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Basic research helps us better understand how people and animals behave, develop and function biologically. Targeted research helps us to better understand diseases. Quality and safety research tests potentially harmful effects of a product. Within this complex landscape of research, studies involving animals are a small, but essential part of the medicines development path. Typically, animal studies represent only 5 to 10% of this process. On average, it takes ten to twelve years to develop a new medicine from concept to market. The average cost of this arduous process is nearly € 1 billion most of which relates to clinical trials in humans and to the administrative procedures for obtaining marketing authorisation and reimbursement. Over the last 10 to 15 years there has been an explosion of technologies in early drug discovery and development. Today, high throughput screening, tissue culture, bioinformatics and computational chemistry are routine technologies in the laboratories of pharmaceutical companies.
What are the various steps in the research process? First, the company identifies diseases and conditions that do not yet have any or adequate treatment. Then researchers look for promising molecules that might treat the disease. Scientists will use computer models and chemical or biological techniques to devise new molecules which may be active against the disease. They may synthethise around 10,000 such molecules in a year, which they screen to see if they could be effective. The actual research stage investigates only a very small amount of promising molecules. It is tested on cell cultures for its potential effectiveness at treating the disease and to look for any toxic effect. Molecules that perform well in the screening process are made in larger amounts. Then pre-clinical studies are conducted to help to assess the safety of the compound. The information from these studies will form the basis of the application to carry out clinical studies on people. So tests involving animals are undertaken later in the process to answer a specific scientific question, and when the answer cannot be obtained through other routes, or when required by law. Such research could relate to disease pathways, the compound’s distribution, metabolism and pharmacokinetics of a compound or be associated with providing essential information to make the decision about first clinical trial in man.
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