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
Incorruptible Evidence: Blockchain's Promise for Faster Drug Approvals w. Dominik Lysek
Dominik Lysek, CEO of PharmaTrail, explains how blockchain technology can solve trust issues in clinical trials by providing an incorruptible audit trail that verifies data integrity. This solution could significantly accelerate the time required for regulatory approvals, partnerships, and acquisitions, ultimately getting treatments to patients faster.
• Blockchain provides a complete, unchangeable audit trail where data can only be added, never deleted
• Most clinical data (99.9%) has integrity, but proving this to outsiders is time-consuming and costly
• PharmaTrail uses private blockchain technology alongside traditional databases for optimal security and functionality
• Blockchain verification can maintain momentum through due diligence processes, preventing deals from stalling
• The technology creates trust by enabling independent verification of data integrity
• Current systems face challenges with data credibility that delay patient access to treatments
• Private blockchains protect patient data while still providing the benefits of immutable record-keeping
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Welcome to another episode of Transformation in Trials. I'm your host, Ivana Rosendahl. In this podcast, we explore how clinical trials are currently transforming so we can identify trends that can be further accelerated. We want to ensure that no patient has to wait for treatment and we get drugs to them as quickly as possible. Welcome to another episode of Transformation in Trials. Today, we're going to focus on the topic of credibility of clinical trials with blockchain technology, and in the studio with me I have Dominik Lysik. Hello, Dominik.
Speaker 2:Hello Ivana, it's a pleasure being with you.
Speaker 1:Absolutely. I've been looking forward to this episode ever since one of my guests recommended you as a guest. I've been very excited, but for my listeners, could you tell us a little bit more about what you're currently up to?
Speaker 2:All right. So my current position is I'm the CEO of PharmaTrail. Pharmatrail is using is providing electronic data capturing software where the data and the audit trail is secured on a blockchain.
Speaker 1:That is very cool and we'll get way more into the details of that. But just to kind of set the stage and get our broad church of audience on the same page of what we're talking about, could you tell us more about how clinical data is usually collected?
Speaker 2:and verified. Well, when I first started in clinical trials, which was probably around 2004, everything was recorded on paper and actually I think that was probably what I've done 10 years and actually you'd be surprised on how many trials today are still done on paper, especially in academia. Trials today are still done on paper, especially in academia, I think. Especially with COVID we've boosted this so-called electronic data capturing, so meaning that you have the case report files, forms in electronic version. There's a whole range of software out there that helps you to record your data and normally the investigators or, if you have patient reported outcomes, the patients, then record their data directly into an electronic system with all its advantages and disadvantages.
Speaker 1:And we'll get into the advantages and disadvantages in just a minute. But just before we really dive into it, if you were to explain to a high school student someone who is maybe 17 years old of what blockchain technology is, how would you explain it to them?
Speaker 2:Okay, the first thing I would say is forget crypto. That is a use case for blockchain. I think the key that you need to know about blockchain is that nothing can be erased. It is always only added. It is a ledger that records all the changes. Actually, it's an audit trail in itself and you cannot ever delete anything on the blockchain. You can always only add to the chain. The second thing is that you practically have I don't know four or up to hundreds of nodes that all are copies of that data and they constantly check that they are identical. So if one of those nodes gets corrupted, it is actually pushed out of the network. So even if you know worst case scenario somebody hacks into your blockchain and tries to change things into your blockchain, they will only be able to get into one node at a time and all the other nodes will realize that this node is corrupted and will push it out. So that is why it on the one side, it is incorruptible data and on the other side, it is as secure as it gets today.
Speaker 1:Very cool and a nice and concise explanation of the key parameters. Thank you very much. You're welcome. Now we've kind of set the stage for how is it that we usually collect clinical data and this concept of the blockchain and this is important because the rest of the episode will be about those two things being combined. So I would be curious to dive further into the problem that we're facing. Problem that we're facing, and that is that challenge that we face as both biotech companies and medtech companies when it comes to the validity of the clinical data that we produce. Can you tell us more about what that challenge might look like?
