Co-Founders End of Year Extravaganza II

Unlock the potential of the future in pharmacovigilance as we chart the transformative journey of the industry in 2024 and beyond. Discover how smaller companies are spearheading innovation by filling niche gaps, while larger players focus on comprehensive platform-level needs. Witness this dynamic balance creating a fertile environment for both cutting-edge solutions and agile advancements. Gain insights into the evolving role of AI, as we transition from an AI-led to an AI-assisted world, where human expertise continues to steer complex processes such as case management.

As we navigate the rapid technological advancements in the pharmaceutical landscape, we explore touchless case processing and the intricacies of integrating regulatory and safety databases. The episode sheds light on the challenges of aligning cutting-edge technology with business needs and the burgeoning curiosity about peer strategies in tech adoption. Our discussion emphasizes the need for standardized processes in business development, highlighting creative strategies like mergers, acquisitions, and partnerships that aim to streamline pharmacovigilance activities and enhance scalability.

Celebrate the accomplishments and resilience of our younger colleagues and the Truliant team as we share key moments of pride from 2024. From executing successful safety summits to crafting significant proposals, the dedication of our team shines through. We offer career advice, stressing the importance of flexibility and adaptability in a rapidly evolving regulatory landscape. Join us as we honor the legacies of Tony DeSouza and Alan Hochberg, and look ahead to a future where innovation thrives through continuous learning and collaboration.

Transcript

Speaker 1 0:15

Welcome to Innovation and the Future of Pharmacovigilance, a podcast series brought to you by Truliant Talks. I'm your host, indy Aluwalia, and I'm delighted to navigate the dynamic world of pharmacovigilance and risk management with you. However, with this being a special episode featuring the co-founders of Truliant Consulting, while their views may be expressed, please note that any mention of vendors, products or services should not be taken as an endorsement. Instead, we encourage you to view the information holistically, considering your department's goals and requirements when evaluating any recommendations. So today we're going to be taking an in-depth look at the events that have shaped the landscape of pharmacovigilance and risk management in 2024. We're going to also consider some predictions for the year ahead, in 2025. So I'm delighted to have the co-founders of Truliant Consulting with me today, but before we begin, jamie, I know you wanted to say a few words.

Speaker 2 1:23

Thanks, indy. I know you wanted to say a few words. Yep, thanks, indy. Sadly, we did lose two colleagues this year who we at Truliant were very close with. Tony DeSouza was someone who most of us have known and worked with for nearly 15 years. Tony was genuinely a wonderful, amazing person. He was a true professional. He was so very knowledgeable and always extremely supportive of us as individuals and more recently, as a business. We all I know I speak on behalf of all of us we all were very privileged to work with him over many years at Novartis and also to have him as a friend, and Alan Hochberg and I first met at the DIA meeting, the annual meeting, nearly 15 years ago. I would say we became fast industry friends. He also was a tremendous source of PV knowledge and expertise. He was always willing to answer my many questions. I would ask of him he would share his perspective. He introduced us to some wonderful people in industry. He was a big supporter of us at Trulian and we miss him dearly. Thanks.

Speaker 1 2:28

Thank you, jamie, for those words. As we look through both the lows and the highs that we had over this year. We had our first ever safety summit, the podcast. We had our first ever safety summit. The podcast, surprisingly had a second and third series. We did webinars with many, many people this year. On top of that, we also instigated our newsletter, which was another thing that we added to our collection of keeping the conversation moving forward. But, saurav, I'm going to ask you first what are your memories from 2024 and what are your key takeaways?

Speaker 3 3:19

I imagine you're talking about and referring to my memories in pharmacovigilance, so I'll limit you to that.

Speaker 3 3:30

Well, I think there are two major things that I've been thinking about. I think last year, when we spoke about what will happen in 2024, we spoke about how we are sort of inching towards what I'd describe as a tipping point. I mean, to me, if you look at any innovation, a lot of progress happens behind the scenes. It gets unnoticed until all of a sudden, you know, transformation happens. If you look into chat, gpt, for example, I mean we saw it first, I think, in November 2022 when it was released, but we all know what all happened for years and decades to make that moment possible, for years and decades to make that moment possible, and I think a lot of what we saw this year is a movement towards that tipping point and we're getting closer, even though there's a lot of focus. If you look into the pharmacovigilance lifecycle, there's a lot of focus on intake right now and there are other areas like signal detection, predictive analysis, et cetera, that necessarily haven't been addressed or have been thought of as use cases that companies can take. But I think it's a matter of time that you have one domino falling and the rest follows. So that's one thing. I think we continue to make the progress and even though you know you can look into this progress and say it's slow, but I think you've got to go back to um, the fact that it all seems very slow and pointless till the point the transformation happens. That that's my first reflection.

Speaker 3 5:22

I think the second reflection comes from a conversation I was having with a friend who runs a small company in the advertisement world. He runs a small AI tech company in the ad world and he was talking about how, in his industry, smaller companies come and innovate. In his industry, smaller companies come and innovate and if you look, there is a pattern to it in our industry as well, and we saw some examples of it this year and I started thinking about it. Why does it happen? And if you talk about large players, companies that are trying to integrate clinical quality safety all in one platform, for companies like these that have such a broad perspective, it is just so hard to focus on a new requirement that Korea has come come up with, or a new regulation that needs to be dealt with, or a use case that's just not relevant to them or too small for them to focus on, and therefore, what happens is you, you have these smaller players that come in and they start to innovate and they fill these gaps, and there are many such examples in our industry as well, and I think a couple of years ago, I used to think that maybe there'll be a lot of consolidation, smaller players will disappear and big companies that are trying to come in and create these large platforms will address all the needs.

