(707c) An Approach for Estimating the Value of Computational Tools in Drug Product Development

Computational approaches to drug product development are beginning to become feasible for many types of dosage forms, and there is an opportunity to exploit these emerging tools in the pharmaceutical industry. However, as with any investment, it is important to understand the business case and potential financial benefits. In this work, an attempt has been made to objectively assess the value of emerging computational approaches to the development of solid oral dosage forms. This has involved collaboration between scientists working in this pharmaceutical development and business analysts with experience in estimating the value of productivity improvements, resource savings, and deferred expenditures. As a result of this work, the value of each of several investment areas has been estimated, so that the relative magnitude of the financial benefits can be understood and future investments can be planned appropriately. The development of a procedure for this type of financial analysis can serve as a model and benchmark for any future analyses of the benefits of computational tools in the pharmaceutical industry.