So as I said, we have Omar Serang from DNA Nexus with us and we have Veda Perkins from Boehringer Ingelheim And perhaps Veda, we can start with you. Can you shortly introduce yourself and also your background for why this topic of doing global submissions, why that is interesting for you? I think it's an extremely interesting topic, looking into submitting ones to multiple regulators. I think it's a dream of the industry, but how did your interest get into this and who are you? What's your background? Sure. Thank you, Rune. I appreciate the opportunity to present today. So Veda Perkins, I'm the Vice President and Global Head of Regulatory Intelligence and Policy at Boehringer Inkelheim. My interest in this is, you know, it's been quite some time now, but I started off as an assessor and program manager at FDA in the Center for Biologics. In that role, 30% of that job when I took it actually was looking at technology and how you could leverage that to improve review. And if you think about it from that perspective, 21 plus years ago, you start thinking about how you can gain some efficiencies in terms of how you're doing review. You're doing things in paper, then ECTD came along. And then about nine years ago, when I left FDA, I came to the industry and I realized, wow, here's all this other stuff that happens upstream that maybe most health authorities don't know. You know, here's opportunities for efficiency as well. So if you think about what you have to do upstream from an industry perspective, all that work, right, to get to the point where you're providing a dossier to one region. And then when you start working for a multinational company, you say, hmm, I'm pretty much doing the same thing when I send it to these other companies. Right. There's got to be a way to basically connect these dots to technology. But most importantly, even when you look at the science of it, there's opportunities for harmonization to be able to say, well, how can we get to the point of reliance and convergence where if I'm doing this for one region, why can I simultaneously not be doing that for another region? So there's a lot of work. That's why I'm passionate about it because we talked about this. It's probably the best way where technology can democratize access to patients is if you can get registrations and approvals done in a short period of time at the same time. Or maybe, you know, soon thereafter. So that's the interest. And that's why we took on Project Prism and Project Cryptics. Perfect. Thank you, Veda. And Omar, how do you know Veda? And what has been your way into this subject? My way, as many things regulatory for DNA Nexus, has been the pathway through Precision FDA. I'm Omar Sarang, Chief Cloud Officer at DNA Nexus. I'm the lead architect for Precision FDA, which just enjoyed its 10th birthday. And I met Veda on Project Prism. This was started, I think it was conceived by Veda and Jenny Hussong from the FDA back in 2023 at RSIDM. And Precision FDA was pretty much the platform that Prism was running on. And so we were brought in DNA Nexus to help support Project Prism and design the interface, design the user experience. And most importantly, for anyone that's seen any of these things, to design all the training videos with my vocal background, instructing people how to use all the various capabilities on Project Prism. So it has been an amazing journey. I have been watching from the side for all these years. But to be in a room with all the regulators and the industry actually hammering out how we can make things more efficient on regulatory submissions was pretty much a watershed moment. Thank you, thank you, Omar. And my name is Rune Bergendorf. I'm a partner at Implement. I've been working in the life science industry for the last 15 years, and I would consider my home regulatory affairs. So I've had the pleasure of also being part of what we'll speak about in a moment. So really happy to have you on board. And I think to just kind of frame the conversation we'll have today, imagine a world where you could do like one global submission to one central location, reviewed across, and really bringing drugs faster to patients. That's the topic. That's what we'll dig into. And put that in the back of your mind throughout the conversation because that's what we have explored. And with that, let's try and bring the conversation closer to what Project Prism is and also Project Cryptex. So before we really deep dive, then Veda, you know, we have talked a lot about Project Prism and there's a lot of acronyms. in this space, but it may not be as obvious to everyone out there what this is all about. So can you just open up a bit on what is actually this Project Prism? We hear it here, there, and everywhere. So can you shed a little light on that? Sure. So, I mean, in a nutshell, it's really about interactive collaborative review, but it's not just about looking at things from a static perspective, like where you're just viewing a document together, right? This is really about providing all the tools necessary for assessors and for the industry to collaborate back and forth. The idea is not unique. As Omar said, we had a lot of validation of this for the Center for Veterinary Medicine for their bioinformaticists. They've already been basically having a dialogue using analytical tools, engaging with sponsors and animal health back and forth, probably for the last four or five years. So the question was, could we create a project to leverage that for human drugs and biologics, right? Because the Delta is pretty small. Project Prism. Prism stands for the Precision FDA Regulatory Information Service Module. And that was just a creative name to basically say, can you create an environment for interactive collaborative review with one to many health authorities, interacting with one to many companies in a collaborative space, using analytical tools in a secure and private environment that accommodates module one to module five, not just ECTD submissions, but non-ECTD, right? Because we do all of that. And that has really been tremendous. The last thing I'll say about it is this collaboration between industry partners and health authorities is important, but this contract, this vehicle allowed us to bring in technology collaborators, right? And that's one unique piece to it. You know, this isn't sort of just industry and health authorities having a conversation and then we try to figure out the technology ourselves. Having that ability to bring in multiple technology vendors who are willing to bring their resources to the table to help solve problem has probably been the most significant, but the most significant thing and why we've been able to ramp things up so quickly in the last two years. Cool. And, and Omar, can you shed a bit of light on, on, you know, what's DNA Nexus connection to project Prism? And I've also heard this TRS, how does that relate to Prism? And certainly. So first thing to dispel some