Tony De Sousa

Today's conversation comes alive with Tony De Sousa, the Global Head of Countries and Regions at Novartis, leading the discourse on a fascinating journey through the world of pharmacovigilance. Tony's intriguing journey from nursing to becoming a significant player in one of the world's largest pharmaceutical companies is sure to captivate you. We delve deep into the evolution of PV, contemplating the influence of European regulations and the complexities of leading a global team.

But that's not all. We also engage in a spirited discourse him being a global leader from the pharmaceutical industry. It provides an enlightening perspective on how personal experiences with cultural shocks have continuously shaped his leadership approach. We journey through the impacts of COVID-19 on work and life, leading to a shift in priorities. He also shares some invaluable insights into the increasingly complex regulatory environment in various regions, and how his company has succeeded in preparing for PV inspections.

Rounding off our conversation, we begin to examine the future of PV and the exciting role that artificial intelligence (AI) may play in this domain. The conversation highlights the current challenges and limitations of AI in PV while emphasizing the importance of risk management in patient safety. Finally, Tony offers his insights on the future of PV, the marriage of PV with data mining and the need for regulatory support for AI advancements. Don't miss out on this riveting conversation that provides a sneak peek into the future of PV.

Transcript

Speaker 1 0:16

Welcome to another episode of Innovation and the Future of Pharma Convigilance, a podcast series brought to you by Trillion Talks. I'm your host, indiyana Wallya, and I'm delighted to navigate the dynamic world of pharma convergence and risk management with you. A quick disclaimer the opinions expressed in this episode are solely those of the individual guest and do not necessarily reflect the official reuse of Trillion Consulting or their company. We're all about fostering insightful conversations here at Trillion Talks and we want you to know that any product, vendor or service mentioned does not imply an endorsement. If you're seeking professional advice for specific situations, we encourage you to go to our experts. Please remember this podcast content is meant for informational, and informational and educational purposes only. Right Today, we are incredibly lucky to have the wonderful Tony de Souza, global Head of Countries and Regions at Novartis, as our guest speaker. Tony, thank you for joining us on this podcast.

Speaker 2 1:23

Thank you, Indiyana. Thank you for having me. I really appreciate it.

Speaker 1 1:27

It's. We're really lucky to have you, and I guess I really want to start by asking the question in PV, which is how did you get into PV?

Speaker 2 1:39

So it's really funny because you know and I'll get into my background a little bit further but I'm a nurse by trait and you are a nurse, and when I was working in the emergency room, it's funny because I had no idea about PV None, and I remember, you know, over 20 years ago, getting an adverse event for and I remember throwing it in the garbage and saying I don't know what the heck this is, you know, and literally put it in the garbage and then a few years later, one of my colleagues from nursing school had reached out to me and said hey, by the way, you know, I'm working at a pharmaceutical company and I'm doing, you know, you know, a, b and C and and a E collection and drug safety.

Speaker 2 2:36

And I was like, oh, that sounds interesting because you know the lifespan within the emergency room is usually, you know, 70% turnover within two years. And I was there for for four plus years and over six, seven ish all together, and I kind of stumbled into it and I took a contractor role as an entry level associate clinical safety is associated at the time and basically doing due diligence, you know, for adverse event reporting and following up with health care professionals. And then I got a permanent position as a data management specialist, which I wasn't a data manager, you know. I had to learn, you know data management, but I did that and that's kind of how I stumbled into it. And then I realized that, wow, there, there, there's a whole career out there that I can, you know, kind of explore. And that's kind of how I stumbled into it.

Speaker 1 3:48

And your your career obviously took off from that point within PV. What, what, what did you think you would end up to be at that point so early on in your career? Or was it just all brand new to you?

Speaker 2 4:01

It was all brand new to me and my goal was to become like an associate director. You know, ultimately, you know, down the road, 20, 30 years, but it kind of worked out a little bit better than I thought. Right, you know, as my career progressed, so did my responsibilities, and fortunately I was able to get to a level where I am right now as head of countries and regions. And I'm not sure if you want me to go through the different steps, because there were multiple steps.

