Biomedical Engineering Reference
In-Depth Information
Phase 2: completed in 2009
• Developed and tested analysis methods within the
OMOP research lab and other data environments
• Established standard data characterization
procedures
• Implemented health outcomes of interest defi nitions
and facilitated comparisons across databases
Phases 3 and 4 will complete in 2010
PREDICTIVE SAFETY TESTING CONSORTIUM (PSTC): HTTP://
WWW.C - PATH.ORG/PSTC.CFM
Members
Abbott, Amgen, AstraZeneca, Boehringer Ingelheim,
Bristol-Myers Squibb, ClinXus, Daiichi Sankyo, Lilly,
GSK, Johnson & Johnson, Merck, Mitsubishi, Novartis,
Pfi zer, Roche, Sanofi -Aventis, Schering Plough, Critical
Path Institute
Objectives
and
deliverables
•
To identify and cross qualify new and improved
preclinical safety testing methods through a
collaboration of scientists from the pharmaceutical
industry, FDA, European Medicines Agency (EMEA),
and academia. This involves validating predictive,
preclinical animal model biomarkers aimed at reducing
the cost and time of preclinical safety studies and
providing potential early indicators of clinical safety in
drug development and postmarketing surveillance.
•
To facilitate the development of new FDA processes for
approving such testing methods and applying these
processes for approvals and guidances.
Description of
consortium
Led by the Critical Path Institute, the PSTC brings
together pharmaceutical companies to share and
validate safety testing methods. The corporate members
of the consortium share internally developed preclinical
safety biomarkers for examination and cross-validation
in fi ve work groups: carcinogenicity, kidney, liver,
muscle, and vascular injury. This should enable the FDA
and EMEA to write new guidances that identify more
accurate methods to predict drug safety. Notably, the
FDA and EMEA scientists are not acting as regulators
but provide assistance and advice to the consortium.
Time frame
Commenced 2006, no end date
Current status
In 2008 the FDA and EMEA published jointly seven new
kidney biomarkers. Working groups running for renal
toxicity, myopathy, hepatotoxicity, vascular injury, and
carcinogenicity.
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