ATMPS and Assurea team up to ensure audit readiness for cell and gene therapy innovators – BioPharma-Reporter.com

ATMPS Hataali is a secure data sharing platform, specially designed as a scalable system for advanced therapies. The developer describes it as a vein to vein, blockchain based, cell orchestration platform, providing full chain of custody, identity, and condition information.

It allows multiple stakeholders - hospitals, manufacturers, couriers - to communicate and coordinate their activities in real time, thereby increasing efficiency, ensuring patient safety and regulatory compliance, Raja Sharif, CEO of ATMPS, told us in May last year.

Assurea, which specializes in navigating the complex regulatory pathway for advanced therapies, has already begun working with ATMPS on a number of collaborative projects, including one for a UK based phase I biotech focused on CAR-T.

The partners want to target pre-clinical companies heading into the IND stage, as well as well providing data rescue systems for therapies already undergoing trials. The latter issue, they said, is a growing area of concern as many biotech companies realize that, as key regulatory touchpoints approach, they dont have a robust enough platform to stand up to intense regulatory scrutiny.

This collaboration enables biotechs and innovators to have regulatory-ready, decentralized data records that have integrity built-in by design.

"Its a completely different way of tackling compliance and provides investors with increased confidence in the results gained and initial valuations.

"Looking further ahead, it also means they can have confidence that trials are progressing as they should, with data available in near real-time and, crucially, have the ability to scale quickly, said Sharif.

Using this blockchain system means even the smallest companies can now operate a continual state of audit readiness, rather than scrambling for records as an audit or inspection approaches, said the partners.

This joint approach will lead to higher valuations, increased security and potentially better returns for biotechs as the immutable records will back up every claim and data point with an irrefutable record, providing greater trust for an industry that has seen a number of prominent data scandals in the last few years, they continued.

This collaboration means that biotechs can reduce costs and increase trust. It takes away so many of the problems these therapies face as they progress through the clinic to commercial. For example, the ability to alleviate silos in the supply chain while providing an end-to-end solution to track and trace for patients and in near real-time is potentially a game changer for the industry in how quickly and [data integrity] issue free they can accelerate towards patients, commented Tanya Sharma, co-founder of Assurea.

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ATMPS and Assurea team up to ensure audit readiness for cell and gene therapy innovators - BioPharma-Reporter.com