American Association for the Study of Liver Diseases / Food and Drug Administration Drug-Induced Liver Injury (AASLD/FDA DILI) Conference

Event Date: May 7 - 8, 2019

Event Location: College Park Marriott Hotel and Convention Center, 3501 University Blvd E, Hyattsville, MD 20783

Diapharma will attend the AASLD/FDA DILI Conference this year. Please click here to schedule a meeting with us or email us directly.

About the AASLD/FDA DILI Conference

There are growing challenges to accurately predict drug-induced liver injury (DILI) risk tied to evolving immunotherapies and in patients with underlying chronic liver disease. This international academic-industry-government conference sponsored by the FDA and AASLD, will hear expert presentations on new treatments with hepatotoxic liability and discuss study populations of growing concern as well as many state-of-the-art scientific tools and methods that are now becoming available for the assessment of DILI risk. There will also be a robust exchange of ideas and debate towards establishing consensus among participants in the meeting as a prelude for a planned comprehensive revision of the seminal FDA guidance on the pre-marketing evaluation of DILI, issued 10 years ago.

AASLD/FDA DILI Conference Topics

Treatment of Liver Diseases

When does DILI get in the way?
Analysis of Hepatotoxicity connected to drugs cleared by the Liver

Drug development in patients with liver disease
Which liver diseases may predispose to hepatotoxicity
Blood and liver cell PK & PD measures in the treatment of liver disease
Altered hepatic transporters in liver disease: are these a prelude to DILI?
When can complications of underlying liver disease become confused with DILI?

Tools for Pre-marketing Assessment of DILI Liability

How good are we at predicting drugs that are hepatotoxic from chemical structure?
Liver cell cocultures: do these discriminate between toxic and non-toxic drugs?
Assessing hepatotoxicity risk profiles in drug discovery
New markers of ALD from NIH networks
In silico and in vitro simulations to predict idiosyncratic DILI

Immunotherapy and Liver Toxicity

What is immunotherapy and what are its unintended hepatotoxic consequences?
What animal models can we use to characterize risk with new agents?
DILI pathways that are immune-mediated: are they overlapping or drug-specific?
Immune-mediated hepatitis and clinical histopathology
Are the molecular targets associated with DILI on immune cells or liver cells?

Immunotherapy and Liver Toxicity

Emerging toxicity profiles in clinical trials of immune checkpoint inhibitors?
Immune-mediated hepatitis in a tertiary referral center – phenotypes and management
Will we reliably predict patient-level therapeutic and adverse responses to treatment in the future?

The FDA Guidance on the Premarketing Assessment of DILI

DILI guidance: goals, challenges and current status
Industry perspectives and initiatives to fill key gaps in the guidance
How should we assess deteriorated liver function in DILI patients with cirrhosis?

Further Considerations for Revising the FDA Guidance on DILI

Can we do better in collecting study subject data and graphic tools for analysis of DILI?
The value of collecting bio-samples in clinical trials
Assessing and managing DILI risk in trials
CDER perspective: DILI guidance for new patient populations and drug classes
Interactive structured panel discussion with audience participation