“Standing on the shoulders of giants,” as Newton put it, is the foundation of science. That’s especially true in biomarker science, as we take decades of experience with laboratory biomarkers to drive the newer field of digital biomarkers.  

“Biomarker” sounds like a trendy new term, but it was first used in 1980, as an abbreviation of “biological marker,” which itself has been used since the 1940s.

Koneksa CMO, John Wagner, and Koneksa CSO, Elena Izmailova, presented the key findings of new research(1) into how we can apply laboratory-biomarker learnings to digital biomarkers at a recent webinar hosted by the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Biomarker and Translation Tools community, together with Dr. Benjamin Vandendriessche, and Mai Mehanna. Wagner, Izmailova, and Vanderdriessche are co-authors of the paper.

In the paper, the group analyzed the factors that contributed to the success of laboratory biomarker methods (which, these days, are included in almost every clinical study protocol) and provided recommendations that could accelerate the development, validation, and adoption of digital biomarkers.

Laboratory biomarkers gained acceptance when scientists started developing definitions and terminology for these tools(2), followed by frameworks that guided their experimental design and validation(3). Similar events have taken place for digital biomarkers relatively recently, starting with the CTTI recommendations for Digital Health Technologies (DHT), and V3 framework by the Digital Medicine Society (DiMe)(4), followed by 2021 draft guidance from the FDA on DHT use in clinical investigations(5).

In the webinar: 

  • John highlighted the unparalleled success of laboratory biomarkers, which are an indispensable part of clinical trials, because they made drug development more efficient and robust. 
  • Elena provided use-case examples of the importance of biomarker validation, and the importance of understanding the technology’s performance, using lessons learned during the pandemic. 
  • Benjamin shared the recommendations of the published paper, which included further developing validation frameworks, defining the criteria for validation, evaluating the user interface, and the necessity of publication for knowledge-sharing.

At Koneksa, we have a diverse group of scientists, some of whom have worked in the biomarker field for decades, working hard to contribute to the transformation of clinical trials. Our work is aimed at addressing the shortcomings of current clinical-trial outcome assessments, which often represent snapshots in time, are prone to high variability, depend on patient motivation at the exact time of assessment, do not reflect what is happening to patients in their natural environment, burden patients and clinic staff, and limit participation in trials. 

Designing and developing digital biomarkers offers an opportunity to address these challenges.

The ASCPT webinar demonstrated increased interest in digital biomarkers from different scientific communities. We are actively participating in the precompetitive work fostered by professional societies and public-private partnerships. 


Additional Reading:

1. Godfrey A, Vandendriessche B, Bakker JP, et al. Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience. Clinical and Translational Science. 2021;14(1):62-74.

2. BEST (Biomarkers, EndpointS, and other Tools) Resource. https://www.ncbi.nlm.nih.gov/books/NBK338448/. Accessed March 30, 2022.

3. Biomarker Qualification: Evidentiary Framework. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biomarker-qualification-evidentiary-framework. Accessed April 27, 2022.

4. Goldsack JC, Coravos A, Bakker JP, et al. Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs). NPJ Digit Med. 2020;3:55.

5. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. Draft Guidance for Industry, Investigators, and Other Stakeholders. Accessed March 30, 2022.