Speaker 1 4:42

I mean, I think I think your career was, was, was was very interesting because in the majority you've stayed at Novartis for pretty much your most of your career, but you did have a slight secondment out, I believe, at some point in your creator Bayer, was it?

Speaker 2 5:02

Yeah, that's correct. So as I grew in in my career and responsibilities within Novartis, I was exposed to many different things, right locally and globally, and also when I realized that I needed further education, right to build within, within the organization and within the industry, and when I evaluated, okay, what's the best educational path to provide, you know, a career path for me? And you know I solicited feedback from the people that I trusted within the organization and outside the organization. And you know it was funny. It came up, you know, you know, an MBA, an MPH, because I had a BSN in nursing. And then I found the program that had an MBA and an MPH.

Speaker 2 6:05

And you know, at that time my life, you know, I was 27 ish, had one child, one on the way, and you know I told my wife and I was still working in the ER, wow, okay, so I was working full time at Novartis and I realized, you know, that's what, what's in the best interest for me and my family, and my wife was really supportive. You know, at the time she's like go for it. So I found this dual program and I said, oh, it's going to take like six, seven years. And she's like go for it. And I did, and I got an MBA, I got an MPH and it kind of, you know, really enlightened me that there's different things besides just being a nurse, you know, and I learned a lot of different skill sets and I kind of grew within my career at Novartis and with the MBA to your point as to why I left today or was there was an opportunity there to be a team leader and I wanted management experience and I went there for a year and I had a team of I think it was like eight to 10 people, but I realized that the culture wasn't aligned with what really I wanted to pursue and I came back to Novartis and I took, you know, two steps back as a senior clinical safety scientist and it kind of grew from there.

Speaker 2 7:46

You know, I did that for a few years and then I got hired into the global RMP role risk management role which was evolving at that time in 2010, with the regulations from the European health authorities and other health authorities that have since evolved, that really wanted, you know, rmps and especially RMPs that are submitted with dossiers, psurs, etc.

Speaker 2 8:16

And I wrote the templates at the time, yeah, and based on the regulations and the demands from other health authorities and I did that for approximately three years and then, fortunately you know, they believed in me and it was a big step in my career at a relatively young age, after I graduated with my MBA and my MPH, and I was, you know, one of the first non physicians to be named the head of the country patient safety had for the US, which is the head of safety in the US in essence for the US, with regional responsibilities for Canada. So the country patient safety had reported to me as well. But then I got you know when we took over GSK, the oncology division, and then sandos and Alcon. I was also the head for all of those different, you know, avenues within the partisan or for the US, or for globally US and Canada at that point from 2013 to 2018.

Speaker 1 9:42

And at that you know there's a, there's a, there's a raft of big D mergers and mergers happening right now. Obviously you've been involved with recent history and past history. How was that to you when you had these new organizations coming with their own structures and you overseeing all of these different areas or these new departments from a new acquisition?

Speaker 2 10:13

Well, it wasn't acquisition per se, it was a merger within the Novartis family. It was very difficult because, you know, you have my equivalent at Alcon, you have my equivalent at sandos, not only within the US but within Canada, and so we had six different locations. Right, we had East Hanover for Pharma and Oncology for Novartis, then in Alcon in Texas, we had a country patient safety had there.

Speaker 2 10:47

And then in Broomfield, colorado, for Sandoz, we had a country patient safety had there and a whole team and they were centrally located which means they did central case processing for all of Sandoz.

Speaker 2 11:00

Then we had Toronto that had Alcon a smaller team there and Boucherville that was Sandoz, that had a relatively large team and then the Novartis team at Sandoz. That was right outside Boucherville in D'Orval. So it was quite difficult to marry these different cultures, different experiences. We're talking about the generic Alcon, very vision focused. So it was very difficult to marry them and when I was announced that I was taking over all of it, it took a lot of travel to go into the different locations. But it was very successful in nature Once we realized that we had one common goal, the organization had a common goal and in my view we had the right leadership at the time to merge everything and it was very successful and that's evident by if we look at the successful inspections, audit outcomes. But it was a lot of work, marrying procedures, right Cultures. It is quite difficult and it takes time and a lot of people, especially senior leaders, they expect things to happen like that.

