ATMPS Ltd/Hataali – a leader in blockchain-based data sharing platforms for advanced therapies – announces a new strategic partnership with Assurea LLC, the USA-based quality and compliance consultancy. 

The partnership will see Assurea and ATMPS offer a fully complaint plug and play ready blockchain solution – Hataali – for end-to-end supply chain management of cell and gene therapies, providing real-time data integrity across both clinical trials and commercial products.

By empowering  smaller, early-stage biotechs with a decentralised and immutable regulatory compliant system, the industry will be able to commercialise therapies more quickly and successfully.

“This collaboration enables biotechs and innovators to have regulatory-ready, decentralised data records that have integrity built-in by design. It’s 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,” commented Raja Sharif, CEO of ATMPS Ltd.

Assurea and ATMPS have already begin working on a number of collaborative projects, including for a UK based phase I biotech focussed on CAR-T. They now plan 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 is a growing area of concern for the industry, as many biotechs realise that as key regulatory touchpoints approach, they don’t have a robust enough platform to stand up to intense regulatory scrutiny.

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.

Assurea, which specialises in navigating the complex regulatory pathway for advanced therapies, point out that both the EMA and FDA are moving in this direction already. Ultimately, this new joint approach will lead to higher valuations, increased security and potentially better returns for biotechs, as these 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.

“It’s very exciting time for advanced therapies globally, but as an industry, we have been in critical need of decentralised, interoperable approaches to data management – particular for novel therapies whereby storage and real time visibility is so crucial. 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,” added Tanya Sharma, Co-founders of Assurea.