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.

Abstract
This study addresses the product-launch planning problem in the chemical-pharmaceutical industry under technical and market uncertainties, and considering resource limitations associated to the need of processing in the same plant products under development and products in commercialization. A novel approach is developed by combining a mixed integer linear programming (MILP) model and a Monte Carlo simulation (MCS) procedure, to deal with the integrated process design and production planning decisions during the New Product Development (NPD) phase. The Monte Carlo simulation framework was designed as a two-step sampling procedure based on Bernoulli and Normal distributions. Results show the unquestionable influence of the uncertainty parameters on the decision variables and objective function, thus highlighting the inherent risks associated to the deterministic models. Process designs and scale-ups that maximize expected profit were determined, providing a valuable knowledge frame to support the long-term decision-making process, and enabling earlier and better decisions during NPD.

Abstract
The implementation of efficient strategic decisions such as process design and capacity investment under uncertainty, during the product development process, is critical for the pharmaceutical industry. However, to tackle these problems the widely used multi-stage/scenario-based optimization formulations are still ineffective, especially for the first-stage (here-and-now) solutions where uncertainty has not yet been revealed. This study extends the authors' previous work addressing the stochastic product-launch planning problem, by developing a new Multi-Objective Integer Programming model, embedded in a unified decision-making framework, to obtain the final design strategy that "maximizes" productivity while considering the decision-maker preferences. An approximation of the efficient Pareto-front is determined, and a subsequent Pareto solutions analysis is made to guide the decision process. The developed approach clearly identifies the process designs and production capacities that "maximize" productivity as well as the most promising solutions region for investment. Moreover, a good balance between investment and capacity allocation was achieved.

Abstract
This study presents an assessment of the main research problems addressed in the literature on New Product Development (NPD) and its methodologies, for the pharmaceutical industry. The work is particularly focused on the establishment of an evolutionary perspective of the relevant modelling approaches, and on identifying the main current research challenges, considering the fast-changing business context of the industry. Main findings suggest a generalized misalignment of recent studies with today's technological and market trends, highlighting the need for new modelling strategies.

Abstract
The chemical-pharmaceutical sector is facing an unprecedented fast-changing environment, with new market and technological trends impacting the companies' operational strategies. Managing the pharmaceutical supply chain (PSC) operations is, therefore, ever more complex and challenging. The goal of this work is to present a comprehensive overview of the current state of the industry and research developments; and then, to develop a new decision-making reference framework to assist in the creation of optimization-based decision support models. This will be achieved through a multi-perspective analysis that encompasses strategic and tactical planning decision-making, in the current and future business context of the chemical-pharmaceutical industry. The findings reveal a lack of research addressing the most prominent trends currently driving this sector, such as patient centricity or new technological developments, thus highlighting the disruptive nature of the expected changes in a highly conservative industry.

Abstract
In a world facing unprecedented challenges, such as climate changes and growing social problems, the pharmaceutical industry must ensure that its supply chains are environmentally sustainable and resilient, guaranteeing access to key medications even when faced with unanticipated disruptions or crises. The core goal of this work is to develop an innovative simulation-based approach to support more informed and effective decision making, while establishing reasonable trade-offs between supply chain robustness and resiliency, operational efficiency, and environmental and social concerns. Such a decision-support system will contribute to the development of more resilient and sustainable pharmaceutical supply chains, which are, in general, critical for maintaining access to essential medicines, especially during times of crises or relevant disruptions. The system will help companies to better manage and design their supply chains, providing a valuable tool to achieve higher levels of resilience and sustainability. The study we conducted has two primary contributions that are noteworthy. Firstly, we present a new advanced approach that integrates multiple simulation techniques, allowing for the modeling of highly complex environments. Secondly, we introduce a new conceptual framework that helps to comprehend the interplay between resiliency and sustainability in decision-making processes. These two contributions provide valuable insights into understanding complex systems and can aid in designing more resilient and sustainable systems.