Colleen Walsh

Discover the intricate world of pharmacovigilance as Colleen Walsh, the Vice President of Global Patient Safety Operations at Alnylam, unveils her personal journey through the ever-evolving landscape of patient safety. In this enthralling episode of Innovation and the Future of Pharmacovigilance, I sit down with Colleen to unravel the complexities she's encountered, from the pivotal Tysabri incident at BioGen to leading R&D compliance at Alexion. Her story is a testament to the resilience required in the face of regulatory upheavals and the innovative spirit needed to navigate from clinical trials to post-market safety.

In a field where the stakes are as high as the patients' lives, Colleen sheds light on the arduous task of merging companies within the rare disease sector, specifically the AstraZeneca acquisition of Alexion. Through her insights, we gain an understanding of the delicate balance between patient support programs and the scrutiny of global pharmacovigilance regulations. Colleen's expertise reveals the pressing need to bridge the gap between regulatory intent and its real-world application, ensuring that patient safety remains paramount while fostering a culture of innovation.

Our discussion veers into the future of pharmacovigilance technology, examining how AI could revolutionize the industry yet poses unique challenges for both behemoths and fledgling companies in the pharmaceutical world. Colleen proposes an intriguing shift in perspective, advocating for pharmacovigilance to transition from a cost burden to a revenue generator by incorporating safety measures early in drug development. Join us on this episode as we probe into a future where pharmacovigilance not only safeguards patients but also drives value and progress in the realm of medicine.

Transcript

Speaker 1 0:17

Hello and welcome to another episode of Innovation and the Future of Pharmacovigilers, a podcast series brought to you by Trudiant Talks. I'm your host, indy Alawalia, and I'm delighted to navigate the dynamic world of pharmacovigilance and risk management with you. A quick disclaimer first the opinions expressed in this episode are solely those of the individual guests and do not necessarily reflect the official views of Trudiant Consulting or their own company. We're all about fostering insightful conversations here at Trudiant Talks and we want you to know that any product, vendor or service mentioned does not imply an endorsement. If you're seeking professional advice for specific situations, we encourage you to go to our experts. Please remember this podcast content is meant for informational and educational purposes only. Today we're incredibly fortunate to have Colleen Walsh, vice President of Global Patient Safety Operations, at our Nilem as our guest speaker. Colleen, thank you for coming onto the podcast.

Speaker 2 1:26

Thanks for having me.

Speaker 1 1:28

So, colleen, generally we ask this first question. I say generally, we always ask this first question, but it is extremely important. How did you get into PV?

Speaker 2 1:44

I know it's always funny when people who are in pharmacovigilance are talking about how they got into the field, because I you know a joke that my son recently graduated, if you will, from fourth grade and they put together a yearbook and kids wanted to be doctors and football players and singers and no one wanted to be a pharmacovigilance professional. So, yeah, well, I actually, when I graduated from university, I actually started off working as a study coordinator at a Boston Medical Center. I'm based in Boston and that was really my first exposure to anything related to clinical research, to medicines development, but I really I really liked it, I really enjoyed it. So, after being a study coordinator for about two years, then I moved into working for a CRO At the time it was quintiles, now it's IQVIA but I was working as a clinical research assistant. So instead of just working on one clinical study at a single site, I was monitoring multiple clinical studies for multiple sponsors across different sites. So I was traveling quite a bit and actually really that gave me a broadened perspective of what clinical research looked like and also a bit more of a peek into the sponsor side of things.

Speaker 2 3:10

Although I was working for a CRO, I was working on behalf of sponsors. So someone that I had worked previously with went to go work for BioGen a company called BioGen and she reached out to me and she said you know, I think you'd really like working here. She was working in pharmacovigilance at the time and, you know, she said, I think you'll appreciate sort of the sponsor side of things and also get more insight into safety, because prior to that time the only thing I really knew about safety was that we collected SAE forms. And so I went to work in the Pharmacovigilance Department at BioGen and that was really my first step into the PV world and I really haven't looked back and that was many years ago over 20 at this point, so dating was a little bit.

