Medicines and Healthcare products Regulatory Agency, and the U.S. Accumulus Synergy plans to consult with the Japanese Pharmaceutical and Medical Devices Agency, the European Medicines Agency, the U.K. 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 looks to create significant value for patients, healthcare providers, health authorities, and biopharma companies globally.” By creating a powerful data-sharing ecosystem, we have the potential to advance delivery of healthcare. “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. “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. 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. 22, 2021 (GLOBE NEWSWIRE) - Ten of the world’s leading biopharmaceutical companies today 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.Īccumulus 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 companies will support the rollout of a cloud-based platform with the potential to transform the way the biopharma industry communicates and exchanges information with health authorities worldwide.īURLINGAME, Calif., Jan. Funded by Amgen, Astellas, Bristol Myers Squibb, GSK, Janssen, Lilly, Pfizer, Roche, Sanofi and Takeda
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