Working Groups

The working groups in the IQ-DILI Initiative are conducting industry benchmarking and actively engaged in work on white papers on topics related to the management and prevention of DILI. The working groups are focused on:

Abnormal Baselines

Monitoring and assessment of potential DILI in patients with abnormal hepatic biochemical tests at baseline

Causality Assessment

Causality assessment in all patterns of DILI (hepatocellular, cholestatic, hepatic steatosis, vascular) and best practices for drug re-challenge

Immunotherapy

Nonclinical Translation

Risk Mitigation and Pharmacovigilance

Pediatric

Immunomodulation

DILI in the Elderly

Gene Therapy

Immune-related liver injury due to immunotherapy, such as checkpoint inhibitors

Adjustments in monitoring and assessment of DILI during clinical trials based on nonclinical toxicology findings

Post-marketing pharmacovigilance programs and Risk Evaluation and Mitigation Strategies (REMS) for DILI

Unique aspects of monitoring for, diagnosing, managing, and preventing DILI in clinical trials and in post-marketing pharmacovigilance activities in the pediatric, including neonatal, population

Monitoring, prevention, and management of Hepatitis B virus reactivation during the development of immunosuppressing drugs

Addressing knowledge gaps and proposing recommendations for future research on DILI in the geriatric population

Characterize hepatic toxicity in emerging gene therapies and develop consensus recommendations for standardized monitoring, assessment, and management for DILI