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
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