myths, Prism, as Veda points out, is a research construct under a research collaboration agreement between industry and the FDA CBER and CEDAR centers. Prism centers. Prism runs entirely on Precision FDA. It is not a separate platform. There's no Prism features, Prism capabilities, so to speak. It runs entirely on Precision FDA. Precision FDA was the FDA's flagship external cloud platform. And this is really an important point. The Precision FDA platform does not sit behind the FDA firewall. It is out on the internet where people, collaborators, industry, academia, other regulators can all collaborate and that's what made it a perfect fit for Project Prism. The other thing that's not, most people are not aware of is Precision FDA was started as a research project. And as such, all of the Precision FDA source code was made open source by the FDA. So, all of the Precision FDA was made open source code. And the Precision FDA was made open source code. And the Precision FDA source code is also used to create other, essentially, nodes in a trusted regulatory spaces network. TRS stands for Trusted Regulatory Spaces. And this is our vision for how we actually get global regulatory stakeholders, and the Precision FDA is connected and doing real work on the cloud. Perfect. Vader, you called me up back in April of this year. And we had a conversation. You had a dream that you really wanted to try and prove something around the fact that these global end-to-end submissions, that was actually, it wasn't really a dream. It was something that could be achieved. And you had an idea of how this could be approached. Can you tell a little bit about your dream and how you wanted to try and move the needle? Yeah, I'd say it's not just my dream. It's probably the dream of many, many people too, right? So, conversations with many people who are interested in this space, you, Omar, many others. I'd say that after we kicked Project Prism off, and we were able to, with ease, basically provide an entire dossier, right, to the agency through a cloud, no gateway, and they'd be able to validate it. And that we were able to do, you know, SDTM and validate it, right? And the agency's saying, hey, you know, we've gained some efficiencies on having to have all these manual, these FTEs having to do some of this manual validation. Once we saw how fast that was able to be done, and they were able to gain those efficiencies, when I called you, it was really about, hey, it's great that we're using this cloud for this health authority collaboration, but there's got to be some benefit. We have to explore the benefit of, if I took that same cloud environment as a company, way upstream, could I see the same benefits as that we're seeing, you know, from the research results from the health authority collaborations? And that's when I said, hey, we need to have this project, and that was Project Cryptics. If there's all this value, return on investment for saying, you know, we have the submission, you know, we're able to demonstrate there's no gateway, you can validate it. There has to be ways that we can connect the dots, you know, whether it be our RIM systems or other systems that we have upstream. So all that work we do for years, before we even get to the point of submitting it to a health authority, can we gain some efficiencies? And that was the dream, I would say, like, end-to-end lifecycle. We have to be able to, the cloud has to be more than just how you provide the submission to a health authority. There has to be some upstream benefit. And I think that was what we needed to explore. I don't think it really had been explored or even proven. You know, would it have value beyond that? And I think that's why we took that on and we were able to demonstrate that it absolutely does. So we really wanted, or you really wanted to kind of prove that we could connect, you know, the applications of Böhringer Inkelheim to the TRS, do the full process, all the data, and what was the timeframe again? Well, I wanted to be able to see if a medical writer, right, from the time that someone who's a content creator, subject matter expert, you're like, do they need to get out of that ecosystem in terms of tools they're using, right? Or could they all be in the same ecosystem? You know, we make huge investments in our systems. You know, we've made huge investments with our OMP system and Viva. You know, can we be able to do that? That was the remarkable part, right? We just kind of said, okay, well, let's give it a shot. And we said, we have six weeks to do this, Runa. You know, can we do it? And I mean, the rest is history is that we, you know, with a lot of other, with a lot of blood and sweat and tears and a lot of other experts coming together, we were able to demonstrate that you can connect your REM systems, go away through to a health authority, have interactions with the health authority back and forth and simulate all of that with real data. And we did it in six weeks. Yeah. And I think I also learned, and you already mentioned that, Veda, that, you know, this is based on precision FDA. It's proven technology. Omar, you mentioned, you know, it's been around for long. It wasn't new. And I think I also learned that, you know, it was much more mature technology than I anticipated. And I think part of the reason why it was possible, even though it was a short timeline, to actually make it work. Omar, what did you think? Sorry, yeah, Veda? I was going to say one important distinction, and I think this will be a good segue for Omar, is we didn't do all of that front-end work in precision FDA. We have our private accounts there. In order to achieve this, we actually said, you know, the question to Omar and to DNA Nexus was, it's all open source. Can I get, I want the same thing that FDA has, but I want it in my environment to do these things upstream, right? So can I have the same features and functions that the FDA has in terms of how they operate with precision FDA? And can we have this instance, this TRS instance to do these things? And that was really, I would say, the catalyst for that, right? We had our own environment, you know, on our side of things to operate and be able to connect those dots. And maybe that's a good segue for you, Omar, because that's the missing component that people have to understand. You know, we could have done some of that just in that native environment, but it was really important for us to have our own version of it to see what we can do and stress test it. The challenge with the RCA is it is an FDA-led initiative. So all of the RCA members are participating on use cases that are selected with the FDA. It's a schedule that the FDA sets. It's a three-year RCA. And the challenge really is for contributing members, they really have to get on the train and be on the FDA's train. And what Berger needed to do was they needed their own train. They wanted to be able to carry out regulatory use case testing, carry out, have