The Business of Bioscience: What goes into making a Biotechnology Product [Hardcover]

Craig D. Shimasaki (Author)

Book Description

Publication Date: October 2, 2009 | ISBN-10: 1441900632 | ISBN-13: 978-1441900630 | Edition: 2009

The Business of Bioscience: What goes into making a Biotechnology Product captivatingly describes the unique and challenging facets within the exciting field of biotechnology business and medical product innovation. Biotechnology is the melding of business and science and, therefore, creates different challenges than those faced by other industries. There are longer development times, costly product development and clinical trials, unique talent requirements, and a changing regulatory environment. In this book you will find practical answers to: Why does it take so long to develop a biotechnology product? What is involved in making a therapeutic or diagnostic? How much money is needed to develop a product idea from bench to bedside? What are the characteristics and backgrounds of entrepreneurs who lead these organizations? How do you go about starting a biotechnology company? This book contains a wealth of technical, business and leadership insights conveyed with a "behind the scenes" look into the everyday challenges in biotechnology product development. The Business of Bioscience is written in a step-wise fashion building upon precepts and summarizing best practices for establishing and growing a successful biotechnology company. Content is presented in a way that is applicable to the novice, through to the experienced biotech or pharmaceutical executive and will interest all audiences having an interest in this dynamic field. Fundamental topics are covered in informative and interesting detail such as the selection of product development milestones and their impact on the valuation of the company, choosing a company business model and managing risk, hiring a biotech dream team, the virtual company, the regulatory process for approving products through the FDA, clinical trials and objectives and raising multiple forms of capital. Within this book you will also learn practical aspects that can be applied to virtually any organization. Such topics include developing a company culture and its hidden competitive strength; leadership and core values – not just for managers but for all employees; the organizational life stages of a company, when and why management style needs to change. This book is a tremendous resource for scientists, professors, medical researchers, pharmaceutical industry employees, venture capital professionals, biotechnology research analysts, business persons, MBA students and those who have a curiosity about what goes into the development of a biotechnology product. For more information please visit: www.businessofbioscience.com

Editorial Reviews

From the Back Cover

The Business of Bioscience: What goes into making a Biotechnology Product captivatingly describes the unique and challenging facets within the exciting field of biotechnology business and medical product innovation. Biotechnology is the melding of business and science and, therefore, creates different challenges than those faced by other industries. There are longer development times, costly product development and clinical trials, unique talent requirements, and a changing regulatory environment. In this book you will find practical answers to: Why does it take so long to develop a biotechnology product? What is involved in making a therapeutic or diagnostic? How much money is needed to develop a product idea from bench to bedside? What are the characteristics and backgrounds of entrepreneurs who lead these organizations? How do you go about starting a biotechnology company? This book contains a wealth of technical, business and leadership insights conveyed with a "behind the scenes" look into the everyday challenges in biotechnology product development. The Business of Bioscience is written in a step-wise fashion building upon precepts and summarizing best practices for establishing and growing a successful biotechnology company. Content is presented in a way that is applicable to the novice, through to the experienced biotech or pharmaceutical executive and will interest all audiences having an interest in this dynamic field. Fundamental topics are covered in informative and interesting detail such as the selection of product development milestones and their impact on the valuation of the company, choosing a company business model and managing risk, hiring a biotech dream team, the virtual company, the regulatory process for approving products through the FDA, clinical trials and objectives and raising multiple forms of capital. Within this book you will also learn practical aspects that can be applied to virtually any organization. Such topics include developing a company culture and its hidden competitive strength; leadership and core values – not just for managers but for all employees; the organizational life stages of a company, when and why management style needs to change. This book is a tremendous resource for scientists, professors, medical researchers, pharmaceutical industry employees, venture capital professionals, biotechnology research analysts, business persons, MBA students and those who have a curiosity about what goes into the development of a biotechnology product. For more information please visit: www.businessofbioscience.com.   About the Author: Dr. Shimasaki has over 25 years of practical experience in the biotechnology industry and as a serial entrepreneur co-founded three biotech companies. Within these companies he has held a variety of positions, including Director of Project Planning, Executive VP of Research, VP of Operations, Chief Operating Officer, and CEO. He has raised multiple rounds of capital, both private and public and has been involved in most every facet of a biotech start-up. He is intimately familiar with the challenges of product development, and led international clinical testing and regulatory approval processes for multiple products through the FDA. He is an inventor of numerous patents for both diagnostic and therapeutic applications. His passion is for the establishment and growth of biotechnology companies focused on developing life-saving products that significantly impact the health and well being of others. He has written this book to provide insight into the inner workings of biotech product development and the practice of starting and building a biotech business. His desires is to share his experiences in the dynamic business of bioscience to help others gain wisdom so they can better manage the risks associated in building a biotechnology company. Dr. Shimasaki received his B.S. in Biochemistry from the University of California at Davis and his Ph.D. in Molecular Biology and Biotechnology from the University of Tulsa and his M.B.A. from Northwestern University’s Kellogg School of Business.