Speaker 1 12:31

Correct, yes.

Speaker 2 12:32

They don't happen like that. It takes time, effort, evaluating the capabilities of the leaders that you're taking over, and sometimes those capabilities didn't marry with what we wanted for future goals, so we had to make changes. But ultimately, if you have the right vision, the right support, and given some of the caveats that's gonna go in between, it was actually quite successful.

Speaker 1 13:05

And after that successful part of your career, you then moved on to be your current position now, which is the global head of regions, and I wonder is there that same sort of dynamic there where it's about marrying cultures and looking at things slightly differently, probably on a bigger scale even from just the US and Canada?

Speaker 2 13:35

Yeah, and so it's funny because I was in my boss's succession plan at the time. But it was a clear understanding that potentially me moving to Basel because it's a global role was not in the cards for me. And then, when I spoke with my wife and my family, it's like it's a good opportunity potentially. But I turned it down because I said you know what, we're gonna stay here, right, we have a great family unit and moving to Basel is not in the cards. And then at the time the global head came back to me and said you know what we want, you and you could stay in the US and we'll evaluate after a year and I took the role. Fortunately, I'm a Portuguese citizen. My wife is all four of my kids and pre-COVID. We decided, okay, we're not gonna move to Basel. But listen, yes, we had the infrastructure within Portugal and my family and her family and we were gonna move in and unfortunately, covid happened.

Speaker 1 15:05

The big C word.

Global Leadership and Regulatory Challenges

Speaker 2 15:09

Yeah, and that kind of was put on hold and we stayed, obviously, in the US and kind of evolved. And the culture shock was, even though I spent a lot of time in Europe and I traveled a ton, one of the things that I realized as a global leader was how much I didn't know Culture, right, I had not been to Africa, I had not been to the Middle East, India. Like all of these different cultures, which dynamics really change you as a leader and it opens your eyes. And it's been the most wonderful five years traveling all around the world and shaping me as not only a human being, more importantly, and impacting it on my kids and sharing those lessons learned. And I could see the difference but as a leader, right, and adapting to the different evolving regulatory environment in the different parts of the world.

Speaker 2 16:26

And one of the things that I realized in PV is that we focus on the big health authorities, Correct, yeah, and what I realized is now the evolving health authority Saudi Arabia, Egypt, Africa they really are demanding in nature and becoming more and more demanding China, Japan and they're departing from the big three, the big four, the big five and doing really domestic related type of regulatory demands and environments and inspecting this, and that's where I've had to learn and adjust and fortunately we've done so really successfully. In the past 15, 16 months we've had I think it's about 19 PV inspections. Forget about GCP and GMP inspections. That PV is always pulled into. No critical findings, no finds, and that's really a testament to our preparation and we've done a really good job of that and the proof is in the pudding.

Speaker 1 17:54

So there are a couple of things I've got off the back of that. The first one I actually wanted to talk about just taking a couple of steps back from some of your comments about your move and potential well, lack of move to Basel and then your potential move to Lisbon and COVID getting in the way. But do you think COVID is a good thing? But do you think COVID, in a weird way, allowed you to be the global head much more effectively, because companies were then saying, well, people could technically work from anywhere. We all knew it. But did it become more prevalent because of COVID? Did it become easier?

Speaker 2 18:46

even oh, yes, and this is the funny thing, and I tell people all the time is I have over 700 associates in 82 countries. That's just FTEs. What I found with COVID, which was very I didn't expect this, was our talent pool, because we weren't restricted from a locality perspective. In other words, in the Netherlands, I could hire somebody 100 kilometers away from the home office. Our talent pool opened up tremendously and I was able to hire in the Netherlands, in Italy, in China I can't even tell you how many countries I mean, the list is expensive and they are all still there and we were able to expand our horizons in our talent pool and it worked out wonderfully. For me personally, it was really nice because I didn't have to travel as much and I was traveling about 60% and, just to give you an example, in January of 2020, I did 32,000 miles. Whoa, yes, in just January of 2020, right before COVID hit, I was in Basel, frankfurt, munich, singapore, south Korea, taiwan, and I'm missing one.

