Welcome to Accumulus Synergy

We are developing a global information exchange platform to transform how drug innovators and health regulators interact to bring safe and effective medicines to patients faster and more efficiently.

Our main goal is to accelerate the availability of safe and effective medicines for patients.

Sponsored by leading biopharmaceutical companies, Accumulus Synergy was formed in 2020 to create innovative solutions that can reduce regulatory review times and transform global data exchange. The non-profit company is creating a first-of-its-kind cloud-based platform intended to support interactions between the biopharmaceutical industry and health authorities worldwide. The single-platform approach aims to improve speed, transparencies and efficiencies in the regulatory process by leveraging advanced technology and tools for data exchange. This will help reduce the cost of innovation and ultimately bring patients safe and effective medicines faster.

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.

We’ve assembled a team of global collaborators to help drive the Accumulus Synergy vision.

Amgen logo
Astellas Pharma
bms logo
gsk logo
Johnson and Johnson
Lilly
Pfizer
Roche
Sanofi logo
Takeda

We’d love to hear from you.