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Service Provider Executive Series #13: Renato Rjavec (ArisGlobal)
99 Plays2 months ago
In today’s episode, Host Steve Gens sits down with ArisGlobal's Renato Rjavec (VP of Product Management, Regulatory). Together, they discuss ArisGlobal’s adoption of advanced technologies, the NavaX platform, and the next leaps for ArisGlobal in the near future.
You can learn more about ArisGlobal and their NavaX platform by visiting: https://www.arisglobal.com
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Transcript
Introduction to Genzen Associates Podcast
00:00:06
Speaker
Welcome to the Genzen Associates Executive Podcast Series, where we explore innovation in the regulatory space. Today, I'm very happy to be speaking with Renato Revovitz from Eris Global.
00:00:18
Speaker
ah Renato, we've known each other for ah quite a long time, and I'm really excited about this session. Certainly, there's long history ah with you. You were back in the original Infotina, then Amplexer.
00:00:32
Speaker
and the last two and a half years in the Ares Global family. We have new roles and responsibilities, so I think our listeners are going to be very excited to hear directly from you on kind of where Ares Global is taking the regulatory area. So before we get started, if you could introduce yourself to our listeners and say a little bit about the company too.
Renato Revovitz's Career Path
00:00:54
Speaker
Thank you. Thank you, Steve. I'm pleased to be taking part of this great series, and I'm honored to talk to you today. Yes, I'm heading currently the regulatory product management here at Aris Global, and I've been in this space for almost 20 years on various positions. I started, as you said, back in Infotina as an implementation consultant, working on several projects, moved into the project management, being responsible for Many global implementations of end-to-end regulatory as well as quality solutions.
00:01:29
Speaker
And then moved more into the solution development and finally product management space. And I've been here for practically 10 years already in this area and building up product management organizations first in Lexer Life Sciences and now as part of ARIS Global.
Ares Global's Regulatory Solutions
00:01:48
Speaker
Here at RS Global, we're proud to have really strong end-to-end regulatory solution offering besides the market-leading safety suite. And we're building it on top of the legacy RS Global, Amplexer, and Scorify that have been incorporated into our offering and the over the last two years.
00:02:09
Speaker
And we are proud to be innovating, incorporating latest technologies and addressing the most pressing challenges within the reg ops with the support of advanced technology, including AI.
00:02:22
Speaker
So thanks for that introduction, Renato, and you know the point that we have at least 20 years, you've seen a lot. And sometimes we have technology fads that come and go, and then some stick, right?
00:02:34
Speaker
And I think for your listeners, everybody knows Eris Global for their safety capability, most for the regulatory capability. But also, you guys are actually in the quality space, too.
00:02:45
Speaker
So I know if you've had an entry out in there with the QMS. So I think just to put that out there. But getting back to, like, you know, some of the technology comes and goes. I mean, one big thing that happened about 10 years ago at least in the regulatory space,
00:03:01
Speaker
is we went from a lot of different individual niche providers to the whole end-to-end platform. And you guys at Aeros Global definitely have a strong end-to-end, and that end-to-end strongly goes into safety too.
00:03:13
Speaker
But all the talk in the last two years, AI, automation, we we call it the advanced technology focused on new product development and also the lifecycle management.
Navix Platform and AI Integration
00:03:23
Speaker
And for us at Gens and Associates, we've always seen Aeros Global talking about the next wave of technology.
00:03:30
Speaker
earlier than everybody else and doing more experimentation, but usually ahead of your competition. So the question I think we could start out with is the advanced technology, early adoption. What's in the base platform?
00:03:45
Speaker
Can you share some of the examples of how you're innovating with advanced technology with your customers? Thanks, Ed. That's a great question, Steve. So we are, in my opinion, now in a very interesting times where there is a combination of various factors that came to the critical point. On one hand side, we have increasingly pressing demand on the regulatory requirements.
00:04:13
Speaker
Demand on having better efficiency and optimizations of the processes also within the regulatory operations to cut down the costs, to be more efficient with internal processes.
00:04:26
Speaker
On the other hand side, we have seen obviously the advancements in on the technology side as well. And what is really interesting that this domain has not been known in the past for taking new technologies very as an early adopter and always a little bit lagging behind.
00:04:46
Speaker
But now we see really the potential that this gets accelerated a lot. That's why we have detected this opportunity and invested into adoption of advanced technologies across all of our products on all of the areas that we are covering.
00:05:03
Speaker
And we did it in a way that is scalable enterprise level, taking into account compliance requirements of the domain, et cetera. by introducing the so-called Navix platform, which is RS Global's cognitive computing engine that applies the latest technology, Gen.AI, Agentic.AI, etc., to various workflows and capabilities across safety, regulatory quality, and medical affairs.
