SUMMARY OF INVENTION
Cell and Gene Therapies (CGT) such as CAR T therapy are the new frontier in medicine. They offer the advantage of personalized (precision) medicine using patients’ own cells/tissues for treatment. CAR T is a form of immunotherapy that uses a patient’s T-cells to fight cancer, whereby the T-cells are separated from a patient’s blood by apheresis (separating plasma from cells) and modified in a lab by adding synthetic receptors called chimeric antigen receptors (CAR). The resulting CAR T cells are then infused back into the patient where the weaponized CAR T cells will multiply and kill cancer cells. The process of extracting cells from the patient, transporting them to a lab for modification, then back to a medical center for patient infusion has very stringent requirements. It involves the exchange of custody of precious patient samples between numerous organizations (both clinical and non-clinical) with little to no transparency and no standardization across the different steps of the process.
ImmunoChain is an end-to-end platform that addresses the challenges in the supply chain cycle for cell gene therapies such as CAR T, by facilitating a closed-loop physical supply chain with a mirrored digital supply chain. ImmunoChain comprises the logistics services company, the software platform for managing the data, and the vessel for transporting specimens throughout the treatment cycle.
- Logistics services manage the physical fleet of Precision Medicine Vessels (PMV), IoT-enabled patient specimen containers that physically store temperature-controlled patient genetic materials
- The ImmunoChain software automates and directs the physical flow of the specimen through the appropriate chain of custody, chain of identity, and chain of condition while simultaneously brokering backend information exchanges
- As treatment progresses, information is captured via IoT sensors, NFC-enabled interactions with the patient specimen, and integrations with clinical and operational systems. All patient data is captured and managed on a private permissioned blockchain to ensure a comprehensive, authoritative, and immutable ledger of the treatment
- Eliminates the variation at the different stages of the treatment cycle by ensuring each step is performed by the right person, at the right time, for the right reasons while capturing all associated data.
- Workflows and chain of custody are tracked and managed full circle: from specimen collection through the logistics process to administration of the therapy to the patient
- Precision Medicine Vessels (PMV) physically store temperature-controlled patient specimens and accompanies them throughout each treatment lifecycle, ensuring chain of custody.
- ImmunoChain software is an orchestration platform that manages all logistical aspects of cell gene therapies and provides a comprehensive, authoritative, and immutable ledger of each treatment
Today’s CGT market is estimated to be worth $4-$5B, and the FDA anticipates that by 2025 10-20 cell and gene therapy products will be approved per year, at which time the market is expected to be worth $15.5B.
Provisional application 63/294,758 filed on Dec. 29, 2021.
Noah Fichter, Director, Supply Chain Informatics & Business Intelligence, Supply Chain, Memorial Sloan Kettering Cancer Center
Rick Peng, Business Development & Licensing Manager, Office of Technology Development, [email protected]