The question relates to safety of drugs in human. Adequacy, correlation and predictability of pre-clinical toxicity studies are a challenge. It has multiple dimensions – among them the most important being drug safety during clinical development and post-marketing safety; it is also decisive in determining time, cost and failures of drug development. The questions that I put forward to open discussion:

1. What is the future of Pre-clinical development?
2. How much should be in-vitro?
3. What is the predictability of In-vivo?
4. Can we replace in-vivo models with more in-vitro, to what extent?
5. By doing this can we reduce the cost of development?
6. Can we reduce time to development?
7. What should be done to bring more predictability into Pre-clinical toxicity development?