Focusing on supply chains before starting a clinical trial can help develop protocols that can withstand delays, unlike current approaches that experts say rely primarily on being reactive to issues as they arise.
“[Supply chains] are often forgotten because they are the very last part of clinical research. That leaves clinical supply chains with many constraints: the protocol, the systems and the manufacturing strategy,” says Amaury Jeandrain, clinical supply strategy advisor at N-Side.
Jeandrain added that because the clinical supply is not involved in strategic decisions, they become a limitation in the chain.
Jeandrain spoke as part of a panel discussion at the Outsourcing in Clinical Trials and Clinical Trial Supply East Asia, held in Seoul, South Korea, from December 3 to 4.
A report from GlobalData shows that supply chain disruptions have become worse and more frequent over the past decade. Reworking supply chains is complex and expensive, and no quick fixes exist.
Hye Jung Yang, clinical project manager at MedPacto who was also on the panel, reiterated the preventative stance, explaining that risk mitigation must be done before the trial has begun. It’s much easier to use data to predict problems than to respond to them as they happen, she added.
One example that came up in the discussion was clinical trials using comparators. Unlike standard care, which can often be purchased locally, the supply of comparator medicines is complex and subject to delays. This includes packaging and labeling, adding time to trial timelines that are often limited.
Jeandrain said focusing on supply chains earlier and building trials around them could have a more meaningful impact.
“If the supply chain could influence the design of protocols, we could have protocols that are supply chain friendly,” he said.
Jeandrain explained that reducing drug waste can have a strong impact on supply chain costs, mediated through chain-friendly protocols.
One area that is harder to predict, the panel agreed, is geopolitical issues. Seoul itself was involved in one fell swoop on the first evening of the conference after President Yoon Suk Yeol declared martial law. Although he quickly reversed his decision, shares of many South Korean pharmaceutical companies fell overnight.
Jeandrain divides supply chain disruptions into two categories: foreseeable and unforeseeable. Predictable issues, such as minor shipping delays and temperature fluctuations, should be taken into account, he says. But the unforeseeable disruptions, including geopolitical disruptions, quality issues and shortages of comparison materials, are “a lot more complicated.”
