This book is a guide to the "big picture" of biotechnology law and business, presenting and analyzing the issues that arise throughout the life cycle of the biotechnology product. The book focuses primarily on the pharmaceutical field, from university research through the development process and into the marketplace. The aim of the book is to provide guidance to the biotechnology legal and business communities by providing a practical and integrated discussion of the many different topics that arise in developing biotechnology products. It is intended to be used by I.P. lawyers, FDA lawyers, business lawyers and biotech executives who want a concise introduction to the most fundamental issues in biotechnology law and business.