A Guide to Biotechnology Law and Business | 
 enlarge | Author: Robert A. Bohrer
Publisher: Carolina Academic Press
Category: Book
List Price: $60.00
Buy New: $48.00
You Save: $12.00 (20%)
New (5) from $48.00
Avg. Customer Rating:  2 reviews
Sales Rank: 313422
Media: Hardcover
Number Of Items: 1
Pages: 362
Shipping Weight (lbs): 1.4
Dimensions (in): 9.3 x 6.5 x 1.1
ISBN: 1594600872
Dewey Decimal Number: 343.730786606
EAN: 9781594600876
ASIN: 1594600872
Publication Date: October 1, 2007
Shipping: Eligible for Super Saver Shipping
Availability: Usually ships in 9 to 13 days
|
| Similar Items:
| • | Biotechnology and the Law | | • | Best Practices in Biotechnology Business Development: Valuation, Licensing, Cash Flow, Pharmacoeconomics, Market Selection, Communication, and Intellectual Property | | • | Building Biotechnology: Starting, Managing, and Understanding Biotechnology Companies - Business Development, Entrepreneurship, Careers, Investing, Science, Patents and Regulations | | • | Science Lessons: What the Business of Biotech Taught Me About Management | | • | Science Business: The Promise, the Reality, and the Future of Biotech |
|
| Editorial Reviews:
Product Description
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.
|
| Customer Reviews:
Excellent Overview April 2, 2008
Some of the most exciting, complex and dynamic issues facing society today are found at the intricate and, at times, uncertain interface marking the rapidly evolving boundaries of law and biotechnology. Within the maelstrom defined by present day societal, ethical and scientific forces, the appropriate application and guidance of a well reasoned legal structure is critical to fostering and maintaining a biotechnology paradigm that is both functional and, on the whole, beneficial to mankind. Yet, while the present legal and regulatory framework has worked reasonably well in addressing the issues of the biotechnology industry to this point, the challenges facing the system are greater than ever before. Simply by picking up today's paper one is confronted by a litany of ethical (cloning, embryonic stem cells), regulatory (biogeneric legislation, genetic therapy) and economic/business (scope of intellectual property protection, reimbursement rates) issues that are often contentious, ill defined and overlapping. To appreciate the ramifications of these and other challenges facing the industry, it is necessary to understand the current structure as well as the source of future pressure points. Fortunately, Bob Bohrer's book, A Guide to Biotechnology Law and Business does an excellent job, both in explaining the many facets of the present legal and regulatory system governing the biotechnology industry and in exploring the open issues and forces that are influencing its evolution.
Lucid, intelligent, balanced and comprehensive, the book is written both for the professional in the industry and for the educated layman in something akin to a Scientific American format. As explained by the author "The book is intended to provide `the big picture' to everyone interested or involved in the biotechnology industry." As one in the industry, I find the Guide to be an admirable first line reference for areas in which I have a need for a detailed understanding but not a need to develop an expertise (e.g. regulatory matters).
Starting out with an interesting overview and using applied examples, the book quickly brings in the role of the legal system (and lawyers) in biotech lifecycle management and implementation of strategy. Following a short technical discussion of the scientific basis for biotech products are relatively detailed explanations of the university tech transfer process and the role of intellectual property in biotechnology. While going through the legal structure, both subjects are enlivened with practical examples that provide a "real world" feel and understanding much deeper (and less dry) than the typical legal treatise. The book then moves into the legal process concerning two of the more interesting "big picture" questions surrounding any business: how to get the money and how to make money. As one in the industry I can't tell you how much time, effort, blood and tears go into these efforts. Here the chapters on business strategy and biotech financing, again with practical illustrations, struck me as comprehensive and provided an excellent overview. This was followed by two very readable and complete descriptions of one of the more critical areas in biotechnology, the regulatory process. In what I found to be one of the most useful sections of the book, the chapters provide a relatively clear description of what has been a confusing legislative history and untangle the present web of overlapping regulations. Finally, the author concludes with a series of chapters on current ethical and regulatory issues that leave the reader contemplating where the industry is heading.
All in all a highly exciting and readable book for anyone interested in obtaining a detailed overview of the biotechnology industry. I would highly recommend it.
A disclaimer: I am a former law student of the professor's and a long time acquaintance. At the present I am an intellectual property attorney with a major biopharmaceutical company.
Great Resource March 13, 2008
Professor Bohrer's Guide to Biotechnology Law and Business is a great resource for professionals that work in the junction of law and biotechnology. While it is a must read for those new to this area, it is also a great reference tool for seasoned professionals. This book fills an important need and should be in every biotechnology professional's reference library.
|
|
|
