Translating Causation To Treatment - Reviewing The Microbiome's Role In Drug Development


Chair’s Opening Remarks



Touching on Targets: Discussing Galectin-3, FGF21 & ROCK2 in NASH


Targeting Galectins in NASH Fibrosis

  • Galectins have a potential role in the pathogenesis of fibrosis across multiple organs
  • Galectin-3 is now being targeted clinically for the treatment of NASH
  • The talk will focus on the challenges of targeting fibrosis and potentially metabolic effects in NASH, generally, and the evidence for Gal-3


Sanjeev Khindri
Director, Clinical Development
Galecto Biotech


The Effects of FGFR1/KLB Bi-Specific Agonist Antibody BFKB8488A in Patients with T2D

  • Evaluating pharmacokinetic and pharmacodynamic responses to BFKB8488A
  • Presenting how biomarker responses suggest the utility of this molecule in treating patients with NASH
  • Exploring possible mechanisms of FGF21 in NASH

Felix Yeh


Selective ROCK2 Inhibitors for the Treatment of Fibrosis

  • ROCK2 is often upregulated in diseases associated with acute and chronic inflammation, including those associated with damage caused by high glucose and high fat diets
  • Highly selective ROCK2 inhibitors developed by Redx scientists have
    demonstrated both anti-fibrotic and anti-inflammatory activity in preclinical in vitro and in vivo models of fibrosis

Nicolas Guisot
Research Fellow
RedX Pharma


Collective Q&A


Panel Discussion & Q&A with Preceding Speakers


Morning Refreshments & Networking


Combinations, Partnerships & Pediatrics: Industry Strategies for NASH


Understanding the Utility of Models to Evaluate Combination Decisions 

  • Assessing different models in the context of Pfizer's ACC inhibitor
  • Critically analysing different pathways for co-administration


Trent Ross
Principal Scientist, Metabolism


Update on the Progress in NASH Combination Therapies

  • Understanding the pathogenesis and rationale for combination regimes in NASH
  • New developments and what we learned in 2019
  • Exploring combination options in clinical studies and future outlook


Nikolai Naoumov
Executive Director,
Hepatology Sciences
& Innovation


How Big Pharma Look at NASH

  • Presenting NASH from a “big pharma” perspective and the opportunity it provides
  • Evaluating treatment modalities for NASH from the perspective of seeking partnerships
  • Analysing where the field is moving to


Michel de Baar
Executive Director
– Business
Licensing, Infectious
Diseases, Vaccines,
Cardiovascular &
Metabolic Diseases


What Types of Combination Studies Should be Being Done?


Panel Discussion & Q&A with Preceding Speakers


Lunch & Networking 


Reviewing Clinical Advances & Regulatory Guidelines from the Last 12 Months


NASH, Now: Therapeutic Targets & the Competitive Clinical Trial Landscape

  • Discussing how current clinical experience and understanding can influence the next generation of R&D and commercialisation decisions
  • Overview of clinical compounds being evaluated for NASH with emphasis on mechanistic differences
  • Evaluating regulatory guidance on development of NASH therapeutics with focus on histology versus non-invasive imaging in drug advancement

Peter Traber
Alacrita Consulting


Regulatory Guidance for NASH with Compensated Cirrhosis

  • Re-assessment of liver biopsy tissue from cirrhotic liver to serve as a reliable surrogate endpoint in clinical trials for compensated cirrhosis
  • Consideration of time to clinical decompensatory events versus the time to completion of both phase 3 and phase 4 studies in the Subpart H regulatory pathway for full market approval in the USA
  • Provide indications and additional data on new agents used for non-cirrhotic indications in the field of NASH

Frank Anania
Division of
Gastroenterology &
Inborn Errors Products


The Impact of the First Approved NASH Drug on Phase 3 Design

  • Evaluating clinical and regulatory considerations for future trial design in NASH, specifically post approval of NASH treatments
  • Discussing the utility of biomarkers to facilitate drug development

Richard Torstenson
Director International
Clinical Development


Discussing Clinical Development in NASH Cirrhosis

Panel Discussion & Q&A with Preceding Speakers


Afternoon Break & Networking


Aligning Drug Development with Patients Needs


Regulatory Initiatives to Advance Patients Goals

  • Outlining the key initiatives of the Global Liver Institute and NASH Council in Europe
  • Presenting a global perspective on initiatives to align patient interests with drug development in NASH

Livia Alimenia
European Officer
Global Liver


The Patient Perspectives on Future Therapeutic Options in NASH & Patient Needs

  • Discussing the diversity of interdisciplinary management
  • Focusing on quality of life of NASH patients
  • Evaluating clinical appetite for sustainable life style change

Achim Kautz
Leberhilfe Projekt


Discussing Patients Perspectives & How to Improve Clinical Trial Participation


Panel Discussion & Q&A with Preceding Speakers


Chair’s Closing Remarks