Post Trial Supply

Compassionate Use in Action

Unmet Need:
Post Trial Supply
Solution:
Pre-Approval Managed Access Program
Europe

A global pharmaceutical company with a novel medicine for the treatment of migraine headaches had just completed a phase II clinical trial in the United States and had patients wanting to continue therapy.

The trial showed a significant reduction in occurrences in patients who did not respond to other treatment options. The pharmaceutical company wanted to maintain supply of the medicine to patients until it became commercially available in European Union (EU) countries.

gap-chart

Knowing of TannerMAP’s capabilities in operating Managed Access Programs, the pharmaceutical company contacted TannerMAP seeking a solution.

The pharmaceutical company did not want trial participants who were benefiting from its trial medicine to take a step backward.

TannerMAP worked with the pharmaceutical company to develop a solution. Initially, TannerMAP was able to ensure supply of the medicine by acquiring clinical trial stock from other global locations; subsequently, it was able to obtain supply directly from the pharmaceutical company once it obtained marketing approval in the United States.

To enable supply to clinical trial participants in the EU prior to EMA approval, TannerMAP managed the regulatory process in EU countries and provided insights on medicine usage for patients supplied through the Managed Access Program.

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