It takes an average of 10 to 12 years (1) to bring a new drug from the discovery stage to the market, and it costs approximately US $802 million (2). This is a very risky process, as only one out of 10 new Investigational New Drugs (IND) entering into the clinical research phase will reach the market (3).

It is understandable that the drug-discovery process leading to a first introduction in humans requires extensive scientific research. In view of economic reality, shareholders and financial analysts look to pharmaceutical companies for large returns on their investments. Each pharmaceutical company

has its own research portfolio of potentially marketable compounds. This portfolio is often referred to as "the pipeline,'' and a "blockbuster" is a compound that, at maturity, generates annual revenues of, or in excess of, one billion US dollars. "Blockbusters" generally fulfill a very important medical need, such as curing or alleviating serious symptoms of a disease, or helping to control pain and suffering, with minimal side effects, and no toxicity.

So many drugs have been discovered and are currently in use that it becomes more and more difficult to discover new ones for new or existing diseases. It is in some ways the Everest syndrome where we are already climbing the highest peaks. While it is not impossible to discover new drugs through simple serendipity like Fleming with Penicillin, the process nowadays is much more systematic and involves very controlled steps to insure efficacy and safety of all products reaching the market.

This first chapter briefly explains the sequential research and development process carried out in the pharmaceutical industry. A large body of knowledge needs to be acquired in order to identify, validate, and develop potentially active substances that may effectively interfere with the course of the disease. As information specialists, we play a key role in supporting each step along the way.

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