In Part 2 of our real time coverage of the highly anticipated NASH-TAG 2023 conference, friends of the podcast Scott Friedman and Rachel Zayas join Louise Campbell, Jörn Schattenberg and Roger Green to review key takeaways from Friday and Saturday in Deer Valley. Following this session, Jörn, Louise and Roger review high points from the Saturday night “Potpourri” and “Regulatory Fireside Chat” sessions. The final feature of this episode is an enthralling and exclusive interview with HistoIndex Co-Founder and Chief Scientific Officer, Dean Tai, who shares captivating data from an AI-assisted histologic assessment of Phase 2 trials on aldafermin and resmetirom.
Scott opens the leading session with a concise summary of his highlights distilled from an event burgeoning with impressive moments. His main suggestion is that the positive momentum of the recent Madrigal announcement energized the wider program. Rachel echoes the idea that “the narrative has changed” as the field enters a promising New Year. Next, Louise points to her interest in the presentation of previously unreleased Phase 2 results from the HARMONY Trial on efruxifermin. And finally, Roger speaks to the evolving roles that NITs play in clinical trial and primary care settings. As analysis advances, Scott nails down an important question: what are the factors that distinguish the responders from the non-responders in the resmetirom trial? This leads the group down a compelling line of interrogation. The question also proves pertinent later in the episode as Dean teases tools to uncover the nuances of how and where these drugs act in the liver and beyond. Other topics explored in the opening session include insights on combination therapy, covert alcohol use, bariatric surgery, nomenclature, NITs, genetics and more.
In the second conversation, Jörn, Louise and Roger dive deeper into Saturday’s session. A major theme: the increasing focus on the role of bariatric surgery in liver disease. Jörn also underscores discussion around moving the field forward with an NIT that predicts outcome as an acceptable surrogate for conditional drug approval. Roger comments that addressing how drugs get used – not how they get approved – shifts focus from the needs of regulators to those of the payers.
Lastly, Dean joins Jörn and Roger to investigate fibrosis dynamics on a continuous scale using AI-based analysis and quantification of NASH features for treatment efficacy. The main idea: highly-precise assessment of liver slides has arrived, sparking a spate of new questions surrounding therapeutic possibilities. It becomes clear that advancements in AI digital pathology are paving a path for an entirely new, imaginative line of thinking for the Fatty Liver field. Surf on to the full feature for more on this illuminating topic.
This episode of Surfing the NASH Tsunami, including the accompanying discussion on zonal and liver-volume corrected analysis of fibrosis and steatosis, is sponsored by HistoIndex, the world’s leading specialist in stain-free imaging for NASH clinical trials. HistoIndex is transforming diagnostic standards and drug development for NASH with its second harmonic generation based AI digital pathology solution.
Categories:
Allied Health Professionals, Cirrhosis, Clinical Trials, Companies, Diabetes, Diagnostics, Histopathology, NITs, Doctors, Drugs/Drug Classes, Fatty Liver, FDA, Investors, Liver Science, Major Meetings, Metabolic Diseases, NAFLD, NASH, NASH-TAG, Obesity, Patients, Prevalence/Incidence, Public Health