00:05:31
Speaker
On the other hand side, we are picking very tailored use cases based on the understanding of the market needs, what's most pressing problems in terms of efficiency requirements, and then utilizing these capabilities on those use cases by providing solutions that fit the end-to-end landscape of our products.
00:05:53
Speaker
And we've announced beginning of 24, the Navix platform at our conference in London, supporting four use cases on the safety and regulatory side to each.
00:06:08
Speaker
Since the launch of the original use cases back in 24, we've been continuously ah launching new additional use cases every three to six months. And we've been aggressive in continuing with additional capabilities and solutions. For example, providing Medra coding agents, compliance monitoring agents, and other capabilities.
00:06:31
Speaker
And we are proud to be progressing in this area very fast. Six months later, we had the first product sold. And this year, we already have practically a dozen customers and many of them already live at this point in time.
00:06:48
Speaker
So we were able to move fast and convert this innovation in our solution space into tangible benefits of our customer in, I would say, a record time for an end-to-end provider.
00:07:02
Speaker
So Renato, could you, for our regulatory listeners, could you give some examples of those use cases? And certainly, you know, from an ideal, you know, into full production, that's that's a really short timeframe. So that that's impressive because that's the thing I've always appreciated, you know, with AERIS Global is once once you make your minds up, you move quickly.
00:07:22
Speaker
So could you just bring home for our regulatory listeners, what are maybe a couple of those out of the four items that you were focusing or AERIS Global was focusing on?
Regulatory Use Cases and Innovations
00:07:32
Speaker
Sure.
00:07:32
Speaker
So let's focus on the regulatory side. And out of those four use cases, the two on the regulatory side were focused on the optimization of health authority interactions and the automation of regulatory intelligence. So these were the problem spaces we identified deemed most interest to start with.
00:07:52
Speaker
And if we go one by one, the health authority interaction is a known area where we meet the demand of high volume processing of the interactions of the correspondence with the health authority.
00:08:05
Speaker
And we worked first to automate the intake part. to make sure that we provide a seamless automation experience and user experience to our customers that can accelerate immensely the intake, which includes automated data extraction, automated classification, automated translation of content, automated linking to the backend system with the appropriate records, summarization, and many other interesting features.
00:08:36
Speaker
And that's just the first step. The next step is obviously to support downstream actions, to extract the queries from health authority, to connect this with the supporting records, taking into account the human feedback, and automate the generation of responses as a next step.
00:08:54
Speaker
And we're happy to see our customers experience significant efficiency gains. So on top of our internal process models on the efficiency gains achieved by the particular solution, we've been validating this with the customers.
00:09:09
Speaker
And we can say that 50% efficiency gains on particular um process flows is a conservative number, and we've seen much higher numbers even. In the regulatory intelligence space, we saw a gap in terms of how advanced technologies could change the way how customers are keeping up to date their internal um regulatory folks with the over-changing regulatory requirements.
00:09:39
Speaker
So we have launched a regulatory and intelligence solution that is taking care of monitoring the regulatory updates ah from proven sources, taking them automatically into the knowledge base, which is being built, taking into an account, again, automated data extraction, translation,
00:10:00
Speaker
handling the version trees when there are updates on the existing records, etc., extracting the summaries of changes and driving further notifications and impact assessment workflows.
00:10:14
Speaker
And beyond that, This knowledge base is being used also as a reference source for ad hoc queries, because nowadays users expect from the systems that the latest technology will allow them to simply ask questions in a natural language and get summarized responses pointing to the sources of information in the back end rather than searching or using keywords, getting to the right record, opening it, finding the right passage in the text, etc., and trying to combine all these pieces of information with the manual effort.
00:10:53
Speaker
So we've seen great interest in this regulatory intelligence use case as well. And I think we kind of nailed two of the top priorities. But of course, these are just two of many that we have on the radar as well.
00:11:07
Speaker
And that's the yeah interesting thing about the time we live in. And I was just presenting the other day, and I think you're familiar, we have our typical regulatory core process, right? There's tons of sub processes. And the headline to it is there hasn't been a time when every step of the regulatory process, there's some type of AI automation opportunity. Usually we focus in different areas.
00:11:32
Speaker
And the two that you bring up, obviously, no surprise, your competitors, everybody's working on the health authority interactions. But what I'm hearing now, and it's good to hear it, because intake is intake. And anytime we can automate intake, just like on the safety side, if you have millions of cases and you can automate just 10% or 20% of the intake, that's a really big deal with that kind of volume.
00:11:56
Speaker
But what I want to highlight, and particularly it impacts the local markets and also in your Reg Intel, which I think not enough providers are working on the Reg Intel. So obviously that's a differentiator for you guys.
