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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.

Biotechnology. --- Biotechnology industries. --- Entrepreneurship. --- Entrepreneurship --Handbooks, manuals, etc. --- Medicine. --- Toxicology. --- Biotechnology industries --- Entrepreneurship --- Commerce --- Biotechnology --- Economics --- Biological Products --- Technology, Industry, and Agriculture --- Biological Science Disciplines --- Technology --- Complex Mixtures --- Social Sciences --- Anthropology, Education, Sociology and Social Phenomena --- Technology, Industry, Agriculture --- Chemicals and Drugs --- Natural Science Disciplines --- Disciplines and Occupations --- Pharmacy, Therapeutics, & Pharmacology --- Industries --- Business & Economics --- Health & Biological Sciences --- Scientific apparatus and instruments --- Design and construction. --- Pharmacology. --- Biomedicine. --- Pharmacology/Toxicology. --- Chemical engineering --- Genetic engineering --- Entrepreneur --- Intrapreneur --- Capitalism --- Business incubators --- Chemicals --- Medicine --- Pharmacology --- Poisoning --- Poisons --- Toxicology --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemotherapy --- Drugs --- Pharmacy --- Physiological effect

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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.

Pharmacology. Therapy --- Business management --- Biotechnology --- ondernemingsstrategieën --- farmacie --- farmacologie --- toxicologie --- biotechnologie --- ondernemen

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As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any

Biotechnology industries --- Entrepreneurship --- Business & Economics --- Industries --- Management --- Biotechnology industries. --- Entrepreneurship. --- Entrepreneur --- Intrapreneur --- Capitalism --- Business incubators --- Biomedical industries --- High technology industries