00:00 Introduction
10:48 What is The Liver Forum and First Impressions from The Meeting
21:14 Panelists Select Sessions of Interest
29:38 Session VIII: Stretch Exercise: New Look at Statistics
36:21 Closing Comments
Joining discussion are Liver Forum Executive Director Veronica Miller and speakers Mazen Noureddin (Houston Research Institute), Michelle Long (Novo Nordisk) and Jeff McIntyre (Global Liver Institute). This integrative meeting aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing an independent and neutral venue for ongoing multi-stakeholder dialogue. The resulting conversations facilitate making the best science-based decisions on how to study efficacy and safety in real time as collective knowledge and experience with therapies for liver diseases develops. This year’s meeting proved particularly stimulating in light of imminent drug approvals.
What is The Liver Forum and First Impressions from The Meeting
Veronica underscores the importance of being able to convene as a community to make advances in how drugs get researched and approved, and how patients participate in this ongoing process. Jeff notes benefits around increasing patient involvement in multiple panels with each successive year. Michelle reminds that “at the end of the day, it’s about making people feel, function and survive better.” She notes that from the patient perspective, halting progression and stabilizing disease are significant quality of life components for treating NASH – a message which could see more amplification. Jörn describes how the energies of the meeting carried through to Europe where he was participating remotely. Roger, who also attended remotely, comments positively on the cohesiveness of the program. Finally, Mazen introduces specific topics explored, namely cirrhosis, the future of combination therapy and clinical trial design.
Panelists Select Sessions of Interest
Each share takeaways around specific sessions that captured their attention in a way that could not have been predicted. Michelle mentions how the agenda as a whole illuminated the depth of the issues surrounding drug development for the fatty liver field. Veronica points to an interactive session titled NASH Drug Development in the Era of Approved Drugs, commending the moderators and friends of the podcast Manal Abdelmalek and Pamela Danagher. She says that hosting an unscripted panel in a safe environment with brilliant participants is a way to “push the envelope and move the field forward.” Jörn notes data presented from the European Heart Journal as an exciting example of exploring and utilizing literature from outside the liver field. Mazen elaborates on scientific concepts distilled from a session on cirrhosis.
Session VIII: Stretch Exercise: New Look at Statistics
Veronica describes a session dedicated to statistics and being impressed with how well it played out. In agreement, both Roger and Jeff share different perspectives as to how the session succeeded. Scott Evans of George Washington University opened with Desirability of Outcome Ranking (DOOR) Analysis. Lauren Dang of UC Berkeley followed with her talk, Hybrid Randomized/Real-World Data Designs: A Case Study of Semaglutide and Cardiovascular Outcomes.
Closing Comments
As the session winds down, the group describes takeaways that might appear in the soon-to-be published slides. If you enjoy the episode, have questions or interest around the Liver Forum and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at questions@SurfingNASH.com.
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