In early March, Koneksa’s Chief Scientific Officer, Elena Izmailova, Ph.D., presented at the pre-conference workshop “Digital Medicine 101” and shared the results of Koneksa work at the “Digital Tools Enabling Clinical Trials, Research, and Real-World Evidence” session at the Cambridge Healthtech Institute’s Molecular Medicine Tri-Conference.
Elena (who is also a co-founder of DiMe, the Digital Medicine Society) and Koneksa’s Market Development Manager, Anna Aronov, report back on their experiences and learnings from attending the conference.
Insights
It’s been interesting to watch the evolution of this conference over nearly two decades, Elena noted, because it reflects the growth and development of the digital biomarker field. The original conference was focused on genetics, but has grown to involve translational medicine and, now, has begun to encompass both digital health and digital medicine – both of which focus, of course, on health data. As Eric Topol noted in the plenary address, data is growing fast, and health data is now more valuable than financial data Wearable sensors and AI are revolutionizing how medicine is practiced – and contributing to the growth of data. He also advocated for the term “accuracy medicine,” instead of “precision medicine,” and the idea of leveraging data-driven approaches, instead of a trial-and-error approach practiced today. Digital biomarkers can fulfill this role. As one speaker noted, digital biomarkers are much more proximal to the outcome than the molecular ones, indicating the potential for a widespread adoption. This also signifies that digital health and digital medicine are becoming equal peers of well established disciplines, like genetics or cardiology.
The conference participants provided very insightful updates on adoption of digital medicine tools, like digital measurements and digital therapeutics, in both healthcare management and human research. The topic of incorporating a patient voice in development and deployment of such tools was repeated multiple times and resonated strongly with the audience, stated Anna.
Challenges
Certainly, the field is not without challenges that need to be addressed responsibly. As we heard in multiple talks, privacy and security remain high on everyone’s radar. Consent, trust, and access to data are important concerns. Moreover, the importance of preventing misleading interpretations and analyses of data was highlighted. There is a lot of room for development of analytical approaches to analyzing continuous data which is not being fully leveraged today but is readily available from multiple biomedical monitoring devices. This issue did not exist for conventional biomarker data collection done with limited data points from predefined times. The new ways of generating, analyzing and interpreting the data collected from digital tools will require standard approaches and practical guidance.
Conclusion
Koneksa team is dedicated to developing and implementing digital biomarkers (dBX) for drug development, making clinical trials more efficient and providing deeper insights using a combination of wearable device and ePRO data. Elena’s talk at the “Digital tools enabling clinical trials, research, and real-world evidence” session highlighted Koneksa’s work on repeated measures using mobile’s parameters and reducing sample sizes in clinical trials which means getting faster answers about an efficacy signal of investigational drugs.
The meeting provided another great opportunity to be a core participant in the evolution of the research ecosystem. Koneksa offered results from clinical studies and examples of innovative data analyses at this meeting. Our team is looking forward to working alongside other leaders to develop and share the best practices supported by scientific evidence.
We are committed to the development of our scientific community. It is remarkable to see the conventional wet lab biomarker space, and the digital-biomarker space, merging together and leveraging insights and knowledge from both fields. People working in the digital medicine field have much to learn from other adjacent disciplines to keep us from re-inventing the wheel.
To learn more about these presentations and our work in general, please contact us.