S4-41.3 – Laurent Castera on the FDA’s NIT Workshop

S4-41.3 - Laurent Castera on the FDA's NIT Workshop
In this conversation, the Surfers are joined by Laurent Castera to discuss the recent FDA workshop for NIT development. Laurent focuses on why this workshop is important within its context of being hosted by the FDA and what that means for researchers and stakeholders across the globe. He also dives into the complexities of hepatocellular ballooning and its potential impact on patients receiving NASH pharmacotherapy.

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 introduces the first part of an interview with Laurent Castera. Roger starts by asking Laurent how he, as one of the few non-American presenters, felt about the meeting. Laurent noted how important the meeting was given that it came from FDA, which the entire world looks to on drug approvals. Jörn notes that his general sense of the meeting is that while researchers have made significant progress with NIT research, particularly around ballooning, FDA might require more data. Laurent concurs, using the pithy statement “inflammation is a driver, liver fibrosis is a killer and steatosis is a marker.” He goes on to discuss the Brunt paper on ballooning before describing that he finds himself concerned that if biopsy is a bottleneck to approval, ballooning is the issue that might limit the number of patients approved for the drug. He sees this as a problem given how confounded the variable is. He closes this comment by noting that while we might have strong biomarkers for fibrosis, we do not seem to have such strength for NASH or drug response. Roger goes on to describe ideas from the past podcast conversation from Season 3 Episode 14 and whether the best next step is to redefine the ballooning variable. Jörn shares an argument from the workshop that if it is so hard for biopsy to measure the necessary variable, why don’t we simply use the NIT? He also asks Laurent to comment on some unpublished data that Laurent was given permission by Dr. Vincent Wong to share at the meeting. Since the data is unpublished, it will not be described in this summary except to say that it appears extremely important and powerful and, hopefully, will pass review and be published later this year.

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 questions@SurfingNASH.com.

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