Bill Ringbloom

Embark on a transformational trek with Bill Ringbloom, AstraZeneca's Head of Global Patient Safety Technical Solutions as he shares his unconventional career trajectory from the financial chaos of 2008 to the cutting edge of pharmacovigilance. With a treasure trove of experience spanning IT, finance, and project management, Bill's insights shed light on the value of adaptable skill sets in the ever-evolving pharmaceutical domain. Tune in and uncover how the fusion of these diverse abilities is not just enhancing global patient safety but is also shaping the strategic role of IT within the healthcare juggernaut.

In the heart of our exchange, Bill dissects the intricate dance between finance and life sciences, proving that the two are more intertwined than one might assume. The conversation reveals how the flexibility of IT not only supported AstraZeneca through the pandemic but also bolstered the rollout of their vaccine. Listen closely as we navigate the thought-provoking parallels that bridge two seemingly disparate worlds, reinforcing the significance of financial prowess in steering the ship of innovation amidst a sea of stringent industry demands.

The episode culminates with a deep dive into the frontiers of data strategy and the monumental efforts in cloud migration for drug safety. Bill elucidates the vision for a 'data supermarket'—where data is not just abundant but actionable—and the intricate balance necessary when enhancing surveillance to serve scientific use cases. Grasp the complexities of IT decisions that are transforming patient safety and R&D processes as we explore how AstraZeneca is steering towards predictive analytics in pharmacovigilance, all while navigating the need for efficiency and the pursuit of scientific precision.

Transcript

Speaker 1 0:16

Welcome to another episode of Innovation and the Future of Farm Covigilance, a podcast series brought to you by Trudiant Talks. I'm your host, indy Alawalia, and I'm delighted to navigate the dynamic world of farmer covigilance and risk management with you. But first a quick disclaimer the opinions expressed in this episode are solely those of the individual guest and do not necessarily reflect the official views of Trudiant Consulting or their own company. We're all about fostering insightful conversations here at Trudiant 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, and today I'm really excited that we have Bill Ringbloom, who is Senior Director, head of Global Patient Safety Technical Solutions at AstraZeneca, as our guest. Bill, thank you for coming onto the show.

Speaker 2 1:22

Hi, indy, thank you for having me. I'm very excited to be here, and happy Friday to you.

Speaker 1 1:27

Happy Friday. Well, it will be Monday when this goes out, so happy.

Speaker 2 1:29

Monday, it's Friday today, though.

Speaker 1 1:34

So, bill, this is going to be an interesting question. I normally ask this question to every guest. How did you get into PV?

Speaker 2 1:44

And I'm going to wager that I'm going to give you a slightly different answer than you typically get when you ask that question. Okay, so I've been in PV now as directly in PV for eight years about eight years and it actually all started with my first five. I was in IT. I was a business partner in our R&D IT group all here at AstraZeneca, and then, during the pandemic and our experience in the pandemic and the work that came through our organization in the pandemic, I moved into global patient safety, directly into this lead role of we call ourselves global patient safety technical solutions, but traditionally it's the concept of your PV systems team, right? So all system ownership and application maintenance and evolution and roadmap build, implementation all that runs through my team. But previous to PV, if we go all the way back to my education, I'm a businessman by academia standards, right? So I have a couple of different business degrees operational degrees, accounting degrees and then I have my MBA and for my first eight, almost nine, years of my post collegiate career, I was actually a financial planner for Citigroup. So working in the finance industry, managing funds, managing receivables, managing all that kind of stuff.

Speaker 2 3:05

When we get to about the 2008 year and the market situation at that point in time was not so well. I had begun to kind of my attention began to waffle on finance, right, like it's very interesting and it's very aggressive, but it just wasn't really suiting my fancy at that point in time. Again, the market was not good, was not very good at that point in time, and Citigroup at that point had begun Well. For those that remember, at that point in time Citigroup was the largest corporation I think the world had ever seen. We had like 120,000 plus employees, right. So I worked for a very specific division and you really didn't know what was going on in all the various divisions around you. But what ended up happening was, with the market situation beginning to deteriorate, citigroup began basically centering themselves around a core set of services, and the division that I was working for was not a part of those core services, so they were looking at rebranding and selling it.

Speaker 2 4:02

So, I and a number of colleagues that were working for that particular division at that point began exploring opportunities elsewhere and what had happened is I had led. So when I left Citigroup I was actually no longer managing funds, I was in. I moved into an IT role well, an IT facing role. So I moved from basically a money manager to, after receiving my MBA, they moved me to headquarters and what the job that I took there was called a field liaison, which basically is the conduit between the. I was the person that knows what's going on on the shop floor, if you will, how our money managers are interacting with their clients, and I was the conduit between us and our information technology teams that were providing the very outdated mainframe computer system that we use at that time to manage our receivables. So bit of a training aspect, the bit of requirements facilitating type of person. But that is where I became introduced and working within a project based setting and around technology and SDLCs and project delivery and implementations and all these kinds of things. So I did that for a couple years, went from business analysts to manager, business analysts, project manager to program manager to portfolio manager. And then one of my colleagues left and went to a CRO and he was doing financial reconciliation. Basically, we had a big laboratory operation, so it was samples out the door therefore, hand voice goes out the door as well and they were looking at implementing an ERP system that was on the market at that time. It's no longer on the market, but I had actually facilitated the implementation of that for city group and they were somebody that, yeah, they were looking for somebody that had the very specific implementation experience with that particular product. So I was connected to the hiring manager. I successfully obtained that role While here I am in life sciences working in this URL. Wow, the interesting thing that happened there is the project that I was brought in to implement was canned about three months into my tenure with this company and I thought at that point in time that I would be back out and maybe reapplying it by actual institutions and rethinking what I'm going to do. Yeah, but they decided to take a gamble on me and they put me in charge of a project Again, this is 2010 to implement an e source capture system in our phase one clinical pharmacology units.

