The pharmaceutical/biotechnology industry is confronted with a number of challenges as it tries to bring new products to patients in need. These challenges include rapidly increasing costs, long cycle times, and low probabilities of success. If these challenges are not effectively dealt with, the ability to deliver pharmaceutical innovation to patients will be severely jeopardized. Given the magnitude and complexity of the problem, no single solution is likely to completely solve the problem Rather it will take a multifactorial approach to address the issues confronting the development or new drugs. One set of potential solutions lies in the better management of drug development projects through the application of the project and capacity management disciplines. This paper will report on how the design, development, and validation of a capacity management system for a pharmaceutical product research and development function can help in part address these challenges. Despite the positive benefits of capacity management, it will take other changes of a more profound nature to significantly alter the cost and time it takes to bring a new drug to patients in need. However, a well-designed capacity management system can facilitate and evolve to accommodate more profound changes. (C) 2009 Elsevier Ltd. All rights reserved.