Speaker 3 7:08

And I think I have changed my point of view on that, because if somebody's trying to, as I said, integrate an entire ecosystem, it's just impossible for them to take care of every use case, and therefore, small, agile players come in and make their mark.

Speaker 3 7:29

And I'm not saying that the industry needs one or the other. I think the industry is well-served in an environment where you have these large players that are addressing what I would describe as, let's say, platform-level needs, and then innovators who can fill the white space, who can create whether it's tools, services, whatever you be and when I was describing what I was saying, I was not just focusing on tools, by the way, it applies to anybody who provides services as well and I think this combination of larger companies focusing on what they're good at and smaller companies focusing on what they're good at is great for the industry. So that is one reflection from this year, where maybe I had a different point of view. As I said, but going with some examples that we saw our own growth and how we've addressed some of the needs, I truly believe that this combination is what the industry needs to continue to move forward. So those are my two top reflections from the year.

Pharmacovigilance Technology and Process Trends

Speaker 1 8:53

Do you think, Ishan, that there's almost a push for this new technology so quickly that actually people just get frustrated that it's not necessarily creating the value that they want almost immediately?

Speaker 4 9:14

In some situations it is To go to a situation where technology can argument the needs of a large or a small pharma is to have touchless case processing as an example and we have the technology to facilitate something like that. But depending on the size of the company, the scale, the category, the kind of products they serve in, the kind of markets they serve in, it's not always touchless and you need to have different requirements in different markets, different countries to have to take care of them. And when you try and push something like that without the right kind of time and focus in defining the requirements and defining the use cases properly with the business requirements and defining the use cases properly with the business, what happens is you end up with a situation where you have the technology but it's not serving the business need or the use case that you set out to achieve In the longer run. One of the things that I in 2024, I totally wanted to happen it started to happen but it's not there there is the integration of some of the larger business use cases, integrating regulatory technology, regulatory databases, with the safety database.

Speaker 4 10:35

All our products are in the regulatory databases, all our safety configuration is always separate and there are countless issues and countless challenges that we've seen in all sizes of companies, and vendors are trying to address this. This is something that is gaining traction as well. And then you have the example of integrating clinical and safety as well. This is a long-standing open use case. A lot of large vendors have tried to address this and, to sort of point, smaller vendors have created tools to to bridge that gap as well in in both of these use cases. But this is something that has started to happen this year and totally is taking shape for for more mature products and more mature solutions in 2025.

Speaker 1 11:23

Do you think that, compared to last year, the way that businesses and departments are looking at these implementations? Do you think the focus has still got the process in mind, or do you think it's all about the technology? I mean, emma, what do you think about that? Think it's all about the technology.

Speaker 5 11:46

Um, I mean, emma, what do you think about that? Well, we've seen a drive really towards people being able to budget for business process when they're bringing in these new systems. Originally, people used to chop out the process side of things when they were going through a large-scale implementation because the budget was held by, perhaps, it and they weren't seen as a necessary step to undertake. But this year we've really seen people understanding that there is a complete process overhaul with these new technologies. It's not just a small change where we're stripping out perhaps some of the inefficiencies, doing our lean kind of assessments on a process. It really is changing the way that people are going to have to work and drive.

Speaker 5 12:34

So it's now looking at well, do the affiliates do a lot more of the heavy lifting because the systems kind of bring in the data and read it and dump it into the fields early on. Should the affiliates be in control, perhaps all the way through data entry and then it moves over to global? Or now we've got translation engines and tools there and there to quite a high standard. Do we shift all that work towards the data entry global teams? So I think people have really understood that there is a need, because technology is really changing the way we work, that the process has to be considered in line with that. So I think we have seen more of an uptake in process being at the forefront of these new implementations, whereas it used to kind of be a second thought and perhaps something that was cut from the budget.

Speaker 1 13:28

So I do think that it is becoming more prevalent that it's required and I think when we're talking about these technologies I think sarah kind of alluded to it earlier we're not just talking about the same case in case out situation with pb, we're not just talking about the same case in case out situation with PV. We're looking at a much more expanded landscape these days. Lacey, have you seen that change in the last year?

Speaker 6 13:57

I think, from a risk management perspective, I think, yes, I would agree with what Emma had said.

Speaker 6 14:04

I think you know there's such complexities and obviously, while there are minimum regulatory requirements that must be met I mean, depending upon the product portfolio, the risk minimization measures that exist, additional PV activities there's a number of different nuances that need to be accommodated.

Speaker 6 14:23

When you're implementing a technology from a risk management tracking perspective and so letting the process sort of help to define the business requirements, sort of help to define the process, I should say, because there is, again, there are technologies that exist, but it's not sort of a one-size-fits-all when you get into, when you're looking at it from risk tracking, because, I think again, there's there's complexities, there's nuances, as the landscape gets much more complex than you know. When you are expanding into new markets globally and there's lots of different requirements, you have to consider lots of different sort of. You know your versioning, your, you know the requirements in each individual sort of region or country. You know your baseline document. Whether you're using the core RMP or your EU RMP, there's so many things to consider and so many different nuances. That, again, from a process perspective, it needs to be flexible and so defining and keeping that process and the business requirements first and foremost and then sort of letting that drive the configuration and development of the technology. That's what we're seeing is being very valued in the space.

Speaker 1 15:34

And let's move away from the technology piece right now. Rosa, what else have you seen over the past year?