Speaker 2 6:35

So literally taking pen and clipboard out of clinicians hands and supplying them with well. Today, it would be a very small tablet of some sort, maybe even a phone, yeah, 2010. It was big, huge, convertible Lenovo laptops that weighed like seven pounds, and we had to, like buy harnesses for people. Let's just say it was a very, very bold ambition that we had, but the technology wasn't there, the peripherals weren't there where they needed to be.

Speaker 2 7:03

The integration prowess, the things like like this is a clinical pharmacology unit, so you have vitals machines and EKG machines and you're looking to integrate with all these things, right? So, like, the Internet of Things wasn't really as powerful as it is today, so there's a lot of tethered like crazy stuff in the like like literally buying, like almost like fanny packs for clinicians to put all their dongles in, to hook up to well, challenge blood pressure machines and stuff like a pretty crazy thing. Yeah. What it did do. For me, though, is I say this all the time if you are interested in drug development and you have the opportunity to spend a significant amount of time in a phase one clinical pharmacology unit, you will get the best crash course in drug development you will ever get anywhere else, because you see it all unfold right there in very, very rapid fire succession, right.

Speaker 2 7:53

So phase one it's dose, click, click, click, click, click, click, click, click, click, click, click. Have a nice day. So you see it all. You literally watch the sample get drawn, taken to the lab to be spun down, to be taken to storage, to get placed in the freezer to be shipped out later that day. You see it from beginning to end, all in the span of a couple hours, because it moves very, very fast.

Speaker 1 8:15

Um.

Speaker 2 8:15

So I worked on that project until 2014 and that's when, actually, it was a colleague of mine that I worked with that icon. He was a business partner of mine left AZ. I left the CRO to come here to AZ and he contacted me about six months after he departed and informed me that AstraZeneca was changing their their footprint and moving from R&D from Wilmington, delaware, here to Gatherburg.

Speaker 2 8:43

Maryland and, as such, numerous people didn't follow their jobs. They opted to take to take the separation package and stay based in the Philadelphia area, rather than picking everything up and moving here to.

Transitioning From Finance to Life Sciences

Speaker 2 8:52

Maryland. That opened the door for me to enter AstraZeneca. So now the transition to PV hasn't even really started yet. I come to AstraZeneca and I took a job as a program manager. Right, I was. I was a bench program manager for R&D, meaning Next project up, next person available with suitable skills, you get the assignment. So I was running clinical projects, I was running risk management projects, I was running, I ran one safety project I won't, I won't take too much time about the details, but it was a pretty big, sizable project and it was the first time I'd ever experienced safety in my life. So that kind of gave it was an intake, so it was an intake solution, consolidation. So I got to learn a lot about how local operates with global. And well, to be completely frank with you, what local verse global even meant at that point.

Speaker 1 9:45

I didn't know anything about this. I knew nothing about PV.

Speaker 2 9:49

So I delivered that project and Then the IT group at that time changed the way that they were structured.

Speaker 2 9:55

We were typically structured in a regional way, right, so R&D has, and it's still, by and large, this way. With AstraZeneca, the R&D hubs are here in Gatherburg, cambridge, uk, and Gothenburg, sweden, mm-hmm, and that's where the bulk of the R&D resources reside in those rehab locations. So I T at that time was scheduled where we had a Sweden team, a UK team in the US team and we crossed borders to a certain extent. But one of the things that was really problematic for our organization at that time is we had people working with clinical operations people in Sweden while we had people working with clinical operations people in US and we were building parallel things. So sometime around the I guess it would be the 2015 2016 time point IT changed their structure to become capability facing as opposed to regionally facing. So now you have a safety team, a regulatory team, a clean ops team, a data management team, and I Applied for and receive the lead role, lead business partner role to be the global patient safety business partner in IT.

Speaker 2 11:00

Mm-hmm so I did that for Four and a half to five years learned everything about safety. You could learn, of course, everything about the technology and safety as opposed to and as well as the Operations in the business and sort of the deliverable of the function itself. And then the pandemic came. That could be a whole podcasting of itself what happened there, but I think everybody knows we had a vaccine right. I think people are somewhat aware of the story of our vaccine and it was a very tumultuous period. We're operating it.

