ATMP’s blockchain-based data sharing platform will be incorporated into Ori Biotech’s cell and gene therapy manufacturing platform.

ATMPS, a spin out from Farmatrust, created the Hataali platform to record scheduling and ordering data for advanced therapy treatments within a blockchain system that enables secure and confidential sharing of data between partners.

Ori Biotech, a developer of automated and scalable cell and gene therapy (CGT) manufacturing systems, has partnered with ATMPS in efforts to provide improved product tracking, scheduling as well as live monitoring of the manufacturing status across the entire CGT supply chain from vein to vein.

Image: iStock/istock_onespirit

We spoke with Najib Rehman, Data Strategy lead at ATMPS, about the collaboration, and how digital technology can help improve the current advanced therapy landscape

BPI: Can you explain how your Hataali platform works?

Najib Rehman (NR): It leverages a blockchain to provide end to end process and data integrity and immutability for ATMP [advanced therapy medicinal product] patient access, logistics and manufacturing.

Because this is a multisite, multi-stakeholder and multi-therapy ecosystem, the use of a blockchain ensures that the need for trust is removed algorithmically from the total end to end ecosystem. It talks to other technologies by using RESTful APIs and combines with a microservices architecture to ensure a flexible approach to supporting as many nascent ATMP processes (including manufacturing) as possible.

Existing technologies struggle with simplifying the complete end to end visibility for all users, as they are developed for single manufacturers or even sole therapies. Another issue is that many competitors use point to point integrations, so every instance is highly bespoke and extremely expensive, while Hataali is flexible and built using open standards of connectivity making it highly cost effective

BPI: Is this an exclusive partnership with Ori?

NR: This is not exclusive – we are already working with other technology and therapy partners. In fact, it does not fit with the blockchain culture to be exclusive. Blockchain based solutions are all about ‘coopetition’ (showing that it is possible to both cooperate and compete simultaneously by eliminating the rate limiting effect of trust – blockchains are trust agnostic!)

BPI: Why is it so critical to use a digital data technology approach to the manufacture of advanced therapies?

It’s no big secret that performance figures (sales and uptake) for licenced CAR-T products have been disappointing in recent years for the major pharma firms that have bought them to market. Reimbursement mechanisms sure are one challenge, but the other is operational access to them. Manual paper-based solutions and sub-optimal digital solutions coupled with ATMPs only being available at advanced tertiary care treatment centres is hugely limiting to current patient access. It recreates bottlenecks to innovation in how quickly new therapies can be developed and manufactured.

If this continues then ATMPs will remain an expensive novelty and will struggle to ever be considered a mainstay of patient care and treatment. Smart connected digital automation of supply logistics and manufacturing will be key to opening up access to these life saving therapies – simplifying the total end to end processes and decentralising the delivery, bringing these therapies closer to the homes of patients so that one day they will be available in any district general hospital, maybe even a within a GP surgery.”

BPI: So how do you hope your tech offering will reduce the cost of goods sold (COGS), and this the price of such therapies?

NR: A proportion of the COGs is in the initial and final 100 yards. If we can collect near real-time data on starting material quality, scheduling slots, environmental and time deviations, other bottlenecks and use this to inform the manufacturing processes then we have the potential for continuous improvement to increase manufacturing yields.

For example, it is accepted that up to 50% of yields fail so even a marginal improvement has the potential to reduce COGs. Furthermore, if everyone is pushing towards resilience and vertical integration then scarce resources will become even more scarce and COGs will go up again – an approach using blockchain can enable a balance of resilience planning and outsourcing that will enable a far more effective use of scarce resources due to coopetition.

BPI: Finally, how do you see the use of digital processes and innovation like this in the advanced therapy space becoming a driving force for the uptake of such systems across the wider biomanufacturing landscape?

Ultimately, it will be inevitable – virtually all patients today will be on other therapies before they are given novel advanced therapies. There will be an intersection of traditional pharmaceuticals, med tech / devices, software-based therapies, wearable diagnostics with ATMPs. A key to managing this complexity will be to identity how we manage it for stratification of medicines, where, in the future, even a standard small molecule pill will be manufactured with an individual patient’s name on it.

To enable this total level of care where chain of identity is critical requires novel ways of managing patient identity that are already in development and will soon be available for all of us to use via a smart phone – healthcare service providers and drug and therapy manufacturers need to get to grips with them sooner rather than later, as they will be fundamentally changing the way we all digitally engage with every other aspect of our lives. We will all expect healthcare to do the same.