3562: Veeva Systems on AI and the Future of Clinical Trials

[00:00:04] Welcome back to the Tech Talks Daily Podcast. I just want to say a quick thank you to every one of you who keep listening, sharing feedback and reaching out after the episodes. And over the last 12 months, I've been on the road at more than 20 tech conferences around the world. And this year, one of my big goals going forward is to meet more of you in person. Whether it is a coffee between sessions, a beer after a long conference day or just a quick hello by a booth. I genuinely love connecting with you all.

[00:00:33] So please check out my itinerary for the year. Learn more about how you can work with me over at techtalksnetwork.com. Hopefully we can make something work this year. And I won't just be the guy that you listen to on your commute to work, but the guy that you've actually met in person too. That's my big goal.

[00:00:48] But today, my guest brings a calm and grounded perspective to one of the most complex areas in technology and healthcare. He's the senior director of strategy at Veeva Systems, and he spends his time thinking about how clinical trials can evolve in a world shaped by new European regulations, rising patient expectations, and a growing interest in AI and emerging technologies.

[00:01:16] Here at the Tech Talks Network, we now have nine podcasts and approaching 4,000 interviews. And that is only possible with some of the great friendships that I've developed over 10 years of podcasting. And a company that I'm proud to call friends of the show is Denodo. Because not only have they been on this podcast multiple times, they also help make sense of the AI data chaos that we're seeing now. Because the data world is louder than ever. AI hype, lake house complexity, and pressure to deliver more with less.

[00:01:46] These are things that I talk about every day on this show. But Denodo is helping businesses make sense of it all because they provide a unified data foundation for trustworthy AI. So if you're ready to unlock real outcomes, simply visit denodo.com today. But now it's time for today's interview. Let me introduce you to today's guest. So a massive warm welcome to the show.

[00:02:13] Can you tell everyone listening a little about who you are and what you do? First of all, thank you, Neil, for inviting me for this great discussion. So my name is Werner Eingebrecht. I am a senior director in clinical strategy within Weaver. So basically what I'm doing, I'm supporting customers in their strategic journey. When it comes to clinical development, when it comes to developing new drugs and medicines, you know, helping them in this journey, you know, how can they get me better efficient?

[00:02:43] How can they utilize better technology? And internally, I think this world is more the glue between all the different functions. So, you know, doing the right thing for our customers, you know, creating customer success, creating industry success. That's, I think, my role. I'm so happy to get you on here with me today because you're someone that has spent more than two decades working across IT and life sciences.

[00:03:11] And there's been so many big changes throughout your career. And I've got to ask, if we go a little bit further back, what originally pulled you towards that intersection of technology and clinical research? And how has that shaped your view of the changes that we're seeing across Europe right now? Because you've got quite a unique vantage point here. And I feel like there's got to be a story there, too. Yeah.

[00:03:34] If I go back, you know, a couple of years, basically, my starting point was really I have done a technical school, which was electronics and software engineering. And then I got attracted by human medicine because my father got sick, honestly. And I spent a lot of time in the hospital. And so I started to medicine and I started to practice also in the university hospital in Vienna as an investigator.

[00:04:04] That was my first touch point with clinical research, you know, getting this exposure basically there. And from there, I got, you know, in contact certainly with the pharma industry and the biotech industry, you know, interacting on clinical studies. And I got the opportunity also to starting to work in the industry really.

[00:04:27] And I have taken that, you know, this exposure to understand also, you know, how a pharma company is starting to develop compounds and drugs basically. So I started there as this traditional roles, you know, as a clinical research associate, you know, as a project manager, learn from scratch on really clinical trials, you know, what you need to do there basically.

[00:04:50] And over time, I got also the opportunity to work for the health authority, which was a nice exposure for me, you know, to understand coming from an investigator role, moving to the pharma industry. Now, how are coming these clinical studies together at the end of the day? How are they evaluated? How are they evaluated? How the safety efficacy profile is evaluated by the health authority?

