Innovation and the Future of Pharmacovigilance

Thomas Kuckuk

• Indy Ahluwalia • Season 3 • Episode 4

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What can we learn from a leader at the forefront of pharmacovigilance and risk management? Thomas Kuckuk, Head of System Operations Management at Novartis, offers an insightful journey through his career, weaving through medical informatics and into the heart of the pharmaceutical industry. This episode promises to illuminate the dynamics of safety technology and strategic program implementation, highlighting the critical differences between development and commercial settings that have shaped his professional path.

We delve into the world of AI, exploring its revolutionary role in safety technology and distinguishing between genuine AI applications and basic automation. The conversation sheds light on the pressing challenges of scaling AI solutions within large corporations and the fragmented software vendor landscape. Insights from the World Drug Safety Congress underscore the urgent need for innovation, steering away from the redundant reinvention of existing solutions, and pushing for a unified approach that truly adds business value.

Thomas and I also tackle the potential of industry-wide collaboration, especially in the context of cloud-based vendor landscapes. We discuss the impact of vendor lock-in on innovation and the promising avenues of adopting standardized data models to foster a competitive environment. By encouraging collaboration and balancing market forces, we aim to enhance patient safety and efficiency, unlocking new possibilities for both large and small players in the pharmaceutical world. Join us for a thought-provoking session that explores the potential of driving innovation through strategic industry partnerships.

Speaker 1

Welcome to another episode of Innovation and the Future of Pharmacovigilance, a podcast series brought to you by Trudient Talks. I'm your host, indy Aluwalia, and I'm delighted to navigate the dynamic world of pharmacovigilance and risk management with you. But first a quick disclaimer the opinions expressed in this episode are solely those of the individual guest and do not necessarily reflect the official views of Truliant Consulting or their own company. We're all about fostering insightful conversations here at Truliant Talks and we want you to know that any product, vendor or service mentioned does not imply an endorsement. If you're seeking professional advice for specific situations, we encourage you to go to our experts. Please remember this podcast content is meant for informational and educational purposes only. Now, with that out of the way, let's get to today's show. Today, I'm absolutely thrilled that we have Thomas Cook, who is Head of System Operations Management at Novartis, as our guest speaker.

Speaker 2

Thomas, welcome to the podcast.

Speaker 1

Welcome. Thanks, Andy, for your introduction. Much appreciated. Great to be here.

Speaker 2

Thanks so let's start with the obvious question how did you get into PV? Yes, so actually I studied medical informatics and got interested in the topics of databases in this kind of medical area during my studies and one obvious option for me was entering the pharma industry right after I finished my studies. My industry right after I finished my studies and started with a small startup, cro, at the time, and was working more in the space of clinical databases or electronic data capture early days and had only some exposure to safety at that time at Nesero.

Speaker 2

Did that for a couple of years and then was interested in joining one of the bigger corporations which were our customers at the time at. Nesero and when I then started at Novartis almost 20 years ago, my first role here at Novartis on the IT side was to support clinical and safety systems, so I was leading a small team. My first role at Novartis managed the operational support of clinical and safety systems from the.

Speaker 2

IT side Between the external vendors and the internal users, the external vendors and the internal users, and so already my first role at Navarra is there. In my first year's August, safety support was part of my team's responsibility. That's how it all started. In between, I then departed from safety and alsoorted from development, even in my school. But that's how it started.

Speaker 1

Now, much later in my career, last couple of years, I came back to safety. And what was the drivers to move away from safety? And then what was the drivers to come back to safety? There must have been something that did that boomerang effect towards you.

Speaker 2

Yes, so after I was leading this operational support team for a couple of years, I was asked to switch to more the implementation side of larger strategic programs and one of my tasks here at Novartis was to implement the clinical electronic data capture dictionary management system. So I was leading strategic programs. Tasks here at Novartis was to implement the clinical electronic data capture dictionary management system. So I was leading strategic programs and through that role of getting experience in leading strategic programs, I was then interested in switching business domains to learn more about other business domains in the pharma world, as I'd spent so far my first 10 years of my professional career in development. And that's when an opportunity opened up within Novartis to experience the commercial side of our business in marketing and sales and I found that a very interesting move for myself to really get a better understanding of the pharma business end-to-end.

