Sibel Guerler

What do you get when you combine a background in neurobiology with a serendipitous introduction to pharmacovigilance? Join us as Sibel Guerler, Head of Strategy and Safety Evaluation at BMS, takes us on her remarkable journey, where life's unexpected turns have led to a fulfilling career in drug safety. Transitioning from managing databases and hard copies to embracing cutting-edge technologies, Sibel’s story is a testament to adaptability and the power of seizing opportunities. Her insights offer a compelling look at how passion and a supportive environment can transform a career into a calling.

Explore the highs and lows of working within large organizations like J&J, as Sibel recounts her early days of navigating complex structures and learning from seasoned mentors. From establishing an oversight group to managing diverse responsibilities in smaller markets, her experiences illuminate the intricate world of pharmacovigilance and the importance of cultivating leadership skills. The episode unfolds with her transition to Celgene, where her enthusiasm for technological innovation reshaped her professional path, showcasing the dynamic evolution of roles in safety management.

As Sibel reflects on the broader shifts in pharmacovigilance over the last two decades, we uncover the impact of pivotal FDA and EMA legislations and the pressing need for modern, agile approaches to safety. With a focus on integrating safety considerations into digital health ideation, she challenges outdated frameworks and highlights the strategic role of safety teams in the competitive landscape of drug development.

Transcript

Speaker 1 0:15

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

Speaker 2 1:32

Hi, very good to be here.

Speaker 1 1:35

So, Sibel, as we always start with this podcast, it's an age-old question how did you get into safety? It's an age-old question.

Speaker 2 1:45

How did you get into safety? Yeah, and it's as many people, by chance. So it wasn't a purposeful career choice. But growing up in Switzerland and just finishing and graduating in neurobiology, I, like many other people, was looking for what can I do after that? I planned to be in academics, but then academics. I was in there for a good 18 months and it just didn't suit me that much.

Speaker 2 2:27

I came into a lab that was very world renowned for what they did, very ambitious and O-Tone, my PO. At the time I wasn't a shark and I didn't intend to become a shark. So I was and I didn't really know what would the pharmaceutical industry have to offer. So for me then looking for jobs in the pharmaceutical industry, in the very beginning it felt odd and I was ultimately found by a recruiter. Um, I have a background in kind of maintaining databases, some sql and r coding that I've done throughout my studies and I've done two years of med school and I've worked for a year in an orthopedic hospital, so kind of at the interface of a little bit of medical knowledge, the scientific aspect, and then with the database, quite suitable for PV. And then when I was contacted as, I think, probably many other people. Unfortunately, I first had to Google what is pharmacoriginals? Because when the recruiter came to me and said I have this role in a group that never hires people off university without experience but they are desperate so we might get you in I was like okay. And then I was reading what pharmacovigilance is all about and all of a sudden I felt like, okay, this doesn't sound like the big bad pharma. I grew up in a household where that notion was propagated about the big bad pharma and the bad medication and that's just, you know chemistry that you put it pumped into your body and obviously I've come a long way since then. And obviously I've come a long way since then. But it just felt like something that I felt, yeah, I can get behind doing that, even if it's just for a year.

Speaker 2 4:41

Right, I didn't go in into pharmacovigilance, into my first role, thinking I would stay there at all started out and my very first day in pv was with heart copies. It was a small vaccines company run by an extremely knowledgeable head. So shout out to katarina hartman and she basically walked me through and then you take the files of the adverse event and then you go and you do this and then after that you bring it back and you put it back here so that the next person can come and take it. So this was my very first day in safety and that's how I started out, and I was lucky as well. So it's not just that the subject matter of PV spoke to me, but it's also. I was surrounded by really good people early in my career who I was able to learn from tremendously and also tremendously fast, and was given a lot of opportunity to learn and grow, and I think that made all the difference for me now, almost 15 years later, still being here.

Speaker 1 5:49

And when you walked in that first day and you saw the filing system and it just brought back memories for me. But when you saw that filing system and you were entering your first case, how, how, how did you feel that? Did you think at that point that this would be your career or did you think, wow, this is a stop gap for me right now?

