The Keystone Conferences are globally recognized scientific forums with almost 50 years of history. Keystone was founded in 1972 in Los Angeles as the ICN-UCLA Symposium on Molecular Biology and relocated to Silverthorne, Colorado in 1990. It became an independent nonprofit called Keystone Symposia on Molecular and Cellular Biology. Over the years, the conference diversified into various scientific topics and geographies.
Koneksa Health’s CEO, Chris Benko, presented at the Keystone Symposia called “Digital Health: From Science to Application,” their first conference dedicated to digital health and mobile technologies, held Jan. 21-25, 2019.
The conference was led by key figures in the field, including Geoffrey S. Ginsburg, Sue Siegel and Eric Perakslis, and included sessions that covered not only digital-technology innovation itself, but also stakeholders’ opinions (academia, industry, and regulatory) on how those technologies can affect the healthcare industry and patients’ lives.
Chris presented data from multiple industry collaborations, including Takeda, Merck, Regeneron, and Sanofi, which focused on validating digital technologies for use in industry-sponsored drug development programs (For details about the collaborations, see below.)
The presentation audience commented on the high scientific value of the experiments presented, and the need to generate similarly rigorous scientific evidence in contrast to the hype that often mars the field.
Andrea Coravos, one of the speakers, who is CEO of Elektra Labs and a member of Harvard-MIT Center for Regulatory Science, said: “Chris's presentation showed real-life examples of wearable technology validation studies based on solid science. My favorite moment of the talk was when Dr. Rob Califf, the former commissioner of the FDA, came up to the microphone during Q&A and highlighted how critical (and surprisingly rare) it was see someone building out the clinical and analytic rigor around these technologies. Lots of people nodded their heads in the audience. As a community, we will need more examples like the ones in his presentation to drive technology innovation based on scientific evidence, not hype.”
There was a good discussion about the future at Keystone that included the need for regulatory-agency participation, as well as the need to strike the right balance between industry and academic presentations. Many parallels were drawn between digital health today, and genomics two decades ago. Participants also highlighted the need for the digital-health community to promote professional development and information exchange beyond conferences.
About the collaborations
The collaboration with Takeda and Merck assessed the utility of several devices, including wearable single-lead ECGs, relative to traditional clinical measures of heart rate and respiratory rate, demonstrating the sensitivity of these tools to observe changes not traditionally captured in a Phase I setting. Some of these results were recently published in Clinical and Translational Sciences, and other manuscripts are being prepared for publication.
The next collaboration, with Regeneron and Manchester University, (and presented at ATS 2018) demonstrated the potential to dramatically improve signal detection in respiratory studies. In an observational study, investigators demonstrated that spirometry data collected electronically by patients twice daily, instead of a traditional in-clinic assessment schedule, could reduce measurement error by more than half. This would enable efficacy analysis several years ahead of a traditional study design for respiratory diseases such as asthma, COPD, etc.
Finally, Koneksa shared data on the development of novel measures to improve signal detection in CNS disorders. Koneksa shared the methodology of validating these tools beyond coefficients of correlation and determination through assessing limits of agreement and reductions in within subject standard deviation (relative to traditional measures like the MDS-UPDRS) to develop more powerful efficacy measures capable of supporting smaller clinical trials.
Koneksa uses a generalized approach to validating digitally enabled endpoints relative to legacy standards. This includes assessing compliance, validity, reliability, and in some cases responsiveness (e.g., the ability to detect a known treatment effect with an existing drug).
To see the press release issued by Koneksa, go to https://www.prnewswire.com/news-releases/koneksa-ceo-joined-faculty-at-keystone-symposium-on-digital-health-300785505.html