Speaker 2:Yeah, so generally, clinical data is always highly scrutinized because so much depends on it having integrity in the data. Unfortunately, that also costs a lot of time, a lot of momentum, a lot of effort and sometimes that is in vain. So let's dissect a little bit blockchain, sorry, biotech and medtech. Okay, I think in the biotech or in the pharma space it's very much about regulatory approval of your drugs. So you run your phase three trials, your phase three trials are provided to the regulator. The regulator puts a very high amount of scrutiny on there and that can take months, whether they inspect sites, generally data. It just takes a long time and that is all something that is time to patient benefit. That is pushed back.
Speaker 2:In the medtech space, or also generally, perhaps more in the startup space, it's your customer for your clinical trial is less the regulator, it is much more potential business partners or acquirers. And again, if you as a small company you come to a large corporate, obviously you're biased because you love your product, You've developed your product, you put your heart into that and they're going to put a lot of scrutiny on that. And especially in the medtech industry, very often they would say oh, you know, we really like the product, but we want to run our own clinical trials. And now we come into real problems because that clinical trial again will take years and all the financials, time to market, time to deal. It's all pushed out and that costs both patient benefit as well as the companies, as well as practically every stakeholder. And that just because there is not enough trust in the system.
Speaker 1:Maybe a question that comes to mind how insecure is the clinical data that we produce? How large are the margins of error that we're looking at?
Speaker 2:I think, first of all, I would say most of the clinical data that is out there has a very high amount of integrity. The biggest issue is how do you prove that integrity? Because you know I think every one of us can Google and you know, if you put in fraud in clinical trials, you will find things that come up, and there has been, and these are unfortunately the cases where it does go through the media and the media hears about it. So Generally, that's also why the regulators, the stakeholders, put that high amount of scrutiny onto that. Again, I want to stress that probably 99.9% of the data out there has integrity. It is correct. What we're trying to do with the blockchain is really to provide a kind of a stamp for gaining trust from outside stakeholders.
Speaker 1:And that is interesting. How can the blockchain technology help solve this trust problem?
Speaker 2:Yeah. So, first thing, what I told you before when I explained the blockchain you cannot erase anything on a blockchain. For any of us in clinical trials, we know that GCP is not about not making mistakes. It's about how to bring out mistakes out in the open and how to take care of them. That is all what the blockchain, which is practically the natural audit trail, gives. It gives a complete and incorruptible audit trail. So whatever has happened in the trial, it can be reconstructed, so to speak, for anybody to look at it. Every query when it was given, how informed consents were obtained, all these things can clearly be seen on the blockchain and because, again, it cannot be changed, it is an ideal medium to get that trust then from outsiders.
Speaker 1:And how would one consume the information that is on the blockchain?
Speaker 2:If we talk about the different stakeholders the people who conducted the trial, potentially the patients, other interested parties- yeah, so that's actually a very interesting question and I did not say that we only work on a blockchain, because that actually would make it very difficult. It probably also would make it fairly slow because blockchain is not a very fast technology. So we practically work on a relational database. That's your standard database that you use in most programs and we have a blockchain running in parallel. But you can get practically a verification of the data that is on the relational database by checking it against the blockchain.
Speaker 2:Obviously, these things run simultaneously all the time, but it is something that we provide an auditor or a module where the auditor can really say all right, these 20 data points I want to have verified against the blockchain and you can get your kind of rubber stamp to see that it is actually correct, including the whole audit trail and perhaps a very small interlude on audit trail. In the past guidances from the FDA and the EMA, the audit trail has become incredibly important Practically for those people who don't know this. In clinical data, the data alone is not worth much unless you have an audit trail behind it that you can show where that data comes from.
Speaker 1:It is actually an interesting development in my mind how much more interest we now have in the audit trail. That used to be kind of a side thing that no one looked at, but now we're actually required to consider our audit trail.
Speaker 2:Yes, because I think it's a little bit like Murphy's Law and now that we're in the age of computers, whatever can go wrong will go wrong, and it probably will go wrong at the same time that the audit trail, because things go wrong because we have so many more data points. The audit trail has become far more important than it was, you know, 20, 30 years ago it was more, I think then. Back then it was mainly for the informed consent discussion that you made sure that you know, you really know what was happening there. Now it is really for every data point, every query, et cetera, that you need to have that audit trail in place.
Speaker 1:And for just trying to put this technology into context of how clinical trials work today. Who would be the customer of your solution? Would that be the sponsor companies?
