The twelfth Liver Forum was held on April 22 and April 23, 2022 in Washington, D.C.

Materials

• Agenda

Presentations

• Setting the Stage
  Veronica Miller, Forum for Collaborative Research

Session I: Improving the Reference Standard

• Challenges with Histological System: Clinician Perspective
  Stephen Harrison, Pinnacle Clinical Research

• Challenges with Histological System: Pathologist Perspective
  Karoline Lackner, Medical University of Graz

• Challenges with Histological System: Statistician Perspective
  Amrik Shah, Karma Statistics

Session II: Improving the Reference Standard

• Assessment of Ballooning: Implications of Recent Data
  Elizabeth Brunt, Washington University

• Assessment of Fibrosis: Experiences from Longitudinal Studies and Novel Approaches
  Nikolai Naoumov, Independent Expert, London, UK

• Assessment of Inflammation: Portal/Septal Inflammation vs. Lobular
  David Kleiner, National Cancer Institute

• Application of Digital Pathology Tools in Drug Development
  Arun Sanyal, Virginia Commonwealth University

Session III: Opportunities and Challenges for NIT

• A Meta-analytic Summary of NIT Applications in NASH Development
  Quentin Anstee, Newcastle University

• Integrating NIT Development within a Drug Development Program
  John Sninsky, Advisor to the Forum

• Validating Surrogate Endpoints Using Existing Data and Collaborative Analyses: Lessons from Virology
  Jeffrey Murray, Advisor to the Forum

Session IV: Diagnostic Context of Use

• Update on Current Literature on Diagnostic COU for Circulating Biomarkers
  Sudha Shankar, Co-chair NIBMLE Consortium

• QIBA and Imaging Biomarkers for Fat Quantification
  Anthony Samir, Harvard Medical School

• MRI and Diagnostic Application of cT1 and Elastography Through the Lens of Regulatory Science
  Claude Sirlin, University of California, San Diego

• Regulatory Perspectives on Qualification of NITs for Diagnostic COU
  Abbas Bandukwala, U.S. Food and Drug Administration

Session V: Prognostic NITs and Their Application in Clinical Trials for NASH

• The NASH-TARGET Approach for Non-invasive Diagnosis and Risk Stratification
  Sidney Barritt, University of North Carolina-Chapel Hill

• Application of MRI and Other Imaging Approaches for Prognostic COU
  Alina Allen, Mayo Clinic

• Circulating Biomarkers and Their Application for Prognostic COU
  Matthew Gee, Siemens Healthineers

Session VI: Status of NITs for Predictive Disease Monitoring/Treatment Response COU

• Integrated NIT Analysis in Drug Development
  Anne Minnich, Bristol Myers Squibb

• Update on NAIL NIT Concept
  Sophie Jeannin, Summit Clinical Trials

• Placebo Arm Studies and Can NITs Be Used to Reduce Variance in Placebo Arm Responses in NASH Trials
  Veronica Miller, Forum for Collaborative Research

• Making the Case for a NIT-based Recruitment and Assessment of Progression to Cirrhosis in NASH Trials
  Arun Sanyal, Virginia Commonwealth University

• Needs for NIT Development to Reduce Misclassification of Non-Responders in Clinical Trials
  Judith Ertle, Boehringer Ingelheim