The Pharmaceutical Industry
Harris, Wayne T., Diversity Employers
The pharmaceutical industry provides tremendous opportunities for career development for college graduates. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), total domestic sales for member companies have increased an average of 11.5% per year from 1970 to 2002. It is this stable growth in sales, which allows for growth in career opportunities. The top areas for college recruitment by this industry are: science, engineering, health professions, finance, marketing and information technology. The member companies of PhRMA include Pfizer, Novartis, Aventis, Eli Lilly, Abbott, Glaxo Smith Kline, Bristol-Meyers, Novo Nordisk and Astra Zeneca.
The previous growth in sales and expectations for the future are fueled by several important trends. First of all, an aging population has an increased need for health care, including prescription medications. It is important to note that development and use of new medicines have contributed significantly to the increased life span that we now enjoy. Secondly, developments in genomics research will result in new approaches to treatment and prevention of disease and a wide variety of new types of pharmaceutical agents. Thirdly, the growing concerns regarding bioterrorism have affected the entire world. Products of the pharmaceutical industry are crucial for adequate response to attacks using biological or chemical weapons.
The development of new drugs requires a substantial investment in research and development. Knowledge of the research and development process allows for a better understanding of the nature of pharmaceutical industry.
The average cost of developing a new drug has increased from $138 million in 1975 to $802 million in 2002, according to the PhRMA. In addition to the financial costs, an average of ten to fifteen years is required to develop a new drug while only 1 of 5000 screened compounds is approved for use as a new medicine. A patent is secured once a new chemical compound is created or identified for a particular biological effect. The United States provides a 20-year patent term and as noted earlier, from ten to fifteen years is required to conduct the required research and development on any new chemical entity.
The research and development process is divided into several stages.
1. Preclinical/prehuman studies
2. Phase I clinical trials
3. Phase II clinical trials
4. Phase III clinical trials
5. Phase IV (Post-marketing Surveillance)
Preclinical studies focus on all the scientific disciplines and are involved with appropriate laboratory tests to assure purity, develop analytical procedures, and assure effectiveness in laboratory models of disease and animal models. In addition, marketing analysis and business planning are conducted simultaneously. If this first stage succeeds, the chemical is tested for safety in humans. This step requires submission of an Investigational New Drug (IND) Application to the United States Food and Drug Administration and approval by that agency. Phase I clinical trials focus on demonstrating safety when administered to humans. The manufacturer sets up a research protocol involving healthy volunteers in which doses of the investigational new drug are administered. The purpose of these experiments is to determine whether the drug causes any side effects and the severity of those effects. If the drug survives the safety study, which could take two or three years, the manufacturer will begin Phase II trials in which small-scale experiments in patients with the condition to be treated are used to conduct an effectiveness study. Once those studies are done, the manufacturer undertakes more complicated Phase III clinical trials to determine whether the drug will work in large groups of people with the disease. Successful results through this process will allow for submission of a New Drug Application to the Food and Drug Administration. …