SME Opinion Piece

Managing Clinical Supply Chain During Geopolitical Unrest

In recent weeks, many logistics experts have been closely monitoring the escalating situation in the Middle East. My feed has been filled with news of flight cancellations to Israel—last week alone, AIR EUROPA, AIR France, AMERICAN, BRUSSELS, LUFTHANSA, AUSTRIA, SWISS, UNITED AIRLINES, DELTA, and KLM all halted flights. While EL AL continues to operate, US security checks can lead to temperature excursions, as checks don’t occur under controlled conditions. Challenger Airlines (CAL) has very limited flights, while UPS is still servicing Israel through Belgium, the Netherlands, and France, but small package volumes take priority, potentially delaying larger shipments. Many courier companies are seriously considering stopping air transport altogether, transitioning to ground delivery via Jordan or Egypt, and then onward by air after inspections.

These developments bring back memories of managing supply chains in the post-Soviet region during periods of unrest, regime changes, and armed conflicts. Drawing from that experience, I would like to share some key observations about how such events typically unfold and what sponsors can do to respond quickly to an ever-changing context.

Consider Budget Implications and Be Ready to Buffer Costs

Sponsors must be prepared for significant increases in logistics costs during geopolitical unrest. As flight routes are cancelled or rerouted, freight rates can skyrocket. Local vendors may also increase prices to cover their own operational risks and rising costs.

To manage these budget implications, sponsors should:

  • Buffer the logistics budget: Plan for freight costs to rise several times over, especially in high-risk areas.
  • Negotiate new terms with local vendors: Work closely with local partners to understand their challenges and negotiate terms that allow for flexibility in pricing, as well as transparency in any additional costs.
Diversify Supply Routes and Balance Risk vs. Patient Access

Geopolitical unrest often means that regular supply routes are no longer viable. Sponsors should work closely with freight forwarders to diversify transport options and ensure continuity of supply. Here’s how:

  • Engage with multiple freight forwarders: Don’t rely on a single logistics provider. Having relationships with multiple forwarders ensures that if one fails, another may have an alternative route.
  • Implement multi-modal transport: Explore a combination of air, sea, and ground freight. For example, some sponsors have successfully rerouted shipments via neighbouring countries and then used ground transportation to the destination.
  • Establish regional hubs: Consider setting up regional depots or storage hubs near affected areas. These can serve as temporary storage points, ensuring that supplies are still available even if main routes are cut off.

When balancing risk and patient access, prioritize patient safety. Sponsors may need to increase buffer stocks in high-risk areas or even move patients to safer regions if necessary.

Securing Biosample Transport During Crisis

Ensuring that biosamples reach central labs safely during unrest requires thoughtful planning. Here are strategies for frozen and ambient samples:

  • Set up regional depots: If political unrest makes transport to central labs difficult, consider setting up regional depots where samples can be stored temporarily in controlled conditions. Frozen samples can be kept in freezers, and ambient samples in temperature-controlled environments until transport is feasible.
  • Work with local labs: In some cases, centralizing biosample testing may not be practical during unrest. Sponsors should explore partnerships with local or regional labs that have the capability to process biosamples without compromising the study’s quality and compliance. Once stability returns, the remaining samples can be transported to the central lab.
  • Crisis zone expertise: Couriers experienced in crisis zones will be familiar with the local customs regulations, border crossings, and the necessary documentation to move biosamples through unstable regions.
  • On-the-ground support: Some couriers provide personnel or resources in affected areas who can ensure that biosamples are handled with care and that local challenges are addressed immediately, such as customs delays or last-minute route changes.
  • Coordinate with clinical sites: Clinical sites need to be informed about the transport schedule and any potential delays in biosample pickups. This ensures that ambient samples are collected and sent as close to the departure time as possible to maximize their shelf life during transit.

Additionally, splitting shipments into multiple routes or sending samples in batches can reduce the risk of total loss if one route becomes inaccessible.

Conclusion

Geopolitical unrest presents unique challenges to managing clinical supply chains. However, by focusing on real-time communication, building local inventories, diversifying transport routes, and using specialized shipping solutions for biosamples, sponsors can maintain patient access and trial continuity. Sponsors must also be prepared for cost increases, working closely with logistics providers and local partners to ensure safe and timely delivery of investigational products and biosamples. By taking proactive steps and maintaining flexibility, sponsors can navigate these disruptions while minimizing the impact on clinical trials and patient care.

Picture of Den Volkov

Den Volkov

With over 14 years of experience in the pharmaceutical and biotech industry, Denis is a supply chain expert who specializes in providing solutions for late stage clinical trials in EEU and MENA regions. As the Director, Supply Chain Operations at WEP Clinical, Denis is responsible for overseeing the global supervision of unlicensed drug supply chain under Named Patient and Expanded Access Programs, as well as setting up project-based distribution culture and supportive QMS.

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