Challenge

A pharmaceutical company developing a disease modifying therapy for a neurodegenerative disease wanted to continue the supply of the investigational product to patients who had completed its Phase 3 clinical trials. These patients were initially receiving access to the medication via an open-label extension. However, when the open-label phase was discontinued, some patients found they were unable to enroll onto alternative clinical trials and were left with limited treatment options.

Solution

Working with WEP Clinical, the company set up an Expanded Access Program (EAP) to function as a cost-effective alternative to an open-label extension. This program helped patients who, in the opinion of the investigator, would benefit from continued treatment whilst the product underwent further research. As global experts in expanded access, WEP Clinical were able to set up the supply chain to the investigator sites in the participating countries of the original Phase 3 trial, to give patients the option of continuing treatment. In addition, by structuring the project as an EAP, access to the medication could be expanded to include patients who had not previously been enrolled in a trial, but who were suffering from the same condition with no satisfactory authorized therapies and no option to access an alternative clinical trial.