Richard Wolf

Ever wondered how a liberal arts major, MBA holder, and former infantry officer navigates the complex world of pharmacovigilance? Our special guest, Richard Wolff, Vice President of Client Relations at RxLogix, shares his unique journey and insights. Richard's diverse background and rich experience at Johnson & Johnson tackling global adverse event reporting reveal the meticulous precision and regulatory understanding required in the field. Listen as Richard reflects on how fresh perspectives can challenge established processes to enhance efficiency and maintain patient safety.

Transitioning into mid-sized companies, Richard discusses the strategic roadmap essential for growth in PV, drawing from his experiences at CSL. He delves into the intricacies of building capabilities, managing inspection observations, and implementing new safety systems while maintaining workforce stability. Hear about his exciting new role at RxLogix and the pressing challenges in the PV industry, including the impact of AI and the complexities of modern PV departments. Discover how regulatory inspections can serve as opportunities for organizational reset amidst increasing complexities.

Pharmacovigilance is not without its challenges, and Richard provides an in-depth look at cost pressures, regulatory changes, and the adoption of advanced technologies like AI and RPA. He explores the implications of these innovations on long-term costs and risks, highlighting the necessity of structural innovation to propel the field forward. Uncover the importance of balancing technology with human expertise to ensure patient safety, and how vendors, service providers, and pharma companies must organize effectively to meet rising expectations. Tune in for a riveting conversation on the evolving landscape of pharmacovigilance and the critical role of structural changes in its future.

Transcript

Indy 0:16

Welcome to another episode of Innovation and the Future of Pharmacovigilance, a podcast series brought to you by Truliant Talks. I'm your host, Indy Aluwalia, and I'm delighted to navigate the dynamic world of pharmacovigilance and risk management with you. But, as usual, 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 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. Well, can you believe it? We're at season three, season three of this podcast, and today I am so excited that we have Richard Wolff, who is vice president of client relations at RxLogix, as our guest speaker. Richard, thank you so much for being on this podcast.

Richard 1:33

Great to be here, andy Been, looking forward to my invite.

Indy 1:37

I know you have so Rich. I have to ask how did you get into PV rich I?

Richard 1:45

I have to ask how did you get into pv? This is the question that uh is is usually gonna gonna get people's attention, so we've all got a little bit of a different story, I guess. Um, I'll take you on a little ramble, it'll be not too long indeed. But uh, I'm liberal arts undergrad, mba, was an infantry officer for a little bit and, uh, we spent five years withenture working across a number of industries and, well, we had our third child and I was working at Johnson Johnson and this was enough for my wife to say time to get off the road. And so this is how I ended up joining Johnson Johnson doing process work, process improvement, project management kind of stuff.

Richard 2:22

I can still remember, you know, the challenges that were faced at that time would work across IT. We had some challenges with video conferencing across the enterprise after 9-11. And these were kind of problems that I would end up being asked to help resolve in different ways. And then they had a safety system they had to roll out and they had to engage safety officers around the world, and there were communication and change management challenges. So I said, well, I'll work on that problem. And then, you know, once that gets sorted out, then I'll move on and I found it really fascinating.

Richard 2:57

I'll be interested to hear a little bit about how you connected at first, but for me it was an extraordinary experience because it didn't seem that hard. Information comes in, it goes into a database, people look at it at a high level to see if the benefit risk profile of the product's changed, they report it out where it needs to go in different ways, and so it shouldn't take that long to solve this problem and move on to the next thing. And yet, you know, 22 years later, I think I'm still not bored. I'm still really enjoy working in this space. I will say, you know, the thing that really drew me in was super, super people, extraordinary focus on on patients, very smart people with best intentions. So it was really challenging to work in that space and I think really hard problems, really complicated problems, which is what I love about it, for a very good reason.

Indy 3:58

So you were doing all this sort of project work for J and j for a while and then obviously the opportunity to to go into pb comes about and, like you said, you thought it was a very simple in out database sorted sort of situation. But did you at the time think it was just another project and you would just move on?

Richard 4:29

It's a great question, I think.

