Fraser McCullum

Feeling intimidated by the thought of AI transforming the world of pharmacovigilance? Join us as we sit down with Fraser McCullum, founder of Imagine Pharmacovigilance Limited, who has spent over 20 years navigating the dynamic landscape of this industry. From his time as a bench scientist to establishing his own company, Fraser offers an insightful perspective on case processing to signal detection, and the future of risk management in pharmacovigilance. 

Our conversation also delves into the feared impact of AI on the conservative PV industry. Fraser clears the air on some widespread misconceptions and provides reassurances about the supposed threat of job loss due to AI. We also explore the increasing role of regulatory oversight in the age of Software as a Service (SaaS), and discuss how pharma companies must adapt to this new reality.

We wrap up with an in-depth discussion on the future of pharmaceutical safety – from nuanced differences in ingestion methods to the rise in stimulated reporting due to Covid-19. Fraser underscores the critical necessity for collaboration within PV, the pitfalls of generic solutions, and the delicate balance of prudent spending and innovative problem-solving. Don't miss this opportunity to tap into Fraser’s vast knowledge and insights - perfect for anyone involved or interested in the world of pharmacovigilance.

Transcript

Indy 0:15

Welcome to Innovation and the Future of Pharmac ovigilance, a podcast series brought to you by Truliant Talks. I'm your host, Indy Ahluwalia, and I'm delighted to navigate the dynamic world of pharma covigilance and risk management with you. But first a quick disclaimer the opinions expressed in this episode are solely those of the individual guests and do not necessarily reflect the official views of Truliant Consulting. 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. Today we are incredibly fortunate to have Fraser McCullum, the founder of Imagine Pharmac ovigilance Limited, as our speaker. Fraser, welcome, indi hi, how are you doing? I'm good, I'm good, thank you. Thank you for coming onto the podcast today.

Fraser 1:20

Thanks very much for the invite. This is something that I've been quite curious to do. I've never done this before. This will be fun.

Indy 1:27

Yeah, hopefully it will be. And actually what I want to ask you as I think it's a question that is always a good small talk question in PV gatherings which is how did you get into PV?

Fraser 1:42

I fell into it by accident. I desperately try not to think about how many years I've been in PV, because it's more than 20. Let's just put it like that it's more than half my life really. I was a bench scientist and I got really, really bored with it and I was pretty good at the kind of innovation, if you like, but the repetitive nature of it just really really bugged me. So I was trying to get out and apply to a CRO for a job as a medical writer of all things, and they rejected me three times, wow. And then I got a call and I still remember I got a call on a really horrible November morning in Glasgow saying we would like to offer you a job in drug safety and I had absolutely no idea what it was. I was so determined to get out of the lab. I just took the job and I've never looked back. It was like the planets had aligned and I've fallen into something I love and I've never looked back.

Indy 2:58

And you've had quite an interesting career through your drug safety experience, so why don't you go through that for our listeners?

Fraser 3:09

Yeah. So, like I said, I started off in a very small CRO that had just opened up an office in Glasgow. I'm obviously Scottish. Those kind of jobs were few and far between north of the border, so I was really lucky. It was myself and a colleague. Both of them were both still in PVE, as far as I'm aware. I haven't spoke to her in a long time and we essentially taught ourselves case processing. She was a nurse About six weeks more experience than I did, wow and we kind of made the episode went along. We were really lucky. We had a couple of patient clients who were quite willing to take us on and kind of teach us, and actually one of those clients ended up as a job, with a full-time job with her in my time in AstraZeneca. So Vicki Edwards quite kindly offered me a position and that was a lot of fun as well. So after about maybe three or four years in CRO went to AZ. They were looking to set up a case processing unit in their UK affiliate and obviously I haven't essentially done that in Glasgow because we were going to be built it from the ground up. I went and did that and I was there for another three and a half years.

Fraser 4:35

Having come from a kind of service provider background, I could see what felt like the writing on the wall from a case processing perspective, because there was a big move that's just as the industry was moving to outsourcing the case processing from traditionally open in house and I thought, well, maybe better go and do something else. So I ended up I went and did some signal detection, signal management at Galea for a while and that was a lot of fun. I learned so much from the other side as a consumer of the information that I used to provide. I think you learn an awful lot from that kind of having that different view of the world. And that's really where I started to think about how we can maybe do things differently. The whole background to that was in those days.

