Chapter 2 - Elements of Drug Discovery and Development

Abstract

This chapter summarizes the strategy and tactics of drug discovery and development and describes an organizational structure in which pharmaceutical industry chemists work. Efforts to create drugs originate a variety of jobs for organic chemists, many of whom work in fully integrated pharmaceutical companies. The employers engage them in six basic operations: discovering, developing, registering, manufacturing, marketing, and monitoring drugs. Medicines fall into three broad functional categories—diagnostic, prophylactic, and therapeutic. Diagnostic products detect or probe diseases, while prophylactic agents prevent them. Many prophylactic agents are biological products, such as vaccines, although some are small molecules, such as ascorbic acid (vitamin C). Therapeutic agents treat diseases and are usually small molecules. To manufacture drugs in these three classes, special companies exist throughout the international pharmaceutical industry. Some drug companies carry out no preclinical chemical or biological research at all and nor any process chemistry or production. These companies are clinical research organizations (CROS), which contract to take experimental drugs through phases I–III of human studies. Moreover, other pharmaceutical companies exist not to market drugs without discovering lead compounds but to find lead compounds without selling finished drugs. Drug discovery firms—an outcome technological innovations—are newcomers in the industry.