Speaker 7 15:46

I think one of the things that we've noticed is the industry wanting beyond technology and focusing on process and maybe from a technology perspective as well and from an organization structure as well, of wanting to know what everyone else is doing. So we definitely see a lot of interest in figuring out because the landscape one, the technology landscape is quite wide and that we also know that there is a lot of organizational changes that companies are going through of finding creative ways to set up their organization structure, setting up their operating model, of wanting to know what options are out there. Is there a best practice? Is there a more consolidated or consistent way of doing things across the industry? So I think it manifests itself in multiple ways.

Pharmacovigilance Business Development Trends

Speaker 7 16:48

So, from a Trulian perspective, there's a lot more interest, for example, that we've noticed, in benchmarking activities across the industry, and sometimes it's very detailed information, or interested in a very detailed scenario or detailed aspect of the business, and sometimes it's quite broad as well. In addition to that, we've also noticed more industry groups being set up and much of it is actually driven by the industry members themselves rather than being led, say, by vendors. So we definitely notice an uptick of that, but I think, again, it's driven by the same desire to understand what other companies are doing, and we've had a lot of customers talk to us about some of these industry forums. I think there's also a need to then spend the time and effort to help facilitate these discussions and drive the outcomes in sharing knowledge across the industry as a whole.

Speaker 1 17:57

Yeah, I think that's a fair point.

Speaker 2 18:22

There's definitely a need to drive the conversation forward.

Speaker 2 18:23

There's definitely a need to drive the conversation forward and this year there are a lot of people and almost dispar I'm saying it with 2024 in the just about in the rearview mirror is we continue to see in 20, continue to see in 2024 even more of more interest in and I'm not talking about the add-on tools, right, but the processes that these. There is technology out there for things like PSMF, pb agreements Forget the technology for a second though just an interest in the business to do better there, right, whether or not they're ready to bring technology in. There is definitely, I think, a recognition that certain areas that are outside of the core case processing the part that we're always very focused on that the performance is better. There's more scalability. There is so much partnering between companies that managing PV agreements, companies that are doing a lot of partnering they have to be really, really good at handling those partnerships and agreements, and that's coming out in the conversations we're having and the questions we're being asked. So you know that's just one example.

Speaker 5 19:34

I think I mentioned PSMF, and there are these other areas where we see industry starting to dig in deeper and figure out how to do better because there's there's demand on them to do better yeah, I think on that, jamie, like we've seen a lot of clients asking us to bring in our knowledge because they want to know, as rosa said, what other companies are up to formalize and template some things that they've been doing over and over and not really made a formal process out of it things like due diligence activities when the companies are look at buying different assets or integrating a new company.

Speaker 5 20:15

How can I do this quicker? How can I do this faster? How can I do this in a methodical way, rather than each time having to figure this out again and again? So we've written quite a few playbooks and templated and done some tools not technology tools, but tools that the business can use to make these things much more efficient and to make sure they don't leave a gap. So they've got every base covered and we've done lots and lots of that, which I think echoes what you're saying, but in another area as well, absolutely.

Speaker 7 20:48

And just to add on to what Emma said, I think a lot of it is driven by companies are getting more and more creative in terms of the overall pharma business development. So interactions and relationships between licensing partners, acquisitions and mergers continue to be areas of interest. So what used to be sort of one-off types of activities like PV agreements or not one-off, but fewer of those activities Mergers and acquisition used to be more of a one-off, or asset acquisition used to be more of a one-off, rare activity, are starting to be more and more common within a business. And all of these activities of course impact PV. So definitely see that as the ability to build up those capabilities and to have a repeatable, established process.

Speaker 1 21:55

I think that links quite nicely with the fact that you know before we were talking about the expansion of technology, but there's also this thing of this last year, the expansion of departments themselves. We're getting new little departments within PV and Ishan. I don't know if you've seen similar throughout the year.

Speaker 4 22:17

We have. We have, I think, in a lot of situations. It's not just the departments, it's each of these functions and the business cases that Emma was talking about and Rosa touched upon as well, areas where divestments and mergers and acquisitions are happening across the board and they keep on happening, mature process to tackle this in an efficient way, where, regardless of the size, there is a method to the process, a method to the madness that always entails in different kinds of data migrations, and there is a set of procedures, people to rely on, who can drive these activities. So, in terms of departments, that's just one area where we've seen a lot of traction because divestments are happening every other month or every other quarter. In terms of large movements, companies are getting acquired as well.

Speaker 4 23:22

But within the space of PV itself, there's a lot more focus on creating the glue between interdepartmental activities as well. I touched upon clinical, I touched upon regulatory. There are alliances trying to define use cases. I think, rosa, you mentioned there's a general push within the industry to have that conversation and let's think of a use case that we can sit together, align on as companies, as industry players, sit with vendors, define requirements, standardize requirements, so that we don't have to go back and again and again, define the same kind of rules and requirements that are based on standard regulations that apply to everybody.

Speaker 4 24:08

Reporting requirements are the same for everybody, but every single time there's an implementation, there is a process of defining the requirements of well, what is the reporting requirement of each and every country? So there is a push to have a set of teams, a set of processes, to even define that within the technology and business spaces. How can we standardize so that if we have to add a product, if you have to add a reporting rule, or if you have to add a reporting requirement, there's a team that takes care of it every time it comes through and it's efficient and easy to replicate as well and validate? Of course, you have to test everything every time you make a change. So how can we do it in a repeatable manner as quickly as possible?

Industry Transformation and Future Strategies

Speaker 1 24:53

I want to ask. So there's been a big shift in the way people have worked over the last few years, the big words being agile way of working. That's, that's the what people have been saying, or they'll say lean and agile way of working. Sarav, do you think, um, what's happened in the last year? Do you think companies have actually managed to implement that successfully, um, that way of working?

