Conference Agenda

7:00 am
Registration & Networking Breakfast

7:55 am Chair’s Opening Remarks

  • Ranabir SinhaRoy Vice President & Global Program Head General Medicine, Regeneron

Facilitating a Holistic Approach to Metabolic Syndrome & Investigating Combination Therapy to Achieve Meaningful Weight Loss

8:00 am Holistic Approaches to Cardiometabolic Disease: Common Disease Pathology, Comorbidities & Combination Therapies

  • Brian Finan Vice President, Obesity Research, Novo Nordisk

Synopsis

  • Obesity, cardiovascular disease, and diabetes: addressing the underlying common disease pathology and outcomes – what can we demonstrate in clinical trials?
  • GLP-1 receptor agonists: what are the next steps in treating cardiometabolic disease?
  • Human-centric approaches to drug development: how do we approach the holistic patient view in cardiometabolic disease from a pre-clinical perspectives in the future?

8:30 am Tirzepatide, Morbidity & Mortality in Obesity: Pioneering a Holistic Approach to Obesity Outcomes Trials

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

Synopsis

  • Investigating an unprecedented step forward in weight loss: development of the dual GIP and GLP-1 receptor agonist tirzepatide
  • Moving beyond traditional outcome trials for individual indications to efficiently assess efficacy in obesity, HFpEF, NASH, CKD, and other obesity-related morbidities
  • Navigating a broader primary endpoint and select type-1 error controlled secondary endpoints to study multiple outcomes in select populations

9:00 am Metabolic Syndrome & NASH Clinical Trials: Considerations for Combination Trials – Where We Have Been, What We Might Consider, & Future Tools

Synopsis

  • Lessons learned from oncology drug development and leveraging precision targets
  • Design choices informed by understanding patient journey
  • Understanding challenges and opportunities in combined trial implementation

9:30 am Panel Discussion: Agents, Trial Design & Collaboration: Breaking New Ground in Combination Therapy with Multiple Mechanisms of Action

  • Mathijs Bunck Associate Vice President, Medical Development, Tirzepatide Obesity, Eli Lilly & Company
  • Brian Finan Vice President, Obesity Research, Novo Nordisk
  • Salvador Augustin Senior Clinical Program Leader, NASH, Boehringer Ingelheim
  • Roberto Calle Executive Medical Director, Regeneron
  • Sudha Shankar Global Clinical Head NASH, AstraZeneca

Synopsis

  • Navigating different combinations of therapeutic agents: what can you combine?
  • Crafting protocols around current standard for care
  • Collaborate to innovate: examining rationale for cross-industry partnerships to forge synergistic combination therapies

10:00 am
Speed Networking

Synopsis

This session is the ideal opportunity to take advantage of face-to-face networking time, and understand who is also prioritising and overcoming challenges within Obesity and NASH drug development.

A New Paradigm in Obesity Drug Development: Next Steps in Harnessing GLP-1 Receptor Agonists

  • Ranabir SinhaRoy Vice President & Global Program Head General Medicine, Regeneron

11:00 am Developing a Small Molecule Oral Agonist: A New Era of Oral Therapies that Target the GLP-1R Pathway

Synopsis

  • Beyond peptides: discovering a potent small molecule GLP-1Ra
  • A big impact in a small package: assessing a small molecule GLP-1Ra in the clinic
  • The future of a small molecule pill: looking forward to convenient combination therapies

11:30 am Beyond GLP-1 Receptor Agonists: Examining Innovative Mechanisms of Action & Clinical Data for the Treatment of Obesity

Synopsis

  • From GLP-1 monotherapy to triple agonists: enhancing effective drug-based therapy for weight loss to rival bariatric surgery
  • Exploring advances in dual receptor agonists, triple receptor agonists and combination therapies for the treatment of obesity, NASH, and metabolic dysfunction
  • Assessing the comparative benefits of different agents and mechanisms of action in these conditions

12:00 pm Correcting Dysregulated Fat Metabolism: Unraveling a Novel Approach to Reverse Obesity, NASH & Type 2 Diabetes

Synopsis

  • Leveraging an oral small molecule therapeutic to sustainably modulate adipose tissue metabolism
  • Targeting the root cause: preventing or reversing fatty liver disease and the progression to NASH
  • Obesity, NASH, and T2D: interrogating animal studies and translation to the clinic

Delineating Evolving Regulations & Payer Perspective to Illuminate the Path to Commercialization

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

11:00 am Global Regulatory Guidelines & Biomarker Qualification: How is the Regulatory Landscape Evolving?

