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Clinical Trials Move Faster When Sites Get Paid On Time · Lab to Lives

• 0:09
  SPEAKER_04: Welcome to Lab to Alliance, the podcast where we ask how do we get great ideas out of the lab and into people's life.
• 0:20
  SPEAKER_04: Your hosts are Alexander B.
• 0:23
  SPEAKER_04: We are TM East and if Anna also Dave Ofido.
• 0:28
  SPEAKER_04: We are improv comedians who are also working in life science.
• 0:33
  SPEAKER_04: On this show, we invite guests from the industry to give us their bold take on how we could get more health with less waste.
• 0:44
  SPEAKER_04: So whether you're developing a next generation drug, innovating in MedTech, or just curious about how healthcare moves from discovery to impact, welcome to Lab2Lives.
• 0:59
  SPEAKER_05: Hello everybody, and welcome to another episode of Lab2 Lives.
• 1:04
  SPEAKER_05: We have Chiara here, our new long-term host, and we are joined this week by Patrick Meiser and Kevin Williams from Ledgerun.
• 1:13
  SPEAKER_05: Patrick, Kevin, how are you today?
• 1:15
  SPEAKER_05: Doing great.
• 1:16
  SPEAKER_05: Doing well.
• 1:16
  SPEAKER_05: Thanks for having us.
• 1:17
  SPEAKER_05: Good.
• 1:18
  SPEAKER_05: No, nice to nice to have you here.
• 1:19
  SPEAKER_05: What we'd like to do to start off with is to uh get a little bit of uh introduction to our guests.
• 1:26
  SPEAKER_05: So the first thing we do is we have a thesis here that there's five main pillars to innovation in healthcare.
• 1:34
  SPEAKER_05: One is the RD development stream, one is product and manufacture, another is corporate, another is compliance, and the final one is commercial.
• 1:46
  SPEAKER_05: So maybe you each can just give an indication of which of those streams are most applicable to you, and then a brief introduction to your you both as well.
• 1:54
  SPEAKER_02: Uh sure.
• 1:55
  SPEAKER_02: Yeah, so uh nice to be everyone.
• 1:56
  SPEAKER_02: Patrick Meiser.
• 1:57
  SPEAKER_02: On the LedgerOne side, I think we fall pretty squarely into the RD piece.
• 2:00
  SPEAKER_02: You know, our software really accelerates and makes it easy for clinical research sites to get paid on time.
• 2:07
  SPEAKER_02: I'm really excited to be here with Kevin.
• 2:08
  SPEAKER_02: Kevin's been in the industry a really long time.
• 2:10
  SPEAKER_02: I'm actually a relative newcomer to the clinical operations space, site payment space, but I've been in technology for a really long time.
• 2:17
  SPEAKER_02: So I've been doing technology across various industries for the last 20 years and have really fallen in love with finding ways to apply technology to really longstanding problems that have existed in various industries for a long time.
• 2:31
  SPEAKER_02: So as I got a chance to understand sort of the pivotal role that you know Ledger Run plays in making sure that clinical research sites are getting paid on time and accelerating drug research and development, uh, that's what ultimately drew me here to Ledger Run.
• 2:44
  SPEAKER_00: Great.
• 2:45
  SPEAKER_00: Thanks, Patrick.
• 2:45
  SPEAKER_00: Yeah, so Kevin Williams, yeah, from a Ledger Run perspective, I'm actually one of the co-founders of the company.
• 2:53
  SPEAKER_00: And you know, really today serve in a in a more mostly a strategic perspective.
• 2:58
  SPEAKER_00: Of course, we still wear lots of hats uh within the organization.
• 3:01
  SPEAKER_00: As Patrick mentioned, we're we're squarely in the RD space.
• 3:06
  SPEAKER_00: So we uh we operate in the clinical trial space.
• 3:08
  SPEAKER_00: Specifically, what I like to tell people is we're in we're in the you know the business aspects of running clinical trials and and of course, you know, being able to move that as quickly as possible.
• 3:18
  SPEAKER_00: A lot of people think of the clinical side for the most part, but there are various business areas, and uh that's pretty much where I've spent my whole career.
• 3:26
  SPEAKER_00: So I've been in you know clinical business operations for about 25 years.
• 3:31
  SPEAKER_00: I was started and cut my teeth in big pharma.
• 3:34
  SPEAKER_00: So I was at Merck for about eight years, doing a lot of the things that you know we may even touch on today, which is clinical business, site contracts, site payments, uh do a lot of clinical outsourcing work.
• 3:47
  SPEAKER_00: So getting to know organizations like ourselves as well as all the other suppliers uh you know in our space.
• 3:54
  SPEAKER_00: And then I've been a founder of two companies, uh one uh CFS Clinical, where we built the first dedicated uh site payment solution in the space, which ultimately was acquired uh by drug dev and subsequently ICUVIA, and then you know Ledger Run, uh, which you know we started at the end of 2018, and really you know, seizing the opportunity to leverage technology in a way to accelerate payments and study startup, and specifically making sure that the payments don't become the uh you know critical path of uh running trials.
• 4:31
  SPEAKER_00: So and ultimately that just flows downstream and impacts you know the whole chain there.
• 4:35
  SPEAKER_00: So I appreciate appreciate you guys having us.
• 4:37
  SPEAKER_05: Oh great to have you.
• 4:38
  SPEAKER_05: And it's nice to have these uh these different perspectives on the on the channel.
• 4:42
  SPEAKER_05: Talking of different perspectives, one of the other things that we like to do is open up the discussion with a question of what's been on everyone's mind this week?
• 4:50
  SPEAKER_05: Are there any big topics in in healthcare and healthcare innovation that you've come across or an obstacle you've hit?
• 4:57
  SPEAKER_05: Uh what has what has been on our mind this week?
• 5:00
  SPEAKER_00: I think for us, I mean, certainly, you know, a AI is the is the hot topic.
• 5:04
  SPEAKER_00: I don't know, it's this week, I guess it's this year.
• 5:07
  SPEAKER_00: You know, the last uh year and a half.
• 5:10
  SPEAKER_00: It's it's the it's the uh consummate buzzword right now.
• 5:13
  SPEAKER_00: But you know, for for us and and the roles that we're in being a unique organization, you know, it's about execution and making sure that we're recognizing the you know the burdens placed on everybody in the chain of you know running trials.
