Forecasting resource requirements for drug development long range planning

摘要

This thesis investigates the use of a task-based Monte Carlo simulation model to forecast headcount and manufacturing capacity requirements for a drug development organization. A pharmaceutical drug development group is responsible for designing the manufacturing process for new potential drug products, testing the product quality, and supplying product for clinical trials. The drug development process is complex and uncertain. The speed to market is critical to a company's success. Therefore, it is important to have an adequate number of employees and available manufacturing capacity to support timely and efficient drug development. The employees and manufacturing capacity can either be supplied internally or externally, through contract manufacturing organizations. This thesis formulates and empirically evaluates a simulation model designed using the Novartis Biologics drug development process and is adaptable to other pharmaceutical organization. The model demonstrates 7% accuracy when compared with historical data, and estimates within 13% of the currently accepted manufacturing capacity forecasting tool. Additionally, three case studies are included to demonstrate how the model can be used to evaluate strategic decisions. The case studies include: a drug development process improvement evaluation, an outsourcing evaluation, and an "at risk" development evaluation.