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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

08.15
Keynote: Review Latest Advancements in NASH Drug Development

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

Synopsis

• Overview of early stage clinical compounds being evaluated for NASH with emphasis on
mechanistic differences with the handful of late stage, phase 3 compounds
• Evaluating regulatory guidance on development of NASH therapeutics with emphasis on the role of histology vs. non-invasive imaging in drug advancement the regulatory feedback on the development of late-stage NASH candidates
• Discussing how current clinical experience can be back translated into preclinical strategies

08.45
Exploring the Latest Regulatory Requirements for Developing NASH Therapeutics

Synopsis

• Evaluating how to validate drug candidates against current regulatory pathway
• Are clinical and preclinical endpoints evolving to the same extent as the clinical landscape?

09.15
Speed Networking

Synopsis

This session is the ideal opportunity to meet face-to-face with the brightest minds working in the NASH field. Specifically designed to connect you with many new contacts, the renowned Speed Networking will be one of the most valuable hours you will spend at the NASH Summit.

10.00
Morning Refreshments

Rapidly Progressing Understanding of NASH Pathology

11.00 What Have we Learned from Genes Modulating Risk for NASH Development?

• Reviewing the emerging biology around human genetics discovered genes that either protect or increase risk for NASH
• More details to follow

Jesper Gromada, Head of Metabolism,
Obesity & Lipid Therapeutics, Regeneron

11.30 Human Gluco & Liporegulatory Physiology & Pathophysiology as Drivers of Novel NASH Therapies

Reviewing the human physiological and pathophysiological basis of commonalities and differences in NASH and related metabolic diseases
• Understanding where to leverage diabetes therapies to treat NASH and where to seek additional pharmacology

Sudha Shankar, Head of Cardiometabolic Translational Medicine & Early Clinical Development, NGM Pharmaceuticals & Nimble Project

12.00 Identifying a Newly Uncovered Mitochondrial Bile Acid Synthetic Pathway as a Potential Regulator in the Transition from Steatosis to Steatohepatitis

• Describing the linkage between oxysterol/oxysterol metabolites and
inflammasome activation
• Identifying new NASH serum biomarkers
• Reviewing Cyp 7b1 as a new target for drug development to combat NAFLD
• Linking oxysterol metabolites to NASH and insulin resistance

Michael Fuchs, Professor of Medicine, Virginia Commonwealth University, & Chief of Hepatology, McGuire VA Medical

12.30 Lunch & Networking

Identifying & Validating Druggable Targets for Development

14.00 Leveraging New Technologies to Identify & Validate Novel Targets in NASH

• Capturing critical pathophysiologic drivers of NASH, including steatosis, inflammation and fibrosis to better recapitulate key NASH biological
pathways observed in human biopsies
• Improving the translation of newly discovered targets into clinical trials
• Evaluating current NASH therapeutic landscape and discussing discovery and validation of new targets
• Delving into how novel computational biology approaches aid target identification and validation in in vitro systems

Ryan Feaver, NASH Program Leader,
HemoShear Therapeutics

14.30 Targeting Oxidative Stress Pathways: Explore the Potential to Mitigate Multiple Aspects of NASH Disease Progression

• Improving understanding of oxidative stress and its linkage to tissue damage and remodelling in multiple disease settings
• Reviewing oxidative stress as an important factor in the transition from NAFLD to NASH
• Learning of several key enzymes believed to be responsible for oxidative stress in NASH
• Exploring the potential of small molecule targeting of these enzymes to ameliorate multiple aspects of NASH disease progression

James Swaney, Director of Biology,
Inception Sciences

Advancing In Vivo Models to Better Represent Human Physiology in the Clinic

11.00 Drawing More Robust Conclusions from an In-Depth Comparison of Current Animal Models

• Exploring experiences gained from developing animal models with relevant NASH biology
• Enhancing the characterization of NASH animal models
• Confidently track the development of steatosis and inflammation, fibrosis, markers of stellate cells, as well as serum biomarkers

Jamie Bates, Research Scientist, Gilead
Sciences

11.30 Novel Animal Models & Combination Therapies to Combat NASH

• Characterizing two new diet-induced NASH models in mice
• Revealing novel preclinical findings on NASH-reducing capabilities of combining FXR and GLP-1R agonists

Hani Jouihan, Scientist, Cardiovascular &
Metabolic Disease, MedImmune

12.00 Targeting Fructose Metabolism for NASH – KHK Inhibitor Update from Pfizer

• Evaluating how increased sugar intake fuels hepatic inflammation and steatosis
• Targeting Ketohexokinase in catalyzing the first step in fructose metabolism
• Demonstrating how treatment with a KHK-inhibitor reverses metabolic dysfunction in several rodent models of NAFLD-NASH
• Presenting preliminary clinical data update

Kendra Bence, Senior Director,
Metabolism, Pfizer

12.30 Lunch & Networking

Utilising In Vitro Models to Better Recapitulate Human Disease

14.00 Overcoming the Challenge of Replicating Human Disease Pathophysiology In Vitro

• Overcoming differentiation of human primary cells in vitro so to better replicate 3D orientation of multiple cel types, physiological hemodynamics and in vivo cell like function
• Demonstrating response to critical pathophysiologic drivers of NASH, including steatosis, inflammation and fibrosis to better recapitulate key biological pathways observed in human biopsies
• Identifying and validating novel targets for NASH and metabolic rare diseases using an in vitro platform

