Life Sciences in the spotlight: Vicore Pharma

Pamela: Hello, everyone. I’m Dr. Pamela Walker, the Head of Life Sciences at Gate One and host of our Life Sciences in the Spotlight podcast series.

Innovation is the key to unlocking the future of health and a transformed healthcare experience. And sitting at the very heart of this and creating incredible buzz are digital therapeutics. Personally, I see this as one of the most fascinating elements of the latest health innovation landscape, in that they serve both patients and systems with enormous benefits. And that’s why I’m absolutely over the moon to be in conversation today with Dr. Jessica Shull, who is one of the pioneers and key Innovators in this space.

Jessica is the Director of Digital Health at Vicore Pharma. She spent years working with the World Health Organisation and other NGOs on international digital health projects, before diving first into digital therapeutics as the EU policy lead for the Digital Therapeutics alliance. Now, with Vicore Pharma, a Swedish biotech, she has just completed a pivotal randomised control trial for the digital therapeutic called Almi, built for people with pulmonary fibrosis and aimed at improving their quality of life. Welcome, Jessica.

Jessica: Thank you so much, Pam. 

Pamela: So, it’s so great to have you with us today. And to kick things off, it would be brilliant if you could share your views on the evolution of the role of digital therapeutics in the healthcare space over the past five years.

Jessica: The role has changed a little bit, I think, over the last five years, what’s happened, and from my point of view, bringing therapeutics into the spotlight at all as a product that existed was the first step. So just having global recognition was a big first step, and that was about five years ago, and just getting the definition right, so everybody knew what we were talking about, the lining on the syntax, that was a big piece of just teaching and repetition and speaking with so many stakeholders who now are all kind of on board on what these products are and how to even evaluate them.

Pamela: And do you want to maybe share that definition with us so we’re all aligned in terms of what we’re talking about? For those that are listening, that are new to the digital therapeutic space.

Jessica: Digital therapeutics are, in short, software that enacts clinical change on a certain disease state. So that’s a very short way of saying it. The Digital Therapeutics alliance has a much longer definition, which you can go to their webpage and look at. But the idea is that the software by itself actually changes a clinical endpoint. And that was the biggest thing to get across people that, no, it’s not tracking a change in medicines, in molecular medicines, and it’s not that this is a self help tool, no, these are actually moving clinical endpoints in clinical studies. So that’s not always obvious to people how software can do that. But if you think about talk therapy, that is a clinical intervention, as it would be in a digital product that is done completely by software, I think in the space.

In the last five years, we’ve also built a community around the assessment parameters for HTA bodies and organisations like the FDA on how to evaluate these kind of products for safety and efficacy. There have been numerous efforts on evidence generation guidelines, so that different countries and different hospital systems and different patient groups even can understand why these products work and how. And I see in the last five years that things have just really ramped up in terms of recognition and use by patients and even caregivers globally. So that’s been the big change, I think, in the last five years. And then there’s been another change because of the reimbursement pathways now. But there’s still a huge space that digital therapeutics are occupying currently.

Pamela: And so then thinking specifically about where we’re now, and maybe it is in relation to access, or maybe some of those examples you just shared, but what would you say are the most exciting innovations that you’re seeing in digital therapeutics?

Jessica: So, yeah, a couple of examples I could think of. There are a few products that do treat type one diabetes that are actually digital therapies, at the same time are monitoring blood glucose and can actually work as a digital endocrinologist, in a sense that they’re actually able to dose and modulate a treatment plan for someone so much beyond just looking at what the blood glucose is, which all continuous glucose monitors can do, but now it actually can automatically adjust insulin dosing. So that, I think, was really phenomenal. And these products have been tested and approved and they are safe, but they’re not always available in every country.

Another thing I think is notable is the subgroups of where digital therapies are being used the most we saw, we work with an older population with respiratory disease. It’s another population that uses digital therapeutics. They have no problem interacting and understanding that this is a benefit through a digital means. And you can look at the DiGA framework in Germany, and how the DiGA’s are being used and prescribed and so forth. And I think it’s a majority, more than 50% of users are women. And so we think digital. And we think, somehow, I don’t know, Elon Musk and the guys, but women and older people are a big portion of the users of digital therapeutics? And is there any sense as to why that is? Has there been sort of anyone looking at the data to make some assumptions and deductions? Because clearly, probably everyone could benefit from it. So how do we take their keenness and move it to the other populations? So I think it’s what’s split evenly. Right?

