Abstract
The first section of this chapter compares and contrasts the similarities and subtle differences between the subsectors of the industry overall. In subsequent sections the steps of the process are elaborated upon, mentioning how larger pharmaceutical companies and biotechnology groups approach the various steps in the process. This chapter comprises drug development research as its primary focus for familiarization with the drug development process and nomenclatures to be used. The pharmaceutical and biotechnology sector supports much of the research base for drugs, medical devices, drug–device combination products, diagnostics, nutraceuticals, and over-the-counter agents. In doing so there are numerous interactions with governmental research groups, such as the National Institutes of Health (NIH) and the National Cancer Institute (NCI), the academic world in both the basic sciences and clinical science, and with various regulatory bodies throughout the world. Basic research, clinical research, epidemiology, and consumer/marketing research all play a role in the overall development process. This chapter outlines the multiple types of research that are done by or supported by the pharmaceutical and biotechnology industry. Life in the pharmaceutical and biotechnology sector is demanding. Currency of information around a science and/or therapeutic area is essential. There are many opportunities and flexibility is an important attribute of the scientists. The stronger the person's science bases the more opportunities he/she may encounter. Interest in scientific communications, business, and management provides many and varied employment opportunities in both the pharmaceutical and biotechnology sector.
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