Speaker 2 11:30

We're still operating on a very old homegrown custom solution that presented a whole host of problems for us dealing with this particular product and that really began shining a light on the need to do something about our systems. We need to upgrade in some way. We're acquiring companies. We have bold ambitions of all these molecules to be delivered. We're doing acquisitions at a greater rate than we've ever seen. This 15 year old I'm sorry clunker of a system just kind of wasn't cutting it anymore. So that's when we really started looking at transformation. What are we going to do to move out of the legacy systems into a new, modernized the state? And at that point in time, that's when global patient safety decided that they wanted somebody like, I guess, me at that point in time to kind of sit as the head of a technical solutions team to kind of put this strategy in place. And I applied for the role and obviously I successfully was offered this role and I took it and I've been here for now almost three years. I've been in this, in this role.

Speaker 1 12:29

Wow, and what's the link between your role and old IT?

Speaker 2 12:37

So I actually partnered very closely with IT to this day, right. So they're kind of the delivery of the way that our working model works. Is Actually we as global patient safety drive strategic direction? And then I partner very closely with he's actually the person that's sitting in my previous role as IT business partner. He and I work very closely together to under to make sure that IT understand what our short, medium and long-term strategy is, and Then we work collaborative together to define solutions and and sort of implementation approaches to meet those objectives. Got it so.

Speaker 2 13:12

I still work very, very closely with IT, like daily interactions, multiple times a day interactions.

Speaker 1 13:19

Okay, so it's. So it's just an extension of so yeah, this, just you're the partner of the IT business partner. Essentially he's yeah, okay, yep correct Yep.

Speaker 2 13:35

I like all technology implementations, like the actual technology infrastructure provision, data privacy assessments for cloud computing arrangements, validation of integrations and all those types of things that's all done with an RIT teams.

Speaker 1 13:50

Got it. I have a thousand questions, but the first one that came up to my mind was you started off in finance and obviously you came into life sciences. There must have been some synergies between, because I've always assumed there were synergies between finance and life sciences in regards to having regulators and stuff like that, but I've never actually spoken to someone who's actually done the flip. Here's my opportunity. What are the synergies between Pine and sand and large?

Speaker 2 14:26

I remember. So at the risk of sounding crass and I hope I don't come off as such I Remember in a graduate school class so many years ago One is one of the professors said he made a statement. I'm probably not nailing it verbatim, but the message is there was Anybody at the big boy table and I don't mean to be gender specific, but anybody at the big boy table understands money. You don't get there if you don't understand money and, being a younger person, that didn't really Resonate with me, right? I'm just trying to get a degree and learn some stuff and get on with my life, right? Flash words to now. That's funny. I make the joke and it's probably not a joke because it's true I May spend more time thinking about financial matters now than I did when I was a financial planner.

Speaker 2 15:23

Right, so it look when you're, when you're, when you're asked to run something, to run a business operation, that business training it's and it's more.

Speaker 1 15:31

It's more than just the finance stuff right.

Speaker 2 15:33

It's that business training how does an organization work organically? It's, it's valuable, it really is. And then when you think about this type of a role where, yes, a large part of our role is what I call run, just keeping our systems up, keeping the performance, keeping them available Right, keeping the work, keeping the throughput going through at, at at the acceptable levels, but there's also an evolution, strategic, build component of this right. So you, I find that my financial Background and that understanding has benefited me greatly when it comes to writing investment proposals and Getting approval to do things such as this massive technological transformation that we're doing right now.

Speaker 1 16:18

And actually Another point that you you said we'll get to the to the big transformation piece in a sec. I'm sure there are people that they only will forward to that bit, but One of the things that you're talking about was strategizing and how. In your role now you have to strategize for the next year, two years, three years. Has it become more difficult in the last year with the sudden availability of AI and the fact that technology is changing at just the most craziest rate at the moment? And how do you strategize for something that, quite frankly, you just don't know what's going to happen next year?

Data Strategy and Transformation Progress

Speaker 2 17:04

It's extremely difficult. It really is, and I think probably the number one factor that we work against when it comes to these types of AI and automation and these novels, the large language models and generative AI and all these things is we can't implement it fast enough and it's still incredibly complex and there's not a lot of low hanging fruit, at least in my organization, when it comes to that stuff, right, like we are impeded by things like, well, data availability is a big impediment for us, right? So I can't do a lot of automation of tasks if I don't have access to the data that I need to do that, or the data that I need to train a model to do that, and we're working through that as an organization. What is our data strategy? You hear a lot of talk around like master, data modeling and management and data lakes and all these kind of things. Right, and I know what we're doing. This may come up when we get to the transformative stuff. I know what we are doing as patient safety when it comes to getting our data in a way that we used to word fair, which is an industry term. I'm sure everybody knows what that is, right, the verification of our data but that's only going to take us safety so far, unless we get ourselves into a situation to where our data is in, where the other meaningful R&D data that we want to use to make our decisions and do our analyses.

