Personalized cancer treatments are one of sciences’ hopes for fighting cancer effectively. But the promising treatments also impose a big challenge: The treatments’ orchestration is a complex task, a dimension that existing IT systems are barely capable to address by existing workflows in the supply chain and transport management of the companies and service providers involved. To better support companies, it is necessary to break new ground.
Secured Data and Documentation in Transgene’s Clinical Trials
The French biotechnology company Transgene uses the Hypertrust X-Chain solution for the clinical trial orchestration of their individualized therapeutic vaccine TG4050 against ovarian and head & neck cancers. The treatment is currently evaluated in two ongoing clinical trials with more than 50 enrolled patients in Europe and in the USA at the end of 2022. For the supply chain and transport management in the clinical trials, Transgene needs a trustworthy process in the background. This is provided by Hypertrust X-Chain. It secures a trustworthy handling solution for the material in personalized treatments and provides an immutable audit trail throughout the treatment process:
- Data Protection in a closed-loop supply chain where only the absolutely needed data is shared with each partner in the cross-company collaborative process.
- Chain of Identity ensures that the final product is returned to the correct patient.
- Chain of Custody means the immutable, tamper-proof records of custody, control, transfer, analysis, and disposition of physical or electronic evidence.
- Orchestration of the heavily distributed supply chain for the manufacturing process, starting with the input generation and ending with the application of the final product/medicine.
- Conditional checks and dependencies for quality checks or evaluations.
The orchestration process creates an immutable audit trail covering the whole process. With blockchain technology, the solution is tamper-proof and tracks all modification of data transparently throughout the process. This is vital in the clinical trial phase for personalized therapies since in some legislations this documentation is required to get a commercial approval to sell a new medicine.
Biotech and pharma companies further benefit from the trustworthy and highly customizable workflow process engine for personalized medicine supply chains, which support the patient’s treatment and recovery. During proof-of-concept implementations together with leading global pharma companies, a production cycle roundtrip time improvement of up to 25 percent could be observed, compared to traditional processes and tools.
Hypertrust X-Chain supports all product lifecycle stages from pre-clinical trials to commercialization. With a broad supplier and service provider ecosystem, companies can accelerate the setup of their Advanced & Personalized Therapy supply chain processes.
About TG4050: TG4050 is a patient tailored therapeutic cancer vaccine currently developed in solid tumors and intending to stimulate the immune system to clear the body of cancer cells. TG4050 is co-developed through a strategic partnership between NEC Corporation and Transgene.
To learn more about the capabilities of the Hypertrust X-Chain solution from our spin-off Hypertrust Patient Data Care, you can read more here: Hypertrust X-Chain.