In our latest interview, we delve deep into the current state and future prospects of digital health within the pharmaceutical industry. We speak with Dr. Leslie Anne Fendt, the Global Program Lead for Remote Vision Monitoring (Digital Health) at Roche. Dr. Fendt shares her expert insights on how digital health is reshaping the landscape, the cautious yet evolving stance of big pharma, and what this means for the future of healthcare.
When you hear 'digital health,' what is your first thought?
When I think about digital health, I wouldn't say I like to constrain the term too much and usually mean it in the broadest sense possible, simply as leveraging digital technology to solve challenges in healthcare, which, very crucially, to me also encompasses prevention.
I think of it in terms of products, but also data and technology infrastructure, and care channels and automation. It's about changing how medicine is practiced and delivered and moving towards prevention and more effective, data-driven, value-based healthcare.
A recent Future Today Institute report states that 'pharmaceutical and biotech companies face a paradigm shift: With consumers in control of their personal data, these institutions may need to leverage incentives to access the data necessary for their work. Do you agree with this view?
To realize the potential of personalized health, pharma companies and everyone else need high-quality data because that's simply the foundation of all learning. I fully agree that when data is for sale, it is only fair that the people whose data it is have a say in the matter. Depending on the value of any individual's data, let's say, for example, in rare diseases, scenarios are likely where patients granting access to their data receive compensation.
However, it takes a lot of effort and large volumes of high-quality data to turn it into something useful, and the juice is not always worth the squeeze. Also, in healthcare and especially for regulated digital health products, data protection laws are very strict, for good reason, and so it is actually very challenging to collect such data. Contrast this to consumer tech, where there are nearly no limits to what data companies extract from their users and where capitalizing on user data is often their core business model.
Big pharma is very cautious about implementing digital solutions. One might get the impression that it is approaching them with reserve. Is this true?
There are so many layers to this excellent question.
I think the observation comes from big pharma, maybe at the beginning jumping in very bullishly and perhaps somewhat naively into the space, and the realization that this field offers up a lot of complexity. I do feel that no pharma has yet completely cracked the code for how to best leverage and operationalize digital health, but that doesn't mean there is no progress.
I see us all getting rapidly smarter and more effective in how and what kind of digital health we are deploying, as well as making better decisions around the old question of build/partner/buy.
A significant shift was that we stopped thinking only about what the technology could do and started reflecting more on where value can be created and captured. That brought a lot of focus to our efforts, which means we're going to do fewer things but in a more deliberate manner and with more power behind each, which, to me, is essential for success.
How is Roche approaching digital health solutions?
Roche has a strong commitment to digital and data in many different facets. The company is actively leveraging digital health to enable and support its core business all along the value chain from R&D to post-marketing, but also building digital health products to commercialize as standalone products.
You recently wrote that 'digital health ubiquity won't come easy, cheap, and fast.' Why?
One of my observations has been that big pharma expected digital health to be something they could put a group of people behind and that could be solved and capitalized on relatively quickly and smoothly, and importantly, without impacting or disrupting the core business. When that didn't lead to the expected results, I feel there was sometimes disappointment with the concept itself. However, I would argue that there was not enough expectation setting up front.
To succeed at data and digital and capitalize on it as a company, the whole enterprise needs to transform. Most importantly, the core business itself prompted and accompanied by a huge change management and reskilling effort. There is no easy way to digitally transform an enterprise; the only way out is through it.
The same is true for the healthcare industry itself. Looking externally, we see that digital health can enable value-based healthcare, but digital health also requires value-based healthcare to thrive. Without us changing our broken system, along with its misguided incentives, people and institutions won't change their behaviors and processes, and adoption of digital health remains low.
No one thinks our healthcare systems are working well, but everyone who participates in them has found a way to make it work for them. Digital health promotes and relies on changing incentives for the greater good, which can severely impact existing business models. For better or worse, incentives drive behaviors, so to drive digital health ubiquity, everyone needs to have a clear 'why' for changing. What makes this extra difficult is that incentives vary widely by geography, specialty, and institution, and there are just so many different stakeholders to align and account for.
