Title: Uncertainty in drug development: insights from a Portuguese firm

Authors: Irina Saur-Amaral, Joaquim Jose Borges Gouveia

Addresses: Department of Economics, Management and Industrial Engineering, University of Aveiro, Campus Universitario de Santiago, 3810-192 Aveiro, Portugal. ' Department of Economics, Management and Industrial Engineering, University of Aveiro, Campus Universitario de Santiago, 3810-192 Aveiro, Portugal

Abstract: 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.

Keywords: pharmaceutical R&D; research and development; innovation; drug development process; DDP; risk management; uncertainty management; risk modelling; uncertainty modelling; risk mitigation; Portugal.

DOI: 10.1504/IJTIP.2007.016306

International Journal of Technology Intelligence and Planning, 2007 Vol.3 No.4, pp.355 - 375

Published online: 16 Dec 2007 *

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