Abstract
BioCelerate, a subsidiary of TransCelerate, is a preclinical industry consortium driving initiatives to increase efficiency and productivity in early stage R&D. Motivated in part by the FDA’s Strategic Plan for Regulatory Science and binding guidance requiring CDISC SEND standard format for nonclinical data, the Toxicology Data Sharing (TDS) Initiative was launched to enable participants to make more informed decisions on compound progression based on increased understanding of on-target and off-target toxicity. Via access to a cloud-based data sharing platform, DataCelerate, participants will have the ability to share, search for, visualize, and export de-identified unstructured (PDF format for legacy studies) and structured (SEND-compliant format) data sets stored in curated toxicology and background control data repositories. Long term, the platform will support and link TransCelerate and BioCelerate data sharing initiatives, facilitating valuable insights across the entire drug development continuum. Presented here are the core capabilities, use cases, and system architecture for the data sharing platform as well as the principles guiding data sharing and collaboration amongst BioCelerate participants.
