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IQ Launches Drug Induced Liver Injury (DILI) Initiative

IQ Launches Drug Induced Liver Injury (DILI) Initiative

September 27, 2016

Drug Induced Liver Injury (DILI) presents a critical challenge to the pharmaceutical industry and patient care. A new collaborative initiative was recently formed within the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) to tackle this challenge. This new group, IQ-DILI, is composed of pharmaceutical and biotechnology companies and focuses on defining best practices for the detection, monitoring, management and prevention of DILI in clinical trials and post-marketing pharmacovigilance programs.

IQ-DILI currently has six working groups focused on:

  1. Monitoring and assessment of potential DILI in patients with abnormal hepatic biochemical tests at baseline
  2. Causality assessment in all patterns of DILI (hepatocellular, cholestatic, hepatic steatosis, vascular) and best practices for drug rechallenge
  3. Immune-related liver injury due to immunotherapy, such as checkpoint inhibitors
  4. Development of strategies to investigate potential emerging biomarkers for the assessment of DILI
  5. Adjustments in monitoring and assessment of DILI during clinical trials based on nonclinical toxicology findings
  6. Post-marketing pharmacovigilance programs and Risk Evaluation and Mitigation Strategies (REMS) for DILI

IQ-DILI members include AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Otsuka, Pfizer, Sanofi, Takeda, and Theravance. A number of other pharmaceutical and biotech companies have expressed strong interest.

IQ-DILI intends to proactively communicate and coordinate with existing nonclinical, regulatory and academic DILI collaborations to ensure synergies and prevent redundant eff ort. IQ-DILI deems it essential to leverage the expertise and perspectives of these academic, industry and regulatory experts in such critical areas as nonclinical testing, new biomarkers, in-silico and in-vitro models, and phenotypes of DILI in clinical practice.

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