Session key points
- Drugs come from a number of sources. The focus of modern drug development is increasingly on novel technologies such as biopharmaceuticals, nucleic acids, and stem cells.
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Clinical drug development can be divided into two stages:
- An early 'learning' phase (usually Phase I and II)
- A later 'large scale confirming' phase (Phase III and IV) - Although the stage of drug development is still usually referred to by phase, the design of studies is often very different from the traditional four phase scheme given in textbooks.
- Many of the targets for modern drug development are aimed at disease modification. This presents considerable challenges for drug development as the type of endpoints in early exploratory studies may not translate into the important long term clinical endpoints of later studies.
- Drug development is long and complex. Management of risk, relating both to safety and to expenditure, is essential for effective development.
- Novelty alone is not enough for new medicines to be a success. It is vital that they demonstrate a clinically meaningful improvement in the benefit/risk equation compared with alternative therapies and are cost-effective for healthcare providers.
