The Biotech Business Handbook : How to Organize and Operate a Biotechnology Business, Including the Most Promising Applications for the 1990s

One comment often repeated to me by coworkers in the biotechnology industry deals with their frustration at not understanding how their particular roles fit into their company's overall scheme for developing, manufacturing, and marketing biomedical products. Although these workers know their fields of specialty and responsibilities very well, whether it be in product research and development, regulatory affairs, manufacturing, packaging, quality control, or marketing and sales, they for the most part lack an understanding of precisely how their own contributory pieces fit into the overall scheme of the corporate biotechnology puzzle. The Biotech Business Handbook was written to assist the biotechnologist-whether a tech­ nician, senior scientist, manager, marketing representative, or college student interested in entering the field-in building a practical knowledge base of the rapidly expanding and maturing biotechnology segment of the healthcare industry. Because biotechnology in the United States and abroad covers many disciplines, much of the information presented in this book deals with the biomedical diagnostic aspects of the industry. Business subjects for the most part unfamiliar to technically oriented people, such as the types of biotechnology corpo­ rations, their business and corporate structures, their financing, patent, and trademark mat­ ters, their special legal issues, and the contributions of their consultants are treated in a manner designed to make them clear and understandable. Front Matter....Pages i-xviii The World Biotechnology Industry....Pages 1-25 Preparing to Enter the Biotechnology Industry....Pages 27-41 Corporate Organization....Pages 43-59 Management Considerations....Pages 61-76 Legal Issues in Biotechnology....Pages 77-91 Biotechnology Funding....Pages 93-122 Biotechnology Project Development....Pages 123-128 Biotechnology Product Development....Pages 129-140 Quality Control....Pages 141-150 Quality Assurance....Pages 151-159 Manufacturing....Pages 161-173 Regulatory Compliance....Pages 175-196 Marketing the Technology....Pages 197-210 Troubleshooting Products After Release....Pages 211-215 Safety in the Biotechnology Workplace....Pages 217-231 Support Services and Facilities....Pages 233-246 Immunodiagnostic Assays....Pages 247-272 Nucleic Acid Probe Assays....Pages 273-303 Human Genome Initiative....Pages 305-330 Bioremediation....Pages 331-351 Gene Therapy Biotechnology....Pages 353-364 The Biotechnology of Transgenics....Pages 365-384 Vaccine, Drug, Antisense, and Third-Strand Therapies....Pages 385-412 Allografts, Artificial Tissues, and Organs....Pages 413-429 Back Matter....Pages 431-461 ... Effectively brings together the many diverse elements that comprise the building of a biotechnology company ... a very useful compendium of information that should find its place in the library of every biotech/venture capital company ... may help many a new company ...-Drug Development Research