Speaker 2

Now there's still other domains next to development and marketing and sales. But that gave me a good, nice exposure, focusing on the country sales operations for a couple of years and then started implementing also systems for the Salesforce at large scale. That was mainly what's.

Speaker 2

Viva CRM solutions, Salesforcecom based solutions, and that also introduced me to the world of cloud computing and this very different area of the business. So it was very interesting to me to see how different the mindset is in a development setting which has a longer time span for some of the initiatives and outcomes to arrive, compared to a sales business, for some of the initiatives and outcomes to arrive compared to a sales business which is very, you know, short-term driven, quarterly sales targets driven, and which then also implies an.

Speaker 2

IT and systems support that is much more targeted to immediate return investment. So that was a couple of years in commercial IT which I very much enjoyed, but as I knew development and was arriving at a point in my career thinking, you know what do I?

Speaker 1

like most.

Speaker 2

I was missing to some extent also the ability, to you know, develop a strategy, implement that strategy over a couple of years, including building relationships within a team, hire talent, develop talent. That in some years in commercial it was also more short term oriented. So I went through a phase where I couldn't really see endpoints of what had started quite often including the relationships and tele-development and such, and I was offered an opportunity to come back to the business side of development and safety.

Speaker 2

I reflected on that and I felt it's actually my preference that I get into an environment that allows me to work in a more steady way and develop strategies and talent, with some time to really allow me to take these steps into execution. After developing the strategy and that's actually in hindsight for the last four or five years in safety, where I'm now on the business side, acting as system owners in my team I felt that was what I expected and I really enjoyed it.

Speaker 1

So you were on the IT side of safety. Then you went off and did what I would say you went to the wild west of the sales and commercial organization and then you came back to safety. But on the business side, was there any big changes? Or was there a surprise that maybe things hadn't moved on? Or where were you when you came back, when you reassessed the landscape?

Speaker 2

yeah, so I mean over the years with the network I had here at novartis or outside novartis, I think it was still well known that things in safety don't move as fast as elsewhere and what happened with the Wanda landscape and the implementations here at Novartis.

Speaker 2

I think it was not a surprise to that extent that things had moved Actually when I was to that extent that things had moved Actually when I was talking to the managers at the time about this position, it was more a topic of interest for me that things hadn't moved and where I thought during my time at commercial I had experienced a number of things, including cloud computing, including some of the abilities to execute on some things more rapidly in today's technology landscape that I could offer in this space to help advance some things more quickly now, more quickly now.

Speaker 2

So I was seeing a fit between the need and the desire that I heard from the business team here and my experiences. I had development expertise from the past. I knew quite a bit about the business domain, but I also had experienced a system implementation side that was quite different from what I had experienced myself before development. So I felt it's actually a good match, a good match up for me to bring some of my experience back and there was quite some openness here on the business side to bring me into this position, to leverage what I had experienced through using commercial Did you find a difficulty when coming back into safety compared to other vendors in other areas of the industry, with maybe a difficulty in trying to push the boundaries with implementations?

Speaker 1

So, for instance, maybe the speed of implementation or maybe the quality of implementations, was it was there, is there such a significant difference between the commercial and the sort of safety side?

Speaker 2

I think there's a very significant difference at least I experience it like that and that's not a difference that is driven by one single reason. Right, I feel the mix of different reasons lead to an environment that has to be also very different than safety. We live in a very regulated highly regulated space where compliance is the number one concern. We had some of that in commercial, of course, as well.

Speaker 2

Everything in pharma is regulated, but it's not even close to be comparable in terms of how much we focus on inspection results, external compliance, but also internal compliance and safety.

Speaker 2

We're still managing a liability here in safety and that has to translate in a certain mindset and a culture to be able, as an organization, to fulfill that right on tasks like complying with regulations that sometimes sound very reasonable. Sometimes not so much if you talk about highly specific local regulations that deviate from what you would consider a common good, standard, things like that. So of course, then certain requirements drive, a certain culture will lead to certain individuals finding a home here. So I think it's a given that objectives that you might aspire to, like quick innovation or rapid change, is not necessarily immediately compatible. So I found a switch. On one hand, if you come from a fast-paced environment, a commercial IT, it's a bit difficult because you also would say I have a number of ideas I can immediately project in a future state, when I think about some things, so sometimes it's a bit difficult that you cannot progress on that.

