Garth Sundem   00:00

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 speaking with Dr. Ivy Weng, Head of Clinical Development and Real-World Evidence/HEOR at Komodo Health, about how Medical Affairs teams are leading health sciences companies in incorporating real-world evidence in medical strategy, and product clinical development. This episode is sponsored by Komodo Health. So Ivy, hello. And it seems like lately, we’ve been chatting a lot about RWE, and Medical Affairs teams have gotten somewhat comfortable with the use of RWE to answer questions that might previously have taken clinical trials. But let’s chat about RWE and strategy. So where does RWE become part of strategy?

Ivy Weng   01:03

Thank you so much for having me today. I think historically, the generation use and dissemination of evidence has been decentralized and also somewhat disjointed. So, I think we’re seeing this shift in the way that life sciences companies think about RWE. And that’s towards a more integrated approach where it’s no longer siloed within R & D, or clinical development, or HEOR, etc. And this approach really brings together randomized clinical trial and real-world evidence-based approaches across all cross functional departments, which benefits patients by generating value based outcomes that translate into clinically meaningful impact in the real world. So I think there are a few pillars where Medical Affairs can really drive RWE strategy. And that’s, you know, with a streamlined vision for evidence generation where we can better articulate value for the payer, the patient and the provider. And when we do that, we can create a range of touch points that are designed to provide tailored information focused on improving outcomes to inform the decision of individual patients. So we’re really seeing this elevation of medical strategic planning across all critical processes within and outside of Medical Affairs.

Garth Sundem   02:28

Okay, you know, it’s interesting, I know the word own is a loaded word. And, you know, it does seem like R & D tends to own the registration of clinical trials. Do you think that Medical Affairs owns RWE? And if so then does Medical Affairs own RWE strategy?

Ivy Weng   02:49

I think that Medical Affairs is well poised to be that hub where this RWE strategy is disseminated. I think, ultimately, it’s a it’s definitely a cross functional decision. But because of where Medical Affairs sits at the intersection of the providers, payers, and also, internally, in the life sciences companies, they’re really well poised to drive a lot of these changes.

Garth Sundem   03:15

Okay. And I hear you say, so first of all, I really like thinking of Medical Affairs more as the hub for RWE, then some sort of owner of RWE, that that makes a lot more sense. But in terms of RWE, you say that Medical Affairs is poised to disseminate RWE strategy, is Medical Affairs, also poised to generate RWE strategy?

Ivy Weng   03:41

I think that we’re seeing a lot of, you know, Medical Affairs functions actually shift to generate a lot of the strategy and that’s in conjunction with internal stakeholders, where sometimes there’s this RW E, COE, or center of excellence. And there are people that provide insight, and they may or may not come from Medical Affairs, but I think Medical Affairs is probably the driver of a lot of that.

Garth Sundem   04:11

It seems like RWE studies used to be used somewhat piecemeal, to answer questions that came up, you know, maybe it was even something that came in through medical information that couldn’t be answered, and somebody said, oh, I can answer that with RWE. Is it that we’re at some sort of tipping point where we have done piecemeal RWE studies, and now we’re looking more proactively to make these part of strategy?

Ivy Weng   04:41

I think that historically, like you said, a lot of RWE has been focused on answering post market questions around real world safety and efficacy, right. But what we’re seeing is this shift towards just using RWE earlier and earlier in the in the lifecycle well, we’re seeing that, you know, our customers are really focused on incorporating, incorporating RWE from the get go. And I think that that’s because, you know, clinical research should ultimately improve patient care. And we’re seeing that there’s significant overlap between post launch and also pre-launch activities.

Garth Sundem   05:23

Okay, well, let’s move to development then. So RWE strategy, you know, there’s so much strategy around launch, but then there also is strategy around development. So how does RWE, and RWE strategy, influence development?

Ivy Weng   05:45

I think that for RWE strategy to really influence development, the trials must evaluate outcomes that reflect real world scenarios and address the concerns of patients, physicians and payers. Like, when we think about how real world data is used in the development space, we can use that to optimize trial design, particularly in assessing trial feasibility, like, you know, the use case around how many patients are, you know, top of the funnel, and then how how many patients are like, patients are likely to maybe fall out of the screening eligible criteria with the inclusion exclusion criteria that’s applied. That’s a use case that’s widely recognized. So patient attrition, and then at Komodo, we’re seeing just very sophisticated methods being used to assess the impact of trial criteria on recruitment, finding more tangible endpoints using real world data, developing that using sources like claims data, EMR data, lab results. And assessing risk as well allows us to really understand a patient population that’s really representative of the real world without compromising the efficacy of the trial. So like,

Garth Sundem   07:16

Yeah, well, no, I was gonna say, you bring that up as an example that’s fairly well used, but actually don’t know anything about that. I just wanted to follow up a little bit. So is RWE kind of a way to? Are you modeling the effects of inclusion exclusion criteria on likely recruitment? Is is that RWE in? Is that how you’re using that?

