Integrated Evidence Generation Planning (IEGP): Cross-functional alignment to optimize value, minimize risk

Garth Sundem  00:00

Garth, welcome to this episode of the Medical Affairs Professional Society podcast series. Elevate. I’m your host, Garth Sundem, Communications Director at MAPS. And today we’re continuing the conversation about integrated evidence, generation planning with experts from Lumanity. Specifically, we’re digging in on the challenges of cross functional alignment. Joining us are Triona Zelesnik, Principal Consultant, Steven Weisman, Global President of Clinical and Regulatory, Lauren Fink, Vice President of Medical Strategy and Susan Daniels, Patient Strategy and Engagement VP. This episode is sponsored by Lumanity. So, ah, Lauren, cross functional alignment. Oh, goodness. We hear about the challenges of it in many contexts. Today, we’re talking about the challenge in IEGP. Can you get us started by helping us understand how cross functional teams can work together more effectively within this IEGP framework?

Lauren Fink  01:11

Definitely. Thank you, Garth and way to start with a very general question to set things up and kick things off. So when we think about a cross functional team. This would include, of course, functional groups like medical affairs, clinical, commercial market access, regulatory and others, but also the regional stakeholders. And the earlier that all functions and regions are involved in helping to shape the iegp, the smoother and more efficient the process should be. While med affairs will typically drive the Ieg process from defining medical strategy and identifying evidence needs to actually communicating that evidence. It’s important to clearly define the other stakeholders roles at the beginning of the Ieg process, for example, the level of input that’s expected from each group and how often the number of individuals participating from each function or region. So who are the voices at the table? What does that representation look like, and then the resources and insights that are expected from each group and that they should bring to the table. And I found that having a tracker of some sort can help keep groups accountable so they know kind of what’s expected of them and when, and then ensuring that key stakeholders can provide input and updates throughout the process will help reach the goal of a unified iegp, and also allow time to work through varying strategic priorities or differences, slight or large that may arise amongst the groups,

Garth Sundem  02:52

right? Small or large that arise amongst the groups. So start early, figure out who’s involved, get everybody at the table, figure out how the collaboration is going to happen. Can I just clarify something from my own understanding, and that is, is medical leading the iegp in all companies at this point? Or, yeah, okay, okay, great, just

Lauren Fink  03:13

to be the case, yes, absolutely that that metaphors drives, drives that process, and kind of ensures that all the voices are heard that need to be heard. Okay,

Garth Sundem  03:22

so it’s med affairs saying, Okay, we’re starting early, and here’s the people that we’re bringing to the table, and here’s how we’re going to collaborate. So it is medical affairs driving this strategic alignment from the start.

Lauren Fink  03:35

Yes, that should that should be the best practice. Absolutely. Okay, cool.

Garth Sundem  03:41

Well, so here’s one thing I think is really interesting about this recording, is that we have representatives from across many of these functional areas. So Steven, you know you’re bringing in this clinical and regulatory perspective. So as you come to this table, led by medical affairs, hopefully early, what challenges are you seeing from the clinical and regulatory team perspective in iegp?

Steven Weisman  04:13

So great question, Garth, and thank you for including me in today’s podcast. So as Lauren said, integrated teams are really critical to success here, and I think also everyone would agree that clinical and regulatory often the leaders in evidence generation, but unfortunately, in many cases, they’re very focused on the here and now and getting the drug approved, and as a result, have a hard time focus on other stakeholder needs and marketplace needs and even things that will change over the over the life of the drug. And so it really is important to have that cross functional team, whether it’s led by medical affairs, which we would certainly recommend as the right approach, that really have representatives from the folks who know the product asset best, know the evidence that’s already been generated, understand the regulatory context. In which it needs to be generated, and really think long term. So having a seat at the table is critical from the very beginning, but at the same time, we would probably recommend that companies think about having individual plants developed for specific stakeholder needs. In my case, it would be the regulatory dynamics, but then to integrate that with the broader needs of the of the team and ultimately the marketplace, to ensure that the that the evidence that is generated is sufficient, but also long, living and enduring to meet the needs.

