Biomedical, Biopharma and Clinical Research

Drug Discovery and Drug Development

Drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, like penicillin. More recently, chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to spot substances that had a desirable therapeutic effect in a process known as classical pharmacology. After sequencing of the human genome allowed rapid cloning and synthesis of huge quantities of purified proteins, it's become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells then in animals for efficacy.

Drug development is that the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, like via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and should include the step of obtaining regulatory approval with a new drug application to market the drug. The whole process from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials – to approved vaccine or drug typically takes quite a decade.