The Pharmaceutical Industry

The challenges for new medicines

In the last two centuries and more particularly during the last century, the pharmaceutical industry has managed to develop many new molecules that helped to save millions of lives. Many diseases are now addressed by existing medicines, although many are still not able to be treated appropriately. The process often begins with a "target", being a particular molecule or biological entity for which new chemicals are being designed and tested. Typically thousands of molecules have to be screened before a "hit" is effective and the "lead" moleculed is optimised. After that, the new compound has to to undergo extensive safety tests before being allowed to be tested in people (in the "clinic", hence the term "Clinical Development"). The drug development process is complicated and costly. Many strict guidelines have to be followed, for example "GLP" (Good Laboratory Practice), "GCP" (Good Clinical Practice) and "GMP" (Good Manufacturing Practice) and if these are not followed properly, the authorities will not give approval. New drugs are protected by patents which provide the manufacturer exclusivity for 20 years from the patent grant, which means that by the time development is complete, a new drug will have exclusivity for around 10 years, which in turn is a reason for a price which is appropriate to recover the costs of research and development of the particular project but also of the other projects that have failed.