Introduction
Drug development is a long, complex and expensive process. It involves the discovery of new molecules with potentially useful pharmacological actions in isolated tissues and organs. These molecules may then be tested in animal models and some will go on to clinical studies (i.e. trials involving human subjects).
The approach to drug discovery is changing. The first part of this session reviews where drugs have traditionally come from and where they are likely to come from in the future. It highlights the emergence of new techniques that allow candidate molecules to be synthesised more easily and based on accurate predictions of their likely molecular interaction with biological targets.
The second part provides an outline of the clinical phases of drug development, which can be divided into an early exploratory phase and a later confirmatory phase. It highlights how these phases build up knowledge about a drug that is eventually presented to the regulatory agency when an application for a marketing authorisation (license) is made.
The final part of the session explores some of the important issues related to drug development, including access to new medicines and managing risk during development.
Prescribers need to have an awareness of how drugs are developed to understand the extent of the financial risks involved in the process, why new drugs are sometimes expensive, and why there is a need to continue to gather evidence about their effects after they are licensed for use.