Speaker 2 18:28

Then I use the term data supermarket a lot Like people in my organization are probably sick of hearing me say that. Right, but that's my vision. Is a data supermarket I can walk in. Of course there's controls and governance around it. Right, it's not a free for all, I understand that. But this concept of I should be able, as a scientist or a physician, go in and say I'd like to look at this and maybe some of this, and what did that trial say? And is there a support program associated with this? I should be able to go in and kind of pick and choose that kind of stuff. So the concept of the data supermarket is only relevant if there's other products over and above safety on those shelves, right, so I don't need to go to a supermarket if my data is already in my pantry, I can get it down right from my native systems.

Speaker 2 19:15

So you ask a little bit about where do I partner with IT? This is a big area where we are partnering very closely with IT to try to get a view of what is the broader data strategy here. Where does safety fit into it? And then what? What time point are we looking at to maybe make some meaningful progress on some of these? We have no shortage of use cases. There's no shortage of a use case. Everybody's hungry to test and experiment and explore. We just, frankly, were struggling to stand up those foundational pieces that we need to do that work in a meaningful way. So we're kind of stuck at foundation and that's impeding our progress to supply these things with the speed with which our senior executives are desiring them to come online.

Speaker 1 20:03

But that's no bad thing, especially in safety, where you talk about your system which is 15 years old. But if we're being pretty honest here, the systems that are out there there are new earth systems in the past three years, but it's been dominated by two companies for the last 20 odd years Yep, exactly. And so actually technological change in PV has been very slow until the last three years again, where it's been incredible rate and there's been incredible failures as well with implementing some of this technology. So actually being at a foundational base is not a bad thing, I guess.

Speaker 2 20:53

Well, to build on that, and you're actually this is actually generating insights for me.

Speaker 2 20:57

There are a little conversation here, so so I should disclaim we do have a fair amount of automation in our operations.

Speaker 2 21:08

We do. We've made a pretty significant and I'm very actually proud of the work that we've done in the ICSR space, and we've even done a bit of work in using NLP to do literature surveillance and stuff, which those are two very exciting things that we did, and then later I'm not aware of anybody else that has a fully operating agent doing literature surveillance. There's no human involved in that process until an article was flagged for review, right, but that first initial scour of our database is done by a robot, which is really really exciting. So now what I'm coming to is, I think and I hope I see this to be true at the end of this work that we're doing for the remainder of this year the learnings that we've got from trying to figure out how to implement these things and the things that we successfully implemented, is putting us in a better informed situation to understand what our foundation needs to be to build these things in a more rapid way, right?

Speaker 2 22:08

So yeah and I never even really pieced that kind of cadence of intelligence built together until we're sitting here talking through it right now.

Speaker 1 22:17

And actually I was just thinking what's foundational to AstraZeneca? Not what's foundational for, necessarily, safety, because, again, safety has been done in a particular way for such a long time. Yes, even when implementing software, we see it a lot I've seen it throughout my career where people will keep the same process but shove a new piece of technology in and expect it to do better. Yep.

Speaker 2 22:48

Don't ever automate a bad process. Look at your process first and make sure what you're automating is what you should be automating. And that's tough to do, right, and especially with I mentioned I have a 15, now going on to 16-ish year old, custom built application. Custom built meaning not just attack the processes, the way that we work around this system are all completely custom and that change management is very hard. When we're talking about we want to question our processes and look to foredoing things in the optimum way. It's very, very, very entrenched. This is the way we do the work here at AstraZeneca. So I think we've made really good progress on that over the last couple of years, frankly, because of some of the challenges that we've had.

Speaker 2 23:37

So we are going into this transformation initiative with a higher palette, or willingness to accept change in what we're doing here procedurally, technologically, footprint, where people are sitting, those types of things. So all of that is aimed to change drastically with what we're doing here. And then the other big thing that I'm hoping that we get out of this is I don't want to be in a position to where we're sitting with the same version of a system year after year after year after year. We have got to get to a place to where we can continuously deploy upgrades to systems to keep them current throughout the life cycle of their use, right? So we're also trying to limit the amount of peripherals that we build around our system that we're putting in. We want everything to be in the same shot, because if we're going to get to a continuous delivery model, it's better that everything's in one place as opposed to managing change through a bunch of peripherals that we've bolted on to it.

Speaker 2 24:38

So, it is very much trying to get to a place to where the statement that I made the last time I spoke on this a couple of weeks back is compliance is just routine, ideally post this right. I don't want to spend a bunch of manpower worrying about LT license to operate and regulatory upgrades and these types of things. All that should be. We should have processes and a way of working with our solution provider that we can do releases in a repetitive right, whether we schedule them and say that it's two a year or one a year, one a quarter. We can come to that If we even if we need to get to it and agreed upon cadence of things. I just need to be in a position to where I'm not struggling to upgrade my systems. I need to be able to do upgrades, keep my stuff current and move on to transformational type ideas.

Global Cloud Migration for Drug Safety

Speaker 1 25:26

So the one question I'll ask before we get into the actual transformation which I'm sure everyone wants to talk about. But there is a risk versus reward on, on, on these big, big journeys. What has been the appetite for risk within the business safety group compared to maybe it who's risk ratio may be slightly higher, I would assume.

