Translating Causation To Treatment - Reviewing The Microbiome's Role In Drug Development

7.50

Chair’s Opening Remarks

 

 

Peter Traber
Partner
Alacrita Consulting

The Mouse in the Room: How can we Push Preclinical Models to be Better?

8.00

Advanced In-Vitro Modelling of Liver Fibrosis

  • Using tissue engineering for drug target discovery and non-invasive evaluation of liver fibrosis
  • Further session details to follow

Massimo Pinzani
Professor of Medicine
UCL


 

8.20

Using Precision Cut Liver Slices to Model Fibrosis

  • Sharing data on testing the ability of clinically approved drugs to limit fibrosis in this model and how this new bioreactor can be successfully used to model fibrogenesis and demonstrate efficacy of anti-fibrotic therapies
  • Demonstrating the utility of precision cut liver slices (PCLS) retaining the structure and cellular composition of the native liver
  • Showcasing the FibroFind bioreactor system that increases the healthy lifespan of PCLS which allows us to model fibrogenesis

 

Jelena Mann
Professor of Epigenetics
Fibrosis Research
Group Newcastle
University

 

 

8.40

Drug Discovery for NASH & Liver Fibrosis Using Human Cell-Based Models

  • Appreciating the discovery of compounds for treatment of advanced liver disease has been hampered by tractable and model systems for disease biology
  • Sharing human cell based model that mimics gene expression in patients with NASH and advanced liver disease for fast-track discovery of liver disease therapeutics
  • Using the model system to identify several novel targets and compounds with completed in vivo proof-of-concept

 

Thomas Baumert
Professor of Medicine, Institute of Viral & Liver Disease
Inserm

 

 

9.00

Are we able to Standardise & Improve Preclinical Models?

 

 

Panel Discussion & Q&A with Preceding Speakers

9.30

Speed Networking

10.15

Morning Break

Deepening Understanding of Liver Fibrosis: Drivers, Targets & Predictors of Progression

11.00

Delineating & Utilising the Complexities of Fibrosis Pathology

  • Evaluating epigenetic mechanisms governing liver fibrogenesis, both in rodent models of disease and in patients
  • Determining grade of fibrosis using hepatic DNA methylation signatures present in the circulating cell-free DNA
  • Describing DNA methylation-histone modification nodes that regulate
    myofibroblast phenotype and fibrogenesis and how targeted delivery of
    epigenetic drugs to HSC has therapeutic potential

Jelena Mann
Professor of Epigenetics
Fibrosis Research
Group Newcastle
University

 

11.20

Importance of Fibrosis for NASH Therapy

  • Targeting multiple fibrogenic pathways with the NOX1/4 inhibitor GKT831
  • Exploring GKT831’s mechanism of action - targeting multiple fibrogenic pathways
  • Comprehensively reviewing understanding of clinical efficacy and safety profiles in liver, lung and kidney fibrosis

 

Elias Papatheodorou
Chief Executive Officer
Genkyotex

 

11.40

Targeting Liver Fibrosis with New Generation Drugs

 

 

Panel Discussion & Q&A with Preceding Speakers

12.00

Lunch & Networking

Validating Biomarkers Against Liver Histology

13.30

Precision Metabolomics: Understanding the Complexity of NAFLD/NASH

  • Understanding Metabolon’s Precision Metabolomiics technology: a mass
    spectrometry-based method that allows for the identification small molecule compounds in a single sample
  • Surveying diverse metabolic pathways simultaneously in a single sample
  • Demonstrating a holistic assessment of NAFLD/NASH complexity

 

 

Kari Wong
Senior Study Director
Metabolon

 

13.50

Novel Serum Biomarkers for NAFLD Identified Using Proteomics

  • Presenting several biomarkers identified using proteomics which successfully track disease progression including ones which can discriminate healthy individuals from NAFL, NAFL from NASH and the stages of lobular inflammation
  • Sharing the first antibody-free serum protein biomarker assay and progress in developing a rapid point-of-care test (POCT)
  • Improving biomarker detection and quantification using a universal calibration mix which can be used for any protein biomarker and up to six different biomarkers in a single acquisition

 

 

Bevin Gangadharan
Research Associate
University of Oxford

 

14.10

Can Biomarker Technologies be used to Predict Fibrosis Progression for Population Enrichment?

 

 

 

Panel Discussion & Q&A with Preceding Speakers

14.30

Afternoon Break & Networking

Contextualising NASH in a Clinical Framework: Strategising Payer & Reimbursement Landscape

15.10

Establishing Relationship Between Doctor’s Needs & Pharma’s Objectives

  • Representing the interests of doctors in Europe
  • Aligning clinical appetite with the direction of pharma

 

Vincenzo Costigliola
Founder & President
European Medical
Association (EMA)

 

15.30

Considerations from NICE on how to Assess the Value of Medicines for NASH

  • How NICE makes decisions on whether new medicines should be funded by the UK NHS
  • Sharing HTA thoughts on use of surrogate endpoints and pricing to account for uncertainty and resource savings
  • Navigating long term uncertainty: predicting quality of life and survival

 

Jeanette Kusel
Director Scientific Advice
National Institute
for Health & Care
Excellence (NICE)

 

15.50

Determining the Natural History of NASH & it’s Impact on Potential Cost Effectiveness

  • Demonstrating the rate of progression in NASH as uncertain and current
    projections likely overstating the future incidence of cirrhosis
  • The majority of deaths in NASH relate to co-morbid diseases rather than liverrelated mortality
  • Presenting the impact of treatments are better considered through the lens of primary and secondary prevention, as is the case for cardiovascular disease

 

Ian Rowe
University
Academic Fellow &
Hepatologist
University of Leeds

 

16.10

Navigating NASH Reimbursement – a European Conundrum?

  • Presenting and discussing the patient conundrum
  • Evaluating the payer challenge
  • Determining the industry response (good and bad)

 

Giampiero “GP”Carlo
Head of Brand:
Cotadutide,
Cardiovascular,
Renal & Metabolism
(CVRM)
AstraZeneca

 

16.30

Goal Setting in Medical Care & Insights for Earlier Pipeline Assets

 

Panel Discussion & Q&A with Preceding Speakers

17.00

Chair’s Closing Remarks