Sue Rees

Imagine stepping into the world of pharmacovigilance with Sue Rees, founder of Sue Rees Consultancy, who has graced the industry for over three decades. As we stroll down memory lane, we relive Sue's fascinating progression from her rookie days at Smith, Kline & French's adverse events department to her critical QPPV roles across the continents. We unravel the compelling narrative of how Brexit prompted Sue's entrepreneurial journey and her contributions to the education sector.

Together with Sue, we traverse through the contrasting paths taken by the FDA and the EMA, and delve into the divergent experiences of countries at varying stages of their PV journey. We also contemplate the ripple effects of the UK's EMA exit on its international reputation. 

Tune in as we contemplate the future of safety in organizations and the potential role of AI in diminishing manual case processing. We investigate the heightened emphasis on safety brought forth by the COVID-19 pandemic and explore effective delegation of responsibility within organizations. Let's tap into Sue's wisdom on the emerging trends of data gathering and legislation, and how the evolving regulations are reshaping career roles. As we peer into the future, we'll consider how technology could revolutionize data gathering, allowing us to concentrate on the clinical and scientific aspects of legislation.

Transcript

Speaker 1 0:16

Welcome to today's episode of Innovation and the Future of Farm Covisions, a podcast series brought to you by Trudion Talks. I'm your host, Indy Arlawalia, and I'm delighted to navigate the dynamic world of farm covisions 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 Trudion Consulting. We're all about fostering insightful conversations here at Trudion 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 that's out of the way. Let's get back to the show. Today we are incredibly fortunate to have the founder of Suri's Consultancy as your guest speaker, so get ready to be inspired, informed and engaged in what will be a fascinating conversation. So welcome, Sue Hi, how are you?

Speaker 2 1:27

I'm very good, thank you.

Speaker 1 1:31

And thank you for coming onto my podcast. I know I've been talking about this for a long time and it's finally here and I'm so happy that you're here.

Speaker 2 1:41

No, it's great. I'm really looking forward to the conversation. I'm interested to see where it goes.

Speaker 1 1:47

Exactly, and just a little personal note. Sue was my second manager in professional environment and I just wanted to say thank you yourself and Sharon Adams, who first brought me into PV, who knew 15 years later I'm still in PV. This is absolutely crazy. So I just wanted to say a quick personal thank you.

Speaker 2 2:13

You're very welcome. It's great as a leader to see people that you work with in the early days of their career kind of see them go on and flourish and do greater things, so I'm always really excited when I see that happening. And there were a number of your compatriots as well who've gone on to do great things, and I'm sure you'll probably have some of them here on your podcast as well.

Speaker 1 2:33

I'm hoping. I'm hoping so, Sue, for those who are uninitiated into the Sue Reese world why don't you give me a brief summary of your career? And actually, more importantly, and a question that I think I'd like to ask anyway, is how did you get into PV?

Speaker 2 2:53

Yeah, yeah, it's a really interesting question and I'll try not to go on too long about this because I have been kicking around for a very long time. I think my official bio says over 30 years. I sort of had a science background, did a science degree, went to the lab, hated it. So I was looking for a new job and I was in those days. We're talking a long time ago. You looked in the back of the new scientist magazine for a job and they were adverts in their jobs and I saw this one that was to work in the adverse events department and it turned out it was written by a guy called Dave Lewis. Many people are who listen to Dave Lewis and if you know Dave, you will know that he has a way with words. And so this job advert sounded amazing. It was about educating prescribers and working on really important safety issues and I thought that sounds really interesting. So I applied for the job to go and work at Smith Klein in French, as it was in those days as a safety scientist and I got the job and that was the start of a very long and fruitful career in safety. So it started off. My job was to. It was part sort of information. We were part of the medical information team. So you'd pick up the phone, somebody would ask a question about the product, reporting the adverse event. You would take the details, you would provide them information and then you would work with a group of staff who did the actual sort of coding and check the cases were correct and provide the information. And that was the start of it.

