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23-25 April 2018 | Boston, MA

56 Expert Speakers  3 Streams  12+ Hours of Networking

Day One
Tuesday April 24, 2018

Day Two
Wednesday April 25, 2018

08.00
Chair’s Opening Remarks

  • Jason Campagna Senior Vice President, Global NASH Lead, Intercept Pharmaceuticals

Evaluating the Rationale & Potential for Combinational Therapies in the Treatment of NASH

08.15
Targeting Multiple Pathways in NASH – Clinical Perspectives for Combination Therapies

  • Nikolai Naoumov Executive Director, Hepatology Science & Innovation, Novartis

Synopsis

• Understanding how liver injury in NASH involves a complex interplay of metabolic, liver inflammation and progressive fibrosis
• Clinical overview of Novartis’ broad portfolio of compounds targeting several pathways in NASH pathogenesis
• Assessing the rationale and recent developments of combination options for NASH
• Exploring options for clinical combination regimes based on the breadth of internal pipeline plus external collaborations for bringing optimal treatments to NASH patients

09.15
Panel Discussion: Combinational Therapies in the Treatment of NASH

  • Michael Crackower Executive Director, Immunology and Inflammation Discovery, Celgene
  • Nikolai Naoumov Executive Director, Hepatology Science & Innovation, Novartis
  • Sean Muthian Executive Director, External Science Innovations, Allergan

Synopsis

• Evaluating current rationale for drug candidate combinations
• Understanding potential for application of different combinations dependent upon population stratifications
• Hypothesizing a successful therapeutic event that could allow patients to come off NASH therapy

09.45
Morning Refreshments & Networking

Evaluating the Immunological & Molecular Pathways of NASH Pathology

11.00 Exploring Inflammation as a Driver & Therapeutic Target in NASH

• Learning molecular mechanisms of inflammation and innate immunity to identify therapeutic targets
• Exploring translation of bench to bedside opportunities in liver disease
• Focusing on signaling pathways and miRNA biomarkers in NASH
Gyongyi Szabo, Professor & Vice Chair of Medicine, University of Massachusetts Medical School

11.30 Minimally-Systemic Next Generation Therapeutic Approaches for the Treatment of NASH

• Bile acid receptors afford opportunities to treat NASH and other diseases
• TGR5 and FXR agonists are promising approaches to NASH however may engender liabilities with chronic
systemic exposure in man
• Minimally-systemic agonists have the potential to afford optimal efficacy without the liabilities and toxicities of systemic exposure

Jeremy Caldwell, Executive Vice President, Chief Scientific Officer, Ardelyx

12.00 Extended Q&A

12.30 Lunch & Networking

Discovering Next Generation NASH Therapeutics

13.30 Discovery & Characterization of Novel MetAP2 Inhibitors in the Treatment of NASH

• BMetAP2i attenuate liver injury, the NASH composite score and the fibrosis score in mouse models of NASH
• Improving in NASH composite scores occur in concert with reduced appearance of preneoplastic cells and foci, suggestive of modification in the progressive disease process
• Benefiting from improved glycemic and metabolic endpoints and hepatic pathways of fibrogenesis
• Examining these results show that MetAP2i

Thomas Hughes, Chief Executive Officer, Zafgen

14.00 Evaluating Progression Towards an Industry Standard In Vitro Model

• How to overcome challenges with in vitro models
• Comparing representation of human disease in 2D vs 3D liver tissue and isolated vs co-culture cells

Ajit Dash, Senior Safety Scientist, Early Development Safety

Manipulation of In Vivo Models in Preclinical Studies

11.00 NASH & Diabetes Preclinical Animal Models

• Presenting preclinical pharmacology results in diabetes and NASH animal models
• Identifying novel biologics for the treatment of diabetes and NASH

Michal Ayalon, Project Champion, Teva Pharmaceuticals

11.30 Metabolic Syndrome as a Driver of NAFLD & NASH

• Preclinical and clinical evidence of entero-hepatic targeting as a therapeutic intervention for NASH
• Cardiometabolic implications in NASH treatment goals