Speaker 2 20:35

But any which way, it was three weeks, that amount of travel, and what we realized is we didn't need to do that.

Speaker 1 20:42

Yeah.

Speaker 2 20:43

Right. We didn't need to do it Now, not minimizing the impact on in-person contact. That establishes rapport, not only within your team but within health authorities. There's value to that, but there's a balance that you have found. And I think the other piece that I probably didn't mention to you is I did when I started traveling again. When I came back from Morocco in May of 2020, from my regional meeting there, I got very ill, with COVID, yes, and I was in ICU for three weeks. Wow, I went into multi-system organ failure, heart failure, kidney failure. I was given less than a 20% chance of survival and I was literally on my deathbed and I realized the priorities, not only professionally but personally, that we could do things differently. When I came back, unfortunately, I became healthy and it kind of changed how I viewed travel. With the blend of my illness and COVID, it kind of like changed my perspective as a leader and as a human being.

Speaker 1 22:13

I mean, I can't imagine. Thankfully I've never been that ill. Even if I did have COVID, I've never really tested positive for it, so I'm a bit lucky. I remember, when COVID came out, all the different rumors of who was susceptible and who was gonna get it worse, and I think I ticked every single box, so I don't know how I got away with not having it.

Speaker 2 22:38

But it's funny, andy, you know and this is how unpredictable the disease is, right, If you think about it, january 2020, where I was, I was in Beijing, south Korea, Taiwan, singapore, right before it actually broke out. I never got sick. I have four kids. They all got it. My wife got it. I had all the vaccines. I never lived my life in isolation when they got it and the irony is I got it much later and I got sicker than everybody else.

Speaker 1 23:22

Unbelievable. Unbelievable and I mean we won't dwell on COVID too much, but it is the one thing that I believe has completely changed our safety profile within companies. I've spoken to quite a lot of people who we talk about, covid potentially being the point where you know we were front page of the newspapers rather than somehow trying to explain what we do in pharma-covidualness. But going back to the big three, the big three I thought big four, it could be said is tends to be how we look at the FDA. Ema, japan and sometimes MHRA comes in and out, depending on if we're in Brexit or not. But what is making these drivers for these regions to diverse away from, or, you know, go away from the path of the big three? And also, there's been some changes from some of the, let's say, lesser known regulatory agencies, like South Korea, which have made drastic changes to both system side and from a process side. What do you think these drivers are?

Speaker 2 24:59

Well, you know that's a little bit tough to answer because a lot of times you can't get into the mentality of the health authorities. So we still have to focus on the big health authorities because a lot of you know it's a trickle down effect where people or different health authorities still especially emerging health authorities they still defer to the guidance from the big three, the big three, four, we say the big five and six within of artists, right, and a lot of the bigger companies will look at those big five or six. However, philanthropy knows to shift. We're seeing that departure where you know, the Korean health authority, the Chinese health authority, right, they are really now going into very domestic and I don't want to use the word unrelated but very specific to their local health authority and their demands sometimes, in our view and in my view, is unreasonable.

Speaker 2 26:23

And one of the paths that we've done, and I believe that all of industry should do, is Give feedback and establishing rapport with the health authority as the legislation is being established. Now there are two paths one where you have feedback and then the second one is where legislation is established without feedback and Establishing that rapport gives you an avenue to give feedback, positive and negative, what's possible, what's not possible, from a systems perspective, from a follow-up perspective and and that's where there's a lot of value in In the active dialogue with the health authority and, believe it or not, they are very willing to listen and If you really valid arguments and I wouldn't say arguments, I would say feedback on what's possible, what's not possible and if we're looking at domestic cases, right, what are they asking? Right, and that's the what you have to take a step back and say, okay, what's the reason that they're asking for a, b and C domestic cases and clinical trials? You know, post marketing, let's see what we have available that we can get back or push back, you know, because a lot of it is not feasible sometimes. And we've seen really positive outcomes in those dialogues with the different health authorities.

Speaker 2 28:11

Korea is a good example, china's a good example.