00:12:08
Speaker
it's It's embedding the translations. The translation software is really getting pretty sophisticated. And you think about all the cost, you know, that... your typical biopharmaceutical med tech industry uses just on translations. And having the intake, the classification, the translation is such a big step in the automation. And eventually the generation, you got speed, you got productivity, and you got cost reduction all in that use case. So ah the fact that on both these important use cases, the health authority interactions and Reg Intel, you're actually embedding the translation in there. i just see that as a really big deal.
00:12:47
Speaker
Because that that that takes time. Typically, send it to a third party. You have double proofing. So that that is very disruptive. it's probably going to drive a lot of cost and really reduce the cycle time. So the fact that you're doing what I would say, dare say, end-to-end in both the health authority interactions and regtel is really important. So that's a good update.
00:13:07
Speaker
um I want to shift because, again, the heritage of AERIS Global, usually if you say, hey, what does AERIS Global do? They'll go to safety first. you know Now, I think more and more people understand that it's regulatory, but you have some maybe brief thoughts on or customers that you have that both have the safety PB and the regulatory modules that, you know, what is that value proposition? And the reason I'm curious about this is we've been seeing, we actually did a pulse survey.
00:13:38
Speaker
Geez, I think it was about 18 months ago, because we started seeing, and this happened about 10 years ago and it's back, where regulatory and safety are starting to report into the same leader and sometimes R&D quality.
00:13:49
Speaker
ah One of our clients calls it the power of three, safety, regulatory, and R&D quality. ah The fact that you have a high expertise in this area, could you kind of share? So that's from an organizational standpoint, but from like that system process.
00:14:04
Speaker
clients that actually have both the the kind of maybe unique value they're getting.
Integrating Safety and Regulatory Processes
00:14:10
Speaker
Yeah, that's really interesting observation. And um we've observed this trend with our customer base as well, where organizationally they're combining safety and regulatory under the same umbrella and sometimes even quality.
00:14:24
Speaker
I believe the goal behind that is to streamline compliance operations in general and to bring best practices and experience that has been proven on one area, maybe to adopt it in the other areas as well.
00:14:38
Speaker
But if we go back, even from the business process perspective, there are many use cases that basically underline the need for interoperability also from the solutioning side.
00:14:50
Speaker
So if we just take the connectivity between the regulatory and safety worlds from the perspective of RIM data, so you have your golden source of truth of regulatory product data, registration data in your RIM system.
00:15:06
Speaker
which is, on the other hand side, required as part of your ICSR reporting. With the introduction of IDMP, the IDMP identifiers need to be part of that record as well. So we definitely want to reuse whatever you have as a golden source of regulatory information on the safety in a seamless manner as well.
00:15:28
Speaker
Another example there is when you need certain regulatory reports to build up your PSMF annexes, and that's another connection that is out there as well.
00:15:41
Speaker
Vice versa, when we think of the safety as a source for regulatory, of course, Safety signals are the most common case where you need those to trigger changes on labeling side with the safety variations, etc.
00:15:57
Speaker
So there is a natural connectivity that goes there from the compliance and business perspective already. And obviously we understand that and despite not being a safety expert, not being able to go in in too much details there, we do have connectivity in place with the help of so-called LS Connect that can support these use cases and we've been implementing this with our customers.
00:16:24
Speaker
And they report that basically they can leverage definitely this connectivity to get better accuracy, faster data exchange, and overall improving the efficiency across the domains.
00:16:40
Speaker
And I think this will in future go even deeper with the ability to source the data from both regulatory and safety areas to bring cross-functional insights.
00:16:54
Speaker
Potentially, with the agentic AI capabilities, you could bring really interesting outputs out there. That's really interesting on the agentic because that's a growing conversation.
00:17:07
Speaker
So we have kind of different expressions of AI. um And when you were talking about the safety signal, and in my head, it's just that classic process. There's a safety signal.
00:17:19
Speaker
A fundamental question is, do we need to make a label change, right? So you have the regulatory impact assessment, and that sets off a whole bunch of regulatory activities globally. So it's it's easy to say it, but the impact on that safety signal, but the regulatory work could be substantial.
00:17:35
Speaker
You know, especially for a large multinational, if you're in 100 countries, maybe it was a significant update to the label or even a small update. It's just a lot of work. And that's why I had mentioned like on the product lifecycle side, you have your obligations, you know, like you said, the safety reporting, pretty straightforward.
00:17:52
Speaker
But then it's all the lifecycle management. If there's a manufacturing change, a change to the label. And I think a lot of people, even in regulatory on the strategy side, underappreciate that level of effort, all those transactions all over the globe just to stay in compliance, make sure the label's updated.
