OUTSOURCING SUPPLY OPERATIONS
Just-in-time: on schedule to rescue the clinical trial supply chain?
Just-in-time has clear implementation pluses in clinical trials, especially amid global supply chain issues. But uptake is yet to peak, says Reynald Castañeda.
T
he inventory management approach just-in-time (JIT), when used in clinical trials, allows flexibility in the supply chain in addition to reducing waste, which can cut costs. Yet, despite these advantages, some sponsors are yet to dive in.
services vice president Craig Mooney. “Some companies might not see the value as they don’t have the tools to measure how much waste there is in their clinical trials. Or some companies rationalise the waste due to imprecise forecasting of required clinical supplies.” JIT uptake is nascent. There have been pilot studies and proof-of-concept one-off instances of JIT use, but the industry is slow to evolve. There is a desire to keep with the status quo that is familiar and comfortable, adds PCI Pharma global vice president of product development and commercialisation Justin Schroeder.
JIT in clinical trials means companies would
only need to build a smaller stockpile of drugs at a time, instead of larger batches, as much as six months to multiple years’ worth of supply. JIT also allows last-minute labelling before the supply is sent to its destination. This is opposed to labelling and packaging far in advance, meaning supply is committed to a Clinical trial sponsors’ reservations stem
from concerns in navigating regulatory requirements, especially in multi-country trials. There is also the expense of having to steer
16 | Clinical Trial Supply Handbook
the company’s clinical trial strategy to adopt a JIT approach. There are hesitations around potential operational issues, and a perception And yet, JIT remains an intriguing option, especially with global supply chain challenges further exaggerated by current events.
Different JIT flavours in clinical trials There are different elements to JIT. Clinical trial sites that work on a drug development programme with multiple trial protocols can put on appropriate labels once supply is used, Mooney says. Alternatively, a local or regional depot can apply the protocol label before it goes to the trial site, or the trial packaging facility adds the label when the drug is assigned to a country, he notes. JIT is based on immediate demand, says
BAP Pharma business development director Luigi Galuffo. As a result, labelling, packaging and release need to happen quickly, with the drug shipped immediately to the site, he adds. But without JIT, especially for multi-country trials, an upfront purchase means labels may need multiple languages. A translation accuracy review is required, which often results in long lead times, Schroeder notes. The biggest argument for JIT is reducing
costs. In fact, it can reduce overage and drug waste by around 50% on average, Galuffo says. With a traditional supply approach, if the trial recruits slower than expected, there is a risk of drug expiry, which leads to wastage, he explains.
If the sponsor has multiple trials of the same
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