collaborators of their own, and to carry it out on their own schedule. So Precision FDA has given many gifts, essentially, to the industry that are now starting, people are starting to become aware of them. The main gift really is what you can do when you build a system that's outside of the regulator's firewall. So all health authorities have a rightfully, I would call it paranoid, but they're very careful with information security. You have patient information, you have proprietary information, and all of this is really what made Precision FDA a success, is the fact that it's not an FDA internal system, which means I can get collaborators on board in a matter of minutes instead of a matter of months. But DNA Nexus really had been a bioinformatics company prior to starting the Precision FDA project. But over the course of the last decade, and again, this is mature technology, cloud technology, cloud security, privacy and quality, all those things we've been doing at DNA Nexus for, as I said, a decade. But to have the acceptance on the part of regulator and sponsor IT departments, to have people comfortable with the security and privacy and quality protections in the cloud, it took, I won't call it a leap of faith, because it's proven, but it took a change of mindset. And that is really the biggest challenge is changing mindsets so that people realize that it's not a technology problem, that we have the technology, but why can't we get out of our own way and start putting it to use in an appropriate way? The best way to think about it is if you look at cloud adoption throughout every industry on the planet, it is pervasive. Like everybody started with finance, like everybody started with finance, moved into healthcare, you know, finance was probably the first vanguard, but people were not comfortable with the cloud a decade ago. Now people are comfortable with it. But if you look at global regulatory stakeholder interaction, there are very few cloud platforms that really provide true platform as a service, like you can run different programs. And Precision FDA is a great example. And you can almost think of Precision FDA as being the vanguard. node number one in the trusted regulatory spaces network. So basically, back in April, we set out on a six week journey to demonstrate that we could do a full entrance submission process involving two agencies, real time review, we had threaded conversations to kind of ease the Q&A part of the process, and basically connecting everything as you alluded to, Vader, with the technology process, and the data. So concluding that from April to June, it was a short timeframe. Omar, I remember we had a kickoff with everyone in the project, and we outlined that timeline. What was your initial thoughts if you kind of bring yourself back to that initial moment? Well, I've done a lot of these productions, Rune, and I sort of took the reins because I realized that this needed direction. It's very much like shooting a movie. You have a script. You have props. You have actors. And so we had to shoot a movie essentially in six weeks to show the concept and the actualization of this end-to-end flow. And fortunately, the team was up for the task. There were a lot of technical challenges. Shooting a movie like this, it doesn't involve just actors, but you have systems, computer systems, cloud systems. And our colleagues from the different software vendors were really flexible in actually getting things to run. For instance, on TRS and precision FDA, you really don't have the capability of running Windows workloads. So our colleagues who were producing document ECT review software, our colleagues from Lorenz, they actually converted their software to run on Linux, which I almost fell out of my chair when I got the call from them saying that they were going to do that. But this shows you how important this is to industry, where you have a company that's been pretty much decades producing Windows software and now saying, okay, let's make this available on Linux so we can actually have this available in the cloud globally. And I think you're touching upon an important element there because I think it really, you know, it proved that it really takes an army to make all of this work. And I think everyone, they stepped up and really put themselves into it. And they really made sure that whatever could be done possible to make it work, that was being done. And I think that was a tremendous effort across multiple different companies and time zones. I remember also discussing, you know, we were covering time zones from yourself. You're in San Francisco also today. So good, very early morning. And I'm in Copenhagen. So nine hours ahead. And I think we really managed as a team to exploit the fact that we were in different locations and really leaning into it. So I think that was really great to see. Veda, six weeks went by and, you know, the results of this was supposed to be presented. What was your thinking when you kind of saw the result? And, you know, that was quite quickly after all of this got in motion. Were you satisfied with what you saw? And had you expected that it would end where it ended? Yeah, I mean, the whole idea of kind of calling it the Holy Grail project is, you know, I'm pragmatic. So I thought, well, at minimum, we're going to put a dent in figuring out exactly how to do this, right? So I guess the pragmatic side of me figured maybe, you know, lessons learned 50% of this we were able to achieve, you know, here's the remaining 50%. We'd present those results. And then of course, we would just kind of press on. Yeah, the fact that when we finally connected all the dots, and we were able to show that we were able to do that, end to end from our REM system all the way through, you know, and then do all that, the interactions, and then all of that comes back into your REM system. Yeah, I was surprised, you know, because I didn't go into this. And I think any of us went into it thinking that it would be done in six weeks. We'd just get closer to moving, advancing that ball forward. But not to be dismissed, as Omar said, you know, our colleagues from Lorenz, you know, having the fact that that's the software that the agency uses, and for them to say, you know, in order for us to really be achieved, we have to get out of this environment, we need to sort of advance the technology and integrate it into this cloud. That was a, I would say a critical piece, right? Because we were able to then really stream how we did some of these submissions, and then the review and all those other pieces. Yeah, the only thing I can say is that result then allowed us, you know, we'll get into it, you know, to say, well, if we're able to kind of do that, why not go from REM and then move further up stream to, you know, what we did with our VivaVaults, right, with clinical and quality vaults. So I was surprised. But maybe I shouldn't have been because the team of people that we actually had