Experts call for a shift from reactive to proactive clinical trial supply frameworks

Contingency plans amid geopolitical uncertainty was a theme highlighted in panel discussions. Credit: Golden Sikorka / Shutterstock 

With supply chain disruptions becoming worse and more frequent over the past decade, moving from a paradigm of reactiveness to proactiveness in clinical trials will help ease strategic decision-making, according to experts.

Prioritising supply chains in clinical trial design was a key topic of discussion at the 2024 Outsourcing in Clinical Trials and Clinical Trial Supply East Asia conferences, held in Seoul, South Korea, from 3 to 4 December.

A report by GlobalData demonstrates that supply chain disruptions have become worse and more frequent over the past decade. Reworking supply chains is complex and expensive, with no quick fixes.  Instances where the chain cannot keep up with demand can create medicine shortages, seen most recently in the pharmaceutical industry with popular weight loss drug Wegovy (semaglutide).

Fiona Barry, editor-in-chief and director of PharmaSource, GlobalData, outlined in a session the key challenges to supply chains. Increased demand and shortage of active ingredients contributed the biggest share for current drug shortages in the US, according to her analysis of the US Food and Drug Administration (FDA) Drug Shortages database.  

Panellists at the conference highlighted that supply chain logistics is often the “last cog” to be implanted and often the forgotten area of clinical research. Because supply chains are not involved in strategic decisions, this can create constraints throughout protocols and manufacturing strategy. Emphasising supply chains earlier on in the clinical research journey could create trials that are more robust to disruptions. 

For example, Amaury Jeandrain, clinical supply strategy adviser at N-Side, said: “If supply chain could influence protocol design, we could have protocols that are supply chain friendly.”

Jeandrain explained that reducing drug waste can have a strong impact on supply chain costs, mediated via supply chain-friendly protocols.

Hye Jung Yang, panellist and clinical project manager at MedPacto, echoed the preventative standpoint, explaining that mitigating risk should be conducted before the trial has commenced. She added that using data to predict issues is much easier than reacting to them once they occur.

An area that might be harder to predict, however, is unforeseeable disruptions. Geopolitical issues are a key source of supply chain disruption, according to analysis by GlobalData. These scenarios, along with problems such as quality issues or compotator shortages, are nearly impossible to predict. Hurricane Helene, for example, created significant shortages in intravenous (IV) fluid bags on the US East Coast due to facility floodings in October – this delayed several clinical trials in the area. In addition, discussions are ongoing about the potential disruption to R&D and manufacturing from 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’s important to list your mitigation options, of which hundreds exist, understand whether these solutions are implementable, at what cost, and prioritise them,” Jeandrain said.

Indeed, attendees at the conference were thrust into a political script themselves, after South Korean President Yoon Suk Yeol declared martial law on the evening of the conference’s first day. Though swiftly U-turning on his decision, shares in many South Korean pharmaceutical companies dropped overnight, demonstrating the volatility industries often face.

In another panel discussion focusing on the airfreight of medicines to clinical trials, experts again alluded to the difficulty in reacting to some scenarios but maintained that various processes can be conducted to prevent unnecessary delays.

Kangpyo Lee, vice president of cold chain container and transport company HanulTL, discussed the no-fly zone over parts of Ukraine as part of the country’s ongoing war with Russia, adding that medicinal products had to be flown to nearby countries instead. The disturbance to transport routes into Ukraine was a key factor in the disruption to clinical trial sites in the region. Lee explained that having “contingency plans” in place for even the most unlikely scenarios is a necessity for robust supply chains.

The International Air Transport Association (IATA) Korea manager Baek-Jae Kim said that collaboration between shippers and operators – along with adherence to regulation and compliance – is important for products arriving through air borders without issue.

Panellists and speakers were unanimous in the need to embrace new technologies. In a snap poll conducted in one of the sessions, attendees said the biggest barrier to implementing new systems that use AI and automation more generally is costs.

GlobalData analysis states that innovative technologies are the answer to preparing for future disruptions. The report states that many areas of the medical supply chain can be automated, including inventory tracking, and managing and restocking processes. Investing in AI-powered tools such as robotics and drones could also speed manufacturing processes by assisting in supply delivery.  

The FDA has welcomed discussion on AI’s use in drug manufacturing while highlighting the importance of a robust regulatory framework.

Barry said in a session: “There are challenges that the FDA will need to work out if it’s going to allow 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’re going to need careful coordination on its future use.”