Speaker 2 4:36

And I stayed in the Smith Klein organisation for 17 years, started off at affiliate level and then I went to work in the in the verbal team and I headed up a post marketing group. And then they reorganised post merger and I headed up a therapy area group there, so got to work across postmarketing. I always say I'm a post marketing girl at heart. That's where I started. But then ended up working on clinical trial development products, seeing much more of the safety evaluation from that side, and then after many years there moved on different organisation back to an affiliate level group and then into a European role, my first QP role, which is obviously when I worked with you at ASI and that was fascinating, not just taking on a QP role but also managing affiliates across Europe and other regions, the dynamics with a Japanese company as opposed to a British company, and then kind of my last role in industry was at Amgen.

Speaker 2 5:47

Where else? Qp again, again different organisation, different, dynamic US company, didn't really know much about Europe, spent a lot of time banging the Europe drum and saw the company go from having I don't know six or seven products 15 products over the space of a few years very innovative working with an amazing team, and was very happy in the QP role. I loved the QP role. I loved what it gave. I loved the fact that I could legitimately have a finger in every pie. I loved that variety. And then Brexit and that was the end of my corporate career because I was very established in the UK. I wasn't going to leave the UK. Amgen just set up really didn't really have other senior roles based in the UK and so I kind of went okay, maybe it's time to retire and I kind of thought that's what I was doing. And I did for about three months. And then somebody approached me about a project and then another one and before I know it I set up my consultancy and I haven't stopped working since.

Speaker 1 7:07

That's fantastic. It's amazing how you felt that that was it. It was the end of your corporate career and suddenly, oh, I'm still at the bottom still, and I believe you're also doing some work in education as well.

Speaker 2 7:25

Yeah, yeah, so I happen to live very close to the University of Hertfordshire and people may know the University of Hertfordshire in the early 90s was very innovative and set up a post-marketing degree in farm covigilance back to the infamous Declan Lewis. That was his kind of setup and I'd always been involved with that. I'd been a guest lecturer on and off for it and so, because I had time on my hands, I kind of just contacted them and went anything I can do for you and they kind of bit my hand off and brought me in, initially as a visiting lecturer and now I'm actually a member of staff. They're a senior lecturer. I run two modules on that post marketing degree. I also run a module for the EU2P, which is like a consortium of European universities that run an online master's course in pharmacoviduance. So, yeah, so I'm now a senior lecturer.

Speaker 2 8:24

I did a qualification in higher education teaching and learning, so I'm a qualified lecturer. So, yeah, it's a really interesting kind of element. I always feel it feels a bit like giving back. So, although it is an employment, it's working with people early in their career. Quite often it's a great way of staying in contact with a lot of people because we bring in numerous guest lecturers and yeah, and obviously I sit and listen to those lectures too and get to hear kind of latest thinking. So it's just a really interesting element that I didn't necessarily think I was gonna be involved in, but actually I'm really enjoying.

Speaker 1 9:08

It's absolutely fascinating. And actually I was just thinking back to your career. You've obviously worked, you've pretty much worked, with the three major components of the world Europe, the US and Japan. You were talking about the differences between those companies. I'm guessing you mean culturally. Yeah, yeah.

Speaker 2 9:34

Yeah, culturally, but also they're understat, yeah, they're kind of the focus of Europe and European legislation. Because I think it's very easy when you work in Europe or in the UK, which was part of Europe at the time is you kind of think that's the only thing you have to take into account. And it's very easy, particularly in a role like a QPPV role, where you feel what you want, what you say, has to happen. And it's actually really interesting to have those conversations where you kind of go but the FDA wants this, or but in Japan this individual also has accountability and you have to kind of go oh yeah, actually there is a broader horizon and PV impacts everybody, all of our patients, globally, and we can't. It just helps lift your horizons, I think.

Speaker 1 10:31

And actually there's a part of me that I want to get onto Brexit in the QPP role, but actually there's a part of me that's been thinking about this a lot recently, which is the fact that there have been a lot of talk about the convergence of regulations throughout the world, but actually has it actually become divergent? Has it basically become more localized than before?

