2015 Volume 14 Issue 3 Pages 161-170
The development of pharmaceuticals is an extraordinarily unique process. However, the aspects that are unique in comparison with other industries have never been clearly explained, either academically or practically. Clinical trials are an emblem of the uniqueness of pharmaceutical development; however, using industry-specific ideas and vocabulary do not enable cross-industry comparisons. This paper analyzes the product development process of pharmaceuticals using a problem-solving model that can be applied to comparisons across industries, and organizes the characteristics as well as effective management techniques. From the problem-solving perspective, the pharmaceutical development is unique because it requires the generation of numerous alternative solutions and complex testing. There exist products or industries that share one of these two characteristics, but only a few products or industries share both the characteristics. These characteristics closely relate to product development management of pharmaceuticals. In other words, considering the cost of product development, it is difficult to simultaneously create many alternatives and conduct complicated tests. Therefore, pharmaceutical companies focus on creating many alternatives in the upstream development process, and then testing in the downstream process, responding to this problem by balancing between the two characteristics and switching at the appropriate time. Determining the timing of this switch is one of the most important management techniques that impacts the performance of pharmaceutical development.