Brian Wamhoff, Head of Innovation, HemoShear Therapeutics

14.30 Targeting Pyruvate Metabolism to Treat NASH

•  Discovering MSDC-0602K as a nextgeneration
insulin sensitizer that is a modulator of the mitochondrial pyruvate carrier (MPC or mitochondrial target of thiazolidinediones)
• Modification of pyruvate entry into the mitochondria results in multiple downstream changes that protect against the pathology produced by overnutrition, including insulin resistance and liver pathology
• Exploring the effects of MSDC-0602K on
preventing and reversing liver pathology including fibrosis are dependent on the MPC. New understanding of the pathways involved will be presented

Jerry Colca, Executive Vice President
& Chief Scientific Officer, Cirius
Therapeutics

Hurdling the Difficulties in Effectively Utilizing Available Patients in NASH Clinical Trials

11.00 Harnessing Understanding of NASH Pathophysiology to Better Standardize Patient Stratification & Enrolment in Clinical Trials

• Evaluating the role of genetics in defining NASH pathology from fatty liver to cirrhosis
• Assessing metabolic drivers of NASH and metabolomic identification of NASH patient subtypes
• Discussing the potential for fibrosis resulting from other pathologies as a substitute for NASH fibrosis during drug development

Andy Nichols, Chief Scientific Officer,
Catabasis Pharmaceuticals

11.30 Applying the QSP Model NAFLDsym® to Predict & Understand Responses to NASH Treatments

• Quantitative systems pharmacology (QSP) modeling with NAFLDsym can predict responses to NASH treatments, helping to optimize and expedite clinical development; and interpret responses to NASH treatments, providing a more thorough understanding of the mechanistic underpinnings

Scott Q Siler, Chief Scientific Officer,
DILIsym Services

12.00 Discussing Opportunities for Patient Recruitment Outside the Hepatology Clinic

• Evaluating opportunity to non-invasively identify early stage fibrosis patients
• Looking at diabetes and cardiovasular patients as candidate for NASH clinical trials

Judith Ertle, Clinical Program Lead,
Boehringer Ingelheim

12.30 Lunch & Networking

Evaluating the Challenges & Opportunities of Drug Repurposing Strategies in NASH Clinical Trials

14.00 Reviewing the Clinical Development of MGL3196 - a Liver Directed Thyroid Hormone Receptor Beta Agonist in NASH

• Advancing understanding that the Thyroid hormone receptor beta agonist in the NASH liver reduces lipotoxicity through multiple pathways
including increase in beta oxidation of liver triglycerides, and has pleiotropic actions in NASH, reducing all the major components of NASH, lipotoxicity, ballooning, inflammation and ultimately fibrosis, while conferring cardiovascular benefit
• Critically analyzing MGL-3196 as the first truly beta selective THR-beta agonist with excellent safety profile in humans and animals that has
been dosed in 200 humans for up to 9 months and has shown excellent efficacy in lipid lowering
• Discussing Phase 2 NASH results

Rebecca Taub, Chief Medical Officer, Executive Vice President Research
& Development, Madrigal Pharmaceuticals

14.30 Monitoring Assessment & Risk Mitigation of Drug Induced Liver Injury in NASH Drug Development

• Assessing drug’s potential to cause severe liver injury based upon early clinical signs
• Use of Hy’s Law and eDISH during drug development for NASH.
• Applying causality assessment and discontinuation rules in hepatic cases.

Arie Regev, Head, Safety Advisory Hub, Chair, Liver & GI Safety Committee, Global Patient Safety, Eli Lilly

15.00 Implementing Imaging in a Multi- Center NASH Clinical Trial

• Understanding current imaging techniques – their value and their limitations
• Discussing upcoming imaging techniques – their potential value and limitations
• Appreciating how imaging can be used as a screening tool

Jonathan Riek, Vice President, Musculoskeletal & Metabolic Imaging, BioTelemetry Research

15.15
Afternoon Refreshments & Networking

16.30
Modelling Progressive Liver Disease Using 3D Bioprinted Human Liver Tissue

Synopsis

• Gain an in-depth understanding of 3D bioprinting technology and its general application in biomedical research
• Understand the translational challenge in drug discovery research today and how using bioprinted tissues can help bridge the gap between preclinical studies and humans
• Become familiar with how 3D bioprinted human tissues are being used to model liver diseases such as NASH and fibrosis

Advances in Development of Non-Invasive Diagnostics in NASH Clinical Trials: From Biopsy to Biomarker

16.45
Identification of Biomarkers for the Diagnosis of NASH

  • Dean Hum Senior Executive Vice President & Chief Scientific Officer, Genfit

Synopsis

• Identifying of Biomarkers for the Diagnosis of NASH
• Detailing parallel development of Elafibranor and an IVD test to identify NASH patients for drug therapy

17.15
Panel Discussion: Non-Invasive Biomarkers – How Near Are We?

  • Sudha Shankar Head of Cardiometabolic Translational Medicine & Early Clinical Development, NGM Biopharmaceuticals
  • Peter Traber Director of The Board, President, Chief Executive Officer & Chief Medical Officer, Galectin Therapeutics
  • Jonathan Riek Vice President, Musculoskeletal & Metabolic Imaging, BioTelemetry Research

Synopsis

• Understanding serum and imaging biomarkers as traceable representatives of NASH pathology and interpreting these against NASH disease progression
• Discussing available data to validate non-invasive biomarker modalities as viable replacements for biopsy in longitudinal monitoring of clinical trials
• Evaluating broader use of non-invasive imaging for screening in general populations as a public health intervention and for use of serum biomarkers in clinics for associated co-morbidities

17.45
Chair’s Closing Remarks

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

18.00
Scientific Poster Session

Synopsis

After the formal presentations have finished, the learning and networking carries on. The Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships.

During this session scientific posters will be presented on validation on novel targets, drugs with new mechanisms of action, in vivo models which recapitulate human NASH and latest progress in validating non-invasive diagnostic and prognostic technologies.