Speaker 2

On the other hand, I also felt it's not that it is. There's no inner logic of that, if you know what I mean. It's like I can sense that the culture we we experience in safety is driven by the needs of this environment and you need to accept it Right.

Speaker 2

So if I if I can use an analogy you know we lived in the US. I moved to the US working for an award for six years, so I'm now based in Basel, switzerland, and then I moved to the US for six years, came back and it's a bit like also what I experienced there. When I moved to the US, there were so many things that I liked more about the culture there than where.

Speaker 2

I came from, but then also I missed some things that I didn't even realize how dear they were to my heart when I was living here in.

Speaker 2

Europe, and so you try to imagine the best of those would be fantastic. So, whatever, in the US people are very much approachable, open, everybody talks to you when you're in the airport. I remember when we had kids, everybody would approach us and you have a quick chat. Here in Europe much more difficult, right. And I thought, wow, that would be fantastic to have such an open, approachable culture here in Europe compared to the US, right. But then after some time, I was missing some of these really deep friendships that go really deep and where I felt in the US, some of these relationships just stayed at a certain level and everybody was okay with it.

Speaker 2

And there was no desire to go much deeper in some of these relationships.

Speaker 2

So then, the dream was let's combine both of these advantages. But you need to accept it that certain, you know, mindset and a certain expression of a culture is only possible in a certain system, right how it's presented to you. You cannot force everything and it's similar here. I fully understand that. I cannot force it and from that angle, I would not say it was difficult for me. I needed to constantly approach it and if I want to drive innovation in this space now, I need to understand the rules of the game here and therefore I would not say it's difficult. It's a challenge. You need to adopt it and you need to see how much can you push up these boundaries, which I definitely am inclined to do, because I experienced some other things that are possible. So, but it's fully understandable for me what the rules of the game are and why it is what it is in this setting.

Speaker 1

And do you think the last 18 months has changed your perspective? Because, quite frankly, with ChatGPT specifically, there's been this absolute, unbelievable shift in risk-taking and it's gone from zero risk-taking to, oh, let's risk everything almost. And within the industry there's a British expression saying it's Marmite you either love it or you hate it. And there is this big sort of cavern at the moment of people who love AI in PV, who are taking these risks, and then you've got maybe the more traditional approach of oh no, we hate AI because you are taking risks. How has the last 18 months been with this massive change?

Speaker 2

I think that's really interesting to reflect on. I'm not sure if anyone could predict where we're headed exactly, also with AI and safety. I see it has been checking up many, you know, restrictions or boundaries we put out before right in our mind, but that's affecting every aspect of our life almost, I feel, and every aspect of our business. So most probably what I'm thinking is it will shake up safety, for sure, but in relative terms, and how much AI will change other domains and other areas? Ai will change other domains and other areas. Again, safety will be much less rapid in adopting because we're risk averse, right, and we have to be risk averse. So it might feel radical even in the space of safety, but compared to other domains, we'll still not be taking much risk, right.

Evolving Dynamics in Safety Technology

Speaker 2

So, and that's also I think that's the right approach again for safety, you know, because there's probably more at stake. So we cannot play around that much and just go by trial and error. Our domain, that's not acceptable and we shouldn't do that. So probably in relative terms to the speed of change in safety, or domain, that's not acceptable and we shouldn't do that. So probably in relative terms to the speed of change in safety, it might help us to certainly be much faster in adopting new approaches and shaking up things that we saw as boundaries, but in absolute terms, I think we'll still be one of the domains that will be very slow to adopt and personally I must say we have been implementing AI in the area of safety for a number of years but have not faced deep conversations with regulators on it in the context of inspections despite us applying this on it in the context of inspections, despite us applying this.

Speaker 2

So time will also tell how some of these conversations will go. We have some clear guidelines from some of the authorities now where we could start building our clear governance around it and our controls, but time will tell how much impact it will really have. And yeah, it will be interesting to see. Do we find very targeted use of AI or safety that really gives us that significant improvement?

