The uppers and downers of drug development. Why do some drug projects succeed in development while others fail? An exploration into the conditions associated with the success and failure of UK rare cancer drug projects.

摘要

The organisation of drug development has radically changed in the last 40 years due to changes in the scientific knowledge base and the availability of new forms of finance. Stimulated by breakthroughs in biotechnology, new investment has facilitated changes to the strategies and structure of the industry. Furthermore, scientific advances have provided greater understanding of disease, drug targets and disease-drug interactions, particularly in oncology. Yet new ways of organising innovation bring new challenges. This thesis provides evidence to inform new policies and business models by assessing the non-technical conditions associated with the success and failure of drug development projects. The thesis presents an integrative theoretical framework that supports a multi-dimensional analysis of the network, organisation and individuals involved in drug projects. This approach is applied to case studies of 11 development projects for rare cancer drugs involving UK organisations. These cases are then compared and contrasted through a descriptive multi-case analysis and a Qualitative Comparative Analysis.ud udThe findings contribute towards an understanding of the environmental conditions for the successful development of drugs. Firstly, the concept of project drag is introduced, to draw attention to the accumulation of issues during development that can cause projects lose momentum and lead to termination. The organisational environment around firms is found to be key; common disruptions are identified, particularly within small firms which are more vulnerable to industrial dynamics than larger organisations. This thesis also highlights mechanisms that can mediate adverse conditions; key individuals, their networks, power and consistent enthusiasm for projects can mediate project drag. The thesis also makes a methodological contribution in the formation and operationalisation of an integrative framework for project evaluation which provides a foundation for further research in this area. The thesis is concluded with policy recommendations of pathways that contribute towards the successful development of drug projects.