Tim confirmed that PK/PD integration is non-trivial. He estimates it would be done on the vast majority of the phase 1 and 2 IAMI trials.

Moving from animal studies into Human requires semi complex modeling so you don’t kill your volunteers. Also phase 1 to phase 2 is more complex than you think. Need a sense of how to integrate the animal models to optimally dose drug regimens high and low. Need some projection of potential drug interactions.

In the future, also need micro array to understand drug metabolism and potential poly morphisms.

A good example that he will throw in from Steve Leeder co director, is more T2, pediatric rheumatoid arthritis and dosing methotrexate properly.

IAMI’s success will drive the volume for these kind of things. Pharmacogenomics would ultimately go to 100% but it would be a fraction of those to start with. Depends on the type of products. If it’s a pretty clean drug with renal clearance issues, no need for any complex modeling. If hepatic metabolism and receptor complexes with genetic mutation, then pharmacogenomic work comes to the forefront.

If we understand fully the mechanisms of action and tie them to pharmacokinetics, then we have a tool to look at dynamics, then dosage regimens. But often it's difficult to make those connections.

Straight up PK study ~20 -30 concentrations in a spreadsheet. Then run through modeling for phase 1.

Phase 2, might see concomitant drugs and interactions. Get greater number of data points.

Early phase 3 many data points. Late phase 3 adds population kinetics.

No real infrastructure to pull the pieces that exist together. Tim has a goal to pull the resources together into a portal.

Last modified 7 years ago Last modified on 08/11/10 09:17:46