Integrated Evidence Generation Planning: Top Challenges for Medical Affairs Teams

Welcome to this episode of the Medical Affairs Professional Society podcast series Elevate. I'm your host, Garth Sundham, Communications Director at Maps. And today we're talking about integrated evidence generation planning with experts from humanity. Joining us are John Howley, President/US Communications, Anne Marie Chapman, VP Strategic Solutions, EHTA, Mina Venkatachalam, I almost got it, Mina, head of Global RWE Consulting, and Wilson Joe VP Medical Strategy with the US Communications as well, this episode is sponsored by Luminity. So John, please get us started. Hi, EGP, where are we now with the challenges in integrated evidence generation planning? Sure, thanks. I think the most significant challenges we see within organizations today are related to their siloed nature between various departments and also the regions. We know that individual departments tend to focus on the evidence needs of their specific stakeholder audiences. So historically, you have clinical and regulatory teams focused on the evidence needed for approval, while you have groups like market access who are focused on evidence for payers. You have regional differences in the competitive landscape, their reimbursement differences, and standard of care across the regions as well. Which are going to translate into prioritization differences for their evidence needs between those groups. So we see that this oftentimes results in a lack of cross-functional and regional alignment when going through this. We really, which really highlights the need to have an integrated approach to strategic planning so that the organization as a whole can appropriately prioritize these evidence needs. Right. And that's the eye, right? The eye and IEGP. It's fine. I'm wondering at Maps courses and our medical communications masterclass just got integrated added to it. So is this something that people are recognizing now that you can't just sit and cling to have and go towards approval and you can't just sit in access and be backfilling the access evidence? Are we now respecting the need for integrated evidence generation planning? I think organizations are starting to identify the plan and trying to work it into their planning process. One of the main barriers that we see that are that organizations, they're oftentimes, they're starting this process too late. There's either a lack of funding or it's not enough resources that are dedicated this. And just because the funding is not available to support the research, that shouldn't limit the organization's ability from initiating the strategic planning process to start prioritizing those evidence needs. Identify resources early to leave the initiative. That's what we're telling our clients. We all know how difficult it is to get the different internal stakeholder groups together and align on priorities. The earlier that we can start to plan for this, identifying opportunities where teams may already be together. There's a lot of congresses where people are traveling to a central location for that congress. Get there day early. Have a workshop start the process. This can help overcome some of these challenges. We definitely feel that the earlier that you start the process and really work it into your annual strategic planning process. This hopefully already involves cross-functional stakeholder groups, hopefully marketing and medical affairs and market access and the other teams are participating in a cross-functional overarching strategy on an annual basis and really setting that up. We know that a successful integrated evidence generation plan is only possible if the organization has alignment on those key strategic priorities that are evolving across the product life cycle. If those evidence needs absolutely need to be an extension and based on your assets integrated strategy as a whole, it really becomes this continual process of realigning and prioritizing your evidence needs as your assets strategy evolves. Really tying the strategic planning processes together is so important in our minds. It's an early planning, cross-functional planning. You can get the plan started and even prioritize what before you have the resources to execute the entire thing. 100 percent. 100 percent. 100 percent. But get the plan in place. Wilson, why is this so hard to get cross-functionally aligned on the IEGP? And why is it so important? Why can't you just silo, clin dev and silo market access and have each one working towards their own needs? Why is this alignment and geographically as well? Why is this alignment so important? Well, it's interesting because the whole importance of integration is that we talk about starting earlys important and budget planning is obviously the key to almost everything. You can only do what you have money to do. If everyone's sitting in their own apartments, doing their own thing, identifying their own needs and then trying to address their own needs independently, we can never get to those commonalities. That's really where the efficiencies are going to be gained. Then people are going to learn from each other because if market access does their own advisory board and then clin dev does their own advisory board and they don't talk to each other, it's quite possible that you're coming to common insights from these other experts. If you don't talk to each other, you're not going to understand what those common insights are and think about how those insights can be leveraged into filling those gaps and figuring out what that evidence plan is going to be. I think it's incredibly important that everyone gets together, aligns on those strategic needs and then comes to a conclusion and alignment on what the priorities are. You could have five different needs across five different apartments, but again, there's only so much money in the pot and we need to figure out organizationally what are the ones that we want to address first, what are the ones that we can address now versus the ones that maybe we're not going to have evidence for for another year or two and then come up with those plans to meet those needs when that data are going to be available. It's important to figure out those gaps and then prioritize them and then address them in order and across time. Another reason why the integration is so important is that not everybody knows what everyone else is doing. We may not know in market access that Clendev and medical affairs are supporting some investigator initiated study. So maybe that's, you know, you've got a particular need that one stakeholder is identified that is already being addressed by another stakeholder. And if you don't get together and talk about what current evidence you have on hand and what studies that you have that are ongoing that are going to be creating evidence down the road, you can't really identify what the gaps are because they might not actually be gaps. They