Designing a Global Product Development Strategy

Pharmaceutical products are truly global in nature-not only in terms of usage but also in terms of the strategic location of different development activities. Clinical trials have been conducted at various locations around the world for years to meet recruitment goals and obtain approvals in multiple countries. However, with increasing worldwide harmonization of regulatory processes and intellectual property laws, and the highly interconnected global economic infrastructure, it makes good business sense to distribute the other steps in product development, such as discovery, early development and preclinical testing, as well. Almost every country accepts the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for clinical and nonclinical pathways for biomedical product development. This acceptance makes it easier not only to conduct multinational clinical trials but also to spread the front-end development steps, such as research and development and preclinical testing, around the globe. Companies use outsourcing and offshoring models to exploit the various regulatory and business incentives available in different countries. Overall, there is an increasing tendency for regulatory strategists and business leaders within a company to work together to create a product development strategy. Regulatory strategy identifies not only appropriate development pathways but also locations conducive to successful execution of the strategy. Company leadership identifies the feasiblity of implementing these pathways. Together, these two approaches form what could be called a regulatory business strategy (RBS), where regulatory pathways are evaluated in the context of overall business strategy. This article describes the various components of a product development strategy that utilizes multinational steps with a global market point of view.