Big Pharma Seeks More Partnerships, Evidence in Digital Therapeutics

Xconomy Boston — 

“Digital therapeutics” startups are starting to win more respect—and investment dollars—from pharmaceutical giants. But the two sides are still figuring out how to work together to capitalize on the potential for apps, devices, and other software-enabled technologies to impact patients’ health.

That’s what stood out to me the most as I listened to leaders from some of the world’s largest life sciences companies—Novartis (NYSE: NVS), Sanofi (NYSE: SNY), AstraZeneca (NYSE: AZN), and Johnson & Johnson (NYSE: JNJ)—talk about their firms’ interest in the nascent field of digital medicine at an industry conference, DTxDM East, held at a Boston waterfront hotel this week.

“These really, really large organizations want [digital therapeutics] to work and want to deploy investments into this,” said moderator Edward Cox, the CEO of San Diego-based digital therapeutics startup Dthera Sciences.

Pharma’s growing interest in digital medicine—in which electronics such as smartphone apps serve as the therapy—comes as the industry has gained momentum over the past year. Last September, a product developed by Pear Therapeutics, based in Boston and San Francisco, became the first software the FDA has cleared to be prescribed to help treat a disease (substance use disorder). The FDA is currently reviewing Akili Interactive Labs’ first experimental product—a mobile video game designed to assess and treat attention deficit hyperactivity disorder (ADHD)—after Boston-based Akili reported a successful 348-patient clinical trial last December.

Meanwhile, Click Therapeutics recently raised $17 million in a venture round led by Sanofi Ventures. New York-based Click will use the money to boost its efforts to win FDA clearance for a pipeline of mobile apps that would be prescribed to treat medical conditions—such as depression, insomnia, and chronic pain—either on their own or in combination with drugs or other standard treatments.

And in August, the FDA granted “breakthrough device” designation to a development-stage product from Cox’s company, Dthera. If the software product, DTHR-ALZ, ultimately wins approval, Dthera said it would become the “first non-pharmacological prescription treatment” for Alzheimer’s disease symptoms.

These milestones help bring legitimacy to an industry still proving itself. But there’s a lot of work to be done on that front, panelists said at Tuesday’s event.

“Over the next five years, we’ve got to focus on showing the evidence with digital therapeutics,” said Joris van Dam, executive director and head of digital therapeutics at the Novartis Institutes for BioMedical Research. “If we fail, it’s because we cannot show outcomes.”

Other big questions pharma companies are mulling: How should digital treatments be priced? How much will insurers pay for them? What’s the business value for drug makers? Can digital therapeutics businesses and their pharma partners make money from these products?

Digital therapeutics startups and pharma companies need each other, argued Melinda Decker, AstraZeneca’s head of “intelligent pharmaceuticals.” But the two sides’ attitudes and strategies don’t always mesh well.

“One of the challenges I find with digital therapeutics companies is their mindset is very much on, ‘How do we sell this as it is?’—rather than how [they] might partner with drug companies,” Decker said. “In dealing with the likes of Apple and Google, everyone is looking for, ‘How do I make Candy Crush and sell it for $5 a download?’ … [Therapeutics are] a completely different model.”

Bozidar Jovicevic, Sanofi’s vice president and global head of digital medicines, said he doesn’t like that pharma companies are sometimes “seen as distributors of digital therapeutics,” rather than more collaborative partners. Van Dam agrees that collaboration is key.

“These technologies have a tremendous opportunity to bring benefits to patients,” Novartis’s van Dam said. “We have a collective, not just opportunity, but collective obligation to get it right. What I don’t like is conversations that start with, ‘Yeah, pharma just doesn’t get it.'”

Pharma might not get it in some cases, he added, but all stakeholders are still trying to understand and advance the sector. The more important problem, van Dam argued, is “How can we work together?”

For his part, Dthera’s Cox said he doesn’t think pharma companies are “slow”—a common critique from startups in any sector seeking partnerships and investments from bigger, more established companies. Rather, “I think they’re rigorous,” Cox said. “It’s not the same thing.”

For patients, one of the key components will be making it easier to manage an expanding catalog of digital health products.

“All the solutions are very siloed,” said Jeff Mathers, senior director of software engineering and emerging technology at Johnson & Johnson Technology. “Nobody wants to download 35 apps” and share their medical information 35 separate times, he said. “That’s just not sustainable.”

In the coming years, Mathers envisions hospitals and clinics making it possible for patients to register for a variety of apps in one online location and more seamlessly use them. Otherwise, “they’ll just go crazy managing all these tools,” he said.