Fraser 5:31

Quite often things would come in in paper. You 'd literally get a letter, or maybe you'd get it in a fax machine, literally a fax machine. Now you don't really these days because everything comes in as an e-fax. But even if it is faxed it's still quite relatively infrequent. So all of this kind of information was coming in paper and you would sit and you type it in and then you'd analyze it obviously, and report it. And even then you would print it to C-OMS and you would send it in and we used to courier it into MHRA Every day. They would be courier, turn up, we'd give them the pile of paper and off we would go. E2b was still a bit of a dream it was just starting to come out, I think. But it was still a bit of a dream because the technology behind that really wasn't keeping up. I don't think, and we can talk about where that's taken us. I think maybe as we go along.

Fraser 6:34

After Gilead I went to Roche and I was there for a long time. I had a lot of fun in Roche. It was hard work, lots of things going wrong or problems that needed fixed. Maybe it was a bit better way to put it, but that's what I love doing is fixing problems and thinking about solutions to ways of doing stuff. So I was there for 14, 15 years and then I decided that it was time to go independent and I set up Imagine Pharmacovidionals and I've been doing this for about two or three years now.

Indy 7:14

And you're enjoying it still. You still love the.

Fraser 7:17

PV. I still love PV. I much prefer PV to actually doing any kind of business development. I'm a really terrible salesman. There's a reason why I do PV put it that way. But yeah, it's a lot of fun. I've had to look at the world and again in a different way, coming at it as a consultant and trying to help shape other people's thinking a little bit so that they can get the outcome that they're looking for. So it's a lot of fun. It's a lot of fun and I've met so many great people.

Indy 7:58

So you've. One of the things you were touching upon was, you know, you started off doing case processing and then you saw the writing on the wall with regards to case processing being outsourced. One of the things that I think about in my career is that I started off as a case processor. I don't have a science degree, so I came in with a law degree, started doing, you know, data entry, working my way through, and then there was obviously a ceiling. Once you don't have a science degree, there was kind of a ceiling that you couldn't really go much further.

Indy 8:39

With the rise of this new technology the AI, the and the fact that outsourcing is quite prevalent within our industry, specifically for the, the more basic jobs, I always thought that outsourcing was cyclical. You know, sometimes it would go off and then sometimes it will come back in and it would. To me it always seems cyclical, but I think the nail the nail is fully being hammered in right now, that it is kind of the death of the sort of basic data entry into PV, and that makes me think about what is the new way for people to step into PV. So a person like me, for instance, who had no idea about PV, and yourself. You know, we kind of have these stories around the world of people just suddenly being in PV.

Fraser 9:44

Yeah, yeah, I think probably a lot of people certainly my age that's the path is that they just kind of fall into it Because it wasn't really a discipline. And I still remember my medical director at the time saying you're coming in at the right time, because this will just grow and grow and grow. At the time, I think E2, ICH, e2a had just been ratified, so we're still being implemented and there was a whole pile of change and people were still working their way through it. So there has been a huge amount of change as we've gone through the 20-odd, pushing 30 years that I've been doing this the the way in. I think it. Probably there are still multiple ways into this, if you think about it. So case processing is still a legitimate way of doing it. It's a different path, I think, and I'll come back to that in a second.

Fraser 10:49

But you know, if you think about it, medical writing, which was where I thought my path would be there's a whole industry around writing periodic reports. These are really complex documents that require not just good writing skills, but you need to be able to understand and manage the various stakeholders that are involved in producing this thing. You know you get people from the medics. You've got the clinicians, a whole pile of people across the industry trying to pull together a story. That's what it is. It's trying to tell a story and that's still, I think, a legitimate way in to PV. You've then obviously got the kind of safety, surveillance side of things, big data, epidemiology.

Fraser 11:46

All of this is still there and again, I think it will change. It probably has changed. You know, I'm not an epidemiologist so I can't really comment, but I think it can and will change. But it's still a legitimate way in. It depends on what interests you. I mean, I think with hindsight I probably call myself a data junkie. That's what I like. I take great pride I still take great pride in seeing a good, well-documented report because you can gain insight from that. Maybe not as an individual report level, but you know, and an aggregate. If they're really well-documented, it makes life downstream an awful lot easier and I've seen that from my side of things. So, to come back to case processing, because that's my bread and butter, that's what I've always done, like I mentioned that. You know it used to be. It would come in on letters or on faxes.

