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Article: Out of the Lab, On the Road, Around the World

By World Courier

Advances in science and medicine inspire logistics providers to keep pace

Why the transport of Cell and Gene therapies is a logistics challenge like no other: Higher than usual performance standards, Ultra-complex timing, and Quality beyond compliance.
The cell and gene therapies being developed today have the potential to cure diseases. To make those treatments possible, another industry has to evolve: logistics.

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 humanity.

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. Regardless of weather, traffic, mechanical difficulties, staffing irregularities, customs regulations, and/or processing delays.

“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, President 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.

Personalized medicine calls for a personalized supply chain.  The future of medicine is the future of logistics as well — and we’re already there.

To learn how to plan logistics strategies for cell and gene therapies, download our free e-book.