Clinical Aspects of Pharmaceutical Portfolio Management

Abstract

This chapter examines the clinical aspects of pharmaceutical portfolio decision-making – a key driver of shareholder value – from the perspective of an Executive Committee reporting on portfolio strategy to a Board of Directors. Areas that are particularly important for shareholder value include a thorough evaluation of manufacturing and clinical drug development costs, commercial expectations, and the clinical risk/benefit assessment for each product. Other ways to evaluate risks associated with portfolio management include competitive intelligence, due diligence, patent protection and regulatory exclusivity. Portfolio managers must be aware of biases that can be inherent in portfolio decision-making, balancing those factors that may artificially increase or decrease the estimated probability of registration or commercial success. Complex tools, such as including adaptive design principles, and large data software tools can also be utilized to minimize and mitigate the risk and bias embraced by both the R&D and commercial factors