Health & Wellbeing
36
CASE STUDY
Predicting drug-induced liver injury (MiP-DILI)
Background
Drug-induced liver injury (DILI) is the leading cause of
acute liver failure requiring liver transplantation in western
countries. DILI also represents a major challenge for
industry and regulatory authorities, since it is the main
reason for the termination of drug development, failed
drug registration and the withdrawal of licensed drugs.
The project
The University brought together key opinion leaders
from academia and the biotechnology sector to
join forces with drug safety scientists from the
pharmaceutical industry and formed a pre-competitive
consortium. Sharing a common goal to improve the
predictive power of current DILI test systems, this
ambitious project set out to develop mechanism-
based integrated systems for prediction of DILI. A key
deliverable will be a novel non-clinical test cascade.
It will be used within the pharmaceutical industry to
select candidate drugs that have lower likelihoods to
cause DILI in humans.
The project aims to deliver innovative preclinical test
systems which are physiological, pharmacological
and pathological relevance to DILI in humans. This is
a major scientific challenge, since the mechanisms
that underlie DILI in humans are complex. The multidis-
ciplinary consortium therefore includes experts in drug
development, drug metabolism, drug toxicology, drug
hypersensitivity, liver immunology, liver cell biology,
pharmacogenetics, systems biology and clinical
adverse drug reactions.
The project is supported by the Innovative Medicines
Initiative (IMI), which is a joint undertaking between
the European Union and the European Federation of
Pharmaceutical Industries and Associations (EFPIA).
Partner
Consortium involving nine academics, six SME and 11 Pharma partners
Activity type
Collaborative research
Academic lead(s) Professor Kevin Park, Faculty of Health and Life Sciences, Translational Medicine, Molecular and
Clinical Pharmacology
Funded by
Innovative Medicines Initiative Joint Undertaking
The need for improved tools
which enable pharmas to
select efficacious new drugs
that will not cause DILI in
humans is clear. MiP-DILI
provides a unique opportunity
for leading scientists from
industry, academia and
biotechnology to tackle this
important challenge jointly, via
pre-competitive collaboration.
Gerry Kenna,
Principal Scientist, AstraZeneca