Speaker 2

in a very short period, because I still see that there's sometimes confusion between automation and AI. Correct that some application of AI is considered a fantastic use case, but literally it's just the usual automation, if you look under the hood, and which should be applied, but as a consequence, such application of AI or whatever, and being called AI is not going to change things dramatically. So we really need to invest our time to assess these use cases carefully and pick the ones that really allow us to make significant changes quickly.

Speaker 1

I think there's two other things off the back of this, which is one, with the increase, or, or, like I said, the last 18 months, specifically there's been a the the vendor market for software has been very volatile. Um, I mean, we've had the same sort of guys there, but let's be honest, it's been. It's been heavily volatile because of the new technologies. And secondly, I don't know if you feel this, but I feel this as a as a bit of an outsider, but the pressure that is put on to pv departments about adopting new technology without them really investigating where the use cases could be used better is really high at the moment. I don't know if you felt these two things Absolutely.

Speaker 2

I mean most companies and I was experienced that for the last couple of years. There's a strong push let's adopt these new technologies as quickly as we can, and probably as many companies went also. I feel we went through a period of trying to adopt this, doing member pilots and then realizing it's much more difficult to implement such solutions in a sustainable way to drive expected business outcomes in the long term. You know, running a pilot and looking at opportunities is one thing, but then implementing it at scale, especially for larger corporations, is a whole different challenge. Also, sustainable implementation and reusability of certain things that we implement have become much more important in the approaches we take and therefore, yes, there's a certain hype, if you want, in the industry or what you also hear in conferences and such.

Speaker 2

But I would argue when I look at the implementation yes, there's a push, but there is a careful consideration at this point what and how to implement it. So I don't see a hectic at this point like it was there probably some time ago, where it didn't matter much if it's sustainable, just get something out the door. We already in a phase now where it's a much more careful consideration what to implement and I think that's very healthy and it's probably a normal cycle how it has evolved. And nobody expected that very immediate hype around AI which, like, surprised everyone that it was taking off so rapidly.

Speaker 2

And now my perception is we're already in a phase in the professional application of these new opportunities where we're more considerate in what makes business sense.

Speaker 1

With regards to implementation in general, the change hasn't happened From the software vendors. There is an assumed model. This is how every company should work and there doesn't seem to be much alignment If you go to one vendor versus another. It's very much that they have interpreted the regulations or the way things should be done processes-wise, based on who they have worked with right.

Speaker 2

Yes, that is true and I think that's an interesting perception I had much more strongly when I came back here on the business side than assessing the vendor landscape. And as you rightly said, there's a strong movement in multiple smaller vendors or mid-sized vendors coming in to the safety space especially, but not only safety development as a whole.

Speaker 2

you can see that space especially, but not only safety development as a whole. You can see that that somehow, when corporations like us came to the conclusion, especially in safety, we don't need a really specific business process for us because we don't see this as a competitive advantage to differentiate us in this domain.

Speaker 2

We're happy to adopt industry standard off-the-shelf best practices. Someone must come to a conclusion if you look at the offering, that industry standard of the shelf best practices doesn't really exist. No, we have a regulatory standard which defines some outcomes or endpoints. How?

Speaker 2

do we get there, let's say, with our processes that are more internal. This seems not to be a desire to harmonize and standardize that and, as you said, I think the perception is, wherever there was a willingness to invest in a certain solution with a certain vendor, companies tried to make that option successful for them in their environment and of course the best they could do, almost, was like make it fit what they saw as the standard from their perspective. But that's always influenced by your way of doing things and the ecosystem that you need to respect like integrations.

Speaker 2

You have other standards you have around, be it technology standards or be it data standards, architectural standards, and so I feel it's a bit surprising to see that that has been going on over so many years. When you take a step back I just come from the World Drug Safety Congress in Amsterdam last week and you look at all these vendors in the space and all the capable people capable people, many conversations with individuals that have a great degree of experience, business technology side, regulations, business processes and all you need but then you look at the results, what this group of people which is in safety, not that big in the end right has achieved.