Speaker 3 25:29

I think that's a hard one to answer, because it's companies haven't reached where they thought they would reach, so they're still in the process of making some of these changes.

Speaker 3 25:47

But I think one thing has dawned upon everybody is that I think maybe there was just too much, too much expectations from the kind of transformation stuff that you're talking about is gonna bring in in such a short period of time.

Speaker 3 26:05

At the end of the day, irrespective of technology processes, people is a big part of this equation and I feel, from that perspective, the changes that you were talking about I don't think have really materialized so far but I would not give a verdict on it yet is how I put it. I think people have made some attempts and they need to learn from it and continue to evolve. I do feel that the traditional ways and the way things have changed will lead us somewhere maybe not exactly where we thought it'll be, so I just keep it at that. I I won't give any verdict on it yet. I I feel that there's definitely uh, there's definitely a potential here, but we just need to taper our expectations of what it would mean and what it what it would mean and what it means to drive a change like this in what is traditionally a heavily people-driven industry.

Speaker 1 27:29

I think that's a fair point and actually, as you were talking, when I was thinking about Agile, one of the things I was thinking about was linked to what Ishan said slightly, but more about regulatory changes. So we've seen some this year. We've seen some big global regulatory guidances sent out and we've also seen quite a few actually at a local level, quite quite a few actually on a at a local level. Um lacy, what were the big things that you saw this year?

Speaker 6 28:06

yes. So from a risk management perspective risk minimization I think two long-awaited um regulations were released. There is the fda rems logic model um guidance that was released, um in addition to gbp module 16, revision 3. So these were sort of in the hopper for a bit and, I think, waiting with bated breath for these to be released, and there was a lot of excitement when this came out a few months ago. I think it's impacting folks in the sense where there's a lot of need to understand what this actually means and ultimately, how do you operationalize and how do you put into practice what has been published. So I think from the GVP Module 16, the Revision 3 that came out, you know there's a lot of enhanced guidance on risk minimization strategies.

Speaker 6 29:21

No-transcript PV framework is really critical because ultimately, again, it all comes back to patient safety, patient health, and so you want to make sure that what you're doing is effective and benefiting the patients and working to mitigate the risk as intended. And I think there's a real emphasis as well on, you know, real world data understanding, you know pivoting, really making sure that you're reacting to the real world and again, it's far, far, far more than a tick the box activity. At this point. I think you know we've seen this evolution of risk management guidances and regulations years in the making, kind of coming from, you know, suggestions and you know, especially from a Rums perspective years and years ago, where you know pre-2019, where there really just wasn't a whole lot, now to being very prescriptive and the assessment of the evaluation of effectiveness and what you need to be doing.

Speaker 6 30:35

So again, there's a lot of thoughtful consideration that's going into risk management. There has been, it just continues to evolve, which is really exciting, and the fact that there's more sort of structure put around this and more clarity is really great. But it's again what do you do with this? Now that you have this information, this guidance, this bit more prescriptive sort of, you need to kind of take this and realize what does it mean for my organization? So I think people are going to be it's going to be interesting to see how the rubber meets the road on some of this, when people come to understanding how, within their organization, this can be kind of fully developed.

Speaker 1 31:18

Thanks. So, with all that, with what's happened in 2024, like I said right at the beginning, from a Truliant perspective, it's been a crazy year. We've done a lot of things, we've gone to a lot of places. We have looked at the environment as well. There's a lot of things that we have done this year. 2025 is going to be a big year, obviously, from a Truliant perspective, we know that next year we're going to try and do the same things that we did this year, just better. But from an industry perspective maybe, lacey, going back to you because obviously risk management, big changes this year yeah, what do you think is going to happen next year?

Speaker 6 32:08

Good question. I think there's going to, yeah, people are really going to be fleshing out these processes, ensuring, again, I think, aligning, making sure that there's there's a need to have the right skill set with these processes. So, again, instead of sort of just purely focused I come back to REMS for a moment. But you know, historically I think there's been more of you know we speak about REMS. You think about more of just sort of, you know, the operationalization of this as opposed to really more strategic and ongoing effectiveness evaluation. And I think, again, it comes down to really just keeping in mind that you can pivot, you can change, you can adapt, evolve the program. Again, it's not just a you write your assessment report, you're done, you check the box, you kind of move forward. So I think we're going to see people really, really trying to understand yeah, how can this best be done in the context of an organization where you have the folks that have the right techniques and skills and what's needed to really evaluate? How do you get the right data to evaluate these programs? What do you do in response to making sure you know? How do you ensure all the right stakeholders are involved? There's a lot that goes into how do you communicate?

Speaker 6 33:29

I think another really big piece here that's come out of revision three from module 16 is benefit risk communication. So how do you adequately then communicate what you find so to your point? I guess it's just going to be a lot of new processes that are going to be required in order to really continue to fulfill these obligations that are set forth by the regulators, and it's going to be exciting to see how people again within the framework of what's been published there are certain requirements, but I think there's latitude as well, so it's going to be exciting to see how people choose to put this into practice.

Speaker 1 34:06

Emma, there's been. A lot of companies are trying to build out their portfolio, but not just on the drug aspects. There's the vaccines, there's the medical devices, there's the I can never say it, but the sort of cosmetic side as well. All of that is coming in. There's new vigilances, the multi-vigilant sphere is now operationalised and a lot more companies now. But what else do you see could potentially happen next year from your point of view?

