Accumulus Synergy Pioneers Transformative Cloud-Based Platform to Enhance Global Regulatory Collaboration and Efficiency in Life Sciences
Accumulus Synergy, a nonprofit organization, is pioneering a transformative data exchange platform aimed at enhancing collaboration and efficiency between life sciences organizations and global health authorities. The organization, formed in 2020, is developing a first-of-its-kind cloud-based platform to improve speed, transparency, and efficiencies in the regulatory process by leveraging advanced technology and tools for data exchange.
The platform’s development is sponsored by leading biopharmaceutical companies, including AstraZeneca, Merck, and CSL, among others. AstraZeneca joined Accumulus Synergy as a sponsor in May 2022, with Jacques Mascaro, Ph.D., MBA, Senior Vice President, Head of Oncology Regulatory Science, Strategy, and Excellence, AstraZeneca, being appointed as a Board Member of Accumulus Synergy. Mascaro emphasized that Accumulus Synergy’s mission aligns with AstraZeneca’s goal to accelerate the discovery, development, and delivery of innovative medicines for patients[2].
Merck, known as MSD outside the United States and Canada, joined Accumulus Synergy as a sponsor in September 2022. Darrel Hicks, Vice President, Global Regulatory Affairs Innovation, Quality and Strategic Operations, Merck, was appointed as a Board Member of Accumulus Synergy. Hicks noted that Merck believes the Accumulus Synergy platform is an important industry initiative that creates a way for companies to collaborate with health regulators more efficiently[4].
CSL joined Accumulus Synergy in September 2024, marking significant progress in collectively bringing together industry stakeholders to advance the mission of dramatically accelerating critical therapies to citizens of the world. The Accumulus membership model is designed to help shape regulatory policy and raise awareness of the need for global harmonization of regulatory processes[5].
Accumulus Synergy’s platform aims to enable a dynamic approach that shifts the focus from documents to data, creating significant value for patients, healthcare providers, health authorities, and biopharma companies globally. The platform will implement the highest safeguards and encryptions to ensure that data is appropriately protected in compliance with countries’ privacy laws.
Jeremy Chadwick, Ph.D., MS, Accumulus Synergy Chairman of the Board and Senior Vice President and Head of Global Development Office, R&D, Takeda Pharmaceuticals, highlighted that Accumulus Synergy has made significant progress since its inception. With the addition of new sponsors and continuing partnerships with global regulatory authorities, Accumulus Synergy is well-positioned to create an information superhighway that enables real-time, efficient insight generation and global convergence toward an innovative and modernized submission process.
Frank Nogueira, Accumulus Synergy CEO, emphasized that the organization’s vision and path towards making it a reality have garnered tremendous industry excitement. The data and information exchange paradigm between those who develop medicines and those who review and approve them is at an inflection point, and broad adoption is critical.
Accumulus Synergy’s mission is to break new ground in health equity by dramatically accelerating critical therapies to citizens of the world. The organization continues to hire additional staff to meet its platform development objectives and works closely with health authorities around the world to support their own data modernization efforts. With its growing team and strengthened Board, Accumulus Synergy is poised to transform the global drug regulatory submission process.