• 5:28
  SPEAKER_00: Specifically for us, we spend a lot of time focusing on the sites and how how we can do things to you know lessen their burden and impact.
• 5:36
  SPEAKER_00: So I would say that's pretty much a routine case for us on a weekly and you know routine basis.
• 5:42
  SPEAKER_05: Yeah, it's it's one of the interesting things about actually, and one it links to innovation in general, because quite often, and I I saw a case like this a while ago where you bring something new into the market, a new technology or a new way of doing things, and you have this whole space of things that you could do with this.
• 6:01
  SPEAKER_05: And in the start, there's a lot of talk about, oh, we could do this and we could do that, we could do the other.
• 6:06
  SPEAKER_05: But I think now we're starting to see some of the actual, well, we are doing X, Y, and Z and sort of narrowing down that space to from what we could do to the actual, okay, this is what we are doing and implementing and making improvements through with sort of AI or anything else.
• 6:21
  SPEAKER_05: That's quite exciting.
• 6:23
  SPEAKER_02: And I think there's a big delta in what you just described.
• 6:25
  SPEAKER_02: You know, I think we're kind of uh, you know, I like the way you you phrase that.
• 6:29
  SPEAKER_02: I think on the AI space, we're kind of like maybe exiting the euphoria stage of, you know, AI is gonna change literally everything.
• 6:36
  SPEAKER_02: And, you know, it is gonna be really transformational.
• 6:39
  SPEAKER_02: But I think we are starting to see places where AI in its current state can really materially change things and where some of that was maybe a little bit of a little bit of bluster.
• 6:49
  SPEAKER_02: And I think what's been really exciting for for me being in the space again, being kind of new to clinical operations is that, you know, I think one of those places where AI absolutely is making a huge difference is in scenarios where humans are in the loop, right?
• 7:03
  SPEAKER_02: And where there is like kind of error-prone, repetitive, somewhat time-consuming tasks.
• 7:08
  SPEAKER_02: And for that to be happening in a moment where all of a sudden there is a bunch of financial pressure on research sites and the cost of delayed and inconsistent payments is maybe bigger than it ever has.
• 7:18
  SPEAKER_02: It's been a really cool kind of opportunity to be right at the epicenter of those things, right?
• 7:23
  SPEAKER_02: Kind of out of the hype cycle a little bit and into a place where we're we're seeing a real impact from AI.
• 7:28
  SPEAKER_05: Maybe a nice segue into the into the meat of the discussion today, because what we also like to dig into is the core thesis and the core passion behind people and what they're doing in this space.
• 7:40
  SPEAKER_05: And so I guess for you folks in in setting up this company, there's a real challenge that you see and a real bottleneck in the way the payment system was working before and and the impact it had on how trials could be run and how drugs could get into people's hands.
• 7:55
  SPEAKER_05: So it'd be great if you could, if we could maybe start to talk about that a little.
• 7:59
  SPEAKER_05: And I'd be interested to hear what it was, this big thesis that you had that you just had to tackle.
• 8:04
  SPEAKER_00: Yeah, having co-founded the company, I mean, really the original vision was to build a you know a practical and functional technology solution that solved real world problems.
• 8:18
  SPEAKER_00: And and and I'll I'll call real world problems in clinical trials that really don't and haven't traditionally gotten the attention they deserve.
• 8:27
  SPEAKER_00: And you know, often you know, I get the question of you either why hasn't this been solved or you know, what's what's the burning platform now?
• 8:35
  SPEAKER_00: And and the reality is there's there's been a lot of yeah, I would say, cool things and you know, more sexy things that you know get get worked on in clinical trials.
• 8:46
  SPEAKER_00: Everybody wants to hear about wearables and you know, an ePro and you know, all kinds of fun technologies.
• 8:52
  SPEAKER_00: When you know, when you start talking about making payments and doing contracts, sometimes people's eyes glaze over.
• 8:58
  SPEAKER_00: And but the reality is we serve in a critical cog in kind of the value chain of running clinical trials.
• 9:06
  SPEAKER_00: And it is essential as much as you know, the clinical data and everything else, you know, without getting a business relationship in place with research sites and administering payments so they can afford to keep running the tests and seeing patients.
• 9:22
  SPEAKER_00: For us and for me in particular, the vision was to create a better mousetrap with a technology forward approach.
• 9:29
  SPEAKER_00: And I think, you know, the cool thing now that we're, I guess about eight years later, seven to eight years later, is that the vision you know I personally laid out to do has not changed, but the accessible technology to you know realize that vision has you know markedly improved.
• 9:47
  SPEAKER_00: And and we probably would have even made that statement a year and a half ago in terms of the technology piece, but you know, with the rapid advancement of of AI, yeah, we're taking advantage of the things that we can do with leveraging AI.
• 10:02
  SPEAKER_00: And so that's where you know Patrick and his team have really come into play, and we're kind of doubling down on that, you know, whether it's agents, whether it's just reducing human effort of repetitive human effort, which is is really largely what a lot of our business is based on.
• 10:19
  SPEAKER_03: So do you see like the strategic empty spa that you could go into when you decided to fund this company, or was it you experienced something so frustrating in your everyday life?
• 10:31
  SPEAKER_03: Like, I'm gonna build something because I'm that tired of this.
• 10:34
  SPEAKER_00: I think it's it's a little bit of both.
• 10:35
  SPEAKER_00: I mean, I was in the trenches, I lived I lived the frustration when I started my career.
• 10:42
  SPEAKER_00: So I I did payments and contracts on spreadsheets and access databases and disbursement vouchers and all the things that make it clunky.
• 10:52
  SPEAKER_00: And sponsors just don't want to pay us, you know, faster.
• 10:56
  SPEAKER_00: I was like, it's not really that they don't want to pay you, it's that it takes an eternity to get through the 7,000 steps to actually get it out the door.
• 11:05
  SPEAKER_00: So for me, I've I've not only lived it and then I've now spent, you know, what was it intentional?
• 11:11
  SPEAKER_00: Yeah, probably not.
• 11:12
  SPEAKER_00: You just kind of fall into it.
• 11:13
  SPEAKER_00: But now I've I've spent now the last whatever it is, 15 years of my career trying to solve for it and was successful once.
