New Research Presented at the FNIH Biomarkers Consortium

The Foundation for the National Institutes of Health (FNIH) is an organization that creates and leads alliances and public-private partnerships to support biomedical research, fighting disease in the United States and throughout the world. The FNIH coordinates and administers research programs, assists with the education and training of new research, organizes educational events, and manages funds to benefit a wide range of health challenges.

The FNIH hosted a public workshop event at the 2020 Biomarkers Consortium titled, “Remote Digital Monitoring for Medical Product Development.” From Feb. 18- 19 2020, the workshop featured a wide range of experts speaking on remote digital monitoring, technology, and drug development, including Koneksa’s Chief Scientific Officer, Elena Izmailova. Workshop participants collaborated to establish a framework to help guide the process of creating remote monitoring measures. They also prioritized a list of high-impact endpoints or measures that can be recorded using mobile sensing and devices.

Koneksa presented new research in the form of a case study, “Cardiac Monitoring in Phase 1 Clinical Trials,” which discussed drug development in two early-stage clinical trials and the value of utilizing digital measures for data collection in normal healthy volunteers. Along with the framework development, other accomplishments of the workshop included an article, “Remote Digital Monitoring in Clinical Trials in the Time of COVID-19,” and two case study analyses, “Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis” and “Remote Digital Monitoring for Medical Product Development.”

The first case study analysis, “Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis,” concluded that the clearance of a biomarker test by the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER) does not indicate qualification or fit-for-purpose use of the biomarker for drug development. The results of the use cases discussed in the analysis demonstrated the importance of the context of use and the need to design experiments in accordance with the context of use rather than extrapolate from the information used for device 510(k) clearance.

Koneksa has also presented at other recent medical conferences, including the ISCTM Annual Scientific Meeting and the MDS Congress. The ISCTM Annual Scientific Meeting featured experts from a wide range of scientific and medical focus areas. At the last Annual Scientific Meeting, Koneksa presented new research on digital clinical measures in Parkinson’s disease (PD) in the form of a poster, “Feature Development of Digital Measures for the Finger Tapping Task,” which described a method that researchers used to determine scoring features for a digital endpoint. The study examines the utility of digital hand dexterity tests in measuring symptom severity and offers insights valuable in developing and validating algorithms for digital measures.

The International Parkinson and Movement Disorder Society (MDS) annual conference features medical professionals from around the world who are dedicated to researching Parkinson’s disease and other movement disorders. At the MDS 2020 Virtual Congress, Koneksa presented “Comparison of Accelerometers Used for Measurement of Upper Body Postural Tremor, and Gait and Balance,” which included sensor verification and analysis of phone-based and wrist-worn accelerometer devices.

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To learn more about Koneksa’s latest research and discover end-to-end, patient-centric digital biomarker solutions for remotely collected clinical data that support agile decision-making, contact our team.