Speaker 1 28:16

Wow, so maybe, well, I'm not. I'm putting words into thoughts and thoughts into words, even the. The other question actually I had in my head was so you went from being the head of the US and Canada, where it was very much established health and processes, I guess as well to To a much more global role. What was the? What was your checklist when you first started that role? Like, what were you like right, what do I need to do? What needs to be improved? Other processes in what was going through your, your head as you, as you went into that new role?

Speaker 2 28:58

Well, understanding the demands of the travel, and this is pre-covid right. So it's sitting down with my family, first and foremost, and my wife, my parents, my in-laws, because I Knew that the man that I was gonna take on my family with me traveling so much, that was the first and foremost thing and if I had their support, I Was gonna move forward with this opportunity, and I did. Then it was realizing, oh Geez, I'm in over my head, I don't know what, I don't know.

Speaker 2 29:43

Yeah, and fortunately, you know, I was a peer To a lot of the people that were gonna report to me, the regional heads, and I had to lean on them and that's why travel was so, so important to go in person and and meet with them, understand their culture.

Speaker 2 30:07

Yeah and you know, I was so moved by the Demith, some of the things that was associated with somebody coming from the US. Oh, they didn't understand the culture and, and you know what, even though I had a huge European flavor right, I mean, I was Portuguese and, you know, spent so much time in Europe I realized that I wasn't culturally adapt. You know, not only the regulatory authorities, but the cultural aspect of the different people in the countries, right, what made them tick Right and and adapt myself as a leader, through what Work, not only in the region, but in countries, different countries within a region, and that was a huge learning curve for me and I leaned on my regional heads and you know what, and just have an open mind as a leader, push back right, share your experiences, especially where I came from, the bottom up, right. So, more or less, even though the country was different, the region was different, but a lot of the work was the same, I see, and that's where I needed to adapt and it took me a few years, right, to open my mind to those different cultures, the different working environment, the different individuals and, and, yeah, it was one of the best experiences that I ever had as a leader.

Speaker 2 31:55

Five plus years later, I'm still learning. And that's the wonderful thing about keeping your mind open as a leader is you think you've got it all figured out, but you don't. And it goes back to you know, and it's funny how things become parallel over the course of life when you work in the emergency room. And it's funny when I think you've seen it all. And Somebody told me very early on in my orientation they said you think you've seen it all and today You're gonna see something you never saw before. And you have to have the mental agility and the learning agility to adapt. And that's something that I've taken with me throughout my career, because every time I think I got it figured out, something comes across in Malaysia, in Thailand, you know, in the US, in Canada, which alters your mindset and you're like, oh geez, I have to adapt here.

Speaker 1 32:58

I Know we've we've had a previous conversation where you were saying that the Middle East, specifically, is quite demanding with their, with what they require, what? What did you mean by that?

Speaker 2 33:14

so, especially the Saudi Health Authority and Egypt. They've Adopted a lot of some of the global standards but, similar to China, they're doing a lot of domestic Type of demands. And then if we look at our organization or global orders at any organization and we look at aggregated documents, right, usually a lot of the health authorities accept, you know, global R&Ps, psurs and in the US, us PRs in lieu of the PSURs. But now what we're seeing in these health authorities that are a little bit more domestically Demanding is that they want something specific to their patient population and something specific from a documentation perspective, an aggregated document perspective.

Speaker 2 34:33

So that becomes challenging, right, and that's some of the things that we're facing and other organizations are facing, because if they want things expedited in a certain fashion, it becomes a system issue. How do you suppress going to other health authorities versus that health authority? And that's kind of what we're facing now across the globe, especially in the Middle East and in Asia. We're seeing those things really create a burden, and I don't mean a burden from a risk to a patient perspective, but an burden from a system perspective and actually making it all work. And that's kind of like where we're trying to balance what works and also the dialogue going back to dialogue with the health authority.

AI in Pharmacovigilance

Speaker 1 35:39

So you touched upon systems there. Do you think that this is where AI could potentially help?

