Sometimes people make simple things complex.  However, most of the time we make complex things impossible.  George Whitesides has a knack for making complex things seem easy.  He is a professor of chemistry at Harvard and a serial entrepreneur. Whitesides co-founded 12 companies which at one point had a combined market capitalization of over $20 billion. These companies included Genzyme, GelTex, Theravance, Surface Logix, Nano-Terra, and WMR Biomedical.

In a post, William Crawford references Whitesides talk on “Challenges to Successful Innovation and Translation” of medical research where he outlined “Whitesides Rules for Biotech Entrepreneurs” or “Uncle George’s Homey Rules for Entrepreneurs”.  These 14 simple rules are, well… simple, but like viewing life in a rear-view mirror, some of these may be seem obvious as you read them but they were most likely borne through adversity.

For instance, rule #10 “Regulatory Agencies are Motivated to Avoid Risk.  Nobody ever lost their job for not approving a product”  For the biotech entrepreneur, the lesson is, when developing and testing your product, be sure to plan on examining every reasonable risk imaginable…and then find a few more”.  The FDA is a risk-averse agency by nature.  Help them do their job by appropriately removing the guesswork from as many product risks as reasonably possible.

Developing a biotechnology product has been likened to building an airplane while it taxis down the runway. You feverishly work to complete product development while the runway (your existing cash, your ability to raise capital and your time) is ever shortening.

Biotechnology product development, at some point, is constrained by time and limited capital. In addition to time and resource constraints, there are “unknown-unknowns”. The unknown-unknowns are things that you did not know, that you did not know, that you did not know. Because biotechnology is the melding of science and business, it creates a business of uncertainty. Biotechnology research begins with promising yet unproven science, although this promise provides the phenomenal opportunity for life-changing medicines. However, because of this uncertainty, product development rarely proceeds in a straightforward manner. This brings us to the first tenet of biotechnology product development – Always make allowances for product development pathway detours.

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