Speaker 2 6:17

well, I did not think that this is going to be my career. It was even worse than that. So they didn't even, as I said, they didn't typically hire off of university or from academia, so they were only hiring, typically, people that had safety experience. So I was the exception, out of desperation. So I was also lucky in that moment, because they felt like I wasn't qualified enough for that and they would have me look at cases so that I understand what they were, go through the archives, understand what happens here and then do reconciliation. So in my first month I would do reconciliation only of single cases and of course I did not think, oh, this is the big joy.

Speaker 2 7:07

I remember that day very well when she showed me, like, how things go. I mean, I did neurobiology. I was thinking about, I was studying how the brain works, right, and I was thinking this is going to be my career because I do have this huge fascinating for how our brains work. And then I was there looking at these little files going from one little folder to the next and I was thinking there was like a part of me who felt like, well, you didn't fit into that highly ambitious, highly ambitious lab environment, right, I wasn't a shark. I ended my medical studies after two years because I was young and stupid and rebellious and that entire environment just put me off entirely, and I've never been this demotivated in my life.

Speaker 2 8:07

So I felt like, okay, I wasn't good there, I wasn't good there, so this is now my punishment. Right, you need to go through this at least for a while, until you figure out what you're good at, right. So that was a part of me just accepting that this is now just what I have to kind of work through. Now. That was the first few weeks. The team then very quickly realized okay, this, this person can do more and has actually a brain on between her ears and on her shoulders that actually works and that we can leverage, and there was a need for support. So I would start then doing cases very quickly, and I would then very quickly I can't even tell how many months in, but just a handful of months in I would work with two very experienced case managers, case processors, and I would be the one creating for the first time for the small company case processing manual. So I went from being nothing to actually trying to coordinate, because there were these two powerhouses who had 10 plus years of experience, but both from very diverse backgrounds and they were fighting nonstop about how cases have to be entered and then my uh, katarina hartman, knowledgeable in all of her wisdom, she was like, okay, like let's do the diplomatic route right, let's do the swiss route, let's have the youngster no threat to anyone actually um, coordinating and guiding us through to getting a procedure for the first time, right. And that was then kind of the first stone and that was obviously very interesting, because when you do that and you go through each and every field in a single, in a database, you learn a lot about what kind of data you actually get, a lot about what kind of data you actually get. And then that was then a stepping stone to becoming the super user for the database, to then managing the upgrade which then became a migration, a database migration, and then at the same time and I think that was even after my four, five, six months I was also able to write PV reports on certain topics, or toxicology reports.

Speaker 2 10:30

It was a small company, right, so when there were deviations in manufacturing and things like that, so I would be the kind of the initial author and then I would have obviously supporting guidance and coaching from that person and then from a medic or from an experienced scientist in the group. It was a small group, we were just a handful of people, so they would then kind of review the work and make sure that I got better at what I did. And that was obviously very interesting and I was, I would say, on track to become a PV scientist. Interesting, and I was, I would say, on track to become a pv scientist.

Speaker 2 11:09

I would also start to do this proportionality rate manually in excel at the time, um, and and review aggregate reports and things like that. So I was, I was on track to becoming a pv scientist. And then we were acquired by a large company, uh, where I quickly realized I do not want to become a scientist. It was very, very, very proceduralized and I was deep into the database and the technology piece at that time already. So that then kind of steered my track into that direction.

Speaker 1 11:42

So when this company got taken over by a bigger company and you decided scientist isn't for me, how. What did you decide to then move on after? What was the point that made you move on to the next company?

Speaker 2 11:58

So first of all, I needed to manage the integration of the global safety database. Right, it was a company that was on track of doing a very large novel database project and we were about to do an upgrade of our Iris Global database and I was then told we have a better idea. You migrate your small, lean, agile database onto, onto that thing. You be our guinea pig, and then we will learn from that. And then that's what I did. So that was my very first task and then I would also at that time I was already managing the entire operations and compliance part of of safety of that small vaccine company, and then I would these two things together and that was very challenging and I was learning and growing so massively that obviously I stayed on yeah, until that was seen through. Yeah.

