KEYNOTE: Transforming Global Drug Submissions—The First Non-Profit Cloud-Based Data Exchange Platform

Multiple worlds have moved online in the past three decades, from entertainment to commerce and the arts. The world of information and data exchange between biopharmaceuticals and regulators has lagged behind in some respects. Filing a New Drug Application may have shifted from driving a truckload of paper to the relevant regulatory authority, to FedEx-ing a CD-ROM, to uploading a set of PDFs through the Electronic Submissions Gateway, but the documents themselves, and the underlying processes, remain little changed. It’s long past time to play catchup — it’s time for a moon shot.

At Accumulus Synergy, our vision is to accelerate the delivery of critical therapies to the citizens of the world in a safe and effective way. We use the word “citizens” intentionally, to include patients, caregivers, providers, and family members. At some point in our lives, we all benefit from medicines and vaccines.

For the first time, we are creating a single data exchange platform between life sciences companies and regulators around the world, changing from the traditional dispatch of static information and documents to an invitation to access a cloud environment to view up-to-date data as it emerges. We are uniquely positioned to leverage technology to reimagine the interface between sponsors and health authorities to accelerate the translation of data to insights for the benefits of patients globally.