Delivering New Value in Healthcare: Rethinking the Role of Digital Tools

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Brian:
Colette as you mentioned, I mean, there are clearly many ways to collect data, and randomized clinical trials do remain the gold standard, but, they're often very narrow in patient type because they have strict inclusion and strict exclusion criteria. Real world evidence, real world data can be an important way to complement the information that we get from those types of trials and they help us look at how medicines work in the real settings, not just in that very controlled space of those clinical trials. We can expand the populations we look at to make it more generalizable. We can look at small sub-populations. We can use real world data to look at rare events, which would really need such large clinical trials that they may not be feasible. And in fact, recently through the 21st Century Cures Act, I should say, the FDA has even opened up for consideration the use of such data in potential regulatory submission. So again, lots of different types of data can be used in many different ways, hopefully very complimentary of one another.

Colette:
And what about, you know, we care sometimes about simulated data, but we don't talk about it that much in terms of its use or its context for use or really how it's evolved. Can you give us some context of how you've seen impactful?

Russell:
Sure, I'll jump in. I mean, simulation is really very interesting. It may not be the most novel concept but in terms of how fast we can arrive at it, it's remarkably useful. As Brian mentioned, the timing of it is almost real to time. And this applies to simulation as well. We at Luye recently did a simulation exercise where we looked at the behavior and clearance of a product and body over a very long period of time. Compared that to a field of other products and ran the same simulation on them. In the outcome, we had one set of bias expectations really. The outcome was very different and it completely changed our position for that particular product. So, stimulation is one example of how critical it is, at least certainly in the marketing product planning phase.

Colette:
And if we pivot for a moment to data collection, I know one of the obviously hot topics we see everywhere now is around the idea of wearables and personalized health, and the collection of that data. Anything from how you're sleeping, to what you're eating, to how you're exercising, but in terms of a real clinical setting, and how we've been able to do that, from an industry perspective to better outcomes. Where have you seen it used to be impactful?

Brian:
Yeah, Colette. Maybe I'll jump in. You know, as a health care practitioner, I think that you and Russell and our listeners would agree with my interpretation of this, is that even a few years ago, we couldn't have imagined the impact that we've seen today. And there are now wearable devices, right? Like an Apple Watch or Fitbit that allow continuous monitoring of various parts of health data. Who would have thought even a couple of years ago that watch on our wrist would be able to generate a medical grade ECG, right? So, it's really fascinating. Now, you take where we are right now, unfortunately, in the middle of this COVID-19 space, and our patients, our family members can't get to their physicians and quite honestly, in some cases, even if they could, they don't want to be there for fear of contagion of the virus. So, I work in the cardiovascular space. That's why I mentioned the medical grade ECGs. But if you think about a disease, such as atrial fibrillation, right? Just because you cannot get to your doctor doesn't mean that we can't diagnose remotely or monitor the disease utilizing some of these technologies. It really is just amazing, the avenues that have opened up and again, I say right in the nick of time for where we are today.

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Colette:
And has there been any specific areas where you've seen the actual evolution of the data itself affect the industry? Any examples of where you've seen it really kind of pivot something?

Russell:
Well, right in alignment with what Brian was talking about in terms of wearables and real time data is also, I'd say the precision of data. The vast amount of data that's collected to very minute detail or component of that data is really fascinating. And the way we use a nano body platform developed with a phage display to provide topography of cells and that, we use that for screening candidates for anti-cancer products. So, that is very precise data. On the other end, on the other side, speed is important too. And I think in a real world example, when we talk about our provider or customer level data, I mean, the records of sales call conversations that's recorded and in turn, put on top of, layered on top of prescribing patterns, research interests, can combine to provide the sales and marketing organizations almost instantaneously with data information that gives guidance on how to really provide messaging and content that's most valuable to that particular individual. And that is ultimately the patient or the patient population is gonna benefit from that.

