Post-Conference Seminar Discussion Day | Thursday December 2, 2021

Uncovering Non-Invasive Biomarkers Day

9:30 am Registration & Networking

10:00 am Exploring Non-Invasive Biomarkers from a Regulatory Perspective to Understand What Features the FDA/EMA Assess When Approving Biomarkers in the Context of NASH Drug Development


• Explaining the ‘Biomarker Qualification Program’ in depth
• Understanding the analytical considerations of the program
• Deep diving into NASH biomarker considerations from an FDA perspective

10:30 am Non-Invasive Tools for Diagnosing & Staging NAFLD & Liver Fibrosis: Current Status & Perspectives

  • Nikolaos Perakakis Professor of Metabolic & Vascular Medicine, Carl Gustav Carus Faculty of Medicine, TU University of Dresden


• Discovering imaging modalities for assessing liver steatosis and fibrosis stage
• Explaining Omics (lipidomics, genomics, epigenomics, transcriptomics, glycomics and proteomics) alone and together with clinical data for developing diagnostic algorithms with the use of machine learning tools
• Understanding challenges related to the development of non-invasive diagnostic tools and ways to overcome them

11:00 am Circulating Extracellular Vesicles as Potential Biomarkers for Nonalcoholic Steatohepatitis (NASH)

  • Davide Povero Assistant Professor in Biochemistry and Molecular Biology, Mayo Clinic


• Introducing the potential for extracellular vesicles to be used as biomarkers for NASH
• Outlining best practices for isolation and identification of circulating extracellular vesicles from biofluids
• Explaining omics analyses of circulating extracellular vesicles from NASH murine models and human subjects

11:30 am Innovative Machine Learning Tool using Protease Activity Sensors to Predict Non-alcoholic Steatohepatitis & Stage Fibrosis


• Describing transcriptomic analysis of human liver biopsies across 2 independent cohorts of NAFLD patients revealed that proteases are widely dysregulated in progressive NASH, and panels as few as 13 proteases have the capacity to discriminate F2+ from F0-F1 with high accuracy (AUC> 0.85).
• Hearing how glympse bio has developed a bespoke library of PEGylated peptides, safe for human use, to detect NASH proteases by releasing cleaved reporters into urine for multiplexed quantification by mass spectrometry.
• Understanding how in rodent models of NASH, we showed that binary classifiers trained on urine samples accurately distinguished NASH from NAFL, separated F2+ from F0-F1 fibrosis, and indicated disease regression and drug response as early as one week following diet change or drug treatment

12:00 pm Speed Networking

12:30 pm Lunch

1:30 pm The Use of Non-Invasive Biomarkers to Enrich Trials


• Which non-invasive biomarkers are available for use now ?
• Which biological or pathological processes underpin the readout for the non-invasive tests?
• Practical examples and potential future use of non-invasive tests for study population enrichment

2:00 pm Promise of Serological Biomarkers for Liver Fibrosis in NASH

  • Detlef Schuppan Professor, University Medical Center of the Johannes Gutenberg University


• Illustrating the need for biologically plausible serum/plasma) biomarkers of liver fibrosis stage, fibrosis progression and fibrosis resolution
• Describing liver fibrosis marker exploration, development and validation based on extracellular matrix biology and advanced proteomics technologies
• Demonstrating examples of the predictive value of novel fibrosis markers being validated in defined cohorts of (NASH) patients undergoing (antifibrotic) treatment

2:30 pm Reviewing the Range of None-Invasive Biomarker Technologies Available for More Effective NASH Drug Development, Considering Accuracy, Reliability & Patient Centricity

  • Hannah K. Drescher Postdoctoral Research Fellow at Gastrointestinal Unit, Harvard Medical School


• Identifying the types of non-invasive biomarkers that can successful discern disease stages/progress
• Update on molecular magnetic resonance imaging (MRI) for NASH fibrosis
• Outlining different non-invasive biomarker types available

3:00 pm NIMBLE: A Public-Private Partnership to Qualify Non-Invasive Biomarkers for NASH

  • Tania Kamphaus NIMBLE Program Officer & Metabolic Diseases Program Lead, Foundation for NIH


• Outlining our partnership structures
• Exploring our goals in the context of public-private partnerships for non-invasive biomarkers
• Exploring the opportunity to impact research through collaborative work

3:30 pm End of Conference