Stage 1 Lead Finding or Establishing Directions One to Two Years

These are studies to understand how alteration of a biological function or mechanism would create a therapeutically useful entity or process. The strategic research of a particular company is usually guided by factors such as its inherent research competence and expertise, therapeutic areas of unmet medical need, and market potential. Market potential is the strongest motivation and as a result companies invest heavily in specific therapy areas. It is not difficult to label companies as cardiovascular, anticancer, and endocrine and other such focussed companies. It takes years, often decades, to pool the scientific and clinical expertise that would provide the combination of elements necessary for efficient new discoveries. However, in recent years, many large companies have begun to look outside for new drug leads; smaller research companies have often proven more efficient. Outsourcing of research, even at the level of research lead compounds, is now a common place, and companies like Abbott Laboratories have developed an expertise in securing new drugs from outside vendors. The in-house expertise development is not limited only to scientific expertise to provide a specific direction, but also at times to a specific type of product, such as biological drugs versus the small molecules, innovative drug delivery systems versus the traditional systems, and so on.

It is not uncommon for large companies to suddenly establish a direction through serendipitous discoveries. Alexander Fleming discovered penicillin as a result of "serendipity." Although many of the drugs that are in use today have been discovered in this way, it is a difficult route for the pharmaceutical industry to follow and breaks are few and far between. More recently, the discovery that the phosphodiesterase type 5 inhibitor (originally tested as antihypertensive agents) can be a good candidate for male erectile dysfunction has changed the focus of research at Pfizer, and as a result, at several other companies.

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