Speaker 2 35:51

Yeah. So yes and no, and I'm not going to go into the details of what Novartis is about, but me personally, my experience and going to various conferences is we talk about artificial intelligence and the utilization of artificial intelligence. The reality is today there is not a one-stop shop. Okay, it's not, it doesn't exist, and I can tell you I've been in sandboxes with 17 organizations it doesn't exist. There are tools that can definitely help with AI that are out there, but they're on silos. So if we look at the different buckets follow up, taking unstructured data into structured data, like in an inbox, in an email translation, legal cases, things like that we're not there.

Speaker 2 37:04

From a maturity perspective, will we get there? Absolutely, but what's going to be what we can use? That's validated, quote unquote from a health authority perspective. So how I look at this and I said we can do a lot of stuff that we're saying. However, if you're an inspection with an FDA inspector, can you validate AI tools? Can you do that? And the answer right now is no to some degree. Yes, there are possibilities. What's their comfort level of errors?

Speaker 1 37:56

Yeah.

Speaker 2 37:58

And I'm not sure what feedback you've received, but this is just my experience and it's been pretty extensive. But I think there's a future there. It's not mature yet.

Speaker 1 38:11

Going back to another point that you made you were talking about previously, one of your roles was doing with risk management planning. How has that interwoven with your current role? Because you were saying how a lot of these emerging regulators are doing pharma provisions at a much more local level with their local populations. Does that stem from the fact that even the risk management plans also need to be very localised for their populations? And if so, is that also a difficulty in putting in those risk management plans to all those different regions?

Speaker 2 39:01

Yeah, so I mean it depends on the health authority and the expectation in the regulations. Some accept what we do from an R&P perspective. They'll accept it, but some health authorities do have local regulations for local R&Ps and that's the challenge that we have to do caveats for the different countries because it's regulation Also some countries. So if we look at an R&P, an R&P is broken down into several different annexes of preclinical, clinical, et cetera. And then there are some health authorities that focus on the REMS part, which is the US specific risk minimisation part, and some accept that and that's the blend that you have to figure out. It's like all right, what do they want? And that, from a core perspective, we have to balance it out and that's been the challenge. It really has been and it's evolving as we move forward, and also the assumption that health authorities talk right.

Speaker 1 40:21

Yeah.

Speaker 2 40:23

Don't make that assumption. They are very independent in nature many times, even though they do quote unquote talk. But you see, as legislation is being driven in the different countries and different regions, we realise that it's very different.

Speaker 1 40:47

Yeah, here's a question for you. Let's say you were at a start-up company who, for some miraculous reason, they have a wonder drug that has suddenly been accepted by every single health authority. How would you, how, as a person from PV, make sure that you are covering all these regulations? And I'm saying this from a different point of view, from a, you know, novastus is huge. What I'm talking about? A smaller company perhaps, who have just stumbled upon this amazing drug.

Speaker 2 41:35

Well, I'll be frank, it doesn't happen that way. No way it doesn't happen that way?

Speaker 2 41:41

So the one thing about PV is you're like a firefighter, right, you know there are fires that start, that you have to, you know, fight. And the one thing that we know in PV is that, very unlikely that a smaller health authority will be innovative in nature in approving something, they will follow the bigger health authorities. Okay. And from a PV perspective, you always have to be guarded Right, this is great, it's going on the market and what you have to do is look at the product. Is it new, right? Is it new in the terms of a class of drug? Okay, because that will always bring unexpected side effects.

Speaker 2 42:41

And I'm not going to give examples from Novastus, but I have various right when we went through clinical trials and things were perfectly fine. And then we go into the post marketing set. Remember, your clinical trial subset is much smaller than your post marketing, you know set. And you have to like kind of project the class, the drug and say you know, from a PV perspective, what are the risks? What kind of due diligence do we do? And we've done this with various products hyper due diligence, okay, we got to get ahead of the curve. We don't want the health authorities telling us what our risks are. We need to do the data collection that's appropriate to identify our risks within our RMP, within our PSURs and our USPRs or other local safety documents, and that is what we do. That is fundamental to what we do is to making sure that we are ahead of the risks. And what's the ultimate goal? Indy, the ultimate goal is to safeguard patients, not protect the organization.

Speaker 1 44:02

Yeah.

Speaker 2 44:03

It's protecting patients and I you know it's really. It's not spoken enough about what we do in PD because, at the end of the day, we're all healthcare professionals.

