KinDyn (pronounced kin-dine) provides expertise in pharmacokinetics (PK) and pharmacodynamics (PD) to the biopharmaceutical industry for both small molecular weight new chemical entities (NCEs) and biologics (Bx). With experience across all phases of drug development KinDyn can help apply these principles to guide the development process. Some critical questions stand between a brilliant hypothesis regarding a particular target / pathway and a successful new medicine: How much drug do I need to get to the target and for how long? - this is largely a question of pharmacokinetics and drug delivery How will I know if it works - what are the required pharmacodynamic characteristics? - to answer this question we need to establish a feasible dose and route of administration as well as a feasible dosing frequency, using appropriate biomarkers to guide these decisions How will I know if it is safe – what is the potential safety liability? - understanding the separation in exposure for desired and undesired effects will help establish the “therapeutic window” Which patients will respond to this treatment? - identification of factors which define a “responder” will help enable a “stratified medicine” approach if this is appropriate Many of these questions can be addressed by an understanding of exposure-response relationships, both for the desired pharmacology and the undesired effects. At KinDyn we aim to help our clients answer these questions.