USING EXPANDED ACCESS to treat various patient groups

Condition

Solid Tumors

Drug Type

Investigational

Trial Phase

Completed Phase 3

About Sponsor

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.

Challenge

The sponsor had an existing EAP with WEP Clinical which was set up for adult patients. As the wider patient population became more aware of the program, the sponsor began receiving requests from pediatric patients.

To deal with these requests, the sponsor wanted to create a separate EAP specifically for pediatric patients.

WEP Solution

WEP Clinical worked hand in hand with the sponsor to create the pediatric (PEDs) EAP. While the program was being set-up, a single pediatric patient was enrolled in the initial adult EAP, as they could not wait for treatment. This patient was then transferred to the PEDS program, with the other pediatric patients, once it was opened.

Additionally, WEP has effectively sourced the compound used to prepare the investigational product and provided it to ex-US sites that are unable to access the formulation in their country.

Outcomes:

0

The program has been running for 1.5 years

0

Over 3250 units of drug have been shipped

0

89 patients have been approved into the EAP

0

Patients in 13 countries* across 4 continents

*Argentina, Austria, Canada, Czech Republic, France, Germany, Ireland, Italy, Malaysia, Spain, Taiwan, UK, United States

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