• 11:21
  SPEAKER_00: And I think we moved the needle, but it was largely a service-based approach with technology to back, and then you know, with ledger run, that there was just another opportunity with some former colleagues of mine to really do it, you know, even better this time.
• 11:36
  SPEAKER_00: And so, and it's still a very specialized space.
• 11:40
  SPEAKER_00: So, you know, getting the right players together to approach it in a practical way, but leveraging good technology, you know, is is what you know gets me up in the morning and and excites me.
• 11:52
  SPEAKER_03: It's quite interesting because we talked about this topic on this podcast as well, at least one more time, about the gap between what's considered clinical and important and what's then what's actually facilitating, allowing for that clinical studies to actually be executed.
• 12:10
  SPEAKER_03: And the business side is often like not even considered when we talk about science.
• 12:14
  SPEAKER_03: And then the second thing I'm thinking about, like, yeah, of course, side must be paid.
• 12:18
  SPEAKER_03: Why is this so difficult to get paid?
• 12:21
  SPEAKER_03: Now you explained a bit, like you you gave us a hint.
• 12:23
  SPEAKER_03: It's like, okay, we have 7,000 steps, and bureaucracy probably is one of the issues.
• 12:28
  SPEAKER_03: But what is that?
• 12:29
  SPEAKER_03: It makes it so difficult for you to get paid for the sites to get paid.
• 12:33
  SPEAKER_00: I'll start the front, and then I think Patrick is probably in a perfect position to answer this because you know he didn't spend his entire life around it.
• 12:43
  SPEAKER_00: So he has a, I think, a great perspective on this.
• 12:46
  SPEAKER_00: But the short answer is when people think about payments, they think about accounts payable.
• 12:51
  SPEAKER_00: Supplier sends in an invoice and somebody pays it.
• 12:55
  SPEAKER_00: It's simple.
• 12:56
  SPEAKER_00: Like, why you know should be able to do it?
• 12:58
  SPEAKER_00: It's been around forever.
• 12:59
  SPEAKER_00: But the reality is sites generally are not business savvy organizations.
• 13:05
  SPEAKER_00: And quite honestly, in many cases, they don't know what they should even be billing for.
• 13:10
  SPEAKER_00: And with the advent of super complex studies, it muddles it even more in terms of what they can bill for and not.
• 13:20
  SPEAKER_00: So a lot of what we've developed from a technology perspective is not just having people sitting around receiving invoices and paying them.
• 13:30
  SPEAKER_00: It's actually figuring out and helping the sites figure out what is actually due to them based on clinical data that has happened.
• 13:38
  SPEAKER_00: And that involves other systems like EDC and so forth.
• 13:42
  SPEAKER_00: So I think that's a good kind of segue.
• 13:44
  SPEAKER_00: And I'll let Patrick comment on this, you know, having a, you know, I'd say a fresher view of the world here.
• 13:50
  SPEAKER_02: Yeah, I had to laugh as you were saying that because that was exactly my perspective when I came in here, which is like, how are we going to create a business out of this, right?
• 13:57
  SPEAKER_02: And I'll never forget in my first kind of week onboarding, I got to sit with our team that's using the software, and you know, it was you know, mid-study, an amendment gets added to a to a procedure, and then the contract has one rate and the budget wasn't updated correctly across a different system.
• 14:12
  SPEAKER_02: And then the trial system recorded a visit, but not the amendment, and then the invoice fails, then it's going through a CRO between a sponsor and a clinical research site.
• 14:20
  SPEAKER_02: And just what hit me in all of this, right, is that you know, historically, people have been the glue connecting all these fragmented systems, and that's what's leading to these incredibly, you know, frustrated clinical research sites, right?
• 14:32
  SPEAKER_02: And then on top of that, you know, I started to learn that, you know, sponsors in a more competitive clinical research market are starting to use their site experience as kind of part of their brand, right?
• 14:42
  SPEAKER_02: And so getting paid on time and having that be simple became a competitive advantage.
• 14:47
  SPEAKER_02: And that's when it really kind of codified to me that there is a real problem here, and and there is a real problem worth solving.
• 14:54
  SPEAKER_02: And it breaks down to, you know, it's not that any one of those individual systems is wrong.
• 14:59
  SPEAKER_02: It's that there are different inputs across all those different systems and there's no sort of shared understanding of what's actually true or what's going on within within that space.
• 15:08
  SPEAKER_02: And so, you know, that was a year and a half ago, a year and a half, you know, in, that's where I I've been spending all of my time, right?
• 15:15
  SPEAKER_02: Is working with the really smart clinical ops specialists employed at Ledger Run and the really smart computer scientists that work on our software engineering team to sort of build systems that are essentially consuming the exhaust across all those systems, making informed decisions based on things that are occurring across that ecosystem, and then ultimately putting that into a place where a really qualified person can QC and sort of say, yes, the things happened as they were supposed to, and resulting in sites getting paid faster.
• 15:45
  SPEAKER_00: The last, you know, kind of sprinkle of complexity I'll put on there is that there's there's the financial component, but then when you have to pay in 50, 60 different countries, every country has its own nuance.
• 15:58
  SPEAKER_00: Just like they do from regulatory perspective, and you're trying to get drug approvals and things like that.
• 16:04
  SPEAKER_00: There are certain ways of doing business from a financial perspective within certain countries.
• 16:11
  SPEAKER_00: They operate differently, their contract structures are different, their requirements are different.
• 16:17
  SPEAKER_00: So all of that has to be accounted for when you're running a global study.
• 16:22
  SPEAKER_05: Yeah.
• 16:23
  SPEAKER_05: I mean, I I like conversations like this because I I'm not very deep into the clinical trial space specifically.
• 16:29
  SPEAKER_05: So I get to be the person to ask the stupid questions, which is nice.
• 16:33
  SPEAKER_05: But there's a there's a real picture building in my mind, and I just wanted to check.
• 16:37
  SPEAKER_05: If I'm say someone running a trial, like a big pharma company, then then this sounds like a real problem because what I want is accessibility to sites, you know, worldwide.
• 16:50
  SPEAKER_05: I want them to be very active and I want them to be easy to engage with, and I want them to be able to recruit, and I want them to be able to run the trials well.
