With supply chain disruptions becoming more severe and frequent in the past decade, moving from a reactive to proactive paradigm in clinical trials will help make strategic decisions easier, according to experts.
The prioritization of supply chains in clinical trial design was a key topic of discussion at the 2024 Outsourcing in Clinical Trials and Clinical Trials Procurement East Asia conferences, held in Seoul, South Korea, from December 3 to 4.
A report by GlobalData shows that supply chain breaches have become worse and more frequent in the last decade. Reworking supply chains is complex and expensive, with no quick fix. Cases where the chain cannot keep up with demand can create a shortage of medicine, which has recently been seen in the pharmaceutical industry with the popular drug Wegovy (semaglutide) for weight loss.
Fiona Barry, editor-in-chief and director of PharmaSource, GlobalData, explained in a session the main challenges of supply chains. Increased demand and shortages of active ingredients contributed the most to current drug shortages in the US, according to her analysis of the US Food and Drug Administration's (FDA) drug shortage database.
Panelists at the conference pointed out that supply chain logistics is often the “last cog” to be installed and often the forgotten area of clinical research. Since supply chains are not involved in strategic decisions, this can create constraints through manufacturing protocols and strategy. Emphasizing supply chains earlier in the clinical research journey could create trials that are more robust to disruptions.
For example, Amaury Jeandrain, clinical supply strategy consultant at N-Side, said: “If the supply chain could influence protocol design, we could have protocols that are friendly to the supply chain .”
Jeandrain explained that reducing drug waste can have a strong impact on supply chain costs, mediated through supply chain-friendly protocols.
Hye Jung Yang, a panelist and clinical project manager at MedPacto, took the defensive view, explaining that risk mitigation should be done before the trial begins. She said it is much easier to use data to predict issues than to deal with them once they happen.
An area that may be more difficult to predict, however, is unexpected disruption. Geopolitical issues are a major source of disruption in the supply chain, according to analysis by GlobalData. These situations, along with problems such as quality issues or computer shortages, are almost impossible to predict. Hurricane Helene, for example, created a severe shortage of intravenous (IV) fluid bags on the US East Coast due to flooding of facilities in October – this delayed several clinical trials in the area. In addition, discussions are ongoing about the potential disruption to R&D and manufacturing as a result of the BIOSECURE Act – legislation aimed at preventing Chinese biotechs and manufacturers from accessing and collaborating with US pharma companies using federal funding.
“To solve them, it is important to list your mitigation options, of which there are hundreds, understand if these solutions are feasible, at what cost, and prioritize them,” said Jeandrain.
In fact, the conference attendees were put into a political script themselves, after South Korean President Yoon Suk Yeol declared martial law on the evening of the first day of the conference. Although he quickly reversed his decision, shares in many South Korean pharmaceutical companies fell overnight, reflecting the volatility that businesses often face.
In another panel discussion focused on the air transport of medicines to clinical trials, experts again mentioned how difficult it is to deal with some situations but said that various processes can be carried out to prevent unnecessary delay.
Kangpyo Lee, vice president of cold chain shipping and transportation company HanulTL, discussed the no-fly zone over parts of Ukraine as part of the country's ongoing war with Russia, adding that pharmaceutical products would need to be flown to neighboring countries. The disruption of transport routes into Ukraine was a major factor in the disruption of clinical trial sites in the region. Lee explained that having “contingency plans” in place for even the most unlikely situations is essential for strong supply chains.
International Air Transport Association (IATA) Korea manager Baek-Jae Kim said cooperation between carriers and operators – along with regulatory compliance and compliance – is important for products to come through air borders without issue.
Panelists and speakers were unanimous in the need to embrace new technologies. In a snap poll conducted during one of the sessions, attendees said cost was the biggest barrier to implementing new systems that use AI and automation in general.
GlobalData analysis says innovative technologies are the answer to prepare for future disruptions. The report states that many areas of the medical supply chain can be automated, including inventory tracking, and management and restocking processes. Investment in AI-powered tools such as robotics and drones could also speed up manufacturing processes by helping with supply delivery.
The FDA has discussion welcome on the use of AI in drug manufacturing while highlighting the importance of a strong regulatory framework.
Barry said in a session: “There are challenges that the FDA has to work out if it is going to allow the implementation of AI in manufacturing. AI brings three main types of challenges to the pharma industry – intellectual property (IP) issues, ethical issues, and regulatory issues. We need careful coordination regarding its future use. “
“Experts call for shift from reactive to proactive clinical trial procurement frameworks” was created and originally published by Clinical Trials Arenaa brand owned by GlobalData.
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