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Stephen Harrison joins Louise Campbell and Roger Green for an insight-laden episode about challenges and opportunities in NASH drug development. This conversation breaks away from commentary around the FDA ADCOM meeting on obeticholic acid after Louise begins with a synopsis of the meeting outcome and her general agreement with the preceding conversation’s analysis. From there Roger shifts focus to a powerhouse paper produced by Stephen (and co-authored by friends of the podcast Alina Allen, Julie Dubourg, Mazen Noureddin and Naim Alkhouri) which was published in Nature Medicine earlier in March 2023. When asked what would be the one or two sentences that could best capture it, Stephen simply suggests the title says it all. “There are tremendous amounts of challenges we're faced with in drug development, but those are equally matched by opportunities.” He goes on to tease that the upcoming EASL Congress in Vienna will provide a venue to unpack pioneering insights which will inform new directions in a rapidly moving field. Specifically, Stephen points to interest in what’s emerging from AI-assisted digital pathology. He underscores the role of AI-assisted digital pathology to be pivotal in ushering in a new generation of NITs.  “We need to fully understand how effective our noninvasive tests are in… diagnosis monitoring, response to therapy, predicting outcomes and predicting the magnitude of effect change that links not to biopsy but to an outcome measure.”

On the back end of this session, Roger asks whether there is a specific subject or sector that will catalyze our understanding and management of patients with Fatty Liver. Stephen immediately points to the diabetic population as a set of patients that are going to allow the field to advance quicker. He reasons that endocrinologists are also working intently to better understand and solve this issue. The remainder of the conversation transitions to the topic of screen fail rates.

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