.jpg)
Transformation in Trials
A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation.
Transformation in Trials
Clinical Trial Supply is like an entire Galaxy with Ryan Keane
How is the pharmaceutical and biotech industry changing in the current financial climate? Our guest today, Ryan Keane, founder and CEO of Korio, shines a bright light on these subjects and more. This discussion is an exploration of our current healthcare landscape, dissecting the challenges companies face as they introduce new technology, the sudden shift in the vendor landscape, and the unexpected destruction of value in biotech due to companies discarding or divesting their assets.
We don't just stop at the surface. Ryan takes us deep into the complexities of customizing Interactive Response Technology (IRT) systems in clinical trials, highlighting the crucial role of education for both buyers and industry employees. We tackle the challenges of communicating complex information to patients and the need for creating reproducible and scalable processes. The conversation veers into the often misunderstood realm of clinical trial supply, the need for a no-code environment, and the importance of having technologically savvy folks who comprehend all the elements.
Guest:
Ryan Keane
________
Reach out to Sam Parnell and Ivanna Rosendal
Join the conversation on our LinkedIn page
Welcome to Transformation in Trials. This is a podcast exploring all things transformational in clinical trials. Everything is off limits on the show and we will have guests from the whole spectrum of the clinical trials community, and we're your hosts, ivana and Sam. Welcome to another episode of Transformation in Trials Today. In the studio with me I have Ryan Key, who is the founder and CEO of Corio. Hi, ryan.
Speaker 2:Hello, how are you?
Speaker 1:I am good and excited about our conversation today. Today we're going to talk about the good times and whether times are good.
Speaker 2:Why not Friday?
Speaker 1:So, starting off, I want us to check in with what is the state of pharma and biotech right now. What's happening, what is the mood, what is the health of our industry as it is?
Speaker 2:I mean, yeah, it's a good question because we, as Corio, we just recently I would say over the last six to nine months have started our formal commercialization push right because we've been building out our platform for most of 2022. And yeah, I mean, I think I need another half a year at least to wrap my head around that question. But, yeah, I'd say initial response has been I mean, we have a lot of contacts and people that we've known for over a decade, that we've been talking with since the very beginning. Everyone's been super responsive to have us in and talk with us and really try to break ground on opportunities to work together. Moving forward Now for everybody, I don't know.
Speaker 2:That is completely different. The world of cold calling and, I think, getting in front of people. A lot of people are just like not now, now's not a good time, let's talk in the end of year, and then the end of year will undoubtedly be let's talk in the middle of 2024. And it just keeps going. But yeah, I've noticed a trend and just kind of a slowness and I think a lot of people are just really hunkering down on what they have right now and what their key priorities are and the days of working through what you're doing right now and planning for times ahead. I just see it's not as prevalent as it used to be. People are just focused on what's going on right now and, I think, the attention to how to plan forward for upcoming opportunities when they don't even know if there's going to be upcoming opportunities.
Speaker 1:I mean a lot of value has been destroyed. A lot of biotechs that were valued quite highly just a year ago have either dropped so much in their stock quarters that they have been selling off their assets or even closing down. So it's been like a culling out there in at least the biotech space. Potentially it is a good thing for larger pharmaceutical companies who are purchasing drugs that were potentially pretty late in the pipeline and rejuvenating their own pipelines, but this definitely kills off a lot of smaller players that have had good drugs and could potentially become their own pharmaceutical companies in the making. It's been rough the past year.
Speaker 2:Yes, it has, and I started it in the space around 2005. And I think a lot of what we're seeing right now is very similar to some of the things that we saw in 2008, 2009 in terms of exactly. Smaller companies have great products, but funding has gotten hard and tight and, yeah, there's just not a lot of capital around to fund some of these opportunities and programs, and so you're left with a lot of people we're talking with. They have one or two things that are going on, and the awareness of whether or not there's something coming up is highly contingent on data coming out for what they have right now, and so it's just, yeah, it is definitely it's tough.
