Conference Agenda

7:30 am
Networking Breakfast

8:25 am Chair’s Opening Remarks

  • Michelle Long International Medical Vice President, NASH, Novo Nordisk

From Bench to Bedside: Exploring Regenerative Medicine to Restore Liver Health & Optimize Clinical Treatment

8:30 am Fact or Fiction? Unraveling Regenerative Medicine for the Treatment of Liver Damage


  • From treating symptoms to curing disease: what is the next milestone in liver injury?
  • Exploring the potential for precision medicine approach to regenerative treatment
  • Future opportunities: advancing the frontier of regenerative medicine in endstage liver disease

9:00 am Human Liver Precision Cut Slices (PCLS): The Unrivalled Preclinical Platform for Development & Testing of Anti-Fibrotic Therapeutics


  • Describing the development of human Precision Cut Liver Slice (PCLS) methodologies
  • Providing examples of how these platforms are utilized for commercial drug development
  • Discussing the use of human PCLS as preclinical drug testing platforms using real life examples

9:30 am Interrogating Cell Therapy Approaches to Liver Regeneration


  • Exploring the potential of replacing diseased liver tissue to restore liver health
  • Advancing cell therapies to replace liver transplants and actively repair damaged tissues
  • Developing cell lines suitable for tissue regeneration in the liver

10:00 am
Morning Break & Networking

Leveraging Robust Preclinical Models to Predict Target Engagement

  • Michelle Long International Medical Vice President, NASH, Novo Nordisk

11:00 am Results from the LITMUS Preclinical Retrospective Study: A Novel Unbiased Approach to Rank Murine NASH Models Based on Proximity to Human Disease

  • Jim Perfield Executive Director Discovery Biology, Diabetes, Obesity & Complications, Eli Lilly & Company


  • Review how a wide-ranging retrospective review of 42 commonly used murine models was conducted
  • Learn how a novel algorithm was developed to evaluate preclinical models to human NASH in 3 categories: phenotype, histology, and liver transcriptome
  • Discover how separate rankings are provided for models based on relevance to NAFLD development and NASH fibrosis

11:30 am The “Free Choice” Diet-Induced Obese Hamster for Evaluating Drugs Targeting NASH & Fibrosis: A Promising Alternative to Mouse & Rat Models


  • Emphasizing the limitations of diet-induced mouse and rat models for evaluation of drugs targeting NASH/liver fibrosis
  • Describing the free choice diet-induced obese hamster as a preclinical model for NASH, liver fibrosis and associated heart failure with preserved ejection fraction
  • Presenting the effects of clinical benchmarks demonstrating the relevance of the hamster model for drug efficacy studies

11:45 am Panel Discussion: Liver Organoids, Precision-Cut Liver Slices & Animal Models: Interrogating Diverse Preclinical Models to Understand Pathophysiology & Screen Targets

  • Jim Perfield Executive Director Discovery Biology, Diabetes, Obesity & Complications, Eli Lilly & Company
  • Quin Wills Co-Founder & Chief Scientific Officer, Ochre Bio
  • Vivian Cong Vice President of Research & Development, Melior Discovery


  • Which are the best preclinical models? Recapitulating complex architecture and metabolic function in liver tissue to test therapeutic efficacy
  • Investigating emerging platforms and technologies for disease modeling and regenerative therapy
  • From research to therapeutics application: bringing the translational gap

Innovating Clinical Trial Design to Engage Patients & Optimize Study Outcome

  • Mathijs Bunck Associate Vice President, Medical Development, Tirzepatide Obesity, Eli Lilly & Company

11:00 am Evolving Innovative Trial Design with Diverse Patient Populations to Optimize Clinical Development

  • Kitty Yale Chief Development Officer, Akero Therapeutics


  • Designing a robust development program to accelerate drug development
  • F1, F2, F3, F4: navigating diverse patient populations in clinical studies to optimize treatment
  • Evaluating clinical development of EFX in Phase IIb and histological outcomes

11:30 am Leveraging a Non-Invasive Strategy for More Effective NASH Trials: From Patient Selection to Predicting Outcomes

  • Vidhya Kumar Vice President, Business Development, Pharma Solutions, Perspectum Diagnostics


  • Enrichment of patient population with a complementary biomarker strategy
  • Utility of an MR-based approach for monitoring
  • Uncovering the association between NASH biomarkers and Clinical Outcomes

11:45 am How Sustainable is Drug-Based Management of Chronic Obesity & When Should Treatment Start?


  • Finite treatment beyond GLP-1 receptor agonists: establishing sustainable treatment of obesity
  • Advancing a safer and more potent method to address the medical need of obese patients in combination with other treatments
  • Navigating early intervention: when does it make sense to start treating patients?

