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In Season 4, Episode 41, the surfers (Jörn Schattenberg, Louise Campbell and Roger Green) review highlights from the FDA's NIT workshop in three seperate interview sessions with guests Naim Alkhouri, Laurent Castera and Veronica Miller. Each guest participated in some form at the meeting and shares slightly differing but incredibly insightful perspectives.

This conversation is the first part of the Surfer’s interview with Veronica. Veronica starts by commending FDA for organizing the workshop and indicates that now we all need to process the data. Roger asks Veronica what FDA might have done better, and she indicates they might have offered more feedback about how far they feel the field has come. She notes that there are many steps ahead and that the FDA needs to be more cautious. She also felt that the mix of data presentations and panel discussions worked well. She points to ballooning and its challenges as the clearest point needing change and then went back to Dr. Johnson’s question about “why are we validating a surrogate with a surrogate?” Roger shares a comment from S1E12 after the first OCA Complete Response Letter and how a regulatory consultant elicited a strong reaction from Stephen Harrison for the same comment. This leads Louise to ask whether we should look to broaden our target outcomes beyond the liver. Veronica notes that we have traditionally looked in an organ-specific way but wonders whether the new nomenclature will focus more attention on metabolic disease, although the topic was not really addressed. As the conversation ends, Roger asks Veronica whether approaches like NAIL-NIT respond to the “surrogate of a surrogate” question. Veronica says that might be right and that other groups like NIMBLE and LITMUS are looking at similar issues, although they sometimes compare to biopsy (which is what drove the surrogate of a surrogate comment in the first place.)

Plenty more ideas are explored as this is both a fascinating and pivotal workshop which covers a range of topics on NITs with presentations by the some of the field's most innovative and knowledgable contributors. If you have questions or comments around the workshop, NITs, drug development or any other themes addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

Stay Safe and Surf On!