Speaker 2 11:00

Yeah, it's a really interesting point. I remember a few years, quite a few years ago now, I did a DIA meeting and we were talking about this globalization and I did a talk and I kind of was talking about right size of farm covigilants, because there is a desire there seems to be so much in style, I say for regulations to converge and to be the same, and from a farmer industry point of view, from a global farmer industry point of view, of course that's what we want. We want to do something once and we want to then give it to everybody. We don't want to have to keep doing the same thing, but in a different format or different time frames or whatever. But actually, from a country-specific point of view, you don't necessarily want to be overlaying the complexities of something like the European Farm Covigilant System on a country that is only just starting its PV journey. If the country is just putting in its first legislation about reporting adverse events, it couldn't cope with the complexities of an FDA or an EU system. And so I think we do have to acknowledge that it's right-size farm covigilants and that, yes, there is an element that says if, mr Regulator, you are putting in your first legislation about farm covigilants please consider seven-day and 15-day reporting. That would make everybody's life so much easier. But don't expect them to take the entire GVPs and apply them straight away, and I think we have to kind of acknowledge that.

Speaker 2 12:46

So I do think there is that element which is it's not necessarily divergent but it's different. But then there is the other element, and the classic example, you see, of this, or the one we talk about a lot, is the FDA's attitude towards clinical trial reporting. Where they've gone, don't send us everything, just send us the really important stuff, and you have to kind of applaud that and go. That makes so much more sense. It would be really good if everybody followed that. So I think there is a divergence, but I think in a way it's good to divergence, because I think it's twofold.

Speaker 2 13:31

It's one it's acknowledging that there are baby steps at the beginning, and the second is it does take somebody brave to go off down a slightly different route and what you have to hope is that eventually everybody will realise that and follow them. We just did that bit in the middle where it's kind of like, well, they're going that way and they're going that way, and actually I have to serve both of those and that's making my life difficult. But I wouldn't want to stop that kind of bravery of the regulators. You know, and I know you're talking about Brexit and I think to a certain extent my hope is that the MHRA do that, that they then go.

Speaker 2 14:10

You know what? We now have the opportunity to kind of speak up, what we truly believe in, and if we are brave and go in this direction, maybe other people will follow. You know it's difficult to tell, because if you are the lone voice, you know you do either end up in that scenario where everybody follows or you just are a lone voice and you end up having to kind of become irrelevant. So it does take that bravery. I don't think the MHRA are there yet, but you know, I know when I spoke to some members of the MHRA kind of pre-Brexit, they were sort of saying that's what they aspired to, but I'm not sure we're there yet.

Speaker 1 14:54

And actually the MHRA and Brexit is again a very interesting piece to talk about because obviously with Brexit, the role of the QP within the UK had obviously disappeared. But I guess the thing that I and many other people thought of was that the MHRA's voice within the EMA was always very loud and it was always very powerful. Obviously they have now stepped to their no longer part of the EMA because of Brexit. Has this changed the way that the EMA and the MHRA have perceived internationally?

Speaker 2 15:39

I mean that's a really interesting point and I don't know that it has. I mean, I think the EMA obviously is still, you know, the representation of Europe. It's still a very, very loud voice and I think the fact that the, like you say, the UK element, the MHRA element, was so strong, I think has shaped the way is in the formative years you know, june rain was head of the Prague in its formative years and I think it, you know it has shaped the way for the way it's going to go. So I think the fact that the UK is no longer part of that I don't think has impacted the perception or the kind of the broad shape of the EMA and the way it operates, in farm covigilance at least. I can't talk for other parts of it, but in farm covigilance I think what's interesting is the MHRA standing, because I think certainly with the sort of clients that I work with, the number of the kind of small West Coast clients, they are still very much keen to understand the MHRA's thinking. I think they are. You know, a number of companies I work with are applying for EU and UK licenses, so they very much want to know what's the MHRA thinking, what's the you know inspection processes. We know the MHRA inspectorate is the inspectorate in the world. Still, you know, and so I think the MHRA still very much has that view in not a few, that kind of perception I don't know from organisations. They want to satisfy the MHRA, they want to satisfy the EMA. So I think that's you know. Neither of them have lost out and are still very important as far as organisations are concerned. I think you know what will be interesting, I suppose, is time. Will the MHRA start to diverge? Will the MHRA start to be seen as irrelevant lone wolf or will it be seen as an innovator and leading the way? Will EMA start to change?

