Amgen – Ten Main BioPharma Corporations Announce Formation of Accumulus Synergy to Develop World Information Sharing Platform
Ten Main BioPharma Corporations Announce Formation of Accumulus Synergy to Develop World Information Sharing Platform
Funded by Amgen, Astellas, Bristol Myers Squibb, GSK, Janssen, Lilly, Pfizer, Roche, Sanofi and Takeda
The businesses will assist the rollout of a cloud-based platform with the potential to rework the way in which the biopharma trade communicates and exchanges info with well being authorities worldwide.
BURLINGAME, Calif., Jan. 22, 2021 (GLOBE NEWSWIRE) — Ten of the world’s main biopharmaceutical firms at present introduced the formation of a brand new non-profit company, Accumulus Synergy, Inc., which is meant to assist interactions between trade and well being authorities worldwide to allow real-time collaboration and information exchange, in addition to information submission.
Accumulus Synergy was fashioned on July 13, 2020, to develop a cloud-based platform to facilitate information and knowledge sharing with the potential to rework the way in which the biopharmaceutical trade interacts with well being authorities. The common-platform strategy to information sharing goals to make the regulatory course of extra environment friendly by leveraging superior expertise and instruments for information exchange to learn sufferers, assist cut back the price of innovation and in the end deliver sufferers new protected and efficient medicines quicker.
“Current methods for data exchange and communication between pharmaceutical companies and global health authorities have not kept pace with advancements in information technology,” stated Francisco Nogueira, interim Chief Government 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 preliminary members of Accumulus Synergy embody Amgen, Astellas, Bristol Myers Squibb, GSK, the Janssen Pharmaceutical Corporations of Johnson & Johnson (Janssen), Lilly, Pfizer, Roche, Sanofi, and Takeda, which have offered funding to assist the platform and preliminary functions. Accumulus Synergy plans to seek the advice of with the Japanese Pharmaceutical and Medical Units Company, the European Medicines Company, the UK. Medicines and Healthcare merchandise Regulatory Company, and the U.S. Meals and Drug Administration, in addition to different well being authorities worldwide.
“I am very excited to see Accumulus progress after over a year of careful planning,” stated Mikael Dolsten, Chief Scientific Officer and President, Worldwide Analysis, Improvement 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,” stated John Reed, Government Vice President, World Head of Analysis & Improvement 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,” stated Dalvir Gill, Chief Government 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 Analysis & Improvement at Takeda. “Accumulus Synergy is an opportunity to reimagine regulatory and data-sharing pathways globally and better deliver on that purpose.”
About Accumulus Synergy
Funded by ten main biopharma firms, the non-profit Accumulus Synergy, Inc. was fashioned in 2020 to create a cloud-based platform, to rework information sharing between the biopharma trade and international well being authorities. The common-platform strategy goals to enhance efficiencies within the regulatory course of by leveraging superior expertise, together with information science and AI, in addition to instruments for information exchange to enhance affected person security, assist cut back the price of innovation, and in the end deliver sufferers protected and efficient medicines quicker. It would work with associate firms, key stakeholders, and international well being authorities to construct and maintain a platform that meets regulatory, cybersecurity, and privateness necessities spanning scientific, security, chemistry and manufacturing, and regulatory exchanges and submissions. For extra info, please go to www.accumulus.org.