Hey, guys. Welcome to the podcast. My guest today is Elizabeth Posh. She is a medical affairs executive leader, and she discusses ways to leverage real world evidence in MSL activities. So awesome conversation. I really think that you guys are gonna like it. If you do, please share it with others. And as always, thank you for your support of this show. Welcome to MSL talk with Tom Caravella, a podcast specifically designed for MSLs and all things field medical. Hey, Beth. Welcome to the podcast.
How are you? I'm good. How are you? Thanks for having me. I am so excited. This is gonna be so much fun. Guys, so I've known Beth for a while, but we actually met for the first time in person recently at a conference and wanted to do a podcast together. And I have to tell you, I'm excited about this topic because we have not covered this, not to this extent. So we're gonna talk about real world evidence and how it relates to MSL activities. So this is gonna be really awesome.
But before we do that, Beth, why don't you do a quick introduction? Yeah. Sure. So happy to be here and good to see you, a couple weeks ago, I think, at our conference. And, we've been talking about this for a while, so I'm I'm glad we kinda made it happen already. My background basically has been medical affairs for the past 15 years. And prior to that, I was on the other side as a clinician myself, KOL, subject matter expert, etcetera. Came over to industry and just worked my way up.
Back in the day, I was in what they called medical marketing, which was really an MSL, but they didn't use those titles. So I was a clinical marketer, which was interesting, but, eventually transitioned over to an MSL. Then I managed MSLs, then I became a director, and then a vice president. And this was all at, very large companies, severe standard med, tech, med device companies.
And then, after getting into senior leadership, I transitioned to very, very small companies in basically the startup role. So I've been doing that the last 6 years where I go in and build a Med Affairs department from the ground up. And my first hire, my first push is always for MSLs, always, always defending, the need for MSLs. And I still function as an MSL. When you're at a small company, you have to wear many hats, walk the sleeve, and do a lot.
So I'm MedInfo, I'm Psi Comms, I'm Eagle review worker, and I'm also an MSL. So it the MSL's just always with me, that role and that need and promoting it. So it's just kind of in my blood and it's my passion. So happy to be here as as a medical affairs leader, but really, speak to the the role of the MSL and and real world evidence. I am so excited because you are incredibly qualified to have this conversation. So this is gonna be a real treat.
So before we get into it, this episode is sponsored by MSL Mastery, which is a program or actually several programs for MSLs and aspiring MSLs. Check out mslmastery.com for more details. There's a program for how to land your first job as an MSL, which is called Aspire MSL. There's learning and development programs, programs on presentations. It's really built out. So check it out. I hope you guys get value out of it, but let's jump into this.
I think the hardest part about this real world evidence thing is it's like a tongue twister. It's like every time I say it, I feel like I'm tripping over myself. So so I'm probably gonna say RWE sometimes, but let's start with what what exactly is real world evidence, and how is it different from, like, your traditional clinical data clinical trial data?
Well, I'm glad you said that because I was gonna give a disclaimer and ask for apologies in advance because I'm sure I'll be using real world evidence or RWE a lot, if you're not I read it on podcast today. So thanks for putting that out there. But it is clinical evidence derived from real world data. So real world evidence refers to the clinical evidence regarding like the usage, benefits, risks of any of the medical treatments and intervention that came from the real world data.
So the evidence is what's based on that data that was collected outside of any of the traditional controlled clinical trials that you may be familiar with or what you hear when you think of studies or clinical trials. So this would be data that's collected from the EHR, the electronic health record, insurance claims, billing data.
In my personal experience when I was in the obesity space, we partner with a telehealth company, and so it was patient data from their telehealth, and we were able to use that data to create evidence. So it uses this data that's generated day to day, usually in a medical practice of some sort, and it evaluates the benefits and the risk of a medical product, whether it's a device or a drug.
And often it's preexisting data or future data, So it can be a combination of both, and therefore, it can be perspective or retrospective. Awesome. Because I'm glad that we start he we started there because there's this is like a buzzword, kinda, sorta. Like, it's it's it's something very important to talk about, and you hear a lot about it. So I I wanna like, I'm I'm curious as to why that is.
Like, how has this real world evidence topic evolved in the pharmaceutical industry, and how does it, like, how does it apply to MSLs? Yeah. And it's and it is confusing. I my my last company, I actually had I gave a little info on what is real world evidence because it's a buzzword. So everybody uses it, but sometimes you can actually use it incorrectly. And they're using it sometimes interchangeably with our clinical trials. And that's not quite the same.