Speaker 2 25:57

Yeah, you're right, the risk ratio and it is let's, let's hire a lower. It is much more accepting of risk than we are in global patient safety. Right, because, at the end of the day, whatever we put into production is what we have to live with, right? So I'd be lying if I said we don't have, and anybody that's done this knows that this is the nature of doing this type of work. Right, like we definitely have challenging conversations sometime about what we need versus what we can wait for and when it's coming, and delivery timelines versus Productivity gain or productivity inefficiencies, like we're constantly Circling around these time points.

Speaker 2 26:45

And when we're saying we're going to drop a release and what's coming with that, first, what isn't coming with that, and right, I tend to become more interested in what isn't coming as opposed to what is coming. Right, the isn't coming stuff is where you need to put other work arounds. I hate to use the word work around because it sounds so negative, but you do need to put a used to word, again, a peripheral, whether that's a tool or a technology or a process or a report or a spreadsheet. It's all those things we have to work through as we are trying to balance the MVP mindset with the fact that we actually have a production to run here.

Speaker 1 27:21

Hmm. So let's get to it. This is a huge transformation for for safety. Why don't you?

Speaker 2 27:31

I believe this is the largest global migration or the largest cloud migration in PV that's been done in industry.

Speaker 1 27:40

I actually think that's true. Yes, that is that's true and it's going to be. I don't know when it will ever be superseded in in in the next couple of years, it will be many years before. I think it will be superseded. But why don't you give a quick tour of what's actually happening?

Speaker 2 27:59

Yeah, sure, so let's start with. So, as I said, I've been in the safety and in this particular journey now for a few years, right, so I won't go all the way back to where it started. Let's start. I typically start this with the pandemic, but I've already noted here that the pandemic was a way to shine a huge light on our systems, are a massive sort of risk, and that was kind of like the catalyst that put us into this transformation mode in the first place. So, post pandemic, we did a lot to kind of bolster our systems during the pandemic, and that I cannot say kudos enough to the teams that participate and it was a monumental piece of work to deal with that particular situation.

Speaker 2 28:38

But we really didn't do anything to address the core issues with our system. We basically gave it some horsepower to make sure it could take the volumes. I say that and it makes it sound like I'm diminishing it, and I want to say again that was a massive amount of work, but it left us kind of in the same place we were at before the pandemic. So we still had the same questions what, what are we going to do about the situation? Because, fingers and toes crossed, we never have that situation again. But it kind of showed you that anything's really possible and your disaster recovery plans sometimes aren't as solid as you think they may be Right. So during the course of the pandemic and the years following we began, we unleashed what we call our bold ambition. Our bold ambition is to deliver 20 new medicines between now and the year 2030. So a massive, massive, massive, massive growth.

Speaker 1 29:28

Objection in that in AZ.

Speaker 2 29:31

We started buying things. The Alexioan acquisition came in 2021. That was kind of like in my experience. That was kind of like the first that kicked off this wave of we're going to be buying things, we're going to be buying things, we're going to be looking to launch new molecules. The volume is coming Right.

Speaker 2 29:48

So now we have AZ sitting in a 15 year old custom system by the way, I'm not a true global system because I don't have Japan in my global system AZ Japan sits figuratively and literally, on an island. They have their own PV operations, their own technology estate, their own case handling partner. All of that is a distinct business unit in Japan. So then we have Alexioan Same situation, another system, another case handling partner, another group, all these types of things. So unification was kind of front and center and what we need to do we need to get off of old systems and we need to unify our organization to prepare for what's coming. So that was kind of like the first immediate, initial catalyst of kicking off what we're doing, this massive migration. So just to give some specs around the actual size of it, it is four million case files, I believe it is four million files, seven terabytes of data being taken from an on-prem environment in Stockholm, sweden, to a cloud environment hosted by our vendor. So massive, massive, massive transition. I noted this when I talked about this last week, just because I think it's really cool.

Speaker 2 31:10

We talked a little bit about here about PV is kind of maybe a bit antiquated in the way we think about certain things, right, and one of those things is we don't really ever throw anything away in PV, right, like, yeah, you hear, life of Product plus seven years. Ours is our records retention policy is actually Life of Product plus 50 years, just to be on the safe side. So it's very true, we don't ever throw anything away. I shouldn't say throw away. That makes it sound like you're just kind of pushing it to a waste bin. It would all be done under careful consideration, of course. Yeah, we are actually disposing in a compliant way, aligned with our Global Records and Retention Policy Group.

Speaker 2 31:53

We are actually disposing of 18 terabytes of data in this migration. There's a little bit of a nuance to that. The way that our old system catalogs files is we save every single version as a distinct version of that file. I see we went and sat with our. So, if you think about it, our Records Retention Policy is acceptable. Use only keeping data for the time point that you need it, don't keeping replicas of it. There's risk associated with that.

