In 2023, Prism is launching a new YouTube series called "Discussing Data Science". I am delighted to share our first episode, featuring Christian Djurhuus.
Christian is a pharma industry veteran who spent nearly 20 years at Novo Nordisk, first as a medical director, then moving into R&D for insulin and diabetes, before transitioning to a focus on digital health. When he left Novo at the end of 2022, he was their Chief Digital Officer within Development.
In this conversation, we discuss the importance of digital health technologies and their role in clinical trials, some of the work that Prism and Janssen Innovation have done to analyze the landscape of digital health, the difficulties in adopting digital health technologies across different social and regulatory ecosystems, and the opportunities and challenges for decentralized trials.
Here is the video! But if you'd prefer to read, there is a (slightly edited) transcript of our conversation below.
Spencer Hey (SH): My guest today is Christian Djurhuus, a Pharma industry veteran who spent close to 20 years at Nova Nordisk. He first served as a medical director, then moved into R&D for insulin and diabetes, before transitioning to a focus on digital Health. When he left Novo at the end of 2022, he was their Chief Digital Officer within development.
Welcome Christian and thank you so much for joining me today.
Christian Djurhuus (CD): Thanks Spencer, and thanks for having me.
SH: Coming from an academic background, I will confess that I'm always a little bit tickled by industry titles. But “Chief” anything is obviously very important, so perhaps by way of further introducing yourself, could you say a little bit more about the Chief Digital Officer role?
CD: Sure. So at least within the the space that I was in, it might have been a case of the one-eyed leading the blind. I am personally a firm believer in technology and how technology can actually help people live fuller lives. That has been kind of my creed since pre-med school.
Within the Chief Digital Officer role, I've had the the privilege of working with a bunch of really smart people designing how digital strategies would work across a a an entity of development within a large pharmaceutical company, and that would be both in terms of defining the strategies that suit the corporate strategies but also ensure that the strategies are executed upon.
It's also fair to say that I do love technology. You mentioned “digital health” before. I really believe that technology is going to help people to a much greater extent than what we see today. Pharma is pharma and sometimes [in my previous role] it felt a little bit like persuading everyone around me that the world is actually round—it's not flat anymore. So here I am, seeing whether I can find a place where where my beliefs and my passion is talking to other people who believe the world is around.
The Role of Digital Technologies in Clinical Trials
SH: One attractive domain of application for digital health technologies (DHTs) would be in clinical trials. How do you see DHTs influencing that space?
CD: There are many players within the clinical trial domain that are coming together to execute a clinical trial protocol: There's the essence of it—the people living with whatever disease. Then there's the clinical investigators, which includes the principal investigators, study coordinators, lab technicians, pharmacies, etc. Then there are either contract research organizations (CROs) and sometimes sponsors (like in my previous role, the sponsors are also the CRO if they execute their own studies).
All of these players need to come together to execute a clinical program. So DHTs, in my mind, are focused on efficiencies across that value chain. But DHTs are also focused on harvesting new insights—and the closer you get to the people living with the disease, the better you are at capturing “unobtrusive” insights in these people, the better you will be able to to actually focus in on what matters to them. And I believe that the DHTs have that prerogative.
So for me that's actually the higher value [for DHTs], if you will. Yes, efficiency is cool, but getting the new insights on how people really live with their diseases and how technologies and drugs and whatever can help them, that's really what matters.
SH: How have you seen adoption with DHTs in the trial space? Following up on your point about focusing on the patient's perspective: Do you see that patients are eager to use these technologies? Or what do you see as the major drivers of adoption?
CD: There isn’t just one DHT. There's a myriad of DHTs out there. Some are less invasive than others, which is why I'm using the the term “unobtrusive”. The more user-friendly DHTs are, the better the data, and the easier the adoption.
I've seen a lot of technophilics loving DHTs; patients not so much. Yet, I've also seen a lot of data where the patients are actually using DHTs day in day out to manage their disease. If that is the normal way of living for these patients, then it becomes less intrusive. I don’t think there is a magic bullet out there, but the essence is that anyone applying DHTs must ensure that that it is as unobtrusive as possible.
