The development of our understanding of disease processes and the resulting discovery of new drugs for their treatment has improved the quality of life throughout the world. It is estimated the world-wide expenditures for ethical pharmaceuticals reached over $300,000,000,000 in 2000. In the US during 2000, sales of prescription drugs amounted to $112,000,000,000. According to the Pharmaceutical Research and Manufacturer's Association, $25,600,000,000 was invested during 2000 on the research and development for the next generation of pharmaceuticals. The Bureau of Labor Statistics states that approximately 330,000 people are employed in the US pharmaceutical industry. Estimates for world-wide industry employment are over 1,000,000. Unfortunately, even with this level of effort dedicated to the eradication of disease, it is estimated that only 1/3 of all diseases known can be causally treated and cured.

Society has made, and continues to make, a significant investment in people and money for this industry. However, there are very few people that understand the entire process of drug discovery and development. How are drugs discovered? How are they developed? How much money is required to bring a new chemical entity to market? What types of people are involved in this effort? What training is required to start a career in the pharmaceutical industry? What are the trends in the therapeutic areas? What are the latest techniques used to discover new drugs? What efforts are being made to streamline the cost of R&D and therefore reduce the cost of prescription drugs?

The practice of using chemical agents to treat disease is not new. Extracts from plants (such as ephedrine, reserpine, caffeine, opium, quinine and hundreds of other biologically active compounds) have been used for thousands of years by "healers" to treat a variety of physical ailments. While natural products were the basis for the pharmaceutical industry, the formal start of the industry has been fixed to 1935 when sulfonamide antibacterials were introduced for general use. The industry has made significant accomplishments in its attempts to cure disease over the last 60 years, however, there are still several areas which lack effective treatment options.

The primary goal of the pharmaceutical industry is to find, develop, and market new chemical entities (NCEs) which can be used against untreatable diseases, or which have superior properties when compared to currently available drugs. This is not an easy, or inexpensive task. Scientists from several disciplines must be able to apply their collective knowledge to define their objectives and overcome the obstacles which are encountered during the testing and formulation of a potential new drug. The development process is time-consuming, labor intensive, and expensive. This series of courses will examine drug development from several points of view.

A.   An Overview of the Industry



  1. What is a Drug?
  2. Therapeutic Areas
  3. Industry Segments and Members
  4. Industry Objectives
  5. Facts and Figures for the Industry
  6. Industry Buzz-words (Frequently Used Terms)


B.   Drug Development: The Short Story



  1. Discovery Research
  2. Compound Development
  3. An Overview of the Process
  4. Time Lines
  5. Attrition Rate
  6. Cost of Drug Development
  7. Combining the Figures
  8. Return on Investment
  9. Summary


C.   Discovery Research



D.   Compound Development



E.   Post-Marketing Surveillance



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