Consulting Services

Hepatology and Liver Safety Consulting, LLC provides expert hepatic safety and drug-induced liver injury (DILI) consulting to pharmaceutical and biotechnology companies throughout the drug development lifecycle, from preclinical research through post-marketing surveillance.

Assessment of hepatic safety and DILI risk during preclinical development, clinical development, and post-marketing surveillance.

Mechanistic evaluation of hepatotoxic potential, including signals such as BSEP inhibition, mitochondrial toxicity, reactive metabolites, and other nonclinical predictors of DILI.

Expert analysis of nonclinical and clinical hepatic data, including evaluation of hepatic biomarkers, imaging studies, and histopathology.
Recommendations on protocol language, including hepatic screening approaches, inclusion and exclusion criteria, monitoring schedules, and dose-adjustment and discontinuation criteria.

Development of liver monitoring and stopping rules tailored to a program's mechanism of action, patient population, and stage of development.

Guidance on special considerations and monitoring adjustments for clinical trials enrolling participants with pre-existing liver disease, including MASLD, MASH, alcohol-associated liver disease, chronic viral hepatitis, autoimmune hepatitis, and liver metastases.
Hepatic risk management and mitigation planning across all phases of clinical development and post-marketing, including construction and revision of risk management plans to characterize and mitigate potential hepatic risk.
Evaluation of individual hepatic cases and causality assessment.

Participation in, and chairing of, Hepatic Adjudication Committees.

Drafting and revision of Hepatic Adjudication Committee charters to meet regulatory expectations.
Consultation on REMS, post-marketing requirements (PMRs), and post-marketing commitments (PMCs) to assess and manage hepatic safety risk.

Assistance with drafting and revising hepatic drug label language, including warnings and precautions, drug-drug interactions, post-marketing monitoring, and dose-adjustment recommendations.

Support for regulatory submissions and interactions, including preparation for meetings with health authorities.
Service as a hepatic safety expert on Data and Safety Monitoring Boards, including review of interim safety data and liaison with sponsor teams on liver-related findings.
Workshops and presentations for clinical, regulatory, and safety teams on hepatic safety principles, DILI signal detection, and best practices in liver safety monitoring.
Hepatic safety due diligence support for licensing, partnership, and acquisition decisions involving compounds with potential hepatotoxic liability.