• 17:00
  SPEAKER_05: And actually, it feels like if that basic mechanism of engaging with them and paying them isn't working, then then none of those things are going to be true.
• 17:08
  SPEAKER_05: And it's gonna make my life harder as a yeah, developer to get the drugs, and that's not even my focus, right?
• 17:15
  SPEAKER_05: I just want the drugs through.
• 17:16
  SPEAKER_05: Is that is that the shape of the landscape?
• 17:18
  SPEAKER_05: Have I got that right or wrong?
• 17:19
  SPEAKER_05: Or or how do you see it?
• 17:21
  SPEAKER_00: Yeah, I I I think so.
• 17:22
  SPEAKER_00: I mean, my you know, my my mission uh uh in this and and others in in my you know our space here is stay off the critical path.
• 17:32
  SPEAKER_00: When payments get excuse me, get on the critical path, that's when there's a problem.
• 17:38
  SPEAKER_00: And that's usually when you hear about it too.
• 17:40
  SPEAKER_00: If payments are going out okay, nobody sort of even knows it exists.
• 17:45
  SPEAKER_00: It's when they stop happening, then everybody knows site payments exist, up to like the chief medical officer.
• 17:53
  SPEAKER_00: It's sort of like the you know, the the unsung hero of you want to kind of stay under the radar, and that's sort of where this should be.
• 18:02
  SPEAKER_00: Because when everybody's hearing about it, it's usually not in a positive way.
• 18:06
  SPEAKER_00: People high-fiving that they got paid, it's it's the latter.
• 18:09
  SPEAKER_05: It's making me think a little bit of just because I was watching a program I've heard it recently, of cruise ships, right?
• 18:15
  SPEAKER_05: Which is you say you're an entertainer on the cruise ship, you want to be there entertaining people, and people are entertaining, and you've got this support structure of the boat that's there.
• 18:26
  SPEAKER_05: But if you're as the entertainer, having to think about the ship, then something's gone wrong.
• 18:32
  SPEAKER_05: You're not entertaining very well.
• 18:34
  SPEAKER_05: No one's going to really achieve what they're trying to achieve here.
• 18:37
  SPEAKER_05: And and so I like that analogy of you're trying to stay below the radar as well, if it becomes important, that in and of itself is then a problem.
• 18:43
  SPEAKER_05: Exactly.
• 18:44
  SPEAKER_03: I'm curious to hear as you started implementing all this new tools and technology, was there any resistance from someone somewhere as you were trying to pitch promote this solution?
• 18:57
  SPEAKER_00: Yeah, I think the resistance isn't about getting paid accurately and more frequently.
• 19:03
  SPEAKER_00: The resistance is generally more of what tools am I required to use in order to get paid?
• 19:11
  SPEAKER_00: And so we live in a world where you know if you think back to the days of EDC when it started, there was you know, there was the original convincing of getting off of paper CRFs and and putting it into a system, right?
• 19:25
  SPEAKER_00: And it took years to to remove that.
• 19:29
  SPEAKER_00: And then you know, we had eDiaries, which everybody finally agreed, and it was proven that you know it shouldn't be done on paper.
• 19:38
  SPEAKER_00: But interestingly, in our space, the back office, there is a high level of resistance to using systems to improve the processes.
• 19:50
  SPEAKER_00: And that goes for you know whether we're trying to negotiate contracts and facilitate that in a more electronic world, or you know, asking sites to you know log into a system because it's like online banking.
• 20:05
  SPEAKER_00: You can see your stuff faster, you can make requests through the system.
• 20:09
  SPEAKER_00: It generally sounds like a no-brainer that, hey, we're gonna give you a tool, you can log in, you can see your payments, and and some sites you know, absolutely love it, and they'll be in there all the time.
• 20:21
  SPEAKER_00: And then others are like, look, I I just want to send in my my invoice like I always have through email, and I want to negotiate my contracts, you know, through email, and you know, we'll sort it out in Microsoft Excel.
• 20:35
  SPEAKER_00: And so what we've done uniquely, and this is you know, our technology also comes into play in the approaches, is meeting the sites where they are, basically saying, look, we've come to the realization that we're not going to force people to use technology they don't want to use.
• 20:53
  SPEAKER_00: I think it'll happen over time, but it doesn't happen as well as the front office.
• 20:59
  SPEAKER_00: You know, you have study coordinators logging into different EDC systems and using wearable tools and ePro and all these other things.
• 21:08
  SPEAKER_00: But for the back office stuff where we live, yeah, we've made conscious investments to say, we hear you work the way you always want to work, and we'll figure out a way to automate that, you know, electronically so that sponsors and CROs can still have the visibility to what's happening when the site calls.
• 21:30
  SPEAKER_00: They can still track it centrally, it can still be done in a timely and accurate fashion, but you know, the sites can operate old school, if you will.
• 21:39
  SPEAKER_00: And so we've spent a lot of time with the technology, and I'll let Patrick talk about that.
• 21:45
  SPEAKER_00: Is you know, how do we leverage modern technologies for our system to let the constituents of of the sites operate like they're still back in the day?
• 21:55
  SPEAKER_03: That is so interesting.
• 21:56
  SPEAKER_02: Yeah, I think that's well said.
• 21:57
  SPEAKER_02: I I think I can't get this imagery.
• 22:00
  SPEAKER_02: out of my head of the uh of Kevin saying, you know, you kind of stay in hidden in the background of something if they hear about you, something's kind of gone wrong.
• 22:07
  SPEAKER_02: I think with sites, what's been interesting is since I got here, bought into Kevin's vision of, man, there are all these cool ways that we can apply technology to solve these problems.
• 22:17
  SPEAKER_02: But the the the bar to kind of get in between the clinical research site and and the sponsor or CRO is actually quite high, right?
• 22:24
  SPEAKER_02: From their perspective, they might be logging into 15 different systems as they're facilitating 15 or so different trials.
• 22:30
  SPEAKER_02: So what's been really fun with various technologies is is figuring out how to inject that technology in a way that doesn't feel intrusive, right?
• 22:38
  SPEAKER_02: So if somebody's been sending an invoice to an email every day or every month rather for years, one of the projects we took on was hey we can actually put software now behind that email address where you send the email as if you like you always did, instead of a human being having to download that PDF and match it up to a budget and make sure that it's in line with what you were to be paid, that can now happen with an AI agent, right?
