This project has been archived.
4β-Hydroxycholesterol Working Group
The objective of the Working Group is to determine the validity, value and deployment of 4β-hydroxycholesterol as an endogenous minimally invasive biomarker of CYP3A activity and identification of drug candidates that modulate CYP3A activity (induction and inhibition) in clinical studies. The Working Group will present its findings to the DMLG and CPLG and in a position paper to be shared among IQ member companies. If the findings of the WG support the above objective, then this position will be communicated to drug regulatory authorities in order to gain acceptance of the assay for use in drug development.
Delivery to date
- Joint industry/academia team formed (eg. University of Washington, Karolinska)
- Key questions identified
- Data collection spreadsheet formed and sent out to companies
- Initial data collection process completed
- Academic sub-team formed to analyse and recommend further work on data
- Bioanalysis sub-team formed to address specific bioanalytical issues
- Biology sub-team formed to address clinical conduct and fundamental biology questions
- Main team re-positioned as a steering team to bring together individual inputs and liaise with IQ Leadership groups
Academic Sub-team
- Initial data collection on methods and clinical results at study level
- Academic team formed to analyse data collected thereby avoiding potential competitive conflicts
- Present analyses indicates further data collection over and above summary level data needed
- New format for data collection identified
- Statistical and modeling input on new data collection ongoing
- Second call for data expected around year end
Bioanalytical Sub-team
- Formed to address specific assay questions
- Significant and rapid progress made, proposal to write two peer reviewed papers on methods
- Currently drafting first paper (to be reviewed by IQ leadership groups)
Biology Sub-Team
- First meeting conducted October 13th October
- Target to produce a peer review summary paper