So I think we just maybe expected there would be more men if there were more men being studied. But it’s just that women are showing that they are just as interested and willing to use these kinds of products. It’s also depending on the kind of product, like if it’s a therapy that is treating depression or anxiety, it could be that men are less likely to admit that they have these problems in the first place. And so there could be something there. But we haven’t done the stats to look at why exactly. It would take some, I think, thorough patient interviews to figure out exactly why. And it’s maybe personal reasons, but also maybe just a matter of access.

Pamela: Fair enough. But that’s a fascinating perspective you shared in terms of the older generation being really active with using it. That’s fantastic and counterintuitive, because I’m sure you get questions all the time about that.

Jessica: Yeah, we did our work before producing a product for this population, but Covid and the fact that everyone was using QR codes and wanted to get on FaceTime to talk with family, that was a big push toward digital. But it’s pretty ubiquitous. I mean, the thing is that as we age in general, as world population, this is going to become just second nature. It’s no longer even a question. Like most people under 20 or even under 25 now, they don’t look at books or if they need anything, if they can help it, they do not leave their phone. They look first at their phone for help.

Pamela: And so I guess, building on that perspective, then, what do you think, from the patient’s viewpoint, that digital therapeutics brings to them that’s better or different from traditional treatment approaches? Is it the connectivity?

Jessica: Yeah, connectivity is part of it. But there are health care disparities, right? Even in the US, that carries, for every country in the world, really, where there is more wealth and wherewithal, there’s more care. But what digital therapeutics can do, because digital devices are pretty ubiquitous, it does reduce the barrier. And so digital therapies can be used at home, they can be downloaded, given without having to go to a pharmacy. And so you’re opening up access to groups that may have been marginalised or may not be able to travel or maybe can’t travel because they’re carrying also an oxygen tank. So it really kind of levels the playing field. And I think we talked about that when digital therapies were first being discussed, but now we’re actually seeing it.

Pamela: That’s incredible. And it’s really in line with the push for health equity and the interest in the health systems and health equity.

Jessica: Exactly. And I think with the rural metropolitan split as well, we tend to think that because cities are the hubs and this is where people buy more devices. I don’t know that this is where digital therapy will be used most, but it’s throughout rural areas as well.

Pamela: And I’d love your viewpoint on the HCP perspective. So, in terms of recommending prescribing, how will existing practises change, or how have they already changed to be able to optimise adoption and the impact of digital therapeutics?

Jessica: So it’s an interesting question, because it depends on the digital therapeutic, in a way. If a digital therapy requires integration into an electronic health record to be prescribed or to be monitored, that kind of thing, it’s more complicated. And we all know that we can’t be creating products that require more physician time. They are overburdened. We have to make things simpler. And so I’ve always said, back when I was advocating at the Digital Therapeutics alliance, to make a tool that provides physicians with actionable information is fine, but we don’t need more dashboards, we don’t need more pretty pie charts. What we need is to be able to philtre down and combine information to come up with actionable or even disease prevention. So that can happen. And that’s just software. It’s just a matter of these epic concerners and saps of the world aligning on that.  

The other side of it, though, is that a lot of digital therapy don’t require physician interaction on a daily basis, or even ever. They can be completely standalone. There’s a product design goal that has to be set first and then designed for. But if a digital therapeutic requires sufficient interaction, involve them from the beginning, and it does happen, there are plenty of products that once a physician understands how it works, they want to use it because they see that they’re giving better care to their patients.  

Pamela: And do you see, you mentioned access before, so I’m curious about how that works from an access or reimbursement perspective. Is it easier than, say, launching a drug? Is it harder because it’s a new pathway? How does it work? I imagine different by country, but just from your experience?