Speaker 1 4:05

Wow. So you were at BioGen for a number of years, for about three years or so. What was your decision to move from BioGen at that point?

Speaker 2 4:16

So at BioGen I was working in the safety side. I was partnering with our commercial colleagues at the time and focusing on sort of some of the quality aspects of safety. I was doing internal audits, but on behalf of the safety team, and then moved more into becoming the liaison with the internal patient support program that we had at the time. I was interested in expanding my scope and doing a bit more, and so that I moved into a role at a much smaller company called Alchemy's. They didn't really have a safety department per se and they didn't have any marketed products. At the time when I joined they had filed an NDA for a product called Vivitrol and that was under consideration by FDA, but they didn't have any marketed products at that point. So I was the first employee, number one in their safety team and I really enjoyed being able to build out a larger group.

Speaker 2 5:21

So between when I started at Alchemy's and when I left, the safety team grew to four people, which doesn't seem like a lot, but it is when you're starting with none, and I really just appreciated the breadth of experience I could gain at Alchemy's and it was really fun. It was fun. There was a lot of problem solving, there were lots of challenges. And then the time when I was there, vivitrol did receive approval by FDA, so we very quickly had to move from a company that was just purely based in clinical trials to supporting a marketed product. So I will definitely say there were times that were very challenging, maybe even a little scary, without having the right infrastructure, but ultimately I think we developed a really strong group and team there. So that was that was I think it was the right decision in hindsight, because I was able to gain, I think, a breadth of experience that I wouldn't have necessarily gotten in a larger organization.

Speaker 1 6:22

Yeah, I think that's a. I think that's a really good, really good point, and especially going from going to a company that has a well, no safety, essentially no past post market safety, and then suddenly bang, we're in post market world. And I think sometimes in a lot of small emerging companies it tends to be an afterthought that you know safety will sort it out once we go post market. But being in a safety department where you literally have nothing to oh, we need, we need stuff, we need to be able to do stuff, must be extremely challenging and but at the same time, once it's, once it's finished well, not finished, but once it's up and going it must be extremely rewarding.

Speaker 2 7:11

It was, it was, it was an end back then I say this because it was like the early 2000s it was we didn't have nearly the amount of technology and capabilities that we have today. Back then, so in some ways I think that probably made it. In some ways it made it easier and in some ways it made it a bit more challenging. But I do think to your point, with a lot of sort of smaller companies scaling up from going from a company that's purely in the in the clinical space and then supporting post marketing, that's a really challenging bridge to gap but also really an exciting one If you're. If you're working in PV, at least from my perspective, one that offers, I think, a lot of career development opportunities and just a lot of exciting opportunities to expand sort of the, the breadth of understanding of PV.

Speaker 1 8:07

Yeah, and so you were there at Alkermes and you'd created this post-marketed safety situation there, and then was it time to move on again.

Speaker 2 8:23

It was time to move on again, and it wasn't because I didn't like the role at Alkermes, it was so at the time I had.

Speaker 2 8:32

You know personally, I had had my first, my son, and I was really looking for just to be able to spend more time with him and a little bit more flexibility in my schedule. So I moved to another biotech company called Vertex and I was at the time came on as a consultant, so I was able to have a little bit more flexibility. I didn't have any team reporting to me, I was an individual contributor. So that allowed me to spend more time with with my son, which is which is what I had wanted to do. But then as he got a little bit older and I actually missed feeling like I was actually sort of part of a team, or at least sort of a more meaningful, meaningful contributor to a team, and that's not to say as a contractor or a consultant you can't be but I think it really depends on the role or and the company that you're working with. So I came on board at Vertex as a full time employee and then was leading up their operations team there, their case processing and their operational team there.

Speaker 1 9:47

And what? Maybe? Maybe excuse my ignorance, but what is the main thing about PV operations? What is it that it does really?

