By collecting and analyzing patient data using wearable devices, Chugai will create new health indicators and provide new value to patients.

Digital biomarkers (dBM) are indexes that objectively visualize the presence of a disease and changes caused by treatment using data obtained from digital devices and smartphones. Digital technology is expected to acquire and analyze data that cannot be obtained from conventional biomarkers^*, so we can utilize them for daily medical practice as well as for drug research and development.

Biomarkers^*: Laboratory data such as vital signs, biochemical/blood test results, tumor markers, and diagnostic imaging data such as MRI and CT. They are used for both the diagnosis of diseases and predictions for treatment.

Chugai leverages wearable devices in multiple clinical development projects to collect and analyze objective and continuous patient physiological data. We are working on early proof of concept in our drug development (e.g., digital endpoint, patient selection, and safety management, etc.) by analyzing previously unobtainable, real-time vital data. In addition, through the development of dBM, we aim to understand diseases more deeply and provide new values for the prevention of diseases, very early diagnosis, and improvement of Quality of Life (QOL) after treatment.

Digital biomarkers (dBM) initiatives

• We use wearable devices and the AI platform co-developed with Biofourmis to validate the possibility of assessing pain objectively and continuously.
• The AI platform of Biofourmis includes a dashboard that a physician can access remotely, a wearable device worn by a patient, and an app. It has functions to obtain, collect, and analyze patients’ vital data. Further, it records symptoms, and quantifies pain using collected data, and includes gamification to encourage patients to continue using the device.
• Device: E4^®

News release “Chugai and Biofourmis Enter into New Partnership Focused on Data-Driven Virtual Care for Endometriosis-Related Pain” (March 02, 2023) [PDF 284KB]

News release “Chugai and Biofourmis Partner to Develop an Objective Assessment of Pain Using Digital Technology” (July 22, 2020) [PDF 196KB]

• We evaluated the association between physical activity and hemorrhagic events reported by patients, as well as biological data collected during the activity by a wearable activity meter.
• Device: ActiGraph Insightwatch
• ePRO: Welby’s exclusive app