• 23:04
  SPEAKER_02: For example, with a human kind of checking that off on the other side.
• 23:07
  SPEAKER_02: So that's been a really fun game and I think something that's been very personally been driving me is figuring out even where there is a little bit of resistance because you know who wants to log into another portal, how do we sort of show the value that you know we can insert that technology and then provide a carrot for folks to engage with that a little bit more.
• 23:22
  SPEAKER_03: I guess that's really the the challenge right like the best uh founders, the best companies are are those that are able to show the vision that would sell something, sell a vision that doesn't exist yet to people who've been used to systems their own lives in the same way and bring them on board.
• 23:38
  SPEAKER_03: And so that's often in at least in my experience the the most difficult thing when we try to apply technology is not really figuring out the problem, figuring out the technology is actually the mindset change of the people that have been involved.
• 23:52
  SPEAKER_03: And I love this because we often talk about this podcast as like the human room right and there's always like this aspect that we often forget to mention like the human behind what do they think?
• 24:03
  SPEAKER_03: What is this challenges?
• 24:04
  SPEAKER_03: What are their worries, right?
• 24:06
  SPEAKER_03: So yeah, that's super interesting.
• 24:08
  SPEAKER_03: And I also found it quite interesting Kevin when you said that we're working so that we can apply modern technology so that they can keep doing the work as they did 20 years ago.
• 24:19
  SPEAKER_00: That was just really cute.
• 24:22
  SPEAKER_00: You want to talk about frustration for somebody who wants to continue to innovate but it's more allowing it to happen at the pace that they're willing to do it.
• 24:32
  SPEAKER_00: And it's a challenge for us as a to develop solutions that can operate in both worlds.
• 24:38
  SPEAKER_00: You know we we want to be the innovators and are the innovators but the you know the the key stakeholders aren't necessarily fully on board.
• 24:47
  SPEAKER_00: So we're you know we're figuring out how to improve it while while kind of uh you know managing both parts.
• 24:52
  SPEAKER_03: That's definitely the way to go you there's like a learning curve in every new thing that someone creates.
• 24:58
  SPEAKER_05: So yeah I mean I'm quite excited I want to jump on that as a principle actually because I think even beyond your particular application in particular area, I think there is a a useful innovation principle in general there, which is we we like to think of what we're innovating as as this piece that we're in complete control of.
• 25:15
  SPEAKER_05: It's the technology and what we're developing but it's got to interact with this wider world a lot of which we aren't in control of.
• 25:22
  SPEAKER_05: And I like your approach because what I've seen more of to be honest is when faced with that companies focus down.
• 25:28
  SPEAKER_05: They just try and take more control of the things that they control rather than say well this piece is uncontrollable but essential and if we want people to uptake this we've got to we've got to have some give and take with what we're doing and and sort of drive this adoption on.
• 25:42
  SPEAKER_05: Is that something that's also you found it sounds like some of the way that you're implementing that is through the presence of AI tools and and and the ability to automate things, making that process easier as well?
• 25:53
  SPEAKER_02: I think so.
• 25:54
  SPEAKER_02: I mean I think what AI has has really done right is through sort of you know synthetic thought, right, which is essentially what the probabilistic AI models are are doing is it it it took things that that could have been programmed before, right?
• 26:07
  SPEAKER_02: That is is technically buildable but pretty brittle.
• 26:11
  SPEAKER_02: It's become a lot easier now to to take sort of pattern recognition and sort of human logic and kind of replicate that in a way that that provides value to some of these work streams in a way that that hasn't been been possible before.
• 26:25
  SPEAKER_02: Again kind of going back to my my my sort of initial statement right I think that's one of the areas where we're still trying to figure out how impactful AI can be.
• 26:33
  SPEAKER_02: You know I think there are folks that are still sort of proposing this idea that AI is going to take over huge swaths of things and can do that today.
• 26:41
  SPEAKER_02: What we found is that what AI is particularly good at today is you know taking a piece of information, knowing where to go look for corroborating information, making firm deductions around how those two things relate to each other and then with a human in the loop to say good job, bad job, that can keep kind of self-replicating can be really really impactful and valuable to a business.
• 27:02
  SPEAKER_02: And as I said at the beginning I just feel very lucky to be in a in a place right now where those those things have kind of intersected our our domain and sort of where AI is is really performing well today have a line.
• 27:14
  SPEAKER_02: And so that's been that's been sort of our sweet spot for for applying AI today.
• 27:17
  SPEAKER_03: So yeah this makes me think about compliance so when you mentioned bringing in a new technology from my experience working in in a team where we used AI we would try to leverage AI data for clinical development there was a lot of compliance work and it was also very difficult because when you talked to the authorities not everyone knew what was needed for the AI models or whatever we're doing to be compliant.
• 27:45
  SPEAKER_03: So my question is how are you approaching that?
• 27:47
  SPEAKER_03: How do you know that your tool is compliant?
• 27:49
  SPEAKER_02: Yeah it's a it's a great question and it's something that we struggled with as we were first thinking about how to bring AI to bear in our software right we obviously had a desire through Kevin's vision to kind of you know solve this problem through a probabilistic approach.
• 28:04
  SPEAKER_02: But there was like a myriad of ways to you know do we start do we start over?
• 28:07
  SPEAKER_02: Do we start AI native?
• 28:09
  SPEAKER_02: Do we build copilots within the application?
• 28:11
  SPEAKER_02: And in doing so we we arrived at a at an architectural approach that you know I don't know whether it was because we were we were that smart or we got a little bit lucky but it ended up greasing the skids a little bit on the compliance side which was we made a very conscious decision that the AI is not going to, the probabilistic code is not going to live inside of our system of record.
• 28:31
  SPEAKER_02: So you have a clear separation between the strict business rules and validation and auditability and what user is logging in.
• 28:41
  SPEAKER_02: That all works the same whether a human being is interacting with it or whether AI is interacting with it.
• 28:47
  SPEAKER_02: And we developed the AI to live outside of the system in the way that it's exposed to functionality and data is through something called MCP, which is essentially an interface that allows an agentic AI agent to to sort of interact with an application.
• 29:06
  SPEAKER_02: So like you know a browser would be that for a human MCP is that for the agent.
