Geotherapeutics: Changing the paradigm of global drug development

The successful discovery, development and marketing of new pharmaceutical products is a complex, time consuming, and expensive process. This is particularly true when marketing approval must be sought from a number of regulatory agencies around the world, each of which represent constituencies that are significantly varied ethnically, politically, and socially. Supported by the International Conference on Harmonization (ICH) process and working together with regulatory agencies, the pharmaceutical industry has been moving towards the implementation of global development strategies that would support simultaneous filings in the three ICH regions (United States (US), European Union (EU), and Japan) as well as non-ICH regions. The recent ICH E5 guidelines serve to provide a framework for evaluating the potential impact of ethnic factors on efficacy and safety endpoints for a particular dosage or dose regimen. These guidelines serve as a first step in the evolution of truly global development programs. The next generation strategy will involve the prospective identification of critical success factors for multi-national trials and simultaneous registration in multiple countries. We have termed this strategy, Geotherapeutics, to reflect the importance of a keen understanding of geographic variation in therapeutics - and all this entails - in the design of truly global development programs.