working on this, you know, like I said, it's a pretty sharp group of individuals who have a lot of experience in doing this. So, you know, again, I thought we would get to maybe 50, 60% and move the ball, but pleasantly surprised that we were able to achieve that in six months, six weeks. Yeah, and it actually enabled us to take another, sorry, go ahead, Omar. So much of this had to do with the contributions from our colleagues. So Lorenz stepped up big time, both in the first presentation that we gave at the Viva Summit in Madrid, and Viva really stepped up big time as we connected all the dots for the Viva Summit in Boston just recently. And to have these vendors who are ostensibly competitive, but working together in the space, to have them work together to bring something that's greater than the sum of all the parts to create that, it was just amazing to see. And to be at the center of this, to be providing a platform that's safe and secure and privacy protecting for all of this work to go on, that's one of the greatest honors of my career, honestly. It's incredibly exciting to be moving the needle. And this is a very difficult area to actually create change. I don't know why, I mean, I know why it is, but it still confounds me that it's so difficult to add efficiencies that seem so straightforward in any other industry that can be so confounding in a regulatory setting. Yeah, for sure. And you're both touching upon the fact that we actually, the fact that we managed to go through it all during the first six weeks enabled us to take another kind of sprint thereafter and basically mature even more and kind of push the envelope even more in a second phase. And that brought us to the presentation in Boston just recently with the latest result from there. So maybe we should move there and step into the actual process that we're going to be able to do it. And then we can go into the process itself. Yeah. You know, I think a lot of colleagues, you know, health authorities, but industry for sure has said, you know, they want to kind of move away from pilots that don't go anywhere. They want pilots to production. So I can tell you that, you know, our intent going into these projects was what's production value, right? So we didn't go in there just as throwing out a resource. And writing a search project and writing a paper, what was production value. That impressive six week sprint that resulted in this, I said, coupled with, you know, our Lorenz colleagues really jumping in there, working with DNA Nexus and FDA. That really was after that a conversation with Viva collaborators, right? They're saying, hey, you know, what about, you know, what we're doing with Vault? We have a clinical, we have these CMC use cases. We have Viva publishing. Can we demonstrate the same thing? And could we do the same thing in a short period of time? And I think that's what that evolution was. It was two things. It was, it's not specific to a particular vendor. The whole idea behind this, as Omar said before, things being open source and with PRISM being a research collaboration agreement and that research might be a bit of a misnomer is that vehicle allows for us to basically publish results, right? The agreement that you have with these RCAs is that you're publishing results for everyone to advance this, right? So with Viva in that second phase, being able to say, yep, you guys have already been working on, the vaults, we've already done RIM, we talked about the publishing. That's really where that was, right? You know, looking at how we actually do business today and say, we're going to do real use cases because if the results of this prove to be true, then let's put them in production. Let's be able, let's get things earlier to market. Let's start putting that, you know, that metric to the test, right? Hey, we want to be able to see if we can gain some efficiencies and gain a month or gain two months, gain a day, gain five days. So that's, that's how we were able to evolve. And if it wasn't for the first six weeks, we've been able to do the second one. And I was also pleasantly surprised that in that short period of time, we're able to do the, the end to end life cycle, Rune. Before we look at some videos, Veda, can you explain the flow of the videos we will see in a moment? So the roles involved and, and kind of the process flow? Right. I think, you know, maybe the best way to do it is just to show it, right? You know, because what we tried to do, I'll just say it quite simply, is how do you take processes that you deal with today? You know, people have a way of operating. And we know that if you change too many things, if you're too disruptive, then you really can't move the needle. So the whole premise was try to leverage the technology and keep, you know, subject matter experts and content creators, you know, doing the same things they're doing now, but behind the scenes is where you gain those efficiencies, right? So we started with, you know, someone who, a medical writer dealing with a clinical protocol. Then you have the submission specialist and the subject matter expert, all the way going through the process of publishing and then having that validated. And then it goes to an agency, right? Then you have someone on the other side who can review that using the tools that are built in, having that interactive collaborative space, those health authority questions, right? So we have that and you'll see it in the video. And Omar did a tremendous job of illustrating that. Here are questions that the agency is asking the sponsor in the same platform, right? In real time, going back and forth, then being able to take that and memorialize it, right? Memorial. And then basically you have those officially communicated and back into your system. So I think that's pretty much in a nutshell, like minimize the impact of change for people who have to do it, gain those efficiencies, leveraging the technology, but then true end to end. And it's not just a submission. It's actually the SMEs and how you do review and gain efficiencies there as well. Perfect. Let's try and roll the first video and see how it looks. Just one other point, though. One of the things I've learned of 10 years working with Precision FDA is if you put something in front of a reviewer that makes their day longer, it will absolutely not get adopted. So it is critical that this stuff all makes the reviewer's life easier because any process that gets into the timeline, any process that really causes disruption on the reviewer's part, it just will not be adopted. So a lot of thought has gone into what can make the reviewer's life easier and how can the reviewers and the sponsors look at the submission through the same lens, even before it goes through the gateway. So that by the time it does go through the gateway, and as Veda says, you know, the cloud may end up being the gateway in the future, but in any case, you don't want the submission to have any