Speaker 1:One other trend that I've been observing is also more partnering between smaller biotechs and larger pharmaceutical companies, and this is completely based on my conversations on the podcast and outside of the podcast. It seems like more companies are partnering earlier to larger pharmaceutical companies and in that way, also getting a smaller proportion of the potential commercial revenue themselves, meaning that they also create this dependence on the larger players for their survival, and this also means something for how they choose to invest in technology, because if you partner already in the clinical phases, that means that you might use the technology of the sponsor company and not build your own infrastructure, and that just wipes out a big market for players such as yourself, I would assume.
Speaker 2:Yeah, the olden days, when you know a previous company I was with you know we had a great footprint across mid-Big Pharma. So anytime you know that model took place or an acquisition took place, you know we usually ended up in a good position because we were already kind of working with top providers. But yeah, early days right now, you're absolutely right, I mean a lot of biotechs that we've spoken to, where maybe we've gotten some communication going the momentum halted just for that exact reason because there was not necessarily an acquisition but a partnership. And then you know those vendors are already in place. And then again it's like what of all the things to disrupt in a new model and a new relationship between two pharmaceutical or biotech companies? It's not to get ambitious, necessarily with trying new providers.
Speaker 1:But then the other thing is well. So if we see less investments in from the biotechs standpoint, I think that for existing players we also kind of see A hesitance to invest in new technology. Right now it feels like people are holding back and saying, well, what we have is good enough, let's write out these times. Is that also what you're experiencing?
Speaker 2:There's two types of tech in the clinical space. So one is a market maybe doesn't exist yet and a technology is being created to address a gap. So maybe there's a process, there's something out there that a technology, if embedded in the process or in the environment itself, is going to solve a problem, and so, and then, on the other hand, you have technologies that are coming into a well-defined market. So, for example, you know choreos and randomization trial supply management. Randomization, trial supply management's been around since the early mid 2000s, so it's nothing new to people. People know they need it, people have it as a line item on every RFP that they're going to do in a phase two, phase three trial, sometimes phase one, depending on what the therapeutic is. And you know. So, for someone like us, we have to explain why we're better than the incumbents. It's a very different model than being a technology provider that has it's not a crowded space, because the space doesn't really exist yet. And so, from a vendor's perspective, yeah, there's not a lot of competition. But where you're competing with is status quo, and in times like you know, when times are tough, I think you know, regardless of what type of you know what bucket you fall in. It's tough as a technology provider, as a buyer, you're just, you're not able to, I think, process bringing in a technology to solve a problem as readily as you were before. But similarly, if you're looking at new providers in an existing space where you have current providers, I think there's also that hesitancy as well, unless that current provider is really dropping the ball on what their deliverables are. But I mean, there's a, there are these. You know there's always been two types of buyers in any space, but obviously in our own is that you know there are people that say look, I have this clinical trial. Ongoing vendors are already in place. Our next clinical trial is not for a year, let's connect then right. And then there's the other people that say have the exact same conditions. You know there's a study that's ongoing. Vendors are already in place.
Speaker 2:But I do want to understand what you have, because I want to do that now, I want to process that information now, I want to get that level of understanding now so that when I if and when I do need someone like you or have to make a change or have to make an addition, I've really solved for that along the way and we love those. But we love. We love that attitude right from my perspective, because it does. I appreciate how busy people are and they really are just focused on the now and getting through tomorrow with everything they have going on right now.
Speaker 2:But I do, I do think that there's value to opening up a door to talking with providers well before you know you're actually going to need them. Yeah, again, it's a bias of mine, right, because I'm, we're a vendor and we want to, we want to get on people's radar, I think, as long as you can. You know, I know, but I know there's a lot of aggressive sales people out there that the second you let them in the door they're, they don't you know, they don't leave you alone, and maybe that, maybe that ruins it for everybody. I don't know.
Speaker 1:I would also say that there's a general transformation of the types of vendors that we have, because before we had some very clear cuts. You need your, you need your ADC, you need your CTMS for concooperations, you need your ETMF, you need your statistical computing environment and that's a nice, a more or less value chain for your systems. But now that's not the landscape anymore. It's changing. There are different kinds of puzzle pieces you can put in place. If you were to describe how Corio would fit into that landscape, how would you? Where would you position it?