Ivy Weng   07:44

In the development space, I think there are three main use cases. And to your point, yes, feasibility, so screening patients that are, you know, maybe, you know, we’re no longer just looking for patients that are, that have breast cancer, we’re looking for patients that are, you know, triple negative breast cancer, they failed two lines of therapy. And that really allows us, you know, using real world data, we can hone in on these populations. As an example, you know, we’re identifying patients for potential recruitment by analyzing the constellation of signs and symptoms on these patients, and applying predictive analytics to identify patients who could have the condition. So that’s one use case. There’s also around rare disease patient finding, and that’s a large part of the value proposition for real-world data where, you know, one, it’s incredibly hard to find these patients. And second, these rare disease patients, they meander through the healthcare system, and they, oftentimes, there’s no direct path to a standard of care. And by studying these data points at scale, it really allows us to dramatically improve the probability of them, you know, getting the care and treatment that’s required.

Garth Sundem   09:12

Oh, so is it that, you know, I think of real world evidence as as claims data, and, you know, other database studies, but you’re, you know, it’s interesting to think about it more in terms of patient identification for clinical trial enrollment, so is it that someone, not someone but peoples with rare disease, would would have sort of real world signatures that you could identify, and thus, I don’t know, suggest recruitment through through, you know, and what do clinical trials outreach those patients then?

Ivy Weng   09:52

Yeah, I think that’s a so with rare disease oftentimes, I think there are many ways to identify these rare disease patients for clinical trials. One, we often work with patient registries or patient advocacy groups to hone in on that population, we’re able to train the models based on true positives. And using those signs and symptoms, we can then extract and extrapolate using our healthcare map that’s representative of the US to predictively identify these patients who potentially could have the rare disease.

Garth Sundem   10:38

Okay, so that was two use cases. What’s the third?

Ivy Weng   10:43

I think the third use case is obvious is the third use case is realizing the potential of synthetic control arms. Oftentimes, yeah, oftentimes, in rare disease studies, the the sample size is so small, and it’s operationally and ethically, you know, it’s not possible for us to have a synthetic as for us to have a control arm in these cases. So what we can do is really generate a mash cohort for these rare disease patients using real world data to really study efficacy and safety of these clinical trials.

Garth Sundem   11:24

Oh, that’s interesting.And is that what people mean, when they’re talking about the natural history of a disease, where your control arm would be modeling what the disease and progression would look like in patients had they not had this intervention? So you can give the intervention to everyone, and then use RWE to model what would likely have occurred if they hadn’t had the intervention? Is that the synthetic control arm?

Ivy Weng   11:52

Exactly. And there are ways that we can do this. And, and this is driven by, you know, just the sheer volume of data that we have access to. I think synthetic control arm that’s one. Sometimes, you know, there are various standards of care. And we’re able to model that as well, where it’s not necessarily so black and white between, you know, patients that receive the intervention and patients that don’t, we’re also able to identify patients that maybe receive other forms of therapy. So that’s also a third arm that we’re able to generate.

Garth Sundem   12:35

Okay, so it’s not just in rare disease where there is no standard of care and you’re trying to develop something completely new. You can do a synthetic control arm that is existing standard of care, and then be testing against that. Okay, neat. Well, so we’ve talked about how RWE is used in strategy and development. What do you see for the future of RWE?

Ivy Weng   13:00

I think that there’s a shift just in terms of how, how life sciences companies are thinking about RWE, there’s this huge emphasis in regulatory decision making. There’s, there’s a focus on working with providers and payers to establish effectiveness in both clinical outcomes and also cost effectiveness. There’s just, you know, policy decisions that are being made globally, where integration of RWE early in the process is absolutely critical for us to drive better patient outcomes. So I think that while RWE has already been used extensively, you know, on the medical side, I think that there’s just a shift in terms of its remit and where it’s being integrated and woven into all facets of a life’s of a product’s lifecycle.

Garth Sundem   13:58

And it’s almost like RWE traditionally was used to suggest things. And now folks are coming around to the appreciation that RWE can be used to, I guess, prove, but maybe that’s too strong of a word, but you know, can be part of regulatory decisions.

Ivy Weng   14:18

Yeah, exactly.

Garth Sundem   14:19

And is it just that the methodologies are being formalized, and the bodies that watch these things are recognizing that RWE is coming of age, and so it’s getting the respect that it finally deserves?

Ivy Weng   14:39

I think that there’s just a clearer and clearer use case for RWE to take a really, you know, to be front and center for a lot of these regulatory decisions. I mean, I think that we’ve seen there’s just an increased receptiveness from the FDA to RWE around utilization and for label expansion and safety purposes. So, because these regulatory regulatory bodies are open to novel trial designs and endpoints, this further drives innovation and drives the behaviors of these life sciences companies to better support and derive population level insights.

Garth Sundem   15:21

All right, well, Medical Affairs is the hub of RWE and RWE strategy. We had RWE used three ways in development, and a future of RWE in which it is increasingly being used in regulatory decisions. So, thank you, Ivy for joining us today. To learn more about how your organization can partner with Komodo Health to drive RWE impact, visit Komodohealth.com. MAPS members don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series: “Elevate”.