What’s the sweet spot for digital health collaborations with pharma clinical studies?

This week’s news that Takeda Pharmaceuticals inked a deal with Koneksa Health, a digital health startup that uses wearables and connected devices to gather patient data, reinforces the point that pharma companies have found a place for digital health tools in drug development. Koneksa Health CEO Chris Benko said he views the natural place for the use of these technologies in clinical studies either in early phases or as an exploratory addition in later phases in a phone interview with MedCity News.

Koneksa only works with Class I medical devices from companies such as Preventice SolutionsCohero Health, and Philips Respironics, Benko noted, and there’s a reason for that.

“We see an enormous challenge with consumer-grade devices because they can create a lot of noise in clinical studies,” he said.

Although there’s an obvious benefit to assessing patients’ health in the context of their daily lives, as opposed to a clinic, there’s still a lot of experimentation to address the hurdles that come from trying to strike a balance between applying digital health tools and verifying the data they produce.

One example is spirometers. People with asthma and other respiratory conditions are familiar with the ritual of going to a doctor’s office and taking the test to measure lung function. But the clinical setting, the time of day the patient takes the test all play a part in the test results. The ability of a mobile device to help patients do these tests in the context of their daily lives may be ideal, but Benko observed that interruptions and variations in routines can make the process of collecting and verifying this data confusing and complicated.

Part of what Koneksa’s platform does is to use text reminders to capture what patients are saying, doing or feeling. “We want to look at the relationship between what the patient tells us and what we observe through the technology,” Benko said.

He noted that one factor that sets it apart from other companiesis that it will work carefully to select and evaluate technology it thinks are appropriate and build significant partnerships with device companies it works with. Just because a pharma company identifies a specific device it wants to use, doesn’t mean Koneksa will agree to it. Benko said that stance has led it to walk away from potential deals.

Takeda marks the sixth pharma partner for Koneksa, Benko said. Although he declined to list all of them Benko noted that Merck is another partner. Merck Global Health Innovation Fund was a seed investor in the three-year-old company.

Takeda will integrate biosensor and wearable technology in several of its early stage clinical studies in the U.S. and U.K., according to an emailed statement from Julia Ellwanger, Takeda Pharmaceuticals Head of R&D Communications.

“Subjects enrolled in these clinical trials use wearable technologies to collect antigraphy, vital sign and cardiac rhythm data,” the statement noted.

The goal of Takeda’s collaboration with Koneksa Health is to make clinical trials more patient-centric.

Among some of the other, more established players looking to expand the use of digital health tech in support of clinical studies are Medidata and ERT. On a smaller scale, Evidation Health and Litmus Health are also active in this area.

Last month, Litmus Health launched a public beta for a product that aggregates data from wearables such as Fitbits and smartphones and connected devices to support Phase 1 and Phase 2 clinical trials.

Original article at: http://medcitynews.com/2016/11/early-stage-clinical-trials-become-sweet-spot-digital-health-startups/