Early Access Program to Support EU Market Access193 Patients. 2 Indications.

The Challenge

A global biopharmaceutical company developing a treatment for a rare liver disease needed specialist support in early access and market launch readiness. After facing setbacks with another vendor and with an EMA approval approaching, they turned to Tanner Pharma, recognized for its speed of execution and agile, compliant, and patient-centric access solutions.

Their goals were twofold: address an urgent unmet medical need and build early engagement with key opinion leaders (KOLs) and treatment centers to ensure a successful commercial launch in Europe.

Our Approach

Working in close partnership with the sponsor, Tanner designed a comprehensive Early Access Program (EAP) aligned with global regulatory requirements. This included developing patient identification and screening tools, physician and site education materials, and a multi-channel awareness campaign to reach eligible patients faster.

A secure, GDP-compliant supply chain was established to maintain product integrity and enable rapid, reliable delivery to clinical sites worldwide. Real-world data (RWD) collection was integrated from the outset to generate regulatory-grade evidence supporting both current and future indications. The program now supports 193 patients across two therapeutic indications.