In 2017, the FDA broke a record for the most new drug approvals, the majority of which were for personalized medicines. While that sector is growing, it must be taken into consideration the complexity of getting those medicines to their intended recipients.
As a global provider of temperature controlled logistics solutions for temperature-sensitive medicines, Cryoport was most recently selected for those duties by DiscGenics. They will be providing the logistics support to its multicenter, first-in-human study to evaluate the safety and preliminary efficacy of IDCT, its allogeneic injectable cell therapy, in patients with single level, symptomatic lumbar intervertebral disc degeneration.
Cryoport serves the biopharmaceutical market with leading-edge logistics solutions for biologic materials to ensure a safe delivery, such as regenerative medicine, including immunotherapies, stem cells, and CAR-T cells.
They say that their goal is so help simplify global cold chain logistics through innovative technology, unmatched monitoring and data capture and support, including consulting, and with delivering the most advanced temperature controlled logistics solutions for the life sciences industry. Contract Pharma spoke with Mark W. Sawicki, Ph.D., chief commercial officer at Cryoport to discuss the logistics, challenges, and importance of the services that they provide.
Contract Pharma: Can you explain the logistics that go into getting personalized medicine to patients that others may not be aware of?
Sawicki: Personalized medicine logistics is very complex and involves both the supply of processed blood and in some cases tumor genetic material from the clinical site to the site of manufacture, and then the transport of the drug product from the site of manufacture to the site of administration. It often involves multiple temperature ranges, very strict timing requirements, and absolutely zero tolerance for temperature excursion. One of the most significant challenges is the complex scheduling of the logistics support, at times down to the hour. You can have up to 9 individual shipment legs in support of a single therapy dose.
Contract Pharma: What are some of the biggest logistics challenges you face with personalized medicines?
Sawicki: The biggest challenge by far is the fact that personalized therapies, in particular autologous therapies, are patient specific and cannot be replaced due to temperature excursion. One must have the ability to understand what is happening to the shipment during transit and have the ability to intervene due to weather, equipment, or personnel handling delays to prevent an excursion from occurring in the first place.
Contract Pharma: On a similar note, what are some of the biggest challenges that drug manufacturers face with personalized medicines?
Sawicki: The complex scheduling of patients who have significant health issues, and may have last minute delays in blood collection or patient dosing due to their condition as well as a lack of standardization at the clinical sites related to training, equipment, and quality of blood product are some of the biggest challenges.
Contract Pharma: Are there any industry trends on that front that you’re noticing?
Sawicki: We anticipate that the regulatory requirements of the equipment utilized for in transit distribution will become more stringent over time and require full accountability of historical performance of the equipment utilized in the near future.
Contract Pharma: Can you elaborate on Cryoport’s role in clinical trials? How many do you support the logistics of?
Sawicki: Cryoport is now supporting more than 200 clinical programs as well as the commercial launches of both Yescarta and Kymriah. Cryoport not only supports the distribution of the clinical source material as well as drug product. We are increasingly being asked to support strategic packaging development, lane validation, as well as end user training of the clinical sites for handling cryogenic shipping equipment.
