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

8.20

Chair’s Opening Remarks

 

 

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

8.30

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

8.50

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
Scientist
Genentech

9.10

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

9.50

Collective Q&A

 

Panel Discussion & Q&A with Preceding Speakers

10.00

Morning Refreshments & Networking

 

Combinations, Partnerships & Pediatrics: Industry Strategies for NASH

10.30

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
Pfizer 

10.50

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
Novartis

11.10

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
Development,
Licensing, Infectious
Diseases, Vaccines,
Cardiovascular &
Metabolic Diseases
MSD

11.30

What Types of Combination Studies Should be Being Done?

 

Panel Discussion & Q&A with Preceding Speakers

12.00

Lunch & Networking 

 

Reviewing Clinical Advances & Regulatory Guidelines from the Last 12 Months

13.00

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
Partner
Alacrita Consulting

13.20

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
FDA

13.40

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
NASH
Allergan

14.00

Discussing Clinical Development in NASH Cirrhosis

Panel Discussion & Q&A with Preceding Speakers

14.30

Afternoon Break & Networking

 

Aligning Drug Development with Patients Needs

15.00

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
Director
Global Liver
Institute

15.20

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
Founder
Leberhilfe Projekt

15.40

Discussing Patients Perspectives & How to Improve Clinical Trial Participation

 

Panel Discussion & Q&A with Preceding Speakers

16.00

Chair’s Closing Remarks