The Biotech Business Handbook

"Beginning in the 1970s, several scientific breakthroughs promised to transform the creation of new medicines. As investors sought to capitalize on these Nobel Prize-winning discoveries, the biotech industry grew to thousands of small companies around the world. Each sought to emulate what the major pharmaceutical companies had been doing for a century or more, but without the advantages of scale, scope, experience, and massive resources. How could a large collection of small companies, most with fewer than 50 employees, compete in one of the world's most breathtakingly expensive and highly regulated industries? This book shows how biotech companies have met the challenge by creating nearly 40% more of the most important treatments for unmet medical needs. Moreover, they have done so with much lower overall costs. The book focuses on both the companies themselves and the broader biotech ecosystem that supports them. Its portrait of the crucial roles played by academic research, venture capital, contract research organizations, the capital markets, and pharmaceutical companies shows how a supportive environment enabled the entrepreneurial biotech industry to create novel medicines with unprecedented efficiency. In doing so, it also offers insights for any industry seeking to innovate in uncertain and ambiguous conditions. Looking to the future, it concludes that biomedical research will continue to be most effective in the hands of a large group of small companies as long as national healthcare policies allow the rest of the ecosystem to continue to thrive"--

A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development

Dr. Michael G. Pappas has distilled in this remarkable nearly handbook over twenty five years' experience as a research scientist at the bench a senior manager wrestling with day-to-day business problems and as a consultant providing critical expertise to small-to-medium size biotechnology firms and the federal government. The result is a gold mine of.

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.

Providing an important and timely overview of research on the exciting area of entrepreneurship in biotechnology, The Handbook of Bioentrepreneurship examines one of the most promising industries of the 21st century. While genetically engineered food and biopharmaceuticals have made biotechnology part of our everyday life, starting a bioventure is among the most complex and risky entrepreneurial tasks given long development cycles, high technological and market uncertainty, and high capital intensity. Providing unparalleled in-depth and detailed analysis, this Handbook sheds light on business models and strategies, financing, cooperation networks between firms and universities, among other issues. With new developments in biotechnology increasingly in the news, this is an important source for readers interested in public policy, entrepreneurship, and business in the 21st century.

As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a ‘how-to’ for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars Case studies are interspersed throughout each chapter to support key concepts and best practices. Enhanced by use of numerous detailed graphics, tables and flow charts

Softbound - New, softbound print book.

This book presents a broad base of information to assist the aspiring biotechnology entrepreneur in understanding not only the basics essential to establishing and running a successful biotechnology firm, but also how the research and development process is connected to production, regulatory affairs, manufacturing and marketing to produce saleable biomedical products. The text is intended for biotechnologists and business people wishing to establish a biotechnology firm.