navigating fda approval while providing treatment access through an EXPANDED ACCESS program
Completed Phase 3
The Sponsor is a global pharmaceutical company focused on developing treatments for cancer and other serious diseases through novel epigenetic medicines. They are committed to improving the standard of care for patients and physicians by creating medicines that are targeted at specific causes of diseases. Their goal is to ensure their medicines are easy to administer and tolerable.
The sponsor received a FDA approval for a specific indication for its investigational drug. The drug was being provided through an EAP, managed by WEP, for multiple indications.
As a result, the sponsor needed to identify the patients with the approved indication and transition them over to commercial supply. At the same time, the sponsor needed to ensure the remaining patients continued to receive treatment through the EAP without any disruption.
Working alongside the sponsor’s commercial team and medical affairs group, WEP assisted in successfully transitioning applicable patients to commercial supply. The investigational product was provided until the commercial drug was received by each respective patient. The remaining EAP patients continued to receive treatment through the program without any change.
As a testament to the efficiency and productivity of the PM team, WEP was also awarded the Investigator Sponsored Trials (IST) program for management and distribution in the US.
The program has been running for 1.5 years
Over 2800 units of drug have been shipped
145 patients have been approved into the EAP
Patients in 21 countries* across 5 continents
*Argentina, Australia, Belgium, Canada, China, Czech Republic, Estonia, France, Germany, India, Italy, Israel, Luxembourg, Malaysia, Netherlands, Singapore, Spain, Switzerland, Taiwan, UK, US