Insights on Temperature-Controlled Air Freight for Clinical Trials

Following is a summary of a Leading Minds Network powered by ELPRO virtual panel discussion titled Temperature-Controlled Air Freight: Global Logistics for Clinical Trials. Expert panelists were Chris Denton, Specialist, Pharma Compliance, Virgin Atlantic Cargo; Sonia Ben Hamida, Head of Special Cargo, International Air Transport Association (IATA); Mark Edwards, Global Trade & Compliance Manger, Kindeva Drug Delivery. Henry Moran, COO and Director of ASC Associates moderated the session. (Photo provided by Virgin Atlantic. All rights reserved.)

Clinical trials involve shipping temperature-sensitive materials like investigational drugs, biologics, and devices to sites around the world. Maintaining proper temperature control throughout the supply chain is critical. This webinar brought together experts across airlines, shippers, and regulators to share insights on temperature-controlled air freight for clinical trials.

Challenges in Clinical Trial Logistics

Henry Moran of ASC Associates opened up the session by asking Mark Edwards of Kindeva Drug Delivery about the main challenges from the shipper's perspective. Edwards explained that clinical trials are different from commercial pharma cargo, as they often involve small, time-sensitive, temperature-sensitive shipments for specific patients in a trial. He highlighted the critical need for continuous improvements in handling, end-to-end visibility, and quality assurance across the supply chain. “If that trial doesn't happen, if that trial is not successful, then we're adding years of time on years of cost onto developing drugs,” Edwards emphasized.

Chris Denton of Virgin Atlantic Cargo went on to acknowledge that clinical trial air freight shipments are specialized and they often “increase the risk of issues like missing shipments.” This is due to packaging that is typically smaller and passive. He outlined measures Virgin Atlantic takes to address those challenges, such as temperature mapping of cargo holds, using dedicated storage areas with log sheets and a first on/first off approach, loading cargo in trim order to minimize ramp exposure, and assigning a dedicated and specialized team of experts to manage and handle clinical trial shipments. This ensures smooth acceptance by reducing wait times with gatehouse and traffic light system on bays. Denton further agreed, “there are a lot of challenges due to differing capabilities of various stakeholders. So, for us it’s about managing those critical control points as best we can, within our abilities,” he added.

Reducing Temperature Excursion Risks

When the discussion moved to reducing temperature excursion risks, Denton suggested that placing visual indicators on packaging might help handlers see when its effectiveness is lowering. Edwards also proposed more information sharing from shippers on optimal handling requirements. “We take whatever protective solutions we can, we do risk assessments. However, we can’t get under the skin of an airport, we can’t get under the skin of an airline,” he noted.

Sonia Ben Hamida of IATA outlined the association’s focus on categorizing packaging solutions and keeping updated on new technologies through their Temperature Control Regulations (TCR) program.

Preventing Mishandling and Losses

On preventing mishandling and losses, Edwards advocated that “airlines adopt technologies like automated scanning and tracking used by integrated carriers.” Denton acknowledged the need to reduce manual handlings with automated systems and noted airlines are open to data sharing systems and technologies like monitoring devices, as long as they meet safety requirements.

Ben Hamida explained IATA's efforts around standardizing the approval and use of tracking devices. She highlighted the importance of data sharing and visibility. “Once you have devices, you have the data. And with this data, each actor, each stakeholder, is able to have the potential to improve, optimize, and increase efficiency of the supply chain,” Ben Hamida noted.

Specialized Handling for Clinical Trials

Regarding specialized handling for clinical trials, Denton indicated that while airlines focus on overall service levels and priorities, they indeed listen to customer needs. “Temperature control storage is provided where possible regardless of service. Instead, the focus of our pharma product is guaranteed uplift and shorter close out times; making sure shipments are available on time and in good condition for last mile delivery. But we do listen to the industry and customer requirements and look to enhance clinical trial handling and increase efficiencies wherever possible,” Denton explained.

Edwards emphasized the importance of communication from shippers. “As a shipper highlighting that this is a clinical trial shipment, I want you to be aware of the impact and sensitivity. Then you can build a solution on a shipment-by-shipment basis,” he said.

Moving from Dry Ice to Phase Change Materials (PCMs)

When asked about transitioning from dry ice to phase change materials, Edwards shared his experience of successfully switching a high-value temperature-sensitive product from dry ice to phase change packaging, which can be more efficient and sustainable. However, he acknowledged the growing complexity for stakeholders as shippers adopt more solutions. He also emphasized that collaboration is key. “We appreciate that we’re giving them a much more complex problem. So, we have to share with all stakeholders what our needs are, and what our requirements are with this new technology. We've got to work as a group to overcome the challenges,” Edwards explained.

Overview of IATA CEIV Pharma Certification

Finally, Ben Hamida provided an overview of IATA CEIV Pharma certification, which covers the end-to-end air transportation supply chain with a focus on continuous improvement through industry collaboration. She emphasized the need to understand shipper requirements. “This is really the goal of the certification program, going beyond the minimum standards and providing flexibility and guidance,” Ben Hamida noted.

Key Takeaways

In summary, the discussion highlighted the unique needs of clinical trial shipments and the importance of communication, data sharing, and collaboration between shippers, airlines, regulators, and other parties to drive continuous improvement. As Edwards noted, "We all face very similar challenges. But rather than doing it individually, if we create that community environment, then we can all work to meet some of those challenges and come up with solutions."