Case Study

Breakthrough-Designation Increases Stress On Clinical Supply Chain

Source: Sherpa Clinical Packaging
Breakthrough-Designation Increases Stress On Clinical Supply Chain

Portola Pharmaceutical’s Andexanet Alfa has been specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors. Approximately one to three percent of patients given anticoagulant Factor Xa inhibitors experience a major bleed, and another 1% of patients require emergency surgery. Major bleeding is associated with an increased risk of severe complications and death. If approved by the FDA, Andexanet Alfa would become the first universal antidote for Factor Xa inhibitors, thus the FDA has granted the drug Breakthrough Therapy designation.

Andexanet Alfa’s breakthrough designation added significant pressures to Portola’s planned clinical studies, accelerating their pace and putting added stresses on the clinical supply chain. This necessitated speedy changes in logistics and clinical supply. Running multiple trials in several countries, with finite drug supplies, complicated matters even further.

Sherpa Clinical Packaging’s built-in flexibility, creative problem-solving, and speed were instrumental in keeping Portola’s multiple clinical studies on track. Sherpa was responsive in the face of ever-changing clinical supply requirements, a common issue with trials for Breakthrough drugs.