When it comes to the logistics of personalized medicine, there is no tolerance for risk, as it may compromise the study and the safety of patients. All supply chain elements need to be perfectly synchronized, which requires collaboration by all of the stakeholders, at every phase. Planning and orchestrating every mile with precision will ensure security, viability, and safety for every patient.
During the workshop “Overcoming The Complexities Of The Personalized Medicine Supply Chain, facilitated by Quick, in partnership with Phacilitate Exchange, Be The Match BioTherapies and Skyland Analytics, we explain why early planning for all aspects of the supply chain is the key to successful patient outcomes. The workshop topics included:
- Temperature requirements for fresh blood, apheresis and finished CAR-T therapies
- Tested and proven cold chain packaging
- Route mapping between the manufacturing and clinical site locations
- Risk mitigation procedures
- Chain of custody protocols
- Synchronized “vein to vein” data management and connectivity for all stakeholders
- Scalability from early clinical to commercialization
Customized Clinical Trial Logistics Solutions
Time specifications and temperature requirements for materials used in autologous and allogeneic CAR-T manufacturing usually come with varying conditions. Each must be carefully considered in advance and requires tested and proven cold chain protocols and packaging solutions according to the climate, travel time and temperature requirements.
For example, most apheresis blood or tissue will require delivery to the manufacturing facility within 8 to 24 hours, temperature 2 ºC to 8 ºC, with close tracking and the tightest possible controls. In comparison, most drugs used for patient infusion needs to be maintained in a stable deep-frozen state (-180 ºC), requiring LN2 packaging during transport. With this, the drug product turn-around to the patient site tends to be more relaxed (< 24 hours), while the chain of custody and security remains every bit as critical.
The manufacturing facilities and clinical sites need to be identified early in the planning process, with consideration of the transit requirements for each leg of the supply chain. Also, contingency planning is crucial in managing around unforeseen events such as flight delays, flight cancellations, traffic or weather events. To minimize the potential for transportation delays, your logistics provider should consider only the most secure “priority” modes of transport such as NFO (next flight out), Exclusive Ground, On-Board Courier, or even Air Charter.
To ensure that each therapy is collected and delivered to the correct patient, strict chain of custody protocols must be enforced from start to finish, with web and GPS tracking throughout transit. The goal is to ensure end-to-end security and control from manufacturing to hospital, and from the clinical sites to manufacturing.
In this workshop, you will learn the importance of engaging in system planning early, since personalized medicine requires robust, automated orchestration, precise logistics, and traceability. You will see how IT systems can improve the process by monitoring every logistics milestone and will also understand why it is crucial to plan for long term scalability, from early clinical trials through to commercialization.
See the complete video below: