Optimising quantitative DDI, drug disposition, PK/PD and in vitro - in vivo correlation strategies
With hundreds of membrane transporters
identified, translating observed non-clinical DDIs into clinical relevance for ADME
studies remains an on-going challenge. Ensuring appropriate in vitro studies are performed using the right transporters, at the right time to meet regulatory requirements, is a major task.
A greater focus on correlating in vitro with clinical outcomes has seen a burgeoning of integrated computational modelling
and simulation studies alongside cellular assay developments. In concert, efflux transporter studies are giving way to a greater interest in influx mechanisms, bringing a wealth of data concerning new transporters, their function and effect on DDIs.
Building on the success on IQPC’s 2012 conference, this year’s meeting takes unites basic, preclinical, translational and clinical research with numerous case studies. New for 2013 will be round-table sessions uniting business development with clinical progress. These will include time and money-saving approaches to meet filing requirements, and new requests from regulators based on known substrates for clinical interactions.
Following extensive discussions with senior industry and academic experts, other key topics will include:
- Case studies on emerging ITC transporters of clinical importance including MATEs, MRP2, BSEP and PEPT1
- Deriving pre-clinical kinetic parameters for the prediction of clinically-relevant DDIs for in vitro-in vivo extrapolation studies
- Applying modelling and simulation techniques to determine the interaction of clinically-relevant co-medicines
- Bench-to-bedside consequences of genetic polymorphisms for novel transporters and their implications for stratified medicine
- OATPB1 variability and clinical outcome studies
- Strategic approaches to ensure regulatory approval during pre-clinical research for transport proteins in the kidney, liver, intestine and brain
- Harmonising different cell-based screening systems to ensure inter-assay validity
- Mathematically modelling structure-function activity relationships to rationally target transporters of interest