Richard 4:32

So I'll use a specific example that some older folks could probably relate to that the challenge we were faced with was can we just simply train folks across Johnson Johnson on basic adverse event reporting, which by now everyone takes this course every time they join a pharma company? At that time, the question was how are you going to train 100,000 people around the world multinational company? And, by the way, what do you train them on? Because it can be fairly complicated and yet you have to put it in simple enough language so that you can train folks in manufacturing sites and they're not going to think that you're out of your mind, to be honest. And so again, fairly simple exercise, but when you try to roll it at a global level, it's challenging and the further you get into it, the more you realize that it's for a good reason. Right, it can be overdone, it can be overcomplicated, but at its essence it's really important stuff and we have to work to make it as simple as it can be without losing the really important scientific, detailed, medical understanding of the issues that are at stake, because patients are at stake.

Indy 5:43

And because you came out of because you weren't necessarily in safety your whole career, did you find the people that you were working with slightly different to the rest of the pharma? Well, j&j at the time.

Richard 6:00

Yeah, and I think I found people who were very detailed in their understanding of the regulations, detailed in the way of thinking and working. So precision is really important. Make no mistakes. Firm in terms of you know what has to be done, because there's no, there's no appetite for error here and passionate passionate about, about doing it as well as I can, to be honest, and I think some will come in, naive to safety, will ask the question why is it so complicated? Why do these folks make it so complicated? It doesn't have to be this complicated and I think that's healthy. Actually, I think that kind of perspective is useful in begging us to ask the question well, we put this process in place five years ago because of a particular issue we were facing, and now it's been replicated. It creates calcification across the processes and in some cases it's got to be continued and maintained, but in others, you know, the problem has been resolved at a more systemic level. So some of those antiquated processes I'll call them can be left to the side.

Indy 7:06

So how long were you at J&J in total? So?

Richard 7:10

12 years and the work there was really also again interesting and fascinating because I had a chance to work on a process for aggregate reporting, for example, which took me in that direction for a little while. Reporting rules, optimizing the reporting rules with countries around the world. It takes you out into the affiliates. It forces all kinds of questions like verification how do you establish a rule that's going to satisfy something in Brazil but that's yet not sustainable in the global infrastructure? So I had some time to work with physicians who were working across different therapeutic areas and taking different approaches, and how can you help harmonize a little bit where it makes sense and then eventually into an operations role, which I really enjoyed.

Richard 7:53

That transition into operations. But it's a different game. Any moment inspection, audit, observation, new business partner challenge, integrations, the different kinds of challenges, and in different workforces around the world too, which also made it quite interesting. The US sort of, you know, pulls on nurses who were later in their career. The UK. They had established nice programs where folks were coming out of school with with some education. As we went on, the Indian workforce was building up in a big way. Japan had very special requests, still has very special requirements, and so all these different challenges in an operations role made that quite appealing, and this is really where I've spent the majority, I think, of my career over the past 10, 12 years career over the past 10, 10, 12 years.

Indy 8:50

So I so you're in uh jnj. So for about 12 years and about about five years you were in pv. Is that right or closer to seven?

Richard 8:55

seven. Okay, yeah, and we're working, actually indeed working quite a bit across the interfaces too, which is another challenge that folks in pv will face. So connecting with, helping them understand why that interface is so important, eventually getting to the technical process of getting cases from studies across into the database, working with regulatory and getting label information just in time, working in quality to reconcile information on technical complaints and quality complaints, call centers who are negotiating for the time with the person on the other end of the phone and yet trying to get the most comprehensive safety information possible as an adverse event occurs. So that interface thing is also another big growth area for me personally and I think folks in PV will understand and that should resonate.

Indy 9:43

Yeah, that's a fair point. So you'd been there for, yeah, so 12 years about seven years in PV, and then you decide to move. What caused your decision then?

Richard 9:57

So I answered a phone call, probably for the first time in 12 years, and I heard of a company called CSL that I, frankly, never heard of before. But the head of safety, a guy named Reinhard Feserach, was described to me by my former boss at J&J as a wizard, a wonderful, wonderful leader in safety, and so it was a bit of happenstance. But when I heard his name and he was trying to build or take a safety organization to a new level, that challenge excited me and interested me, and so I decided to take a bit of a leap and join CSL and it was a wonderful experience, great, great 10 years.

Indy 10:39

And you did multiple roles at CSO. Is that correct?

