adjusting to new brexit landscape while providing an EXPANDED ACCESS program
Condition
Gastrointestinal Stromal Tumors
Drug Type
Investigational
Trial Phase
Completed Phase 3
About Sponsor
The Sponsor is a global pharmaceutical company focused on designing and developing precision therapies for cancer, rare diseases and immunotherapy. With headquarters in the US, the sponsor has a diverse portfolio of newly FDA and EMA approved products as well as promising investigational medicines in its pipeline.
Challenge
The sponsor has had an EAP in place with WEP Clinical since 2018 that involved receiving the study drug at our UK warehouse facility and shipping out from there to EAP sites.
However, following the UK’s exit from the EU at the beginning of 2021, there were a number of supply chain and logistical issues that had to be addressed quickly in order to ensure there was no disruption to treatment access.
WEP Solution
In preparation for Brexit, the WEP Clinical team strengthened our company’s EU distribution capabilities by setting up warehousing facilities in Lisbon, Portugal and Rheinberg, Germany. To avoid dealing with any disruptions or additional fees when shipping to and from the UK, WEP Clinical repositioned EAP supply from our UK site to the new Lisbon and Rheinberg sites. During the process of making this change, our excellent working relationships with the Sponsor as well as our distribution partners meant that any issues, delays or deviations were handled effectively and always with the EAP patients’ best interests in mind.
Outcomes:
The program has been running for 3.5 years
Over 5600 units of drug have been shipped
612 patients have been approved into the EAP
Patients in 31 countries* across 5 continents
*Argentina, Australia, Austria, Belgium, Canada, Croatia, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Oman, Poland, Russia, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UK, US