errors. You don't want a day, you don't want a week of delay at all at this stage. So getting the game. So getting the reviewer's life, making the reviewer have better tools, that's also a really critical aspect of this. Otherwise, the process change just never will happen. To the video, I'll give a concrete example. Long time ago. So as when ECT first came to Center for Biologics, the very first one, it was very crude, right? I think the initial tool was a homegrown tool, and it was going to make review very, very difficult. So two things happened. When you basically, you know, they demonstrated the tool. All assessors said two things. They're like, one, just show me where the print button is, right? Or the second one was, I'm going to call the company and ask them for a paper copy, right? That's exactly what happened, right? The truth of the matter is, is that a reviewer is going to figure out a way to work around the process so that they can be efficient because they're not just doing one thing, right? So you have to take that into consideration and basically just, it's paramount that you're going to do that. You maintain those things because no one wants to know where the print button is anymore, right? No one's asking for paper copies. The technology has evolved and matured where it's taken those reviewer requirements in there so it does meet their needs. And probably now if you've met any of them, they probably wouldn't go back. So, Omar, you're absolutely right. And we have to continue just operating knowing that we have to have the knowledge workers front of mind when you're developing technology. Perfect. Gentlemen, let's roll the video and see how it looks. Behringer builds a submission content plan in VivaRim that will be used for an original IND application. Using the wizard, a submission was previously created to build the structure for construction of the ECTD submission. The content plan is opened to add a clinical protocol document into Module 5 where the STF for the protocol is located, retrieving the protocol. document document from the library by its document number. After finding the approved document, it is placed into the protocol section placeholder and locked. Now we locate the Module 3 section where the placeholder for the manufacturer document is located. Searching or filtering the library, we find the document and place it into the manufacturer section and lock it. The content plan can now be finalized based on our specific configurations and requirements to prepare it for publishing. I remember the first time I saw this video, I was kind of unimpressed because I looked at the video and I was like, this looks like normal. It looks regular to me. And we had the same conversation, and we had the same conversation, when we were in Boston also recently. And you touched a bit upon it already. But I think this, for me at least, it's so important that what you see is similar and actually also carried out by people who do this process normally. Can you try and put a few more words, Veda, on why this is so important that it's not something completely alienated to the people who are doing this? This process is day in, day out? Yeah, absolutely. You know, a lot of our technology vendors, Lorenz, Viva, others, you know, they spend a lot of time, you know, really going through working with users to be able to get to a certain point, right? So that's not trivial. It's not like you just threw it over the fence, you know. In many cases, people, you know, they tweak these things. And we said before, you know, people and their job resources are always at a need. That you have to gain those efficiencies and kind of lean in on how they do business, right? So like you said, you may not be able to do that 100% of the time. But that was the whole point, right? If they're able to do their job knowing that behind the scenes, they don't even know what's happening, right? It's just all kind of built in. The closest you can get to that, that's important. You know, this is a cultural piece, too, right? It's all buy-in, right? We talk about process. We talk about technology. But you have to get people bought into it. And if it's too disruptive, you know, then that's problematic. So that's the reason why, like you said, when we saw it, like, well, what's different? And then you say, well, that's the point, right? You know, close to nothing should be the case. And then you move from there. One good example of that, I remember long conversations about structured authoring when I was still at the agency. We were working with some, you know, vendors that were demonstrating certain things. And they said, listen, this is very simple. We've solved the problem. And then they demonstrated how you would do it. And it was actually quite good. There was only one thing that they had to do. They're like, so whoever's actually doing the review, all they have to do is just tag metadata. This is how they tag metadata as they're going through their review. And as soon as I saw that, I said, well, that's the end of that. Structured content authoring is going to be another bit of a delay. Because if you're asking someone who's doing a clinical review that they have to tag metadata while they're doing the review, that might be a challenge. But that's really the point, right? It's just one example of keep it the way that people do business now. And then let it evolve from there. Perfect. Let's try and roll the next video. Now we are moving from the Viva part of the process and into the TRS. And perhaps we will see something here, which is a little more new, at least. It looks a little different than what we're used to. But let's have a look at it. Viva RIM, combined with DNAnexus' trusted regulatory spaces, provide an end-to-end platform for multi-agency regulatory submissions. Behringer accesses their Viva RIM instance from TRS regulatory workstations using the Viva API to streamline multi-agency submission and information request interactions in a secure cloud environment. Behringer downloads an IND and a CTA from Viva to the TRS regulatory workstation to be presented to the FDA on Precision FDA and the EMA in an EMA-Behringer space on the TRS Commons. The Viva submission downloader tool authenticates with the Behringer Viva RIM and retrieves the submissions, staging them in the Viva download folder, for further action, for further action. Conversion of the EMA submission into structured FHIR data was also requested. Behringer uses the submission uploader on the TRS regulatory workstation to present selected submissions to multiple agencies. The submissions are uploaded to both an EMA-Behringer space on the TRS Commons and to an FDA-Behringer space on Precision FDA. Time-based access keys are required to access these spaces and in addition to uploading the appropriate submission for each agency, discussion threads are created in these spaces notifying each agency of the submission. FDA reviewers use the Precision FDA