Richard 10:44

I did different roles, so mid-sized company, you know it's a little less structured, less siloed, more hats to wear. I did mid-regions for a while, initially linking to the affiliates and safety officers around the world. Pretty quickly, after pulled case management, medical evaluation, we had the products there are fairly unique and require a special interface with manufacturing sites, so so there was a function there and then of course there's business process and and the financial management of the function and these kinds of things that all rolled up into operations and so, you know, had the opportunity, as the company was growing, to help build out capabilities in these respective areas.

Indy 11:30

Was there a specific role that you enjoyed more than anything else between all these areas in PV that you actually worked in?

Richard 11:42

I think that the area that was of greatest interest to me was and I was lucky to have management leaders who appreciated the idea that there's a lot to do, especially in a small going to mid-sized or mid-going to large pharma organization. You can't do it all at once. You really have to sort of lay out a strategic roadmap that's informed by inspections, that's informed by acquisitions as you're going. But you really have to sort of lay it out, commit to where you're headed and then build over time and bring the people along. To be honest, so I would say establishing, leading, building that roadmap, along with some great peers that I had in leadership teams who understood the challenges and operations but also had their own unique demands and expectations of operations. And so how do you roll out a new safety system, right, that impacts the workforce pretty directly. And then you have some significant inspection observations and how do you respond to those without reacting to those, as it were? So you know you've to those without reacting to those, as it were. So you know you've got to be able to solve that problem.

Richard 12:48

But I've lived in organizations where you shift this way and that and it's uh, it's frustrating, it's, it's exhausting for the workforce. It's uh. It doesn't build confidence that you know where you're headed. So having a strategic, you know intention of where you're going and then being nimble enough to take opportunities as they come and inspection gives us a chance to sort of reset focus and generate resource required to establish new roles where they have outsourced case management without terrifying the workforce, right. So, by putting people in roles that they can have oversight, without giving them certainty that the jobs were all going away. Talking about gradually turning down the number of people in the company through attrition as people go, you don't backfill but but doesn't mean people are being terminated per se, and that was the context at the time. Not every company has that opportunity. So I think it was the strategic pathway getting people on board, coming along together, building talent as we went through the process. Not sure if I answer your question so directly, indy, but that's really the way that I felt about it.

Indy 14:08

There's a couple of fascinating points that I'll probably come back to that you said in that, but I just want to maybe close the chapter on CSL and talk about well, first of all, congratulations and your new role at RXLogix. So how's that going? Thanks, indy.

Richard 14:25

Well, I'm three weeks in, but so far so good. I'm really excited about this new role. You know, having left CSL a little while ago gave me some time to think about, you know sort of where's the best way for me to contribute here in the next chapter. I've known Raj for 15 years, have watched the focus the company, has watched the products they've built out over the years. Give me a lot of confidence.

Richard 14:50

The space right now, the PV space, is, I think, at a really special moment. It's got, as usual, cost pressure, but I think it's extra special cost pressure. So if you step back from PV a little bit and just look at the mainstream media and talk about how people are not so happy with the paybacks on AI and the hype of AI, well, it's fairly acute inside the safety organizations and the expectations We'll talk about, I think, a little bit more, but that makes it, I think, an interesting time. And the relationship between the vendors and the pharma companies and the service providers is probably the most dynamic space I've seen it in, uh, in many years I absolutely agree with you.

Indy 15:33

I think I am previous previously. Uh, I'd always thought about my career that I missed out on the great 2012 E2B debacle, but it's surprising that I don't think a couple of years ago I would have a couple of years ago, even maybe a bit further I would have worried about, uh, thought about that. You know, there'll be so many vendors in this space, so many, um, innovative ideas coming out of nowhere. It's it's just been very, very surprising, but fascinating, especially for someone like me that likes likes to uh talk about these things. But I I wanted to go back to a couple of points that you said and and I think they link to a bit more of a conversation.

Indy 16:30

But the first one was you were talking about, um, you know, inspection findings being a being a reset for companies, um, and I find that interesting because at the moment I would say, um, some of these regulatory agencies are struggling, and I would even put out there to say that maybe regulatory inspections are not really giving the opportunity for companies to reset, for companies to reset, probably down to the fact that PV departments now are, you know, 10, 15 times more complicated than they were before. Before, it was like three departments. Now there's like 15 departments within a PV department. So how do you think companies currently and in the future because I'm guessing this isn't going to be a quick change by regulatory agencies how do you think that they can reset, as it were?

