Video: Logistics Leaders: The Real Cost of Quality
By Ray Hornung, MBA, MBCI, CEM, CBCP |
Cell and gene therapy products are life-critical, as the cells being collected, transported and delivered are irreplaceable. For the patients awaiting these therapies, it is often their final opportunity for another chance at life. This is why there is no room for error in cell and gene therapy logistics, with a great deal of importance on early planning and contingency measures.
Orchestrating the logistics for human-based therapies is more complex than many people realize. No matter how well designed your supply chain these therapies are subject to variability at each stage of delivery.
For example, autologous CAR-T therapies require collecting cells from a patient who is very ill. This occasionally means that the collection date must move at the very last minute due to a change in the patient’s health, or that the collection may take longer than expected, delaying cell pick-up and resulting in missed flights. Supply chain disruptions ranging from travel delays to security concerns may also occur due to adverse weather conditions or other unforeseen challenges.
If the cells being transported are fresh cells, there is only a short window of viability for delivery to a manufacturing site, which could be across a country or across continents. Even when the cells are cryopreserved, upstream changes can cause a ripple effect across the entire supply chain. In addition, each therapy being manufactured is patient-specific, so necessary steps must be taken to ensure the right product gets to the right patient, in the right condition, at the right time.
Cell and gene therapies are complex, yet the challenges associated with orchestrating logistics for them can be managed effectively through early planning, robust contingency measures and working with well-versed logistics partners.
Early planning to reduce risk
As recommended in the ‘Logistics by Design’ framework presented by World Courier and Cell & Gene Therapy Catapult, planning and implementation of cell and gene therapy logistics should occur early in clinical trials. This is when the number of patients, along with collection and infusion sites, are somewhat limited. This stage should also include experts throughout the supply chain.
Early planning gives a cell and gene therapy company enough time to test its logistics model by running mock-shipments and then working to overcome any barriers they encounter. Doing so can help a company scale up and be ready for commercial launch.
Contingency planning to provide on-time product delivery
Even with early planning and a solid logistics strategy in place, situations can occur that are beyond anyone’s control. A strong contingency plan is critical to ensure cells or final products arrive when and where they are needed.
Contingency planning isn’t only necessary for large-scale events that may affect logistics, such as a hurricane impacting the ability to fly in or out of a region. It is also necessary in more common situations such as a missed flight due to an extended cell collection.
You never know when situations like this will arise, so establishing partnerships with experienced teams who can overcome the challenges inherently linked to cell and gene therapy transport can make all the difference as to whether or not these therapies arrive in time for waiting patients.
When someone’s life relies on your product, the steps you take to plan for both the expected routine and unforeseen events will safeguard the systems, processes and relationships which are in place to deliver.