SH: You mentioned that there isn't just one DHT. Instead, it's really a landscape of different devices. One dimension of this landscape, which you've spoken to just now, is obtrusiveness. But trying to map out this landscape of DHTs is actually how we initially got connected. Prism is working with Jansen to analyze the landscape of DHTs, and one goal of this work was to produce a repeatable, scientifically rigorous method to quantify the volume of DHTs used in clinical trials (specifically with an eye towards measuring waste).
Prism now has completed a manuscript that's about to go out for peer review; we've released a public ontology of DHTs; there's a public analysis that replicates a 2020 study live on our app; and we developed a data science product that any sponsor could use to analyze the landscape of DHTs in their trial portfolio. I think you've seen all of these outputs. So I am curious to get your perspective on them. Anything in these outputs strike you as valuable?
CD: I see [Prism’s work] as very valuable—but there's a lot of valuable stuff in the world. Most pharma companies or medical product developers have either time-to-market as the most valuable [goal], or they have more patient friendly measures, or how many patients can you actually impact with whatever product you're developing, or which markets [to enter]—the world is a very heterogeneous place, so which markets are we looking at. So all of these different cuts, if you will, of what needs to be in play to utilize these technologies are super important.
Where does the the complexity of DHTs lie in that hierarchy of importance [for companies]? I think that differs a lot.
Quick disclaimer: I have nothing to do with Apple, except that I actually love their user centricity. But very few DHTs are as easy to work with as [my ear buds]. If I were to open [their case] now, my earplugs would automatically connect. None of the technologies that I've been able to work with [in the clinical trials space] have that luxury. So they're very complicated. That means that it's complicated for the patients. It's complicated for the sites, for the study coordinators, etc. It's complicated all around. So where in this hierarchy [of value] would [simplifying the landscape of DHTs] apply? And that's also why some of the DHTs today are not as user-friendly as you would want, because in the hierarchy, you can't allow it to be.
SH: That’s actually something I wanted to ask you to say more about: What are the major barriers to [more user-friendly DHTs in trials]. My initial thought is that trials require a certain level of scientific rigor, and that this prevents the DHTs from being so user-friendly. Or is it something different?
CD: No, I usually have verification and validation as a [core principle]. You can't just assume that whatever technology you have works in another disease area, so it's upon the sponsors (or whoever chooses the devices) to make sure that it's actually verified and validated for the intended purpose. Period.
But above and beyond that, there's usability elements and those usability elements are vastly different depending on where you want to execute your clinical trial protocol. So part of the work you've done with Janssen would obviously indicate that “bring your own device” (BYOD) technologies are a lot better for various reasons: Patients are familiar with their device. [They] don't have to walk around with yet another device. [This avoids] the whole “do I leave it at home or do I carry it with me” element. All these kind of [elements] require that the space that you're executing the trial in allows for BYOD. In very many instances, it does. And in others, it does not.
So when we're moving into DHTs using wearables or other sensors to capture data, that connectivity between the [measurement technology] and the data conduit—the smartphone, the watch, whatever—is essential. [Under these circumstances], you cannot do BYOD, because then you'll have a myriad of different technologies that [are unlikely to all work reliably together], and then you lose the link. Which is back to my point about making sure that [the whole trial operation] is actually doable. You also need to execute your trial within a certain period of time. Having people withdraw from a trial because of complexity is not fun. Believe me, I've been there. So we have to have all of these kind of ecosystem mentalities in mind.
SH: Let's transition there to this issue about, as you put it, the ecosystem. There's a lot of DHTs that you think are sufficiently robust to add value, both in clinical development and in real world patient care. But it sounds like you are not seeing the level of adoption that you think maybe could be there. Is that is that fair to say?
CD: Yes, it is. But it's also that these devices are robust for a particular purpose. It's a little bit back to my point about the intended use of a device: It makes a huge difference whether you're using a device for fun (e.g., tracking your exercise with your Fitbit) or you are using it as a part of a data acquisition model for a clinical trial that has to undergo regulatory review. Major difference between whether you're using a device for a diabetes study whether or whether it's a Parkinson's study. People move differently [in these two patient populations], so you need to make sure that the device makes sense in this context.
SH: That resonates with some of the work I did back in my academic life. I was working a lot on evaluating the evidence for diagnostic testing, biomarkers, and cancer. This is a different domain of technology, but there were similar issues. A particular biomarker test could be great for one type of cancer and diagnosis, but maybe not-so-good for another one. Which then leads to the challenge of [validating these tests for all the different potential use cases], and also the question of who is going to generate the data. Who is going to do the work to figure out where [a test] works? Whose responsibility is it?