Navigating Cost Pressures and Regulations

Richard 17:45

It's an interesting question and I've spoken with a couple of folks recently about this. So one thing that I haven't looked hard at the data on but I think it feels about right is that if we think about 10 years ago, you had consistently 10, 20 percent increase in the number of events you're processing year over year and everybody was experiencing it because awareness, because of you know, capabilities, we think largely it's sort of flattened right with the. If you took covet out, um, the argument is and I'll be interested to see that data one of these days is is has it truly flattened? Because it kind of feels like it has. So then that challenge, if that challenge goes away, regulations, volume 9A, volume 9, volume 9A, gdp these were massive right, big shifts that you had to respond and react to Inspection observations. People were more naive, right, so there were more findings.

Richard 18:40

However, I think post-COVID we still haven't seen as many and heard of as many as we would have before, which can be down to they're still coming out of the COVID. They're resource constrained, they don't have maybe the inspectors trained as well as they used to have. You know, it can be a number of different reasons. Maybe companies have just gotten it so well that there's not a lot to find. I find that harder to believe, especially if we think about you know, some regulations as they continue to evolve here are going to make shifts.

Richard 19:14

The other observation was it seems sort of static, not that much changing. I'm also not convinced. I think the EUAI Act is well, it's a little bit tangential is one of the ones that people are going to have to take note of, I think, to the degree that they're using that stuff. The combination of products continues to be a topic of consideration for different companies and I think that we may anticipate some more inspection observations that are discussed more broadly across industry over the years ahead here. But it's a good point. It's a good point and I think your observation is correct. I have seen a couple just very recently, so it could be that that trend is going to start to turn.

Richard 19:59

Okay, but let me answer that other little bit, because you asked the question how do we reset if we don't have funding? The cost pressure, the cost pressure is extraordinary. The expectations for some form of dropping that line item, especially in operations over the coming years, you know, assume, assume flat volume. I should expect to see a decrease in cost because of advancing technologies, because of, you know, the outsourcing, and that's not new pressure. It's just that it's been pressed so hard that that should force some kind of reset. You're in a corner where you've got to do something fundamentally different in order to respond to that pressure.

Indy 20:39

And that's fascinating, because the other point that I wanted to go back on was you were talking about jobs going away due to attrition, and actually it conveniently sort of ties in with that. And obviously there's another piece as well is that you know companies are driving down costs immensely, are driving down costs immensely. Um, and there is a huge piece of the you know the c-suite basically saying you must implement technology, because the assumption is is that the technology will replace the jobs, and so in in a, in a, in a weird simplified equation similar to the whole. You know data in to a database, data out Surely that's going to reduce all cost pressures and you know jobs will be removed and, yeah, everything will be hunky-dory right.

Richard 21:39

Well, I mean, that's the idea, right? That's the C-suite pressure that we talk about. It's not going away. And this is the conundrum that you think about how can they do it? Well, I've discussed with the vendors and you know, in a vendor now you have to start to live this in a different way. But they can only use the advancing technologies and some of this more cutting edge stuff to the degree that their most conservative customer is prepared to allow them to. So it's going to be difficult to expect that they will be the ones driving that down.

Richard 22:15

Companies in some cases are building add-ons or building AI type capabilities on top of the databases to drive it down, but that's got a cost burden that comes with it. You and I have talked before about the idea of RPA, and that was an interesting idea a few years ago. But the maintenance costs, the implications of the change to an interfacing function, these are big costs, and so the question here is if companies are investing in that stuff internally, have they thought through the total cost of ownership long term, and is that the right answer to get where they need to go? The other part of it is can we just press the service providers, the, the companies that do the case processing other activities like that and force them to drive the innovation that the use of advancing technologies and drive the cost down seems to be a bit of a trend right now, but that's got implications too.

Richard 23:07

If you're driving your vendor in that direction, you take advantage of that. Your switching costs become higher if you decide to move in a different direction later. You still have significant oversight responsibilities with regards to the EUAI Act and things like that, so that you understand what's being done with your data. You understand what's being done with your data, and so in that whole system, there's a lot of complexity that I think will have to be worked through, and in the short run, I think you're probably right. I think that's the way it often happens. This is the number you're going to take your number of people. From this to that, we're going to see our short-term gains and then implications will have to be dealt with what's the total cost of that?