AI's Impact on a PV's Department Evolution

Fraser 12:49

Emails just happened, but it wasn't great. You didn't have all of these really clever CRM systems that you have to trove through these days and you were essentially shuffling paper around. I still remember having banks of case files, case files which no longer exist, and I think, the way that I look at it I think you mentioned the AI and I think that's probably the hot topic. Really. You mentioned the AI. The way I look at it, it's not that it's taking people out of case processing or anywhere else in PV. It's changing the way that people do that, and I still think there's a role for people in that. It moves the process along, so it's no longer a data entry process, it's an exceptions-based decision-making process, and I think that if you think about it like that, it opens up a whole different way of thinking about it, but a different opportunity for people, and I think it's a lot of fun. I think it could be a lot of fun.

Fraser 14:07

There are huge implications and still some really meaty problems that still need to be ironed out. That's the reason why we don't really have an AI, a fully AI-based system yet. People claim that it is, but I don't think it really is and it's not through one, or trying. I think it's just a difficult thing to do. And just a word on AI, because this is a tangent we probably don't want to go down, but I think there's a huge misconception about what AI is Correct, and it's fed by media traditional media outlets talking about the end of the world which it may bring about.

Fraser 14:55

The end of the world. That's a different conversation. Let's not go there. You've also got all of these movies, from the Terminator to the Marvel movies, all of this kind of stuff which is basically saying that AI is bad Because it makes a good story. You need a bad guy and why not make it an AI system? And I think that warps people's perceptions about what it actually means. Let's not necessarily go down that route, but it's just a word of warning that it's not as simple as that. It doesn't have the ability to replace humans not yet and maybe not ever, and that's a really good point.

Indy 15:41

I think one of the things I was just thinking about was PV is notoriously skeptical about any new technology, whether it be simple, rules-based systems which could actually help them to make their processes a lot easier, or even the move from fax to eFax. When I started my career, I remember that there was a fax machine and we were getting seoms from our partner in Brazil, and I remember when we moved to eFax it was such a big deal. But I remember at the time thinking well, my phone can play clips on YouTube. Like, surely we should have moved to this before.

Fraser 16:36

And that's exactly why I moved into this kind of tried to move into this arena really is. I could not believe that I was still doing 20 years later, still doing essentially the same job as I had been when in my hand I had crazy tech I mean my phone is. You know, if you showed that to my grandparents, who are passed away, it would be like magic to them. Yeah, and you take it for granted. Yeah, and there are technologies out there that I think, if you adapted and adopted correctly, completely transform PV and move us away from this thing, this kind of view that you have to enter data into a database, that are ways that you can don't have to do that.

Fraser 17:24

You mentioned sort of simple robotic automation, and you know that's been around for years in PV, but the adoption of this, you know it takes a lot of effort because we are, as an industry, very conservative and reticent to take on this thing, because I think there's a level of fear which I think is is multifactorial, but because of the regulators. I think that's one factor. The regulators are people don't want to be seen to, you know, they don't want to get it wrong and adopting technology at the cutting edge in such a heavily regulated environment comes with risk, and I think it's for a lot of people that risk is not appropriate maybe, or they don't want to take it. I think that's something that we need to look at and to tackle. But then there's the thing about well, it's going to take my job. So, at a personal level, people are thinking about it's going to take my job, which it may do.

Fraser 18:37

But if you think about it differently is, if you adapt the way that you work, you can grow with the new technology as opposed to being replaced by it, and that's the kind of thought process that I went through. Yeah, I won't be necessarily be typing data into database anymore, but I will be interacting with the data and making decisions that an AI system can. So it's it's about working together and that brings up, that opens up a whole different conversation around technology and data science and all the rest of it, which you know I don't have the answers to all of it. I've got an opinion, yeah.

Indy 19:25

And actually thinking about that a little bit further. You're mentioning data science and has so in the past we're going to be kind in the past 20 years of your career, the whole shape of a PV department has completely changed Right Again, when I started off, we were doing case processing in house, so the case processing team was rather large. We'd have safety scientists, we'd have medics and that was kind of the main, the main crux of a PV department. But now we have you know you're talking about safety surveillance, data analysts, I mean it's it's, it's a changing face of an actual PV department.

