Drug Development: Challenges and Hurdles
Alfred Burger
Drugs are so much part of our lives that we give little thought to the road they have to travel in order to arrive in a bottle in the bathroom cabinet. We read news reports about physicians who cure dangerous diseases with medications, but these stories seldom mention what intellectual effort and technical skill led to the chemicals with which the patient was treated.
Few people understand what medications they use. When asked, they will explain that they take "a prescription," "green tablets,"and the slightly more knowledgeable take "pills for the heart" or "nerve pills." Another stratum of patients may know the trade name of a medicament, but almost none knows that the hundreds of drugs on the shelves of drugstores are products of research and development of about 40 or 50 of the great international pharmaceutical firms in the industrialized countries. Their number is shrinking every year because it now costs an average of $ 55 million to place a novel drug on the market. Few companies—only about 22 in the whole world—can finance such ventures and wait out the four to eight years of clinical trials that must satisfy the demands of regulatory government agencies.
