Mechanistic Quantitative Systems Pharmacology (QSP) models inform decision making along the value chain from drug discovery to development. To support the development of novel diabetes therapies, we apply QSP models ranging from mechanistic model platforms via mechanistic PK/PD models to clinical trial simulators. The following use cases will be presented:
* We use a diabetes model platform covering all relevant parts of human physiology (e.g., glucose-insulin homeostasis, lipid metabolism) and pharmacology integrating data from various studies to provide mechanistic understanding and to assess the potential benefit and risk of new mechanisms of action.
* We apply focused mechanistic models of the glucose-insulin system to model clinical data at the individual patient level (time course data of glucose, insulin, c-peptide after meal challenge). Thereby, we provide mechanistic insights into effects of a novel dual agonist (so-called oral minimal model method). In particular, we quantify drug effects in terms of insulin action, secretion, and meal glucose rate of appearance, estimated by using meal test data of a Phase 1 clinical study.
* We apply a Diabetes Simulator (trained with individual patient data) to inform clinical study design for novel insulins by running clinical trial simulations in virtual populations.