Speaker 2:Yeah, so, yeah, a few things on that comment I already agree. So there's, there is this shift, right? Think one of the problems with the shift stems with vendors ability to articulate the shift. I do think a lot of vendors in the e-clinical space tend to market to other vendors. If you've ever read it, everyone says it. It's almost like the level of detail and really how words roll out and what people choose to talk about at conferences and what people choose to say about LinkedIn.
Speaker 2:I find it's almost like every vendor they really want to market to their competition, to let them know what they're saying. It becomes this pinball effect of communicating information that is so over the top in detail that maybe as a competitor of another IRT provider, I understand exactly what they mean. But as a biotech that does I don't know even a big pharma company that does 50 trials a year that might require IRT the IRT provider probably does 200 trials a year. They know even that much more. So try to visualize being a small biotech that does one trial or two trials or three trials a year, the information that you're communicating to try to transpose the current world order to the new world order. Now you're surprised why people don't show an embrace of change just because nobody understands what the hell you're talking about.
Speaker 3:So I think there is a level of marketing that I don't know.
Speaker 2:that necessarily resonates with the buyer being the pharmaceutical biotech company. I think it resonates more with the competition. Then what happens is, as a competitor, you go oh look who they just said we have to say that Now you have and I'm going off in a tangent here but 2022 we spent a lot of time in R&D and I really didn't pick my head up much. I didn't go to conferences, I was just in a poll doing lots of stuff. I finally went to a conference in May of 2022. I remember vividly. I went there and I noticed one very similar thing across every exhibitor everybody had DCT on their booth. Oh, my God.
Speaker 2:It's like you weren't allowed in the door unless you had it's something that decentralized trials. It was insane. I got there and I was like I don't understand what anyone does. I should. I'm embedded in this industry. I'm walking and I'm just everything. It didn't matter what you did, what your service was. It was decentralized trials, dct, dct, just for like.
Speaker 2:Let me preface this I'm in full support of all that. This is not me knocking that, but what I am knocking is the way that vendors are articulating what it is exactly, which I would argue that most don't even understand what it is, but it has to be on that booth. I think that's a big problem in our space. The way that people are trying to get people to change is they're failing to understand who they're talking to and what their level of comprehension is. On the big picture, if we want to see anything really change, we have to get better at that. It's not easy. If you're talking about Corio and our slither and the randomization trial supply management piece, it is really hard. It's hard to go from being in an environment all day, every day. For years I've been in IRT. For 12 years my co-founder's been in it. For 20 years, our core team. It's like we've been in it for like all we've done. How do you explain to people what they need to understand in a way that is practical and digestible? It's hard, it really is. Messaging is one of the hardest things that exists. When I make fun of everybody else, I mean I'm making fun of them, but it's also I'm acknowledging that it's a difficult thing for people to do. Where we fit in the change of it all is mostly on our side of the fence is really what we're focusing on.
Speaker 2:There is, like I said, I randomize trial supply management. Interactive response to whatever you want to call has been around for decades. You randomize patients, you manage your drug supply, you're integrating with other systems, you're passing data. That's the bread and butter of IRT. It's been in place. The user, whether it's the site randomizing or managing the dispensation of drug or it's the drug supply manager that's controlling drug from location to location throughout the trial, it's all there. I mean that's the thing. It's like another IRT provider like how many more do we need? That's always. There's plenty out there. Everyone does the same stuff For us, I would argue no, not everybody does the same stuff.
Speaker 2:I think, from a user perspective, there's the element of things getting a little more seamless and straightforward, easier to navigate. Great that's. Technology gets that way. What we're focused on is really the area that I think we have the most control over. That is, our own team's ability to build and deploy clinical trials.
Speaker 2:Anytime a sponsor needs an IRT system, the vendor is building essentially a unique instance every time, but studies have gotten so complex and what people need to do with the user and there's a lot it's not just an off-the-shelf product that people license and you do what you need to, like a Salesforcecom. There's a lot involved to building and deploying these trials. Everybody needs something different. Every protocol is designed a certain way. Every sponsor approaches their drug development different than another, and so you get into this process where you are creating this unique thing for everybody. And even if they're sharing the same 75, 80, 90% of the meat and potatoes of it, there's still a level of difference, and that level of difference is where IRT providers have gotten themselves in trouble over time, because when they're young and they're small, they're nimble, they have a low amount of customers, not a lot of demands.