Indy 23:48

because if the c-suite and I don't mean this is in a monetary terms, but if the c-suite are saying, right, you need to reduce cost, you're not getting as many cases, um, let's be fair that there is different types of PV being done now. So you know risk benefit analysis, the signals, I mean risk management. There's plenty of newer stuff that isn't the basic entering data, but still you'll have the C-suite pressuring down for the cost, um, but still you'll have these c-suite pressuring down for the cost. Then you have, um, these more and more complicated regulations and on top of that you will then have maybe less people in the who who have that experience. Now, what's the total cost of that for a pv department? And uh, sorry, actually one bit that I did miss was going back to the inspection aspect. If you have inspectors who can't fully inspect to the detail that they were before again, because of complex system full of regulations, then what is the cost? Is the cost to the patient or to the patient safety, or is it something else?

Richard 25:12

I think it's a good question. I guess I would say the first thing is, you know, typically when you make a mistake in safety, it's only lag indicators, that sort of indicate. So when you make a fundamental mistake and you've gone too far this way or made a big shift in a system that's not quite going to satisfy the global expectations the way you thought they were, you don't feel that for two years, three years, and then when you do, it's quite difficult to reverse and to come out of that position. So I think that observation is a very good one. It's a lag indicator. It will be lag indicators that tell you it's gotten you far.

Richard 25:50

The other observation that I've talked to some of the other PD ops folks across industry about is where do future leaders come from? Where do innovators who are going to drive this stuff come from? We used to have a pretty significant number of folks in the US and Europe who understood and grew into those roles. Of those there's a very small percentage who really wanted leadership roles. Many of them liked what they did in their particular place in the safety function but didn't aspire for the politics and some of the financial aspects and people management and leadership and things like that. And so now that pool's smaller and I think that's going to be a more difficult, you know, situation to reverse, because the the resources don't exist, or they, they only they'll exist in lower numbers than they do today yeah, that that's a great point.

Indy 26:44

I've had similar discussions recently about, uh, junior pv staff, um, moving to more senior roles and how they just can't, because there's like a a weird rule that you must have x amount of experience, but then the pool of experience is getting smaller and smaller and smaller. And so how do you push them forward? But the point that I'm trying to get at now is based on what you were just saying. Actually, one of the things that we had talked about that I have spoken to people about, about um, uh, that I have spoken to people about was the fact that with the increased regulations, it's almost robotic like before.

Challenges in Pharmacovigilance Innovation

Indy 27:32

Maybe a few years ago definitely pre-covid. 10 years ago maybe you had innovators who were able to push back against regulators and regulations because they were like that yeah, this is, this is not right and this doesn't work. But now you're going to have a group of people and who are essentially just following regulations blindly, thinking that that's enough to get them through whatever inspection, through whatever, as long as we're following the rules. And I think PV has always been innovative and has always been well, we need to push back at this, we need to push back at that. But if you don't have the sort of experienced players that we used to have to be able to do that, then how is that going to happen in the future?

Richard 28:23

I think it'll be a little while until until you get to that point.

Richard 28:26

Indy, there was a there was a recent example of, I think it was, an E2B convention that was mandated by by um, and I don't remember the details of it, but it was mandated by one regulator, and the industry sort of went into uproar almost immediately, because if we were to comply with that, we would be breaching local country requirements in every country in Europe, and so there were enough people and enough momentum to bring that argument back, and the regulators sort of backed off the position.

Richard 29:00

So there's still a pool now, five years from now, there'll still be a pool. You know, as you look further down the line, I think then you're going to have to start to ask the question, because I don't think that this need for patient safety is going to go away. I don't think that the way in which it's regulated differently in different countries and regions around the world is going to go away. I don't think that the way in which it's regulated differently in different countries and regions around the world is going to go away, and so that piece of complexity is going to have to be managed by folks operating in a multinational environment.

Indy 29:32

And how about this need for innovation with AI? That again is coming top down.

Richard 29:44

Well, I don't think that pressure is going away. I just think that safety heads and heads of operations are going to have to respond to the question what are you doing to demonstrate that you're leveraging the advancing technologies to drive our costs down? How that will be done, I think, remains to be seen. Someone asked me to take a position on it the other day and I don't. I don't know. I know I know what the current trend is, what people are trying to do by pressuring the service providers to drive this stuff in. I'm not sure if that's going to hold up or not.