Speaker 2 10:02

I think you know PV operations, the way they look at it is, it's sort of the foundation that allows the what I think sometimes are perceived as the more glamorous elements if you can even call anything in PV glamorous, that might be like an oxymoron, like a jumbo shrimp, but I think it's the foundation that allows the other work in PV to be done, you know.

Speaker 2 10:26

So I think a lot of what people, when people think of of pharma co vigilance or at least people within pharma co vigilance they're thinking of, you know, signal detection and really getting a more deep understanding of the benefit risk profile of the product and and really embedding safety in early development. So there's the development safety update reports now and so that we're really understanding the safety profile of a product from very early on through the product lifecycle. But in order to do that, you know, and in order to actually sort of meet the regulations, you do have to have the operational infrastructure in place. And so while it's not necessarily, I guess, the most glamorous part of of of pharma co vigilance and I guess it's the same for any like clinical operations as well it's really the foundation that allows the other work to be done.

Pharmacovigilance Career Transitions and Regulations

Speaker 1 11:23

Well, yeah, I think that's. I think that's a good way to put it. So you were at vertex as an independent contributor and then eventually came on full time once, once that was available to you, and then you went back to Biogen. I did.

Speaker 2 11:50

So the same person that had initially introduced me to Biogen was still there at the time and they had gone, they had undergone some organizational restructuring. So in the interim, when you know, between when I left Biogen and came back, there was a fairly significant safety story that emerged from Biogen and had to do with their multiple sclerosis drug called Tysabri. Tysabri launched and was really, you know, I think, seen by many patients, healthcare professionals as sort of the next that like the best thing that had happened to MS patients and quite sometime it was efficacious and it really just, I think, afforded a new effective for many treatment. When the product was very newly on the market, we detected some cases of progressive multifocal luchoencephalopathy, or called it's called PML. It can be a fatal brain infection and so Biogen had decided to voluntarily remove Tysabri from the market and really, I mean, that was that's PV. In my opinion, that's really PV working. You know, throughout the time Biogen worked to implement a very, very specific, very involved risk management plan or in the US it was the REMS and ultimately brought Tysabri back to the market, but with very strict conditions. So you know, the patient population that would be able to access Tysabri was definitely much smaller than initially considered, but it was still an effective treatment. And I was really, really impressed by how Biogen sort of managed that journey of Tysabri and I think that they had very candid and open conversations with regulators and at the time I think it was probably the first REMS program, or at least the most involved REMS program that had, you know, ever been on record for for a product.

Speaker 2 14:10

But with all of the work that Biogen had done to bring Tysabri back to market, there was a lot of changes in the safety organization and so the person that I had known had reached out and said would you be interested? They had developed a reporting and submissions team that was just very specific to global regulatory submissions, both on the expedited side and on the aggregate aggregate side, and that was one element of PV that I knew was important but I really didn't have a lot of expertise or depth of experience in, and so it just seemed like something new and something that I could learn and something fun I actually took. It was sort of a step back, to terms of title, from what I was doing at Vertex to what I was doing at Biogen, but it was. It was again something new, something fun to learn about, and once I was at Biogen I also took on some other responsibilities. There were some additional organizational changes, so also became responsible for the quality team that was embedded in safety, and that was when I really started getting involved in a lot of regulatory inspections, which was also something that it's always interesting to read.

Speaker 2 15:29

The regulation that's sort of in the code of federal regulations in the US or in the European Armicle Vigilance legislation. I think it's quite another experience to actually defend how you've interpreted that regulation and how you're actually operationalizing it, and you definitely need to do that in an inspection. So that was. I experienced quite a few of those while I was at Biogen for the second time.

Speaker 1 15:57

And was Biogen? Well, the second, let's call it Biogen Part 2,. Was Biogen Part 2 essentially the first time that you were opened up to more global regulations, or was this, or was it still the same from your previous roles?

Speaker 2 16:17

There were. We did have some EMA, some European inspections while I was at Vertex, but they were more focused just because of where the company was in its development. They were more focused on GCP inspections. So Biogen was really the first time that I was working quite a bit on GVP inspections globally.

