Uncertainty in drug development: insights from a Portuguese firm

摘要

Our study identified and analysed risks and uncertainties associated with the Drug Development Process (DDP) and managerial practices/methods to reduce them. Our approach was two-fold. First, we developed a theoretical model of risks/uncertainties and methods. Second, we performed an in-depth case study in a Portuguese firm to validate and enrich that model. We explain differences between theoretical and empirical insights and address key issues from the empirical study. Our final model has nine risk areas (divided in internal and external) and 15 methods (divided in outward and inward), and represents a significant instrument for further validation within pharmaceutical firms.