Ten biopharmaceutical companies announced the formation of a new non-profit corporation, Accumulus Synergy, Inc., which is intended to support interactions between industry and health authorities worldwide to enable real-time collaboration and data exchange, as well as data submission.

Accumulus Synergy was formed on July 13, 2020, to develop a cloud-based platform to facilitate data and information sharing with the potential to transform the way the biopharmaceutical 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 benefit patients, help reduce the cost of innovation and ultimately bring patients new safe and effective medicines faster.

“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.”

The initial members of Accumulus Synergy include Amgen, Astellas, Bristol Myers Squibb, GSK, the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), 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. Food and Drug Administration, as well as other health authorities worldwide.

“I am very excited to see Accumulus progress after over a year of careful planning,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer. “This project reflects the importance of collaboration among stakeholders to improve pharmaceutical development, with the potential to enable faster and more efficient exchange of information and data with health authorities.”

“Collaborations focused on science and advanced technologies make us more efficient and ultimately accelerate our ability to improve outcomes for patients – an approach Sanofi has fully embraced,” said John Reed, Executive Vice President, Global Head of Research & Development at Sanofi. “Accumulus’ coordinated efforts to lead data-sharing solutions will reduce the time it takes to make innovative new medicines available to patients, and that’s a goal worthy of support.”

“The Accumulus Synergy vision is transformative. Accumulus Synergy will proactively engage global health authorities in building a cloud platform to enable efficient filing and review of documents and data. Importantly, Accumulus will build upon and complement the collaborative efficiency solutions developed by TransCelerate BioPharma, Inc. This will result in an acceleration of medicine access across geographies and reduce drug lag,” added Paul Stoffels, Chief Scientific Officer, Johnson & Johnson.

“We are pleased to see Accumulus advance its strategic objective to transform communication and data exchange between biopharma companies and health authorities, an effort complementary to the objectives of TransCelerate Biopharma. We look forward to our continued collaboration with Accumulus in areas of common interest,” said Dalvir Gill, Chief Executive Officer, TransCelerate Biopharma.

“Health authorities, physicians, and biopharmaceutical companies all share a common purpose to bring safe, transformative medicines to patients as quickly as possible,” added Andy Plump, M.D., Ph.D., President of Research & Development at Takeda. “Accumulus Synergy is an opportunity to reimagine regulatory and data-sharing pathways globally and better deliver on that purpose.”