Speaker 1 13:01

And then where did you move on to next and what was?

Career Evolution in Pharmacovigilance

Speaker 2 13:05

yeah, that that was. That was a big step. So, because I came from this small background, um and we the large company was jnj I'm sure I can say that um and I through the database migration, I was the person who had to pass on the unwanted message of this new thing is no good, and obviously I did so very clumsily in the beginning and you know, I violated, like all of the rules of matrix leadership and how to speak up in a matrix, complex matrix organization. But I had a mentor who unfortunately passed away now, um, colin cornhill, and he really took me a little bit under his wing and coached me through that. So when that entire adventure was over, I was actively looking for something in his organization and one thing that they did not have yet was then the oversight group. That didn't exist at J&J at that time. Okay, yeah, yeah, yeah.

Speaker 2 14:17

I think sometimes people, because we are complying with regulations, sometimes in safety, we forget how recent everything is and how much everything is in flux, just because we've achieved some level of stability. Now. It hasn't been that way. Yeah, and this is not that long ago, right? Yeah, a decade ago maybe. And then I would.

Speaker 2 14:44

I wasn't the head of that group.

Speaker 2 14:45

I was kind of a manager, senior manager, I can't remember exactly in that group and I would help set the leader up for how to do when the oversight um at j and j um, so that was then a completely new thing, um, new learnings, learnings that I still to this day draw from, because this entire contract thing and measuring and KPIs and uh, that that's ultimately when you work in safety, that's, that's always relevant.

Speaker 2 15:23

So I I felt like that was a very, very good learning, um, but then I had the opportunity, um, to move into a local safety officer role. Oh, okay, and then I had the opportunity to become the local safety officer for Switzerland and for Austria, which was the master at that time, and, um, yeah, so I dove into that adventure, which opened up a completely new set of eyes and uh, and, and now I am of the opinion that everyone who works in global pve should work in local, local PV once in their lifetime, even if it's just for kind of like a small tour of duty or secondment, or however you call that of kind of like five, six months, but it really opens up a whole new world because you realize that at the local level they are wearing 200 hats almost every single day.

Speaker 2 16:32

And then maybe, if it's a boring day, maybe it's just 10 different hats, but if it's an exciting day you're doing so much right, especially in the smaller countries. It might be different if you're in one of the major markets, like Japan or UK or so, but in the smaller countries you just jump from, you just do so much different things. It was a treasure trove of learnings, I would say, but it was also a huge, huge amount of pressure to do all of those 200 hats justice, right. So it both things were true at the same time. But I really believe that when you do that kind of work, you also start to realize that the company is being served, and especially the HCPs and the patients are being served in the markets and not in some global PV function. And when you start to realize that that's actually where the music is supposed to play.

Speaker 2 17:32

And then you see how PV organizations traditionally are set up. Where actually is the global driving most of the things? Where actually is the global driving most of the things? And the local international PV is more kind of a afterthought customer, like a third, second or third tier customer, of what the global teams do. You suddenly start to realize, okay, there's so much work to be done. That was very fascinating. And then I moved in. Then I changed organization organization. I left J&J because I needed to reduce my commute.

Speaker 2 18:05

I was pregnant with my second child and I had a two hour 15 minute commute and I was just like, yeah, and in Switzerland Switzerland is we, you know resilient US people, they they have much more resilience to doing a long commute. For us in Switzerland that's like a big tragedy if you do that. So after doing that for a while, and while I was expecting my second child, I just thought, okay, I need to change my living situation. We tried to move closer but that didn't work with my partner's work ultimately. So I had an opportunity to join Celgene and case management. I would not have case management by if I had like free choice, but it was a great opportunity Nonetheless. I must say I've really learned a lot there as well. And then I think from there it really became. I had a leader who would give me a lot of space and resources. I still work with him, sam Wallace, and he gave a lot of space and protection to do technology projects.

