A drug development from risk management perspective

Hulín, Michal

The purpose of this diploma thesis is to understand financing of drug development from an enterprise risk management perspective as well as to critically assess the efficiency of the ISO framework and risk management techniques used for determining whether to fund drug development or not. The diploma thesis is divided into theoretical and practical part. The first part starts with perception and assessment of uncertainty and risk in the past. It describes how risk-averse individuals attempted to deal with uncertainty and different risk. This is followed by the evolution of traditional risk management into the fast developing enterprise risk management. The text further analyses commonly used risk management standards COSO ERM and ISO 31000:2009. However, the main focus is on the critical assessment of analytical tools which are frequently used for evaluating and assessing risks, especially financial ones, during drug development. The theoretical part is finished by a drug development process, whose phases are briefly described. The practical part was written in co-operation with AstraZeneca, a top-notch pharmaceutical company. The overview of its business is preceded by an explanation of current issues in the pharmaceutical industry. Furthermore, the risk analysis is conducted with respect to the ISO framework. Subsequently, selected risk assessment techniques are applied on the simplified financial model of two different drugs, which was created based on AstraZeneca's real data. These risk assessment tools are used in different phases of drug development so it could be seen clearly how the results are changing during a project. The outcomes of this risk analysis are compared with original plans used by AstraZeneca which were used for deciding whether to fund drug development or not.

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