[00:05:19] I got this exposure and I have taken this opportunity really to understand better how, you know, we are evaluating clinical trials and what are stopping us maybe to get new compounds, new drugs to the market. This was a nice exposure. It was certainly always, you know, also exposure to some of the technology we had. Now, back in the days when I started working, it was more, you know, on very paper.

[00:05:47] I have to say, when I went to the research sites, I collected a lot of paper manually and shipped it then to India, you know, so that they could scan it. So that was basically my initial role there. And before I joined Viva, which is now five years ago, I got a little bit also the exposure to the CO industry.

[00:06:09] So the clinical research organizations who are helping basically the pharma and biotech companies, you know, in running these clinical trials, in setting them up, in finding also the sites, finding the right patients, helping that with the whole, you know, run of a clinical trial. I got exposure there in sales and account management, which was really nice.

[00:06:29] And so I got in contact with Viva and I felt, you know, this is a great opportunity to combine my background, my technical background, my medical background, and also my master in medical law, combine that together in a more strategic role to help customers, to guide them in with different perspective, from a legal perspective, from a medical, but also from a technology perspective, help them with that.

[00:06:58] So that's really my journey where I'm coming from. Now, what helps me also outside my role at Viva is really I'm working pro bono as a type of mentor with healthcare startups. And that's a very interesting, you know, role you have because you're getting involved in very dynamic, small startups, just a few people always there, you know, and they have great ideas.

[00:07:27] And they have a great innovative setting. They do not know always, you know, where to go with that. And that is where I try to support them. But it gives me also exposure to another business, which is very dynamic and, you know, very attractive as well.

[00:07:48] And fast forward to present day, where everything we're talking about here, the European regulatory environment feels like it's shifting incredibly quickly with the AI Act, the evolution of GDPR. Then we've got the AI Act EU. When you talk to biopharma leaders, what is causing the most pressure? And where do you see the biggest opportunity to modernize? What are you seeing here? Yeah, you're right. Definitely.

[00:08:14] All these regulations which are coming into place, you know, from the European Commission are basically here to reshape, you know, how we are running trials to help also Europe to create more transparency, but also to create more efficiency.

[00:08:31] Now, this is really a big journey for the pharma and biotech industry, you know, in terms of, you know, staying compliant, you know, following this framework, you know, the regulatory bodies are setting out to them. And I think the challenge they are facing is, you know, it puts a pressure on internal collaboration, I feel, a lot, and on data.

[00:08:56] So how you're managing data, how you're, you know, utilizing new technologies, you know, to process this data, to harmonize this data is a key element. And I think the other one is, again, this internal collaboration, you know.

[00:09:10] So if I'm expecting from a health authority that they are speeding up their processes, right, in shortened response, you know, timelines, you know, how quickly they are responding to you, they are expecting the same from you, right? They're expecting also from you as a biotech or pharma company that you're also speeding up, you know, your response timelines maybe.

[00:09:36] And I think this is coming down to really to the internal more intense collaboration, which is needed during these days. It's really expected also. You can run, you know, shorter timelines. You can reduce, you know, really the response waiters, for example, only if you have an internal efficient way to collaborate. Yeah, and I think it's worth highlighting that these regulations actually aim to bring stronger transparency.

[00:10:05] And ultimately, better oversight to clinical trials. So how do you think companies should think about adapting maybe their processes so compliance can become a driver of improvement rather than a burden, how it's traditionally been seen? Because it's a hugely positive thing, isn't it? Yeah, yeah, I agree.

[00:10:25] So these regulations and innovations, you know, are increasingly connected basically with compliance central to trust and quality. I think this is a key element here. And I think it's an amazing opportunity for the industry to turn a regulation into an innovation. And I think that is where the industry should go to.

[00:10:50] So as an example, transparency reporting, again, you know, this transparency reporting is something which is seen from the industry maybe as a burden on the one hand. On the other hand, increased transparency can also attract patients. It can attract new research sites, you know. So taking this regulation and turn it into an innovation, you know, yes, I'm increasing the transparency.

