by Craig Shimasaki
Ready for Takeoff?
        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.

Product Development Detours
Unplanned but Anticipated Detours
        Product development pathway detours are scientific issues that must be overcome in order to return to the original product development pathway.  These scientific detours may include, an unplanned development of a new cell line to express a product in cell culture without Fetal Calf Serum (FBS) because there is not enough FBS commercially available to meet scale-up requirements—such as what occurred with Tissue Plasminogen Activator in the mid-1980s.  Other detours may include an unplanned need to resolve a false-positive problem in a biological assay that was used for selecting lead molecules, after learning these molecules did not work when moved into animal models.  These detours arise from the unknown-unknowns.  Things you did not know, that you did not know—until you got there.  The remedy is to make allowances for them because it is certain that all companies will encounter this phenomenon.

        Universally, proposed product development pathways presume everything will work smoothly as planned, rarely allotting any time for unanticipated work.  Of course, who wants to show a potential investor that they are not aware of all the problems when developing a product!  This type of poor planning is a grave mistake.  

        It is vital to make allowances for the unknown-unknowns, because at some point in development, cash and time become the two critical limitations of a biotechnology company.  Companies that do not make allowances for detours along the development pathway, quickly run out of capital and become drained of the ability to reach the next significant product development milestone.  

Company Valuation Spillover
        This problem becomes compounded since company valuation (the monetary value ascribed to the company) is tied to product development milestones.  For instance, a company with an IND (Initial New Drug) Application on Clinical Hold with the FDA has a different valuation than a similar company with an accepted IND that is beginning Phase I clinical trials.  These two companies have different valuations and differing abilities to raise capital to further their development work.

        That is not to say that INDs cannot be put on Clinical Hold and still be successful.  It simply means that if you only allocate time and capital to reach the IND filing point without allowances for detours, you may be forced to raise capital at a time when the company’s valuation is not reasonable, and depending on the financial market, it may be difficult for the company to raise capital—period.

The Take Away Tidbit
        So, be aware of, plan for, and make allowances for the unknown-unknowns during product development.  In doing this, you will provide your organization with the best chance for success in reaching its product development goals.