may be things that are already being addressed. So it's incredibly important that everyone gets together and talks to each other. Is study design also part of that? I can imagine piggybacking an endpoint on a study that someone else is already working on and then discovering that you don't have to do your own separate study to get that endpoint. You know, are we also collaborating in study design then? Absolutely. So another thing in terms of talking about how most efficiently to sort of get to the answer that you need to fill out together a gap. It isn't always the case that you need a new randomized clinical trial to address something, right? Those are long, those are expensive. Maybe it's something that we could do by looking at some real world evidence that exists. And I'm sure, you know, me and it can kind of talk to some of the ways that we can be more efficient in thinking about integrating real world evidence into the the evidence generation plan. Well, at H-O-R as well, I mean, so it's not that we have to be running a clinical study whenever we have a question to answer. You know, Amarie, there's a whole nother toolkit here. There's the H-O-R toolkit, right? And at the same time that we're working towards regulatory approval, should we be looking out into the data landscape and layering on H-O-R approaches and mean it will get to RWE approaches this. well, but what are we looking at or how do we add HOR to the IEGP? That's a lot of happiness. It is. I think the main thing is, you know, as both John and Wilson have said, you're integrating the team early allows us to, I'm dealing, listen to what's going on. Listen to the clinical trial design as you've been talking about, because a lot of the focus in the early days is very much around that regulatory approval process, which is at a much more regional level. When we come on board, and when we really kick in, it's later on, but we're talking about country-specific. We're talking about what's happening in the US, what are the payers looking for? We're looking in Europe at health technology appraisals. They're old, generally, on a country-specific basis. So we need to know, is the study design appropriate for all of our key markets? Is the evidence basis? The endpoint correct? Is it going to be recognized by our HTA agencies? Even though it is recognized by regulatory. An example, for example, you know, an active comparator is unlikely to be the standard of care in every single market that we're going to launch in, but our payers, our HTA bodies, they'll be looking at what is the comparison standard of care. So we can look at what's in the literature. We can look at clinical trials. Sometimes again, we'll look to Mina and go, "Right, we need an RW study down on that country. What is the standard of care?" Because you might not know if it's a rare disease. So we can identify those things early. And that's important because if you don't have the right comparator at that stage, your evidence package is not going to get you the market access you want. You might not even get reimbursed. You might get a delay decision. You might not get the price that you're looking for. And if we understand that earlier, that can be fed into the commercial team and think about it. We can do economically justifiable price modeling, which is pretty straightforward, but that can help with all those internal discussions and the moves and shakes that you need to do internally to manage expectations. Because price you want in the US is unlikely to be the same in each of the markets in Europe. So again, you know, it's important to think about what we can provide and get us involved early so that we can help with those informed decisions. And is that widely accepted? When you go to the IEGP team, planning team, and you say, "Okay, we need to be planning for after approval. You know, we need to be planning for access. We need to be planning for reimbursement." Do people say, "Great, how much money do you need?" Or are people, I don't know, still sort of focused on the clinical studies and you have to talk them into including H-E-O-R and the I-E-G-P? I think it can vary. I'm part of it, which is what's great about all of this, is raising awareness across the different departments of everybody's challenges. Everybody has challenges. And at different points in that process, some have higher priority than others. So for example, I can raise and I can look, you know, that this could be an issue later on and think about what we can do. Sometimes I can get it in there, you know, sometimes if it's, you know, a recommendation to add a quality of life instruments, a disease-specific one as well as a generic one, it's relatively straightforward to do. And if I'm in early enough, I can do that. And that can have big implications for me later on for that market access perspective to make it that easier for us. Sometimes it's not feasible, you know, it's just not feasible, it's a done deal. So what else can I do? And it might be that it is later on, but at least people are aware of the need. And again, it's allows them more informed decisions about who needs to take priority where and maybe helps with the planning. So, you know, if we're going into phase two now, phase three's in a couple of years, at least I'm making those, I'm making my waves now that I'm going to need a budget in a year and a half because I'm going to need to be some major stuff because you haven't let me change the clinical trials design. So that's also that kind of internal planning. Well, and I hear you aligning with John, you know, early and then get your priorities and, you know, maybe then start to look at what's what's realistic, but but know that all of these needs are going to exist. You know, so Mina, let's get to RWE in the IEGP. And let me also say my, my wife is an educational psychologist and I cannot get over saying IEP, the individual, what education plan, it keeps popping into my mind and IEGP is just killing me. But so the RWE, it isn't that, you know, we want to know things and the first thing we should ask is can we get this with RWE and then we don't have to do a clinical study or what is the role of RWE in the IEGP? Yeah, well, first of all, I think E could be education and evidence because I think part of it is that I think you're, I mean, people have talked about a few different sort of toolkits, you know, primary market research is one tool adapting the clinical trial as a different tool. RWE is another tool that's in the arsenal of ways to kind of address the priority evidence gaps that you've identified through the IEGP process. So you go through the process to know what your gaps are and then you go through this design phase, which you've talked about a little bit and the design phase is now what are you going to do with that gap? And you'll, a lot of options on the table, like we've talked about, but a lot of times from our experience, those options don't quite fit for a variety of