IGF::OT::IGF SBIR Topic 379: DigiBioMarC: Digital BioMarkers for Clinical Impact- Moonshot Project(Fast Track)

Medable, Inc., Palo Alto CA

Investigators

Abstract

The overall objective of this Fast-Track SBIR contract project is to develop DigiBioMarCTM (Digital BioMarkers for Clinical Impact), a scalable and flexible cloud-based platform to capture and analyze wearable, implantable, or external device data. This platform also provides an informatics tool for automated data aggregation, integration, and machine learning algorithms. It is based on the scalable user-centered Medable platform, which implements standardization and normalization of patient-generated data to drive health insights. DigiBioMarCTM will compare and combine disparate data streams to understand contextualized patient physiology in real time in order to identify disease and/or detect changes in disease/health status. It also will support cohort and clinical studies, particularly those testing digital biomarkers from wearable sensor technologies. This Fast-Track project will focus on product development with an ultimate aim of a product that improves cancer research data and clinical trials, enhances clinical care, and that can be used to engage patients in preventive health behaviors and treatment adherence. The Phase I goal is to develop a data-agnostic DigiBioMarCTM prototype for validation in Phase II. The Phase 1 Go/No-Go decision point to proceed to Phase II will be a working prototype with specified features for further development and validation in Phase II.