• 29:11
  SPEAKER_02: And again it wasn't necessarily it wasn't the driving principle behind the architecture was the compliance piece, but the sort of a happy accident that happened with that is it's become much easier now to get sort of approval and and sign off and compliance checks through our customers and that the way that we present it is all of the same things and safeguards that would exist in a human being make them making a mistake or a human being doing something nefarious are are being applied to the the AI.
• 29:38
  SPEAKER_02: It's just an AI interacting with this application instead of a human.
• 29:42
  SPEAKER_02: We certainly have work to do there there is additional compliance around you know how are you training your data?
• 29:47
  SPEAKER_02: Are you isolating your data are you firewalling all of that so that data is not being shared, et cetera, et cetera.
• 29:53
  SPEAKER_02: I I I will say that that decision to kind of keep those things completely separate where every agent is logged in, all of its actions are audited, they can be shut out of the system, the fact that they're interacting in a very similar way that a human being was has made that much more palpable to our to our customers who are obviously in a very highly regulated industry.
• 30:13
  SPEAKER_00: And what what is interesting further on that as you can imagine and if you've already been doing some work in that area is there's there's no shortage especially on the big pharma side of of organizations asking us what are you doing in AI and you know what what are your plans what are your roadmap like but then when we tell them yeah we're actually doing real things they're like whoa whoa whoa timeout you're you're you're not you're not using anything of ours and yeah like I know we asked a lot but here wait let me send you some documents and yeah so then there's all kinds of legal paperwork really where we have to lay out you know as all the things that Patrick just discussed.
• 30:54
  SPEAKER_00: I I don't think that's dissimilar to you know other things people run with the good ideas and then you know all of a sudden it's where where the rubber meets the road it's like well wait a minute like we need to think through this for it makes sense and we might laugh about the fact that we get a lot of questions, right?
• 31:11
  SPEAKER_03: But it's also the fact that we get all those those many questions allows people to then sit, think through, and then you know intervene if there is any problem or because sometimes especially when you're great from a technical perspective you can go so fast and build something so fast and maybe implement it too fast.
• 31:29
  SPEAKER_03: And then it's very difficult to catch up if something goes wrong.
• 31:33
  SPEAKER_02: And I say just to add on to that one of the fun kind of joys for me is we've had a couple of big customers where we've kind of gotten them to go to kind of go to battle with their own compliance departments once they saw the impact of the of of the resulting work, right?
• 31:45
  SPEAKER_05: So it's interesting because it's it's another area where the the human side comes into this right which is the new innovation or new technologies they're equally exciting and terrifying and and there's almost that dynamic going on in the same company or even in the same people which is we absolutely want this new exciting technology but we absolutely also want it to not be a problem at all and never never again come come uh come up to this level where we need to think about it because then we've got a really big problem what I have.
• 32:15
  SPEAKER_00: Without without a doubt but that's one of the challenges you run when founding and building companies you go through a period of time where you you you've built a lot of good stuff but you you're not IBM yet so to speak you know and there's a lot of things that you have to cover you know in between and do you you know it's it's finding that balance of being fast cycle and nimble and also adhering to all of the you know heavy requirements that you need to have and and I think just the the level of scrutiny and compliance and questioning around you know everything.
• 32:48
  SPEAKER_00: And and in our in our particular space we we've we run the line of like where what level of compliance we have and I've been in this space a long time and we're in a gray area of are you GCP?
• 33:01
  SPEAKER_00: Do you have to be GCP?
• 33:03
  SPEAKER_00: Are you not?
• 33:04
  SPEAKER_00: Are you GDPR compliant?
• 33:06
  SPEAKER_00: Because we're in like this weird gray area and it's been ever since I started my first company in this in this area.
• 33:13
  SPEAKER_00: So it's really more around educating and making sure that you have the right principles in place.
• 33:19
  SPEAKER_03: I feel that all of us with each other when we work in this project and with this new innovations we all become also a little bit of psychologists to each other because then you have to really support the you know also the stress of because it is quite stressful to work with compliance because it's a serious thing.
• 33:39
  SPEAKER_00: What what what I've truly found most of the compliance and audit people I've dealt with they they know dealing with that part is a challenge but most of the ones I've I've worked with over the years understand that and look for ways to make sure that we're being compliant in a way that makes sense or is manageable.
• 34:01
  SPEAKER_00: Sometimes we may you know think otherwise or argue but it it's it's around the practicality it's for the for the same reason why when years ago when aggregate spend started and you know you can't whine and dine doctors and like I was back in my big pharma days when suddenly we were getting questioned whether we could send a candy bar to a physician or give them give them snacks at at the investigator meeting because we we were undue influence.
• 34:33
  SPEAKER_00: Sometimes you have to take a step back and kind of really look at what logically makes sense, what's the spirit of the controls you know like you were just saying you so it's a little bit of a you know emotional uh session to to kind of figure out like are we are we all doing the right thing here I mean it could always just be an amazing candy bar though.
• 34:52
  SPEAKER_05: That's uh there's probably a candy bar that's good enough.
• 34:54
  SPEAKER_00: I mean maybe maybe it has the golden ticket in it.
• 34:57
  SPEAKER_00: I I don't know.
• 34:57
  SPEAKER_00: It just What were you guys handing out, Kevin?
• 34:59
  SPEAKER_00: What kind of candy bars?
• 35:00
  SPEAKER_00: They were literally straight up Hershey bars.
• 35:02
  SPEAKER_00: Like there was nothing you know and but it's just you you go to extremes and you have to find the the right spot in the middle.
• 35:10
  SPEAKER_00: But but truthfully when it comes to an unknown level of modernization you know that that has come so rapidly with with AI in particular that we're talking about you know we we have to make sure we do things prudently with the right controls in place.
• 35:27
  SPEAKER_05: It almost feels like as as as people, as creatures, we're very system oriented.
• 35:32
  SPEAKER_05: And some of it is just about getting people to accept a system that needs to change.
• 35:38
  SPEAKER_05: And the piece I do a lot is is sort of regulatory and quality.
• 35:43
  SPEAKER_05: This topic comes up a lot which is quite often there is a solution out there to bring in something new and to get it approved or or to adjust your quality system if it's needed.