Fraser 20:19

Yeah, I mean, I think when I, when I started my career, the volume of people, if you looked at the totality of a PV department, more than half of it was probably case process, because it was, it was brute force data entry. You're right, there was medics, but a lot of that was was reviewing cases as opposed to reviewing signals necessarily. The whole quantitative signal detection piece was really just still as I remember it being born. If you like, despite my youthful good looks, you'll always be young.

Indy 21:02

To me, for it it's a number and it has.

Fraser 21:09

It has moved and I think you know sometimes people notice the technology moving with it, sometimes they don't, and sometimes, actually, that has. The move has been come through the technology, or sometimes the technologies have to catch up with the changing requirements from the regulators, the process, whatever you want. However, you want to look at it and much more. Now I think you've got this tension, dichotomy, however you want to put it, between the kind of PV department, the IT department and then now it's starting to come into a more data science, data engineering question, as people are looking at these big data sets and trying to glean insight from from that, and it's everybody's, you know it's. I don't think it's, I don't think it's well managed. Personally not always any me I think too many people are thinking about it as they are their baby or they're this is my department without thinking about it at a much higher level and thinking about what's the outcome that we're trying to get here and is there a way that we can work together to make it better?

Indy 22:30

And that is the question what is the outcome?

Fraser 22:36

What is the outcome? It has to be at a patient level or a population level. You know the kind of end user, if you like, is is ultimately a patient and what. What the science of PV is trying to do is to protect them, to make sure that they have the right information to make the right decisions around the medications and the treatments that they're getting. Ultimately, that's what it is. Next, level down, you've got again.

Fraser 23:13

You've got this kind of tension between the regulators and the industry, because the regulators are there to make sure that they get that the industry is doing what it needs to do to to to have that outcome.

Fraser 23:27

That's why you have things like, you know, pv systems, the GVP modules in Europe or or or the equivalent elsewhere in the world, databases, information. It's all coming about to drive that, and that's where the inspections are coming from is to make sure that the that actually industry is compliant with all of the legislation that goes around. That you know it's arguably the most heavily regulated part of of daily life. Really, it feels like it's the most heavily regulated being in the middle of it. So it's. It's that's the outcome that we're trying to get to, and I think if you try and keep that in mind. It makes some of the decisions and some of the the the paths that you want to take become clearer, I think, as opposed to the traditional piece taking it from the beginning of the process, which is processing data and then working on. But it's better to start with what's the outcome and what I see where the two mean.

Indy 24:46

Yeah, I think that's a fair point. And you bring up regulatory agencies. Do you think hmm, try not to be too controversial here Do you think the facts that regulatory agencies are not so involved in industry? Do you think that they are actually in a bubble and don't understand the complexities of being in business in pharma provisions?

Fraser 25:21

And I'm going to sit on the fence a little bit. I think yes and no. I think there are certainly aspects of the day-to-day operation at an industrial level, that that the regulators don't understand.

Fraser 25:41

I remember sitting in front of a regulator I will name no names or no countries involved and I was talking about submission rules, which from a PV, from an industry perspective, it's common parlance. We all understand a set of rules configured in the database that enable submission, because when you send them out literally millions of submissions every year you can't do that manually because you would run out of people, so you use your rules to manage that for you. And this gentleman looked at me. He was like what do you mean submission rules? And he just had no concept of what that was. I mean, this was many years ago, so you know it may have changed now. This is I'm going back at least 10 years and that was. That was kind of a revelation. This is the guy, one of the people who sets the regulations didn't understand the impact of what they were doing. I think it's probably changed a little bit, but I think you can still see some of that. And there is this dichotomy between those that set the rules and those that that follow them, because it's it's difficult and when you multiply that by the, how many countries? 200, which is along around the world, each of them having slightly different requirements.

Fraser 27:13

Trying to make that work. Well, it's a nightmare, but be it keeps me in a job, so you know it's helpful. I think to some extent. I think, unfortunately, they can move towards Harmonization that I mentioned. I see to a that kind of move towards harmonization. You don't really see that coming around quite the same way, even talking to the e2b, they talk to me to be Even the individual files that get fired around the ether and they're all slightly different. Yeah, and the dates, it's what it's. Where's the balance? And I don't know that the industry and regulates Regulators, of course the balance right and trying to manage that stuff you can, and that's where technology could really help, I think.

