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 case study highlights the clinical supply challenges that come with the breakthrough-therapy designation, and offers a look at possible solutions.
The Significance of Portola’s Andexanet Alfa
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.
Clinical Supply Management Solutions
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.
As Portola was given rolling recommendations from the FDA on how to proceed, their clinical supply needs changed at a moment’s notice. Sherpa’s responsive project management, in-house label printing capabilities and rapid turnaround times on production and batch records allowed Portola to meet expedited timelines for all Andexanet Alfa studies.
The strength of Sherpa’s global depot network ensured that all of Portola’s international clinical sites had the necessary supplies as they were needed.
“We needed our drug product delivered faster than what we and Sherpa had planned. Our project manager at Sherpa was a champion at getting her team together, performing last-minute labeling when we needed and getting it distributed to the site when we needed. It showed how dynamic Sherpa is and how available they are to help their customers.”
–Kimberlyn Seideman Commercial Packaging Manager
Sherpa and Portola created a trusted partnership and collaborated closely to keep Andexanet Alfa studies on track. Creative packaging, responsive and flexible project management and operational systems and a strong global depot network have kept disruptions to a minimum. All trials are running optimally, and Andexanet Alfa is poised for regulatory approval in the U.S. and E.U.