Speaker 5 34:41

Well, one thing that I've been asked multiple times about when I bumped into people from the industry at congresses or when we popped in to have a coffee is conversations around business case for structured content authoring content authoring. So if you look at it just in a silo say you just want to attack your PSMF and have something to help you with structured content there, the business case doesn't work out, the numbers don't work out, the ROI is too long. But structured content authoring can go across multiple patient safety functional areas, but also into other functions like clinical and regulatory. So I think it takes us back to something that we were talking about for 2024, is how do we break down those silos and work closer with those other functions to bring together a real good business case that sees the ROI a lot quicker? On some of these tools that will help us become more efficient, produce higher quality and do things in a shorter amount of time.

Speaker 5 35:52

We might need to work together and get our heads together. So one of the things I think is going to happen in 2025 is that we'll need to start talking outside of our silos not just within PV, outside with clinical and with regulatory to try and make some of these things happen and to try and get the budgets to to really make our lives easier. We're getting more and more workload. It's the same thing every year less and less budget. But if we put our heads together, we can use that budget more wisely, and I think that's going to be a big theme that comes up in 2025.

Speaker 1 36:37

Saurav, do you have any other thoughts on what?

Speaker 3 36:38

your predictions are for next year. No, I think people in the group have covered it well. I'll just reiterate the point that I said in the beginning, and I have a firm belief that in 2025, we are going to see some successes in the Indian tech space with respect to a few implementations, but I also see that we will see companies start pushing for how could we use technology in other areas. And while I'm at it, I think you initially spoke about expectations with this whole technology, ai and how everything, all jobs, would just go away and everything will be done by technology. I think those expectations, the way they were, all that hype is in the past now. So I do feel that there is realistic expectations now on what you can achieve, that we're going to be living in a what I would describe as an AI-assisted world as compared to an AI-led world. So AI or technology, you know, is your partner, is your assistant, whatever you want to call it to help you achieve a certain objective. And I think it applies to our industry and other industries as well. And I think, with those expectations, with that understanding and um expectations, beyond the hype, what we've started to realize, or what the industry has started to realize is that there's no big bang. There's no.

Speaker 3 38:43

You know, you wake up one morning and you achieve touchless case processing, or I don't think there's a thing as touchless case processing. I think it's a myth, because can I process a case without touching it? Yes, but that's just a case. Can I process all the cases that are coming in, with all the variety in the real world? I don't think so. It'll always need to be guided by humans.

Speaker 3 39:07

Let me just put it this way, and I think people have come to terms with it. They've tapered down their expectations, these grand visions of and some of it the industry itself is to blame with of how 80% of cases would be touchless processed, how all non-serious cases would be touchless processed, and all that sort of stuff. I think a combination of that understanding of what's possible and the expectations around what we want to achieve in what time? You'd see that some use cases within even if I sort of go into intake, some use cases within them 2025 will prove that those specific pieces would just become household in a couple of years, just like everybody can do certain things I mean, let me just pick up an example Everybody can do reporting rules. Today it's a household thing. I think a few of those use cases will become household things in 2025 and 2046. That is what I expect to see. You know, a good understanding of what's possible and realistic expectations of what technology can achieve.

Speaker 1 40:36

I think that's fair. And, jamie, over the last year, you have gone to multiple conferences, spoken to many, many of our clients, many of our non-clients as well, and many of our partners, et cetera. Can the conversation next year move away from AI? And what is that conversation next year? Because for the past two years, it's been pure AI. So what's the conversation we're going to have next year?

Speaker 2 41:07

Well, I would say it depends who you run into and who you talk to. But what I could see happening, based on what I've observed last year and what Saarabh said and I fully agree with everything I've heard so far is, yes, I think we can get away from hype right, but what I think we will see happen next year because we have been talking about predictions is there remain a lot of leaders and decision makers, some of them newer in their roles, wanting to drive change right. So it doesn't have to be a tech change. Sometimes it manifests with some technology, but there are a lot of leaders out there who are unhappy with what they've got, whatever it is, and they will continue to push for the change that they think is best.

Speaker 2 41:59

And in some cases going back to what Ishan was saying and Indy you were asking about we will see more organizational changes on a large scale. We will see more restructurings of teams, because in some cases that's what they need. There are some there are more than some who are unhappy with the technology they have either across the board or in pockets. They're going to drive the change from that perspective. So you know, they say change is the only constant. That's always been true. It will be true in 2025. And I think that's where the conversations will. You could say where they're go, where they will go or where they will continue to go. Right, it's constant transformation of the business. It'll just continue with different themes and whatnot.

Speaker 1 42:50

And I think Rosa mentioned this earlier about the fact that there are more forums, there are more people wanting to talk through different conversations. So, ishan, do you think next year there'll be more conversations than there were, um, even last year?

Speaker 4 43:10

I absolutely hope so, um, because that's for the better of the industry itself. I think having um more and more industry players contributing towards the growth of industry collectively identifying Emma made a good point do more with less is a constant every year. The budgets are decreasing, if not increasing, and it's not just the budgets Headcounts are getting impacted in a lot of places. You've seen this, you've heard this. In terms of the overall landscape, I think there will be a push for the larger players to come to terms with what do they want, with all the vendors that are out there With each implementation. There is no need to define the requirements. Intake is pretty much the same thing that everybody needs in terms of how they want to accept cases, how they want to see cases.

Speaker 4 44:10

I like the point that Saurabh made about technologies that are household now. Ten years ago, auto narratives were fancy. They were luxury. These days, auto narratives are fancy. Um, they were luxury. Um. These days, auto narratives are the norm. Um 2025 should should be a year where um not just auto narratives, but ai driven, not an ai assisted narrative, should be the norm, where the systems the, the, as we call it, the standard systems should, should have that capability. I think there will be a push to have discussions around ROI and do more with less, and of course we as independents in the industry can help drive some of those discussions and, of course, contribute to the overall growth of the industry as well.

