Logística de terapia celular y genética en acción
Los pacientes, los centros de investigación y los planes están en orden: ahora comienzan los verdaderos ensayos
We recently described the four-part planning process used by World Courier to prepare for every eventuality, before a cell or gene therapy study begins.
How does the plan play out in the real world?
To find out, we talked with Arnold Bernard, Senior Manager, World Courier Specialty Group in New York.
Q. What is the first step in shipping cell and gene therapies?
A. Investigator sites book shipments up to two weeks in advance. Flights are booked three days out, using only priority cargo services. Local airline management is pre-advised of the flight details and expected check-in time. Airline ground staff are mobilized and instructed to dedicate maximum attention to the shipment.
Q. How do you monitor the shipment during transit?
A. Shipments are checked in at the last possible moment. Proactive tracking alerts are sent at 15-minute intervals before scheduled milestones – airline tender, check-in, flight departure, shipment recovery. Email alerts follow the shipment throughout its journey.
Customer service and operations staff monitor each shipment from pick-up to delivery, providing immediate response to any developing situations. GPS, temperature monitors and tilt-meters may also be used to provide time/location tracing capabilities and other data.
Q. How can you prepare for the unexpected?
A. We engage local service providers able to provide eleventh-hour support in every study location. If a courier, ambulance, helicopter, air charter or even a police escort can help defuse a situation, they can typically be mobilized and deployed within the hour. As individual shipments prepare to go live, we review weather forecasts, local traffic conditions and any international events such as strikes, national occasions, and security restrictions that could potentially create problems. If necessary, we design secondary routings.
Q. What is your first priority if alternate actions are required?
A. Keeping everyone apprised of the situation, even when the news isn’t good. Everyone from the clinical director at corporate headquarters to local investigators, medical teams or the production manager at the manufacturing facility needs to know everything we know.