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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

08.45
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

A Decade of NAFLD/NASH Clinical Trials – What Have we Learned?

09.15
Notes from the Field: Strategies for Successful NAFLD & NASH Trials

  • Linda Morrow Vice President and Chief Medical Officer, ProSciento

Synopsis

• Lessons from 10 years of trials in the NAFLD/NASH space

• Recruitment and subject retention strategies

• Multi-site trial design and delivery and targeted biomarker selection

Discovering Next Generation NASH Therapeutics

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

  • MetAP2 inhibitors attenuate liver injury, the NASH composite score and the fibrosis score in mouse models of NASH
  • Improved NASH composite scores occur in concert with reduced appearance of preneoplastic cells and foci, suggestive of modification in the progressive disease process and benefits from improved glycemic and metabolic endpoints

Thomas Hughes, Chief Executive Officer
Zafgen

11.30
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,
Genentech

12.00
Lunch & Networking

Evaluating the Immunological & Molecular Pathways of NASH Pathology

13.00
Role of Inflammation in NASH driven fibrosis

  • Learn the role of chronic inflammation in fibrosis
  • Understand the role of type 2 cytokines in chronic inflammation and fibrosis
  • Evaluate the collaborative roles of IL13 and TGF-B in fibrosis

Thomas Wyn, Vice President Inflammation and Immunology,
Pfizer

13.30
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

Manipulation of In Vivo Models in Preclinical Studies

11.00 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

11.30 Understanding TGFB Signaling in Experimental Fibrosis Models

  • The MR is expressed on activated MØ’s but not tissue resident macrophages
  • Fatty liver progressing to NASH and cirrhosis requires both M1 and M2 phenotypes
  • Data in animals and humans will be presented demonstrating the quantitative scoring and localization of activated MØ’s in NASH livers
  • Animal data with therapeutics targeting the MR in prevention and treatment of NASH and fibrosis

Michael Goldberg, CEO, Navidea/
Macrophage Therapeutics

11.45 Extended Q&A

12.00 Lunch & Networking

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

13.00 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

13.30 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 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 DirectorGenentech

11.30 Tailoring imaging biomarkers to your mode of action in NASH drug development

  • Discussing precision imaging biomarkers in NASH: difference between diagnosis and drug development
  • Understanding the importance of assessing cardiometabolic imaging biomarkers in NASH

Lars Johansson, Chief Scientific Officer,
Antaros Medical

11.45 Extended Q&A

12.00 Lunch & Networking

Enhancing Progress in NASH Therapeutic Discovery

13.00 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

13.30 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

14.00
Morning Refreshments & Networking

14.15
Afternoon Refreshments & Networking

Objectively Assessing the Relationship of NASH with Other Diseases

15.00
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

15.30
Keynote: NASH and cardiometabolic sequelae – one-way street or bidirectional relationship?

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

Synopsis

  • Association of NASH with metabolic disorders and cardiovascular morbidity and mortality
  • NAFLD and extrahepatic malignancies
  • Pathophysiological mechanisms linking NASH to metabolic and cardiovascular disease

16.00
Keynote: Harnessing Lessons from the Clinic to Address NASH Going Forward

Synopsis

  • 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

16.30
Chair’s Closing Remarks

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