13th DIA Japan Annual Meeting 2016

The high attrition rates and increasing costs in drug development has been highlighted many times in the last decade by regulators and others and modeling and simulation (M&S) such as model informed drug discovery and development (MID3) and program level M&S has been identified as one methodology to make drug development more productive. MID3 is a quantitative framework for prediction and extrapolation, centered on knowledge and inference generated from integrated models of compound, mechanism and disease level data and aimed at improving the quality, efficiency and cost effectiveness of decision making. Program level M&S simulates across phases (e.g. Phase 2 to Phase 3) and directly incorporates operational and business information into the simulation. This enables quantitative comparison of alternative adaptive programs, comparing each on the scientific uncertainties resolved relative to operational and business drivers such as cost and time. This session will highlight the practice and application of M&S in drug development and its future.