Speaker 3 45:01

And I do want to make a comment on the.

Speaker 3 45:04

You know, whether it's the hype, whether it's, you know, within the boundaries of realistic expectations, you will continue to hear about AI and I think the reason why I say it is because I hear it as much as I do in our industry, as I do in other domains industry, as I do in other domains. Everywhere I go, anybody I speak to people in different domains the phones we use like if you saw, whether it was Samsung, google or Apple releasing their phones. Nobody's speaking about hardware anymore. Everybody is talking about Apple intelligence, google is talking about Gemini. It's just everywhere I go to my kids school and they're talking about AI.

Speaker 3 45:55

You will continue to hear about it and I think it's for the good as long as, as we were saying, as long as people have realistic expectations with what it can do, I think it can do wonders to how we lead our lives, including in pharmacovigilance. And, yes, it's going to be a challenging time with respect to, because jobs will transform, certainly, but people who are ready to adopt and can learn the new ways of doing can really lead us into the new ways of working.

Pharmacovigilance Industry Trends and Insights

Speaker 3 46:40

Yeah so yeah, I think that's a fair point.

Speaker 1 46:43

And actually I wanted to say one other thing. It just reminds me of a podcast episode that I did in season three no plug intended, but anyway. Sybil Gerla said it's amazing with PV that you turn the light on and everyone's amazed that you managed to turn a light on. But this is just something that is expected. And actually, with this new technology, um, I was going to ask, do you think what we have is an ability to be able to get compounds out faster? Um, so can we get um the sort of small and um sort of novel compounds, um from smaller and you know, uh, biotechs coming out? Uh, do you think there's more of that happening? Uh, next year?

Speaker 2 47:34

yeah, actually, sarb, you mentioned your kids, which made me think of youth and young and younger pharma, smaller companies. Um, that's another one that you know we're seeing the continued trend of, or we have seen and I think we will continue to see the trend of larger pharma essentially acquiring their pipelines by acquiring these young and cool companies fast moving, and I think that's something we'll continue to see in the new year. It's very interesting to see the different paths that some of them take. You know, some of these companies are essentially born and become full-fledged commercial products companies on their own, which is pretty cool to watch, right, because that's not an easy path and some of them grow to a point to be acquired. So I think we'll continue to see that and indeed, to your question, yeah, I mean, I don't see that slowing down anytime soon. It's been very interesting to watch and, of course, to work with companies like that to support them.

Speaker 2 48:45

One of the things we didn't talk about is sourcing strategies. So, as companies are debating, do we have the right process, do we have the right technology? You know, the right org the approaches to sourcing is hot, has always been hot and continues to be pretty hot. So that's another one I wanted to put out there.

Speaker 3 49:07

Yeah, thanks, amy. I just you know the question, indy, that you just asked. I'll just take a minute here.

Speaker 3 49:14

I was prepping up for a talk when I was trying to look for examples on how technology is being used in drug discovery and somebody forwarded a paper to me and I realized how already technology helps us reduce the number of potential compounds that need to be tested. And also technology can make predictions, for example, about toxicity of a drug, without us even injecting the drug into a human being, of a drug, without us even injecting the drug into a human being. And when I look into something like that and realize that it's already there, it's not that it's a prototype, companies are already using it and I look into some of the use cases we have on TV side. It's just a matter of times. But going back to your question, yes, I think technology will help us get the drugs faster into the market and it'll also help us keep them safer or keep keep the patient safe so we're coming to the end of our of our and you know, normally on the podcast I would say, well, what's next for PV?

Speaker 1 50:31

I'm going to change that today, because you're such a bunch of special people. I'm going to ask you two questions and I'm going to ask each of you individually. I'm going to keep talking so that you've got a bit of time to think. But the first question that I want to ask is what is your proudest moment of 2024? Hopefully this has got either something to do with PV and risk management and Truliant, but if it doesn't, it's fine. But then the second question I want to ask is what's your piece of advice that you would give someone within PV and risk management for 2025?

Speaker 1 51:11

Remember we talked earlier about the changings of departments, how departments have definitely changed in 2024. I think some of the things that we may not have touched on is that there has been a massive brain drain in PV departments, where efficiencies have come in and so, unfortunately, people have become not required by their companies, and so there is actually a great resource out there of people who have great experience, who could help, maybe even give context to some of the stuff that is going on in PV right now. So, as I said, that second question is really aimed at the people who are in PV right now and are thinking towards next year, and that piece of advice that you'll get them. So, jamie, with that we're gonna do first yep, both those questions, so proudest moment. And then the advice that you would give someone for 2025 yep okay, I.

Speaker 2 52:27

It's hard to pin down one proudest moment, because this team, you know, impresses me every day. Just even hearing what people are saying here is a proud moment, because it's like gosh, I've been doing all this other stuff, not even thinking about all the cool and fun and interesting things that are happening. So, right there, that was a proud moment. I think many times, and surely a few pointed ones. I can't share specifics here, but where our team has come together and just pulled off significant I'll just say, some very significant wins for us that I don't take for granted. Um, and it just proves, you know, you get the right people together, we can do pretty much anything. Super cliche, but true. So we had a few of those this year. Um, advice to anyone gosh, I wish you would give me a pass and let me come back to me on that one, but that's tough for the reasons that you said.

