VivoSense Joins the FNIH Biomarkers Consortium

VivoSense announces that we have joined the Foundation for the National Institutes of Health’s (FNIH) Biomarkers Consortium! This new partnership strengthens our joint mission to facilitate the development of novel digital biomarkers using new and existing technologies, including evidence for their qualification in diagnostic medicine, therapeutic development, and clinical practice improvement.

VivoSense Chief Science Officer Kate Lyden, PhD, will join the FNIH Biomarkers Consortium Cancer Steering Committee, and Director of Science Ieuan Clay, PhD, will become a member of the FNIH Biomarkers Consortium Neuroscience Steering Committee.

Digital measures, including endpoints from wearable sensors, offer the incalculable potential to inform and improve all aspects of healthcare, from developing new drugs and therapies to understanding disease progression and diagnosing conditions. As digital health technology continues to evolve, our partnership with Biomarkers Consortium provides an invaluable platform to drive innovation by increasing the impact, credibility, and consensus around our work and that of others.

Ieuan Clay, VivoSense Director of Science, commented,

“The FNIH Biomarkers Consortium has been a leader in recognizing the importance of multistakeholder engagement and patient-centricity to identify, develop and qualify digital measures to improve drug development and regulatory decision-making. Their approach aligns perfectly with the VivoSense approach – building strong foundations through co-creating measures that matter to patients, early regulator engagement, and excellent science to address evidentiary requirements. We look forward to learning from and contributing our thinking to the Biomarkers Consortium community.”

Steve Hoffmann, the FNIH Director of the Biomarkers Consortium, added,

“VivoSense brings a depth of expertise and insights for digital biomarkers that will help broaden the Biomarkers Consortium membership and augment our efforts to accelerate the advancement of innovative and meaningful measurements vital to the development of new treatments, informing regulatory decision making, and improving patient care. The FNIH is grateful to have VivoSense’s partnership and engagement.”

About VivoSense

VivoSense, Inc. develops and validates real-world digital clinical measures and provides end-to-end services and solutions for their delivery in clinical trials. Our hypothesis-driven framework provides analytical and clinical validation leading to FDA approval. VivoSense delivers novel digital biomarkers from wearable sensor data, constituting primary and secondary clinical endpoints in regulated international pharmaceutical trials. VivoSense is dedicated to improving patient clinical research and care.

About the Foundation for the National Institutes of Health

The Foundation for the National Institutes of Health (FNIH) connects the world’s leading public and private organizations to accelerate biomedical breakthroughs for patients, regardless of who they are, where they live or what disease they have. Together with leading scientists and problem-solvers, and a successful track record of navigating complex problems, the FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and trains the next generation of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.

The Biomarkers Consortium brings together various partners to identify, develop and qualify potential biomarkers to improve drug development and regulatory decision-making. More information on the Biomarkers Consortium and how to join can be found here: https://fnih.org/our-programs/biomarkers-consortium/join.