Speaker 2 44:18

And every single one of us you, me, my wife, my parents, you know whatever family members you know, whoever is listening here, we're all patients and you want people like us that really have a vested interest in protecting patients, and that's what we do. So if you see a wonder drug, there's no wonder drug that doesn't have side effects. Everything has side effects. What's our job? To identify those side effects, quantify them and communicate them appropriately, to have physicians to make educated decisions in their prescribing practices and that varies from country to country. Sorry, I hope I answered your question. I gotta be honest here, tony.

Speaker 1 45:07

That was the most eloquent way I've ever heard PV explain to someone. I think I will quote that many, many times and you could quote it as much as you want, because it comes from the heart. You can quote it as much as you want, but it comes from the heart.

Speaker 2 45:21

I'll be honest with you. I'm really passionate about what I do, I'm really proud of what I do and I have a wonderful team. And I've seen it in practice and I'm not gonna get into details, but I've seen the safeguarding of patients' well-being and what we do. And people don't understand it unless you live it, and I've lived it, yeah.

Speaker 1 45:48

I'm so happy that you brought it back to patients. We're on the final stretch now and I have to ask the next question, which is the main question really, Because the podcast is called Innovation and the Future of Pharmacovigilance. So my question has to be what's next for PV? Where do we go next? What happens next?

Speaker 2 46:17

So it's really funny. In my view again this is my opinion is we have to focus on fundamentals, right. If you go to inspections like I have, at the end of the day, there are fundamentals in how your databases run, how your clinical trials are run, how your post-marketing studies, whether it's a patient-oriented program, social media, how you collect data into your database is fundamental in whether you do risk management, signal detection. That is still fundamental, and a lot of people that I talk to in industry they forget about those key pillars that bring the data into your database and the evaluation of that data. Now, on the other hand, this is where the marriage of the future happens. It's garbage in, garbage out, good data in, good data out, and that's where we at least I have found that a lot of what we look at right now is garbage in patient-oriented programs, social media, lack of follow-up, lack of quality of what we are evaluating from a scientific perspective and what we can bring back to the regulators, patients and the community as a whole. And that's where the future of PV for me is the marriage right.

Speaker 2 48:03

There's a big gap in my view. But if we can data mine right, what's out there? If we can look at social media effectively, if we can look at patient-oriented programs. Patient-oriented programs is a great example. That represents more or less 50% of the volume of post-marketing cases that come into, you know, especially the bigger companies that are really active. What kind of value are we actually getting from that data? The answer is really none. If we look at the value of what's coming in versus signal detection right, which what we do from a medical perspective, is there really any value that's changing, or labeling right, or label which drives prescribing practices, is it really being done? The answer is no.

Advancing AI in Medical Data Analysis

Speaker 2 49:08

I don't believe it is. Maybe in some other organizations it is. I don't see it. But if we can marry the future of PV and really doing the appropriate data mining and evaluating that from a medical safety perspective, from a risk perspective, that's where I wanna be, at least as a leader. How can we do that and get rid of the gray right, get rid of the BS that we're just doing exercises, like you know. Okay, we're gonna enter this in da-da-da but nothing really happens, like it doesn't add any value, and that's where I wanna get to from an AI perspective. Is it gonna happen overnight? No, I don't think it's gonna happen, and some people will tell you one to two years. No, unless we get the regulators on board and there's a marriage of convenience where we feel comfortable moving forward with such tools, do we feel comfortable being in that inspection room defending something that we did? You know something a little bit different. Good luck, I don't think I feel that comfortable yet.

Speaker 1 50:31

Hope that makes sense you know that was fantastic. Again, tony, thank you very much. And, tony, thank you for joining me today. There's so much more that we could talk about and I hope to be able to talk to you again soon.

Speaker 2 50:47

Yeah, it was my pleasure, and anybody that wants to discuss with me, I'm more than happy to talk about it.

Speaker 1 50:54

Thank, you, and that marks the end of series one of the podcast. We have a special episode for the end of the year with our co-founders, but for everyone else, I'll see you in season two. Thank you very much. Thank you very much.