About the Author

Dr. Shimasaki has over 25 years of practical experience in the biotechnology industry and as a serial entrepreneur co-founded three biotech companies. Within these companies he has held a variety of positions, including Director of Project Planning, Executive VP of Research, VP of Operations, Chief Operating Officer, and CEO. He has raised multiple rounds of capital, both private and public and has been involved in most every facet of a biotech start-up. He is intimately familiar with the challenges of product development, and led international clinical testing and regulatory approval processes for multiple products through the FDA. He is an inventor of numerous patents for both diagnostic and therapeutic applications. His passion is for the establishment and growth of biotechnology companies focused on developing life-saving products that significantly impact the health and well being of others. He has written this book to provide insight into the inner workings of biotech product development and the practice of starting and building a biotech business. His desires is to share his experiences in the dynamic business of bioscience to help others gain wisdom so they can better manage the risks associated in building a biotechnology company. Dr. Shimasaki received his B.S. in Biochemistry from the University of California at Davis and his Ph.D. in Molecular Biology and Biotechnology from the University of Tulsa and his M.B.A. from Northwestern University’s Kellogg School of Business.

Product Details

• Hardcover: 300 pages
• Publisher: Springer; 2009 edition (October 2, 2009)
• Language: English
• ISBN-10: 1441900632
• ISBN-13: 978-1441900630
• Product Dimensions: 6.1 x 0.7 x 9.2 inches
• Shipping Weight: 1.3 pounds (View shipping rates and policies)
• Average Customer Review: 5.0 out of 5 stars  See all reviews (12 customer reviews)
• Amazon Best Sellers Rank: #793,669 in Books (See Top 100 in Books)

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Most Helpful Customer Reviews

5.0 out of 5 stars A great guide May 1, 2013

By Dkav

Format:Hardcover

One of the best instructional books out there about the commercialization of science. I used this when I started working in at a biotech company and the book gave me many ideas which I relayed to the CEO. We have increased and reinforced our business tactics since.

5.0 out of 5 stars Excellent resource April 15, 2012

By HudsonRiverBio

Format:Hardcover

I am a medical oncologist, inventor and recently a life science enterpreneur. If you are thinking about starting a biotech company, I'm not aware of any resource that comes close - this book is exactly what you need. I found myself coming back again and again, and the answer I was looking for was often right there. In fact, I have reached out to Craig Shimasaki and he is now helping me in an advisory role, something I would also highly recommend. If I had talked to him from the beginning, I would have saved myself a lot of frustration and a lot of money in legal fees.

5.0 out of 5 stars Where was this book when I needed it? March 11, 2012

By JMA

Format:Hardcover

After 17 years at Big Pharma out east I came to California to begin my small biotechnology company career. After 24 years and 8 companies later as a Business Development executive then CEO, I can only report that I have had a heck of a run but had to learn everything from the ground up and made a fool of myself too many times in the early years. There was no internet, partnering meetings, knowledgeable vendors, real business models or even many mentors as the industry was so young at the beginning. Had I had access to the knowledge between the covers of a book like this I would have been higher on the learning curve much earlier. But then Dr. Shimasaki was probably learning on a parallel track not far from where I was working. He has documented his experiences into a volume that is invaluable to anyone heading out to be successful in a company, large or small, in the pharmaceutical world. Sometimes it is too easy to focus on just your role in a company rather than understanding what all the moving parts are and how they fit together. No excuse now. This is not a one time read but rather a reference book to go back to many times. I refer to it often in my Business Development seminars and with my clients. Run, do not walk, to Amazon to get your copy. You never know enough in this business.