Pre-Conference Workshop Day
Tuesday, September 24, 2024
8:00 am Check In & Coffee
Preclinical & Translational Track
9:00 am Workshop A: Maximizing Translatability of Models: A Comprehensive Comparison of Existing Models
Synopsis
- From GAN diet-induced models, to organ and chip, precision liver slices, and organoid models, which model is optimal? This workshop will be a deep dive comparison in vitro and in vivo model complexity and translatability
- Discuss developments which impact the suitability of different models for testing targets
- Comparing robustness, scalability, and reproducibility between model types
Clinical & Regulatory Track
9:00 am Workshop B: An Understanding of Insulin Resistance, Implications to MASH Pathophysiology
Synopsis
New treatment options are provided by a combination of incretins and insulin sensitizers
- Insulin sensitizing pharmacology impacts the underlying MASH pathology providing a new understanding of the underlying pathology
- Incretin treatments impact more than underlying obesity and also provide unique opportunities in combination with insulin sensitizers
- A round table discussion will discuss which features of the MASH pathology are most relevant to selection and assessment of treatment options and how to consider the potential for impact on hepatic and extrahepatic outcomes
11:00 am Morning Break
11:30 am Workshop C: Enhancing Patient Selection for Liver Biopsy in Trials
Synopsis
This presentation will discuss screening algorithms for trials with different fibrosis and NAS score criteria. Current VCTEbased algorithms, such as FAST, Agile 3, and Agile 4, are not optimized for trial-specific needs, leading to high screen fail rates from liver biopsy. The ALADDIN study addresses this gap by using machine learning models trained on various fibrosis and NAS cutoffs. It integrates routine lab parameters, with and without VCTE, using data from 15 global centers and 5,000 patients. Separate test and validation sets ensure robust, generalizable findings to improve trial screening outcomes.
11:30 am Workshop D: Innovative MASH Treatment & Non-Invasive Fibrosis Testing: Advancing Multifunctional Drug Development & the Galactose Single Point Method
Synopsis
Delving into promising results for SNP-6 Series in treating MASH with multi-functional effects and a POC Quantitative Non-Invasive Test for MASH: Insights from animal and clinical trials. Showing clinically significant improvements in biomarkers of liver injury, inflammation, and fibrosis in a Phase 2 study in patients with MASH. Exploring a safe, simple, and highly sensitive quantitative liver function test. A potential new clinical management for subjects with NAFLD.
1:30 pm Lunch Break
2:30 pm Workshop E: Illuminating Novel Target Identification for MASH
Synopsis
This presentation will discuss screening algorithms for trials with different fibrosis and NAS score criteria. Current VCTEbased algorithms, such as FAST, Agile 3, and Agile 4, are not optimized for trial-specific needs, leading to high screen fail rates from liver biopsy. The ALADDIN study addresses this gap by using machine learning models trained on various fibrosis and NAS cutoffs. It integrates routine lab parameters, with and without VCTE, using data from 15 global centers and 5,000 patients. Separate test and validation sets ensure robust, generalizable findings to improve trial screening outcomes
2:30 pm Workshop F: Exploring Non-Invasive Tests & Biomarkers for MASH
Synopsis
This workshop will focus on the potential of oral insulin as a novel treatment for MASH. A recent Phase 2, double-blind study conducted across five sites demonstrated the advantages of oral insulin over placebo in improving liver function and reducing disease progression. Attendees will gain insights into the therapeutic potential of oral insulin and its role in future treatment strategies.