Pre-Conference Seminar Day

Tuesday, November 29, 2022

Harnessing Digital Pathology & Non-Invasive Biomarkers to Drive Standardised & Accurate Interrogation of Efficacy

Disentangling Disease Pathogenesis to Identify & Validate Novel Targets

9.25 Chair’s Opening Remarks

Sudha Shankar, Global Clinical Head, NASH, AstraZeneca

9.25 Chair’s Opening Remarks

Kitty Yale, Chief Development Officer, Akero Therapeutics

9.30 Application & Use of Non-Invasive Biomarkers in NASH: Characterizing Diagnostic Performance & the Road to Validation

  • Unlocking novel diagnostic tools to drive earlier diagnosis and reduce disease burden on patients
  • Driving pre-competitive collaboration to better define patient populations and find promising non-invasive biomarkers
  • Towards a new era of biomarkers: investigating the future of improved disease recognition and non-invasive diagnostic options

Sudha Shankar, Global Clinical Head, NASH, AstraZeneca

9.30 Unlocking the Arc of Discovery: Exploring Underlying Pathophysiology & Target Identification for NASH

  • Holistic approaches to drug discovery and preclinical development
  • Exploring preclinical data to lay the foundations for clinical success in NASH
  • Opening up a world of possibility: early data and translation to the clinic

Mette Guldbrandt, Vice President, Global Drug Discovery, Liver Disease Research, Novo Nordisk

10.30 How AI-Powered Pathology in NASH is Addressing Key Challenges Today & Paving the Way for Improving Drug Development Pathways

  • Reviewing how AI-based NASH assessment offers improved endpoint measurement and patient enrollment in NASH clinical trials
  • Adopting a comprehensive digital pathology lab operations solution for better clinical trial outcomes: Summit & PathAI strategic partnership
  • Moving beyond NASH-CRN scoring: the need for better assessment of treatment efficacy and changes in NASH disease severity

Eric Walk, Chief Medical Officer, PathAI

Sophie Jeannin Megnien,
Chief Medical Officer, Summit Clinical Research

10.00 A Comprehensive View on the Disease Biology of NASH as a Guidance for Novel Therapies

  • Exploring excessive intracellular fatty acids, insulin resistance, and the role of innate immunity
  • Understanding multifactorial pathogenesis of NASH
  • Examining the interrelationships between cardiometabolism and NAFLD

Michael Cooreman, Chief Medical Officer, Inventiva Pharma

10.30 A NIMBLE Approach to Breakthrough: Revolutionizing Diagnosis, Monitoring & Treatment of Metabolic Liver Disease with Non-Invasive Biomarkers

  • Correlating non-invasive markers with clinical and biopsy outcomes to move the needle on validation
  • Establishing the performance of available non-invasive biomarkers in clinical trials
  • Useing non-invasive biomarkers to diagnose presymptomatic NASH, characterize disease progression, and monitor treatment

Helen Heymann, Senior Scientific Project Manager, Metabolic Disorders, Foundation for the National Institutes of Health

10.30 Unraveling Mechanisms of Injury & Repair &
Advancing a Peptide Analogue to Target Diseases due to Metabolic Dysfunction

  • Developing a peptide analogue to target NASH and liver injury
  • Analyzing signaling pathways and disease mechanisms
  • Evaluating reduction of cell injury, inflammation, and fibrosis in preclinical models

Henry Hsu, Chief Executive Officer, Allysta Pharmaceuticals

11.00 Morning Break & Networking

11.30 Non-Invasive Imaging Biomarkers in NAFLD & NASH: Updates from the NIMBLE Consortium

  • Overview of non-invasive imaging measures for diagnosis and disease monitoring
  • Outlining ultrasound and MRI biomarker validation studies completed as part of the NIMBLE consortium
  • Discussion of imaging biomarker performance metrics and future implementation in clinical trials

Sarah Sherlock, Senior Director, Clinical & Translational Imaging & Head of External Imaging Alliances, Pfizer

11.30 Leveraging Artificial Intelligence to Identify Drug Leads & Establish Safety & Efficacy from Human Derived Data

  • Harnessing an AI-based platform to discover drug leads for NASH that identify metabolic pathways and fibrosis, and mitigate clinical risk at Phase I and Phase II
  • Centralizing large datasets to identify promising leads and translating to studies in humans
  • Employing artificial intelligence to explore the scientific underpinnings of the biology and clinical spectrum

Anjali Pandey, Senior Vice President, Nonclinical R&D & Chemistry, Aria Pharmaceuticals

12.00 Session Reserved for PharmaNest


Pharmanest Logo

12.00 Harnessing Endogenous Metabolic Modulators to Target Multiple Disease Pathways in NASH

  • Monitoring disease progression and therapeutic efficacy with non-invasive biomarkers in clinical studies
  • Reversing NASH through targeting multiple pathways
  • Managing diverse patient populations and investigating clinical data: with and without type 2 diabetes and navigating pediatric studies

Margaret Koziel, Chief Medical Officer, Axcella Therapeutics

12.30 Lunch & Networking

1.30 Screening, Staging & Outcomes: Investigating Biomarkers for Clinical Trials in NASH

  • Biomarker use in clinical trials: endpoints and screening
  • Standardization and optimization of biomarkers in NASH: how good can they get?
  • Developing and validating biomarkers for use in clinical practice

Nezam Afdhal, Chief of the Division of Gastroenterology, Hepatology & Nutrition, Beth Israel Deaconess Medical Center

1.30 Targeting Mitochondrial Metabolism to Treat NASH and Additional Chronic Liver Diseases

  • Identifying MCJ as a novel target to modulate mitochondrial function to treat liver steatosis, inflammation, and fibrosis
  • Reviewing how efficacy has been demonstrated in multiple animal models of NASH and additional liver disease models
  • Defining next steps: translation to the clinic and consideration of other indications related to modulating the target of the kidney and heart

Cynthia Arbeeny, Chief Scientific Officer,Mitotherapeutix

2.00 Session Reserved for Antaros



2.00 Panel Discussion: Mechanisms, Targets & Therapeutic Potential: Dissecting Exciting Opportunities to Drive Novel Therapeutic Strategies

  • Investigating disease pathogenesis and a holistic understanding of metabolic syndrome to shape future directions of therapeutic development
  • GLP-1 receptor agonists, peptide analogues and microRNAs: mapping promising targets to regulate metabolism and NASH disease progression
  • Moving the needle on combination therapy

Marc Thibonnier, Founder & President, AptamiR Therapeutics

Henry Hsu, Chief Executive Officer, Allysta Pharmaceuticals

Scott Kelly, Chief Medical Officer, CytoDyn

Cynthia Arbeeny, Chief Scientific Officer,Mitotherapeutix

2.30 Panel Discussion: Biopsy: Should we Standardize it or Replace it?

  • Developing digital pathology to standardize biopsy assessments or advancing towards validation of noninvasive biomarkers: where should the emphasis be?
  • Traversing the high screen failure rate in NASH clinical trials
  • Invasive, expensive, and unreliable: what’s the next step in establishing efficacy?

Richard Torstenson, Senior Director, Global Regulatory Affairs, AstraZeneca

Nezam Afdhal, Chief of the Division of Gastroenterology, Hepatology & Nutrition, Beth Israel Deaconess Medical Center

Sudha Shankar, Global Clinical Head, NASH, AstraZeneca


2.40 Chair’s Closing Remarks

Kitty Yale, Chief Development Officer, Akero Therapeutics

3.10 Chair’s Closing Remarks

Sudha Shankar, Global Clinical Head, NASH, AstraZeneca