Speaker 2 19:25

So back in the day then the new fancy thing was robotic process automation, and then we did the bot. We had the first validated bot in the entire company and then we were integrated. We bought by BMS, so my second acquisition and then we were able to do just before that we were able to deploy both in Celgene and BMS. So my second acquisition. And then we were able to do just before that we were able to deploy, both in Celgene and BMS, the first AI model in a GVP process, so in-case processing, and that basically then opened the door when an innovation group was created to say, okay, this, this lady here, she seems very stubbornly motivated by that. Um, how about we? We put her in that position and then that's what?

Speaker 1 20:17

yeah, and then, how is that different to your current role? Or is that not really that different, or is there an evolution of that?

Speaker 2 20:26

Yeah, that's a good question and, by the way, you gave me good feedback by messing up my title in the very beginning of the podcast, because the title is dreadful. I kind of chose it because it seemed like the least dreadful one, but all those fancy-pancy words strategy and safety evolution, not safety evaluation.

Speaker 1 20:56

Oh sorry. No, it's fine because it is a funky title. No, I think I read it completely wrong. I'm just looking back at my notes and I wrote it down as evaluation as well.

Speaker 2 21:04

Because that's what we expect, because safety evaluation is a thing and safety evolution is not yet the thing, right, that's why. So I had the privilege of reporting into a really great individual, samin Desai, and he then moved into IT into a really great individual, samin Desai, and he then moved into IT. And so my start in innovation was reporting into him. And then when he moved over into IT and we're now partnering on initiatives together which is fantastic is that then I would start to head up the innovation group, but then I also had vendor oversight because of my past experience under me, and then now it is a bit. We're now no longer a true innovation group. The group has grown.

Speaker 2 21:56

So I have we're now nine people in total but we do strategy with the senior leadership team team, help them define the priorities for the year, and then we are driving and kind of catalyzing to, in partnership with the different functions, strategic initiatives, right, oftentimes with a digital component.

Speaker 2 22:18

We have a function that's digital capabilities that tries to progress digitization across the organization. We have kind of like a metrics governance type of function that tries to also then bring in a more, more Right Measuring are we moving in the right direction at the right speed? Are we moving in the right direction at the right speed? So from that perspective, it has evolved quite a bit, as opposed to an innovation group, who is mostly focused on ideation and doing proof of concepts. But a lot of the work and the tools that we're using are still very similar. So the spirit is still the same same, but it just has, I would say, maybe more oomph now because it's also it's evolving right and we're learning and we're maturing as well I mean, to be honest, that's that is quite a fascinating career you've had.

Speaker 1 23:18

Um, the fact that you know, you started off in the lab and then you went and just did normal case processing, yeah, um, you managed an operations team and then, you know, you uh went into vendor management relationships and then you then went to local pv, which is even more crazy because, let's be honest, I think, I think if you were to say to someone that they went from vendor relationship management to local safety, a lot of people would say, well, that's a complete step down. But actually, from your perspective, actually it was a brilliant masterstroke of a career decision. Masterstroke of a career decision. Yeah. Then then going into global case management and then this whole digital innovation, into, uh, strategy evolution, I mean it's quite an incredible career and it's it's not been the longest of careers.

Speaker 1 24:18

And I want to point out something that you specifically said, which is the history of PV is very recent. Yes, and you know, I think you've had a fairly, you know, a 15 year career is pretty, is pretty, still pretty young. And you know, with talking about when you started, you know we had folders and paper. It's incredible. I mean it's been a fascinating career? Certainly, and the question I have to ask is how has those experiences made you as a leader now, the fact that you have gone through all these different processes? You touched upon it a little bit earlier about the fact that actually, secondments are a thing that you would encourage, but what do you think that those experiences have built you as this leader now?