Speaker 2 17:52

Somebody said to me the other day I had an interesting conversation with somebody. We were talking about patient information leaflets and MHRA had always been a pioneer for patient-friendly language, ensuring that patient information leaflets were usable, were readable. They'd started doing some pilot work on including broader information in the patient information leaflets et cetera, sort of pre-Europe, as it were. And so this individual we were talking to them and sort of saying did we think? I make sure we're gonna go back to that route?

Speaker 2 18:31

But also he sort of said, now that the EMA has lost the MHRA's pragmatism. They was concerned that the EMA would kind of almost go more severe, more closed-mind if that's not the right word but maybe more rule-following. If we think of some of our European colleagues in some countries they have a very they're in a super-strawl sort of we must follow the rules and I think there was a concern that the MHRA's voice once it's gone from that, that maybe that becomes the dominating way forward. Which I hadn't really thought about and I thought was a really interesting sort of comment was that whole that the MHRA and the UK staff are going to be filled by perhaps the more sort of hard-line elements.

Speaker 1 19:30

That's interesting, and a couple of conversations I've had about the MHRA recently have been things like how are they able to, with our government, the UK government, and the funding that they have compared to what they had when we were in Europe, and how are they able to be able to commit to all these inspections, to be able to be innovative? Or is the fact that because their budget is so decreased that actually they have to be innovative simply to survive?

Speaker 2 20:11

Yeah, I think that's exactly it. I think what drives you to be innovative? I think if you talk to the great innovators, I think that kind of something has to happen, something has to drive you to be innovative. If everything is comfortable and everything's staying the same, there is no impetus to change. And so the fact that they have been through such a big change and, let's say, a potentially resource-constrained, has kind of forces the innovation.

Speaker 2 20:48

So we saw already the fact that they were already starting to do more things like remote inspections, and then obviously COVID then kind of pushed everybody down the remote route and they really embraced that and then going to carry on that way. The fact they've changed their inspections now to be less kind of overarching and more specific, they've gone. We're not going to look at everything for everybody, we're going to target and we're going to target in these specific areas. So I think it does drive you to change and innovation. And I think, no matter what element you're looking at, it is that something always has to trigger an innovation. And if you're comfortable and things are all happy and it's not a great inducer to do something different, but hard times or resources or big change are the things that make you do something differently.

Speaker 1 21:48

And talking about innovation and big change. Obviously, like I said, I've just been to the World Drug Safety Congress in Europe and the big thing, absolutely every track I think there are 11 tracks, and every single track is touched upon this, which is AI, and I know so you're not the most fascinated when it comes down to systems of AI, but I want to bring a different, maybe, perspective, because I heard a couple of things which worked me. I wasn't there in the session so I can't actually vouch for any of this, but it was a conversation I had had with someone, and the conversation had said that, within one of the sessions, someone had said you could teach a data analyst PV, but you can't teach a PV person data analytics, and that really irks me stars. And secondly, it got me into another thought, which was I'm not science-based.

Speaker 1 22:58

I did law, I came into PV and I was very lucky that Sharon had the ability to start doing data entry, and then it took a while, but I did finally get it and start doing well within PV. My thought then goes into this path, which is well how the new people going to come into PV Data entry was the path for the majority of people. So what do you think the future is for people like me? Essentially, how do we get into PV?

Speaker 2 23:40

Yeah, and that is an area that I've had discussions and thoughts and spoken about quite a lot because, you're absolutely right, case processing was always seen to be kind of like the entry level into PV, and we've already seen that declining over the past 10, 15 years, with a lot of offshoring of those roles from UK, europe, us and so really diminishing that entry level and it is concerning that we are potentially throwing people into quite a complex arena. Let's face it, we don't talk normal English when we're talking PV. We have all of our own terminology and phraseologies. It is a complex area and we're throwing people into that at a more senior level and I've seen this a lot with people coming in into science roles, particularly with physicians coming straight in, where potentially they're just not seeing the big picture. We've also got to that role now.