Speaker 2:So normally the sponsor companies are always the ultimate deciders. I mean, big Pharma normally tells the CROs or whoever they're working with which system they want to work with. There is a lot more stakeholders. There are the CROs that you know, especially if they're giving a large contract, meaning that they should really run the whole trial, they can probably also decide which software to use. And then there are, you know, the small companies. Then there are the investigators in academia, because you know the investigators, they want to use the software as well. And then you have the clinical trial operatives that might not really care about, you know, an audit trail or data integrity. They just want things to run smoothly in your trial. My colleague always says happy sites, happy life, and that is true. So we are trying to build a software that really has something for each one of those stakeholders.
Speaker 1:That makes sense and for the situation where it's about partnering for the trial, the drug or potentially being acquired by a larger company, what would be the advantage of having the data stored in also a blockchain format?
Speaker 2:of having the data stored in also a blockchain format. So I think what it really provides is that trust and that data integrity that companies are looking for when they look at a new product or at a company that they want to acquire Because they are, they don't want to take a wrong decision and because clinical data is very often for those startups or for those early stage companies, that is their core value that they are selling. So to have more trust in your core value will get you through a due diligence process faster. You will keep momentum faster. You will keep momentum and I can tell you from my own startup experience. You know very often you come in there, you get a lot of excitement because you have a nice product, you develop something amazing, and then the scrutiny comes in and you know management might just move on to the next best thing by the time that due diligence has been performed. So if you can keep the momentum, the chance that you will get to a deal is faster.
Speaker 1:So if we have more validity in our clinical data and if we have trust in the data that is created, we could potentially accelerate the speed of getting solutions whether they be drugs or medical devices to patients.
Speaker 2:Absolutely, and this is, by the way, I think, for all of us in the healthcare industry. That should be the ultimate goal. It is trying to get treatments to patients as fast as possible.
Speaker 1:Absolutely. When we were just starting this call, before we started recording, we briefly touched upon the public or private blockchain, where you mentioned an important distinction of just because it's in the blockchain does not mean that it's public. Can you tell us more about the difference between the two?
Speaker 2:Yeah, so practically most people that heard about blockchain in terms of cryptocurrencies. Those are public blockchains. They are distributed around the whole world, they are lying on each computer, etc. We work with a private blockchain, with a private blockchain, that private blockchain. So our system is cloud-based and there is think of it like a small cloud, very located. That is four to six nodes that I explained before that make up the blockchain, but all these nodes lie within, you know, one, two, three different facilities. It's not publicly accessible also, so it's.
Speaker 2:You know we are still dealing with healthcare data, even if on the blockchain there is only anonymized. We are in clinical trials. We need to adhere to privacy laws. You know in Europe, gdpr. However, we also need to adhere to what the informed consent and the data protection declaration there allows us to do, and it allows us to record the data, to use the data and to record the data, to use the data and use calculations on the data. However, we're not allowed to publicly share that data, even the outcomes. Yes, in publications, yes, but individual data, even if it is synonymized, we're not allowed to do that or only to the regulators, people that we explicitly grant access, and obviously, in any software that you're using, that needs to be, you know, adhered to, because otherwise we'll run from one issue to the next.
Speaker 1:Yeah, that makes sense. What are some of the challenges of building a product on the blockchain? Despite the blockchain being a technological opportunity for quite a while, we haven't seen that many solutions at least applied to pharmaceutical use cases yet. What makes it difficult?
Speaker 2:Yes, so generally think of it. The blockchain is a ledger, so there are certain file types, for example, that it simply cannot do. You want to keep the little bytes of information fairly small. For example, if you would have large images, 3d images, you cannot store those on a blockchain. With those, we can only store the metadata, meaning when was it recorded by whom, etc. That we can record, but not the actual data because it is a ledger. So it's, you know, as anything that is simple, numbers is really easy for us. Anything that becomes more complex we cannot record one to one on the blockchain. So that's when we need to refer to the metadata and do that.