Richard 30:19

I know that the you know I've just joined one of the companies that I think has a viable position right in this space, and there's not a whole lot. I know there are a lot of folks advancing on that, but there are probably five that I can think of, and I spoke with one of the heads of one of the others just yesterday. The question is how many can the industry sustain? How many companies are going to take a risk on an unproven leader in this space? How long until someone takes a risk on an unproven candidate and realizes the implications of getting that wrong? These are big questions. I think Indy, and so I love the question, but I don't have the answer for it right now.

Indy 31:15

I mean, I don't think we're going to have an answer for a significantly long time. I suspect the next 18 months is going to be fascinating, especially in the software world. But there's another interesting trend of other service providers, vendors, who enter the cases and I think again you touched on that a little bit earlier where they say well, do you really care? If you give us the cases, we will reduce the case by X amount, we'll give you the lowest cost. Everything is going to go by the book. Is that all you need? I mean?

Richard 31:54

So I can reflect. This goes way back. I'll reflect back on earlier days, way back. I'll reflect back on earlier days.

Richard 32:05

I was in the process of understanding this complexity and how it worked and how we had to move through all the steps and what kind of qualifications people had. And I observed one physician sort of stand up and say I got two of these cases. They look like this, they don't seem right, it's something's not right here. And this was the beginning of the observation of a really important, fundamental, you know, safety issue. And then in the 10 years since you know that, probably five more time same kind of situation.

Richard 32:35

I recognize and I have this debate with colleagues in signal more and more you know they're able to detect and pick up these kinds of things through large data, through analytics, through complex modeling. But it there's still a degree of the individual physician who understands the product, understands the clinical setting, understands the patients who care so much about the patients, um, that, that, um, that. I think I'd hate to see that get lost because for me that the patients are the most important thing and I think most of the folks I work with in safety feel the same way yeah, that's a, that's a.

Indy 33:14

That's a fair point. You were talking earlier a little bit about the I'm paraphrasing here about the almost failure of AI, and I think we've talked previously about the ROI of AI. What are your thoughts on that? In the last five, six years, I think, two quite interesting ai alternatives that came about which didn't quite work, um, and then you've got companies now who are also trying to integrate ai, maybe slightly differently, um, but um, it's definitely changed in the last year, I would say, because of chat gpt right, that chat gpt changed the world, but um, I I wonder again and and again I'm linking to something else here as well that you've said um, which was about, you know, the, the marketplace in general. What is it going to take to get a PV department to embrace this technology and for regulators to be happy?

Challenges in Pharmacovigilance Implementation

Richard 34:31

I mean I would probably point to one that most people will be familiar with a huge number of cases coming in under extraordinary circumstances over the last couple of years where regulators and some from industry came together and acknowledged there's risk and acknowledged it's impossible to do this otherwise and we're going to move through that window. And they did. It's a burning platform, indy. I know it sounds like generic. It's a burning platform, Indy. I know it sounds like generic. It's back to early Accenture days, but there needs to be some fundamental burning platform in a company in order for someone to take. I think this kind of risk Burning platform could be that the CEO is just so passionate about it. It's got to happen. More likely, there's a large volume of cases. There's a problem financially that needs to drive something down and someone's going large volume of cases. There's a problem financially that needs to drive something down and someone's going to have to say there's a risk, don't think it's that great.

Richard 35:26

The regulators have definitely acknowledged. They're open to have conversations about what you're doing and I think, like with many things in safety, it's going to have to evolve gradually. Where someone takes a risk because they need to, or maybe they don't feel it's a risk but it's perceived as a risk, is successful. We talk amongst ourselves it's largely pre-competitive stuff, and then others sort of recognize the advantage, look at their own financials, their own ROI, and then come along Because I think you know, as I said, I think it's going to happen.

Richard 36:04

I agree with you. The ROI is where it has to go. I think there's a significant advantage to thinking about that in terms of total cost of ownership. One of the heads of operations I've spoke with recently talked about you know, can someone give me a TCO total cost of ownership IT as well as PV. That includes PV systems costs, service provider costs, all the infrastructure costs within the company and just give me a number and show me that it drops over a period of years? And if you can give me that and commit to it, I'm good. So I think it'll be interesting to see who and how many of those solutions come to the front. But I think we're going to see more and more of them.