Speaker 2 53:29

I think it's very hard for someone early in a PV career to advance in it. I struggle to comprehend how one should go about it. Quite honestly, I don't want to give a disingenuous answer. I would say you have to never stop learning, right Acquiring. There's the subject matter, but then, on top of that, this is like a true consulting answer. Right, it's all the other skills. Right, it's the non-technical, the non-subject matter skills that are going to help someone move ahead in a. You know, in this space, because of all the things we were talking about, you know every regulation inside and out that doesn't help you drive change in an organization. You have to have so many other skills. So that's a rather it's a somewhat narrow answer from someone who's been working in business transformation her whole career. But that's that's my advice. Right? Is the, the upskilling beyond just the technical PV skills? Now you can put somebody else in the hot seat.

Speaker 1 54:38

I will, I will, I'm looking now. I'm looking now, ishan.

Speaker 4 54:46

I'd say among many moments which made me really proud the safety summit was one of those and, of course, what we've achieved as a team. One of the moments that really swells me with pride is feedback from one of our clients that acknowledged us as thought leaders and the value that we brought in in helping them tackle a really large transformation that they were in progress with, that they had embarked on and helped extend and manage their business, represent their business interests, without any bias on any product or any particular service or any particular area. That moment made me realize that what we have made here is really special. We are not tied to any particular technology or any particular bias. We really are able to freely and objectively help our clients and look out for their interests and these things. Actually, when you hear feedback like that, that makes a day and for this one that made my year, that's one in terms of proudest moment.

Speaker 4 56:02

In terms of advice, I'd just say just remember the basics of what we need to do, to not just deploy. Coming from a technology background, not just to say what we need to deploy in technology, but across the board, even with processes, define, test and then deploy. Just don't get into identifying the fancy stuff that can change your life. Try and get the basic stuff right. The fancy stuff that can change your life. Try and get the basic stuff right. Please give time to test and verify the expectations that you have before deploying anything in any technology and then, once you're there, give time for things to mature, because with every new set of product, every new set of technology, there is a lead time to gaining those efficiencies that you're looking for. It's not from day one. Give it time, prepare for it, plan for it, and then I think you'll yield the benefits in the longer term.

Speaker 1 57:02

That's great advice, rosa.

Speaker 7 57:05

Yeah, I think I have to agree with Ishan that the Safety Summit has been one of the big achievement for Truliant, and the success of it and the quality of the content that the team was able to pull together and the contribution and the very willing contribution of our industry friends who made that possible, was very impressive. But the other thing that I want to mention is and I can't take any credit for this, but the ingenuity and the creativity that the team came up with at the Road Drug Safety Congress in Amsterdam of having our booth being held up by customs and putting together a very nice, homey and warm environment that I've heard multiple feedbacks on at the Boston Safety, at the Boston World Drug Safety Congress and actually having comparing, you know, a very professional set up booth versus a very homemade but very warm and very genuine and very inviting environment. There wasn't like one was better than the other. It was very different. People appreciated both. So I mean that's an incredible achievement, given that a lot of thought was put into a very professional looking booth, a lot of time was invested in creating that, but something that was pulled together very organically uh, and very last minute uh, creating pictures frame. You know, getting pictures frames from Ikea and getting furniture from Ikea. That was incredible and people had amazing things to say at the subsequent um amazing things to say and the subsequent Congress that I heard the feedback on was very impressive and very proud of the team for having pulled that off.

Speaker 7 59:18

In terms of the advice, I think pulling together some of the themes that Sara and Jamie mentioned in terms of organization, reorganization and sourcing strategies that are constantly evolving and the evolving landscape out there in terms of growing and having an AI-assisted technology environment, is this concept of a job role that focuses on oversight right.

Speaker 7 59:49

So in the future, there are a lot of the value add really that people provide in various departments, not just in PV is about oversight of the technology, building knowledge, building value into the technology and almost think of it as taking all of the experience that you've had in industry and then thinking of it as a teacher teaching the system how to do something, and then, from a sourcing strategy if we're going through an outsourcing strategy or changing vendors or making adjustments of what stays in-house, building up internal capabilities and balancing that out with external capabilities and vendor capabilities to be able to balance those capabilities and to provide oversight of those capabilities not just doing the work yourself, but ensuring that the work is done effectively, that there is compliance, that there's efficiency. How can we continue to do this better? That oversight role becomes more and more important and more and more key as the industry continues to evolve.

Team Pride and Career Advice

Speaker 1 1:01:03

Great Thanks for reminding me of all my nightmares. Rosa, Emma, proudest moment and a piece of advice you'd give people for 2025, please.

Speaker 5 1:01:14

Rosa stole my proudest moment, which was going to be the World Trade Center competition.

Speaker 7 1:01:20

But you actually take credit for it because you were part of the team there.

Speaker 5 1:01:27

So I quickly thought of another one. One but I think actually is just as important is actually our younger generation of trulian um colleagues. They have expanded their knowledge so much since joining the team into really different areas and complex areas of PV. To see how much they've grown and to see how much they're now capable of I feel really proud of them, like they're just so fabulous, they're lovely to work with, but they're so knowledgeable now as well and that's, you know, a really a proud moment for us as the founders. To have seen them like, chosen them and seen them grow is just fabulous, and I think my advice it it actually comes from the safety summit as well.

Speaker 5 1:02:20

So, as you know, I've worked on the career track and the people that spoke about careers in PV really made some fabulous points and I think that would be my advice is don't just look at what is your next one stepping stone. Take a step back and really look at the whole big picture and become a really well-rounded, knowledgeable person, not just in one single silo, because you'll reach a limit person, not just in one single silo because you'll reach a limit. Let's have like work in all of the different areas and make sure you get exposure, step up and offer your help in a project that takes you outside of your comfort zone so that you can become much more of a well-rounded and well-grounded person, because then you don't have a ceiling, you'll pick up skills that can take you anywhere and everywhere, and I think that was really my key takeaway from the safety summit track and I really think that's important piece of advice to to live by.