Speaker 2 25:28

well, in one word, entirely, because I think I was a crappy leader at the beginning. I think you know and I always say this to my team as well like a broken record, I actually truly believe there are no good leaders or great leaders. I think leadership is a series of actions that you take Actions between human beings, right, which makes it different from managing a process or managing a system right. It's about sensing what's needed, managing yourself in a way that you can show up in a most productive way and then interact with other people in a way that is helping the collective to get where it needs to be. So it's a series of actions, which also means that you need to learn to do as many actions as possible, and you need to learn to, meaning you can be a great leader this year, but then if you say, I've achieved my thing, I'm now just going to kick, you know, kick back, put the feet up and not do much, you're going to be a crappy leader next year, right? So I really think there is a and and, and this is not my original thinking. I'm, I've I've learned that as well and in leadership courses and so on, but this has really resonated with me, because I think it's profoundly true that it's really how you show up, in all of the little things that you will always and I definitely do that, and I think everyone else does too mess things up and there are missed opportunities and and and little situations, even if they're like teeny, tiny small in the moment, where you are not a good leader. Right, because you miss to do that critical action that would have helped everyone move forward in a good way. Right, but then, at the end of the day, you've done I don't know hundreds of these little micro actions and then I think it's being put on on on a scale right, how many of them were the right and the good ones, and how many of them were you know so, so, and how many really bad ones did you do? And then, at the end of the day, that that determines whether you you are good at that, and I think diverse experiences are absolutely crucial.

Speaker 2 28:31

Right at being a good leader, because you learn to be adaptable. You learn that there is never just one way of seeing things and one way of doing things. You learn that there are many different ways and you learn all and many different perspectives and you learn that several things can be true at the same time. Several ways of doing things can be bad or good at the same time. You learn how to also understand your own limitations without being intimidated by it.

Speaker 2 29:12

Because every time you come into a new setting so, for example, you've mentioned that, the global role to local safety officer it was a risk.

Speaker 2 29:22

It felt like a risk and it felt like not necessarily a good career move, but somehow I felt I needed the excitement because I knew that the vendor oversight role once the basics were established, I knew this is not going to be interesting to me Compared to the big, big things I did before.

Speaker 2 29:44

I knew I'm going to be bored out of, out of my mind if I stay there. So for me, I had to take that risk because I knew I need, I need something new, right, and. But it felt like I had this level of angst because of that, because of that traditional thinking, because I was thinking, oh, I'm gonna lose my global scope. That kind of it sounds really silly now in hindsight, but it did scare me and it was such a nice surprise to see that, yes, this global thing has closed but a whole new thing has opened as well. And I think what happens when you do these different types of things is you also get more self-confident, and I think not in a cocky way, in a very humble way, because you realize every time you come somewhere new, you're kind of nothing.

Speaker 1 30:45

Correct.

Speaker 2 30:46

And that's okay. And then you learn and you can find a way to add value and get appreciation and bring progress to wherever you go.

Speaker 2 30:59

And that gave me a lot of yeah, I don't know whether that's a term, I'm coining it now humble, humble, self-confidence, right okay, yep because I think, as a leader, one of the biggest one is one of the common downfalls that I see in colleagues that I like very much and hold in high regard is that there's a profound insecurity sometimes and that the actions that they take, even if not on purpose, are always a certain percentage is targeted towards satisfying that need to not feel insecure, and that's just a drain for everyone, right, it's a drain for the team, it's a drain for being effective. So I think just being kind of learning to just realize things happen I'm here, I'm not that important, but I can add value and that's completely fine. And you've done this and repeated this in a lot of different settings is tremendously powerful it's fascinating and talking about adding value.

Speaker 1 32:19

So when we first met at World Drug Safety Congress, you were on a panel which was talking about people and transformation and change, uh sort of safety ecosystem. Um, in general, how do you bring that that across? And and you, sorry, you were talking about value creation is what I was saying how did you, how do you bring that across across the safety ecosystem then to create that value?

Speaker 2 33:01

yeah, oh, I wish I had an answer for you. Um, if I had an answer, I'd probably buy truliant and make it gigantic but you don't need to be.

Speaker 1 33:22

You don't need to be that nice to us.

