The sponsor is a global specialist healthcare company that develops and commercialises medical products for critical care, cancer and other serious disorders. The patient communities they serve typically have limited treatment options available to them.
The sponsor received FDA approval for an important rescue medicine that is used to save a patient’s life after an overdose occurs on a specific cancer treatment. To serve an unmet clinical need, the company wanted to find a way to also make this drug available to patients outside the US. The sponsor decided to partner with WEP Clinical to provide a Post-Approval Named Patient Program (PA-NPP), which would supply the drug on an unlicensed basis in Ex-US countries. However, as this is a rescue medicine, the drug must be administered within a matter of days.
This meant WEP Clinical had to find a process that allowed requests to be fulfilled and drug delivered within 48 hours anywhere in the world.