Speaker 1 1:03:20

So there, my two thank you, emma, and I'm going to go to Lacey because I feel like we started with Saurav and I think I think it's appropriate that we finish with Saurav too.

Speaker 6 1:03:36

Perfect. Well, emma took my proudest moment? No, but just I'll piggyback onto that because I think it was. It's always these perpetual feelings of just being very, very proud of the team that we've built. But I think not too long ago I was just sitting at a team meeting. So we have our team meetings every Friday where everyone comes together, whether we share news on a project or share some learnings or whatnot.

Speaker 6 1:04:05

It's just such a great chance on a very routine basis to convene just as a Truliant team and come together. It was just sitting back and looking at all of the faces on the screen and it was just so impressive and so heartwarming again because it's such an incredible group of talented individuals that we have cultivated to come together to be what is truly it now. And it just gives me chills in a sense, because it's just it's not an easy task by any means, and in building a team and growing that team is so it's such hard work, but seeing the output, seeing the results of all of that hard work and just everyone is just so excited to help the clients. Everyone is so excited about what they do. They love their roles and their work in PV and they love working together as a team. Everyone just comes together and really is so supportive of each other. So it just it sounds cheesy, but it is. It's so true, it's just. It's such a wonderful group of folks that makes up the Truliant team, and so it's just. It makes me proud, it makes all of us proud, to sit back and look and say, wow, we built this. All these folks came together and look at us now From an advice perspective.

Speaker 6 1:05:20

I think it's just that underlying sort of current, the theme that we've spoken about, just the need for flexibility. So if you're coming in, your job today will not look the same as it was one month ago, one year ago, two days ago, depending upon the changing regulations, the technology landscape there's. Everything is just developing and evolving at a just an incredible pace in this area. Just such a need to be nimble and flexible and understand that you're to keep on top of things. You just need to be in sponge mode to really be learning and absorbing lots of new content and skills and developing that skill set to keep up with, you know, the more refined type of activities that will be required once some of these more tactical and transactional things are accommodated by technology. So those are my pieces of input, saurabh okay.

Speaker 3 1:06:17

Thank you, indy, for giving me the maximum amount of time, but you know, as it always is, there's always a con, because people have spoken about a lot of things, but I think to me two things stand out. One is the safety summit. I still remember the conversation we had where you initiated this idea and you know, from that idea, sometime, company with with a lot of means, with a lot of free time to do these things, but still we all, all of us, pitched in behind that idea to make that possible. And you know, I'm a hundred percent sure, everybody in our company in some shape or form contributed to making it a reality. So that, you know, that feeling of everybody trying to pitch in and doing their best to make something possible wasn't, was an immense feeling and it gave me a lot of proud and happiness.

Speaker 3 1:07:39

The other thing I'm going to talk about is is probably more self-centered, but, um, it's. There was a, there was a big proposal that I worked on, and it's not necessarily about the proposal. Once again, once we stared at the work that needed to be done there, this team that I'm extremely proud of gave me the permission to lock myself up in a room for four to five weeks. Usually our jobs are, you know, most of the day is just a list of transactions that you have to go through, and not that I don't enjoy it, but every single day there is a task list that you need to go and you're jumping from one thing to another and getting distracted by an email that comes while you're working on a presentation and eating your breakfast, possibly, and then you're reminded of everything that needs to happen during those four or five weeks. However, a I got the permission from this team and I was excused from a from a lot of my other duties, and I got a similar permission from my family as well. So I spoke with my wife and said this is what is needed and I have to share that.

Speaker 3 1:08:51

It was an experience that I cannot forget, because, not that I don't wake up every morning trying to do something special for Trulian, but those days I would just wake up at 6 am and I would be at my chair and I would just work tirelessly. I would just wake up at 6am and I would be at my chair and I would just work tirelessly. I would just not tire and I was reminded of how, when you focus on one thing, what you could achieve. And in that process and this is something that I've shared with Indy in that process there was a time where I was completely detached from any outcomes. I'd actually forgotten about the outcomes. I was just working on something and that was that. And it told me the importance of giving focus in the world we live in, where we're not just and I'm not just talking about work.

Speaker 3 1:09:50

I think we live very distracted lives. You know, our phones are buzzing notifications, we work from homes. I always have craving to go to my fridge and find something. We're just always distracted.

Speaker 3 1:10:04

But in that four to five week period, I cut down on most of the distractions and, um, as I said, I I was not thinking about the outcomes at that point in time and and that lesson has stuck with me and every time now that I get that opportunity of course, you know four weeks is a luxury, but even it's a, even if it's a three hour, uh, even if it's a three hours window that I get. And this is where you know, when you ask this question, I already knew I was going to talk about it and therefore all I was focusing on what other was saying, without thinking about what my answer would be so that that is definitely a lesson and therefore I I don't think I have to talk about any piece of advice that that experience that I had is a is an advice in itself is try to minimize distractions around you, and when you've got something, you know, if you put your heart and soul into it and focus into it, um, you will automatically produce wonders. So there you have it.

Speaker 1 1:11:07

Thank you, sarah. What a way to end the podcast. Co-founders, thank you very much for joining me for another year of this. I know when this meeting went into your calendars you all rolled your eyes. We've made it through. So thank you again and I'm going to put the meeting invite for next year now.

Speaker 2 1:11:29

Thank you. Thank you, Wendy.

Speaker 3 1:11:31

Thank you, wendy, thank you.

Speaker 6 1:11:33

And have a happy holiday to everyone. Happy New Year everybody. Yes, bye, bye, bye, bye.

Speaker 3 1:11:39

Bye, bye, I'm out.