• 35:53
  SPEAKER_05: But actually the bigger effort tends to be in convincing someone to change the system.
• 35:58
  SPEAKER_00: Is that your challenge is is that what you you're sort of facing as a piece of work to do yeah I think without a doubt I mean change and change management regardless I've been asked when you know we've sat down with you know some of our big clients yeah before we've kind of you know put the ink on the paper like what what what do you think is one of the biggest things we may not be thinking about and I said it it has nothing to do with with the software or anything like that.
• 36:25
  SPEAKER_00: It has to do with change.
• 36:27
  SPEAKER_00: Because change can be hard.
• 36:30
  SPEAKER_00: We deal with that I think on a regular basis and and as innovators you know like just you know use the technology log in it's gonna be great you know but uh you know but not not everybody looks at it this way they're like look I'm I've been doing this for 15 years this way and and yeah like you know your your system sounds cool and and awesome but like like I just I just want to do it old school so send me the send me the spreadsheet or whatever or let me just email my invoice in like I've always been doing it because I yeah I'm gonna punch the clock at five o'clock and and go home and and I don't want to deal with it.
• 37:06
  SPEAKER_00: So a lot of what we've done is is recognize that you you need flexibility.
• 37:13
  SPEAKER_00: Flexible also means a lot of extra work you know there's a lot of extra thought that has to go in you know developers like we're building this technology why don't people just go in and use it as we intended I'm like well that's that is ideal yes that is nirvana for all of us but that's just not reality.
• 37:31
  SPEAKER_00: So then we have to we have to sort of build it multiple ways like you can get to the same endpoint but you know we have to give give a couple different flavors of how to do it.
• 37:42
  SPEAKER_00: And I think that's you know an approach that yeah we've agreed on as a as a you know leadership team as we continue to build the product it's it's a lot more work I can tell you that I mean Patrick himself will attest it's a lot more work.
• 37:57
  SPEAKER_00: Like what lane do we want to be in?
• 37:59
  SPEAKER_00: And yeah we're we're we're trying to kind of be in both lanes a lot of the time.
• 38:03
  SPEAKER_05: On the topic then of both change and difficult options I think that's a nice time to round out our discussion and move into our quiz portion of this oh Kira's rubbing her hands with glee.
• 38:17
  SPEAKER_05: I think what I'll do is because I I'm in the Ivana role today who usually creates the quiz I will ask you the questions I will remove myself from giving an answer and you three can battle it out.
• 38:29
  SPEAKER_05: Ready to fight also I usually lose these quizzes so I'm also very happy to be in this seat.
• 38:34
  SPEAKER_05: So the quiz that Ivana has prepared for us is about the costs of clinical trials.
• 38:42
  SPEAKER_05: Again this is a no states quiz this is just for fun it's about us understanding more about the the industry.
• 38:48
  SPEAKER_05: The quiz consists of three questions and yeah we can start with the first one which is focused on phase two clinical trial costs I think some people might have an advantage here because phase two trials evaluate both the efficacy and side effects of a drug in a larger cohort usually 70 to 300 patients the exact budget fluctuates dramatically depending on the disease being treated and the trial design but how much does a phase two clinical trial typically cost?
• 39:19
  SPEAKER_03: Is it A over a hundred million US dollars B between seven and twenty million US dollars or C 13.5 million US dollars I I I I would say it's the it's the seven seven to uh whatever it was the B I I say I corroborate I've seen a lot of uh those numbers so I would say it's in there that is the right option just to be a contrarian I'm gonna go with the non-range let's go C.
• 39:47
  SPEAKER_01: Let's just see if that's the right answer.
• 39:49
  SPEAKER_05: What I will say is I have metagamed these quizzes before because uh it can be a path to success.
• 39:56
  SPEAKER_05: Let's see the correct answer is technically if C is correct B would also be correct.
• 40:05
  SPEAKER_05: So it's funny that you should mention that because this is actually one where there are two answers that Ivana has given us.
• 40:11
  SPEAKER_05: It is both between 17 and 20 million dollars and by definition 13.5 million dollars on average yeah we needed the mathematician to be answering this one.
• 40:21
  SPEAKER_05: Oh Ivana is so tricky when she does that yes she actually didn't mention in this one that there's more there could be more than one correct answer but now we know.
• 40:29
  SPEAKER_05: Okay.
• 40:30
  SPEAKER_05: Question two then is what is the price tag for a phase two clinical trial across different diseases?
• 40:39
  SPEAKER_00: Oh from lowest to highest okay so we have cardiovascular oncologin rare diseases and hematology what order do you think those are in in terms of the costs for phase two I I'd put cardiovascular on the bottom thenatology and then oncology and rare disease.
• 40:59
  SPEAKER_03: I would also put cardio at the bottom because it's probably there's more also more people I would put hematology as the highest maybe because it needs more tests.
• 41:11
  SPEAKER_03: I don't know maybe and it's also maybe it's more rare compared to oncology.
• 41:17
  SPEAKER_03: So it might be difficult more difficult to get more people but I'm not sure I'll do the same.
• 41:23
  SPEAKER_02: I think there's a smaller patient population with uh hemophilia so let's go cardio oncology.
• 41:30
  SPEAKER_05: Yes well I can tell you then that the lowest cost is cardiovascular at about 7 million due to the more accessible patient pools largely then in the middle is oncology and rare diseases at 10.2 to 11.2 million what Ivana's written here is that that cost is driven up by yeah complex tumor imaging and and more difficult recruitment compared to cardiovascular and then at the top end at an average of 19.6 million is hematology due as you said Chiara I think you get a bonus point this for this for the the highest amount of laboratory work and and specialist testing that's needed.
• 42:09
  SPEAKER_05: The final question then which is also an arrange from lowest to highest if we're getting challenged today this and at least tonight we don't have the double negatives because sometimes we have double negatives.
• 42:20
  SPEAKER_03: Like the question is what is not not and then like arranges these part as fun quiz and part as torture.
• 42:28
  SPEAKER_05: So yeah okay this question is about the percentage of total clinical trial costs that go towards different aspects of the trial again arranging from lowest to highest we have site monitoring and management management we have clinical procedures and we have administrative and clinical staff.
• 42:53
  SPEAKER_00: Unfortunately this one depends grant costs generally average like 30 to 50 percent of a total study budget so I would probably have to say grants most expensive then monitoring.
