End-to-end Cell & Gene Therapy Orchestration

Practical example and current challenges

• The first innovative cell and gene-based cancer treatments reached the market in 2017. The therapy is highly personalised, very complex and involves different stakeholders from distinct entities and professions in close coordination. To create added value from digitalisation, therapies could be built as a closed-loop supply and data chain which guarantees delivery of the correct medication based on the patient’s own blood or tissue cells in time and quality.
• As advanced, highly personalised cell therapies require a specialised manufacturing process, a forward integration of new stakeholders is needed. The production converts from manufacturing for the mass market to a nano scope due to lot-size-1 und personalisation requisites.
• A further challenge is to maintain data privacy and security while simultaneously sharing relevant process information across stakeholders as the data provided is highly confidential. It is therefore essential to establish a trustful environment that ensures in time and quality treatments while being regulatory compliant.
• With currently more than 1000 cell therapies in development (Q4/2019) it is apparent that a manual process will hinder quality, scale and effectiveness. Thus, there is an urgent need for a significant amount of digitalisation, automation and standardisation across the ecosystem resulting in improved therapies for patients. The formation of a standardised network will remove the current friction that is impacting scale and commercialisation of advanced therapies. Thus, wide coordination and automation of information as well as process flows will improve the therapy supply chain by connecting all relevant stakeholders in the production process.

What added value does the "GAIA-X project" offer?

• GAIA-X is the basis to establish a network for organizing, orchestrating and optimizing the supply chain for advanced and personalised therapies. GAIA-X ensures automation, quality and adherence to standards through cross company workflows.
• GAIA-X will also be a significant catalyst for ecosystem building and adoption to scale of the “cell and gene therapies supply chain network”. It provides a neutral ground, where the participants can collaborate on eye level, as its concept and architecture promote openness, data sovereignty, data security, interconnectivity and transparency to base collaborative business processes on.
• As a joint solution GAIA-X will prevent proprietary software, individual ownership or vendor lock-in creating an environment for a sustainable, long-term solution for advanced and personalized therapies. The concept of GAIA-X will lower scepticism, and concurrently the threshold for participation. Consequently, it will lead to better and more widely available therapies for patients while ensuring commercial viability for entities executing the process.
• Further added value is a guaranteed chain of identity as well as a chain of custody. It also enables real-time alerts and the integration of distributed IT-Systems while maintaining protection of crucial data. The GAIA-X Federation Services is the appropriate concept to pursue cross-technology interoperability on trusted connections and data infrastructures.

Use Case Team

• Raimund Gross – Hypertrust Patient Data Care