Speaker 2:People can do anything. I mean, if you build a house, you want to build a custom house. It's yours, everything about it is this is your kitchen, this is the way that you want this to look. This is your backyard. You get a custom thing when you have a team that does it, but what if that team has to do that approach two 300 times a year? And I think that's where you get into trouble, because you're trying to replicate that same level of customization and flexibility time and time and again, and what vendors usually do is they inject a level of services, customization of people to twist and turn their platform, to get it to do all these fancy things, and so there's a reliance on people to get it right. There's a reliance on people to know that if they stepped out of bounds of their platform's capabilities, they got to go fix this over there.
Speaker 2:Like I said early days, anyone can do anything. If you got every ROT provider together and you cleared their schedule and gave them one protocol, everybody would create a great opportunity. How do you keep doing it? So that is really the focus of Corio. I mean we were part of many organizations across our career, of kind of the startup phase to becoming that legacy provider and seeing all the stops along the way where things got a little tricky, because maybe there are elements of the platform that were not really thought through in the very beginning and the inception of the company, and so really, that's what we're focused on.
Speaker 2:We're focused on our side of the fence of the delivery and it's almost for us. Everyone talks about patient-centric, site-centric, client-centric, customer success. Everything's about the buyer. We're almost approaching it as employee success. Our client is our own people, because we can't do anything for the patient or the site or the sponsor if our own team is crushed.
Speaker 2:I mean, you're telling people to build Detachment Hall every time, whether it's ECOA, irt or some of these new electronic data capture methodologies, and you're giving them hammer nails and that's it. You're saying go do this over and over again. It's exhausting and people burn out, they quit, and the endless cycle of hiring new people, training them, getting them on work, and then you catch your breath and by then there's a whole class of other people that have left. They're burned out and for us it was like we don't want to go down that path. We're not going to fall into the same missteps as everybody else. We are going to set up a platform with the right guardrails and breadcrumbs put in place so that our own team can build and deploy these custom solutions in a way that is reproducible and scalable, and that's it Right. I mean. So we are not building this new technology in an undefined space and this is not our. I mean, I think there's a great home for that and I really commend people who do that.
Speaker 2:For me and my founding team it was all about look, this is a space we understand very, very well. We've seen it evolve. We've seen it go from startup to legacy provider. Let's really hone in on these pieces that we know will protect us from becoming the people that we're trying to correct. But not only that how can we get to a model where actually, our platform gets better over time? That never happens. It's always the reverse. It's like you start kind of throwing duct tape and bubble coming holes to fill things.
Speaker 2:That was on. We've set up an architecture and a framework and an ecosystem where we've gone outside of E-clinical and really tapped into a lot of things that have already been solved in other industries, other technology industries. So that was really important for us is to not just build a company that is built by the ghosts of IRT past. You know what I mean. That's what everyone likes to build something new. It's like, so surprised it's with the same people that have been here for 20 years. There's a value to making sure you don't abandon E-clinical and familiarity because there's a. You can't just go outside of E-clinical and technology and pharma and expect to people to understand and appreciate what is important to a pharmaceutical company. But as far as like technology building, we really did get other perspectives in the mix to make sure we were building something that was in fact different.
Speaker 1:I would be curious to hear more about what do you do specifically to ensure that your team is able to survive this customization. Do we have some practices? Is it the skill of the team? Is it the technology? How do you ensure that? Because I think that's very important.
Speaker 2:Yeah. So you know, I guess kind of the simplest way to put it and I may not say it right, but I mean you think about the way that things are now, as, like people's product is it is what it is and the way that they've modified it on a per study basis is they've taken that base platform and then they've manually added a bunch of stuff on a per study basis and so basically, anytime you're deploying an IRT system, you're probably deploying a unique instance of your product every trial. So if you're an IRT provider and you have a thousand trials in production, you're basically managing a thousand products, which is crazy. It's hard enough to manage one, but to have that many out there, it's irresponsible, I guess is really a good word to put it. What we're doing is from a per-study basis. We are in a no-code environment, but at the platform level is really where all of our features exist and they're reusable and they're tested in a way where, as we're deploying clinical trials, we truly are able to reuse these validated components in a way that it minimizes, if not eliminates, on a per-study basis.