regulatory workstation to visualize the M11 protocol contained in the IND. FDA review. EMA reviewers inspect the CTA as HTML and JSON. The EMA is presented with links to the CTA both as a webpage for visualization and as FHIR structured data for programmatic access. In both cases, the health authorities and Behringer visualize the submissions through the same lens. The FDA is acting as the lead agency for compilation of information requests and they post a discussion thread with an attached IR question list in the FDA-Behringer submission space. On the TRS, Behringer runs the HAQ processor to retrieve the compiled information request from Precision FDA and process it using generative AI. An access key is provided for Precision FDA with the FDA-Behringer space location to pick up the compiled IR, along with the Behringer-Viva RIM system, URL, and credentials. The information request is retrieved from Precision FDA and analyzed, and HAQ entries are created in the Viva RIM for each question. Additionally, discussion threads are created for each question in both the FDA-Behringer space on Precision FDA and the EMA-Behringer space on the TRS Commons. Okay, that looked a little different, so familiar, but different framing. Vader, can you give a few words on what are we actually seeing here? Because it may look different, at least the frame, but this is, at least in my opinion, quite amazing. Yeah, I think if you look at it, you know, I think what's really important is the whole question that we had was, what do you have to do in order to actually do review and assessment from the beginning to the end to where you have a decision that's taken? So, I think what was really important about what Omar showed here was, it wasn't about showing a clinical protocol that was ICHM-11 compliant. You put it into a space and then people were able to look at it, right? What you actually, if you focused on it was, what are all the things that you need to be able to do if you're going to create and review a clinical protocol, right? So, many things that are use cases in and above themselves, such as like information requests or health authority questions, those are just really natural derivatives of what you're going to do, right? So, this isn't static. So, I think it's interesting if you look at it from that lifecycle approach, rather than saying, well, here is an ICA or here is a clinical protocol, now I can see it, now I'm going to look at it. The approach was definitely lifecycle to say, well, here it is. It's validated. We did it in FHIR, you did it in JSON. What's the next natural thing? I've got analytical tools where I can analyze this. Great. I have questions for the company, so I've got this information request. How do you memorialize all of that and support that back and forth? And then ultimately, when you're done, you get to a decision point. How does that just feed back into your system? So, I think that's really the take-home message when people look at the video. It's sort of like you can look at it in the context of I was able to put a protocol here and people were able to see it, but I would suggest that everyone look at it from exactly what steps were done in order to support more efficient and effective interactive collaborative review to get things done more efficiently. I think that's the main point. I was really impressed by the health authority questions, right? The ability to be able to take that, see that back and forth on the same environment, right? You're not going back and forth on the phone call or emails or doing these other things. You can ask the question in that space, get it addressed, analyze things together too if you want to, right? Because the tools are there. I think that is the really impressive piece. And then once that's all said and done, you can already realize those efficiencies and how that just goes back into your system automatically and then you move on to the next thing. Yeah. And Omar, when we look at this, you know, we have different regulators, we have different companies involved. There are, you know, data being transported. We look at data in different pieces of software and applications and, you know, it's a lot of moving parts that are coming together and yet it seems so like integrated and interconnected. How is all of this possible and how is that handled? Is it secure? You know, it's like, what's the dearest asset, our data that we are transporting through this. The foundation of all this is the security, privacy and quality controls that the platform provides and that anything running on the platform inherits. The way Precision FDA ended up working at all was because we ended up with a FedRAMP authorization that allowed PHI, protected health information and protected health information and personally identifiable information to be stored on Precision FDA. And once we had that, it was really a matter of having the proper application programming interfaces. So all of these programs can talk to each other programmatically. They don't have to have a web interface. So the trusted regulatory spaces workstation that you saw, where it was pulling discussions in, creating HAQ entries for Viva, all of that stuff is taking place sort of under the covers because the Viva API supports the interconnection and sharing of data. However, the companies have to know that where they're sharing that data is protected. And if it's good enough for the FDA and good enough for FedRAMP, then it certainly is good enough for a pharma company. So having the demonstrated capability and the demonstrated security, privacy and quality controls, that was critical to making all the pieces. But then I've got really sharp colleagues, my colleague, my colleague Raju Rayavarapu, he also came from the FDA where we worked on projects on Precision FDA. He has been working with DNA Nexus for over the last year, and he has done just some amazing work to be able to take the Linux -based system that is Precision FDA and TRS and to connect that to Viva, connect it to Lorenz, and create this end-to-end where the TRS is sitting in the middle, communicating with Precision FDA, communicating with the Behringer, Viva Vault, and communicating with the DocuBridge product. All of these things can work together in the TRS environment because, again, there's the foundation of the house, which is the security, privacy, and quality controls that enable this data to be shared. And I think also a really important fact is that you can, you know, when you share complex data sets, you can even look at those data sets in their native applications. So you completely eliminate the need of export, import, and data loss in such, or even skewering of the data format. So I think that that's quite interesting. I see, guys, we are being carried. One other point on that, Rune. We really don't want to live in a world where the data has to be shipped around all these different places. We think that that's antithetical to security. We