A Guide to Biotechnology Law and Business

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.

"Understanding the molecular pathways in disease processes is critical to discovering new drugs. The equally important task is to understand the legal pathways that enable biotechnology commercialization. This book charts the course in a way that greatly improves the odds of success."—Drew Senyei, M.D., Managing Director, Enterprise Partners Venture Capital, La Jolla, CA

"Bob Bohrer has provided a thorough and thoughtful guide to the biotech industry. His experience, which is based on years of examining the biotech sector, is shared in this book and provides a comprehensive and organized overview for the scientist, investor, service provider and anyone else associated with the biotech industry. This is a must-read for both the experienced biotech executives and those new to the industry."—Lisa A. Haile, J.D., Ph.D., Partner and Co-Chair, Life Sciences Group, DLA Piper US LLP

"Professor Bohrer is well positioned to write this comprehensive volume. He was most likely the first legal academician to definitively determine what biotechnology incorporates, and has never stopped reflecting upon the scientific, legal, and social/ethical issues involved. Not only will person now interested in biotechnology benefit from this book, but future historians will thank him."—Douglas Dale Busch, Former General Counsel of The Salk Institute