Managing Global Trial Supply Risk: Expert Insights

Christy Owings, Vice President and General Manager of the Americas business unit, Thermo Fisher Scientific, connected with PharmTech to discuss the growing complexity of global clinical trial supply chains. Owings has spent more than 16 years with the company, all within clinical supplies delivery, and now oversees 18 sites across North and South America.

"I think what we see is that clinical trials as a whole are becoming ever globalized and more complex,” Owings says. Rising complexity puts a premium on early planning and a solid global supply chain infrastructure, she adds.

Owings points to Latin America as a region where sponsors often underestimate the logistics involved in bringing investigational product across borders. Sponsors need a green-light-to-ship process in place before importation, plus documentation staying consistent across every filing. Without this, a shipment can sit in customs, exposed to temperature excursions putting drug product and trial timelines at risk.

Mexico's random screening process illustrates the stakes, Owings says, since transportation timelines can extend with little warning. When a large quantity of bulk drug product intended for patients is held up with no clear point of contact, the effects ripple across an organization.

"It's stressful for the supplies organization, it's stressful for the clinical organization, it's stressful for the entire company," she says.

Owings' recommendation centers on partnership: working with an importer of record with an established relationship with regional customs authorities, in-country expertise, and a track record sponsors can rely on. Coordinating shipment approval ahead of transport, she added, reduces the odds of a hold-up once product is in transit.

The goal is straightforward: get investigational material to its destination safely, on schedule, and without unnecessary delay to patients waiting on trial data.