One of the things that I found is that there are really so many questions, so many possible uses for these technologies, that it quickly becomes clear that we are never going to learn it all. We’re never going to have the quality of evidence we all would like to have. Nevertheless, we still have to make decisions. If we want to use a technology in a particular use case, then we do a dive and validate it for those parameters.
But it seems that although pharma companies have an interest in validating DHTs, insofar as they want to use them in their trials, they're not the makers or owners of the devices. Do the device makers care about this level of validation? At the end of the day, do the incentives pull them in the same direction?
CD: They may. That's back to the calls for partnerships. Pharma companies are great at drug development and commercialization of drug development. Device developers are great at device development (are allegedly so). So partnerships are needed in order to go into that space. That could be academic partnerships or corporate partnerships. You know from from your work with Janssen, for instance, that they're very good at generating these partnerships. On the European side of things, [Janssen is] also good at engaging in activities to make sure that these [digital endpoints] are actually developed and validated so that you have things to pull out of the library, if you will.
But essentially, if you want to deploy a digital endpoint or a captured endpoint in your clinical trials, then you own it and you need to make sure that you can assure that it's both verified and validated for that particular purpose.
SH: Another piece of the puzzle I'm curious to ask you about: What have you seen as far as physician comfort with adopting DHTs, whether in the context of a clinical trial or their clinical practice?
CD: Well, you know I'm a physician. I think physicians are as different as anyone else. That being said, most people engaged in clinical trials are on the more curious side of the spectrum and equally so with respect to technologies. So there is a gaussian distribution of love for technologies, but it's probably skewed towards favoring application of DHTs.
My experience is that physicians really enjoy being able to have that investigator oversight by different means [due to the DHT]. So rather than just being blindfolded for a period of time between the visits, they actually have opportunities to follow their patients and they really enjoy that.
Decentralized Clinical Trials and Sustainability
SH: Why don't we transition now to talking about decentralized clinical trials. This is obviously one of the things that DHTs can facilitate. But I'd be curious to start with a definition. How would you define “decentralized trial”? And then, what is your perspective on a shift toward decentralized trials in the industry?
CD: Every trial has a lot of names. It was “remote decentralized clinical trials” now it's “DCTs”. People who are very much into decentralized clinical trials don't believe that it's anything unusual these days. So now we should just revert back to talking about “clinical trials” because [decentralization] is just how we do it. It's all over the place.
In order to avoid that kind, I really enjoy Clinical Trial Transformation Initiative (CTTI), so I always use their definition whenever I'm discussing DCTs.
[Note: CTTI defines DCTs as: trial “executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product is shipped directly to the trial participant).”]
SH: What excites you the most then about seeing a future where there are more decentralized trials?
CD: What excites me the most is that DCTs enable what we're striving at. Whether we are regulators or pharma or medical product developers in general, we all carry the same objective. There are people out there suffering from diseases that we want to help.
So what really excites me about DCTs is that with brick and mortar studies, you are confined to a very particular group of people who can actually allow you spending time in a clinical trial. It is hard work being a clinical trial patient. With DCTs you can bring much of this to patient's homes. You can untether, if you will, from brick and mortar sites and better democratize access to clinical trials.
Those are some of the the best benefits of doing DCTs. That allows us to move from evaluating “merely efficacy” into something that I believe is close to effectiveness. Because you have a more general part of the population taking part in clinical trials—we have democratized it. You get outcomes within that clinical trial that mirror real world data. So the efficacy/effectiveness discussion becomes mute.
So those are things that really excite me because then we will be able to both effectively develop things, but ensure that you actually get data that you can use not only to to get regulatory approval (because of the efficacy data) but also ensure reimbursement (because it's close to effectiveness data).
SH: I love that. It just sounds like that's a win-win. There are just so many parties that can benefit from that kind of change—regulators, developers, patients, device makers. That is really exciting.
CD: At some point in time, yes.