One of the goals of the digital health transformation is to shift from a treatment-oriented to a prevention-oriented system. What does this mean for big pharma?
That's one of the toughest nuts to crack for big pharma to understand how far into prevention they may want to go. I don't yet see big pharma playing or seeking a big role in prevention, in itself or with digital health. Most of the focus I see is on better understanding, treating, and managing disease, which is near-term where pharma can add the biggest value.
For most big pharma companies, that shift and its potential impact are still in the "wait and see" category – maybe except for GLP-1 manufacturers aiming to prevent obesity-related diseases through pharmaceutical weight management.
How are pharma companies remodeling their strategy since the digitalization of healthcare has accelerated?
At the highest level, all pharmaceutical companies have understood that successfully implementing data and digital in their business model has become mission critical. We see different focus points being set on driving R&D productivity and effectiveness vs. customer engagement and differentiation vs. standalone products, as well as various approaches in partnering vs. internalizing efforts. Still, digital seems to be a core aspect of nearly every big pharma company.
Roche has several mobile apps in its portfolio for diabetes patients, among others. What future do you see for this type of solutions?
As a digital health enthusiast, even if I don't work in this space myself, I often look to diabetes and cardiometabolism for inspiration on what's possible because digital health has become table stakes. Diabetes, for example, is a chronic disease with a very high and complex self-management burden and, as such, an ideal use case for digital health. That's why we see great adoption in this space and why this area continues to be a beacon for what the future will look like.
Do you think that so-called digital therapeutics should be subject to the same stringent regulations regarding, for example, clinical trials and safety of use as drugs?
Risk stratification is essential and should inform the regulatory and evidence burden. Of course, there is a danger of allowing harmful solutions to hit the market, which needs to be prevented at all costs. Still, there is also a concern about making the evidence hurdle so high that it becomes prohibitive for companies to develop novel innovations and, at the same time, overwhelming for the regulatory authorities to review them.
This could – at best – deprive us of innovative solutions and – at worst – grow the number of solutions on the market that technically fall into the regulated space but currently operate in a non-regulated manner.
Analog to pharmaceuticals and physical medical devices, digital health solutions should demonstrate safety and effectiveness. However, this must be guided by their level of risk and, then, importantly, should also be recognized through higher reimbursement.
The FDA has recently qualified Apple Watch's AFib history for use in clinical studies. Is the ability to apply digital biomarkers something pharma is waiting for?
Not waiting, doing!
That's certainly a space that big pharma is interested in, closely watching, and actively experimenting in. I would go as far as to say that for most new trials, there is at least the consideration and debate of including digital measures. It won't make sense everywhere and depends on existing digital biomarkers' availability, clinical evidence, and rigor. This is a super hot topic.
What is currently being discussed – regarding cutting-edge technology – most frequently in Basel, the basin of the pharma industry?
Oh, I won't be able to thoroughly do this justice here. Basel has become a hotbed not only of pharma but also of biotech, healthtech, digital health, and beyond. Of course, the large pharma companies in Basel focus heavily on integrating data and digital everywhere in their value chain, searching for more effective R&D, better customer engagement and education, and offering comprehensive health solutions.
Also, on the start-up side, we see a lot of activity. For example, the Day One Digital Health accelerator acts as a launchpad for digital health ventures, covering everything from digital neurorehabilitation to supporting elders in taking their medication.
And on the midterm horizon, quantum computing is becoming the next frontier, led by Quantum Basel, Switzerland's first commercially viable quantum hub. Advances in quantum computing will allow exponential growth in computational capacity and the ability to lift AI into the stratosphere and enable use cases we can only dream of today. So, this relatively small city packs a big punch when it comes to the future of health!