Speaker 1 16:40

Yeah, and I'm guessing that was a big, was it? Well, actually I should ask that question was it a big difference going between GCP and then GVP?

Speaker 2 16:54

I think the biggest sort of change. At that time it was right around 2012, which?

Speaker 2 16:59

is when the, at that time, the European legislation changed quite a bit.

Speaker 2 17:06

They came out with the good pharmacovigilance practice modules, and so I think it was a unique time point because there were lots of companies that were just again trying to align with what those regulations required, for example, the pharmacovigilance system master file. I think that was probably now. I know anyone who works in PV, at least outside of the US, knows what that is, but at the time it was really kind of something new and it's such a cross-functional document that there was a lot of marketing and a lot of. We had to work quite a bit with many cross-functional teams to even explain what this was and why they should care. So I think that the 2012 legislation in Europe really did. I think it changed the way in which pharmacovigilance teams had to approach their work Because, like things like the PSMF, it sort of proceduralized and made mandatory from a regulatory perspective that cross-functional communication and collaboration. And that's not to say it didn't happen before that time it did, but now we had sort of a regulatory requirement to ensure that it happened.

Speaker 1 18:37

Yeah, that's really interesting. Maybe we'll come back to that. Your time at Biogen eventually comes to a close, and then we move on to Alexion. What was going on there?

Speaker 2 18:56

So at the time when I left Biogen it actually was they were spinning off their hemophilia business. They had two hemophilia products and so they had spun off their hemophilia business to a new company called BioVeritiv. And there were a number of employees that they spun off with BioVeritiv and I was one of them At the time. They sort of spun me off as the head of R&D compliance for the new company, which was a very, you know, while flattering, I didn't necessarily feel where I was, just in terms of having younger children, where I was with my personal life, to start up a sort of a new organization in a newly formed company. I just didn't feel like I could give that activity the amount of time and attention it would need to be successful.

Speaker 2 19:54

So I decided not to spin off with BioVeritiv and move to Alexion. But the idea of quality did intrigue me. The fact that Biogen had decided to sort of spin me off in inequality role made me think that they did have some confidence in my capabilities to do it. So I actually at Alexion moved into a role within the quality organization, not under the pharmacovigilance organization but because I can't seem to get away from PB. I was supporting pharmacovigilance, the regulatory affairs team and the medical affairs team. So I was sort of the quality business partner supporting those organizations at Alexion.

Speaker 1 20:40

And you spent quite a number of years at Alexion. I did, and then is that the point in which AZ bought Alexion?

Speaker 2 20:52

Yeah, yeah. So AstraZeneca acquired Alexion, or the announcement that they acquired Alexion was in I think it was December of 2020. So we were all working at home. It was, you know, the midst of COVID. So AstraZeneca purchased Alexion because they wanted to create a rare disease business unit and Alexion for listeners who don't know was really focused in rare disease. But the regulatory approvals that needed to happen for that purchase it was probably another year or a bit more than another year before the companies actually really started working together, Because we had to kind of keep the business separate until all of the regulators sort of approved the acquisition.

Speaker 1 21:47

And how was that? Because Alexion wasn't a small company by any means. Right, it was still quite a substantial business I mean not the size of AstraZeneca, but it was a substantial business and at the time of merging it must have been fascinating to be these two companies.

Speaker 2 22:07

Well, it was, I think, any you know acquisition or merger. You're bringing together two company cultures. One of the things that was you know that I found at Alexion was because it was based in. It was a rare disease company there were. There was obviously not very many patients. So while you're running clinical trials, you're definitely not running clinical trials that have thousands and thousands of patients.

