Quantitative Disease, Drug, and Trial Models^*

Quantitative disease-drug-trial models allow learning from prior experience and summarize the knowledge in a ready to apply format. Employing these models to plan future development is proposed as a powerful solution to improve pharmaceutical R&D productivity. The disease and trial models are, to a large extent, independent of the product, but the drug model is not. The goals are to apply the disease and trial models to future development and regulatory decisions, and publicly share them. We propose working definitions of these models, describe the various subcomponents, provide examples, and discuss the challenges and potential solutions for developing such models. Building useful disease-drug-trial models is a challenging task and cannot be achieved by any single organization. It requires a consorted effort by industry, academic, and regulatory scientists. We also describe the strategic goals of the FDA Pharmacometrics group.