00:18:11
Speaker
if there's the variations, you know, a lot of times that's like 70% of regulatory's work is on that lifecycle management. So the fact that you're making really great strides there, and I couldn't even, I'm not an expert in safety, just the volume of cases that keep on going up.
00:18:26
Speaker
So kind of automation and connectivity and like to term you were using interoperability of this is really, really important. So you know what the last question is? Anytime I have the guest, it's an opportunity about what's happening in the future. And I thought but today is, we'll say this advanced technology is a bullet train.
00:18:46
Speaker
You know, it's it's moving very quickly. So maybe the next 12 to 24 months, where's the AERIS Global Platform going to be? I mean, you had the two great use cases, the health authority.
00:18:58
Speaker
you know, interaction, drag and tell, but there's other things that that you guys really want to solve. So what are the next steps or maybe leaps that we should expect from Eris Global, Renato? Yeah, so definitely two points to start with.
Future Predictions for Ares Global
00:19:13
Speaker
Prediction is very difficult, especially if it's about the future. i think it was Niels Bohr that said, so we will continue to stay agile and react on changes in the environment, the upcoming customer needs and new requirements, but also evolution of the technology.
00:19:28
Speaker
On the other hand side, Lincoln said that The most reliable way to predict the future is to create it. So we do have our strategy and we follow our strategy along the way.
00:19:40
Speaker
And we do believe that investment in our core Navax platform with a core set of capabilities that can serve multiple use cases is a long-term investment.
00:19:51
Speaker
because it is scalable, it can support many use cases without additional investment in the technology as such, but on the other hand side, also ah able to adapt new technology evolution behind the scenes, plug it in without the change of the core platform.
00:20:08
Speaker
So we are on one hand side leveraging what we built and built on top of it. Further, on the other hand side, stay flexible with the regards of the technology evolution. We do understand that there is not just innovation that is expected from our customers. Compliance is the base requirement. And we've seen in the survey last year from the regulatory professionals that 97% of the regulatory leaders have seen significant expansion of the regulatory obligations over the last five years.
00:20:45
Speaker
And similar percentage is expecting the same trend also for the next five years. So the pressure is there. We need to respond to these new requirements within our solutions.
00:20:59
Speaker
But also not all markets are the same. Global pharma companies operate globally on many markets. And there some markets which adopt new technologies and new ways how to collect inputs such as structured data to perform their assessments, while others are still lagging behind.
00:21:20
Speaker
And those companies need to be served on all these markets. So we do pay attention on ah various types of requirements that our customers have on various markets with the same attention.
00:21:32
Speaker
The trend that we see definitely that our solutions that now seamlessly connect data, content and process aspects of the regulatory affairs will get even tightly connected and eventually blend those three elements together with the help of advanced technologies.
00:21:51
Speaker
So the distinction between structured data records content and the process flows will be more and more fuzzy, I would say. But it is our responsibility to make our solutions robust and handle this in a transparent and compliant way and supports the customers to be more and more efficient and to stay compliant along the way.
00:22:15
Speaker
Yeah, it's certainly an exciting two, three, four years coming up, a lot of change going on. And I think it's a nice reminder that although the big conversation and shiny object is AI automation and all the good things that it's going to bring.
00:22:31
Speaker
There's still compliance. And we used to use the term cost-effective compliance because you have to be. It's pretty binary. Are you compliant or not? Right? But how can you really do that smartly and spend more of your money on the innovation side versus if you have inefficient processes, data structures, some of the things that you pointed out?
00:22:50
Speaker
you're going to be carrying a higher burden of compliance costs, and then you don't have budgets to do the interesting things. And I must give you a hats off. Abraham Lincoln was one of our best presidents here in the States, and you had a quote from him about creating the future that was very...
00:23:05
Speaker
inspirational Renato so thank you for that so I think that's it for today love to have you back in 6 to 12 months do a check-in but with our audience they might want to get a hold of you what's the best way for them if it's website email LinkedIn what would you suggest Yeah, definitely. yeah Anyone interested is welcome to reach out. Go to ariesglobal.com and fill out the form to connect with our teams or reach out personally as well on LinkedIn.
00:23:35
Speaker
I'll be happy to respond. Yeah, for our listeners, you know how to get hold of us just on LinkedIn or similar to what Renato said on our contact form off the website. So thanks again, Renato. really great conversation. It was nice to really dive in, not only on a regulatory conversation, but this core connection.
00:23:54
Speaker
The processes and all the interactions that happen every day between regulatory and safety. It's really, really important kind of connection. So thank you so much. And yeah, let's have you back again in like six to 12 months.
00:24:08
Speaker
Thank you, Steve.