Forgotten Cure Assignment Part 3 4/23/19

2. One of the biggest problems in phage therapy has been in the approval process. Describe the trouble surrounding FDA approval and recommend some suggestions to improve the process of phage therapy approval.

One of the biggest issues that Sulakvelidze had was the FDA’s unrealistic expectations because phage do not work the same way antibiotics do, they cannot be tested or treated the same way during the approval process. Phage mutate and change so often that constantly sequencing every new phage in a cocktail is prohibitively expensive. Sulakvelidze and his company did not have the funding to do all of the necessary testings for FDA approval, so they had to put their VRE project on hold. A similar issue was faced by GangaGen so they, like Sulakvelidze, chose to focus on animal applications first. Many of these issues stem from an FDA approval system that does not understand bacteriophage and underfunded research.

I think that the easiest way to improve the process of phage therapy approval is to improve the basic research of phage first. When the author describes the conference held by GangaGen, Ry Young calls for a renaissance in phage research, and while this idea was initially not as well received at the conference, I think it would improve the process of phage therapy approval. I think if more were understood about phage in the first place it might make the FDA approval process easier because there would be less unanswered questions, and much of the research that small start-up companies do not have the funding to do could be done, at least conceptually, as part of the process of learning more about bacteriophage. In addition, I think that Sulakvelidze and GangaGen were smart to realize that it is easier to work with animals first. By focusing on making food products safe first, these companies were exposed to the approval process at less stringent standards and helped normalize phage. While this won’t directly improve the process of phage therapy approval in humans, I think that using phage in other industries first would help make phage product testing more uniform and easier to cross apply to people over time. I think that with a larger body of phage research, and phage usage in other industries the approval process would be improved and some of the concerns the FDA outlined when working with Sulakvelidze would be mitigated.