Jessica: Yeah, exactly. It’s very different, country to country. We can take the US as an example. So there are two kinds of digital therapies. One is the sort that does not require huge oversight and is considered a very, very low risk kind of device, and that does not even require a reimbursement pathway. It does not have to be prescribed. So those kinds of products, and you’ll see that Achilles is doing this now, can be over the counter, like your aspirin or something like this.

It’s still a treatment, but it’s no longer prescribed with a huge amount of oversight. The other side of it is a type of digital therapeutic that requires a prescription. And that I would say is akin to launching a drug, just because once the drug is available on the market has passed all the barriers to be prescribed. For the digital therapeutic, the problem is that there are ways to have it prescribed, but you just have to find the way that works best. And it depends on the product, the state, the disease indication, the kind of interaction it is. Because there are ways to reimburse through Medicare that are depending on if the physician has to train the person or if the physician can get reimbursed for the training themselves. I mean, all kinds of little details like that. So it’s possible. But I believe the CMS is looking at ways to make that simpler because it just doesn’t make sense. I mean, if these products can help patients, why make it so many hurdles to come to a point where they can be sustainable?

Pamela: And so I guess my last question for you, Jessica, is taking that last statement one step further. And instead of looking back on the past, looking ahead to the next five years, and I would love to hear your predictions for this space and the impact you think that Digital therapeutics are going to have.

Jessica: So, interestingly, this year, FDA set up a new set of guidelines on digital products in general, but also on digital health products and digital therapies that can be produced in combination with molecular therapies. So this is the direction that digital therapists have always. They were always going to go this way, in a sense. And we can see with ozempic and the digital therapies that can potentially be paired with those kinds of products, like the huge potential gain for patients in this area, I believe sooner than five years seven, that it will be fairly straightforward to have a digital therapy prescribed alongside molecular therapy for many disease areas. So with those like companion digital therapeutics, what do you think that they will be doing? Like, will they tend to be doing one of two things, if they’re companion to a molecule, or do you see it as anything they can do?

So many things. I mean, it really depends on the disease area. So with something like type two diabetes, of course, what the patient wants, what the physician wants, what everyone wants, is to not be dependent on insulin. And so that’s very easy to say. And ozempic does some things and it does help, but it’s not a cure all. And so what a digital therapy can do is actually see day to day what the patient’s doing, what are the triggers, what is your actual glucose, what makes that effect take place, and really, in real time, serve as sort of a mini endocrinologist with that patient all the time and have a far more long lasting and effective outcome in the long run. That, to me, is a fairly straightforward first case, but that can be the case for many disease areas, talking about Alzheimer’s or Parkinson’s or so many. I mean, even in our case for respiratory diseases, for pulmonary fibrosis, definitely the more a patient is involved in their own care and aware of what’s happening to them, and can be on a day to day able to grasp a plan that’s tailored for them in a customised way through the digital therapy therapeutic that will lead to better outcomes.

So it’s like treatment modulation and treatment optimization, and I guess in treatment and optimization, because I’ve seen other digital therapeutics that support, say, anxiety reduction to get better outcomes in terms of whatever the sort of treatment experience is, which is more, I guess, outcome optimization versus modulation, which is sort of what you were describing with your mini endocrinologist in your companion. Yeah, I think it’s both. I think it’s a combination of those things.

Pamela: Yeah, it’s incredible. Any other predictions?

Jessica: I just see the space really expanding now. And so 2023 was a year where a lot of pharma companies unfortunately closed the doors on digital therapies, which I saw as so short sighted. I mean, I just wanted to take each of them aside and say, look, what are you doing? Because you’re going to have to open those doors again. And it just looks so flip floppy. So I see that pharma will invest heavily in digital in the next five years, especially as we have a huge population that’s only getting older and we don’t have enough people to go around to take care of everyone. And so I also see this kind of therapy and this kind of personalised monitoring and integrated care going into old age residency homes, that kind of thing, it’s a big problem. And I think this is one of the only ways we’re going to solve it.

Pamela: That’s incredible. Jessica, thank you so much for sharing your expertise with us today. I’ve learned so much, and I’m even more excited about this opportunity. And that draws our podcast to a close. So a big thank you to our guest today, Dr. Jessica Shull from Vicore Pharma. Your insight has been invaluable.