ABSTRACT

Biotechnology encompasses a wide variety of scientific, business, and operational endeavors in life sciences. Virtually every aspect of biotechnology has two common themes: to extend our knowledge of life sciences and to produce a product or service that someday will improve the condition of humankind. Biotechnology firms rely on both public or private financing and partnerships with traditional pharmaceutical firms to provide capital needed to reach their development goals. A metaphor to planning a biotechnology operation is taken from the organized development of the mammalian neural, muscular, and skeletal systems. Biotechnology operations have borrowed many concepts and operating principles from the drug industry. Indeed, both drug and biopharmaceutical development projects often focus on preventive and therapeutic biopharmaceuticals intended for use in humans. Product development planning is said to happen in a backward manner because the process begins with generation of a targeted product profile, which in fact is a draft of the product label with product claims.