ABSTRACT
Drug development decisions are complex as they involve many functional considerations and input from many disciplines in the pharmaceutical company. The clinical and regulatory teams tend to focus on options that satisfy Food and Drug Administration (FDA) requirements and help the asset to gain market authorization as quickly as possible with the least amount of clinical risk. Validation of forecast assumptions generally requires a mix of market research and analogue analyses. Drug development and commercialization decision-making often requires tough trade-offs between regulatory requirements, access needs, development investment requirements, launch timing and probability of clinical success. The decision-making process needs to include a clear identification of critical objectives for success beyond FDA approval, an identification of multiple development options that are aimed at meeting each of these objectives and a robust analysis of the impact of each of the development strategy options on commercial forecast and resulting risk adjusted net present value.
