ATMPS Ltd/Hataali – a provider of blockchain-based data-sharing platforms for advanced therapies – announced a new strategic partnership with Assurea LLC, the USA-based quality and compliance consultancy.
The partnership will see Assurea and ATMPS offer a fully compliant 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 decentralized and immutable regulatory-compliant system, the industry will be able to commercialize therapies more quickly and successfully.
“This collaboration enables biotechs and innovators to have regulatory-ready, decentralized 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 begun working on a number of collaborative projects, including for a UK-based phase I biotech focused on CAR-T. They now plan to target pre-clinical companies heading into the IND stage, as well as providing ‘data rescue’ systems for therapies already undergoing trials. The latter is a growing area of concern for the industry, as many biotechs realize 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 approach.
Assurea, which specializes in navigating the complex regulatory pathway for advanced therapies, points 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.
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