Ten pharmaceutical companies have joined forces again to launch Accumulus Synergy Inc., a non-profit effort to pool data in the cloud and interact with regulators, in the hopes of speeding the drug approval process.
Ten pharmaceutical companies have joined forces again to launch Accumulus Synergy Inc., a non-profit effort to pool data in the cloud and interact with regulators, in the hopes of speeding the drug approval process.
The companies – Amgen, Astellas, Bristol Myers Squibb, GSK, Janssen, Lilly, Pfizer, Roche, Sanofi and Takeda – have previously pooled clinical data together in the precompetitive consortium TransCelerate BioPharma Inc. The members have all contributed funding to Accumulus Synergy, but details have not been disclosed.
Accumulus Synergy began in July 2020 and is led by interim CEO and Roche/Genentech vet Francisco Nogueira. Nogueira’s previous roles include vice president at Roche and Global Head of Regulatory Excellence for its subsidiary, Genentech.
The primary goal of the new collaboration is to reduce regulatory review times through improving the speed and transparency of the exchange of drug-related data. According to Nogueira, “Current methods for data exchange and communication between pharmaceutical companies and global health authorities have not kept pace with advancements in information technology.”
Newer cloud-based technology, as well as advanced data science and artificial intelligence, will be employed in an effort to improve regulatory efficiency, which Accumulus says will “reduce the cost of innovation” and deliver drugs to patients faster.
Accumulus Synergy will be accessible to regulators and other governmental bodies worldwide. Plans are in place to collaborate with the Japanese Pharmaceutical and Medical Devices Agency, the European Medicines Agency, the U.K. Medicines and Healthcare products Regulatory Agency, the U.S. Food and Drug Administration (FDA) and others. In a recent trademark application, the company said it is developing “downloadable computer software for aggregating, converting, processing and transferring health, medical and scientific data to a cloud platform.”
The 10 founders are among the 19 members of TransCelerate, another non-profit designed to improve precompetitive data sharing in the pharmaceutical sector. Accumulus Synergy aims to go beyond company sharing and focuses on improving regulatory interactions.
Paul Stoffels, Johnson & Johnson’s CSO, said the approach complements the efficiency solutions created through TransCelerate. In addition, he says, “Accumulus Synergy will proactively engage global health authorities in building a cloud platform to enable efficient filing and review of documents and data.”
Johnson & Johnson’s Janssen unit is an Accumulus member.
TransCelerate launched its data sharing platform, DataCelerate, in 2018.
The non-profit has already begun work with regulators to evaluate use cases, including parallel review, a collaboration between the FDA and the Centers for Medicare & Medicaid on medical devices. They are also evaluating use cases around chemistry, manufacturing, and control (CMC) stability updates.
