One Platform, One Mission
Current methods of information exchange between life sciences organizations and national regulatory authorities haven’t kept pace with 21st-century medicine. At Accumulus, we’re on a mission to change that.
Information Exchange Ready for an Upgrade
In 2020, there was an industry call to action to bring outdated methods of information exchange into the 21st century. Pharma develops therapies and regulators review them. But what’s been missing is a modern technology platform to facilitate real-time information exchange and efficient collaboration across multiple organizations.
Too Much Time
Outdated methods of regulatory interactions are slowing down the availability of life-saving treatments. On average, it takes 10 years from when a drug is discovered to when it receives its first regulatory market approval. And once approved initially, it can take up to four more years to approve its use in developing countries. When you add it all up, it can take 12 - 15 years to approve a medicine for worldwide availability and use by patients.1,2
Too Much Paper
A new drug application dossier is about 1-3 million pages of information. Given more than 140 regulatory authorities, and only 12 jurisdictions that accept the required content digitally, getting a drug approved is still a very paper-intensive process!
A More Efficient Way
We believe there’s a more efficient and collaborative way to exchange data and information in regulatory submissions. And that’s where the Accumulus comes in.
Founded as a nonprofit technology organization, we have a profound mission: to accelerate critical therapies to citizens of the world. We’re transforming how information flows between industry and regulators. Instead of static document-based processes, think of instant communication, real-time data exchange, dynamic insights, and ultimately a digital dossier in the cloud.
Our goals are to:
- Move away from static documents to standardized, aggregated, and actionable content
- Evolve from event-driven interactions to more dynamic, real-time interactions
- Replace organizational and regional silos with harmonized collaboration and information exchange across geographies
- Accelerate the availability of medicines to patients worldwide through global collaboration and real-time data exchange
…leading to a new era of regulatory connectivity!
“Ultimately, our mission is to dramatically accelerate critical therapies to citizens of the world.”
Francisco Nogueira
Chief Executive Officer, at Accumulus Synergy
Citations
Van Norman GA. Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs. JACC Basic Transl Sci. 2016 Apr 25;1(3):170-179. doi: 10.1016/j.jacbts.2016.03.002. PMID: 30167510; PMCID: PMC6113160..
Phrma Foundation. Research and development continues long after a medicine is initially approved (2022). Available at: https://phrma.org/en/Blog/research-and-development-continues-long-after-a-medicine-is-initially-approved#:~:text=On%20average%2C%20it%20takes%2010,always%20part%20of%20the%20process.
Related Resources
Accumulus Synergy Responds to FDA’s Customer Experience Strategy for Fiscal Years 2024 to 2027
Accumulus Comments to the Food and Drug Administration (FDA) on the development of the Data and Technology Strategic Plan
Accumulus Synergy Responds to FDA’s Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange
Accumulus Synergy Responds Food and Drug Administration’s Information Technology Strategy
Re-Envisioning Pharmaceutical Manufacturing- Increasing Agility for Global Patient Access
