Abbvie, Merck, Roche, Genentech, Regeneron, Sanofi and other big names in biopharma have signed on to a new project from the Digital Medicine Society’s (DiMe) Digital Health Measurement Collaborative Community (DATAcc) that aims to set industry benchmarks for digital technologies.
The Building the Business Case for Digital Endpoints project was announced June 6. Neuroscience trial tech firm Cumulus Neuroscience said June 11 that it had also signed on as a partner, bringing the total participant tally to 38. Besides private companies, the FDA and a handful of institutions and nonprofits are also on the list.
For Cumulus, joining the project comes back to its experience with CNS trials. Endpoints “are tied to traditional pen and paper assessments, which lack any objective physiological data, impacting researchers’ ability to efficiently establish drug effect, drug target engagement and inform patient stratification,” Aman Bhatti, M.D., Cumulus CEO, said in the company’s press release. He added that the company often engages with industry professionals who “champion” digital endpoints at their firms but struggle to get the support and budget they need to implement them.
The project will ultimately give those individuals resources they need to make their case. Collaborators will first work on coming up with a value framework for digital endpoints then will create a business case model and forecasting calculators, DiME spokesperson Victoria Bangieva, Ph.D., program director at DiMe, confirmed to Fierce Biotech via email. The work will continue through early 2025.
The effort comes on the heels of the FDA’s decision to allow historical atrial fibrillation data from Apple Watch to be used as an endpoint in clinical studies. The ruling made the watch’s tech the first digital health product to be qualified in the agency’s Medical Device Development Tools program, a conduit toward expanding the technologies that can be used in research without extra review.