Workshop: Drug Development and Toxicology

Researchers all over the world develop new drugs and billions of euros are spend on this. Thousands of new chemical entities or proteins are designed and tested in vitro and in vivo. The step from bench to bedside is in most cases a huge hurdle and most experimental drugs never reach the clinic. Obviously new drugs are tested in animal species to assess safety and efficacy before they are being tested in humans. However, mice, rats or any other animal species are not similar to man. The metabolism of drugs varies significantly between different animal species and consequently the effects in man are difficult to predict. Adverse effects may be completely absent in mice yet lethal in man. How can this be tested? How safe are drugs before they go into man for the first time? In particular new protein-based drugs such as antibodies create new problems. How to test new drugs to prevent toxic effects in patients? How to bring new drugs as quickly as possible to the clinic yet protect the patient from unsafe drugs? Situations where drugs have to be removed from the market with great losses should be prevented, yet sometimes it happens.

There is no clear answer, but this session will highlight some new insights and show some possible solutions. At least it can make you aware of the complex problems and the long way new drugs have to follow before they reach the patient.