December 3rd, 2017
(written by lawrence krubner, however indented passages are often quotes). You can contact lawrence at: firstname.lastname@example.org
As phages are in a continuing red-queen evolutionary game (running as fast as you can to stay in one place) with evolving bacterial defenses and specific phages can be specific to sub-species of bacteria, there is no way of making money in this game if you have to prove “efficacy” to the FDA before you sell your specific phage for a specific sub-species of bacteria that are continually evolving.
To play this game, we will need an automated system to speed up the evolutionary selection of lytic phages as the bacteria evolve with hundreds of variations on the shelf to cover the evolutionary options open to the bacteria. All these variations need instant approval, but that would create a finite risk that the zero risk tolerant FDA won’t allow.
In a Petrie dish of E. coli, you can add a lytic phage that will kill 99.9999% of the bacteria in a few hours but by the next day, the bacteria have evolved resistance to that phage. This is what that CRISPER cas9 gene editing system is all about as the bacteria evolve to cut up the virus meanwhile the phage is mutating and evolving methods of countering the defense.