In this chapter, the life history of a successful drug will be outlined (summarized in Figure 4.1).

A number of different strategies are adopted by the pharmaceutical industry in their efforts to identify new drug products. These approaches range from random screening of a wide range of biological materials to knowledge-based drug identification. Once a potential new drug has been identified, it is then subjected to a range of tests (both in vitro and in animals) in order to characterize it in terms of its likely safety and effectiveness in treating its target disease. The developer will also undertake manufacturing-related development work (development and initial optimization of upstream and downstream processing; Chapters 5 and 6), as well as investigating suitable potential routes of product administration.

After completing such preclinical trials, the developing company apply to the appropriate government-appointed agency, e.g. the Food and Drug Administration (FDA) in the USA, for approval to commence clinical trials (i.e. to test the drug in humans). Clinical trials are required to prove that the drug is safe and effective when administered to human patients, and these trials may take 5 years or more to complete. Once the drug has been characterized, and perhaps early clinical work is underway, the drug is normally patented by the developing company in order to ensure that it receives maximal commercial benefit from the discovery.

Upon completion of clinical trials, the developing company collates all the preclinical and clinical data they have generated, as well as additional pertinent information, e.g. details of the exact production process used to make the drug. They submit this information as a dossier (a multivolume work) to the regulatory authorities. Regulatory scientific officers then access the information provided and decide (largely on criteria of drug safety and efficacy) whether the drug should be approved for general medical use.

If marketing approval is granted, the company can sell the product from then on. As the drug has been patented, they will have no competition for a number of years at least. However, in order to sell the product, a manufacturing facility is required, and the company will also have to gain manufacturing approval from the regulatory authorities. In order to gain a manufacturing licence, regulatory inspectors will review the proposed manufacturing facility. The regulatory authority will only grant the company a manufacturing licence if they are satisfied that every aspect of the manufacturing process is conducive to producing a safe and effective product consistently.

Pharmaceutical biotechnology: concepts and applications Gary Walsh © 2007 John Wiley & Sons, Ltd ISBN 978 0 470 01244 4 (HB) 978 0 470 01245 1 (PB)

Figure 4.1 An overview of the life history of a successful drug. Patenting of the product is usually also undertaken, often during the initial stages of clinical trial work

Regulatory involvement does not end even at this point. Post-marketing surveillance is generally undertaken, with the company being obliged to report any subsequent drug-induced side effects/adverse reactions. The regulatory authority will also inspect the manufacturing facility on a regular basis in order to ensure that satisfactory manufacturing standards are maintained.

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