FDA today hosted their eagerly awaited workshop on animal models in support of narrow-spectrum agents for A. baumannii (Abau) and P. aeruginosa (Pae). It was a really full & interesting day at the end of which my confidence that we can actually register narrow-spectrum agents for these two pathogens (and others that are even less frequent) is really improved.
We don’t have all the answers, but the basic shape of the answer is apparent and FDA is firmly committed to making it happen. An extended version of what I heard today is found below my signature, but here are the core elements:
All best wishes, --jr
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Extended notes from the 1 Mar 2017 FDA workshop on animal models to support narrow spectrum agents
ii.Degree of mimicry of infection in man is not as high
ii.Use standard benchmarks to prove the model is sensitive
ii.You could think of this as using the animal data to support a larger alpha or a Bayesian prior