Munich (DE) – The development of advanced and personalized therapies, such as Cell & Gene Therapies (also called Advanced Therapy Medicinal Products, ATMPs), brings with it a complexity of patient-specific processes as well as numerous stakeholders, that requires new collaboration paradigms.
For this reason, SAP and Hypertrust Patient Data Care (HPDC) have worked closely together to create a proof-of-concept implementation for the integrated orchestration of processes using cross-company workflow orchestration.
Challenges of new therapies
ATMPs that are individually tailored for each patient offer groundbreaking new opportunities to treat serious and often rare diseases as well as disorders such as leukemia. They develop and produce medicines that are based on human genes, tissues, or cells to initiate processes for regeneration. However, these therapy processes are challenging to control and costly as they rely on a flawless interaction between very different participants along the treatment process. Clinics, laboratories, logistic service providers, pharmaceutical companies and contract manufacturers need to work in close coordination.
This is more challenging the more IT systems are involved, information has to transition across company boundaries where process steps and status are not transparent to everybody.
The above outlines how cell & gene therapies show specific characteristics compared to more traditional therapies. These result in new and additional requirements for process execution and supporting IT systems:
- Specialized handling of sensitive products for example cryo preserved
- Adherence good practice quality guidelines and regulations (GxP)
- Make-to-order production and small lot sizes for individual patients
- Automation to reach scale for full commercialization
- Uninterrupted chain of identity and chain of custody to ensure patient safety
- Coordination and collaboration of many stakeholders along the process
- Visibility and traceability throughout orchestration
These challenges can be addressed by reducing complexity, driving automation, defining standards, and providing transparency to involved parties. Cross-company workflows are one measure to provide the required information flow to address the last three of the list items above. The technical proof-of-concept between SAP and HPDC shows how this can be achieved. The case has been presented as part of SAP TechEd 2021 and the video replay is available.
We choose a scenario with a reduced business process as basis for the technical implementation.
The treatment process starts at the hospital where a physician uses Hypertrust X-Chain to order a treatment for a specific patient. As sensitive healthcare data is involved, data privacy and protection must be always ensured. Therefore, only anonymized data leaves the hospital and notifies other participants in the network.
Once all necessary data is entered, information flows to a pharma company to validate eligibility for the therapy and a contract manufacturer (CMO) to produce the drug. As soon as the patient data is validated for completeness and correctness, the CMO gets notified and can plan production in her manufacturing execution system. Furthermore, associated logistics information and timelines will be exchanged to ensure transports of cell material between clinic and production site.