Setting Up a 24/7/365 Emergency Medicines Supply Service for a Post-Approval Named Patient Program with Tight Timelines
Condition
Cancer
Drug Type
Approved
Where Approved
US
About Sponsor
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.
Challenge
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.
WEP Solution
To overcome this challenge, WEP Clinical developed a 24/7/365 emergency medicines supply service. We set-up a call-centre, which makes us available to physicians and hospitals at all times, including out of working hours, weekends and holidays. We also put together a response team made up of staff members who are on hand to receive requests, process orders and manage product delivery 24/7/365. We worked with the sponsor to ensure we had the infrastructure in place to store and handle the product at our global warehouse facilities, so we always have adequate supply on hand, locally, when a request is received. We can now guarantee the sponsor that we will deliver product no later than 48 hours after receiving a request, with most orders currently being delivered within 24 hours.
Outcomes:
Product delivered within 24hrs
750 units of drug have been shipped
81 hospitals currently in scope
Patients in 17 countries across 4 continents