Regulatory Oversight of Software Providers

Indy 28:06

So that's an interesting question. We were talking about how technology could help. We have Several companies in facts, I would say, in the recent couple of years has been multiple companies Suddenly coming out of world works thinking that they, they know and understand PB the best and they're able to Create a system that would ultimately be able to be the savior of PB. But there's this move to SAS Software as a service, which is very different to how traditionally we have Bought software. We, we as a PV group of Of people, have gone to vendors and said, well, we need a system to do this, build me a system to do this. It's not quite right. So we want you to make changes here, here and here, with the move to SAS and cloud-based systems, where essentially this, the vendor becomes the, the owner of what is designed in that software.

Indy 29:24

Is there a question that regulators need to be looking at software vendors? I realize this is very controversial Is there? Is there a need for regulators to start looking at software providers? Because you know you're You're a customer of these software vendors and they're saying this is the way that you should report to this particular place and If they cannot update the software in time to make any quick changes. Whose fault is it that that has not gone to the right place at the right time?

Fraser 29:59

That's a huge question. It's a huge question, I think. So, let me. Let me maybe replay a little bit Caps, a background, if you like. So I think the short answer is yes, there's a need.

Fraser 30:17

I think that there's a likelihood that it will happen and that the reason that I say that is when you look at regulatory inspections that used to be done solely on the pharma company like, more and more you see instances where the service providers that became the case process I feel like the service providers that the farmers industry are using are being inspected to make sure that they are are Doing the right thing just Probably the easiest way to describe it and that's happening either through the inspection of the client or directly with the service provider itself.

Fraser 31:02

I think you'll see that happening again, but this time it'll be with the tech providers as opposed to the service providers.

Fraser 31:10

So you will get inspection of the tech companies either through, I think, initially probably through the pharma company itself, and eventually I think it will come that they will actually inspect the tech providers and they're going to have to work that through because, you're right, they are providing a service to multiple clients and they're not always getting it right and the clients are left holding that particular baby, trying to work out how do we come become compliant. And so I think I think the short answers, I think it will come and indeed it is no already happening because a lot of the you know, I've been involved in negotiating a few contracts around this kind of SAS provider and I was very clear that we needed to get the provider on the hook to provide support, because it's their system that we are using and if we don't have the ability to Talk about in it the way that we would have done had it been in on you know, a homegrown or a non-prem solution and we need to get their support to do that.

Fraser 32:38

And there's a whole pile of service level agreements and disaster recovery and all of that kind of stuff that you need to then think about to make sure that you have that and that's an expectation of the regulator.

The Future of Pharmaceutical Safety

Fraser 32:50

So you either going to go direct to the service, the tech company provider, or through the pharma company to get that information, so it'll happen one way or another. It's an interesting question around their ability to flex to the regulations and I think you know without naming names I'm not going to cause any any, any problems I think there are some of the companies out there are not great at responding or understanding even the nuance that different health authorities have. You can't just have a blanket approach. You know everybody talks about, like, sending a to be file. Yeah well, that's fine, but who to an unquench profile? There's a whole pile of stuff in there that that I think gets lost when you think about an e to b file. There is no such thing as one e to b file really, and I think until you really get that understanding in the tech companies, you're not going to be able to have that kind of real end to end service.

Indy 34:02

Yeah, I think that's a fair point. I've obviously worked for a few tech companies and but my thought has always been the same, which is, I think a lot of providers, especially the newer providers, are looking at the PV problem in quotation marks as it's just a workflow you get information in, you transform the data and, yes, send it out, and I think that's the way that tech companies look at it. But there's there's nuances between for all of that.

Fraser 34:40

Yeah, yeah, I think you're right, and I think there are some of the newer players have looked at this and seen exactly what you described it's ingestion, it's processing, it's egress, essentially in process out and it's a workflow and it's at its simplest level.

Fraser 35:03

That's all it is. The problem is that it's never that simple, because you I tried to work this out once and I got to a number that was really, really horrible If you look at all of the different methods of ingestion. So you've spoken about it, you've got voice, you've got video. Now I had a couple of weeks ago I had a tech talk with an ideas event report on it. I didn't know, you know, we had to work out what enough to do with that. I'll come back to tech talk in a minute, because that's an interesting story, that's something we need to think about.

