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Leveraging Digital Biomarkers to Transform CNS Clinical Research

At the recent Digital Biomarkers and Clinical Measures in Neurology meeting, Koneksa was honored to speak on the importance of digital biomarkers to research into central nervous system (CNS) conditions, among a variety of excellent presentations.

Chief Medical Officer Dr. John Wagner noted, “One of the panel discussions I found particularly interesting was a spirited patient panel expressing patient perspectives on digital biomarkers in practice. The panel was chaired by Amir Lahav, Head of Digital R&D, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma Holdings America. The patient panelists were a highly engaged group of patients with a variety of neurologic conditions. The discussion covered the issues that were most important to patients, including the question of what motivates or discourages patients from using wearable devices and mobile apps in clinical trials. One of the panel’s conclusions was the importance of sharing digital data from trials with the enrolled patients, both during the study, as well as after the conclusion of the trial.”

Dr. Wagner presented, with Digital Biomarker Director Andrew Pearlmutter, on “Leveraging Digital Biomarkers to Transform CNS Clinical Research,” in which they highlighted the potential digital biomarkers have to:

      • Accelerate clinical research timelines with patient-centric at-home measures
      • Optimize R&D decision-making with more sensitive and objective measures that improve how study & program resources are allocation
      • Deliver new clinical insights that improve how we understand CNS diseases and investigative therapeutic efficacy alike

Andrew explains what Koneksa’s doing in this field: “The U.S. Food and Drug Administration’s 2021 draft guidance has clarified industry best practices for developing and deploying new fit-for-purpose digital health technologies (DHTs). Koneksa has developed, and is comprehensively validating, a range of CNS digital biomarkers in line with this guidance — including a Parkinson’s disease digital measurement solution that includes app-based task assessments, digital actigraphy measures, and electronic patient-reported outcomes for activities of daily living (ADL ePROs).”

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