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Colette:
That's great and certainly one area that ability to collect data in that way certainly fits nicely into where I'd like to go next, which has talked a little bit about the technology that's used to run the clinical trials themselves. And certainly wearables have played an influential part in some of the changes in that particular area. But generally speaking, trials have remained fairly unchanged, probably, I'd say, one of the most areas that's had the least amount of innovation. It's starting to change. And we've talked a little bit about in the industry, what does it look like to have a more patient centric versus a more site centric trial, and what does that mean? And I think we've seen the unfortunate consequences of that with COVID, with trials coming to a screeching halt and what that means for drug development and for the patients. I mean, can you outline for the audience maybe what it looks like as to why it makes sense to really push forward and innovate in the area of clinical trials and truly make them more patient versus site centric?

Brian:
Yeah. You know, Colette, this is such an interesting topic. I wish we had more than a half hour and we had all day to talk to the folks here about this. I know Russell and I would enjoy that. I mean, some of what you're talking about was happening pre-COVID. If you think about the Apple Heart Study, again, I fall back to cardiovascular experiences that's where I'm most familiar, right? They were running a virtual trial and they were having a lot of information coming from the watch. They were also having telehealth visits. Now, I say to people all the time. Telehealth existed before COVID. But did you really know anybody who had a telehealth visit? Probably very few. It was complicated. From a billing perspective. People were worried about a liability perspective. Did insurance cover it? And I think that evolved to where telehealth over the last few months has become an everyday experience for physicians, health care providers, and their patients. I think the clinical trial work is evolving as well. Right now in most countries around the globe, clinical trials other than COVID type process ground to a halt. The hospitals and the doctors are so busy, they're so focused on COVID. They don't have the time. And they don't want, as we talked a little bit about before, to have people coming in and exposing them to potential contagions in the hospital center. So now, the trials that are continuing are the ones that have been able to successfully navigate this change. To have everything from consent forms, through visits, through data ascertainment done virtually. As I mentioned, a number of times you have wearable devices. You have biometric patches. There are biometric shirts that you can wear, that can monitor so many different parameters, that depending upon the type of clinical trial, you can get that data. And of course, most people have a smartphone or access to the internet. So, questionnaires and data forms of that sort can be filled out online as well.

Russell:
Brian, I think it's interesting what you brought up because along that when people are taking medication remotely as part of these studies, I understand there's a myriad of apps that they can use on their smartphone to give quality to the result that they're taking the medicine at a particular time.

I'm just very curious because your example, Brian, was terrific regarding telemedicine and there were pharmaceutical companies that have been investing in telemedicine for years and years and years with really, like you mentioned, not a lot of utilization, then COVID came. And from my perspective, what I saw was actually a reduction in regulation that gave the providers some confidence that they didn't have. They try to be compliant. The liability just wasn't there the way that it was perhaps pre-COVID. And I'm wondering, have you seen any regulation or inklings of regulation changes coming down the pike of this in terms of trials?

Brian
Yeah, it's a fair question, Russell. And I think the answer is yes. But whether or not they will last post COVID or they're just here for the interim, is a perfect example. And I would just add, it's complicated because a lot of the trials that we run, as our listeners know, are global in nature. And there are different rules and regulations. Privacy is a perfect example of that. I think somebody, Colette, I just saw have typed in a question about that. So, it's great timing, right? It's very different depending upon where you are. The European Union has very strict rules about data and data collected. They're used elsewhere. I think right now, there's some relaxing of some of these regulations. There's a desire to get information out there and not suspend you know, the capture of data. I don't know, Russell, what will happen over the long term. I hope we still have some of these opportunities to continue to think about and continue to brainstorm ways to make these trials better. But as you know, and you've heard me say, at times, I think we need to be careful as well, because the digital world is helpful, and it can help us get around some of these things, but I think it has to serve a purpose. We don't wanna go there just for the sake of having the coolest, neatest technology. So, I think it's gonna be a bit of a give and take.

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Colette:
That kind of leads well into the next question, which is, we've talked a little bit about what data is and multiple ways that we're collecting it and the quality of it. But how do you make it meaningful? And essentially, what do you do with it, right? What does it mean for everyone, all the stakeholders and ultimately with the goal in mind that at some point, it will result in some sort of quality of care for a patient that we're serving? So what are your thoughts on how to do something with the data, essentially?

