Statistical Modeling Identifies Optimal Clinical Supply Strategy

A top tier global pharmaceutical company was preparing for a Phase III trial of a biosimilar immunology treatment and was under time and budget pressure to develop and execute a flawless supply plan. The sponsor was in a race to market, and the go-live date for the trial was set. In preparation, the sponsor had already procured enough of the expensive comparator drug to match its first three production campaigns for the investigator drug.

There were a number of challenges that the sponsor faced such as; would the supplies on hand be sufficient to meet patient demands, could the supplies be used in time to avoid wastage despite the fact that they were due to expire in eight months, could distribution match demand given that the sites had limited space in which to store the patient kits?

Almac worked with a business partner who specializes in advanced analytics to simulate various demand and supply scenarios. Almac’s Supply Chain Management (SCM) experts ensured that the initial assumptions on which the simulation was based on were accurate and detailed enough to support a robust model.

Based on the output of the simulation model, and in consultation with Almac’s SCM experts, the sponsor was able to select a supply strategy that presented an acceptable level of risk.

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