Simulation-optimization approach to clinical trial supply chain management with demand scenario forecast

In the pharmaceutical industry, the development activities that are required to bring a new drug to market involve considerable expense (upwards of $1 Billion) and can take in excess of 10 years. Clinical trials constitute a critically important and very expensive part of this development process as the associated supply chain encompasses producing, distributing and administering the candidate therapy to volunteer patients located in different geographic regions. A number of different approaches are being pursued to reduce clinical trial costs, including innovations in trial organization and patient pool selection. In this work, we focus our attention on improved management of the clinical supply chain. A simulationoptimization approach is presented, including patient demand simulation and demand scenario forecast, mathematical programming based planning, and discrete event simulation of the entire supply chain. Three case studies with different demand types are reported and compared to demonstrate the utility of the proposed approach. © 2012 Elsevier Ltd. All rights reserved.