The ~150 of us who gathered in Washington yesterday and today for the NIAID’s PK-PD workshop enjoyed a very rich conversation. It’s really hard to capture the full debate, but here is a brief slide set that summarizes the main things that I heard and learned. More materials can be found online at this link.
The heart of the workshop was an extended debate about the nature of a “robust PK-PD package.” We also had a good discussion of what PK-PD both can and can’t do. See the slides, but the critical material is also excerpted below my signature.
Given the intrinsic variability in all biological assays, a core message was that PD target estimates may differ substantially by method and by lab. A lot of the discussion focused on ways to manage this variability. Building substantial depth by testing multiple isolates in multiple models and by use of benchmark (internal control) compounds were all discussed as ways to build confidence around an estimate.
Overall, I see PK-PD as a field that continues to evolve rapidly. You definitely need an expert at your side (and it was great to have all the PK-PD gurus in the room!) but it is possible to find solid ground via careful work.
Many thanks to team NIAID for making this event happen with a special thanks to Tina Guina and Ann Eakin for their proactive leadership!
All best wishes and safe travels, --jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust
Follow me on Twitter: @JohnRex_NewAbx
Text from two of the slides
What is robust dose selection?
What PK-PD can / cannot do