Speaker 2 32:24

We were actually in offense of our Records Retention Policy by saving all those outdated previous versions of files that we didn't need to save. We sat down, we talked to our Records and Retention Group. They've agreed with us wholeheartedly and we were able to only migrate the most recent version of the case in my legacy system plus the audit trail, and we have everything we need and we can dispose of again 18 terabytes of data. I just think that's cool because we have sustainability goals and carbon neutrality and compute power to keep all that data and what we're paying to our elsewhere service providers, because you're paying by the right, you're paying by the storage.

Speaker 2 33:08

I just think that's really. That was just when I was asking the team for some fancy statistics to give in these types of talks. They didn't give me how much we threw away, but when they showed me the numbers I was like where do the other 18 kilobytes go? Just out of curiosity. So it's these little benefits that we see coming out of our program that we didn't even tag to our business case. We didn't assume that we would be meeting a sustainability goal by disposing of a fairly sizable amount of our information.

Speaker 1 33:36

That's something that you wouldn't even go into a big project, even thinking about. No, no, to be fair.

Speaker 2 33:42

Absolutely not, but it's things that we'll definitely celebrate because it's I think this is the third forum that I've mentioned that in and I always get literally a gasp. I gave the speech in a room a few weeks back in the room gasped when I said it. We disposed of 18 kilobytes or 18 terabytes of data literally met with a gasp in the room. It was kind of funny.

Speaker 1 34:09

Do you think with this transformation thing, the project, there is a risk of perfectionism from business? Essentially, the fact that you have this custom system, this custom process, you're moving to a completely new system. It's probably it's not probably it will have gaps because of your process. There will certainly be gaps, yes, how do you deal with that as a leader, when you're dealing with these sort of situations where there are gaps and it's just, you had a specific process before.

Speaker 2 34:52

So, being completely honest, I actually think this is where me not being a longtime lifer in PV and safety is actually a benefit, because I'm not mired by 15 years of this process or this system. I shouldn't. I'm using poor choices of words here. Mired is a very negative term. That's the wrong word to use. I'm not living with the experience of 15 years of this very specific process.

Navigating Change and Efficiency Improvements

Speaker 2 35:20

And let's also say that we've been in this process for 15 years, so, by and large, this is the way PV is done at AstraZeneca, so we don't really have a hugely solid understanding of how this is being done elsewhere. So if we're not getting this, then surely this has to be. This is a task that needs to be done. How is it being done elsewhere? So we don't really have a lot of visibility to that too. So what I'm getting at this is what I'm putting this out as a level of complexity is the gold standard we're comparing to is our legacy systems.

Speaker 2 35:58

In most cases, the question is well, how does that do it? And I have to constantly keep reminding them. We're not asking how that does it. We're asking what we need to be and how we should be doing it tomorrow, not asking how were we doing it yesterday. And then back to the not being a lifer comment. Sometimes I'm asking very ignorant questions just simply because I don't know, and it actually helps. It helps move. Why are we doing that? Again, I'm sure we all have this experience. Every so often is you ask a question that you think is maybe even get you laughed at a little bit, and you realize there's not really a clear answer to that question.

Speaker 2 36:41

Why do we need to do that again? Is that actually the regulation or is that just how we're doing it today? So it's definitely a tricky process. I will say that I'm actually really, really, really happy with my counterparts and their willingness to kind of be creative in how we're approaching certain things. So the MVP mindset is, I think, alive and well, but the problem is, certain things are obligatory. You don't have a choice. You have to do this task right.

Speaker 2 37:18

So it's those kinds of things that we really do spend a lot of time thinking about. How are we going to live with this? Can we live with this? If we are going to live with this, how do we do it in a way that doesn't completely deplete our efficiency or our productivity? So it is a constant, constant process, and we talk about this at least three different times a week. We have sessions around exactly this change control, change management, requests coming in, requirements, solutionings of those requirements system I'll use the word gaps and limitations, things like that.

Speaker 2 37:50

Right, because, as you said, indy, there are going to be some things that we aren't going to get, at least in this first iteration of release. So we just need to sit down and be very, very mindful of exactly what it is we can and can't live with. Another really good thing that we have is we have an equally as long relationship with our case handling partner. They have been fantastically cooperative and collaborative in this process, so actively joining us, sitting next to us in these conversations about, well, can we live with that? If we were going to live with that, what would that look like on the case handling floor. So that has been a very huge asset for us too is just that collaboration and that very mature and open relationship with our case handling partner.

Speaker 1 38:38

I also wanted to just go back to another point that you've made earlier, which was about you deciding that you needed to go to a SAS solution.

Speaker 1 38:48

Maybe I'm paraphrasing here you needed to go to a SAS solution and that you have decided that the best course for AZ is to go to a one stop shop. Now there are two trains of thoughts here, and this is just generally out there for safety at the moment. There's the thought that you go to a one platform system or you go to a SAS solution, which ultimately should be able to integrate with absolutely everything, and it means that in the future, you can pick and choose. We talk about gold standard systems all the time and that actually in PV it's very hard to integrate gold standard systems, but ultimately, we should be in a situation within the next year where you should be able to say I want the best literature system, I want the best this system, I want the best that system. Was that conscious decision simply to get the foundations correct, or was it? And what are your opinions on this whole debate about going to a one platform system versus multiple SAS vendors?

