DIA EUROPE 2021

Disclaimer: speakers are representing the Accumulus project and not individual company views during this session. Spiraling costs in R&D together with the availability of new technology and new forms of evidence are forcing a much-needed disruption in the approach to regulatory submissions and approvals. A radical transformation is needed from a static transactional exchange between sponsors and regulators to a dynamic approach capable of exploiting the full range of data sources and digital tools. This session will demonstrate how Accumulus-Synergy is taking this aspiration from theory to practice via execution of use cases in partnership with regulators. This first-of-its-kind global collaboration between our industry and regulators provides a platform for real time information-sharing and accelerated access of medicines for patients. Accumulus Synergy is working with the FDA’s Oncology Center of Excellence (OCE) and other global health authorities to design, develop, and deploy, a full-scale, cloud-based parallel review solution enabling collaborative review by regulators. We will explore the long-term aspirations and regulatory design considerations and show how tangible progress is being made in the near term via use cases with regulators for parallel review and CMC stability updates.