Drug Candidate Selection
One of the crucial steps in drug development is the selection of the most optimal clinical candidate, i.e. the NCE/NBE with the best chance of clinical success. For this purpose in vitro and in vivo studies are conducted to permit further selection of lead drug candidates with desirable absorption, distribution, metabolism, excretion, toxicology (ADMET) properties as well as pharmacology and efficacy to assist in the prediction of clinical ‘drug-like’ properties. Completion of the drug candidate selection studies will provide the data to support the nomination to ‘clinical candidate’ of the best compound within a list of potential candidates. It is key to eliminate potential drug candidates that are likely to fail in clinical trials as early as possible in their development (‘Fail fast and cheap’).
There is no standard drug candidate selection program and the success of such a program is founded on the quality of the questions that are asked. What information is needed for a specific compound, with specific chemical-physical characteristics and a specific clinical indication and/or clinical requirements?
Already in such early phase a good target product profile is required to be able to direct the necessary questions to be asked. Mostly a step-wise approach is taken in the selection of the ideal clinical candidate, with (especially in the early steps of selection) clear go-no go criterion.
Kinesis has designed multiple candidate selection programs for different types of products. Based on that experience Kinesis can help you with asking the right questions, optimization of your program or provide a second opinion (gap analysis) on the followed selection program and the decisions taken. Have the data been evaluated properly and have the right compounds been selected for the next step?
Johan te Koppele, Ph.D.
Tel: +31 76 54 80 671
Phone: +31 (0)6 44 53 86 37