Fraser 35:42

And so you've got voice, you've got video, you've got paper, you've got email, you've got fax, you've got, you know, all sorts of things, ways that the information can come in, different people that can send it regulatory authorities, patients, healthcare providers, service providers, you know, at any point this can all fall apart and you've got to be able to manage all of that.

Fraser 36:07

Then, when you get it, you've got all of these different systems. So there's usually an email system, there's usually the database, there's usually other feeder systems that provide information, dictionary management, all of that kind of stuff. Any one of those things can fall apart. You've then got all of the people that are processing this so large company Roche, astrazeneca, novartis and yet there's hundreds of people, maybe thousands of people, I don't know processing all of this data. At any one point they can make a mistake. Then you get submission that was on the back end that try and manage this information, send it to the right authority or the right recipient, and if you multiply that all together you get a really horrible number about the number of places it can go wrong. The fact that we can get anything out the door is a miracle.

Fraser 36:58

It's only because the people that do it understand how that all fits together, and I think the more traditional tech companies are Argus.

Fraser 37:11

They've got the experience to at least understand that they might not be able to fix it and they might not be able to do anything about it.

Fraser 37:19

There's problems there as well, but the new guys haven't got that experience yet, even though they've maybe stolen some of the staff, if you like, from the traditional guys trying to put all that together, and there are multiple examples where they've just not been able to do it. I think it will come. It has to come because at some point we are going to run up servers, provided personnel, because the data volumes just keep going through the roof. So it will come, but it's just it's not there yet. I don't think, and I think, trying to look at it as that simple ingestion, processing, submission workflow is missing a lot of the new ones that we traditionally deal with manually and you can pick all of those little bits separately because each one has a separate solution from an automation perspective. I think, rambling now and maybe getting right into my stride, the one that's probably closest to being correct or, from a technology perspective, closest to being solved is probably the submissions piece on the back end, because that's it's rules based.

Fraser 38:33

You know the regulations say if there's, do that yeah, that's relatively simple to do as a rule, whereas getting to that point can be quite difficult because the information is junk a lot of the time.

Indy 38:50

And that's it. I think newer providers specifically, I think they look at it as oh, there's information here, but they don't. Because they don't understand the information, they don't realise it's junk. Talking about data volumes, covid did a lot to help PV. I guess it is with company run. That's true. But I was talking to another guest and they mentioned the fact that you know it was free publicity for adverse events reporting and I was like I never really thought of it like that, but absolutely you could go into a conversation with someone and say I work in drug safety and they immediately understood what I was talking about for once.

Fraser 39:38

Yeah, I had very similar experiences. I'm sure anybody in PV probably has, because it was everywhere you know and everybody was concerned about safety profiles and reporting adverse events. I reported an adverse event. Wow, it's very unusual for me to do that.

Fraser 39:57

Yeah, thankfully not that bad, but yeah you know, the number of people that sent reports in was just astronomical. Because it was and it was. We are taught to watch out for these kind of events, where it's essentially stimulated reporting. And this is probably the big example of stimulated reporting in a lower seat, because we treated billions of people as an industry in a very short space of time and it was everywhere, because that for two years, that's all we talked about was called yeah, it is staggering to me that the sudden switch around I mean COVID itself, the pandemic was.

Indy 40:50

You know there was a lot to say about that, but from a drug safety perspective it was oh wow, we're front page. I don't think I ever imagined PV to be front page and you know people having to the companies themselves, the pharmacies companies, the biotech companies rolling out PV personnel to explain PV to people, was quite incredible.

Fraser 41:21

Yeah, it was.

Fraser 41:22

I mean, as an interested bystander I was quite happy not to be in a vaccines company or a COVID vaccines company at the time.

Fraser 41:29

As an interested bystander, it was amazing to watch the way that it kind of played out and been able to help my friends and family understand what's actually being said, taking away all of the emotion and hype, if you like, around a lot of this.

Fraser 41:49

You know, when this was trying to explain why seeing some adverse events after several million doses have been sent out was not actually a surprising and not really a problem and basically being an advocate to go and get a vaccine, you know it was. You know, unofficially it felt great because I was able to put the, like you said, put the perspective in it. From a PV perspective, it was a fascinating time. I do think that had we been able to have the technology that I dream about available at the time, it might make life a lot easier for the poor people who are actually processing these millions upon millions of adverse event reports. You know I've been at the sharp end of stimulated reporting many years ago and it's tough. It's tough and that's the reason that I no longer read the Daily Mail or anything, and I've said about that.

