It is well known, that the pharmaceutical industry is struggling with increasing cost and length of R&D projects. Earnings of a drug drop drastically after patent expiration. Thus, the industry spends much effort on reducing Time-to-Market. In the literature, little attention is given to drug launching activities after the drug has been approved. In this paper, we present a recourse-based stochastic model, which allows for time phasing the market entries to balance the fluctuating demand with the fixed and periodic production of the active pharmaceutical ingredient. The two major risk elements during launch are forecasting inaccuracy and the risk of a required label change from local regulatory authorities. Robust solutions are found by implementing the Robust Optimization framework.
Computer-aided Chemical Engineering, 2011, p. 935-939