Speaker 2:And then obviously we need to interlink that blockchain with the rest of the software. So don't think of it in. You know, there is a little blockchain somewhere completely separated. It is an integral part of the architecture of the software, so that all the data immediately is recorded both on the blockchain as well as on those relational databases. How these two speak with each other. That all is not trivial and that's kind of. You know, our CTO would be more the person to talk to about that, because I'm a chemist by training. I'm actually not a software person. But it certainly is more challenging to incorporate a blockchain into what otherwise would be a normal cloud-based software.
Speaker 1:This is a great segue, Dominik, to talk more about your background as a chemist and otherwise. How did you discover this problem of trust and validity of clinical data and why did you decide to solve?
Speaker 2:it okay. So first of all, I um, um, yeah, I have a. I'm a chemist, I have a phd in biophysics. Uh, I then, um, started my career doing clinical research for a biomaterials company here in Switzerland and then, very short time, I worked for two years for a pharma startup or biotech startup here in Basel and my boss there, thomas Meyer. We stayed in contact throughout my journey because I then founded a company called Credentis that developed enamel regeneration mechanism. So something completely different and perhaps a lot more at home for me as a chemist than a pharma trailer is.
Speaker 2:But when Credentive was acquired, thomas actually came back to me and he said they were running into some issues in their clinical trials and it was really kind of reproducing some events that happened, some events that happened.
Speaker 2:And you know how can we uh, you know reap, how can we reproduce everything that happened and reconstruct it so that we really understand what happened? Um, and he had that idea of using blockchain technology and, uh, because I had a little bit more time at my hands again, he asked me whether I wanted to get involved and it was coming a little bit back to my roots because I could completely see the issues in the clinical trials and I immediately saw that fit of blockchain of really providing trust and data integrity. And actually then in the last few years it also is the security part that I think when we first talked about PharmaTrail we didn't even think about that because we couldn't imagine hacks into clinical trials, but they have happened and especially hacks into healthcare systems have become, you know, all too common these days. And I don't say the blockchain is ideal, but at least up to now nobody has managed to hack into a blockchain because you would need to hack into all nodes at the same time and that is certainly challenging.
Speaker 1:Yes, so far so good. We'll have a different reality on our hands when someone actually pulls that off.
Speaker 2:Yes, yes, and let's hope that it won't come to that, and at least you know I think they're going to be easier targets in the vicinity than hacking into a blockchain, so perhaps that is a little bit of protection as well.
Speaker 1:Well, it absolutely makes sense and I like how your journey kind of circles back to the roots of trying to build trust in clinical trials. Dominic, as we start rounding off, I always ask my guests the same question in the end, and that is, if I gave you the transformation trials magic wand that has the power to change one thing in the life sciences industry, what would you wish to change?
Speaker 2:So, when it comes to the clinical trial industry, is I think that there is more believability and also belief in the data that we are providing, and I think that has a lot to do with how scientists sometimes fail to communicate our findings to the common public. You know, I always say that for a scientist it's always this is great, but and all the common person hears is the but Whereas for us scientifically, if we don't use that, we almost feel like we're not scientific. So I think there is really a lot that we could communicate better and therefore also get more trust in the medicines that we bring to the patients, because I think we unfortunately all see too clearly that that trust is not always given, too clearly that that trust is not always given Even if we that are within the system have no doubt about the validity of the data and the drugs that are on the market. But somehow there is a lot of distrust or not enough trust out in the general public.
Speaker 1:Agreed, and also, like those cases of where the ball is dropped on trust, they somehow seem to cancel out all the many cases where the data is valid, no mistakes have been made, no fraud has been conducted, which is the vast majority of the cases.
Speaker 2:Absolutely, absolutely.
Speaker 1:So I completely agree to your wish there, Dominik. If our listeners would like to learn more about yourself or the technology that you're building, where can they find more information?
Speaker 2:Well, first of all on our website farmatrailcom. Well, first of all on our website farmatrailcom, and then my LinkedIn page, or the Farmatrail LinkedIn page.
Speaker 1:Yeah, I think that's where you would find most of the information, certainly about me, but also about Farmatrail and what we offer. That's awesome, Dominik. This was a great conversation. Thank you so much for joining me thank you Ivana for having me you're listening to Transformation in Trials. If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivana Rosendahl on LinkedIn. You can find more episodes on Apple Podcasts, spotify, google Podcasts or in any other player. Remember to subscribe and get the episodes hot off the editor.
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