[00:11:17] It is a burden for me to provide this transparency reporting out to the world, basically. On the other hand, I might attract more patients. I might attract more sites. It is, I think, really important. And it also relates, you know, for example, with the AI Act, you know, turn this general public concerns into benefits for the patient. That is how I see this regulation, for example.

[00:11:44] I see that more, you know, yes, it is a regulation and it hinders maybe some of the innovation. But as a biotech company, as a pharma company, you are anyhow in a very high regulated environment. But what it does, it gives your patients the security that the clinical trial is not an experiment.

[00:12:04] It is an extreme well-controlled and documented process to ensure the patient is getting early access to new treatments in a secure setting. And that is how I think we should also as an industry communicate to our patients that we are following this AI Act, that we are following these guidelines to ensure the patient safety.

[00:12:27] And that they have really a secure network to feel comfortable in participating in a clinical trial. So turning that again into innovation, that is, I think, where the industry should go. Yeah, and I think AI, we're already seeing it influence areas like patient recruitment, data integrity, and indeed trial operations that we're talking about there.

[00:12:53] I'm curious, which use cases do you think feel ready for broader adoption? And which one still needs stronger evidence or clearer regulatory guidance? Because you have to move a little bit more cautiously and a little slower in this industry. But are there any areas that you see are stronger than others? Yeah, yeah, definitely. So I think, first of all, I think when it comes to AI, I feel, you know, there is a foundational work which needs to be done.

[00:13:23] And that is coming down to having clean data. First of all, no AI environment can fix if you have poor data, if you have unconsolidated data, if you do not have qualitative high or high quality data, basically. The other thing is, I think, also to have defined processes, you know, where you are applying AI, you know, define your processes very well. AI is not here to help you in your messy processes. It will never help you with that.

[00:13:51] So you need upfront define your processes well before you're applying AI. And I think the last thing is also defining a clear outcome, what you're expecting exactly. Now, in terms of, I think, the clinical, you know, compound development, I think where AI is already quite broad used, I think, is drug discovery.

[00:14:14] Drug discovery, you know, molecule screening, you know, this more non-clinical development with data analysis is an area which is not directly exposed to problems. Patients, first of all. So you can more try out, you can, you know, be more experimental, if you would like to say that. So I think this is an area where I think AI can easily be applied.

[00:14:39] Other things may be a site selection, patient recruitment also to identify, you know, that when it comes to areas like trial planning, optimizing your study protocol, optimizing that. There's so much data needed to do that. I think that is an area where we still have a journey. We're still moving, you know, to a good model.

[00:15:03] I think in that case, I think there are always pilots available out in industry, but I do not believe this is already the maximum we can get out of that. And that is also to, you know, when it comes to the trial execution, for example, when it comes to real patient data, you know, that's also an area when it comes to safety and so on, where a lot of data is needed.

[00:15:27] But most of them you currently do not have, you know, consolidated available that AI can make decisions based on that. This month, I'm partnering with Alcor. And if you've ever tried to hire engineers in another country, you probably know just how painful it can be. Different laws, patchy support and partners who don't truly understand engineering roles. So Alcor approaches this from a different tech point of view.

[00:15:56] They specialize in Eastern Europe and Latin America, and they're able to combine EOR capabilities with recruiting. So you get one partner handling everything and they help you choose the best location for your stack, find developers with the right depth of experience and run proper assessments so they can onboard people quickly. And they also give you a model that respects both transparency and margin.

[00:16:22] Most of your spend goes directly to your engineers and the fee will decrease as the team expands. And you can even transition everyone in-house at that time when you're ready without having to worry about a penalty. And that structure is why a mix of early stage and unicorn stage companies use them as they scale. So if you want to take a look, visit alcor.com slash podcast or tap on the link in the show notes. But now, on with today's show.

