help patients in need. So I really appreciate you, the both the questions you ask and the fact that you're interested in the space and creating interest in the space.
Speaker: Thanks for listening to The Healthcare Theory. Every Tuesday, expect a new episode on the platform of your choice. You can find us on Spotify, Apple Music, YouTube, any streaming platform you can imagine.
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Speaker: Repeat, thehealthcaretheory.org. Again, i appreciate you tuning in and I hope to see you again soon.
