Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, political, regulatory, and commercial factors that define the scope of biotechnology. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in more than fifteen advanced biotechnology programs including MBA programs at UC Irvine, Tepper, and Schulich; the Johns Hopkins biotechnology MS/MBA program; and extension programs at Berkeley and UC San Francisco. This second edition significantly expands upon the foundation laid by the first, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables.
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Yali Friedman is Chief Knowledge Officer at Washington, DC-based New Economy Strategies and holds a doctorate in biochemistry from the University of Buffalo. He currently guest lectures for the Johns Hopkins MS/MBA program in biotechnology and has been a guest lecturer at the Tepper School of Business and University of Buffalo School of Management, teaching classes on the business of biotechnology. In supporting New Economy Strategies' activities in technology-based economic development, he has published papers on topics such as strategies to cope with a lack of management talent and capital when developing companies outside of established hubs, entrepreneurship in biotechnology, and new paradigms in regional development.Yali has a long history in biotechnology media, having created a Forbes "Best of the Web"-rated web site on the biotechnology industry at biotech.about.com for About.com, a NY Times company, and managed it since 1999. His other projects include the Student Guide to DNA Based Computers, sponsored by FUJI Television, and DrugPatentWatch.com, a pharmaceutical industry competitive intelligence service based on a business plan that was awarded second place in the Panasci Entrepreneurial Awards Competition.
Great opportunities await those who have the technology, skills, and perseverance to bring new biotechnology products to market. Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, political, regulatory, and commercial factors that define the scope of biotechnology. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in more than fifteen advanced biotechnology programs including MBA programs at UC Irvine, Tepper, and Schulich; the Johns Hopkins biotechnology MS/MBA program; and extension programs at Berkeley and UC San Francisco. This second edition significantly expands upon the foundation laid by the first, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.
Biotechnology inventions and products are changing paradigms in healthcare, agriculture, and industrial processes. Great opportunities exist for those who have the technologies, skills, and perseverance to bring new biotechnology products to market. These opportunities stem from the disruptive effects of biotechnology on existing markets, but they are tempered by a unique set of scientific, regulatory, political, economic, social, and commercial influences.
Understanding the dynamic and linked contributions of the interdisciplinary array of factors affecting the commercialization of biotechnology is essential to operate in the biotechnology industry.
The biotechnology industry is not defined by a set of products or services, but by a set of enabling technologies. Whereas the literal definition of biotechnology encompasses everything from traditional agriculture to soap-making, modern definitions describe applications relying on more complex and sophisticated techniques such as genetic engineering and other forms of directed modification of living things. This book defines biotechnology as the application of molecular biology for useful purposes. This distinction is important because, whereas inclusion of traditional activities describes processes with established markets and mature technologies, the focus on modern techniques reflects the innovative and revolutionary possibilities of molecular biology: manipulating living organisms and parts of living organisms to capitalize on scientific discoveries and improve upon existing solutions or serve new markets.
Biotechnology has applications in health, agriculture and farming, environmental remediation, and industrial processes. Within the diversity of biotechnology applications, there are two basic modes of development: products and services. Certain drugs, such as those produced in bacteria, yeast, and mammalian cells, are examples of biotechnology products. The distinction between biotechnology-derived and traditional pharmaceutical drugs is discussed in greater detail in Chapter 4. Biotechnology research tools that are sold to pharmaceutical and other biotechnology firms are also examples of products. Services can be sold to research-intensive companies or to companies further down value-chains for downstream application. Genetic testing is an example of a biotechnology service and is used to determine parentage, resolve identity issues in criminal cases, and screen for predispositions to disease.
The possible applications of biotechnology are defined by current scientific knowledge and abilities, and the capacity of companies to develop marketable solutions from current knowledge or through additional research. The commercialization of biotechnology applications is further promoted and limited by numerous legal, regulatory, and political factors. Patents serve both as a barrier to entry and motivation for development. Changes in patent law can have profound implications on the ability of biotechnology firms to operate profitably and obtain financing. Approval from bodies such as the Food and Drug Administration, Department of Agriculture, and Environmental Protection Agency is also required before many biotechnology products can be marketed or even tested. In addition to controlling the application of biotechnology, special governmental incentive programs can also motivate the development of applications that might not otherwise be commercially attractive.
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