Speaker 2 40:00

Good question. So buy versus build, versus all eggs in one basket, versus the differentiation of your partner network, those types of things, and I don't think there is one sort of silver bullet answer to this, because you're always managing technology. Strategic direction is different than the business is strategic, which is it's different. So, ideally, technology would like to reduce the number of partners that we're working with and reduce the number of contracts they're managing, reduce the number of systems we're maintaining and upgrading, but for us, I want best in class across the board, best in class what does it do best? That's what I want.

Speaker 2 40:40

So for me and I'm only giving my opinion if you talk to my business partner in IT, he would probably have a very different sort of response to this, and we work very collaboratively together on this. This is about laying down the foundation system that does the task that everybody in industry needs to do. So back to my comment about buy versus build you buy what's routine, right? I should be able to buy a system that can collect my cases, house my reporting rules, send cases to authorities and partners per those business roles and give me a reporting platform to generate data extracts from. There's nothing niche in any of that in my opinion.

Speaker 1 41:26

Mm-hmm.

Speaker 2 41:27

But when we get into the automation type stuff, right.

Speaker 1 41:32

Mm-hmm.

Speaker 2 41:33

Again. Ideally, our strategy right now is we should be working with one partner At the end of this, but I will. I will, I'll say now For this first big. So our global migration off of legacy system to our new system is scheduled for September of this year. Mm-hmm, so only six months out, and we are bolting our existing Automation platform on to our new system as an interim step, because we don't see an equivalent Lee at any equivalent, equivalently mature system coming from us, from our solution provider. Right now we don't. And this is this is what's interesting about automation Once you automate and I've mentioned here We've done some impressive work in case handling automation and it is driving pretty significant benefit into our operations. But now that's a benchmark you can't deviate from, right, that's where you are right.

Speaker 2 42:32

That's that you. That's your starting point. Now, right going back from that, from productivity and cost and efficiency, that baseline is non-negotiable. So in the run-up to this, when we were looking at where our partner solution was versus where our solution was, in Order to retain the efficiencies that we have in place today, we had to make that decision to retain portions of our legacy estate in our new estate.

Speaker 1 43:00

And did you do time in motion studies before you went?

Speaker 2 43:04

extensive, extensive, extensive. Actually, it was one of the most extensive data collection efforts I've ever been a part of. We spent months on that. That's a couple years back. That's part of our business case build, but we did sit down Painstaking detail how many minutes per step are people spending on this in our process?

Speaker 1 43:26

So what happens when you do the time in motion study once? So would you do the time in motion study when you are At the testing phase of the new system, or will you do it once you are live and maybe a few months down the line? When will you do that?

Speaker 2 43:44

then right now. It's scheduled for after we're live. Okay, let's leave it there right now. It's scheduled for after we're live. I don't see it being pulled into being a pre-release situation. I that won't be the case, we'll do it after. And why I said I'll leave it there is. We'll see where our productivity is with this first release. And Look, the idea here is yes, we have very, very, very high commitments to our senior executive team about what we're doing here.

Speaker 2 44:15

It's not about compliance, it's not about cloud migration. There is a significant amount of efficiency and productivity gain associated with this. Yeah, but there isn't this blind expectation that all of that is coming on day one with this big connection. So we will have that conversation with our senior team around where we are, what we get, what we got, what we didn't get, what our plan is to resolve the what we didn't get situation post go live and then we can we can kind of like Decide again when the best point to start checking in on our productivity is. But we will go through that exercise again at some point in the future to test the benefit and the successful realization of that with this program, and it won't be a one-time exercise. This is going to be something that will be expected to do on a recurring basis, whether that's quarterly, whether that's by annually, whether that's annually. We'll decide that later. That it is. It's been very well explained to us that, and we have a little model in place.

Speaker 2 45:15

We've already partnered with senior executive team to put a model in place. What are our KPIs? How are we going to measure it? Those types of things. So, yes, we will be Measuring our commitments and our productivity sort of delivery after this, for sure.

Speaker 1 45:29

Yeah, I think that's a this, a point that a lot of a lot of other sort of senior leaders in PV they, they kind of miss out, which is, I think there's a lot of talk about efficiencies, automation, ai, ml, large language models, everything, but actually you have to also have a baseline on what you currently have, yeah, to see if any of that is any is even worth the investment. I totally agree, totally agree.

Speaker 2 46:02

And and we're kind of, we're kind of so. Another thing that's going on here is like we started the cotton we kind of started to release in the earlier portion of this, talking about like technology and how fast it's coming and how quickly it's coming and how quickly can we actually use it and implement it. And your senior executive teams won it yesterday. Like it's it's just very it's a it's a constant piece of work to keep understanding that where are we going and where should we be putting our efforts right? Like we're all so stressed for time. There's so much work going on and everybody has ideas. Like I said, there's no shortage of use cases. So another thing that's going on sort of in my organization is we're trying to, let's say, reinvigorate our innovative spirit, if you will right.

Speaker 2 46:46

Turning back to and not I Use the analogy of hammers looking for nails, I feel we take that approach a little too often.

