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

by Michael G. Pappas

Overview

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.

Product Details

ISBN-13:	9780896033207
Publisher:	Springer-Verlag New York, LLC
Publication date:	06/01/1994
Series:	Including the Most Promising Application
Edition description:	Softcover reprint of the original 1st ed. 1994
Pages:	461
Product dimensions:	8.50(w) x 10.98(h) x 0.04(d)

Table of Contents

Preface.- List of Tables.- List of Figures.- 1 The World Biotechnology Industry.- The Ancients and Fermentation Science.- More Recent Advances.- Chronology.- Research and Development.- Foreign Governments and Corporations.- Summary.- Pertinent Reading.- 2 Preparing to Enter the Biotechnology Industry.- Biotechnology Programs.- Cooperative Education.- Groomed for the Job.- Employment Opportunities in the Next Decade.- Summary.- Pertinent Reading.- 3 Corporate Organization.- Noncorporate Businesses.- Corporations.- Indemnification.- Summary.- Pertinent Reading.- 4 Management Considerations.- Management Structure.- Research and Development.- Confidentiality.- Great Scientist, Terrible Manager.- Transition.- Crisis Management.- Summary.- Pertinent Reading.- 5 Legal Issues in Biotechnology.- Patents.- Patent Laws.- Patent Application Components.- Trade Secrets.- Trademarks.- Corporate Identity.- Summary.- Pertinent Reading.- 6 Biotechnology Funding.- Funding Sources.- Strategic Alliances.- Spinoffs.- Consolidation.- Pitfalls of Consolidation.- Private Placement.- Venture Capital.- Syndication.- Government Contracts.- Government Grants.- Human Subjects.- Summary.- Pertinent Reading.- 7 Biotechnology Project Development.- Informal Project Development.- Formal Project Development.- Project Review.- Prototypes.- Summary.- Pertinent Reading.- 8 Biotechnology Product Development.- Prioritizing Projects.- Product Development.- Summary.- Pertinent Reading.- 9 Quality Control.- Types of Quality Control Tests.- Sampling.- Stability.- Methods for Determining the Stability of Assay Components.- Summary.- Pertinent Reading.- 10 Quality Assurance.- Specifications Development.- Trend Analysis.- Stability Testing.- Current Good Manufacturing Practices (cGMP).- Freedom of Information Act (FOIA).- Summary.- Pertinent Reading.- 1 1 Manufacturing.- Manufacturing Facilities.- Manufacturing Process.- Summary.- Pertinent Reading.- 12 Regulatory Compliance.- Device Classifications.- Current Good Manufacturing Practices (cGMP).- Critical Devices.- Medical Device Reporting Regulation (MDR).- Premarket Approval (PMA).- PMA Format.- Safe Medical Devices Act.- Drug Approval.- Medical Device Export.- Chemical Diversion and Trafficking.- Summary.- Pertinent Reading.- 13 Marketing the Technology.- Targetting the Right Customer.- Marketing Studies.- Demand.- Supply.- Side-by-Side Comparisons.- Scientific Approval.- Advertising.- Quality.- Sales Representation.- Deceptive Advertising.- Summary.- Pertinent Reading.- 14 Troubleshooting Products After Release.- Customer Service.- Product Bulletins.- Product Recalls.- Summary.- Pertinent Reading.- 15 Safety in the Biotechnology Workplace.- Health and Surveillance Programs.- Laboratory Accidents.- OSHA.- Emergency Equipment.- Material Safety Data Sheet (MSDS).- Hazardous and Toxic Waste Regulations.- Drug-Free Workplace.- Equipment.- Summary.- Pertinent Reading.- 16 Support Services and Facilities.- Accounting.- Legal Counsel.- Facilities Maintenance.- Secretarial.- Security.- Warehouse/Annex.- Summary.- Pertinent Reading.- 17 Immunodiagnostic Assays.- Monoclonal Antibodies.- Analyte Detection.- Immunoassay Formats.- Direct Immunoassays.- Indirect Immunoassays.- Antibody-Based Assays.- Rapid Test Kits.- Summary.- Pertinent Reading.- 18 Nucleic Acid Probe Assays.- Nucleic Acids.- Tools Used in Recombinant Protein Development.- DNA Probe Assays.- Commercial Kits.- Summary.- Pertinent Reading.- 19 Human Genome Initiative.- Model Organism Genomes.- Information Technology.- Controversial Issues Regarding the Human Genome Project.- Collaborations.- Technology Transfer.- Summary.- Pertinent Reading.- 20 Bioremediation.- Scope of the Problem.- Recycling.- Environmental Remediation.- Bioremediation.- In Situ Bioremediation.- Regulatory Issues.- Biodegradation.- Summary.- Pertinent Reading.- 21 Gene Therapy Biotechnology.- Gene Therapy.- Guidelines.- Future Prospects.- Summary.- Pertinent Reading.- 22 The Biotechnology of Transgenics.- How Transgenics Works.- Production of Transgenic Animals.- Commercial Potential of Transgenic Animals.- Guidelines.- Chimerics.- Transgenic Plants.- Transgenic Fish.- Summary.- Pertinent Reading.- 23 Vaccine, Drug, Antisense, and Third-Strand Therapies.- Eradication Versus Control.- Revival in Vaccine Research.- Vaccine Development.- Recombinant Vaccines and Drug Treatments.- Strategic Partnering.- Hurdles to Successful Antisense Therapy.- Summary.- Pertinent Reading.- 24 Allografts, Artificial Tissues, and Organs.- Osteogenesis.- Allografts.- Controlled Drug Delivery.- Artificial Organs.- Diabetes.- Summary.- Pertinent Reading.- ApPENDIX I. ADDRESSES OF PUBLIC HEALTH SERVICE SBIR CONTRACT OFFICIALS.- ApPENDIX II. ADDRESSES OF PUBLIC HEALTH SERVICE SBIR GRANT OFFICIALS.- pPENDIX III. ABBREVIATIONS AND ACRONYMS.

Editorial Reviews

...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

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