Whilst pharmaceutical companies developing therapeutics often attract the headlines with regenerative medicine clinical trials and approvals, logistics plays an enormous role in the clinical development and commercialization of these products, Cryoport told this publication.
CEO Jerry Shelton said the company supports over 200 clinical trials, with 23 of those secured in the third quarter of 2017 alone, and a quarterly earnings call on March 6 would shed more light on how the logistics company has grown in the space.
Two years ago the company was involved in approximately 15 trials, he added, so the expansion has been rapid with ever increasing interest in the regenerative medicine space, in particular with the advent of chimeric antigen receptors (CAR) T-cell therapies.
Cryoport is the sole logistics provider for the first two commercialized CAR-T therapies, Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarata (axicabtagene ciloleucel).
As both Yescarta and Kymriah are rolled out commercially, Cryoport’s major focus will be to support those companies, said Shelton.
However, Shelton noted there are likely to be another four companies to reach the commercialization stage this year with cell therapies so the need for cold chain logistics in regenerative medicine is ever growing. Without a doubt regenerative medicine is the fastest area propelling the company’s growth and one of the hottest areas in the biopharma business, Shelton added.
There are some very unique challenges in dealing with CAR-T therapies and the patients involved are have very serious conditions such as AML and NHL said Shelton adding that there is no room for error in terms of delivery of these products.
Whilst the company has a large base of operations in the US, it also has European headquarters in Amsterdam and Asian facilities based in Singapore. The company plans to upgrade its European operations with a new facility in Amsterdam later this year, as well as expanding its facilities and locations in the US, said Shelton.
The primary reason for the aforementioned growth will be to support the US and European commercialization of Yescarta and Kymriah, he explained. Shelton noted the company has approximately $14m on the balance sheet which it may invest back into the company.
One of the company’s leading cold chain logistics solution is the C3 shipping solution, which integrates packing, informatics and logistics to ensure products can be transported between 2-8 °C. The C3 solution is designed specifically for autologous solutions.
However, Shelton noted that the company may explore different temperature range solutions in the future if there is a demand driven by new customers and clients.