So you can't just lump this under studies, so to speak. And really, how this has evolved, it's more recent. About 70% of new drugs and biologics, their regulatory submissions are really now part of the FDA, and it includes real world evidence. So up to 70% in the past, it wasn't quite as high. So that use and acceptance of this RWE in the in the pharma and biotech industries has really increased dramatically just in the past few years.
And so the MSLs are really in a unique position to champion this use and communicate its value both internally and externally, and even just for the sake of, like, what I'm doing today is education. Like, well, what exactly is that? So I think that's where we're we're looking at that that buzzword. I think we're gonna be hearing a lot more of it. It's not going away, and it's it's evolving. Yeah. Well, I guess that leads to my next question. As you're talking, like, so how?
Like, how do MSLs take this real world evidence and work it into conversations with health care professionals and key opinion leaders? I'm sure there's gotta be some nuance to this. Yeah. Well, for sure, they're gonna need a deep understanding of of the science like they do in any other study or or trial and but really understanding the science of that particular design of the real world evidence, the data capabilities, and then an ability to dialogue kind of with 3 different stakeholders.
So in this instance, you might be talking to providers, patients, and payers. There's a big emphasis on payers. A lot of times you're using this real world evidence, and I've used it, in the past myself for payer presentations. Now, not every MSL might be doing market access or payer presentations.
I know there's different you know, the larger companies might have a vast number of MSLs and specialties, but smaller companies, that MSL might be wearing multiple hats, and they're doing presentations to payers or even, patient societies. So they can utilize the information that's collected throughout a product life cycle, the utilization patterns, the economic and the clinical outcomes, and then share the publication.
So hopefully, the med info or med cons or someone else in med affairs, or even your if they have health economics or biostats department or division, have published this data. Because that's really what's really most helpful, because then the MSLs can, can, you know, share that in that capacity.
And if not, the MSLs are kind of pushes back to that internal stakeholder, sell that need to publish it internally to the metaverse group or whomever that might be, to get this data published so that they can have those particular conversations with those patient providers, the payers, or whoever it might be. Yeah. I mean, it seems valuable. It seems like this is really important, and I can understand the buzz. But what are I would imagine there's gotta be some challenges.
That, you know so when MSLs are presenting real world evidence, are there challenges, and how do they typically overcome it? Yeah. There there can be because there's the complexity of data in this rule of evidence, because it's multifaceted. So it's not your clinical trial design, clinicaltrials dotgov. You know exactly what you're looking for. There's multiple reasons.
When I've done, from a MediFERIS leader perspective, when I'm setting up RWE or looking for partnerships and strategizing, it's multifaceted. I'm looking at for the whole department or the company why we need different components of it. So it can be very difficult to convey that key message clearly when you're an MSL. So we did all this, but what part is important, and how do we share that?
So they need to understand the ability to simplify that data for the particular audience with very straightforward language, and even using data visuals and focusing on what are those key takeaways. Because there's gonna be challenges among the the diverse stakeholder background. There they can be the HCP, the payer, a researcher, KOL with very different mindsets, and they're looking for different outcomes. So the MFL is going to really need to ensure the relevance and that engagement.
So, you know, considering different templates and talk tracks for each stakeholder type. So the data is the same. Right? You're not manipulating the data, of course. Data's data. You have the real evidence. But how do you present it to different stakeholders? So that's where those templates and key talk tracks will need to be developed and understood so that messaging is is relayed appropriately.
And then obviously, don't forget the regulatory considerations as well, depending on what particular real world evidence was used, for as such, and then what approval was it used for reimbursement? Was it reused in the approval process?
So at the end of the day, really a joint decision maker amongst, you know, industry, the MSLs, the Med Affairs Group, understanding those key challenges in the real world evidence can really go a long way when they're trying to determine that appropriate use and how they progress in the field. Yep. Yeah. Well so then where do they get this info? So how do MSLs stay current and stay updated with the right real world evidence and and the right data to be able to factor into their conversations?
Yeah. You know, like like anything, any professional, there is continued head on this, Lee, or not. So it's a good way to grasp real world evidence and really the analysis, understanding what that is. So professional networks. And when I was working closely in a couple of positions ago, a couple of companies ago, very closely with our HEAR organization, because we were trying to get out, this real world evidence. It was in infant nutrition. So I'll just leave it at that.
