Spiraling costs in R&D together with the availability of technology are forcing a much-needed disruption in the approach to regulatory submissions and approvals. Additionally, current methods for data exchange and communication between pharmaceutical companies and global health authorities have also not kept pace with advancements of information technology. 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 technology tools. This global collaboration provides a platform which will improve stakeholder interactions, accelerate medicines to patients and exchange real time data globally.
Led by Francisco Nogueira, the Accumulus interim CEO, and a team of highly experienced pharmaceutical executives, the company in consultation with health authorities worldwide is designing, developing, and deploying, full-scale, cloud-based solutions that could enable collaborative review by regulators. The Accumulus team is currently evaluating use cases with regulators for parallel review and CMC (chemistry, manufacturing and control) stability updates, focused on identifying critical components that may improve the time of new drug applications and approvals.
