Digital therapeutics (DTx) are becoming a valuable component of pharma’s development and commercialization strategies. When done right, they can help improve drug efficacy and provide valuable support for people with complex, chronic conditions.
Biofourmis, a data analytics company, brought together digital health experts from Roche, Capgemini, and its own subject matter expert to discuss how pharma can maximize the value of DTx. Here’s a brief run-down of what they discussed.
Why Develop Digital Therapeutics?
Digital Therapeutics Alliance defines DTx as evidence-based therapeutic interventions driven by high-quality software designed to treat, manage, or prevent a disease or disorder. Used independently or as an adjust therapy, they provide a safe way to support, improve, or replace current standards of care.
As the FDA and other regulatory bodies announce their support of digital health and approve more DTx, a growing number of pharma companies are partnering with technology companies to get a jump on the DTx space. Why gamble? Geoff McCleary, vice president, global connected health practice leader for Capgemini discussed the following:
Benefits for Pharma
- Provide additional information on patient activity during “at home” clinical trial activities
- Provide additional data on medication adherence and patient progress
- Provide an opportunity to intervene earlier
Benefits for Patients and Providers
- Increases patients’ confidence in ability to take medication as prescribed
- Potential to improve patient experience
- Opportunity to integrate DTx into patient-provider workflow, giving doctors additional information to work from
For all their benefits, many DTx challenges remain. Device platforms may not integrate with existing data capture and/or data management systems used in clinical trials or with electronic health records (EHR) systems. Patients have expressed concerns about data privacy and security. Reimbursement remains a big question mark.
That said, the DTx market is growing, especially in rare disease, gastroenterology, respiratory, and mental health. And established pharma/biopharma companies have the R&D and commercialization engines to support widespread adoption, if and when it happens.
The webinar speakers, which included Paul Upham, head of smart devices for Roche/Genentech; and Jaydev Thakkar, chief operating officer for Biofourmis, offered the following suggestions:
- Apply behavior design to DTx to improve their usefulness.
- Consider the platform upon which you build and provision DTx.
- Bring in cross functional team early in the process to discuss DTx strategy.
- When designing clinical trials, get clear on objectives (outcomes/endpoints) and use cases. What problem are you trying to solve?
- Compile clinical evidence for efficacy and safety data as well as comparative effectiveness (if possible) and cost-effectiveness data?
- Consider the partners you’ll need and establish criteria for partner selection.
- Get clear about intended use and any claims you want to make about the product. Collaborate with regulatory affairs to establish a regulatory strategy and pathway.
- Engage with the FDA and any other regulatory bodies early and often. Their preliminary feedback will help steer you on the right path and avoid potential roadblocks later.
Watch the webinar to hear more about how to choose the right DTx strategy.