Garth Sundem  05:33

You bring up a really interesting point, and that is that not only are we trying to align iegp with what we see as these cross functional internal needs, but we’re trying to make sure that iegp meets the needs of external stakeholders as well. You’re talking about meeting the external needs. Do you see that being a challenge of clinical and definitely regulatory as well. What I’m wondering is, I always feel like Medical Affairs is the one bringing in this external perspective, right? We’re the one generating insights. We’re the one talking with these external stakeholders. Do you see a role for clinical and regulatory in aligning with these external stakeholders as well? Oh,

Steven Weisman  06:18

absolutely, because everything in the way of evidence generation takes place in a regulated environment, and so that evidence it is generated has to be compliant. It needs to align with current guidelines and thinking, and also needs to be reported to regulatory authorities. So even if the goal is to develop content for payers or develop content for HCPs, it still has to be done in a regulatory compliant manner. And so there are lots and lots of stakeholders, but we talk about evidence. And you know clearly the primary stakeholder in the early stages is the regulatory body to allow the product to be approved. But that regulatory and clinical engagement continue on through the whole life cycle of the product. So you really do want the clinical and regulatory team engaged in all the activities that relate to evidence generation for all audiences, both the internal and external, and that they be adaptable and changeable as conditions change, as new products come to market, as medical standards change, as guidelines change, even as regulatory thinking and new data evolves. Okay,

Garth Sundem  07:19

and so I imagine that that’s a challenge faced by clinical and regulatory teams. I you know, I can imagine that the medical affairs leading the iegp has this perspective out into the external landscape, says, We would like to do this. And I think that people erroneous, erroneously think that then regulatory says, No, that’s not the worry, is it or whatever?

Steven Weisman  07:46

Okay, so regulatory doesn’t want to be the policeman, for sure. They want to be a party to the success of the product and ensuring that it’s used appropriately by patients and caregivers. So absolutely, it all has to be done in a regulatory compliant manner, and therefore the regulatory team can provide guidance, but really with the same goals as the rest of the team, to ensure that all stakeholders have information sufficient to use the product appropriately. So I think regulatory can be a big partner, but I think one of the constraints that’s always present is budgets, and the regulatory team is, you know, fixated on getting the product approved, and their money is really committed for those purposes and those purposes alone, but one really needs to think about as you design studies and design programs to meet regulatory needs that you’re also meeting the broader needs of all stakeholders, so that a study that’s done for regulatory purpose can be double duty for payers or for HCPs or for patient information or anything else, right? And that’s

Garth Sundem  08:46

having the right endpoints and starting early with those through the darn study, right? Absolutely. Well. Speaking of the external landscape, there is one stakeholder group that we try to keep at the center of everything we do, and that is patients who are certainly external. And Susan, you happen to be an expert in in the patient engagement perspective of the iegp. So, you know, we, we look at these things so often from the perspective of the company, or I should say, historically, we have, we say we want to get this drug approved, it’s it’s going to provide better safety and efficacy, and that’s as far as we look. And that drives, has driven our strategy that’s changing. So how do we bring in patient perspectives into iegp planning? And again, make sure we don’t get halfway through the darn study and realize that we should have had a patient centric endpoint. How do we bring them in early? How do we bring them in at all?

Susan Daniels  09:57

Oh, no, we definitely bring them in. But. Sure. Thank you for your question. And encouragingly, there’s been a really intentional movement recently in terms of recognizing that need, the need to include the patient perspective, and by patient, I include families and caregivers and their supporters in evidence, generation, and that’s all aspects of medicine development, not just as clinical trial subjects. It includes trial and product design through to real world evidence generation and beyond, into access strategy, and it makes perfect sense, incorporating patient insights ensures that treatments and trials are designed with the actual needs and experiences of the end user in mind, and this aligns with industry’s shift to really become more patient centric. I’m sure everyone would agree that patients provide unique perspectives, and critically, that lived experience of a disease or a drug and how that impacts their daily lives. So collecting this insight as part of an evidence generation plan ensures that evidence more accurately reflects these real world experiences, and you can also identify areas of potential misalignment to healthcare, professional and physician insight, and that has critical implications for for decision making. And you know, as Steve has mentioned, regulatory bodies and payers are increasingly requiring evidence that demonstrates a product’s value, and this includes from the patient’s point of view, so including patient insights, particularly at a strategic early evidence generation stage, will strengthen those submissions and improves the chances of regulatory approval and ultimately reimbursement. But what we’re seeing frequently across pharma, and what we’re talking about today is that without a centralized governance structure and plan for patient engagement and insight generation, teams are operating inside those limiting operation opportunities for cross functional collaboration, sharing of that insight, so that results in duplication of efforts, inefficient use of resources and missed opportunities, really, to leverage those patient insights across the entire product lifecycle. So a more sensible approach is developing a standardized framework for patient insight activities, one that embeds patient teams early into development planning and identifies touch points for insight generation across the entire life cycle. And critically, this should also define and determine where external communities like patient organizations and patient advocacy groups can provide direct input into the process and co creation opportunities, and that helps facilitate not just insights, but long term, enduring partnership model for companies, because ultimately, the final decision sits with the patient. They will decide if they will put a pill in their mouth or a needle in their arm or a device on their body and in some cases, paying for this. And so why wouldn’t you want to collect and share those insights that will help you make sure they see the value in your product? And I might be biased, but I really think that this is probably one of the most important insights to gain,

Garth Sundem  13:37

and one that we’re just learning how to gain in many ways well, so now I I really see why the iegp is broadened past only the clinical and regulatory needs. And you bring up iegp for access, seems like one of the major goals of including patients in the planning process. Do you think that that goal of access with patient input into evidence is so dominant that patient engagement really is a market access. I don’t want to say ownership. I always hate that word. But you know, do you think patient groups should be have their point of contact in access, or is this something that comes straight to medical affairs. Do the patient groups sit at the table for iegp, or are they working through one of these functions? And if so, which which function?