Indy 36:48

And actually to talk about your total cost of operations, is there enough data within PV departments and operation leaders to be able to know what it currently is, to be able to benchmark it against potential future?

Richard 37:07

It's hard because in some companies the IT and the safety departments are tightly coupled, really well linked together. You have an IT organization with a really good understanding of the cost and the implications. You can have a PV department that really understands their costs at a very detailed level. It can be done, indy, but it takes an extraordinary amount of effort to develop those business case with confidence. But it certainly can be done. You can add caveats. You can add you know, degree of precision, confidence. You can find a way through it. The hard part is you know the rotating leadership and management. If you make that commitment, you're looking at multi-year commitment and often management objectives and things like that are on shorter time cycles. So what you've seen, I'm sure, is they start down a strategy that really is going to take three years to get there and you get a new leader and it shifts in a different direction and so you're back to square one.

Indy 38:10

Another fascinating point. That has made me thought of another point, which is implementation. Implementation, um, I think one of the clear reasons of failure in the last few years has been that implementation of this, the any technology in pv has been long, slow, achingly slow. Even companies that suggest that they are true SaaS companies I don't think there are many real, true SaaS companies in the PV world. There may be one or two, but not many. One of the biggest issues has been if you're going to change, it's going to be a multi-year change and, to your point, maybe the failures were actually down to the fact that there was regime changes, there were cost pressures. Covid suddenly turned up, but how do you think realistically, in the next let's say, 18 months, that vendors like yourselves will be able to get clients onto systems at a quicker speed so that they're able to take advantage of these technologies?

Richard 39:29

So I think here we have to separate a little bit. I think smaller firms I'm seeing at least examples of really really tight, extraordinarily short implementation windows Makes sense. They don't have the scale, they don't have the calcification I mentioned earlier. The bigger companies I mean, you know as well as I do the bigger companies have got multiple different entities that have been folded together, safety conventions that have come from 30 years ago that are still impacting the quality of data in the systems. So you know. Short answer yes. I think that smaller firms, less complex firms, firms that are willing to understand that there's an industry standard that is satisfactory to a certain, you know degree that should be possible in these shorter timeframes. Bigger companies is going to continue to be a challenge.

Indy 40:22

Okay, and do you think the likes of using project management styles or ways of working like Agile are things that maybe PV departments should be picking up on, or do you think it's purely down to the vendor to be able to implement much quicker?

Richard 40:48

Well, you know, my experience has been that there's a project management oversight that the company really needs to step up and take quite seriously and manage. There's an accountability within the vendor. There's an accountability within the vendor. There's an accountability within the integration partner, if you're using one, and you basically need someone who's going to hold all three entities to task, because it's not uncommon for individuals inside the pharma companies to be quite rigid in how they want to execute a certain process, and the reality is, in some cases, those are those legacy processes that were put in place because of a particular thing, and so you need some kind of project manager over the top of the whole thing. That's absolutely holding vendors accountable, but also holding integration partners and also holding internal staff to task, and I think if you do that, your chances of success for implementation are much greater than they would be otherwise.

Indy 41:47

I think that's a fair point. I think we've come towards the end of our conversation and, as we all know, on this podcast we have a question that we must ask. Our podcast is called Innovation and the Future of Pharmacovigilance. So the question is to you, mr Wolf what is the future of pharmacovigilance? What is next?

Structural Innovation in Pharmacovigilance

Richard 42:20

I think we've been talking about it for for a while here, and I think that what's what's next is is the, the systematic or the structural approach to how we're going to resolve this need to deliver on the promise of advancing technologies while keeping quality, while keeping patient safety first, while while not tolerating errors and move it forward. And I think that you know the innovation for me here there's lots of innovation happening at a technical level. There will be innovation in terms of developing new roles, you know, identification of people who can step into those and out of those roles, but I think the fundamental innovation is going to be the structural one, which is how are those three entities going to organize in order to help satisfy those expectations? And that I mean the vendors, the service providers and the pharma companies. And so, while some would say that's not really innovation, I think it is. I think it's structural innovation and I think that it's fundamentally necessary to carry pharmacovigilance forward to where it's expected to go to.

Indy 43:27

Richard, thank you very much for this conversation today and thank you for being my first guest on season three.

Richard 43:36

Delighted to be here. Indy, Thank you very much for having me on. I look forward to seeing you soon.