Catarina Moreira Marques

Abstract

Abstract

Abstract
This paper presents an innovative approach to solve the product-launch planning problem in the pharmaceutical industry, with uncertainty on the product demand and on clinical trials. A mixed integer linear programming (MILP) model, incorporating Monte Carlo simulation (MCS), was developed for optimizing the process design (process-unit allocation and scale-up decisions) and for capacity planning (acquisition of new units), considering the products that still require development, and the products that are already in commercialization. MCS is performed in a two-step procedure, based on Normal and Bernoulli distributions, in order to capture the effects of demand variability and trials pass-fail uncertainty, respectively. Product-launch decisions are made taking into account the probability distributions of alternative process designs, of new capacity requirements, and of the coefficients of the objective function. The applicability of the proposed solution approach is demonstrated in an illustrative case study. © 2016 Elsevier B.V.