Case Study - Managed Access Solutions
193 patients. 2 indications.
One mission - Move faster.
The Challenge
A global biopharmaceutical company developing a treatment for a rare liver disease needed specialist support in early access and market readiness. After facing setbacks with another vendor, they turned to Tanner Pharma Group, recognised for its agile, compliant, and patient-centric access solutions.
Their goals were twofold — to address an urgent unmet medical need, and to build early engagement with key opinion leaders (KOLs) and treatment centres to ensure a successful commercial launch in Europe.
Our Approach
Working in close partnership with the sponsor, Tanner designed a comprehensive Early Access Programme (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 Impact
The programme now supports 193 patients across two therapeutic indications, with medicines provided free-of-charge in future commercial markets and for-charge in non-commercial territories.
Tanner continues to manage the transition to commercial supply in the EU, while real-world evidence from the programme contributes directly to FDA and EMA submissions for a new orphan indication.
Beyond the Programme
Tanner also helped the sponsor launch a charitable access programme for low- and middle-income countries (LMICs), ensuring equitable global access to treatment. To relieve supply-chain pressures,
Tanner provided clinical labelling, packaging, and distribution services, conserving commercial inventory and optimising global logistics operations.
How we deliver
