THE PURPOSE OF THE GUIDE
The Guide was designed to present a framework for evaluating a business concept and describes the many steps involved in starting a biotechnology company. The first three chapters of the Guide ask the reader to consider and explain how a new concept will succeed where old concepts have failed. Subsequent chapters are more of a how-to manual on assembling the various pieces that make up a company (e.g. patents, people, and real estate, and funding). The Guide may help to manage the reader's expectations of the risk, reward, and effort involved in starting a company.
The term biotechnology here refers to companies whose products require laboratory or clinical development, including medical devices, diagnostics, and pharmaceuticals. In many ways, all startup companies are alike. However, the biotechnology industry, with its long product development cycles and heavy reliance on science and intellectual property, warrants its own text.
The Guide prompts the reader to ask the right questions. The more one knows about the venture-creation process, the more likely one is to ask the most fundamental question, "Does the idea actually justify starting a new company?" and other questions, for example:
- How much will it cost to develop and commercialize a product?
- How large is the market?
- Will customers buy the products and how much will they pay?
- What's the competition?
- Will patent protection be required and feasible?
- Will it be possible to attract the right professionals to the company?
- Will investors want to invest?
- What else could I be doing with my time?
BUSINESS BEFORE SCIENCE
The common denominator among entrepreneurs is creative initiative; they pursue opportunities that are not obvious to others. While entrepreneurs must possess the ability to tolerate tremendous uncertainty in their decision-making, good science demands precision, creating an internal conflict for business-oriented scientists.
Scientists have a reputation for sometimes failing to appreciate the difference between a science, a technology, a product, and a company. The goal of a company is to develop and sell products that will generate enough profit to justify the effort and capital that goes into building the company. Science and technology are just a means to that end. Therefore, to be true entrepreneurs, scientists must learn to put business ahead of science when developing a commercial strategy. These precepts underlie much of the advice contained herein.
FOCUS ON DRUGS
Many of the examples in the Guide concern drug development because pharmaceuticals command more attention and capital and offer the greatest potential rewards of any products in the biotechnology sector. A large chapter is dedicated to clinical drug development. Medical device regulatory issues are also discussed in their own chapter. Readers interested in other businesses, e.g. instrumentation or agricultural biotechnology, will still find the Guide useful but may need to draw their own parallels.