Conference Day 2

8:55 am Chair’s Opening Remark

Applying Digital Pathology & Advanced Image Analysis to De-risk the Path From Preclinical Studies to Late-Stage Trials Through Enhanced Understanding of Efficacy

9:00 am Discovering Novel Biomarkers for Digital Analysis

  • Peter Boor Pathologist & Experimental Nephrologist, RWTH Aachen University

Synopsis

  • Identifying the type of biomarker required for quantitative fibrotic measurements
  • Considering methods to compare basal levels after the biomarker has been picked up

9:30 am Factoring the Slow Disease Progression by Developing Realistic Study Designs for Fibrosis

Synopsis

  • Conducting early biomarker studies and addressing how predictive they are for late stage
  • Exploring innovative suggestions for faster studies in fibrosis with a biomarker that has shown a certain level of predictability for a disease

10:00 am Morning Break & Networking

11:00 am Utilizing Digital Pathology to Enhance Quality of Clinical Readouts

Synopsis

  • Addressing current state of tissue analysis as a semi-quantitative clinical endpoint with large variability
  • Streamlining clinical trial progression by integrating digital pathology more easily

11:30 am Scrutinizing the Translation Between Animal Models & Human Patients for Stronger Endpoint Determination

Synopsis

  • Exploring patient-derived models to test novel therapies in a high throughput manner
  • Using fibrotic models of multiplexing several readouts for a bigger picture

12:00 pm Panel Discussion: Expanding the Horizons on Innovative Avenues for Standardized Readouts

Synopsis

  • Discussing the importance of multiple readouts to enhance efficacy
  • Exploring a new format of constructing a panel of pathologists for standardized readouts and image interpretation

1:00 pm Lunch & Networking

Unlocking Disease Pathogenesis: Redefining Early Assessment of Heterogeneous Fibrotic & Inflammatory Disorders Through Leveraging Digital Pathology

2:30 pm Quantifying Changes in NASH Histology Features in Treatments for Children & Adult

  • Joel Lavine Professor - Pediatrics, Columbia University

Synopsis

  • Utilizing image analysis techniques to identify alterations that provide insights for drug discovery and safety applications Evaluating and comparing how different imaging techniques reflect in pathology
  • Recognizing the “real world” importance of adapting or including alternatives to liver biopsy in implementation of care

3:00 pm Using Digital Pathology in Pre-Clinical Fibrosis Research & Bridging the Gap With Human Studies

  • Yury Popov Co-Director, Pathogens Immunity and Inflammation Translational Hub, Beth Israel Deaconess Medical Center

Synopsis

  • Selecting previous human studies for early diagnosis to understand which tests are needed
  • Deciding on an early or a late long study
  • Exploring how to non-invasively solve fibrosis over time

3:30 pm Panel Discussion: Updates on the Current State of Fibrotic Diseases

  • Jerome Rossert Vice President, Head of Clinical Renal, Late CVRM, AstraZeneca
  • Tania Kamphaus Director - Metabolic Disorders, Foundation for the National Institutes of Health
  • Michael Badman Translational Medicine Expert, Novartis AG
  • Juliette Chen Global Evidence & Outcomes Leader, Takeda Pharmaceutical Co. Ltd.

Synopsis

  • Sharing the current understanding of what we know about fibrosis today
  • Comparing current state-of-the-art approaches to examining disease progression in the heart, kidney and liver

4:00 pm Chair’s Closing Remarks