Speaker 2 24:54

When I started, which was back in the dark ages, you did a bit of everything. You did a bit of cases, you did a bit on the analysis, you spoke to the regulatory team, you went to the regulators. There was a lot of that. And now we've kind of because functions have got so much bigger, the roles have got narrower. You are a safety scientist for one particular product, or you are a compliance person, or you've overseen cases. We've got these very kind of narrow roles, and so I do think we need to be more innovative on how we bring people in. I don't have a problem bringing people in to be a safety scientist, but we have to make sure we give them the opportunities to observe and understand the PV system. We have to make sure we're giving them excellent training that they are able to understand not just their link in the chain, but the whole chain.

Speaker 2 25:55

How does information get to them? What does the case look like? How is it processed? Okay, you might not be a case processor, but you need to be able to find your way around the database. You need to understand which fields are auto-populated by AI, which are typed in. Where does that information come from? You need to understand all of the caveats that come with the spontaneous report. You and I know that the information you get is very limited, and how it's kind of forced into a database to a certain extent is quite variable, so you need to understand all of that. You need to understand where your piece leads next if it's then going on to be reviewed by a physician or a more senior scientist. What are they looking for? What are the caveats of information? If you make an analysis of cases, what's the potential impact of that if it then goes to your safety review committee or whatever?

Speaker 2 26:53

So I think we can still bring people in and we absolutely still need people to come in, but we need to fill the gaps. We need to give them excellent training, whether that's in-house, whether that's external, whether that's sending them off to get a post-marketing degree, whether it's whatever it is. We need to rotate people.

Speaker 2 27:13

I was always very keen on moving people around.

Speaker 2 27:18

As I said, as a leader, it makes me feel really happy when I see people like you doing really well. But for me, if somebody came to me and said I'm resigning because I've got such and such a job, I was always really happy for them because I wanted them to move and get new experiences. I've certainly been in a scenario where people have left, they've gone to work for other organisations in different teams, got different experiences and then they've come back more well-rounded, more senior and able to move on to the next level. So I think it's been to us as leaders to ensure that we are giving people the training, giving them the opportunities, moving them around so that they can then be the us of the future. I got that just almost serendipitately through the roles that I had and the organisations I've worked in, but we now have to work to make sure other people get that really well-rounded view, because otherwise, yeah, the systems aren't going to system, the PV system isn't going to work if people don't understand where they fit in that whole chain.

Speaker 1 28:28

I think that just brought back a memory of when I did resign. As I had to say, when I got the job at Hamgen and I think the first words, I was very nervous and I think there was some sort of event happening in our building. I went to you and you just went fantastic and I was like, oh, I did not expect that as a response. So I was like, wow, she wanted to get rid of it. But there we go.

Speaker 2 28:53

No, no. I never want to give people and I always used to say tell me, you're moving to a better job. If I felt somebody was moving to the same job in another company, I felt I'd failed. But if they were moving to a better job, a different job, a new opportunity, then, yeah, absolutely fantastic. But if you're moving to the same job somewhere else, then I felt I'd failed them. So that would be my response.

Speaker 1 29:24

How do you feel that again we're going down the systems path a little bit, but again maybe more of an alternate view?

Speaker 1 29:33

We have several companies out there let's say that old vendors, who are essentially trying to converge everyone to their way of thinking, and these particular vendors all think they have the correct way in which to do certain bits of safety. Be it a signal software, be it a case processing software, a database, be it just how to deal with emails, for instance, they all have their specific nuances. And a company like Trudion, this isn't meant to go like that. But companies like us who go in and look at their processes and say, well, you're not necessarily matching the system here that you've currently got. But the thought comes as I've worked at product companies. I've worked at two product companies where decisions are being made by people who actually don't really know a lot about safety, and isn't that a bit of a worry as well?