Susan Daniels  14:50

Yeah, I think in terms of access, what we’re seeing is certainly the need for a diversity of data to support access and regulatory activity. T which, more and more is including patient experience data, and it’s too late when you’re submitting to any of these payers regulatory groups to be asking for that experience. You know, at the end of the submission, it needs to be built in and baked into your early generation plans, so that you are making sure you are collecting it and collecting the right type of information that is going to enhance your submission. And what we’re seeing, you know, in the case particularly of some quite busy fields like oncology and others, the differences in some of these applications are quite minimal in terms of things like efficacy and safety, and often it is those secondary endpoints, the quality of life issues, that actually can make a significant difference in terms of acceptance, and that’s really important for patient communities as well.

Garth Sundem  15:58

You know, it seems to me, there may be another cross functional partner that we haven’t hit yet, and it’s a very important one, and that is the cross functional partner of commercial. So, you know, Trina, you’re our expert here in commercial, is such such a major partner? Well, okay, everybody is, I’m not going to put commercial as an umbrella over everything, but how do we get the commercial perspective into iegp early and, you know, I and why? Why would we, and how would we? How do we get commercial at the table, what? And what’s their role? What do you think? Trina,

Triona Zelesnik  16:41

so nice question. Thank you. I think the first thing to recognize is why it’s a challenge. And it’s often because those stakeholders, the commercial sort of representatives and your future brands, Owner, for example, brand lead, they’re not consolidated around the asset in that early clinical development phase and and we’re not in any way suggesting that you consider your redesigning your development program to think about that so early. But I think having a lens, or having somebody at the table who can speak to what your future commercial need or expectation may be is really, is really important. And I think in some cases, that’s an external partner, in some cases, that you know an asset lead, or perhaps a portfolio lead, who may have assets already on the field, or in later stage in in development, who can speak with that sort of commercial voice and bring that to the table. But I think, just as Susan says, the importance of bringing your patient down, it may not necessarily impact your primary endpoint, but it will absolutely have an impact on on an accurate and impactful collection of your secondary endpoints, and the sort of peripheral data, evidence that you’re looking at generating in a timely manner. And I think commercial has a very similar impact. It really just allows you to make sure that when you bring that product to field and start talking about it with the stakeholders, you know, post in the post regulatory access market, it has everything that they’re looking for, as much as much as you can that they’re looking for. And it really resonates with with those stakeholders, be they HCPs, it can, in some cases, be other medical stakeholders that touch your patients, for example, infusion nurses as well as the patients. And I think it’s just important to make sure that that voice is early.

Garth Sundem  18:22

Voices early. I have another question from my own understanding, and that is that, so the target product profile, you know, I know that commercial sometimes uses that as a springboard in some ways. You know, the TPP, what we want to be able to say about the drug and then the iegp fills in some of the evidence that allows you to say those things about the drug is, is that true? Well, first of all, is that true, and second of all is, is commercial aligning? I don’t want to say only at the level of iegp, or is commercial also at the level of of TPP in some way, and Springboarding off of which one of those both, neither. So both,