Speaker 2 22:36

You know the patient support programs that are run in rare disease companies, often the like sort of case managers have. They really create relationships with the patients because it's such a there are, there's not, there's just not many of them. And frequently you know the patients that have rare disease. Their journey from sort of symptom onset to diagnosis can be many years Because not many HCPs are necessarily aware of their condition or don't necessarily know the. You know the sort of the symptom ontology or the what to look for, and frequently I think rare diseases are a diagnosis of sort of exclusion, so HCPs are looking for other things before they finally get to the diagnosis of whatever the disease is.

Speaker 2 23:31

And so understanding that that sort of patient journey and not only just the patient but their family, sort of the impact on them, I think that's something that Alexion did very well and AstraZeneca, I think, recognize that because they didn't have that rare disease unit. But it's it's just it's very different in terms of just the scale of treating kind of more prevalent disease versus rare disease patients. And I will say that I think AstraZeneca was very keen to learn about that and understand that and I think on Alexion the Alexion side it was it was really interesting for us to see just the machine that AstraZeneca was with respect to how they could approach much larger clinical trials. They could approach, you know, market just the sheer number of patients for some of their products, very, very different.

Speaker 1 24:26

And I can only imagine. And then we get the close of that chapter of your career and we come to your present day, essentially, where you are the VP of Global Patient Safety Operations at Nilem, and it's probably a company that some people have not heard of.

Speaker 2 24:50

So Nilem again sort of going back into the rare disease space.

Speaker 2 24:54

So Nilem is a company that has been focused on the development of products for rare and ultra rare disease.

Speaker 2 25:02

They use a very specific technology, one that they've been researching for the past 20, probably 20 plus years, focused on RNA interference. So they the challenge at Nilem. I think that they understood the technology work, the science work. A lot of the challenge that they had was around delivery of how they could deliver this technology into tissues in the body, and they've been able to master that in hepatic tissue and liver and then, once they were able to understand how to deliver that technology to hepatic tissue, they were able to target a number of rare diseases. They're still looking to be able to deliver the product to other tissues in the body. I think that's a challenge that it's not only on Nilem that's working on it. There's a number of companies now that are looking into sort of the RNA eye space, but all Nilem has been really one of the first to be able to do so successfully and I was intrigued by their story and also just excited about being back in kind of a smaller company and one that was focused in rare disease.

Speaker 1 26:24

It's a completely fascinating journey and thank you for going through your career. I absolutely love hearing how and why people make these decisions in life. I want to go back to a couple of points that you said throughout there that I didn't want to interrupt too much, but we talked about GVP guidance coming in 2012 and you gave an example of the PSMF, and you were also saying about inspections and the interpretation of these regulations, guidelines, etc. And there is a question here which I'm sure is very intriguing, which is like the intent of the regulation or guideline versus what actually happens and how do they come together. I mean, there's a great effort at the moment to try and get all the regulations almost harmonized, and I've said this in previous podcasts that you know the big few are trying to Trying to bring all this together, but you are getting some smaller agencies out there that are actually trying to be a bit more innovative with their, with their, with their regulations by. Anyway, the point is is that what's what can bring together that intent versus what the actual regulation is?

Challenges in Pharmacovigilance Technology Implementation

Speaker 2 28:01

Yeah, and I mean it's so to your point. I think they're EMA, I think does a really good job of trying to be much more explicit in their requirements. I know FDA has has some new guidance out, but some of it is still relatively outdated and I think a lot of companies look to the EMA legislation and regulation to sort of develop the processes and procedures in their pharmacovigilant system. But I'll you know, I'll take patient support programs as an example, because and this is going back some time, but there was a period of time where I think mhra in particular was very, very interested in patient support programs and in ensuring that Adverse events, all of the adverse events that were collected through patient support programs, were Collected, reported appropriately, and I know that they found some instances in certain companies where that that didn't seem to be the case, and so while I was at one of the companies where I had worked at, we had a number of patient support programs that were ongoing and, sort of as a Preemptively, we did a retrospective review of our programs and and found a number of Unreported adverse events which we then collected and needed to database and then analyzed to ensure that there was no Impact to the safety profile of the product, which which there wasn't, luckily, at the end of it. But it did make me reflect on just we had spent no millions of dollars to do this retrospective review of of these programs and collect adverse events that ultimately didn't didn't really have any impact on the safety profile of the product. And so it got me to thinking around just how patients and healthcare professionals use patient support programs. The purpose for which they're established is really around providing Patient support, around access to product, patient adherence, potentially reimbursement. You know, certainly in the US that's a big piece of it, but they're not necessarily, and so so the adverse events that are reported out of those programs are almost always incidental in nature. And if, if a treating physician or healthcare professional had a true concern or, you know, an unexpected event that occurred to a patient, I don't necessarily know that the patient support program reimbursement, for example would be the first line of defense that they would call.