[00:16:51] And when you look at patient recruitment, I think AI is often discussed as a way to better match volunteers to studies more quickly. But what practical benefits are you seeing on the front line here? And are there any additional safeguards that matter most to regulators and sponsors now, just for anybody in the industry that might be listening? What are you seeing here?

[00:17:14] So I think the interesting thing in our industry is that, you know, we are talking certainly on more complex trial decides. We are talking on more complex compounds. But the reality is we have more complex diseases. And what I mean by that is, you know, when I talk about oncology, when I talk about breast cancer, historically, you know, we diagnose the patient, you know, she has breast cancer. That's it.

[00:17:44] During these days, you know, we have genomic analysis. We have biomarker analysis. You know, we can identify very detailed what exactly type of cancer this woman has. You know, is it a triple negative, for example, cancer, you know, which requires a different therapy, you know, for example.

[00:18:04] So it's a much broader data set on the diagnostic side you have today, which leads then to much more complex trial designs also. And I think what a key element here is the access to this data, the upfront access to the data when it comes to electronic health records, you know, accessing this, you know, is still a challenge.

[00:18:29] And it needs a lot of safeguards also from the regulatory to grant access in the future to this highly, you know, secured information. I think this is something where we can see a lot of benefits moving forward. But again, getting direct access to the broad information, which is already available, not to retest, you know, everything again, not to put too much burden on our patients.

[00:18:57] But it requires also from the health authorities, you know, first of all, in Europe, for example, a lot of collaboration, a lot of alignment, you know, what are the standards for electronic health records, you know, how can we harmonize and standardize that across Europe, for example.

[00:19:15] And how can we integrate that and give the right information maybe to some of the sponsors, certainly always with the secure network, you know, to save, you know, patient information, which are not, you know, should be not publicly available. And we should also mention ACT-EU, which is pushing for greater collaboration, faster approvals and indeed improved trial quality.

[00:19:45] So how prepared are companies for this shift and what steps will help them adjust without slowing work that's already underway? I think the industry is starting to get prepared. There's a lot of regulations out, particularly in Europe, you know, with the Data Act, GDPR, EI Act, you know. And while these regulations are all very restrictive, there's also revisions coming out of that.

[00:20:11] You know, we have just recently heard from the European Commission also, it's called Digital Omnibus, which is basically changes in all these regulations, which open it up. It extended timelines for AI Act, for example. So it gives also, I think, the customers and industry a little bit more time to adjust and adapt. Other initiatives like the Biotech Act is also out.

[00:20:34] And it's a great initiative from the European Commission because it covers the entire life cycle of a healthcare product. And it comes from initial research and funding to development, manufacturing and market access. We are always focusing on development.

[00:20:53] But I think sometimes the bottleneck also, you know, in these regulations is more how we are getting the funding even for this, you know, to develop compounds in Europe in a more efficient way. The other one is maybe manufacturing. We have sometimes limited, you know, manufacturing capacities in Europe to get that.

[00:21:15] So having a much more cohesive perspective, how we can, you know, improve the healthcare biotech industry in Europe, I think is important. And I think companies are getting prepared to that. But it requires certainly a strong collaboration. I think a more intensive collaboration between the industry and the health authorities as well as the European Commission.

[00:21:44] I see that over the last few years. I see, you know, when we are looking back to COVID times, you know, we were able to expedite clinical development a lot during these times. And I think what a good outcome of that is also that what I see personally is a much intensive collaboration between the industry, the EMA, but also the European Commission.

[00:22:09] So I think that is also a key for success to be better aligned, you know, in these targeted areas. And you are someone who follows emerging technologies very closely. And there are so many different ones out there at the moment. And a lot of these emerging technologies are beginning to converge.

[00:22:28] If we look at everything from, I don't know, blockchain to IoT, how do you see these tools fitting into the future of trial oversight and evidence generation and long-term regulatory confidence? Do these emerging technologies excite you at all? And what are you seeing here? Yeah, absolutely. I think, you know, when it comes to blockchain, IoT, you know, those are things really, I think, who, you know, can benefit or the industry can benefit a lot, you know.