Triona Zelesnik  19:09

both, I would say, commercial, are not the owner of either. You know, if you’re, if you’re getting to the point where you have, you know, you’re ramping up your commercial framework around your asset, and you don’t have either an iegp or a TPP. You’re probably a little late on the development of those, but certainly they are. They are important tools. And I think, I think it’s also important to just think about what timely means and what early means. You know when, when I think about early I’m thinking about that sort of really early clinical development, which is not a timeframe that is traditionally considered early in a commercial sense, but because I’m looking at that from an iegp perspective, that’s what early means to me, or to us, or to those of us that are that are working at trying to foster and facilitate the developments of that, you know, holistic, integrated evidence plan. And I think that the point was made. Earlier, when we think about the importance of making sure that you have a plan for your individual functions and what they’re going to need and what stakeholders they need to engage with, and you know how they need to impact and engage there, and then being able to make sure that you have a program for laddering it up. If I think about sort of three things that I’ve seen that really impact the success of an iegp, we touched on some of these. And I think some of these actually allude to discussion in our in our previous podcast. The first is that vision, right? Like making sure that across the business there’s a really harmonized vision for what you want out of this asset, what you want out of the therapy area, the portfolio, etc. And as part of that is, what does the business need? That’s maybe commercial lens, what does the business need and what’s this expectation? And if you do this in that sort of early IGP, that really sets you up for success. I think Lauren mentioned it like having a plan for the plan. So that’s a tracker, for example. It’s all well and good for identifying the gaps, and, you know, identifying the evidence needs, but making sure that you treat this as a living document, you’re revisiting it and making sure that you’re pulling through your learnings effectively. There’s a specific cadence that people are clear, you know, when those internal stakeholder voices are going to be heard, and sort of who’s, who’s at the forefront, you know, as this process rolls forward, and then the last one is maybe one I’m not sure that we touched on yet, and that’s the having a structure, a winning structure that you know facilitates the success of this. It sounds simple, but when you have sort of cross functional teams working and cross alignment, cross referencing on ongoing activities to make sure that you don’t get that duplication, you know, you’re maximizing the value, etc, those things require a structure that underpins that success, that that, you know, that facilitates that kind of collaboration and facilitates that kind of transparency. And I think when it’s a very pragmatic, I guess thing that drives success, but it’s really important. And I think when we think about any of the times that I’m engaging with with clients who are looking at trying to help, or, you know, companies who are trying to make sure that this process works, that’s one of the things that we’re really looking at making sure they have is a structure that supports that success underneath it. Wow,

Garth Sundem  22:05

it’s almost like, because iegp is so early, this collaborative structure for Success provides a blueprint for all of the collaborations that are going to have to take place throughout the life cycle. You know, I’m imagining that commercials at the table learning about patient insights early that may influence the iegp, but this is also a preview of the patient insights that are are potentially going to inform a lot of the commercial strategy after approval, right? I mean, you’re doing your own patient engagement for commercial strategies. Do you carry anything forward from the patient perspective and iegp to your later strategic planning?

Triona Zelesnik  22:49

Absolutely, I think if it’s done, if it’s done early, the benefit, the benefit to commercial is huge, because as you’ve built your your clinical plan, as you’ve moved through and sort of engaged with your regulatory stakeholders, and as you’ve developed the evidence, sort of snowball that’s building behind this asset, if you’ve wrapped patients into that, when it comes to that commercialization timeframe, there’s already a body of information and a body of evidence, and obviously in those intervening years, the market will have shifted. And I think Susan alluded to this about making sure that you stay close to those stakeholders and to those patients, and you allow the voice to be heard, not just, you know, at the initiation, but sort of throughout. And it really allows you to strengthen everything as you go forward. There is obviously an element of pragmatism to this. And you know what’s as I said to you, there’s different stakeholder internal functions that will be at the forefront at different time points. But there really should be, ideally, a thread of all the different functions that are going to be important from the beginning, and then it sort of swells and grows as it goes through. And I caveat that by saying you have, don’t, you can’t forget the non obvious ones. So there’s sometimes, you know this can be other internal folks who have potentially a big impact on your asset also need to be included. And I’m thinking about, for example, digital so often there are assets coming forward where, at least in a commercialization perspective, a digital element, be that tool or tracker or endpoint generation, etc, is going to be important. And it’s really critical that they’re not an afterthought, that they are also a stakeholder. As I said, that thread needs to go right back to the beginning. Are you considering what they’re going to need is that right back into the bedrock of your IGP? They may not be a huge role in the beginning. It may be something that accrues, you know, impact and value later, but it’s important, I think, that we think about some of those non obvious stakeholders on an internal perspective that needs to be included, because that allows us to be timely. And I think for all functions, all of us would agree, the biggest challenge that we have is when we realize late that we need something, and you’re scrambling, and your opportunities for development and sort of collection of that evidence is limited, and it then becomes potentially. Disproportionately costly or troublesome, and in some cases not feasible. So I think having that thread go right the way back and allowing yourself to reflect on what you’re going to need and when you’re going to need it, you can look for that synergy. You can harmonize the investment. You can, ideally, you know, plan things in a manner that is, you know, least disruptive, and has maximum value and impact,

Garth Sundem  25:22

so that digital doesn’t say way down the line. Oh, wait a minute. Didn’t somebody mention something about a digital tracker for treatment, compliance and efficacy? Oh, okay, shoot, we’ll get that to you next.

Triona Zelesnik  25:35

Or did you? Didn’t you want me to be considering as a really innovative digital consideration for an endpoint. Yeah, oops.

Garth Sundem  25:43

All right, so early and everyone and with a structure, we’re out of time today, which is all right, because we are going to keep going with this series. And I’m happy we are, because there’s a lot more that I want to dig in on. But for now, thank you, Trina, Steven, Lauren and Susan, for joining us to learn more about how your company can partner with lumenity. Visit the lumenity.com iegp, perspectives page maps members, don’t forget to subscribe. And we hope you enjoyed this episode of the medical affairs professional society podcast series. Elevate you.