The purpose of this talk is to provide a broad understanding of the process of developing a new drug. It begins with an overall industry perspective of this task, then progresses through the various stages of drug development from discovery up through FDA approval process, marketing and beyond. Devloping new drugs is a high-risk business, a long and costly venture. Only 1 in 5000 compounds synthesized and 1 in 5 tested in humans ever reaches the market.
Few drugs are likely to recover their investment costs.
The talk describes drug development process as it was done traditionally and the changes that have happened over the last decade and are happening now. It will also discuss briefly the way information technology is affecting the process.