Speaker 2:Having that custom stitching that takes place. That's very subjective and how this person would do it. That's where the danger is. If you have one developer that they conceptualize something a certain way, they're going to build it their way and then a whole other team can approach it a different way. So that's where the danger comes in that variability that can exist on a per-study basis. That exists not only at a development level but also a project manager level. Everyone just looks at protocol and it's going to approach it a different way. So for us it was all about containing that response so that there's more control and it minimizes the risk of any one individual or team approaching something in a way that could deviate from best practices and maybe be the wrong decision.
Speaker 1:So it seems like you are a very mature team that know the space, know what you're doing, know what usually fails and are actually able to put something else in place to rectify some of those things that always go wrong. Are there any downsides to being very well versed in this space?
Speaker 2:Absolutely, and I think that goes back to the challenges of communicating to your buyer. When I came into IRT in 2011, I didn't even know what an IRT system was. I was a bio statistician by training. I did a few years of business development and then I took a job at an IRT company, and I actually found that I had a lot of success in the first few years of me being in the space because I did really really take the time to understand the product as much as I could. I think that's really important as a business development you should know who you work for and really go deeper than the sales deck to get it, and so I was very interested.
Speaker 2:I was surrounded by a lot of good people, but I think my limitation in the space was an advantage because, as I mentioned, I was talking with people that they don't live and breathe and think about IRT all day, and that's a hard thing to jump from doing that all day to then communicating with people in a way that they can actually be responsive and connect with you. So, yeah, that's hard, I mean. I think we're making amazing decisions in our platform that are so dialed into what needs to be done, and for me. I'll take that any day over the difficulty of messaging and marketing, but it's hard. It's not only on the buyer side, but we also hired a lot of people that were outside of industry, as I mentioned.
Speaker 2:So we have Alan from IRT that have been in the space for decades. Then we have software engineers and test engineers, us designs that they don't come from the space and now you have to. So for putting aside even your buyer in the pharma company, educating your own company on what it is we do and how we do. It is a challenge Because you can't take that for granted. I mean, they're coming in and they're trying to, they're approaching an engineering problem and they have to be able to wrap their head around what is the problem we're trying to solve, versus just being given like an engineering story to go and build something without any idea of what exactly the outcome is. So yeah, that's always going to be challenging, but I mean, like I said, I think it's a better problem to have than, I think, going into a space naive to what exactly the true problems are and then building something that isn't in its entirety really going to complete the picture.
Speaker 1:In general, my observation is that clinical trial supply is misunderstood. Only people who have actually been in this space for a while understand what's happening. Because you would need to understand clinical trials, you need to understand CMC, you need to understand supply chain and operations and also just the reality of the sites. So it's very hard to kind of find people who understand all these elements and who are also technologically savvy, and it feels like a very small world where people kind of know each other who work in this specific space.
Speaker 2:Yes, very small, very small world and, yeah, and sometimes a little closed off too right, Because they do feel very. It's a tight-knit group, everybody is, you know, and then it's also, yeah, it's a tough. There's so many workflows and specialties in our space that it blows your mind, you know. I mean you sit in a venture capital presentation or something about. Well, why are there so many vendors? Why isn't there just one thing that does it all? And that's the perception. It's just like it's so overly complicated. With all these pieces and all this, you know just just one thing you know, and it's within each one, if you really really kind of zoom in is a whole galaxy.
Speaker 1:Exactly yes.
Speaker 2:And if, from you can look at it from a far and be like, oh, it all connects, it all makes sense, then you kind of you zoom in and you're like, wow, this is. People build their lives around understanding just this one piece, and it takes so much time and so much energy to do that. And so it's not as simple as just you know, having this one thing that just, yeah, does it all, connects it all. So I think one of your questions earlier was you know, what are we? Another piece, I think, as it relates to outside of our closed fence, of our own processes, is just the concept of, of integration with other providers and just the heavy lift that I think exists today, that you know doesn't have to exist tomorrow.
