Koneksa was privileged recently to present at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) alongside colleagues from the U.S. Food & Drug Administration (FDA) and the private-public partnership Critical Path Institute (C-Path).  

ASCPT is an organization for those who study the science of medicines and their use. The presenters were (in the order of session presentations): Dr. Elena Izmailova, the CSO of Koneksa Health; Dr. Anindita Saha, the Assistant Director of the FDA’s new Digital Health Center of Excellence (COE); and Dr. Diane Stephenson, the Executive Director of the Critical Path for Parkinson’s Consortium at C-Path. 

Our session, “Digital Technologies: Innovations That Transform the Face of Drug Development,” was introduced by Dr. Hazem Hassan of Regeneron, who provided attendees with an overview of digital technologies, and co-chaired by Dr. Bilal AbuAsal of the FDA, who moderated the Q&A.

Elena’s presentation discussed validating a digital health technology (DHT). DHTs don’t fit squarely into the realm of either biomarkers or electronic clinical outcome assessments (eCOA)—they have features of both. And so, the scope of validation experiments for DHTs includes features of both biomarkers and eCOA, which constitutes a substantial amount of work. The most efficient way to handle this reality is to spread the risk: to work pre-competitively and collaboratively by sharing the experiments and the data so everyone can learn.

 Dr. Saha spoke about the FDA’s support of the field and support of the companies doing work in it. This is evidenced both by the creation of the COE, as well as the recent guidance they have issued on remote digital data acquisition in clinical trials. (To learn more about that guidance, see our recent post.) She discussed the considerations that the agency has when reviewing endpoints that involve the applications of DHTs.

 Dr. Stephenson spoke about how badly consensus-building and data-sharing is needed—and how badly it’s needed to be done more—to improve the use of DHTs in drug development.

The session was well attended, which indicates a growing interest in DHT among the ASCPT community. During the Q&A session moderated by Dr. AbuAsal, there were more questions than time; moreover, the questions were very insightful and reflected current thinking among scientists who are embracing the idea of going digital for clinical trials.

The effort of developing digital measures is complex and difficult, though potentially very rewarding. Silos slow innovation, and so, the speakers urged the audience to help us succeed in moving the field ahead. We have enthusiastic regulatory support, and we have colleagues across pharma, technology, and healthcare doing great work alongside us.

The ASCPT community can do a great deal to help our field progress because of their expertise in bioanalysis, modeling, simulations, and setting up clinical trials for success. While digital biomarkers are different from conventional biomarkers like imaging or lab biomarker assays, the knowledge and skills needed to create and apply them are applicable, and that expertise can greatly enrich the digital field. It’s encouraging to see this pharmaceutical development-focused organization—and its members!—become increasingly interested in DHTs and the ways they can improve drug development.

Get in touch with Koneksa to learn more about our work with digital health technologies.