Speaker 2 30:42

And so I think that there is a disconnect, and that's just one example of sort of the intent of the regulation and then how companies interpret it and how, and really the return on investment of the operationalization of the of the regulations, and I think that happens. That was quite a few years ago, but I've seen that happen quite a bit. I know that there are some industry organizations that are that interact regularly with regulators, but I still feel like there's a bit of hesitancy to just look bad on the part of a lot of industry, both biopharma and and larger pharmaceutical companies. So one of the things that I think would be helpful was a more, I guess, transparent dialogue between regulators and companies around around the challenges that are that are sort of our fraught with these regulations and how they're actually implemented, and taking, I think, a more, I guess, pragmatic approach to what is actually required.

Speaker 2 31:49

Because, you know, quantity does not necessarily equal quality and and many, many of the reports that are received through these programs are of limited utility.

Speaker 2 31:59

They're limited information and there's a lot of effort going into collecting follow up that we just frankly don't get. I think when you talk with, a lot of regulators understand this as well as that. You know, once you're in the post marketing world, the value and sort of the quality of the data in post marketing reports is generally much lower than that of clinical trials, just because there's a lack of Sort of standardized collection. So I think we can be smarter with how we deploy our resources, both human and financial, in terms of how we're collecting this information and the ways in which we're doing it. But I do think that dialogue with regulators is one, is one step. The other piece of it, too, is that I mentioned earlier when sort of first starting out in my career at least, we didn't have nearly the technology Back then- that we do today, and so I do think that there's a component of technology that we could use to make the process of adverse event collections much less onerous for all involved.

Speaker 2 33:11

The caveat to that is that I think, while if you go to industry conferences, I think you'll see AI and machine learning and you know kind of the frontiers of pharmacovigilance on every conference agenda that you attend, I think, in actuality, when you really start talking with people about how much technology is actually being implemented in pharmacovigilance, we're just scratching the surface. I think there's a lot more work to be done in that regard.

Speaker 1 33:42

I think that's a game. Fantastic points, especially with the technology front, where PV for someone who's a bit of a tech freak I love tech, I always have, I always get the latest iPhone, I always get, you know, the latest, whatever I can. But the reality is that I remember very early on in my career I started around. Yeah, very early in my career I remember that I had a phone that could send messages, that could. You could watch YouTube on. You could do so much. You could even track things on there. So if you had blood pressure you could just quickly type into your phone. You know this is my blood pressure today and then you know when you go to the doctors you can say, well, here was my blood pressure, sort of points.

Speaker 1 34:45

But PV has always been reluctant to take on technology. But what is really interesting in the past couple of years with this AI piece is that it's gone from yeah, you know what we're a bit worried about introducing technology to oh, no, no, no, we need AI immediately. There's there's been no middle path, no sort of graduation of maybe we should automate things, maybe we should just workflow things, maybe it's no straight to AI. And one of the reasons I started this podcast and why I started trillion talks in general was that all the conversations are about AI, but it's getting muddied with the fact that there are processes that need to be thought about and the correct technology needs to be applied to those processes and also specifically for smaller companies.