Synopsis

  • How set in stone are endpoints and what is needed to validate surrogate endpoints?
  • Establishing a clinical pathway to correlate non-invasive biomarkers with clinical outcomes and considering what is required to demonstrate efficacy in combination therapy
  • Harmonizing global regulations in the context of distinct regulatory expectations and exploring precision medicine in NASH

11:30 am The HepQuant Liver Function Test to Enhance Drug Development

Synopsis

  • Experience in monitoring liver function in clinical trial
  • Update on Regulatory path and results of pivotal study
  • New developments on the horizon

12:00 pm Panel Discussion: Reflecting on the Last 3 Years in NASH: Is there a Horizon Beyond the Setbacks?

Synopsis

  • What has worked and what hasn’t?
  • Do we need a new normal in trial design and clinical development for NASH?
  • Adapting mindsets: how do we ‘fail earlier’ to accelerate the pathway to successful therapies?

12:30 pm
Lunch & Networking

From Bench to Bedside: Elucidating Disease Pathogenesis & Driving Translation to the Clinic

1:30 pm Dolphins & Humans: How a Common Saturated Fat Deficiency May be Driving NASH

Synopsis

  • Understanding pathophysiology of NAFLD and NASH in dolphins and links to iron overload
  • Using metabolomics to identify a saturated fat in fish that reduces progression of fibrotic disease
  • Translation to humans: potential role of nutritional C15:0 deficiencies as an underlying driver of NASH

2:00 pm The Challenges of Developing Drugs for NASH Cirrhosis: The Example of Belapectin

  • Pol Boudes Chief Medical Officer, Galectin Therapeutics

Synopsis

  • Addressing cirrhosis in patients with clinical signs of portal hypertension
  • Interrogating therapeutic efficacy and expanding the scope of target patient populations
  • Innovating clinical trial design with adaptive design to determine dose and better understand efficacy

Delineating Evolving Regulations & Payer Perspective to Illuminate the Path to Commercialization

1:30 pm Predictive Models for Assessing Risk for Drug- Induced Liver Injury in Drug Development

  • Minjun Chen Staff Fellow Division of Bioinformatics & Biostatistics, FDA

Synopsis

  • Annotation of drug induced liver injury risk for developing predictive models
  • Computational modeling for liver toxicity and disease prediction
  • Assessing the potential for a drug to cause severe liver injury in drug development

2:00 pm Panel Discussion: Obesity, Diabetes & NASH: What do Payers Need to See?

Synopsis

  • Defining payer expectations and considering long term value
  • Assessing higher risk patient populations and preventing comorbidities
  • Harmonizing global patient metrics

2:30 pm
Afternoon Break & Networking

Standardizing or Evolving Beyond Biopsy? Clarifying the Next Step to Monitor Disease Progression & Establish Therapeutic Efficacy

  • Allison Goldfine Director, Translational Medicine Cardiometabolic Disease, Novartis

3:00 pm Clinical Imaging Enables a Holistic Approach Towards Obesity, Insulin Resistance, & Downstream Organ Treatment

Synopsis

  • The importance of expanding the current drug development perspective of obesity to consider effects beyond a single end organ
  • Examples of how both individual drug targets and single end organs can fit into the larger disease picture
  • Clinical imaging techniques like MRI and PET can provide non-invasive biomarkers and a multi-organ assessment of treatment efficacy

3:30 pm The First True Fibrosis Resolution Biomarker in NASH

Synopsis

  • Extracellular matrix remodeling is the common denominator in all fibrotic disorders
  • Targeting tissue formation and tissue degradation reveals anti-fibrogenesis or fibrosis resolution
  • Quantifying tissue remodeling shows different modes of action for reversing liver fibrosis

4:00 pm Defining an Achievable Endpoint to Move Towards the First Approved NASH Therapeutic

Synopsis

  • Establishing endpoints required for accelerated approval and outcomes needed to achieve full approval
  • Navigating pitfalls with histological endpoints and conversations with regulators
  • Reflecting on industry setbacks: what do we need to do differently next time?

4:30 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

5:00 pm Chair’s Closing Remarks

  • Allison Goldfine Director, Translational Medicine Cardiometabolic Disease, Novartis

5:10 pm
Drinks Reception & Scientific Poster Session

Synopsis

The Poster Session allows you to connect with your peers and continue to forge new and existing relationships. Scientific posters will be presented on the very latest advancements in next generation therapies and clinical development for obesity and NASH to inform the direction of future drug development efforts.

For more information or to submit your abstract, please email info@hansonwade.com

End of Day One