• 43:11
  SPEAKER_00: Although see but monitoring's also changed now it's not all on site anymore.
• 43:15
  SPEAKER_00: So that it used to be much more expensive.
• 43:20
  SPEAKER_00: So that one's a little bit of a tricky one because it may not be as expensive anymore because it's more a lot of it's remote.
• 43:26
  SPEAKER_00: It used to be all the travel costs.
• 43:28
  SPEAKER_00: So I'm I'm tossed up on the monitoring one I I I guess I'll still say second on the monitoring and then third on the the the last one.
• 43:39
  SPEAKER_05: What was the last one again?
• 43:40
  SPEAKER_05: I site monitoring and management, clinical procedures, administrative and clinical staff.
• 43:45
  SPEAKER_05: I can tell you in this category is payments for physicians, research nurses and site coordinators is what I have listed here.
• 43:53
  SPEAKER_00: All right yeah so now this is actually considering the sites and see I was I in my mind just because I'm When I always looked at that, it was more of the spend of if you think a sponsor running a trial, which they're not accounting for.
• 44:07
  SPEAKER_00: The only way they're accounting for the the staff time is through the grants.
• 44:14
  SPEAKER_00: And I would have expected that to be in the clinical procedures.
• 44:17
  SPEAKER_00: So it almost sounds like this got split.
• 44:20
  SPEAKER_00: So now I'm not sure, but I would still say procedures is the highest.
• 44:25
  SPEAKER_05: Well, I will say, Kevin, I I I think you're dead on on all of this.
• 44:30
  SPEAKER_05: Site monitoring and management came out definitely lowest.
• 44:33
  SPEAKER_05: That's apparently 9 to 14%.
• 44:36
  SPEAKER_05: I think all of us are gonna have to take issue with Ivana here because clinical procedures is second or most with a range of 15 to 22 percent.
• 44:48
  SPEAKER_05: And administrative and clinical staff also appears to be uh second or most because the range is 11 to 29 percent.
• 44:56
  SPEAKER_03: So okay.
• 44:59
  SPEAKER_03: So another tricky question.
• 45:02
  SPEAKER_03: Oh yeah.
• 45:04
  SPEAKER_05: All letters of complaint addressed to Ivana's email address, please.
• 45:08
  SPEAKER_05: Amazing.
• 45:09
  SPEAKER_05: Good job she isn't here.
• 45:10
  SPEAKER_05: Well, thank you for that and humoring us for that.
• 45:13
  SPEAKER_05: We all learnt a lot.
• 45:14
  SPEAKER_05: That's amazing.
• 45:16
  SPEAKER_05: That leaves us then just to tie up the episode.
• 45:19
  SPEAKER_05: What's the either the favorite thing that you've picked up on on the episode or the most important thing or the the thought that you'd like to leave our listeners with?
• 45:28
  SPEAKER_02: Sure.
• 45:29
  SPEAKER_02: I I've I've I've got maybe two.
• 45:30
  SPEAKER_02: I I think you know, one theme that that kept coming up today that I'll be thinking about for a while is technology would be easy if not for the people, right?
• 45:37
  SPEAKER_02: Um also none of my organization as no, it's not us that's wrong, it's everyone else who's wrong.
• 45:42
  SPEAKER_02: But that's uh that's a real key issue.
• 45:44
  SPEAKER_02: And then the second one is I'll think about this when there's a range of questions.
• 45:49
  SPEAKER_02: I'm gonna pick the precise in the middle one every time because that could also be correct.
• 45:54
  SPEAKER_00: When and Dow go with B.
• 45:56
  SPEAKER_05: I can also go.
• 45:57
  SPEAKER_05: I mean, the one that I really liked that we danced around a bit but didn't directly address.
• 46:03
  SPEAKER_05: But I like about your guys' approach is is really think about and deliver to the customer needs.
• 46:08
  SPEAKER_05: And that's both the core customer needs, which is these folks need a better payment system, and them let's say the ancillary customer needs, which is some guy wants to carry on using his Excel spreadsheet from 20 years ago and to email the same email address.
• 46:24
  SPEAKER_05: And it's nice that you've delivered to all of those in uh in in this system.
• 46:29
  SPEAKER_05: I I like that.
• 46:30
  SPEAKER_00: I appreciate it.
• 46:31
  SPEAKER_00: First, I I I really enjoyed the conversation, by the way, that this this was fun.
• 46:35
  SPEAKER_00: Um so I I I appreciate you guys having us, you know, to to chat for an hour.
• 46:40
  SPEAKER_00: Yeah, but for for us, uh and it and it's been you know kind of our mantra too is yeah, we got yeah, yeah, you use use AI responsibly and make sure you're solving you know real problems, not you know, using AI to try to find problems to solve.
• 46:56
  SPEAKER_00: So and I I think that that that goes a long way.
• 46:59
  SPEAKER_03: And I'm gonna close with a funny one because to me it really stuck with me when you said Kevin, we're innovating so that people can keep doing the things that they've always done, which is quite an oxymore, but at the same time shows the way you're working, uh serving the people you're trying to solve the problem for.
• 47:18
  SPEAKER_03: So again, it's it can sound funny, at least to my ears, but it's actually the best way to to innovate because change management resistance from what we used to do, it's uh the most challenging obstacle to overcome.
• 47:35
  SPEAKER_03: So I think that's uh that's my take.
• 47:37
  SPEAKER_05: Then that just leads me to say, Kevin, Patrick, if people want to find you to continue this conversation or look into more of what you do, where's the where's the best place for people to track you down?
• 47:47
  SPEAKER_00: I I I think that yeah, the easiest place, one they can either find us on LinkedIn or you know, or our email addresses or uh reach out to ledgerun.com.
• 47:57
  SPEAKER_00: You know, and yeah, of course we can leave our emails behind as well.
• 48:01
  SPEAKER_05: Okay, well, thanks very much, folks.
• 48:03
  SPEAKER_05: It was a really good conversation, really fun, and thank you for joining us on the podcast today.
• 48:12
  SPEAKER_04: This was Lab2 Lives.
• 48:16
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• 48:22
  SPEAKER_04: What is your take on how we get from the lab to making a difference in patients' lives?
• 48:27
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• 48:32
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