Speaker 2

It's not, you know, blowing me away if you look back right, because it seems to a certain extent that unfortunately, all those talented people have been asked to invest themselves again in reinventing the wheels and doing the same things over and over again. I mean another intake solution, another analytics tool, another tool to do a little bit of this and a little bit of that, which, in another marketplace, is fine because there's so much space for many vendors. When I again go back to my commercial world, a regular sales model allows you to serve many

Speaker 2

industries with some basic components of a sales system, a CRM system. It's not so different to sell product A, b or C right, but here safety is highly specific. So the marketplace is not big enough to allow dozens of solutions right to be developed and be driven with a lot of innovation constantly. So I see a pattern that in this ecosystem between the sponsors and the vendors, and then facilitators, consultants, we're still busy at least that's my perception from discussions with my peers, but also the vendors in repeating the same quite a bit other vendors in repeating the same quite a bit and after significant projects and a lot of investment and effort put into projects, you arrive at not so much incremental improvement over what you had before.

Speaker 2

You switch the solution, you switch the platform, you have a new technology applied, but if you look at the effort, you have to invest in a lot just to maintain the basics and the time invested in incremental innovation or advancement is minimal. So it must have to do for me also with the lack of some agreement on what good looks like. What is a standard business process? What could be standard data elements to use? You know what could be standard?

Speaker 2

you know interface architectures that we adhere to, interface architectures that we adhere to, and you know that could be driven by a number of factors, of course, which are obvious. If you can establish a kind of effective monopoly on something, the barrier of entry is high, or for a sponsor to switch solutions is a significant effort without an immediate return on investment, then the market evolves like this. It's understandable to me, right, and it makes good business sense for whoever is running a business in this space and therefore we need to. I would challenge and I do that in my conversations with peers now, but also with vendors to challenge do we want to be in this space? Is this what makes us happy at the end of the day?

Speaker 2

And I define happiness at a very personal level, so I mean when I leave the office. Every day makes us happy at the end of the day. And then I define happiness at the very personal level, so I mean when I leave the office every day, or when I summarize my yearly achievements at the end of the year and look back at what happened in my professional life. Can I really be proud of having managed again issue a solution and some basics another year? Is that what, what?

Speaker 2

inspires me what drives me, what really makes me proud of what I contributed with all my, you know, emotional energy that I bring to work every day?

Speaker 2

Or is it just something else to aspire to, to have, you know, even more fun and more inspiration from breaking up some of these boundaries and saying, actually, how about safety shining as a domain, saying you know, we broke out of some of these patterns and in the end, would you feel, feel if I'm speaking now as a member of a sponsor organization that is buying software, that is hiring consultants to help us, I would even argue all parties involved in this setup would benefit from more rapid change, from from a more open architecture, from a bigger drive to move on right Because even vendors would enjoy it that they have a more dynamic environment where innovation is rewarded and where they can see the results of these advancements as a positive success.

Speaker 2

And right now I feel the incentives are not necessarily lined up in that way. In this space for safety systems, especially where I'm dealing now, there's still enough reward for meeting the basics, that's fine. Keep the business afloat out of trouble, that's good enough. Quite often, unfortunately, the cost of change is high and the barrier of entries are significant, and so that's a question I ask myself really would we all together, in this ecosystem that we're living in, safety systems enjoy some more dynamic?

Driving Innovation Through Industry Collaboration

Speaker 1

involvement. I think what you said, though, is fascinating, and actually there are a couple of bits that I picked out specifically that I was thinking about. One was the enablement to be able to switch solutions based off some, you know, easy data migrations, for instance, data migration of one safety system to another. It's an absolute nightmare, and it's getting worse. You know, it's not just one type of database. It could be JSON files, it could be some other sort of file that's hidden somewhere and stores data, and then, secondly, there is this insular thing and I don't know if it's to do with the move to cloud which is, once you're in our cloud, it could be an AWS cloud, it could be a Microsoft cloud, it doesn't matter. Once you're in our cloud, we've got you, and moving away is difficult, and that's the way that these vendors are thinking right now. It's nothing is new, right? It's just another way of keeping you longer.

Speaker 2

And I mean you know that from a vendor perspective. I think it seems very obvious to me as long as you can keep your customers hostage to certain extent, you would do it. I mean that's rules of the game. I did my MBA later and you know well when I was in the US and you learned that in school you know how you can define the market and how best you can create a kind of monopoly like Scraven and lock a customer in, and that's a fair business model. We need to accept that. I think that's fair.

Speaker 2

But on the other hand we all know that is stopping the urge to innovate and to challenge yourself and if we mean what we say, especially in an area like patient safety, we want to do our best for the patients. You hear it in every patient centric, patient safety conversation and we all want to be there. I mean that standstill that we experienced in some way in this domain it's not acceptable.