Speaker 2 33:26

No, because then we would go off and consult and give everyone the key to the castle. I think, because I think, if I understand your question maybe just to frame it for people who might not be thinking that much about that as I do, because I almost obsess about that question I'm just taking a step back right of the safety ecosystem, together with health authorities and CROs, and in the MAHs is we've done a revolution because we've inserted ourselves into a system that is the fast shareholder quarterly reporting cycle as a big cost center that does not add immediate value from a commercial perspective right, and only in the rare instance that really something goes awry and we can catch it beforehand, which is also also difficult to measure because it's a hypothetical. So we've managed to insert us, insert the legislation, the system, the oversight, the processes, the people into something that did not want us. So I really feel like we are all warriors because we, if you've been in safety for more than a decade or for this, this amount of time, you've been to places where you were not wanted and you had to make sure that you somehow get a seat at the table. So I actually think we are like a bunch of revolutionizers and a bunch of warriors. But and this is where this is where it gets really interesting how we had to do that is by is by leaning on legislation and saying this is the legislation, we need to be compliant, and that was the key for the door, to open the door and for us to get a seat at the table Right, which is why so many people in safety now are so stagnant in their thinking, which drives me absolutely insane, because the how we did it suddenly becomes the why, which is so wrong? Right, because we did it. We did it how? By adhering to legislation and making everybody else in the organization understand that this is the legislation and we need to adhere to it. That's how we did it, but why we did it? And what we did was disrupt the system and make sure we find a space in something that did not necessarily want us there wasn't like.

Speaker 2 36:32

We are the only science because, as per who definition, we are science. Right, pharmacogenesis, science the only science that I know scientific field that has been brought into existence by a legislative poll. Think about that. Everything else astrophysics, programming, computer science, mathematics all of that was brought into life by people's curiosity and then, at one point. It reached a tipping point and there was value to be created, there was value to be generated, there was money to be made, status to be gained. So things became true.

Speaker 2 37:18

Scientific disciplines, right, and pv is different. P PV started out in an industry that had its value creation by generating drugs that help people and that we can sell in a profitable way, which I have no problem with. That's a good thing. But it needed the legislative pull for us to come into true existence. And obviously there were already people in many companies that did safety before that, right in the 50s and the 60s and 70s. But it was more kind of like a side project of people who held themselves to really high standards as it was a true discipline.

Speaker 2 38:07

Yet right, and it was tragedies ultimately that led to this legislative poll. Right. And now we have established that. We have established a foundation right. When I speak to people sometimes I use the analogy of building a house and we now have the piping with the flowing water and the sewage and the electricity. That's now established. So when you go out now and you want to talk to an architect about the house that you want to build or you talk to your friends about it, you wouldn't talk about the electricity, you wouldn't spend time about it. And then I go to the light switch and then every time I click, the light comes on, right, you don't, you don't spend your time talking about that, right?

Speaker 2 38:58

but in safety, we still talk about the light switch and we still talk about, and then I flush the toilet and that just goes down and how we report these basic things, we still report up to the company's leadership team or even the board right Submission compliance, icsr submission compliance and we still talk about those things as if they were the interesting thing, because we gotten so used to the how, which is adhering to standards, that we forgot the why we are here in the first place. So I really hope that, at least in my vicinity and I know there are many, many like-minded people in the industry that we can get to a place where people start to think about okay, let's go back to why we did it and what we did. Why is doing keeping patients safe? And how we did it is by being really disruptors and warriors and pushing things and expanding things and progressing things. Um, so that's that's what I'm hoping to see, right, and I think the people aspect there, because I think we've we've met about it through this, uh, this, this panel that was talking about.

Speaker 2 40:23

If you want to do digital transformation, the key is not the system, the key, like in a system, like a technology system, but the key is. The key are the people, right, and I think that's that holds true. But for that, to get us to that next place, those people need to realize and have a bit of metacognition, a little bit of contextual perspective, and realize that it's not just about adhering to compliance, but that there is a why adhering to legislation. But why is that legislation even there and what are we trying to achieve? Why is that legislation even there and what are we trying to achieve? Because now, I think data and technology enables us to do more.

Speaker 2 41:19

Society has in the last 20 years, since we are having, I think, fda legislation was around 2005. And then 2012 was the EMA legislation, the GDP modules, and that really shaped how PV systems look today. Right, those two I mean there were legislations before that already, but those two, I think, brought it to the next level. But I think since then, technology has advanced. I mean, in 2005, basically, no one had a smartphone, right.