Brian:
Yeah, Colette. I think that goes just to what I started to mention there. I think one of the biggest worries, Russell, I'm sure you guys hear this also from healthcare practitioners, "What am I going to do with all of this data? How am I going to understand what is important, what is not important?" We're actually doing a project right now within the atrial fibrillation space. We've partnered at the Eliquis Alliance, with Pfizer, Bristol-Myers Squibb, and Fitbit to try and understand exactly that piece of information. How do you take all of this data? How do you make it usable? How do you get it into the physicians workflow? How do you get them to understand what's urgent, what's not urgent? How does the doctor then incorporate that information into their decision making? So, I think, again, we need to do this. We need to do this the right way, and not just say, "Here's everything you ever wanted to know," but not helping people understand what to do with it. So, this big data in medicine has to be managed somehow. And I think figuring out that last mile, that piece from data ascertainment to data understanding to making a shared decision between the patient and their physician on the best treatment is the area that we need to work through now.

Russell:
Yeah, I would agree. I mean, once you do with it, where it comes from, I go back to my dark matter example. It's absolutely everywhere. But to your point, Brian, before you just wanna capture everything, it's most important to understand how it's gonna be used and how it's gonna be measured. You know, I've been in the industry for over 20 years and I've seen products get shelved because they will be on the wrong set of data matrix so that they didn't need to be that way. So, it is everywhere. It's critical, but how we use it is still a challenge. But I think the more we think about it and make it part of everything we do in terms of our work, the more comfortable we'll be with it and be able to use it in a more helpful way.

Colette:
And just to add on to what we're doing with it, maybe just thinking for a moment about how we're doing it. Obviously whether it was pre-COVID, or during COVID, there was always an element of combination in-person, whether that's from a medical affairs perspective, HCP interaction, or commercial field for sales, ACP interaction. I mean, how do you see, and to your point before Brian about not just doing things for the sake of doing them. But where has it really been a positive experience to leverage a technology or a platform in that experience of the HDP interactions with your organizations?

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Russell:
Well, I think virtual communication was something that was inevitable. I don't necessarily believe that it will completely replace in person, face-to-face in certain situations. But the environment and what we're going through right now with COVID, and when it comes to virtual communication has really forced people to become much more comfortable with virtual communication that really in the past wanted nothing to do with it. But again, it's been around for a while. I remember there's a paper, a famous paper that looked at patient satisfaction with virtual office visits. So, I think it was something like 160 plus change, divided equally by gender, and they had virtual animated providers at the end of their computer. And then they measured what their satisfaction level was. And interestingly, when it was a male-male interaction and in certain types of communication, there was no change in their patient satisfaction or satisfaction of that particular visit. But when it was female to female, there was a significant increase in patient satisfaction. So, I think it gets to the fact that we need to tailor how we communicate virtually and make sure that that communication is specific to the particular audience. Maybe more so now than ever, when we're in virtual mode.

Brian:
Yeah, you know, Colette, maybe if I can just add one thing, because Russell, you just made me think our Congresses are becoming virtual. Our Congress, we're talking about data, right? A lot of where new data works its way out and gets to the healthcare practitioners is these large Congresses, where data is presented in different forums and they've all gone virtual. Now, again, whether they'll stay that way or not, is something to see. But thankfully, these avenues still exist for communicating the data. And I think, we have to be more creative not only in that Congress space, but in our commercial interactions, right? Our sales force interactions, our medical to medical interactions with our field medical directors. We need to come up with tools, devices, better ways of getting this information out there. Because I think that's one of the big roles that both of our organizations serve, right? It's making sure that doctors and their patients have the information they need to make real respectable decisions when it comes to treating patients.

Russell:
Right. Yeah. You know I love that. I was having a conversation this morning about a conference that we were planning on attending in October, and it's gone completely virtual. So, to your point, it's happening, and much like the regulation question from earlier, I'll be curious to see how long and if that keeps filling past this COVID. That will be really cool. Really the reach is enormous.