Indy 43:02

So this podcast is called Innovation and the Future of Farm Covisions, so I want to ask you without AI, let's avoid AI for us. Where are we going to next? Where's the next thing? I mean, covid was an unexpected sort of big bang, but what has that taught us? And where do we now go from innovation and generally the future of farm covisions? One of the things that you'd said earlier was whose baby is it?

Fraser 43:39

with regards to PV in itself, yeah, I mean it's an interesting one. I don't think you can avoid the AI topic. To be perfectly honest, I think it's one of these things that it's there. It may be still a little bit of hype, but it is coming. I think it's unavoidable. Whose baby is it? From a company perspective, I think it's the company's baby, unfortunately, I think, because you've got these three groups of individuals or groups within the organization that are maybe not as connected as they could be. Everybody's got their own opinion on it.

Fraser 44:29

I come from a PV department. I am biased. I'm just going to say that right out there. We understand the data, we understand the process and the regulation much more than anybody else, but we cannot do it in isolation because we don't have the skill set. Like I said, I'm a PhDs in molecular pharmacology. I'm a biochemist at heart. Really, I work with a whole pile of people nurses, doctors, other scientists.

Fraser 45:05

It's a very science-based, life science-based discipline. Yes, we do understand data and there's examples, loads of examples out there of people who cross over between that kind of life science, medical science, into data science. There are a few people I'm sure you do as well, indeed that can make that link, but they're few and far between and there are other people perhaps who come into PV via the tech piece, but they are relatively few and far between that actually been able to bridge that gap, because it's a different discipline. It's technology, it's not life science, and I think everybody has their own view of how things need to work and I think the only way that you can do it is if you do it as a team. And I have seen plenty of examples where that's kind of worked well and examples where it's not worked so well and it's kind of failed a little bit, where, because the technology people see it as well, it's a technology problem and to an extent that is because they're the ones that manage the boxes that the servers sit on. They were the ones that manage. Coming back to the SaaS piece, they're the one that manage the SaaS service provider. But at the end of the day, even when you, even without AI, that technology is doing PV work and the only people that really understand it are the PV people.

Fraser 46:42

So trying to do it in isolation is a disaster and not listening to what PV needs and trying to force, and again, there are examples in my experience where companies have been forced to take a solution, one solution over another, and it doesn't actually meet the requirements that PV have got. And I'm not talking necessarily about big projects or big solutions. It's about trying to do what's cheapest and therefore you have to plug the gap with people and process. And what looks like cheap isn't actually cheap because you're just moving the cost from one department to another and I think only by looking at it as a holistic problem do you actually get the biggest bang for your buck. I had an old boss and if you're listening, thank you. I'm going to steal a quote from you from many years ago and it's lived with me forever and it was essentially a presentation that he did and it was an equation on it and it was new system plus old process equals very expensive old process, and I think that for me it's kind of shapes.

Fraser 48:04

The whole argument is you have to do it together, you have to look at the whole thing, otherwise you're just going to blow money that you don't necessarily need and at the end of the day we're a cost.

Fraser 48:15

We don't sell medicines, really, you could argue. Maybe we do, but at a discipline level we don't bring in revenue necessarily. That's other people's job, that's people who sell the product. So you know we have to be we do have to be careful about the amount of money that we spend and being wise about it. That doesn't necessarily mean that being cheap about it is the right thing to do either. You know there are systems out there which are relatively cheap, but the amount of effort to make the work is astronomical. And you can only get so far by outsourcing, which is where the AI thing comes in. For me, I think it's expensive technology, but it's just outsourcing in a different way and therefore you can get, if you look at the holistic piece, you can get more bang for your buck if you look at it in that way of thinking, if you like. So it doesn't become. It becomes much more team based outcome rather than an individual department coming at it.

Indy 49:31

So I don't make any sense.

Fraser 49:34

that sounded like a rant, fraser, you never rant. You don't know me well enough then.

Indy 49:44

Fraser, thank you very much for joining me today. It's been absolutely fantastic having you here. I've really enjoyed our talk and I hope to speak to you again soon.

Fraser 49:59

Likewise, Andy, it's been a pleasure. Thank you very much for allowing me to rant.

Indy 50:06

Maybe we should start your own podcast, angrypv, or something GrumpyV yeah, grumpyv excellent. Well, thank you very much.