[00:22:56] I think blockchain, you know, when it's all about decentralized activities, like blockchain is decentralized database, really, you know. It's more resistant to tempering, you know. It's more resistant to fraud, you know, to breaches. Yes. So, I think, and it boosts us also, I think, you know, the data integrity and the patient safety.

[00:23:18] So, I think this is an area where, you know, I think we can, in clinical development, definitely create a more, you know, resistant environment against fraud and any breaches when we are utilizing these technologies also in clinical trials moving forward. And then the Internet of Things.

[00:23:40] Internet of Things is certainly, we are seeing in our daily life always, you know, we have always connected devices, you know, which are, you know, speaking to each other. And I think in clinical trials, it's also coming more in clinical development, you know, we have trials with decentralized elements. So, giving patients more flexibility for some activities to stay at home, but also to be continuous monitored, really having better real-time insight.

[00:24:10] All of that needs results in faster decisions. When I have a constant ongoing monitoring of my patient, regardless if the patient is in the hospital or at home, I have better insights. I can react better. I can, you know, adjust maybe the treatment for this particular patient in a faster way. But I can also adjust maybe the entire population of this study in a more quicker way.

[00:24:38] And I think this is all leading to this type of technologies, accepting them and utilizing that. So, I think both, you know, initiatives, I think, are a great benefit in the future for, you know, clinical development as well. And I think that is a powerful moment to end on today. But we've only scratched the surface and, at the same time, covered so much information in a 30-minute conversation today.

[00:25:05] So, anyone listening want to dig a little bit deeper into this conversation with you or your team or just keep up to speed with some of the developments as they come out throughout the year? Where would you like to point everyone listening? So, I think definitely point, first of all, to our website. There's a lot of information there, you know, how we were supporting the industry, how we are thinking about, you know, a cohesive, consistent platform approach. I think that's one source, really, the industry is looking for.

[00:25:34] The other one is Viva Summit. So, we have twice a year, you know, an event. It's in May in Copenhagen and then in Boston later on next year in October where we are bringing together the industry. And the intention of that is really that our customers have a peer-to-peer discussion.

[00:25:55] It is really for them to talk to each other, you know, what trends they are seeing, you know, to talk to us also where we see maybe some future initiatives coming up in the industry. I think this is a great way to engage with your peers. This is a great way to engage also with Viva people here and also, you know, certainly with the wider industry. Well, as I said, we covered so much there from the evolving regulatory landscape.

[00:26:24] AI's role in clinical research and the importance of breaking down silos for better compliance. I'll add links to everything you mentioned there and I would encourage people listening that are interested in exploring this to get in touch with you guys and keep up to speed with some of the developments coming out. But more than anything, just thank you for taking the time to sit down with me right in the heart of the holiday season and sharing your story. Thank you so much. Thank you also very much, Neil, for this great discussion.

[00:26:55] So a big thank you to Werner for such a thoughtful discussion there. I really appreciated his take on how regulation can build trust rather than slow progress. And his pragmatic view on where AI fits today versus where it still needs stronger foundations, I think really hits home. So I'll add links in the show notes so you can learn more about his work, upcoming events and some of the initiatives we discuss. As always, I'd love to hear your thoughts.

[00:27:24] How do you see regulation shaping innovation in your industry right now? So before I wrap things up today, just a quick reminder that I'll be back on the road again this year, attending and speaking at events across different regions. If you're heading to any of the same conferences or just fancy grabbing a hot coffee or a cold beer while I'm nearby, take a look at my itinerary and the different ways we can work together over at techtalksnetwork.com.

[00:27:52] I'd love to meet more of you face to face and keep those conversations going beyond the podcast. Zuckerberg's famous for his resolutions, wanting to create a smart home, learn Mandarin, become a cage fighter. Me, I just want to pop by and say hello to my listeners. But that's it for me. So thank you for listening as always. Speak with you soon. Bye for now.