Case study 21

Company U’s lead programme was completing its global Phase 3 pivotal study. The company had decided to enter the Japanese market on its own but did not have a clear roadmap of how to build the local organisation. A team of experienced Japanese regulatory, supply chain and commercial experts were put together. The team put together a step-by-step capability building plan taking into consideration the likely timing of the launch and the scale of the organisation to be built. The company, then, was introduced to local functional experts that started to provide interim cover for key functions.