Speaker 2 46:58

We should use chat, gbt, we should use nlp, we should use blockchain, we should use these things, and then we're out searching for what we should be doing with them. The way that we're trying to turn our mindset now is let's talk about our business problems and look. It's very true, finding a good problem is actually quite hard to do. Hmm, right, what are the problems we actually should be working on? And not everything needs to be a big boil, the ocean thing, right, like, let's start small. Like, if we really want to use these novel texts in different ways, my opinion is you need to start a little smaller, a little bit more manageable. And the other thing that we need to be better at is we need to be better at failing, and I don't use failing as a negative, that's a positive term. As a matter of fact, in my team, we don't use the word fail, we use the word learn, we learned, we didn't fail we learned.

Speaker 2 47:52

We need to be more. We have to have a better appetite and appreciation for Sometimes this just doesn't pay enough to be a concept. We should be thinking about it anymore and let's move on. So, in parallel with this transformation, changing the old ways of working, implementing new, bringing people along that change journey, trying to reinvigorate the way people think about innovation and how we're framing the problems that we want to tackle, putting a bit of a we call we use the word ecosystem in place, like how are we Capturing, rating, curating and deciding with leadership what we should be doing? So all of this is it's very, it's actually very exciting.

Speaker 2 48:32

And yeah, just just to kind of see where we like Indie, I'll tell you, when we first started talking about this business case in 2021, it was not well received at the masses, like people did not understand why we need to move Right, like it. Just why do we need to move? What, what? What? We got through that. We got through the emergency. Why do we need to move to? Now? Everybody's on board. Of course, I get challenges, of course. Of course, people speak up and tell us they don't like certain things or give us I want that. I welcome those things. It's not in my mind in any type of a toxic way here, like everybody is on board to be successful of this, which is you asked me about, how do we manage this change in expectation? That makes it a lot easier in of itself that people are willing and understanding the need for this and we can work through our challenges in a positive way.

Speaker 1 49:26

Fascinating. So this is my final question. I always ask everyone the same question and I think it's going to be very interesting coming from you which is what's next for PV?

Speaker 2 49:41

So if this door was open and the people outside of it would hear me say it is data, data, data, Right, Like yes, we're laying down foundational systems, yes, we're implementing automation to reduce manual efforts and drive cost efficiencies and productivity gains and short and turnaround times of our case handling process and we're trying to implement more modern reporting solutions to maybe move more towards I don't like I always say self service and everybody always says self service until they really see what self service is but we are trying to move to a more at least empowering scientists and physicians to utilize the tool directly, as opposed to coming to a group of specialists, which is kind of what our model is now.

Speaker 1 50:24

Right.

Speaker 2 50:24

So that's all kind of like foundation and, dare I say, operational and transactional if you will. But when I look at the use cases that are coming in it's data, right, I as a safety physician, need to layer clinical trial non serious clinical trial on top of the serious cases I have in my database. I want to look at lab values, I want to look at real world data, I want claims, I want EHR, I want all this stuff. And when I look at those, right like, I want to identify a signal faster. Well, the only way you do that is to have more data, to look more places, right.

Enhancing Surveillance for Scientific Use Cases

Speaker 2 51:00

So this is kind of like my big hang up this year is, day to day Where's our, what is our data strategy? When is the awareness, this concept of us having direct availability of data that we're authorized to have access to? When is that coming? Because, being completely frank, I'm struggling with moving on some of these things because of that immediate rate limiting step. Right, so we want to look all these places but we're kind of hindered a jump in getting to the places we want to look, and then we could have a whole another conversation about what comes out of the back of that. Right Like like the surveillance area is is. I love surveillance and.

Speaker 2 51:38

I'm really looking forward to kind of getting the transactional piece laid down so we can turn our attention more to those scientific, scientific use cases, like. But all of those are science, they're all data in nature, right so? But the duality of that operation is always very interesting to me. We want to look more places, we want to cast wider nets, we want to find more starfish, if you will, right, but we don't want to drag back any more rocks. We don't want to spend any time on any noise, right, we want. We want to look more places that we don't want to exert more manpower on false positives, right so. So that's always like that duality of looking more places but being really precise in what you're pulling back, because you don't really want to pull back stuff that people don't care about.

Speaker 2 52:26

I know I'm saying it very bluntly, but noise means something we shouldn't have looked at. False positive means something we shouldn't have, human shouldn't have looked at it in the future estate. So that's kind of what's next for PV in my mind is getting through this transformation for the rest of this year in the early part of next, and really beginning to dig into these more high science business use cases in a much deeper way, and my analytics team can't wait for it. My TA scientists can't like. All all of them want it. We're just building this foundation to try to make it a reality.

Speaker 1 53:01

Bill, I feel like I could do a five part series with you. It's been absolutely fascinating talking to you today. Thank you for coming on.

Speaker 2 53:10

Absolutely. Thank you for having me anytime. It was a fun conversation and, as I said, I generated a couple of insights in this as well, just talking through things, so thank you for that.

Speaker 1 53:19

Thanks Bill, thanks everyone.