think that's antithetical to having for efficiency. The data should be able to live in a place, and people should be able to look at it in a way that's authorized. And that is the tough thing to achieve. There has to be objectivity. You know, a sponsor cannot be presenting just half the data to the reviewer. All of the stuff has to be very transparent. And this is where the challenges come in. But we think that this is a challenge that can be met, and Project Cryptics is really demonstrating that it's not a technology problem. We can change our processes to be more efficient. And it really is up to industry to a large degree to say, we want these process changes and to help the reviewers and their agencies to effect these changes without causing massive disruption to the review process. I see time is flying. So let's jump to the next steps and the scaling of this. So, you know, we've seen now that the process works. The technology integrates. The data flows. But of course, the big question here is then, what does it take to actually adopt this as full scale? So, Veda, I think your dream came through. You demonstrated, we demonstrated that technology is not the problem. It works. So what do you see as the next step? What does it take to get this into the industry? And basically move from the state that we are in now into the real world? Yeah, that's a good point. I think it's just a matter of awareness now, you know, Forge, you know, thanks to Viva for being able to host and we were able to demonstrate and provide these results. But I think it's just a matter of what we said we were going to do from the PRISM RCA and also what we committed to as a part of Viva is to say, you know, our goal now is that we've proven that it's just really an implementation science exercise now. Right. That's, you know, we did everything production grade using real data with the tools that we have. You know, the next thing is basically say, okay, how, what, what other use cases can we apply it to? So now we just talked about how we just dealt with, say, some CMC, you know, how you saw that happen with an M4Q data set and that was converted to FHIR and we validated that. And then, of course, what we did with, you know, the ICHM 11 clinical protocol. There are other use cases that we're working on through PRISM, which is a real world data. Trying to connect data brokers, do some other things. I think that's it. It's like, we're just looking at, we've identified a few other internal use cases. Like, hey, now that we've been able to demonstrate this, can we apply it to that? And simply, if we can prove that to be out and prove that out, then it's a production thing. For everyone else, you know, that's what we said was we want to provide these results, right? Very objective. Like, you know, what's that technical blueprint? You know, I can tell you right now that that's ongoing. And, you know, once we have it available, we're going to make that public. All of the outputs from the research collaboration agreement are going to be made public. I think it's one of those things where you could take our word for it. But the whole point is to provide everyone the blueprint for them to try it themselves. See how it works in their ecosystem. Yeah, because at this point in time, again, getting back to what Omar said, if it was already being used for veterinary medicine review, we had a pretty good idea that this was going to work. And the fact that it's secure and private enough and they've been working on the FISMA high environment to basically be able to do that. And we're able to secure our module three and the tools are there. You know, now you just keep on tweaking. But I think the big question has been answered. So I think that's where we are in Bringer Ingelheim, exploring how we can leverage it. But really, I think this is a good forum and I appreciate you hosting it to provide these documents so that people can review those results themselves, maybe even kind of extend that to other things that we haven't even thought of. And then, like I said, give it a try themselves to see if it works for them. Yeah, very nice. And Omar, on the technology, it seems to work. How do you see that? Like the architecture of this and where are we maturity wise? Well, at this stage, we have Precision FDA has been around for 10 years. It's very mature. The Trusted Regulatory Spaces Commons, which is the first instance of the Trusted Regulatory Spaces nodes that has been in production now for the last few months. And in terms of the Trusted Regulatory Spaces, and in terms of the Trusted Regulatory Spaces, and in terms of the Trusted Regulatory Spaces, you can work on the Trusted Regulatory Spaces platform and carry out your regulatory use cases of your choice with the collaborators of your choice on the schedule of your choice because you have all of the same capabilities available to you that Precision FDA provides to the FDA and other PRISM project owners. So there is really nothing to wait for. And the lift to actually get a Trusted Regulatory Spaces. This is not a months and months process. It is very straightforward to embark upon a regulatory journey using Trusted Regulatory Spaces. Veda, any last comments from your side before we move to the Q&A? No, I would just say that if you want to reach out and you're interested in more, like you said, this was under the Research Collaboration Agreement. These results will be published. There was a bit of a delay with FDA given some transition. You know, I understand they'll have the website posted. And just from Project Cryptics, you know, we said that we would also do that. So I don't know, I think probably in the next couple of weeks we'll have that blueprint of how we were able to connect those dots. But I would say if you really want to be impressed, one of the coolest things I've seen from this whole project, you know, and I give credit to our colleague, Sibi Abraham from AstraZeneca from the ISPE connection, taking that Secure Bloom dataset, right, in PDF, and then for it to be converted into FHIR. The one really cool thing that was able to be demonstrated in this platform was the data visualization of taking something that had an impurity profile and then an amendment that's structured to show that not just from reading it, but then basically just having data visualization tools show you, like, this is what the original was, here's what the change was, and in seconds being able to, for a reviewer, for an assessor to say, here's the difference, then do a deep dive. That's probably one of the most impressive things I've seen. You know, the whole idea behind leveraging structured data, we're talking about FHIR, we're talking about these other things, for an assessor or for a content creator to be able to have DV tools that show them, you know, in an instant, what's going on, and for them to do a deeper dive is probably, out of all the things I think are quite impressive about the efficiency, it's