reasons, you know, you can't go to do a new clinical study, you can't adapt the clinical trial you already have. Primary market research is really useful, but it's not considered robust enough for HTAs or regulators that they want something kind of more robust. And then, Anne Marie mentioned kind of the published literature. That's great if there is published with published literature, but sometimes there isn't. When you have rare diseases or even now there's so many therapies coming in this really niche population, like mutations specific line, if there would be a certain prior treatment, and there's nothing published for that specific patient population that you're trying to identify. So that's where real what evidence comes in because it's a nice way to sort of be another tool in the arsenal that you can leverage when those other approaches don't quite fit because you can use real evidence to address the evidence gap. And it seems like real world evidence, just the sources and our ability to analyze real world evidence. And, you know, even even harmonize real world evidence across different data types, you know, are you seeing an increased role for RWE in the IEGP? Oh, completely. I think we see a lot more demand now. One of the good things that's happening with this IEGP process and the more that it's being kind of adopted is a point made earlier about study design and can you kind of harmonize study design? So we often see clinical and reg issue in RWE study, H-E-R-R issues in RWE study, and then even post-market, there's a different RWE studies its commission. And now when you look at it more holistically as like the pathway of commercialization, you become more efficient about what study you're trying to execute, what sources do you want to use, how can you engage with them in an effective way? So you don't need to maybe do those multiple studies. You've identified a source that you can go back to in a different way multiple times or do one study if you can and the timelines permit within kind of one one kind of protocol and stuff. But yeah, there's so many kind of demands now in terms of RWE. I actually think data isn't the issue. It's more how you use the data because that's the real question. And that's where when you go through the design process, you need to really think about how you want to use real-world evidence. So it's easy to maybe say you're going to address it with RWE, but you want to really think about what's the research question you're trying to answer and what variables do you need for that? And how is that defined in the real world versus the trial? Because there's a lot of differences in the real world versus the trial. So thinking that through, then thinking from a very pragmatic perspective, do you want to leverage secondary data or do you want to do anything prospective? You know secondary is going to be more cost efficient, more time efficient. So is that feasible? And if that is feasible, then what type of data? Like you mentioned, there's so many data sources. So is it claims data? Is it something more clinically rich like EHR and disease-specific registries? What kind of data source are you looking for? And then also things around just really, really practical things like timelines like Wilson mentioned. You know, you need to think about how long it takes to set up a study, execute it, and get the results from it to see that it feeds into how you want to address this evidence gap. So if the comparators are an issue and you need it by the time you're doing an HTA submission, you got to work backwards from that date and see from when you started the process, is it actually feasible to address this with real world evidence? Before you actually just say that you can kind of address it with RWE, without thinking through some of these logistics. Okay, there's about 15 things I'd like to dig in on there. But okay, let me ask a simple question first. You start early, you're Aliantross functionally, you're putting together this IEGP, you're identifying the data gaps. Do you inevitably have data gaps arise unforeseen during your development process or if you've done this right? do you identify all of the data gaps, you know, prospectively, proactively, and represent them in your IEGP from the start. You guys have been so nice in taking turns, but let's step all over each other now. Who wants to jump in on that? - I can go first, tap. I think you're never perfect. Obviously, you're never going to have everything identified early. But I think this is also not a one time process, and I think that's what you do. Like the market landscape is always changing. So you can do this process now, and then there's new competitors that come on some market, a new landscape, and you need to sort of reassess, or are your evidence gaps still the same, or have they evolved in some way? So I think this is really important to be seen as something that you do continual updates do, so that you do kind of keep ahead in terms of future evidence gaps that are going to come up because it's not a one time thing. A one time thing you will definitely miss things in the future because the landscape is just evolving so quickly. - Okay, so then my follow up to that is when an unforeseen data gap, evidence gap arises, does everyone cross their fingers that that gap can be addressed with RWE or HUR data so that we don't have to start another five year clinical study. And is that what people are doing now when a data gap arises unforeseen? Please can we answer this with RWE? - RWE, and I would say also things like systematic literature reviews, - Yeah, cool, okay. - These primary market research, so I don't see RWE as like a single like savior to all your evidence gaps. - Yeah. - And it's impossible to be that, but it's definitely increasingly being used, you know, just from the example of comparator efficacy, like so many single-armed trials are coming out now, and they're being approved from a regulatory perspective, and it creates a lot of challenges, market access, and RWE is kind of more and more being used as a way to address that gap, alongside exploring, you know, systematic literature reviews and network meta-analyses and those other deliverables and tools within the kit. - Okay, so start early, start aligned, cross-functionally, and geographically. Get your plan in place, even if you can't resource the low priorities right away now, know that this is going to be a living document, that you're going to have to address unforeseen data gaps, and that may be through a number of strategies, some of which are evolving right now. Let's leave it there for today. Thank you, John, Wilson, Ann Marie, and Mina for joining us to learn more about how your company can partner with Luminity on Integrated Evidence Generation Planning and Beyond, visit Luminity.com. Maps members, don't forget to subscribe, and we hope you enjoyed this episode of the Medical Affairs Professional Society, podcast series, Elevate.