Digital technology that would be considered cutting edge just a decade ago is now widely available — and pharma companies are beginning to embrace the world of digital therapeutics to both understand and better treat patients.
The definition of digital therapeutics is somewhat fragmented. There are several ways to understand how patient data, cognitive behavioral therapy or companion apps can be used either passively or actively to improve patient outcomes and the overall healthcare system. Drugmakers are exploring these options — carefully and methodically — to see in what ways digital therapeutics can fit into the work they already perform.
For much of pharma, one of the driving forces behind the adoption of digital therapeutics is remote patient monitoring, which allows for insights throughout the drug development life cycle, said Jaydev Thakkar, chief operating officer of the digital health company Biofourmis.
"Most pharmas are looking at how they can combine digital therapeutics with drugs, where they have over decades perfected an engine and have a strength and expertise," Thakkar said.
But even with the promise of technologies like drug companion apps or remote monitoring tools, the digital therapeutics space is still fresh — which, by nature, isn't pharma's forte.
"Pharma certainly remains — in many areas and not just digital — a bit more conservative," Thakkar said. "There is a good reason for that, which is that they have a very different responsibility when they bring innovation, a different bar, and pharma's acceptance of new things like digital intervention takes quite a bit of internal convincing."
As more digital therapeutics solutions become part of the core pharma model, the companies bridging the gap are approaching coalitions with a combination of gung-ho enthusiasm and cautious optimism while recognizing the limitations that need to be addressed.
The Big Pharma approach
The biggest pharmaceutical companies in the world now have digital teams exploring the potential of digital therapeutics and where they fit into the more traditional paradigm of making and selling drugs.
"There is a conviction on the pharma side that, yes, this is something that truly can benefit patients and actually effectively combine with a drug strategy," Thakkar, who spent 14 years at Amgen before coming to Biofourmis, said. "One lesson I recollect learning back at Amgen was building a cross-functional alignment early on was key — ultimately, it's a win-win when we educate pharma, and it creates pathways for what can or cannot be done when the right expectations are set from the beginning."
Pharma giants like Novartis are wholeheartedly trying to involve digital solutions to make the most out of the therapies they are already delivering to patients, said Lauren Bataille, head and digital director of the Swiss company's digital strategy and partnering division.
"Pharma is getting more comfortable with the idea of digital therapeutics as its own wing … but it’s just taking a bit of time."
Director of clinical trial management, Curebase
"We're looking to understand how we can take these evidence-based solutions that are digital, work with our partners at different healthcare systems, our (key opinion leaders), to see how we can implement a solution like a clinical decision making tool or a medication adherence app, and how that functions as an add-on to the therapy compared to the standard of care," Bataille said as part of a panel at the DTx East conference held in Boston at the end of September.
Bataille, who has a background in patient advocacy with the Michael J. Fox Foundation, said that bringing the patient into the solution is a critical part of the process, especially when it comes to a companion app. Novartis was running a mid-stage trial for an injectable drug aimed at kidney transplant patients — the shot would not be administered with the same regularity as the standard-of-care oral pill that patients were used to, so adherence was a concern.
"We wanted to make sure we developed a co-digital solution that provided all the information not only about the trial but targeted information with nudges about when patients needed to take the therapy, because it's critical," Bataille said. Unfortunately, she said, "as these things go," the trial didn't meet its endpoint, but from this seed of innovation, Novartis developed an infrastructure that's now being used for other therapies to develop similar tools.
These innovations have become increasingly important as the world changes, particularly during the COVID-19 pandemic when home monitoring became the norm almost overnight, said John Cairns, the global head of digital in the oncology unit of France's Sanofi.
"What's important is looking externally, looking at how things have changed and how you need to adapt — the drug life cycle is very long and technology changes very quickly and patients' needs change very quickly," Cairns said. "We do tend to replicate what's happening in other parts of the business and we should all be a little more joined up, in all honesty."
One of the challenges that many of Big Pharma's digital heads have pointed to is integrating with the core tenets of their historic institutions. For that, Bataille said there can be a little bit of hand-holding to bring more traditionally minded units up to speed.
"We're in traditional medicines companies trying to bring digital transformation, and it's truly a cultural transformation," Bataille said. "Particularly in the R&D space where you're working with folks who have been doing clinical trials in the same way for 20 years and that mindset shift is critical."
Ultimately, though, the adoption of digital therapeutics has potential to help patients receive better care from pharmaceutical companies and the healthcare system, said Josh Raysman, vice president of the Digital Innovation Lab at Pfizer.
"There are lots of challenges, but what we're most excited about is this idea of patient need and an understanding of patient need at a level that I would argue would never happen before," Raysman said. “And it's not just patients but prospective patients — we start at the very beginning of the journey where we can increase (detection) and general awareness in a personalized way and carry that through the patient journey."
The evidence limitation
Discussing the potential for digital therapeutics to change the patient journey also requires a step back to understand what work is yet to be done. In that respect, many of these digital leaders agree that it comes down to evidence.
In drug development, a proof-of-concept study shows direct measurable results. With digital therapeutics, those signals are harder to display in the same way, said Raysman.
"Most folks are skeptics, and candidly we have an evidence challenge," Raysman said. "There's been some great work, especially lately, in generating evidence, but I'm hard-pressed on any given day to bring forward evidence that justifies the vision — I believe it's there, but the challenge for us is working together to generate that evidence."
Digital solutions have always suffered from a lack of comparable standards of care, even outside of pharma. For Whitney Stewart, director of clinical trial management at Curebase, which places an emphasis on decentralized trials, this can come down in part to the difficulty of developing a placebo arm for digital therapeutics. Some companies have created "sham" apps that do not contain the therapeutic part of the real digital therapeutic, but these methods have been difficult to repeat, Stewart said.
"Pharma is getting more comfortable with the idea of digital therapeutics as its own wing … but it's just taking a bit of time," Stewart said. "There's hesitation and probably a little bit of nervousness around how digital therapeutics get approved."
The testing and approval around digital therapeutics is currently not as cut and dry as it would be around drugs, she said.
"With a traditional pharmaceutical, you would create it, and it would be how it is and you don't have to retest it, and it's approved — but with digital therapeutics, the product is constantly being iterated on, and you might have to retest in a future version and track that."
Overall, pharma companies are riding the digital wave to the extent that the evidence allows, and leaders are leaning in to make it part of the business model by working with other departments within their organizations. After all, digital leaders not only have to sell the product — they have to sell their ideas to the people within their own company, said Suhas Krishna, vice president of digital health product management at Bristol Myers Squibb.
"Pharma is very good at making drugs, selling drugs, making money from it — so oftentimes what we're seeing internally is that we need to show that we're solving some unmet primary medical need," Suhas said, adding that understanding the value capture is equally important.
"If we can get a good balance between those critical areas, and there's a credible story about how this is supporting BMS's mission, helping patients, helping providers, that sweet spot is what we're looking for," Suhas said.