probably one of the most impressive things I've seen. So if people want to know more about that and reach out, that was presented the DIA annual, I think you have a video on that, Omar, maybe that's something we can provide to people so they can see it. Very, very powerful to see those tools be able to take that data and then visualize it in a matter of seconds. Yeah, this was the whole point about making it, providing the same lens for reviewers and sponsors to look at the submission and to look at the parts of the submission, like the M11 structured clinical trial protocol, and to be able to visualize it or to be able to visualize what the effect of the effect of the change was in the manufacturing process. Let's take some of the questions that we've gotten in. Let's take an easy one first. So that is, is it a prerequisite to run Viva to try out an end-to-end process? The answer is no. You know, the whole, that's a good question. You know, the whole point of the resource collaboration agreement was to get down to how you can connect all these dots. So if you happen to be a Viva company, if you happen to be using another tool, the whole idea is that this is all interoperable. That was standards and interoperability were key to this. So if you're using another vendor, the idea is like, how can you work with them to connect the dots, right? As we demonstrated, we use Lorenz for DocuBridge, but we also did Viva Publishing. So that was just a good example of how you can do that, you know, just whoever your vendor is, take these technical blueprints. That was the whole point. Give that to them and see if they can't, do the same things that other tech providers have been doing. And actually even it would be really good to try out much more technologies because, you know, as an industry, I think we have a common interest of getting as much of this tested out as possible. So the more different technologies we can try out, the more mature we can get the process. So I think actually it's just a strong encouragement to try out with whatever technology you have at hand. Yeah. Once we heard it was open source, we're like, okay, great. Now we're on the right footy and let's try to see what we can be done. Absolutely. There is another question here is, you know, what should I do to get started? You know, I'm listening in. This sounds great. What can I do to get started? Well, I think that's a good question. I think if we can provide some outreach, we have documentation, you know, so we have materials we presented publicly and we haven't talked about this, Rune, but we can provide some of these things that we presented publicly. And that's because, you know, we only have an hour here. And they say, here, here's a deck that kind of describes exactly what we discussed today. Cause you may want to take that back. You know, here are some other documents, supporting documents. And then I'd also say, you know, reach out, you know, being the principal investigator there, we have other connections. Maybe it's through trade association, maybe through some other things that we're doing. I say, reach out to anyone here to figure out what that interest is. But certainly if it's a matter of just requesting more information, we can easily do that. Also, if you go to the DNA Nexus website and look for trusted regulatory spaces, that'll also give you a connection into this whole effort. Yeah. Once that FDA website gets published too. So that's where those results will be published. I think that'll be an important piece as well. And I think that the last update we have is that, you know, that's still an ongoing thing they're working on. But as Omar said, you can go to their website. You can request some information. If you've been attending DIA or some other venues or Viva Summit, I think if you were at the Viva Summit, you'll get the package. of what was presented there, you know, two weeks ago. Last question, Viva, and a brief answer. What do you think the long-term impact could be of this if we succeed as an industry? Well, well, two things. You know, we had a couple of goals. One was the technology is not an issue, knowing that there's plenty of other things that have to be addressed, right? But if you can get to that whole one centralized location global assessment, right, there's that reliance play. That's the one. For industry, we talked about it is reliance on health authorities that want to be more efficient and give us more time. So can you review this faster? But I think really the big one for me and I think for industry is how can we get earlier to market by providing that to an assessor faster? Where can we gain some efficiencies where we say instead of December 2025, I'm actually able to give it to a health authority in October. And oh, by the way, the mechanism by which I did that, there are one, there are more that there are five assessors or six health authorities that are in this one space, like an Orbis, like an Access, right? They start to see the technology and the opportunity and the potential. They start to adopt that too so everybody can converge. But you might share, these are real hardcore things, right? Getting earlier to market, democratizing access to patients by having one global sort of regulatory assessment forum, that would be the goal. Perfect. Omar, Veda, it's been an absolute pleasure to speak to you for the last hour. Just to round off, I think it's incredible to see how things are moving. As I said in the beginning, I've been working in this space for the last 15 years. I cannot remember a time in my life where we have something which is contributing in this way. We, you know, there are basically no losers here. Everyone wins. We have the possibility of working in this. We have the possibility of working in a smarter way at the sponsor side, at the regulator side. We bring drugs basically quicker to patients. We democratize the access. I think there is such potential in this. And I think that's also why it's important that we as an industry see this as an opportunity to get together and try and really move the needle. I think it takes the industry to also make the change. So I hope that some of you out there are also willing to join the movement and try this out. And, you know, let's figure out it's not perfect, but we can make it perfect together and make it work. So I hope that you will join the movement and get on board, try it out, share your results, and then hopefully we can make this impact together. So thank you very much for listening in. We will share the video, the recording of this. We will share the presentations. We will share the presentations. And then I can, I think, speak on all three of us on our behalf and saying thank you for listening in. And please engage if this is a topic of your interest. We'd be more than happy to have a conversation or just share experiences. So thank you very much for listening in and participating. And have a really good day. Thank you.