What we do
Once the innovative idea has been through the first phases of testing and starts to show its potential, the situation becomes complex and the number of questions to be answered to reach the next level increases exponentially. A successful candidate molecule needs to be drugable. This means that in order to be able to become a drug it has to get into the body, reach the target organ or tissue and achieve concentrations that produce a meaningful effect. At the same time, at these concentrations it needs to be reasonably safe even if it is slightly overdosed or given concomitantly with other drugs.
Just fulfilling the regulatory requirements (eg IND and protocol approval), will allow the molecule to proceed from one experiment to the next, however, critical questions related to drugability may be ignored or insufficiently addressed and could lead to unnecessary failure downstream. There are endless possibilities for additional experiments and experimental designs that can be considered to address questions that may or may not be relevant at this stage and for the special situation of your asset.
We have the know-how to help you finding your path through the “jungle” and focus on the relevant and value adding experiments. We use good science and contemporary data analysis (Modeling & Simulation) to drive scientifically sound decision making and minimize the resource requirements to demonstrate the true potential of the molecule as quickly as possible.