The Business of Bioscience

1. Front Matter

   Pages i-xxiv

   PDF

2. Introduction

   • Craig D. Shimasaki

   Pages 1-7

3. What Makes a Biotech Entrepreneur?

   • Craig D. Shimasaki

   Pages 9-26

4. Start with the Idea: Licensing and Protecting Core Assets

   • Craig D. Shimasaki

   Pages 27-41

5. Significance of the Right Business Model and Managing Risk

   • Craig D. Shimasaki

   Pages 43-52

6. Legally Establishing the Company

   • Craig D. Shimasaki

   Pages 53-71

7. The Product Development Pathway: Charting the Right Course

   • Craig D. Shimasaki

   Pages 73-93

8. Developing a Marketing Strategy

   • Craig D. Shimasaki

   Pages 95-116

9. Financing Your Company – Part 1: Raising Money, Capital Needs, and Funding Sources

   • Craig D. Shimasaki

   Pages 117-145

10. Financing the Company – Part 2: Funding Stages, Valuation, and Funding Tools

    • Craig D. Shimasaki

    Pages 147-170

11. Corporate Culture and Core Values in a Biotech Company

    • Craig D. Shimasaki

    Pages 171-178

12. Hiring a Biotech Dream Team

    • Craig D. Shimasaki

    Pages 179-195

13. Strategic Alliances and Corporate Partnerships

    • Craig D. Shimasaki

    Pages 197-204

14. The Regulatory Process for Biotech Products

    • Craig D. Shimasaki

    Pages 205-221

15. Company Life Stages and Changing Management Styles

    • Craig D. Shimasaki

    Pages 223-232

16. When Do You Call it Quits?

    • Craig D. Shimasaki

    Pages 233-238

17. Conclusions and Serendipity

    • Craig D. Shimasaki

    Pages 239-242

18. Practical Help: How to get Started?

    • Craig D. Shimasaki

    Pages 243-247

19. Back Matter

    Pages 249-269

    PDF

My journey into this fascinating field of biotechnology started about 26 years ago at a small biotechnology company in South San Francisco called Genentech. I was very fortunate to work for the company that begat the biotech industry during its formative years. This experience established a solid foundation from which I could grow in both the science and business of biotechnology. After my fourth year of working on Oyster Point Boulevard, a close friend and colleague left Genentech to join a start-up biotechnology company. Later, he approached me to leave and join him in of all places – Oklahoma. He persisted for at least a year before I seriously considered his proposal. After listening to their plans, the opportunity suddenly became more and more intriguing. Finally, I took the plunge and joined this ent- preneurial team in cofounding and growing a start-up biotechnology company. Making that fateful decision to leave the security of a larger company was extremely difficult, but it turned out to be the beginning of an entrepreneurial career that forever changed how I viewed the biotechnology industry. Since that time, I have been fortunate to have cofounded two other biotechnology com- nies and even participated in taking one of them public. During my career in these start-ups, I held a variety of positions, from directing the science, operations, regulatory, and marketing components, to subsequently becoming CEO.

• Bioscience
• Business
• Shimasaki
• biotechnology
• goes
• lead
• making
• product

• InterGenetics Incorporated, Edmond, U.S.A.

  Craig D. Shimasaki

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 ofbiotech 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.

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