8:15 am Morning Refreshments
Reviewing Preclinical Studies & Clinical Progress to Bridge the Gap to Enhance the Translation of MASH Therapies
8:55 am Chair’s Opening Remarks
9:00 am Formulating Innovative & Patient Centred Phase 3 Trials to Improve Results for Translating More Drugs to Clinic
Synopsis
- Designing Phase III MASH trials to integrate robust methodologies and evaluating efficacy and safety across diverse patient populations, accelerating the path to regulatory approval to bring therapies to patients faster
- Incorporating non-invasive testing throughout Phase III trials to reduce patient burden and enhance data collection efficiency, leading to more comprehensive and patient-friendly assessments of treatment response
- Implementing patient retention strategies to ensure sustained participation in long-term Phase III studies, providing more complete and reliable data for demonstrating durable treatment benefits
9:30 am Evaluating Drug Safety Using Comprehensive Preclinical Assessments to Ensure Safer MASH Therapies
Synopsis
- Employing comprehensive preclinical assessments so potential safety issues can be identified early in the drug development process to lead to safer MASH therapies for patients
- Utilizing a wide range of preclinical models and techniques to provide a thorough understanding of a drug’s potential toxicity profile to, minimize the risk of adverse events in clinical trials and improving patient outcomes
- Integrating advanced preclinical safety data with clinical trial design to enable the development of robust risk mitigation strategies to ensure the long-term safety and efficacy of MASH treatments
10:00 am Characterizing Disease Progression Through Longitudinal Preclinical Studies to Inform Long-Term Clinical Strategies
Synopsis
- Conducting longitudinal preclinical studies to more accurately understand MASH progression to lead to the development of long-term clinical strategies that effectively address the disease course
- Employing longitudinal preclinical models to enable the identification of key drivers and mechanisms of disease progression to facilitate the design of targeted interventions for personalized treatment approaches for MASH patients
- Leveraging insights from longitudinal preclinical data to allow for the development of predictive biomarkers and surrogate endpoints to monitor treatment response, optimize clinical trial design, and accelerate the development of effective therapies for MASH
10:30 am Navigating the Path to the First MASH Therapeutic Approval & Progressing Beyond to Advance Clinical Development Strategies to Expand the Horizon of Approved Drugs
Synopsis
- Delving into the strategic clinical development and trial design methodologies that led to the unprecedented first therapeutic approval in MASH, setting a crucial benchmark for future candidates
- Reviewing the comprehensive clinical data and real-world evidence to demonstrate the significant efficacy and safety profiles that underpin the treatment’s success and inform optimal patient management
- Exploring how lessons learned from Madrigal’s development journey, alongside ongoing research, are influencing the design of subsequent clinical trials and accelerating the pipeline for next-generation MASH therapies
11:00 am Morning Break & Networking
Employing Cell Targeting Approaches to Enhance Liver Cell-Specific MASH Treatment Precision & Minimize Off-Target Effects
11:45 am Reducing & Reversing Liver Fibrosis Using Targeted Elimination of Pathogenic Stellate Cells
Synopsis
- Identifying pathogenic stellate cells using advanced markers for targeting the primary drivers of liver fibrosis
- Developing antibody drug conjugate for the selective delivery of payloads directly to pathogenic stellate cells to minimize off-target effects
- Establishing the in vivo pharmacokinetic and pharmacodynamic relationship for optimizing dosing, predicting efficacy, and ensuring safety in reducing liver fibrosis
12:15 pm Identification of Targeting Pathogenic Cells for Fibrotic Disease
Synopsis
- Utilization of ‘omics to identify pathogenic cell types, mechanisms, and targets
- Methods to validate transcriptionally identified targets for development of therapeutics
- Applying novel therapeutic approaches to target unique pathogenic cell populations
12:45 pm Lunch
1:45 pm Roundtable Discussion: Adapting Trial Methodologies to Reflect Real-World MASH Populations to Broaden Treatment Applicability
Synopsis
- Implementing more inclusive trial designs that incorporate diverse patient populations to ensure trial results are generalizable to a broader range of MASH patients to lead to more effective and equitable treatment strategies
- Utilizing real-world data (RWD) and patient registries to provide valuable insights into disease progression and treatment outcomes in routine clinical practice to complement traditional trial data and enhance the development of patient-centred treatment approaches
- Exploring novel endpoints beyond traditional histology to capture the full spectrum of MASH-related outcomes, including patient-reported quality of life and long-term complications to facilitate the development of therapies that address the holistic needs of MASH patients
Harnessing GLP-1s to Maximize Treatment Effectiveness to Expand the MASH Therapeutic Potential
2:45 pm Harnessing GLP-1s to Maximize MASH Treatment Effectiveness to Expand the Therapeutic Benefits of This Class of Drugs
Synopsis
- Reviewing GLP-1 mechanisms, including the unique biological actions of GLP-1 receptor agonists in targeting key pathways of MASH pathogenesis to demonstrate their potential to improve liver health to offer a novel therapeutic avenue for MASH patients
- Presenting GLP-1 clinical evidence in MASH patients to demonstrate significant improvements in histological endpoints and metabolic profiles to establish their efficacy in treating the disease
- Discussing expanded GLP-1 applications to explore how the versatility of GLP-1s in addressing multiple comorbidities can expand their therapeutic benefits beyond the liver to offer a holistic treatment approach for MASH patients and improving their overall health
3:45 pm Panel Discussion: Expanding GLP1’s Role to Target MASH-Related Comorbidities to Improve Holistic Patient Outcomes
Synopsis
- Detailing GLP-1s effects on comorbidities to illustrate how these drugs can address a range of MASH-related comorbidities to offer a comprehensive treatment strategy to improve overall patient management
- Highlighting the benefits of a holistic approach to understand the advantages of using GLP-1s to manage MASH and its associated conditions to lead to better coordination of care and a more integrated approach to treatment
- Emphasizing improved patient outcomes to lead to better overall health and well-being for MASH patients to reduce the burden of multiple diseases, and improve their long-term prognosis