Speaker 2

I mean that's not compatible with our desire to do the best we can for this ecosystem, for the patient. And if it's only like saving money in pharmaceuticals, that's also an important aspect right, and where we should consider it's not just acceptable that we say, okay, safety costs X, that's just a fixed cost, there's nothing you can do about it, you have to pay for it. If you want our drugs, you have to pay for it. I mean it's not fair, we should stay on our toes, but that is what the market gives us. I think, in general terms, when you want to have that market working well, on one hand, rewarding these investments by steady revenue for companies that invest, they need to have a revenue stream to allow them to make these investment decisions.

Speaker 2

That's fair. They need to be protected in some way. Decisions.

Speaker 1

That's fair.

Speaker 2

They need to be protected in some way. On the other hand, you want to have some competition, some challenge to drive the innovation.

Speaker 2

It's very classical, basic theories of the marketplace. So apply this to this space I would want to fight for, at this point where we are, we need to try to find a model that is allowing the market to be a bit moreiencies in a core system that I have with. You know the customization here, there, but that's not really a sustainable model and that's really also not changing the way these monolithic systems are being looked at. Right, because that's still right now what everybody that I talk to the way these monolithic systems are being looked at. Right, because that's still right now what everybody that I talk to at least would say yeah, in the end you still need that centerpiece, that database or whatever, right, and you can build stuff around it.

Speaker 2

I would start challenging that and say in today's technology world, the opportunities are there.

Speaker 2

If we would agree on a standard or standards for data, for architecture, for interfaces, for processes, then I can imagine a future that even in this specific safety world, we could create an environment that allows innovation to come in in smaller pieces and the switching cost is much lower. Now, I had that immediate experience on the Salesforcecom platform as I worked a couple of years right where a large corporation like us could switch the actual solution on a Salesforce platform in a very quick fashion with very minimal cost change, because the platform did define data and architectural standards. Now we will not arrive at such a platform model, I would say, for the whole industry safety, but the concepts could be applied If we come to an agreement on certain data model standards and architectural standards for interfaces and processes. More importantly then, I could imagine a world that if a couple of sponsors get together and say, yeah, we declare this is our standards, it could get started to be adopted more widely and the vendors then have a sense of security. If I adhere, to those standards.

Speaker 2

I have this customer base and that could be appealing for the larger vendors and the smaller vendors alike. And then the larger vendors who could be challenged by smaller vendors because you could more easily switch in a module.

Speaker 2

And these modules are not standalone solutions. That you know again, you would apply, like we do often today, but honestly, there's some interface but it's, you know again, customized to ecosystem. No, it would be stamped right and you could really say, okay, I can invest in this module in the long run if nothing better comes along. But it might keep the larger vendors on their toes to say I don't want to have these small vendors invading my space.

Speaker 2

So I'd rather invest a little bit to advance this module where a new vendor is coming up, and that's the very traditional way that innovation can be fostered through the market. But I feel it's a bit on us sponsors right now to also direct that to say you know what. We long for this standard. But you vendors don't have an inherent interest, obviously, to define that standard as long as your business models are working fine. But why should you? I fully understand that Regulators don't want to get involved in what we do internally. It has nothing to do with that.

Speaker 2

They say that's none of our business to think about how you do these things internally, so we're just measuring you by outcomes. So it can only be us, I feel, as sponsors in this marketplace, to help shape a different way of working. So that's where I felt, after some initial adjustment, being back into safety, where I just needed to get adjusted to okay, what is the operational need of the day? How do we keep the ship afloat? Now, as I feel I have experienced some of that for some years, I just wanted to get in touch with peers and I started having these conversations with my peers from different companies saying couldn't we think about such a future and who would be willing to invest into that?

Speaker 2

their time and experience to test out if we could achieve something through such things.

Speaker 1

And that would be a relatively lower cost than an implementation of a software that they have no idea what it's going to be in.