12:15 pm
Lunch & Networking

Cardiovascular, Metabolic & Kidney Diseases: Organ System Crosstalk in the Age of Multimorbidity

1:00 pm One Drug Multiple Targets: Simultaneously Modulating Several Target Genes in Obesity, Diabetes & MAFLD


  • Developing targeting microRNA oligonucleotide therapeutics for cardiometabolic disorders
  • Mice, rats, monkeys, and in silico: demonstrating proof of efficacy in vitro in primary cultures of human cells and animal models
  • Modulating multiple target genes with miRNA ONTs to treat multi-factorial diseases

1:30 pm Hepatocyte Transplantation into the Upper Abdominal Lymph Nodes Through a Minimally Invasive Endoscopy Approach: Developing Ectopic Livers Through Organogenesis

  • Paulo Fontes Co-Founder & Chief Medical Officer, LyGenesis

2:00 pm Cholestatic & Metabolic Liver Disease: Uncovering A Mechanistic Understanding of FXR Agonist Induced Pruritus & its Therapeutic Potential


  • Defining mechanistic understanding of FXR agonist induced pruritus and cholestatic pruritus
  • Uncovering a key pruritogenic cytokine, IL31, as a candidate target of FXR agonism
  • Investigating translation to the clinic: correlating IL31 with degree and severity of itch

Scaling the Chasm of Diagnosis & Patient Enrolment to Improve Meaningful Recruitment & Retention

  • Mathijs Bunck Associate Vice President, Medical Development, Tirzepatide Obesity, Eli Lilly & Company

1:00 pm Patient Segmentation & Enhancing Understanding of Efficacy: Leveraging Machine Learning to Predict Fast Progressors & the Value of MRI


  • Constructing a model to predict survival time of patients with NASH and/or portal hypertension, and identify fast progressors
  • Evaluating current performance in treating patients with cirrhosis and features of portal hypertension, real-world evidence
  • Non-invasive biomarkers for portal hypertension: HVPG vs integrating MRI into clinical trials to monitor therapeutic efficacy

1:30 pm Using Real-World Data to Increase Study Efficiency: From Diagnosis to Enrollment to Recruitment to Retention


  • Diagnosis: Identifying undiagnosed patients to expand potential enrollment pool
  • Enrollment: Set realistic enrollment goals by estimating size of eligible patient pool through assessment of the prevalence of specific variables used to determine inclusion and exclusion
  • Recruitment: Identifying patients at higher risk for developing outcome of interest using AI/ML
  • Retention: Continuing to “follow” participants even if they no longer are actively participating in the study

2:00 pm Driving Innovation in Patient Selection: Rethinking Inclusion & Exclusion Criteria


  • Investigating clinical trials for NASH in HIV-infected patients
  • Evaluating novel biomarker outcomes in NASH and considering comorbidities
  • Beyond NASH: driving studies in cardiovascular and metabolic disorders

2:30 pm
Afternoon Break & Networking

Dissecting Clinical Updates to Influence the Next Generation of Trials

3:00 pm Phase 3 Development of Resmetirom: A Selective Thyroid Receptor- Beta Agonist for the Treatment of NASH

  • Rebecca Taub Founder & Chief Medical Officer, Madrigal Pharmaceuticals


  • Examining the mechanism of action of thyroid receptor beta in the NASH liver
  • Exploring Phase 3 development program for non-cirrhotic NASH
  • Exploring Phase 3 development program for NASH – cirrhosis

3:30 pm Solutions to Improving Randomization Rates & Lower Screen Fail Rate

  • Guy Neff President & Chief Executive Officer, Covenant Metabolic Specialists


  • Pre-screening patient journey with trial qualifying efficiency
  • Departmental collaboration, aligning medical and business team
  • Site study specific enrolling data analytics to improve business intelligence

4:00 pm Breaking New Ground in Targeting Dysfunctional Metabolic Pathways in the Liver: Inhibition of FASN in NASH Patients with the First-in-Class Drug, Denifanstat


  • Evaluating the ability of FASN inhibition to improve the key drivers of NASH by: reducing liver fat, inflammation, and fibrosis
  • Validating digital imaging and non-invasive diagnostics as biomarkers of liver injury and predictors of response in clinical trials
  • Exploring initial clinical data in FASCINATE-2, a Phase IIb denifanstat study

4:30 pm Chair’s Closing Remarks

  • Mathijs Bunck Associate Vice President, Medical Development, Tirzepatide Obesity, Eli Lilly & Company

4:40 pm End of Day Two