I'm based in Denmark and just prior to Christmas we received a wonderful gift from the European Medicines Agency (EMA) on recommendations for DCTs in Europe (FDA has been ahead of the game for quite some time). So now the regulators are becoming more and more acquainted, obviously due to the pandemic, with the use of DCTs and elements of DCTs and describing how, when, and where it can be used. This allows for broader use because otherwise it has been the “lowest common denominator” game. Lot of things could happen under FDA purview. Very few things could happen under EMA purview. And since it's the same protocol that sponsors are executing worldwide, you will go for the lowest common denominator.
This also goes into a new regulatory environment taking shape for how to deploy these DCT elements. In 2023, it looks like the ICH E6 R3 will be finalized, which will merge these considerations by FDA by EMA and others. That's where I really believe the common regulatory framework will unfold.
SH: I want to connect the decentralized trials up to issues about sustainability. Do you see the movement towards DCTs helping to reduce the cost or footprint of research?
CD: Yes, definitely. But I think there are sustainability implications in all different aspects of the term. There's affordability issues, there's the generalizability that we discussed before, there’s diversity (i.e., how to make sure that that the ones really intended to use the product have also been started in the development program), and then there's the environmental component. So all of these kind of things, in my mind, are kind of the next frontier.
I also think that this is not going to be optional. Focusing on environmental sustainability is something that not only is going to be required [by regulators, for example], it's also going to be required by those people that are employed by the companies. People want to work for a sustainable company.
Looking back to how this is being seen, at least in in parts of industry, I'm quite impressed by what's happened in sustainable marketing initiative, which was originally a U.K. activity, but is now broadening out into other large pharmaceutical companies. My previous company was also part of the sustainable marketing initiative, where DCTs are seen as one of the tactics to make sure that the environmental sustainability is observed within clinical trial conduct—and that's that's quite exciting.
What are the biggest data gaps in the field?
SH: We want to ask everybody that we talk with on Discussing Data Science the same three questions. The idea is to explore how the the answers may vary or overlap across experts and industries.
So question #1: What do you see as the biggest data gaps right now in the field?
CD: I see nothing but data gaps. But let me try to answer from the space of diabetes, which was kind of my home.
Many years ago, people measured the glucose by peeing in a cup. Then technologies were developed to make it so that you can poke your fingers. Then technologies were developed so you can actually look at your glucose levels minute by minute. All of these elements created fewer and fewer data gaps. And that's just within glucose. There's so much more that goes on in a person living with diabetes.
So data gaps are all over the place. For me, it's a matter of the unobtrusiveness we discussed before. And also: How do we actually get an environment where we can share these data in a data-privacy mindful manner, maintaining the intended use of the data, and so on and so on.
I think we are very much living in the data void. You can see it by the petabytes that companies are acquiring these days. Moving into omics, etc. It's a totally different ball game.
What excites you most about the future of research?
SH: Question #2: What excites you most about the future of research?
CD: I'm an outcomes guy. Research as such is just an output. Conduct a study, you get some insights. You may want to file it and get an output in terms of a regulatory approval. But no patient or person with whatever disease was helped by that.
I really don't care what color a cat has just as long as it captures the mouse. So for me, it's a matter of helping people, and I think these DHTs are going to really catapult that into a different space.
If you could wave a magic wand…
SH: Question #3: If you could wave the magic wand what would you change about the industry?
CD: Linearity. I think most organizations are linear in their mindset. There is a core capability and you “milk” that core capability because it's a linear mentality. You don't look to the side. So my magic wand would be that the exponentialism, if you will, of healthcare can be more easily done.
Perhaps quoting Bill Gates: We all believe things are happening within the next 2 years, but we kind of forgot the fact that it's a little slower. But it will happen within 10 years, and hence we become lulled. So the exponential people are in the 2-year space, the more linear are in the 10-year space. So my magic wand will enable that that link is better obtained.
SH: I think I follow that but, I'm curious can you give an example of the linear way of thinking?
CD: Linking it a little bit back to my comment about the data void: The linear way would be that, all things being equal, this particular product will be beneficial, but you're not looking to the side or having a discussion about disruption. My magic wand would be that an organization would be better at looking to the side, especially at the point in time where change is happening in a pace we haven't seen before and where technology is moving the needle on healthcare at a bigger pace than ever.
SH: Christian, thank you so much for joining me today for this really interesting conversation, and thank you for being the guest number one on Discussing Data Science.
CD: It was a privilege Spencer. Thanks for having me on your show.