The design of a cold supply chain for advanced therapies can contribute to the success or failure of a global clinical trial. Phase 1 logistics are typically quite manageable, with a small number of participants within a given geography. However, as the trial progresses to subsequent phases, with national if not international enrollment, the logistics challenges can affect recruiting, as well as the selection of investigator site and manufacturing locations. Consider this hypothetical scenario:
The family of a 5 year old girl anxiously awaited the news. They had learned of a clinical trial for a potentially lifesaving therapy that could save their child. It was a breakthrough treatment that modifies stem cells. When reinjected, the stem cells would attack the vicious cancer that threatened her life. Because she was too fragile to travel, the treatment had to take place near their home in northwest United States. But then their doctor delivered the crushing news – it would be impossible to enroll their daughter in the trial. The sponsor had selected a manufacturing facility in western Europe. The extracted stem cells had to be in their hands within a short timeline, and the flight schedules and customs process made that an almost impossible task.
This sponsor would have been faced with a difficult decision of not serving the patient, or establishing a secondary manufacturing site to better serve their target geography.
Clinical trial Supply and Logistics Market Forecast ($bn), 2015-2016
Source: VisionGate 2016 Clinical Trial Cold Chain Logistics Forecast, 2015-2016
The number of trials investigating biologic compounds has increased by 900% from 2009 to 2013 and today, around a third of R&D pipeline projects are biological drugs.1 In the five years to 2021, the number of companies operating in the cell therapy industry is expected to increase at an average annual rate of 11.8%.2
These trends are driving significant growth and demand for a cold supply chain where shipments require strict controls and constant monitoring to ensure the integrity of their contents. The complexity of these logistics can influence country selection for the trial participants as well as manufacturing locations. For advanced biologic therapies, timelines and product stability are critical. Trial participants must be located within reach of the manufacturing facility to ensure consistent and reliable movement of the inbound sample and outbound therapy within prescribed guidelines.
As clinical trials continue to become more global, sponsors can benefit from engaging logistics subject matter experts to design a de-risked supply chain while managing overall costs. The solution must be scalable, allowing seamless transition throughout all phases of the trial to eventual product commercialization.
Key considerations include:
- What temperature ranges are involved for the inbound and outbound shipments?
- How long will the samples and/or therapy be stable at given temperature?
- How large is each individual shipment?
- Is there available capacity (air carriers and scheduled flights) to cover the desired geography?
- What delays might be introduced due to regulatory challenges associated with these new therapies?
- How will manufacturing schedules be coordinated with patient extraction to ensure sample viability?
- Is there sufficient infrastructure to ensure reliable transport?
- Will the customs process introduce delays that might risk sample and/or product integrity?
A well-designed cold supply chain takes all of this into consideration. When dealing with advanced therapies, logistical failures are not an option. The earlier a trial sponsor engages with subject matter experts, the greater the opportunity for successful outcomes for both sponsor and patient.
1 VisionGain 2016 Clinical Trial Cold Chain Logistics Forecast, 2015-2026
2 IBISWorld Industry Report – Cell Therapy in the US, August 2016