In the past two decades, gene-based clinical trials have increased by almost 500%. The global market for regenerative medicines – including cell therapies, gene/gene-modified cell therapy and tissue engineering – is poised to reach $67 billion in 2020.
While the majority of cell and gene therapies are still experimental – aimed at rare single-gene disorders – researchers hope to build on their successes to develop treatments for multi-gene disorders, including heart disease, hypertension, diabetes, arthritis and Alzheimer’s disease.
That makes the success of clinical trials now underway vitally important. To make those treatments possible, another industry has to evolve: logistics.
Therapies that contain live materials are produced and packaged under strictly controlled conditions. They must be transported around the world and delivered on time, at optimum temperature, so they arrive in perfect condition.
“Researchers dealing with cell and gene therapies already face many obstacles given the novelty and unpredictability of the science, the small size of patient pools and a typical single-dosing model,” said Sam Herbert, chief operating officer at World Courier.
“In delivering cell and gene therapies to the patient – whether during a trial or as part of a treatment plan – it is critical that the therapies are delivered on time and in pristine condition.”
For clinical trial results to be accurate and replicable, biological samples must arrive at investigator sites in the same condition that they left the lab. Compliance in the lab, the production facility and the hospital or treatment site is fairly easy to assure. Compliance in the outside world, where the unpredictable happens every day, is not as easy.
Even small cell and gene therapy trials are immensely complex, with many moving parts and no room for error. In this research environment, not only the science, but the entire process from start to finish must be flawless. Researchers, sponsors, clinical teams and supply chain providers supporting the project can settle for nothing less than perfection.
Cell and gene therapies are produced one-by-one under strictly controlled conditions, using live bio-materials. Time and temperature variation could destroy them, so they must arrive at the clinical site on time and pristine condition.
In theory, that’s a tough job.
In the real world, it’s much harder.
Weather, air traffic, road conditions, climate zones, customs regulations and processing times can’t be allowed to delay delivery, or affect the temperature-controlled packaging of the samples and therapeutic materials.
To ensure success, World Courier starts working with study sponsors years in advance.
Our dedicated project team plans a personalized supply chain, develops customized operating procedures, trains all personnel who come in contact with the shipments from lab to clinic and works with airlines personnel and international customs agents to make sure everyone knows what is at stake and how to handle the shipments.
In real life: a case study
World Courier planned and executed all logistics for a developer of immuno-oncology products during a Phase II clinical trial. Under evaluation was an autologous, dendritic cell-based therapy for cancer patients, to extend remission time and possibly overall survival. The therapy was granted an orphan drug designation by the FDA and EMA, and received fast track designation by the FDA after the Phase II trial.
The therapy owner’s manufacturing sites were located in Europe and in Australia. Shipments of starting cell material had 24 hours to travel from the clinical sites in Europe and Asia to the central manufacturing sites. Over a period of 20 months, World Courier delivered 245 shipments containing more than 2,000 kilograms of materials to treat 63 patients. Therapeutic materials travelled by air freight and road, and were hand carried to their final destination.
Our clinical sample delivery success rate was 100%.
The best logistics partner for your clinical trial is one who has been down that road. Contact World Courier to find out more.