Speaker 1 41:50

Correct.

Speaker 2 41:51

Like life was different. Back then Social media didn't exist the way it does today, like it was in its infancy. And when I think about when I started out in safety, which was now 14 years ago, I think about when I started out in safety, which was now 14 years ago, I think we had the files right that go from this thing to this cabinet and then they go here and then we go there. So Life, society, technology, expectations as well, are massively shifting. Expectations as well are massively shifting, and I think that in itself makes it possible to do more than what what was laid out 20 years ago in legislation because legislation is also years in the making, right. So it's it's it's it's 15 to 25 years ago that the thought process went into those two legislative polls, and since then so much has happened and so much more is possible that I think it is intellectually lazy to just think that's all that safety should be.

Speaker 1 43:04

Again, fascinating insights there. Um, intellectually lazy I. I love that. And actually there was another thing I was thinking about and I may have just lost the plot because of the last thing you said but, um, I was thinking are there people deliberately being ignorant about where safety is?

Speaker 1 43:29

because I I can tell you now, this year I was in a conference where someone still was saying safety needs to push up and be on the be at the table. But actually your argument that you've just that you've just spelled out, is absolutely true Like safety is at the table. And to go back to that intellectually ignorant piece, have we come to a point where we are so where we are, so we have used the legislation as a crutch so much that we need it to help us push any agenda that we possibly need to do.

Speaker 1 44:18

Yeah, so it's there's several questions in there, what you just said yeah, I'm so sorry, but I had so much on my mind.

Speaker 2 44:33

They're all really good ones. So let's start with the beginning. I think and you're spot on People still have this thing about the seat at the table because, you know, two things can be true we exist, we have the headcount, we have, we exist, we have the headcount, we have the resources, we have the databases, we have seat at certain tables, but safety is not yet. I mean, at least at BMS, but I'm pretty sure it's the same elsewhere. And especially, I think, if you are in a small biotech company that goes through, comes to commercialization, oftentimes early on, biotech completely outsourced and you know that, right, because you work at the company who takes on that work occasionally Right, so early, early on in, it's completely outsourced because it's just not yet worth to a small biotech company to implement a safety pharma questions department just yet. So oftentimes in those early stages, safety is outsourced. And then only when it, when we approach commercialization, that's usually when they start to think about now, now let's build out an actual internal safety organization, and that means then they also need to still fight for that seat at the table because the company has functioned without safety before, right. So that means that that is still true and I don't want to deny those kind of experiences to those people, because that's still true. But even in a company like BMS, where safety is very well established and respected for example, we are having a very good connectivity with our digital health organization, which is part of IT. But we just had a conversation just yesterday with them and this is a very friendly, collaborative environment, right, there is like no challenge on a human level at all, right, and still we were talking about when is the right moment for safety to be brought in for ideation, because we also realized it probably would be more helpful if safety could be involved much early on in ideation so that the digital health solution is being set up in the best way possible, leveraging the knowledge that the safety physicians have. Right, they know the risks better than anyone in the company of their particular compound. They might also have really relevant clinical experience from being physicians in practice that they can bring to help devise something that's actually viable right beyond just a clinical trial, and so that's also a conversation where we're talking, which is also about having a seat at the table, and I think this is now where it's shifting.

Speaker 2 47:21

I think putting out drugs to the market has become more expensive, right? That's a known fact. The amount of dollars that need to be poured into development until the compound can be commercialized is increasing constantly. And then we have technology supporting drug development as well, meaning also that the competition is getting tougher, meaning that what you can do because ultimately comes down to a benefit risk balance. That's what it's all about, and in the past risk was left to safety and benefit was left to kind of the rest of the company and in development, to drug development.

Speaker 2 48:13

But I think in how effective a drug is, there's much progress being made that there's also less leeway of being able to do huge strides there, of being able to do huge strides there. The field has become more crowded and that makes the focus shift more to safety. Because if you want to affect the benefit-risk balance so that it's as positive as possible, so that you can be as successful on the market as possible, and the benefit is getting more and more maxed out in in just the progress that drug development organizations have made in the entire industry in the last decades, right now suddenly also risk becomes more relevant. And now that we have electronic health records, now that that we have variables, suddenly you can manage risks in ways that were inconceivable 10 years ago. Right.

