Is poor research the cause of the declining productivity of the pharmaceutical industry? An industry in need of a paradigm shift

For the past 20 years target-based drug discovery has been the main research paradigm used by the pharmaceutical industry and billions of dollars have been invested into this approach. However, recent industry data strongly indicate that the target-based approach is not an effective drug discovery paradigm and is likely to be the cause of the productivity crisis the industry is experiencing. However, from a theoretical and scientific perspective the target-based approach appears sound, so why is it not more successful? The purpose of this paper is first to analyse the real-life implementation of the target-based approach to identify possible reasons for the high failure rate and second to suggest changes to the drug discovery approach, which can improve productivity.

► Despite huge investment in R&D Pharma has seen falling numbers of drug approvals. ► Most drugs fail due to lack of efficacy, suggesting the wrong drugs are developed. ► Simplistic approaches and poor scientific principles in R&D appear to be the cause. ► A paradigm shift is needed to improve our ability to develop effective drugs. ► The focus must be proper science, understand the clinic and understand the risks.