This book is the result of more than a decade spent investigating the biotechnology industry. My interest in biotechnology started when, as a biochemistry graduate student, I found an opportunity to create and manage one of the first websites on the business of biotechnology. Taking a biochemist’s approach, I began dissecting the biotechnology industry to isolate the key elements and study their interactions. While web pages are excellent at conveying short notes and discrete topics it quickly became apparent that there was a strong need to compile my investigations in a different format—a book with comprehensive and integrated coverage of the business of biotechnology. With the desire to delve deeper into the key drivers of the biotechnology industry and provide greater coverage of the interrelation of its disparate elements, the first edition of Building Biotechnology was produced in 2004. Subsequent editions have seen the text grow substantially as the industry has undergone significant changes and new topics have been added.

Because the biotechnology industry is influenced by, and faces unique pressures from, scientific, legal, regulatory, political, and commercial factors, the onerous challenge of merging the respective contributions of each of these disparate domains was critical in writing this book. Building Biotechnology is presented in five sections: a general introduction; the science of biotechnology; legal, regulatory, and political issues; the business of biotechnology; and, a conclusion.

The scientific, legal, regulatory, and political issues are presented prior to the business fundamentals because in order to understand the business of biotechnology it is necessary to first understand how these factors shape the industry and make the business of biotechnology different from other industries. Many issues, such as drug development, are described in more than one section, providing different contexts on their fundamentals and practice.

The final section ties together the material from the previous four sections and provides additional commentary on how to engage in biotechnology business development, considerations in developing an investment strategy, and career development guidance. A comprehensive set of appendices follow, containing Internet links, an annotated bibliography, and a detailed glossary.

Several special considerations have been included to promote accessibility. Individual biotechnology companies and products are referenced in different examples and anecdotes to reinforce the concepts presented. Extensive cross-references are also included throughout the text for those readers taking a “cafeteria approach” and reading the chapters out of sequence. The annotated bibliography and detailed glossary facilitate continued learning for interested readers.

I hope that by breaking down the biotechnology industry to its key drivers and by providing numerous case studies, you will develop an appreciation of the independent and combined scientific, legal, regulatory, political, and commercial influences that define the scope of commercial biotechnology.

Yali Friedman, Ph.D.