In 1919, Karl Ereky, a Hungarian engineer, coined the word biotechnology, and nearly a century later, the industry has come of age. Burrill & Company report that $350 billion has been invested
in biotechnology so far. Global revenues have risen from $23 billion in 2000 to more than $50 billion in 2005 (1). The company
estimates that in 2007, the pharmaceutical and biotechnology industries in the United States will spend more than $55 billion
in research and development alone. Of that figure, biotechnology research and development will total approximately $12 billion.
These amounts reveal the rapid rate of expansion in the biotechnology industry. A financial investment, however, is only part
of the development of a well-designed plan on the path to innovation.
Life-science biotechnology industry professionals in particular have very interesting challenges to address when plotting
a course of development. As the development of cutting-edge products and technologies by life-science biotechnology companies
continue to revolutionize the healthcare industry on a global scale, this rapidly expanding environment and marketplace demands
special considerations with regard to the development of growth strategies.
To avoid common mistakes, a commitment to establishing growth initiatives that emphasize efficiency and safety has become
critical in the life-science biotechnology sector. Simply pouring money into research and development does not mean a successful
new drug product will result.
Effective growth strategy consists of many moving parts, from funding to design trials, each of which must be carefully mapped
out from start to finish in a multiphase plan that focuses heavily on regulation and efficiency.
According to Michele Washko, vice-president of strategic services for the Life Sciences Greenhouse of Central Pennsylvania
(LSGPA), a company dedicated to the investment and development of life-science biotechnology companies, a common development
mistake is the failure of scientists and investors to maintain a synergistic relationship with each other. Doing so may ensure
that discovery in the lab later translates into something suitable for commercialization and that the time to do so is within
projected expectation and as efficient as possible.
To foster successful strategic growth plans, life-science biotechnology companies should design with the following considerations
in mind: how to secure investment and financing, efficient process development and scale-up, the creation of effective partnerships,
and how to implement the overall strategic plan within regulatory guidelines.
Financing. Because it takes approximately 8–10 years for biotechnology companies to mature, the best financing or funding situation
is one in which investors will invest what is commonly referred to as "patient capital." In contrast to other industries,
an investor must understand the length of time to market and the regulatory approval hurdles a life science biotechnology
company must overcome before a return is generated. According to Washko, a typical funding cycle at the LSGPA develops in
this fashion: the technology will begin with a researcher in a lab who has received federal funding such as an National Institutes
of Health grant. This sort of capital is very desirable because it doesn't dilute the stake of the inventor or the lead investors.
Next, an inventor might access "friends-and-family money" such as taking out a second mortgage or personal loans. Also, inventors
may have the opportunity to take advantage of the Small Business Technology Transfer Program (STTR) or the Small Business
Innovation Research (SBIR) programs. These small-business programs expand funding opportunities in the federal innovation
research and development arena. The programs encourage a transition to commercialization and create joint venture opportunities
for small businesses and the nation's premier nonprofit research institutions. After these funds begin to dwindle, biotechnology
companies must look for outside investment, which often comes in the form of debt or from dilutive funding sources. The LSGPA
provides and assists companies in this area with their multistage funding process through their own investment platforms in
addition to creating funding relationships with venture capital firms and angel investors.
Process development. One of the most important issues a scientist must consider throughout the stages of the company growth process is how to
create continued value. A strong scientific advisory board is crucial, as it often has a deep understanding of the invention
or new technology and acts as a liaison between patient advocacy groups and other organizations that can help extend the life
of the original discovery.