Ten leading biopharmaceutical companies have formed a new non-profit corporation, Accumulus Synergy, Inc., which aims to support interactions between industry and health authorities worldwide to enable real-time collaboration and data exchange, as well as data submission.
 
Accumulus Synergy aims to develop a cloud-based platform to facilitate data and information sharing to transform the way the biopharma industry interacts with health authorities. The common-platform approach to data sharing aims to make the regulatory process more efficient by leveraging advanced technology and tools for data exchange to help reduce the cost of drug development and ultimately bring medicines to patients faster.
 
The initial members include Amgen, Astellas, Bristol Myers Squibb, GSK, the Janssen Pharmaceutical Companies of Johnson & Johnson, Lilly, Pfizer, Roche, Sanofi, and Takeda, which have provided funding to support the platform and initial applications. Accumulus Synergy plans to consult with the Japanese Pharmaceutical and Medical Devices Agency, the European Medicines Agency, the U.K. Medicines and Healthcare products Regulatory Agency, and the U.S. FDA, as well as other health authorities worldwide.
 
“Current methods for data exchange and communication between pharmaceutical companies and global health authorities have not kept pace with advancements in information technology,” said Francisco Nogueira, interim Chief Executive Officer of Accumulus Synergy and Vice President of Regulatory Affairs at Roche.  “In consultation with health authorities, Accumulus Synergy seeks to modernize, integrate, and streamline communication and data exchange between biopharmaceutical companies and global regulators, as well as to facilitate potential regulatory harmonization in priority areas, using the latest in cloud technology.  By creating a powerful data-sharing ecosystem, we have the potential to advance delivery of healthcare. Accumulus Synergy looks to create significant value for patients, healthcare providers, health authorities, and biopharma companies globally.”