Trusted Research Environments for Biopharma Innovation

This document is a technical report that outlines the role of Trusted Research Environments (TREs) in facilitating external innovation within the biopharmaceutical sector. It describes how TREs enable biopharma companies to securely manage sensitive data while maintaining compliance with industry regulations. The report details the challenges faced by biopharma in external collaborations, including data security risks, complex regulatory compliance, and fragmented collaboration tools. It presents the TREs as a solution that provides secure, cloud-based platforms designed for sensitive biopharma data, ensuring safe and compliant collaboration. The report explains the 'Five Safes' framework utilized by DNAnexus TREs, which includes safe people, projects, settings, data, and outputs. Additionally, it highlights key capabilities such as secure multi-stakeholder collaboration, built-in regulatory compliance, advanced data integration, and embedded analysis tools. The document also provides a case example demonstrating the effectiveness of TREs in accelerating drug discovery and improving productivity in pharmaceutical pipelines.