Case Study: Post-Trial Access
PTA Continuity Across Europe and Latin America
30 Patients. 23 Sites. 10 Countries.
The Challenge
A US pharmaceutical company with a portfolio of oncology products had completed a phase 3 study for monotherapy treatment of a rare kidney cancer. While the trial failed to meet its primary endpoint in the study, some patients were still responding to treatment. The studied drug already had US FDA and EMA approval in another indication, and the company wanted to support trial patients wishing to continue with treatment. With trial sites in Europe and Latin America, the company had out-licensed commercial rights for the product in the approved indication to a commercial partner for Europe, but had retained the rights for Latin America.
Our Approach
Tanner worked with the company to identify the regulatory pathways that would need to be followed in each country, including submission of a post-trial access protocol in Brazil. For each investigator that expressed interest in continuing treatment for patients, Tanner supported the site with navigating the regulatory pathway for access. For sites in Latin America, Tanner sourced US-labeled product from the company in the US. For sites in Europe, Tanner purchased commercial product from the company's European partner, stored the product at a Tanner warehouse in Germany, and labeled product to comply with local regulatory requirements.
