Conference Agenda

8:55 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

9:00 am Fact or Fiction? Unraveling Regenerative Medicine for the Treatment of Liver Damage

Synopsis

  • 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

9:30 am Hepatocyte Transplantation into the Upper Abdominal Lymph Nodes Through a Minimally Invasive Endoscopic Approach: Developing Ectopic Livers Through Organogenesis

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

Synopsis

  • Hepatocyte transplantation into lymph nodes, organogenesis and the formation of ectopic livers: leveraging cell therapy for the treatment of ESLD
  • Discussing alternative therapies for patients with ESLD who are deemed to be unsuitable candidates for standard liver transplantation
  • Discovering first-in-human application in a Phase 2a dose escalation clinical trial

10:00 am Interrogating Cell Therapy Approaches to Liver Regeneration

Synopsis

  • 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

10:30 am
Morning Break & Networking

10:45 am
Leveraging Robust Preclinical Models to Predict Target Engagement

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

11:30 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

Synopsis

  • 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

12:00 pm Panel Discussion: Liver Organoids, Precision-Cut Liver Slices & Animal Models: Interrogating Diverse Preclinical Models to Understand Pathophysiology & Screen Targets

  • Jacob Jeppesen Vice President Type 2 Diabetes & Cardiovascular Disease Research, Novo Nordisk
  • Jim Perfield Executive Director Discovery Biology, Diabetes, Obesity & Complications, Eli Lilly & Company
  • Quin Wills Co-Founder & Chief Scientific Officer, Ochre Bio

Synopsis

  • 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

11:30 am Evolving Innovative Trial Design with Diverse Patient Populations to Optimize Clinical Development

  • Kitty Yale Chief Development Officer, Akero Therapeutics

Synopsis

  • 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

12:00 pm How Sustainable is Drug-Based Management of Chronic Obesity & When Should Treatment Start?

Synopsis

  • 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?

12:30 pm
Lunch & Networking

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

1:30 pm One Drug Multiple Targets: Simultaneously Modulating Several Target Genes in Obesity, Diabetes & MAFLD

Synopsis

  • 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

2:00 pm Forging Success in Type 2 Diabetes: Treatment & Reversal of T2D & Interrogating Cross-Talk in Metabolic Syndrome

Synopsis

  • Investigating cross talk in metabolic syndrome: from T2D to obesity to NASH
  • Does T2D represent an attractive path to market? Understanding market access with opportunities and implications in NASH and obesity
  • Pioneering a new generation of gut-targeted polymer therapies to achieve pharmacologic duodenal exclusion: targeting the root cause of metabolic syndrome, improving blood glucose, and examining future potential in obesity and NASH

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

1:30 pm Patient Segmentation & Enhancing Understanding of Efficacy: Leveraging Machine Learning to Predict Fast Progressors & the Value of MRI

Synopsis

  • 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

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

Synopsis

  • 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

Synopsis

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

Synopsis

  • 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

4:00 pm Cholestatic & Metabolic Liver Disease: Uncovering A Mechanistic Understanding of FXR Agonist Induced Pruritus & its Therapeutic Potential

Synopsis

  • 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

4:30 pm Chair’s Closing Remarks

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

4:45 pm End of Day Two