Globalising clinical development in Japan

Abstract

Most global pharmaceutical companies, no matter where they are headquartered, are struggling to effectively integrate their Japanese operations into a new global structure. In the past, companies would have worked on development plans for the whole world ‘except Japan’. But those days are quickly evaporating and companies need to set out in a new direction. Japan is taking part in the trend for globalising clinical trials. Companies are working hard to leverage global operations and are quickly taking advantage of the opportunities offered by the Japanese government. Two typical approaches have emerged to address this emerging tide of globalisation. The first of these can be called, ‘mirror image myopia’ and the second, ‘Japan-centred syndrome’. Both of these approaches are attractive at first glance. However, the practicalities of the current environment demand that companies not try for a quick-hit, generic approach but rather a customised approach that matches their global strategy. Some practical ideas are presented to help avoid common pitfalls in globalisation relative to your Japan operations. In the end, by taking a balanced, strategic approach, companies can make the most of their global operations in Japan – whether these be Japan-based or globally based organisations.