Speaker 2 30:48

Yeah, I mean, nobody can know everything and as a safety person, you also know that if you want to bring in something new, you have to get the buy-in of other parts of the organisation. Usually safety has very little budget If you want to do anything new or if you have to kind of go cap in hand to whoever's got the money. And the other thing I found was working with particularly smaller organisations is the layers between safety and senior management are very small and so often that person who is in charge of safety, let's say, isn't really a safety person either, because they're having to look after clinical and medical and lots of other things as well and the true safety expert is actually somebody really quite junior. So yeah, that's what happens. I think the best organisations are those where safety is respected for what it is. So whoever is representing safety helps the organisation understand the good and the bad of what's needed and is respected for that. And I think if you have that, then whoever is making the decisions kind of understands what is needed. That doesn't mean to say they're an expert, but they respect the information that's coming from the experts and they understand that safety is a core element of any pharmaceutical company and needs to be done correctly. I mean, that doesn't necessarily answer your question, but I think it's important that whoever is making decisions for safety understands the why and not just the what.

Speaker 2 32:56

I think it's very easy for us to get caught up in the what. What are we doing? What is the time frame? What is the compliance? What system are we going to use? Rather than the why are we doing this? What is the end goal? What are we trying to achieve? And it's not compliance at all costs, and it's not compliance at no cost. And it's around. I'm no saint at this, but you have to sometimes pull yourself back and go actually, what is going to keep the patient safe? That's what we're doing this for. We're doing it to ensure that the patients who take our products are able to do so in a way that is of biggest benefit and of smallest risk. And all of the rest of this is Is driving us to that golden.

Speaker 2 33:57

Whether it's a database, whether it's an audit, whether it's a signal, whether it's, you know that's what it's all driving to, and so sometimes you just kind of have to go okay, step back. You know, do we need, do we need it? You know I, you know that systems. I had a conversation with one client a few months ago where they were determined they were going to spend an awful lot of money On some very fancy signal detection software when they had one product with 200 cases. No, no, but we need it.

Speaker 2 34:31

And you know we need to play with the big boys. No, no, you don't need it be, it won't work. You know, you just need to look at your cases each month. That's all you need to do. It's not very sophisticated, but that's actually appropriate for your size of database. If you want to do something fancy, you know, pay somebody to go and look in Fda bears database, or did you base or something. But don't bring that in for your own database won't work. And so I think you know, I, you know it's not the what it's, it's why, and and if you've got A good head of safety who can represent, you know, the safety organization to whoever is making the decision and have those conversations, then you kind of hope the right decisions are being made. I think that's absolutely fair.

Speaker 1 35:27

Obviously, I talked about my experience, but I think exactly what you're saying. Again, I was thinking back at so many Heads of safety or, you know, chief medical officers as they ended up going up into and how many of them actually cared about safety. I think there was always this safety is the cost factor that we have to do, and and that was it really. But going back to another, another point that you were talking about, about outsourcing, and I think that's a good point and the fact that you know jobs are being outsourced, I've noticed a little bit of a trend where people are starting to think of a more hybrid model where they have Some, some of the work outsource and it's not necessarily just case processing.

Speaker 1 36:18

I've seen I've seen, certainly, where I could go reports are outsourced, some of the signaling outsourced. It's all about safety that could actually essentially be outsourced. But it does seem that some of the bigger guys are sort of coming into this sort of hybrid state rather than fully everything outsourcing. And I was thinking back to a few years ago where outsourcing was a big thing and then suddenly everyone brought it back and then it went back and I was just thinking is outsourcing essentially just cyclical?

Speaker 2 36:48

Yeah, I think I mean I think you're right, I think you know. You know every outsourcing was the thing. Everything was outsourced off shore, or whatever you want to call it, and it was a lot of. It was cost and efficiency driven and organizations then kind of went perhaps we've done too much, we've lost, you know, back to your point, we've lost the expertise, we've lost the knowledge of our own PV system, and we need to bring some of that back. We need to make sure that we've got really good oversight.

