The Russian invasion of Ukraine continues to have a devastating impact on the lives of Ukrainian people and on global economies, affecting everything from food security to energy affordability. Where clinical supply chains are concerned, the conflict in eastern Europe is causing significant disruption.

With no inbound or outbound flights in Ukraine, and varying disruption to flights in surrounding regions including Belarus, Kazakhstan, Moldova, and Russia, assuring vital supply to patients is becoming increasingly challenging for sponsors operating in these clinical trial hotspots.

Effective planning is fundamental to developing optimized distribution strategies. But what happens when unplanned events unfold? What actions should be taken to ensure risk is mitigated and operational continuity upheld?

Prioritize business continuity

Unplanned events present themselves in many different ways, from disease outbreaks to volcanic ash clouds, adverse weather events, technology outages, and even war. Anticipating the risks and having business continuity plans in place will minimize disruption and protect patients.

To create a business continuity plan, all factors that could impact distribution in the regions a trial is taking place must be monitored, including political instability and legislative changes. Plans should relate to critical areas, including information security and local electricity infrastructure network and provide alternative solutions if ‘plan A’ is rendered unfeasible. This way, regardless of the significance of global issues that might arise, sponsors are prepared and can take well-considered steps to protect supply.

Plan what you can, prepare for what you can’t

While it is impossible to plan precisely for the unknown, sponsors can take steps to limit the impact of unplanned events by embracing supply chain agility.

This starts with developing strong, risk-based distribution strategies to support protocol needs at the earliest opportunity. Through review and analysis of each of the components that will influence the creation of an appropriate distribution strategy, sponsors will create optimized operations that are agile enough to respond to unforeseen events.

Central to this is understanding of both country requirements and product requirements. Compiling country-specific data, custom clearance times, shipping lanes, transit timelines, and the number of sites per country, will provide a “control tower” of information to support international drug distribution efforts. Likewise, reviewing product value, risk-level, how quickly and easily product can be replaced if destroyed, handling/temperature requirements and shelf-life will help inform optimized strategies that can minimize waste. 

Understand the impact on clinical supply

When disaster strikes, conducting a rapid assessment of the supply implications is essential before tailoring and enacting business continuity plans.

Sponsors should begin by assessing the timing for the initiation of any new patients, sites, and clinical studies. To gain a full understanding of where their IMP is positioned, its expiry date and volumes, supply inventories should be reviewed at each site. If a site is impacted, mitigations will need to be introduced to ensure displaced patients can continue accessing supply.

Mitigations that may be an option to help prioritize resupply to high-risk patients or sites include direct to patient distribution and site to site transfers to a nearby country, utilizing multimodal transport and non-typical routes. In relation to site transfers, sponsors will need to assess the feasibility of registering patient visits in different sites if the unplanned event has caused the original site to close. Site/patient transfers of clinical supplies may not always be possible, as is unfortunately the case in the Ukraine currently.

Keeping lines of communication clear and open with various stakeholders and establishing an informed operational approach and communication strategy, is advisable to deliver the effective collaboration needed to move with pace and purpose.

Extending projection windows and/or increasing site buffer stock of IMP and supply components in areas considered to be at imminent risk of secondary disruption can also be appropriate mitigations. As can evaluating procurement strategies and timelines.

Any proposed changes to supply should be incorporated into IRT design to ensure streamlined management of inventory and shipping logistics. This information can also be used to inform document preparation and pack/label set-up of patient kits. If changes are introduced, alternative distribution routes or scheduled import activities to impacted countries must be evaluated in conjunction with relevant regulatory notifications.

Keep a finger on the pulse

Global drug distribution is far from straight-forward at the best of times, but recent years have served to tear up the playbook.

When unplanned situations unfold mid-study that have the potential to derail distribution, rapid decisions must be made about continuing with recruitment and trial activity at impacted sites.

Responding responsibly and effectively requires continuous monitoring to identify the priority shipments and viable shipping lanes that will support the evolving distribution needs and minimize disruption.

By planning early, thoroughly, and often, and by developing effective business continuity plans, sponsors can operate with increased agility to minimize risk and deliver vital drugs to market. 

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Sharon Courtney is Logistics Services Manager at Almac Clinical Services. As an international logistics specialist having worked for over 21 years in clinical supply chain, she has expert knowledge in a number of key areas within the end-to-end supply chain process including management and control of temperature sensitive shipments; risk mitigation; developing and managing robust relationships with transport partners; chain of custody responsibilities; active and passive shipping solutions; and import/export country knowledge.