Speaker TBC

12.00 Understanding TGFB Signaling in Experimental Fibrosis Models

• Identifying a cross-tissue fibrosis profile as a common metabolic signature
• Cross-examining liver fibrosis models with metabolic changes in response to fibrotic signals in other fibrosis models

Ji Zhang, Scientist, Merck & Co

12.30 Lunch & Networking

Emerging Preclinical Biomarker Developments in NASH for Better Translation into the Clinic

13.30 The Use of Non-Invasive Imaging & Biomarkers in Early Drug Development

• Selection of non-invasive biomarkers to establish proof of concept (POC)
• Using non-invasive biomarkers to transition from proof of concept to later-stage clinical trials

Edgar Charles, Director, Exploratory Clinical & Translational Research, Bristol-Myers Squibb

14.00 Determining Molecular MR Imaging of Oxidized Collagen to Monitor Active Fibrogenesis in Preclinical Models of NASH

• Non-invasive measurement of treatment response in NASH clinical trials remains a challenge
• Oxidized collagen formed during lysyl oxidase-mediated collagen crosslinking is a novel biomarker of active fibrogenesis
• Molecular MR imaging of oxidized collagen decreases after anti-fibrotic treatment in preclinical models of NASH

Bryan Fuchs, Assistant Professor of Surgery, Harvard Medical School

Harnessing Clinical Lessons Learned to Advance Clinical Trial Design

11.00 Keynote: Harnessing Lessons from the Clinic to Address NASH Going Forward

• Increasing public understanding and appreciation of relevance, scope and impact of NASH
• Improving physician education and appreciation of NASH diagnosis and management from primary care through specialists
• Designing effective patient identification, screening, education, and support strategies and content
• Supporting the development of therapies to treat NASH

Donna Cryer, President, Global Liver Institute

11.30 Utilization of Non-Invasive Technologies to Evaluate Endpoints in a Relevant Phase 1b Population

• Delving into Retrospective data analysis to design and optimize NAFLD/NASH study inclusion criteria
• Secondary endpoints design to quantify target engagement
• Analyzing Biomarker data collection to evaluate pathway activity

Paul Grayson, President & Chief Executive Officer, Bird Rock Bio

12.00 The FGF21 Pathway - A role in NASH?

• Exploring the FGF21 as a hormone – physiology and pathology
• Harnessing FGF21 as a therapeutic – a metabolic regulator
• Potential mechanisms of action on the liver

Puneet Arora, Senior Medical Director, Genentech

12.30 Lunch & Networking

Enhancing Progress in NASH Therapeutic Discovery

13.30 Evaluating Clinical Trial Data from Acetyl CoA-Carboxylase Inhibitor

• Learning of the latest data from Pfizer’s ACC candidate in NASH
• Retrospective evaluation of clinical trial design
• More details to follow

Bill Esler, Senior Director, Pfizer

14.00 Exploring the Potential of GLP1 Agonists for the Treatment of NASH

• Evaluating available clinical data supporting the concept
• Analyzing ongoing clinical trials

Matthew Coghlan, Senior Director, Novo Nordisk

14.30
Afternoon Refreshments & Networking

Objectively Assessing the Relationship of NASH with Other Diseases

15.30
Keynote: Clinical Trials & Endpoints in NASH Cirrhosis

  • Peter Traber Director of The Board, President, Chief Executive Officer & Chief Medical Officer, Galectin Therapeutics

Synopsis

• Evaluating the differences between pre-cirrhotic and cirrhotic NASH including pathphysiology, clinical complications, progression, and prognosis
• Demonstrating the potentially relevant regulatory endpoints in NASH cirrhosis clinical trials
• Presenting the current state of results of completed studies and the design of ongoing studies in NASH cirrhosis

16.00
Keynote: Overview on NASH Heterogeneity & Relationships as a Sequel of CVM Disease

  • Aimo Kannt Cluster Head Comorbidites & Complications of Diabetes, Sanofi

Synopsis

• Prognostic biomarkers of NASH progression
• Patient stratification and targeted NASH therapies
• How liver disease impact cardiac structure and function
• Therapeutic approaches addressing both NASH and cardiovascular disease

16.30
Chair’s Closing Remarks

  • Jason Campagna Senior Vice President, Global NASH Lead, Intercept Pharmaceuticals