Speaker 2

Very much, because the picture I have in mind is this when we do our projects, even for smaller projects, we sit down, we draft our requirements. We have long-term success with vendors. It's not unusual that we have to educate our vendors on the details right, be it the business process, be it technical requirements, and so, in a sense, if I do that in the context of a project with one vendor, if I do that same thing first with my peers to agree on the standard and then hand over this common standard to the vendors, it's probably not so much more effort for us as sponsors If we just all agreed and say okay, instead of you continue developing your new requirements for your new intake tool that you want to deploy next year, why don't you invest your time in developing the intake standard process, intake standard definitions, as, to make one example, it could come at very little incremental cost to us as sponsors if we only agree to drive them. And you know we've been brainstorming that as I started discussing this under the umbrella of the Pistoia Alliance with peers.

Speaker 2

You know we had this idea already. That's like if we just start pooling what we have already all the requirements, documentation, process documentation we already have which, for instance in our company I already checked from the legal perspective, there is no constraint sharing that in a safe space which, for instance, the Pistoria Alliance would allow us to share because of the legal framework around it. This is not, you know, some confidential information we hold in our company. We can share such general requirements. We could open that up and most probably, if I talk about requirements in our space or costs in our space, more than 50 for sure.

Speaker 2

Probably even a relatively high number like 80 or 90 would be overlapping, and you can very quickly, very quickly come to an agreement when they arrive some standard, then yes, I understand there is some detailed conversation.

Speaker 2

We can get difficult because you work in your ecosystem, you have specific requirements and so on, and we would need to, you know, invest some time to find out where do we draw the line? What's what's part of the standard? It's not. But see that that's my current thought. If we, if we test that out, we should see very quickly how much of a standard we probably already have in a sense, but it's not been declared as that and has not been shared as that and therefore has not been used in our vendor interactions so far.

Speaker 1

Is there a big difference between a company, say, the size of Novartis GSKs Bayers of this world, compared to the size of Novartis GSKs Bayers of this world, compared to the majority of the companies who would benefit from this? So the more smaller mid-size maybe not even mid-size, let's talk smaller who may only have one or two compounds, how can they benefit from this in your view?

Speaker 2

Yeah, so I think there's a difference in such a high experience. I think we make our lives super difficult very quickly with endless conversations on thinking about all the specific scenarios that we've seen and that we experience.

Driving Innovation in Pharmacovigilance

Speaker 2

And it's probably true that we go through many inspections or many conversations with many different products and markets that we deal with. And therefore, yes, it's probably true that we would argue we have much more sophisticated requirements than a smaller company. But in the end, if you start challenging some of these requirements, probably we could have pushed back on a number of them in the past over the many years as they were established. Were they really critical? Were they really critical? Were they really important? I would go even so far, even in our conversation with the authorities. Right, if you get a finding doesn't necessarily mean you accept it. Without a proper discussion we have the opportunity to challenge these findings. I'll say is it really meaningful? Um, and is there another way to meet the expectations there than just implementing another special requirement for a special scenario? So I think actually looking at the needs of a mid or small-sized company compared to large corporations would be very healthy and helpful for us, also as a challenge. As larger corporations say, okay, what is really required on top of what a smaller company also needs? And there is some requirements, for sure.

Speaker 2

But I would challenge myself and therefore it would be nice in this conversation not to only have big corporations but also smaller companies, and in turn, if we could come to some agreement where even between large corporations and small companies we come to some agreement and say, okay, this is standard, and probably smaller companies say, okay, this and this and this part of the requirement is going a bit too far, but we can still agree to it, then I think it should enable smaller, midsize companies very much to adopt standard solution off the shelf much more easily than it's done today.

Speaker 2

That would be my hope, because the great issue I see all the time is that I might get a system off the shelf with some functionality pieces and lots of options to configure and then openness to customers. But if I ask a simple question, can you give me this standard process of the shelf and the corresponding standard configuration implementation that you kind of can do with the press of a button if I don't have any other needs expressed? I think you cannot get that At least that's what I'm hearing and every such implementation comes with quite some effort. Yes, I know there's companies out there that have developed some standard approaches, standard configurations and such, but when it comes to the process side it's quite difficult. So if we would, as an industry, start agreeing, on some of this.

Speaker 2

I could clearly see that every company, real estate aside, I could clearly see that every company real estate size could immediately benefit from that. Then, even for smaller companies, they might have reason to switch providers. There's many reasons why you need to switch a provider If it's only that that provider has some difficulties and stops their operations or whatever right, so you might have other pressures to switch a provider.

