ATMPS and Assurea team up to ensure audit readiness for cell and gene therapy innovators
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.
Sharif told BioPharma-Reporter this week that the partnership with Assurea is globally-focused. "The majority of customers we speak with will have a predominant interest in serving US-based customers."
A specialist in navigating the complex regulatory pathway for advanced therapies, Assurea will oversee protocol development and regulatory requirements in combination with the ATMPS blockchain solution, he said.
"Even the smallest biotechs will be able to maintain ongoing states of audit readiness – in an area that can often seem opaque and using a traditional paper-based approach results in great complexity," commented Sharif.
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 don’t have a robust enough platform to stand up to intense regulatory scrutiny.
By providing an integrated solution, said the ATMPS CEO, planning and protocol stages can be accelerated while also providing clients with scalability using the same existing system.
"For many other developments, they would go through several iterations of protocol and sample handling systems before becoming commercial – and they may in fact be forced to re-invent the wheel once regulators become more deeply ensconced with the cell orchestration platforms used and accompanying documentation.
"This project can provide a truly regulatory compliant platform and therefore remove some of the bureaucracy around providing therapies."
Greater trust
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, he said.
“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,” said Tanya Sharma, co-founder of Assurea.
