Integrating Drug Supply Issues with Strategic Preclinical and Clinical Development

Abstract

The clinical research phase accounts for almost one-half of all the development costs for a new drug. As a result, activities that attempt to coordinate and link the manufacturing, preclinical, and clinical aspects of a program can have a significant impact on the time required to develop a product. There are a number of key activities in each discipline where critical information needs to be shared and activities need to occur in parallel. Since each discipline's priorities must occur together, synchronous convergence of the activities need to be coordinated. Early in the development process a company needs to consider the market, where the studies will be performed, supply requirements and shipping logistics, and how this will all be orchestrated to achieve the end result, an approved product.