Speaker 1 49:16

Yeah.

Speaker 2 49:17

It's also the possibility now to manage risks actively is changing, and I think this is where we can start to actually become part of the value creation, because going from transactional to value based sounds very fancy, fancy and, admitting this now openly, for a very long time I did not understand what it meant, like I read it on slide occasionally, I even said it myself, but I didn't really fully grasp what are we meaning with this?

Speaker 2 49:59

And now, at least to me, it's much, much more clear now. And this is instead of just assessing the benefit risk balance and reporting out to health authorities through our reports and all of that that we do, this is the benefit-risk balance. We now start getting into that chapter where we can start to proactively manage it, influence it so that the benefit weighs more. Also, personalization genetic testing right in oncology, for example, where you can have certain biomarkers Is that the right person for the treatment and so on or is that person at risk for a certain severe adverse event, yes or no? Like there are now all of these opportunities that were just not even an option 10 years ago, right.

Speaker 1 50:46

Yeah.

Speaker 2 50:46

And 10 years.

Speaker 2 50:48

Most of us and those that take the time to listen to it we might have already been in safety 10 years ago, and this is now completely different, and I think we're not yet at the stage where technology and data and all of that and the biomarkers are this advanced yet that we can expect an automatic pull right.

Speaker 2 51:16

It's not yet that if you don't do these things as a safety organization, you're going to be fired, right? We're still. We're still away from that and I have no clue when that's going to come. But I think that's the value creation. That's why, also, I always have to smile when people look to health authorities and say but they need to legislate so that we have the power, because I think the next step is legislation will always be there, right, there will be new legislation coming out and we will be able to leverage that again to try to be compliant and try to adhere to that right in a way that we should. But I think there will be value that can be generated through proactive safety, and that's when things get really interesting and that's when the seat at the table will be given freely, right.

Speaker 1 52:20

Yeah, sabelle, it's been absolutely fascinating and as we draw a close onto this podcast which, honestly, I could go on forever and speak to you about multitude of, I still have about 50 questions, just what you've just said I'm thinking about. You know, legislation doesn't seem to be able to cope with the pace that pharma companies are working at. There's so much we could go into, but and it shouldn't.

Speaker 2 52:52

It shouldn't. Who, who, who said that legislation is to pave the way? It has never been that way anywhere.

Speaker 1 53:01

Right, and it's, it's, it's, it's fascinating and, like I said, I wish we could talk forever. Maybe not forever, but at least maybe another couple of hours. We can do the part too. Um, but you know the the? The podcast is called innovation and the future of pharmacovigilance. So, sabelle, what's next for PV?

Speaker 2 53:27

So I think that we need to get the fundaments.

Speaker 2 53:34

We need to shift our focus from the electricity and the sewage system and the flowing water to the fancy terrace that we're going to build and to whether we want to have an attractable roof or whether we want to have a winter garden or whether we're going to have fancy Japanese toilets everywhere. And I think that shift, going from just adhering to legislation and nobody denies everybody wants flowing water and everybody wants electricity this is an achievement, nobody denies that, that we all want it.

Farewell and Thanks

Speaker 2 54:09

But we've established it, we've proven that we can do that. And I think now I'm looking to all of the leaders in in in the industry to step by step uncover what the rest of the house is going to be and shift the focus away and not let those basics and fundaments of a house take away all of the focus and really make sure that we have the discipline to have the focus on what can be next, and it must be something that will generate value and that's most likely by being able to not just assess benefit risk balance but to really actively manage it and and and improve it for patients sabelle, thank you very much for joining me on this podcast.

Speaker 1 55:01

Uh, I'll say again, it's been absolutely pleasure to speak to you thank, I've enjoyed it as well.

Speaker 2 55:07

Time flew by.

Speaker 1 55:09

Time did. Thank you again and goodbye everyone. Bye.