Speaker 2:Right, and again I go back to other technology spaces. You know, if you go on Amazon to, you know, buy something, there are payment elements that are embedded. You don't see them. You know your whole workflow is not affected by all the other moving parts and all the other moving vendors that are part of that ecosystem. And I think that's kind of where a lot of our space needs to head, where, if vendors do get to a better spot of integration capabilities, then sponsors really can just kind of go into one vendor platform to start the process and it just does happen seamlessly to interconnect and do all those pieces in that way and I think that's how you get to the dream of interconnectivity.
Speaker 2:You're not gonna necessarily find one vendor that does it all you're gonna have. You're gonna appreciate that every vendor knows their space very, very well and there's a lot of complexities and don't overlook all of that. However, the way that these systems are interoperating with each other behind the scenes can get a lot more seamless and give the experience from the user's perspective, whether it be site, whether it be clinical drug supply manager, whether it be anything that they can just go into one place and have all these moving pieces. But there are separate entities, they're different companies and those companies should focus on just their thing, should be niche product, but the level of integration enables that experience. I think to be the dream, but in a way that is more practical.
Speaker 1:Yeah, I would tend to agree. One of my dreams that I hope I'll get to at some point is creating an overview of this changing landscape that we're seeing with vendors in the clinical space and kind of say, well, this is how the clinical the processes evolving, these are like the changes that we're seeing. This is how trials are becoming more complex. These are the different vendors that are playing into different stages of this process. This is how they could fit together and just kind of make a living catalog of that, so it might be easier to choose. It would be an impossible task because it would change all the time, but I think that would about the marketing and communication task you were talking about before. So you want to put.
Speaker 2:You want to map it out and put, like each vendor at each you want to okay. Yeah. Like that's, that is like there's like a going on, there's like a going back to like you know, my, my PCT thing is like there's that graph, right, there's like a lot of vendors on that graph and the vendors that are at the top love to recirculate that in LinkedIn, so everybody's like every few seconds.
Speaker 1:Brian, we always ask her guests the same question in this podcast, and that is if you, if we gave you a magic wand and you could use that wand to make one wish, that would change something in the life sciences industry, what would you wish for?
Speaker 2:I do think that there's that constant struggle with raising awareness to patients with what their options are. You know, I think it's, it's said, I noticed it a lot Again it's so far out of our area of expertise. You know the concept of patient recruitment and retention and it's, and it really is, it's, it really is something that I wish, I wish was just more available to people that need what they need. It is very even when you're in a position as a patient where you are looking for a solution, it's hard to find right, and so in situations where people don't even know to look in the first place, then there's a level of difficulty there. Right, so I do I think the education and to patients and making it easier for people to find these solutions, it just yeah that's. I just wish that was, I wish that was better, I wish it was easier. I just think that would. Yeah, I mean the getting that resolved and moving things faster. In that regards, I wish we could, we can do better at.
Speaker 2:So yeah, like I said, it's so far outside of like our view we talked about. Just every company is in their own, their own ecosystem, their own niche, their own, you know, just planted of whatever their focus is on, and we're not really close to patient recruitment and on all that, but I see it Like I do pay attention to it and I actually have my own personal experience within my own home where a family member is looking for something and it's fine. It's just not. You're like, you're kind of on your own in so many different ways and I just wish that was different. So cause we're all, yeah, we're all trying to try to move things faster and I just, yeah, I think it's just it all starts with getting patients awareness of what their options are, in a way that it's you know, it's gonna get, you know, keep the ball moving. So I would say that that's a good wish.
Speaker 1:All right, that was true.
Speaker 2:Seconds to think about, but I did wanna, I did wanna think about it.
Speaker 1:No worries. Well, Ryan, if our guests want to reach out to you and learn more about yourself or Corio, where can they find you?
Speaker 2:They can find me at well, on LinkedIn, I'm there, and otherwise Ryan R-Y-A-N-N-A. Corio clinicalcom, k-o-r-i-o clinicalcom. And yeah, hopefully I'll be in. I will be at a lot more conferences in the upcoming you know upcoming. But yeah, I'd love to hear from people. I'd just love to connect with people and talk things out and understand what their problems are looking to solve.
Speaker 1:So, that's awesome. Well, thank you so much for coming on the show, Ryan.
Speaker 2:Thank you. Thank you, Ryan.
Speaker 1:And I'll see you in the next one.
.png)