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

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

dili liver assay measurement test kitAbout 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

  1. When does DILI get in the way?
  2. 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

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