Speaker 1 35:52

A lot of this AI stuff is fine, but when you have large amounts of data, but when you come down to a smaller company where there isn't so much data necessarily, how does the cost difference or the cost variable come down to the smaller company? I mean, if, for instance, our Nylon were to say you know what, we're gonna go get an off the shelf AI, fully automated PV system. I'm sure it would cost quite a few million, which is something that you know. Realistically, you might not be able to spend on a PV system. Sorry, I think I've gone off on one there, but my point is that I completely agree with you that technology can help in certain aspects, but it's about selecting the right technology, I think.

Pharmacovigilance Challenges and Future Trends

Speaker 2 36:46

I agree, and I think you know to your point on sort of larger companies versus smaller companies. So while I was at AstraZeneca I mean that's a very large pharma company they have just they have data to forget data lakes. They've got like data oceans. They have so much data so and they do have significant resources to select different technologies you know AI or machine learning or they have more financial resources to dedicate toward sort of implementing AI in a way that's going to be meaningful. I think that the challenge there was just almost where to start, because there is so much data and not all of the data was of equal quality, and I know that's been an age old conversation is sort of you know, just because you have a data point doesn't necessarily mean it's useful, and a lot of it goes into how it's collected and isn't looking at the right thing. So I think some of the challenges for larger companies is just really kind of understanding where to start or where to best deploy the resources that they have to get some meaningful output from the application of AI.

Speaker 2 38:06

With smaller companies, my observation is that you know the data. They don't have such a large quantity of data, but then it comes down to cost, because you know, I think the a lot of artificial intelligence, a lot of the cutting edge technology, if you will, in PV is still relatively new and definitely expensive. And so I think for smaller companies it's a different challenge, but it's around. There's a lot of convincing I think that needs to happen of the organization at a whole, particularly for PV, in terms of is the investment worth the return? And so what I've observed is that, you know, in many regards, the smaller companies are sort of looking to see what happens at the larger companies and what works and what doesn't, for them to then agree and align on, you know, a path forward.

Speaker 1 39:07

And do you think again, looking at intent of the regulations, do you think that the regulations themselves are biased towards the bigger companies and their processes because of the amount of data that they go through, rather than the actualities of a normal pharma company?

Speaker 2 39:33

I think to an extent yes, because I think if I look at sort of some of the industry consortia that typically work with regulators, many of there is a very heavy representation from big pharma, and that's not, it's not a value judgment, it's not a good or a bad thing. You know, I think large pharma has more products on the market. They're impacting more patients typically than smaller pharma, and certainly for rare disease companies or biotechs. So I do think that you know, I understand why that dialogue would happen with the larger companies, but the infrastructure and the challenges even that are in place at larger companies are not necessarily the same as at smaller companies, and so I do think that there's an opportunity for smaller biotech pharma companies to have more dialogue and engagement with the agencies, not just around individual product approvals and applications, but really more broadly around pharmacovigilance challenges, pharmacovigilance systems. I think that that's starting to change, but it's still very much weighted in the in the favor of big pharma when it comes to dialogue with regulators.

Speaker 1 41:01

Yeah, I think I can agree.

Speaker 1 41:04

I think there's a chicken and an egg situation where you have big farmers who are able to provide resources to those consortia versus where, let's be honest, some people do not have the time they do not have maybe can go away for a week on a workshop or something to talk about something.

Speaker 1 41:37

But it's a fascinating conversation regardless, because actually you're right, there needs to be something there to be able to push forward the agenda of the maybe midsize to lower farmer companies who are not in the same league with regards to how they can implement things. And actually there was another point that you made earlier in the podcast, again going back to that PSMF piece about cross functional Ness of PV, and maybe this is kind of linked to the regulations as well. But there is this whole movement about moving PV from being, oh, we are a cost to actually we could be revenue because we can spot things earlier on if you include us earlier on in the whole clinical pipeline. And there's this governance factor, right, and certainly some of the bigger companies are now have chief safety officers, I've noticed recently. But that's a lot of conversation. But how do you move it downstream or maybe higher up the organization? Actually?

