Day One
Tuesday, October 23, 2018
Day Two
Wednesday, October 24, 2018
08.50 Chair’s Opening Remarks
NASH, Now – Reviewing Clinical Success & Failure so Far
09.00 Regulatory Landscape in NASH
Synopsis
- Outlining the regulatory approaches for new drug registration in NASH
- Updating on clinical endpoints strategies
- Updating on the Elafibranor clinical program
09.30 Acetyl-CoA Carboxylase Inhibitors from Bench to Bedside & Back Again
Synopsis
- Outlining the potential of ACC inhibitors to address multiple pathogenic drivers in NASH by exerting direct benefits on steatosis, hepatic inflammation and fibrosis
- Evaluating how Pfizer progressed a systemically acting ACC inhibitor into clinical development in 2010, but this compound was terminated due to an unexpected safety finding
- Reviewing learnings from this first inhibitor, as well as detailed studies informing the mechanism of the unexpected safety findings, and how these were used to shape the design of Pfizer’s second generation ACC inhibitor which is presently in Ph2 clinical development
- Discussing the learnings from the first generation ACC inhibitor, how these influenced the design of the second generation ACC inhibitor, and clinical experience to date with this 2nd generation compound
10.00 Speed Networking
Synopsis
This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the NASH field and establish meaningful business relationships.
10.30 Morning Break
Addressing Challenges to Inform Future Pipeline Decisions
11.30 NASH as a Component of Systemic Cardiometabolic Disease
Synopsis
- Demonstrating the association of NASH with metabolic disorders and cardiovascular morbidity and mortality
- Outlining NAFLD and extrahepatic malignancies in the context of NASH
- Analysing pathophysiological mechanisms linking NASH to metabolic and cardiovascular disease
12.00 Roundtable Discussions
Synopsis
Practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas. A valuable chance for attendees to unite around hot topics and debate collectively advancing drug development.
1. Preclinical modeling of key aspects of NASH pathology
Richard Lee, Director, Ionis Pharmaceuticals
2. How long and large should a phase 3 NASH trial be?
Meena Jain, Director, Clinical Development, Cardiovascular & Metabolic Disease, MedImmune
3. What do we know/ can we understand about the pricing and reimbursement landscape?
Donny Wong, Global Analytics & Insight Lead, CVRM Early Assets, AstraZeneca
4. Assessing the application of biomarkers in NASH drug development so far
Stephen Rossi, Senior Director, Clinical Development & Medical Affairs NG, Biopharmaceuticals
12.30 Moderator Feedback Panel
Synopsis
Following roundtables, moderators will share key themes discussed and conclusions reached with the wider audience and open the floor for Q&As, allowing full delegation discussions on each topic area.
12.45 Session Reserved for Metabolon
13.00 Lunch & Networking
Robustly Understanding NASH Pathophysiology for More Precise Candidate Development
14.00 Addressing Heterogeneity & the Role of Genetics in NASH Patient Populations
Synopsis
- Highlighting potential differences in predispositions and drivers that lead to population heterogeneity
- Outlining the latest understanding of genes modulating risk for NASH drug development
- Addressing NASH non-responders in the context of limited understanding of disease progression
Beyond the Biopsy: Biomarker Predictability to Support Drug Development
14.30 The Role of Macrophages in Non-Alcoholic Fatty Liver Disease – From Biomarkers to Treatment Targets
Synopsis
- Outlining the role of macrophages in NAFLD to NASH transition
- Proving macrophage activation markers as biomarkers for prediction of NASH severity and treatment effects
- Showcasing macrophages as targets for NASH prevention and inhibition
15.00 Afternoon Break
15.30 Targeting the FGF19 Pathway for the Treatment of NASH: From Benchside to Biopsy
Synopsis
- Discussing the structure activity development and pre-clinical models establishing the biologic activity of an engineered FGF19 analogue
- Evaluating the non-invasive imaging and laboratory markers of steatosis, inflammation and fibrosis associated with the treatment of NASH with NGM282
- Reviewing the translation of activity on non-invasive markers to histologic-response for NGM282
16.00 Developing an In Vitro Diagnostic Test (IVD) In Parallel to Advancing a Drug Candidate
Synopsis
- Primer on different types of diagnostic tests
- Overview of NASH diagnostic landscape
- Identifying biomarkers to aide in the diagnosis of NASH patients
16.30 Non-Invasive Learnings From Clinical Studies of Therapeutic Agents
Synopsis
More session details to follow
17.00 Chair’s Closing Remarks
17.10 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.
Whether you’re presenting or not, this is the session to hear your peers’ progress and learn more about emerging candidates, novel in vitro and in vivo modalities, and the validation of non-invasive diagnostics alongside drug development.
