Clinical supplies & logistics
industry standard for temperature control to be automated. “There’s still a lot of pharma companies that have a manual process in place.” For sponsors and trial managers, then, tapping into IRT’s potential could mean more efficient excursion control – and, therefore, a smoother and safer trial.
“If you look at oncology treatment, where you need to take blood samples and then go to a manufacturing facility that makes an IMP to treat that same patient, you really need to ensure that you get that IMP back.”
Henk Dieteren More efficient trials
Being able to accurately track the temperature of individual units creates new opportunities for direct-to-patient trials.
Jan Pieter Kappelle is senior supply chain strategist and advisor to the Bio Supply Management Alliance (BSMA), and he stresses the importance of monitoring for risky fluctuations in temperature. “At all stages where the clinical drug is either put in inventory or moving from location to location, there’s an expectation that temperature controls are in place,” he says. IRT can be used to instantly monitor drug temperature at each of these touchpoints, and for quick communication between the necessary staff if there has been an excursion. This can hugely speed up the process of either releasing or quarantining a drug. Typically, a temperature monitoring device is included within the drug shipment that can vary in complexity. Many have constant measuring capabilities and can produce a PDF file, which is then uploaded into the IRT system, Kappelle explains. “The IRT system becomes the system of record with respect to the temperature monitoring information.” If there has been an excursion, the IRT system can set the necessary actions in motion, says
senior analyst for UAT and validation and clinical IRT Tom Schiavon, who is currently advising global biopharmaceutical company Bristol-Myers Squibb. “The [IRT] will automatically quarantine the drug, send an alert to the person responsible to review the data, and then allow it to be released for use or damaged. If damaged, typically IRT will automatically trigger a replacement shipment.” While this certainly boosts efficiency, Kappelle notes that the industry standard is mostly passive monitoring, which means there is one standalone device measuring temperature that gives a singular output once that job is done. “I see a trend into a more real-time, dynamic kind of temperature monitoring,” he says. “Because the cost of medication is increasing, and so you really cannot afford any kind of loss of product financially.” Monitoring is also traditionally done on shipments rather than on individual units. As the industry moves towards more complex drugs and personalised medicine, robust tracking on individual units is going to be increasingly necessary, says Dieteren. “If you look at oncology treatment, where you need to take blood samples and then go to a manufacturing facility which makes an IMP to treat that same patient, you really need to ensure that you get that IMP back. This is really, really specific, and our IRT system needs to serve that complexity.”
Enabling direct-to-patient trials Being able to accurately track the temperature of individual units creates new opportunities for direct- to-patient (DTP) trials, too, says Kappelle – although there are still a few kinks in that process to iron out. Typically, a shipment will be sent to the patient from the hospital via a specialty courier, that will likely have a passive temperature logging device in the box. When the package has been delivered, the courier needs to open it and take out the device, stop it, and bring it back to the office to determine whether there was an excursion. “That’s kind of weird for two reasons,” says Kappelle. “One, I wouldn’t like the courier in front of me to open up my package and take something out. And the second thing is that, for a couple of hours, I don’t know if the product is good to use or not.” Real-time temperature monitoring here could instead give insight on the product’s condition at any moment, say via an app, which removes the need to not only open the box but to do additional checks back at the office. Ideally, adds Kappelle, the patient would also have an app that they could use to check the safety of the product and provide any necessary feedback. IRT can also provide the flexibility needed to organise DTP trials in the first place. “You need
18 Clinical Trials Insight /
www.worldpharmaceuticals.net
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