Speaker 2 43:01

So that you know I think we had talked about earlier having safety involved earlier on in drug development, and I do think not every company, but there are. I think it is a movement toward having pharmacovigilants, like safety, specific staff involved in early development teams certainly clinical development teams, but so that there are, so that the data and the programs themselves have someone who is looking at the protocols, the structures, the data outputs through a pharmacovigilants lens. I do think since, at least when I started in pharmacovigilants and where we are today that that is there's been a lot of progress made there. Where I see there could be a bit of a breakdown is that transition from clinical development applications, like applying for a marketing authorization, and then moving into post marketing, because then I think you're working with a lot, a lot, a lot more functions. It's not, it's not only sort of clinical and regulatory and safety, but there is commercial and there's medical and there is, you know, manufacturing and you're starting to reach more patients and, from what I've seen, it's that it's that move from from clinical development and investigational product into a marketed product.

Speaker 2 44:39

Where we haven't done and we I mean pharmacovigilants, at least the pharmacovigilants teams of which I've been a part, we haven't done the best job of partnering with those teams to really demonstrate the value of safety. I still think that there is a fair bit of reactivity in the post marketing space and just sort of setting things up because we have to collect this information and we'll get in trouble if we don't. And I do think we need to shift that narrative, like I still see routinely looking at adverse events. You know, training slides, it's, it's, it's well, this is what's going to happen. You could, you could, get your license revoked or you could, you know, get fines, and a lot of it is very punitive and I think we really need to sort of shift the value proposition there.

Speaker 2 45:33

We're still working on getting that right, but I think it's less around. I think safety still in the post marketing space is very much seen as just something you have to do and necessary evil you have to. You have to have this in place so you can collect adverse event information, because if you don't you're going to get in trouble. And I think there's an onus on not only on pharmacovigilance teams but also it goes again back to dialogue with regulators around how we can shift those activities to actually be more of more value.

Speaker 1 46:08

I think. I think that's fantastic, and actually, you made me remember that old adage Well, it's not an old adage, it's the old thing that I always got taught, which was if you do not do your job, your QP PV will go to jail, and that was that was the one thing that they always used to dangle. But as we come towards the end of the podcast, there's always another question that I always ask, and it's a fairly simple one but very complex to answer, and that is what is next for pharmacovigilance and risk management.

Speaker 2 46:49

I think, I mean, I think that there there's a lot, there's a lot of things that are next.

Speaker 2 46:57

I think we're I mentioned earlier, we're sort of only scratching the surface of what technology can do and not to sound like a you know that that that's a trope or that I'm being overly optimistic but I really think that we're only just beginning to understand how AI and machine learning and technology in general can be applied not only to pharmacovigilance but but essentially to drug development.

Speaker 2 47:30

Because of the complexities of you know sort of the fact that we are dealing with human lives, but also patient privacy and and just being a very highly regulated industry, I don't really think we're going to be super early adopters of all of the technology.

Technology

Speaker 2 47:50

But I do think the ways in which we are looking at data, the ways we're in collecting data, the ways that patients are even interacting with companies, and the technology and tools available to us to analyze that data are going to dramatically change over the next, certainly over the next 10 years and beyond, and I think what that's going to require is a concerted effort by both regulators and industry and and patients and healthcare professionals themselves to understand the potential for what that landscape could look like, but then also to develop it and define it. You know, right now, I think it's, I think we're only just beginning, which is which is a really again, maybe overly optimistic, but I really do think we're only we're at the beginning of this and I think it's going to be better wherever we land. I think we're actually, I think it has the tremendous potential to be more meaningful than it is today, but it's going to take a lot of work to get there.

Speaker 1 48:58

I think that's a fantastic movie title TV technology the beginning.

Speaker 2 49:04

Exactly. Maybe it's a horror movie, we're not sure.

Speaker 1 49:08

No, not quite sure yet. Colleen, it's been fantastic speaking to you today. I thank you very much for coming on. It's been, it's been for me fascinating.

Speaker 2 49:19

Yeah, no, thank you. Thank you for having me. It's been, it's been great talking with you as well.