Digital Therapeutics and Market Research: Bringing a New Paradigm to the FDA

At this year’s IIeX Health in Philadelphia, InCrowd partnered with Pear Therapeutics, a Boston-based startup pioneering the field of “prescription digital therapeutics.” The presentation was a double dose of innovation, with a therapy-focused company leading the FDA in the development of a new category of software-based products with demonstrated clinical efficacy and a real-time market intelligence platform helping to educate and understand the market of diverse healthcare stakeholders in this novel category.

Digital therapeutics—a combination of technology and proven clinical, outcomes-based data, so patients can receive a therapeutic regimen and outcome through a digital device—are the next frontier within the pharma world. At IIeX Health, Alex Waldron, the Chief Commercial Officer at Pear Therapeutics, along with Katie Ka, InCrowd’s Head of Research and Strategy, talked about how real-time market research insights has helped Pear lead the charge.

To date, the FDA has approved Pear’s reSET, a digital therapy for patients with a substance abuse disorder, including marijuana, alcohol, or stimulants, and re-SET O for patients with opioid use disorder.

When Pear was first awaiting FDA approval for reSET in September 2017, it needed to quickly gather market insights from patients and physicians. For patients, the questions were around access to digital devices, data plans, and how they would engage with a digital therapeutic. For physicians, Pear wanted to know how they would incorporate it into their treatment regimen.

“We needed to very quickly go into the market and test our concepts,” Waldron says. What makes the market research insights and intelligence collaboration with InCrowd so powerful is the completely novel therapy paradigm Pear is establishing, and the iterative, evolving nature of this paradigm.

In working with InCrowd, Pear was able to get results in 1-2 weeks, reach any stakeholder in their target universe, and be nimble with iterative waves and versions and responders.

In addition, given that Pear’s products will evolve from a firmware and software perspective that won’t always require FDA approval, and that this rate of evolution will be much faster than that of a typical drug, Waldron says a real-time market research platform is vital to Pear’s success. “We will need to quickly test and see if pieces of metadata from an upgrade or update on efficacy, or safety, or engagement, is critical for us to roll out to everyone,” Waldron says.

Some of the key questions facing Pear as it moves forward is when a modification to the app affects efficacy and outcomes, versus just being a feature upgrade or visual experience change. To help answer these questions, and inform the FDA’s regulatory process, Pear will be working closely with InCrowd to get real-time market insights from patients, payors, and physicians.