OUTSOURCING SUPPLY OPERATIONS
pre-printed on the label and the latter added at Sponsors may have two protocol stickers
attached to the same drug product, and the irrelevant sticker can be taken off at the trial site. That then leaves the details of the trial in which the medicine is eventually used, Berthelot says.
Expense misconceptions addressed JIT is a fairly recent concept in drug development, despite longevity in other sectors. And so, preconceptions and hesitations may cause sponsors to shy away, says Almac JIT supply chain solutions manager in Northern Ireland, Lyn McNeill. Perhaps the most common misconception is that JIT is a more expensive method of assuring supply compared to ones a company is used to. JIT requires sponsors to run smaller operations more frequently, which many assume removes the economies of scale advantage, McNeill explains. However, it’s important to look at the bigger picture, because even though initial overheads of JIT may be higher, the scales soon tip back to JIT’s favour with eventual cost savings in waste reduction, shortened timelines, ability to pool supplies across multiple protocols, and lower investment for accountability and destruction, she notes. Forecasting is critical for JIT. With only small batches of drugs purchased at a time, there is a need to predict how enrolment might look at is how much risk is a sponsor willing to take in terms of buying a small amount of product? And some sponsors are not willing to take that risk.” But JIT allows for a quick reaction. Purchasing can be increased or adjusted according to enrolment speed, he adds.
The switch from JIT to a traditional model is possible
Another is the perception that JIT is only suitable for small studies. But JIT can also example, JIT can be used at the start of a study where the demand can be unpredictable and location of patient population unclear, she says. Once enrolment has stabilised, operations can switch to a more traditional approach. The tipping point for a switch requires planning and
18 | Clinical Trial Supply Handbook
early communication on expectations to ensure process alignment and smooth operations down the line, she adds. A hybrid model featuring JIT and a traditional approach is also an option. This can be ideal in trials with multiple arms where some treatments are optimal for JIT in terms of price and drug availability, McNeill explains. JIT may require more administrative effort.
(QP) to review every label as it goes out, and that would be laborious to do one at a time, the label management expert says. One answer may be automation, where the QP can get an image of the label and approve it electronically, or the task can be outsourced to companies that provide QP, he adds.
Zooming out, JIT relies on a tightly controlled network of drug product and substance supply, packaging and labelling, product release, distribution, and storage. All this needs careful orchestration to be successful, Schroeder of PCI Pharma says. And if any link in the chain is compromised, delivery to the patient could potentially be disrupted, he adds. Schroeder notes his company aggressively fosters a culture of proactive communication and risk mitigation strategies, but also leverages available technologies.
Flexibility is critical with current events Current events further underscore the reality raw material shortages and supply chain trial hotspots until recently but, with recent events, sponsors may re-evaluate their clinical strategy and decide the drugs supplied to those countries would be better repurposed, Schroeder adds. Still, compassionate and ethical reasons are added factors for deciding. Supply chain challenges argue for innovation.
and not just assume you can’t do it. It is not unprecedented, and you can learn from others’ experience,” Mooney says. that are brought to us are evolving – innovation doesn’t stand still. JIT may be able to provide a solution to future challenges that are yet to appear.”
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