ABSTRACT
The pharmaceutical industry is experiencing great challenges in trying to maintain their profitability. Most governments and private payers are increasingly challenging the pricing of approved products. As a result of this trend, we are seeing that sponsors are trying to maximize efficiency of product development. There is an increased focus on quantitative methodologies and optimization. There is also an increased utilization of platform trials as a replacement to series of independent trials. While relevant methodologies have been developed, much more work on proper implementation of these methods and concepts is needed. This chapter will define Pharmaceutical Frameworks. At the high level, the role of Pharmaceutical Frameworks is to provide elements and procedures that enable optimization of Pharmaceutical programs and portfolios. The chapter also explains how to set-up Quantitative Frameworks that involve Platform Trials.