Speaker 2

Even there, then you would benefit as a smaller company. If there is a standard established in the marketplace that your switch income is very minimal, which in relative terms, can be a very significant cost for a smaller company, so I think there should be something in it for every size company.

Speaker 1

I see I think that's very refreshing. I think with these big industry sorts of alliances or you know sort of things that go forward, there is very much a skew towards the bigger organizations. But you're right, at the end of the day, if you can find a way that smaller organizations, who are actually going to get the benefit, um, of what you're doing, they're more likely to gain more benefit from what you guys are working on because for them it will be less. You know they've got more important work to do. They don't need to sit there worrying about if an intake system is truly going to hit all their requirements. They should, you're right, they should be able to know yes, it will. We just have to pick a provider, um, and I think that's fascinating.

Speaker 2

And also I don't see in our ecosystem that we're living on an island as large corporations. That's not at all true, especially on the safety. I mean we have hundreds of license partners as a big property that we interact with on a daily basis. We acquire products and licenses in a regular fashion or we divest.

Speaker 2

So all of these interactions we have with other companies of any size we have that as large corporations, as a company, should be facilitated in safety space through such a step, because you know data migrations, data exchange, any kind of interactions, even agreements, right that we sign. All of this should be easier to agree on and execute and less of an overhead cost if we want to execute these business decisions right so it should facilitate that.

Speaker 2

So, yeah, I I see a win for, for all parties, and in the end I could see that probably some bigger vendors might feel I don't want to say threatened, but they might ask a question like what would that mean? Would we lose our ability to monopolize some of this? And I mean it could be, but in the end I still feel that the vendor is good in this place. Actually, they have a much easier way to reach customers as well if they provide a good solution. I mean, if they have a good solution and they claim they have the best in the marketplace, there's nothing to fear. It's actually a positive for them as well, because the entry into a larger share of the market is easier if the standard is there. So a good solution will be rewarded, no matter what.

Speaker 2

And as we hear from everyone, they think they have the best solution. So if they really believe that, then they shouldn't fear. So I mean, yeah, it's easier said than done, probably for some of these vendors, because internally they don't know what deficiencies they're battling at any point in time.

Speaker 2

But you know what I mean. It's like if they really believe they're innovating and they're advancing, that's a plus for them and I would hope that the marketplace develops to be very diverse and I hope that we land with a number of very good vendors still, you know, in future. As it is today and as I said, I truly believe when I have these conversations, especially with vendors, they're very smart and talented individuals in these companies that often I feel, also on purpose work for smaller companies because that desire to move fast and innovate and do something quickly which they're given in that space for a smaller company only that what they're being asked to do is to reinvent the wheel really quickly and in new bright colors, in a new fashion, and they enjoy that. But it would be much more beneficial for everyone if they would be asked to crack the real innovative. You know um packs more on the edge I think, I think, I think you're.

Speaker 1

That is absolutely spot on, um, and now we have to come to our final question, a question that I ask in every podcast, which is uh, thomas, what's next for PV?

Speaker 2

That's a very open question. So my dream for PV is that we get much better at managing the liability, which is still the core focus that I see if I talk to my business colleagues here or peers in other companies.

Speaker 2

Let's try to get better at managing the basics and the liabilities in a much more efficient way that we free up our time at an individual level for our bright minds to focus on some real fun, innovative space, and I think it's our own decision if we want to do that or not, and so we all can decide individually. Do I want to improve the management of the basics, the liability aspect, to an extent that I can free up my own energy, my own time, my own focus, to spend more time on the future-looking stuff and if enough people do that in the PV space, which, at least from the conversations, I have a number of peers get that people want to do, that they're inspired by the opportunities provided by technology, but not only technology, but not only technology, but also especially technology, then there should be a real fun space to play in, and I'm really happy that I can be part of this community.

Speaker 2

I'm looking forward to great partnerships and relationships in this space and hopefully to some significant innovation happening in the coming years that we can all be proud of as a whole ecosystem of vendors, consultants, facilitators and sponsors.

Speaker 1

Thomas, thank you for this conversation. It's been fascinating.

Speaker 2

Thanks so much, Indy, for having me. It was a pleasure.