And obviously, you have your your patient, which is the infant, but you have technically the consumer, which is which is mom or the parents. So they needed real world evidence. The, the parents aren't going to clinical trials trying to understand that to make a decision for their infants. So they needed this evidence and using networks like what's called ICE4, which is the International Society For Outcomes in Pharmacologic Research, which really has a your real world evidence focus.
And we would probably never think, well, what MSL or MedAffairs would be involved in that? But if you don't necessarily have to join, but look at these organizations and see the type of publications that they're putting out and the research that they're talking about. And most of it is real world. So just you get that grasp and that understanding. We're so indebted and trained to clinical trials, and that's what we've done.
Most of us have done them ourselves, if we came up through, you know, PhD programs or whatnot. But really understanding what types of other studies are out there and what they're looking for and why and how they're designed. So it's stepping kind of out of that comfort zone. So I would, I would start with that. Just good old continuing ed, looking at other platforms. And then, you know, just the traditional conferences, literature monitoring, collaborate with data providers.
Maybe you have, Biostats groups or these groups in your organization where they're gonna give you access to hopefully some of that high quality data and and expert insights. Don't be afraid to ask questions. I imagine that MSLs that get really good at presenting real world evidence become more valuable to their to their external stakeholders in in a lot of ways. Mhmm. But you mentioned you you mentioned HEOR, and you mentioned the payer side and market access and reimbursement.
Like, where how does this make them valuable? Is it as it relates to those things? Is it a combination of things? Because I imagine that if you're really good at this, this this is what makes a top performer. Yeah. No. Absolutely. So it is with their MSL professionals the depth of their stakeholder connectivity. So both internally and externally, they're going to play a key role in shepherding this development of these research questions for real for real world evidence.
Here we go with the time quiz. It finally came up. Where they use cases, and they can connect groups across the field. So we can take this multiple ways. So perhaps internally, we're looking to do real world evidence that but how do we start? Who do we partner with? How do we collect all this data? So we can use, utilize the MSLs for their connections in the field, and it's kind of like insight gathering, and they can come to us and say, so and so has they have this database.
So I worked for the obesity space, and a lot of these prior practice clinics had these massive databases, and they didn't know what to do with this data. And let's tap into that. Let's partner with them so they can bring that internally. Vice versa, they can go externally, and maybe they need to connect groups to field some of the answers to some of these questions that a society has, if it's a new disease or a new treatment option.
Again, I keep bringing up obesity, but that is my most recent background. And as we all know, it is a very hot topic because it was recently recognized as a disease state before it wasn't. Therefore, as I'm sure you're aware, a lot of these obesity drugs are not covered. So you're going to need payers to cover them and you need to be able to present that to the payer world, which is typically not the traditional way MSLs are used to presenting.
So there's an enormous amount of opportunity for the MSLs to really expand and put another feather in their cap, you if you will, to help both their internal organization and then their external customers as well. Yep. And is there, like, is there, like, a skill to this or a require or a required set of skills that might make an MSL better at this? I think just the ability to want to learn and and do more and excel and think outside the box.
And if you're not looking to just do the day to day, you know, mundane and and how to carve a space for yourself or a niche, then having that drive and that interest will will take you far. And and the ability to push and then to see the value, I've had to sell this myself many times, in organizations. Like you said, it's a buzzword. Not everyone gets it yet. So constantly selling, why we should do this.
And then in fact, we had a large partnership with a telehealth provider, and we were able to get 20,000 patients in less than 6 months. So you're not gonna get that in a clinical trial. But that was a push because they when people haven't heard of anything, well, let you know, they wanna see the results right away, especially the commercial team. They're very results driven, and I can't promise you results.
I can't guarantee that overnight, but I can get you high volume and quality data and very specific data that would be helpful to us. So there's an opportunity there to really benefit both the company and, the MSL, but having that ability to kinda think outside the box and the foresight and, you know, the confidence to ask for that and push for that if you really believe in it.
Yeah. Well, when you say selling it, I it also leads me to believe is, like, does real world evidence play a role in complementing the or enhancing clinical trial data in discussions about, like, product safety and efficacy and the impact? Oh, absolutely. Yeah. Yeah. So the rule one evidence can really address some of the significant limitations that you see with randomized controlled trials. For example, an RCT, and the results, they might have limited generalizability.
