Pharmaceutical medicine, drug development

FIG. 1. Pharmaceutical drug development events, a simplified view. Preclinicah Medicinal chemistry, combinatorial chemistry, process research. Clinical. Process R D Manufacturing (operations). 

In order to encourage pharmaceutical companies to invest in orphan drug development, legislation provides for a number of incentives. These include application fee waiver (the extent of reduction varies with the region of the world, and in the European Union it is 50% for all fees since 2002), market exclusivity and protocol assistance. In the European Union, there is 100% reduction in the fee applicable to the provision of any scientific advice. The fund made available by the Community for fee exemptions for orphan medicinal products amounts to= 3 700000 in 2005. 

One of the developments that has contributed substantially to the improved quality of drug development is the emergence of Pharmaceutical Medicine. Pharmaceutical Medicine is the discipline concerned with the medical aspects of research, development, evaluation, registration, monitoring and marketing of medicines in the interest of patients. In Great Britain a Diploma in Pharmaceutical Medicine was introduced in 1975, and in 1989 the Faculty of Pharmaceutical Medicine was established as part of the Royal College of Physicians. Subsequently, similar developments took place in other countries. 

Thalidomide was born out of the Pharmaceutical Industry in the 1950s. At that time the Pharmaceutical Industry comprised a multitude of competing Companies, many of which were not dedicated to drug development, with few or no laws governing development and marketing. Chemie-Griinenthal, who developed thalidomide, was a subsidiary of a soap and cosmetics manufacturer (Dali Werke, Maurer, and Wirtz). Many new medicines were simple concoctions... 

Kennedy S.P. and B.J. Bormann (2006). Effective partnering of academic and physician scientists with the pharmaceutical drug development industry. Experimental Biology and Medicine 231 1690-1694. 

---