Speaker 2 37:25

I think the focus now is on oversight rather than necessarily the doing. And you know, I've always you know always said delegation, not abdication. You know, from my mind, that's the key thing. You know, whatever we do, whether you call outsourcing or partnership or off shore and whatever, you are delegating your responsibility as an MAH. But you cannot lose sight of it. You know you are responsible for that, you are accountable for it. You know you haven't completely abdicated your role there, and so the the focus is on oversight and quality, which I think is absolutely right.

Speaker 2 38:06

Whether it's cyclical, I'm not sure I know. I once had this conversation when I was leaving one organization and going to another, and it was a time where there seemed to be a lot of churn between Do you have people who do All elements of the case you know, the case processing and safety evaluation or do you separate your groups out? And I said to people, I'm under no illusion that this company I'm going to is on a different cycle, it's just a different place on the circle, you know. So the fact that they might have two groups, you know at some point they'll bring them back into one and then they'll separate them out again and then they'll offshore them and then they'll break, you know. So we do think there is a certain cycle that we go through. I think all organizations are going to be able to do that. We go through, I think, all organizations, all organizational design, whether you're talking about PV or any other organizational design, is to a certain sense cyclical. Because, because it just is, you know, you reorganize. Everybody will have been through numerous reorganizations, either within a company or they move companies. Then it's like, well, we're going to split the groups, we're going to join the groups, we're going to have an expert doing this, we're going to have a centre of excellence. Now we're going to bring it all into one. Now we're going to split the groups, you know, because organizational design there's only a certain number of ways you can do it, so we do think that's it. We're going to split the groups Because organizational design there's only a certain number of ways you can do it, so we do think that it.

Speaker 2 39:38

And I think with the, you know, a lot of the offshoring is that I don't think we're necessarily going to ever come back to though within PV, of organizations having sort of giant in-house case processing centres, for two reasons One is, I think, the cost. It is proven to be more cost efficient to operate in other countries. And secondly is the AI thing. I think you know we've always had always, certainly in my lifetime a level of auto. You know auto coding, auto listedness, auto narratives, and you know I think those are going to get better and better. We've already seen, you know, the use of natural language processing, et cetera and things to kind of pull out adverse event terms from large volumes of text. You know it's inevitably going to go down that route.

Speaker 2 40:42

So I don't think companies are going to then have 20 people sat in a room, you know, in the centre of Europe somewhere entering cases.

Speaker 2 40:53

I don't think that's necessary. I think there will come a time when they won't have 20 people sat in a room in India or the Philippines doing that, because that will be taken over by AI, but what they will have is people ensuring that those processes are robust, that they are looked at. You know that there is a sense element, you know. Call it QC, call it QA, call it review, call it, you know whatever. But you know you can't take, you can never take the scientific and medical evaluation out of safety. You can take away the kind of you know, typing bit, but you can't take the brain power out of it and you know you need to ensure that that's still there. So I think there'll be a shift to the emphasis, but you know we're never going to get rid of ICSRs. We're just going to get rid of, get rid of, change the way in which those get from point A to point B. I think.

Speaker 1 42:03

I think you're absolutely right and actually there was a. There was one more point that I had in my head when you were talking previously, which was about how safety is perceived in companies, and it's a. It's a pretty simple one, but do you think COVID and the COVID pandemic increased the visibility of safety with companies?

Speaker 2 42:31

It certainly did in the wider world. You know I've spent 30 odd years trying to explain to people what my job is, usually covered with a pretty glazed look. Come COVID, suddenly, you know, certainly in the UK June rain from the MHA Ray was on the telly all the time. People were talking about side effects, people were being told to report them. You know it certainly got a much greater visibility than than it had done previously. So I think certainly, you know, within the general population there was an elevation.

Speaker 2 43:11

And I think for the vaccine manufacturers, I think you know, safety was obviously a very key element. You know, and that's the same with, I think, for vaccine manufacturers, for any vaccine, because you know, and I used to, because I used to work on vaccines when I first started in my career and it was always that thing of you, you were giving something to a perfectly healthy individual. So the safety element has to be so high. You know, unlike a medicine, a drug that you're giving somebody who's sick, you know vaccines you're giving to healthy people and brought after children. So the safety element is always a high part of that discussion. So I think for the vaccine manufacturers, safety obviously was very critical. For everybody else Did it have an impact? I don't know. I mean, I think and obviously I sort of came out of the corporate world just before COVID and so it would be really interesting to talk to somebody who still works in a corporate environment.