That's very common beyond the actual test population, because clinical trials generally have strict inclusion and exclusion criteria, which might not accurately reflect the clinical patient population. So understanding that methodological approach that's used to conduct research both in the real world evidence setting and the clinical trial settings.
So knowing those methods and that inherent limitations of the RCTs is really a substantial opportunity for that real world evidence to supplement and even potentially accelerate clinical trial evidence, beyond just the regulatory decision making capabilities. Yeah. And what like, we talked about the importance of this. We talked about how this is kind of a buzzword. Like, is this the is this going to be continue to be a buzzword for the foreseeable future?
How does this affect the future of the MSL role? Does it become more important? Does it evolve in some way? Yeah. Absolutely. So, you know, into this perfect segue, kind of just piggybacking on the on the last question. So in 2000 late in 2016, the 21st Century Cures Act actually was a turning point in the development of real world evidence because it established a legislative mandate where the FDA would actually evaluate real world evidence for regulatory approvals.
In the past, it was purely clinical trials. So this act actually represented this congressional recognition of the evidence that real world evidence could actually have as a potential. And so the FDA actually has outlined some plans for guidance on on how industry, you know, can use this for the regulatory approval. And under that program, there's evidence, not just only from clinical trials that's not only gonna be considered, but now evidence from real world evidence.
However, you know, there it has its caveats, we won't get into all there's a lot of documentation on that as you can imagine. But they're allowing what's like a various hybrid or pragmatic trial design or observational studies that could generate real world evidence. So that's gonna provide more collateral for the MSLs if you think about it. So what they can and can't talk about, you're looking from a compliance or regulatory legal perspective.
Now that this the STRS Act, and even as as long as 2018, things are still coming to fruition. These things were passed through Congress, but not everyone's embraced them yet. It's still why it's a buzzword. But there'll be opportunities for more of that data to be shared and and discussed before they're just relying on the the standard clinical trial. Got it.
And so there there's definitely going to be a lot of maybe some newer MSLs and even aspiring MSLs that that might be listening to this episode. So I'm curious. What advice would you give to those folks on what they might need to know about just getting good at presenting real world evidence and developing the you know, you how helping it to develop stronger relationships with their external stakeholders?
Yeah. I think that that's a good question for any MSL, whether you're you're new or you're coming into this for the first time or the 100th time, the AgnesUp professional's depth of that stakeholder connectivity is really key. And connecting any of those gaps, both in the field, in a way that they can enhance their knowledge as well as the company's knowledge and their customer, right, if you will, any of the KOLs.
And I think the big thing here is working with the internal medical affairs group through understanding of the real world evidence that they'd like to incorporate. And then so getting your buy ins, if you will, from the company, from your larger organization, What you can and can't use, what's available to use, and taking that data and that info, and then incorporating it and finding a KOL where you've got an excellent rapport with a great relation almost like a mentor.
Like, I I've I've had folks like this when I was in this and even, even to this day, I, I call, KOLs now for personal medical advice sometimes, Hey, I'm having my gallbladder out. What do you think of this? So someone that you have that kind of close relationship with, where it's okay to not be a 100% confident, sure, but let, let's try this out.
Like, let's take this data for a test drive with them, if you will, and sit down and ask them what they think is important and what their colleagues or their societies or their organization might find relevant, reliable. Because you're just you're trying this out. Right?
I'm not necessarily saying see what sticks, but talk with that KOL who you've kind of got that mentor mentee relationship with, that very, close knit communicative, capability where you can just pick up the phone and call them and see what they think. And then listen to the constructive feedback and tweak your presentation from there and kinda do a dry run with them and and go running with it. Yeah. Awesome. I'll tell you, this was great stuff. I learned a lot.
And, I love these conversations that are kinda novel, at least for me. Like, I'm not an expert on real world evidence. I could hardly even say it, but we did get through it. We did. Not too bad. Yeah. Awesome. Well, Beth, you're the best. I really appreciate you taking time to do this, and we'll have to do it again. Yeah. Absolutely. This was great. So good to see you, and hopefully, we can do another one soon. For sure.
And, guys, thank you as always for all your support, for listening to the show, for sharing it with others, and we will see you next time. Thank you so much for listening to the show. If you've enjoyed it, please subscribe so that you don't miss episodes in the future, and feel free to leave a rating or a review or a comment. Thanks again, and I look forward to seeing you again soon.