Session 3: Drug Development
Once a lead molecule has been found through the process of drug discovery, the process of drug development is used to bring a new pharmaceutical medicine to market. Preclinical research on microbes and animals is part of this process, as is requesting regulatory status, such as through the US Food and Drug Administration, to begin human clinical trials for an investigational new drug. It may also include the step of securing regulatory approval with a new drug application to market the drug. It normally takes more than ten years for a vaccine or medication to be approved, from concept to preclinical testing in the lab to clinical trial development, including Phase I-III trials.