Speaker 2 44:15

But I think the shift to remote working has potentially, I was going to say, damaged I don't damage is like work, but I don't think it's helped but the visibility of organizations like safety, because safety has always been seen to be a bit of a background thing. And I know, you know, the best organization I worked for that really had safety at its forefront was Amgen and that was down to an incredibly inspiring leader. But she made sure we were visible. You know you had to be in the meeting room when we went to the meetings of the top 500 in the organization. We had to sit in the front row.

Speaker 2 44:56

You know we had to make sure we went up and introduced ourselves to the senior leaders in other part of the organizations. You know she made sure that I went out to the US at least four times a year to be visible and there was that whole thing about visibility to ensure that safety was in people's minds. And I think the fact now that people kind of sit at home a lot of time, don't go back into the office necessarily, a lot of it's done remotely. I think that has not helped the visibility of safety and probably a number of other parts of the organization, because you're kind of losing that human touch and that visibility. So in that respect I think COVID and the knock on to the remote working has probably not helped it for many organizations.

Speaker 1 45:49

That's a really fair point, I guess. When COVID hit, I was just I was in product company, so for me it was a very different experience than being within safety itself. I guess I've got to ask my final question, and this podcast is called innovation and the future of farm covenants, and the reason why it was named so is because that's what I'm interested in when are we going next? We we've there's been so much disruption recently. We've talked about Brexit, we talked about COVID, and where are we going? And this isn't necessarily just about systems or AI, et cetera. This is just the future we touched upon how do people enter into PD? And so, yeah, what are your thoughts? It's a big question.

Future of Data Gathering and Legislation

Speaker 2 46:46

It's a big question and I think there are lots of different elements to it. I think AI is obviously a big thing. I think the like say the way we, the way we gather data, the way we put that data on the database, I think is is going to change. We've seen already it's definitely going to happen. I think the type of careers we have, as we said, is inevitable, that that that's kind of changing and I think you know the legislation is changing. I think we'll change. I think we will see that divergence and then hopefully coming back together.

Speaker 2 47:29

I think, you know, to a certain extent the legislation kind of has to play catch up. You know, I know you and I have had a bit of a conversation about ICH E2D, which I was involved with at the beginning the revision, you know, and the aim of that was to try and bring legislation that was written in the early 90s, you know, up to speed with all of the different ways we're getting information in now. And one of the reasons you know I'm not involved now because I had to step down when I left the corporate world, but you know I still try and follow it and my understanding is one of the reasons that's taking so long is actually the divergence, you know, because you're trying to get people in room to come to a consensus and everybody's legislation is different and everybody's wants and desires are different and trying to come to consensus is actually proving really hard. So I do think that we are going to see more divergence in requirements and I like to think that hopefully we might come back together.

Speaker 2 48:29

Maybe maybe we get to that point where the everybody is entering data and gathering data, you know, through a I'll say AI is a very big term but using all of those technological advances, maybe we get to the point where that's all happening almost kind of automatically, so you don't have to focus on that anymore, and therefore the more clinical, scientific judgment part is where the legislation really lies and that can come back together because we all agree the end goal is the same, as we've said, it's to keep patients safe. So so I think maybe we're going to see a bit of a fuzzy period for a while where there's, you know, people are exploring these new tools, the legislation is going a bit all over the place and maybe ultimately often say not my lifetime, not my working lifetime. But you know, ultimately it might kind of come back together because we don't have to worry about the ICSRs. It's kind of that just kind of happens and we focus on the evaluation and the judgment and because we all have the same end goal, it comes back together. I don't know.

Speaker 2 49:38

Watch this space.

Speaker 1 49:39

I think that's exactly it. Watch this space Well. So thank you very much for joining me on this podcast. It's been a pleasure speaking to you. It's been fantastic. Thank you very much.

Speaker 2 49:51

Thank you for having me.