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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[V6-S5] Utilization of Modeling & Simulation in Drug Development - From Trial Design to Decision Making

Session Chair(s)

Hidefumi  Kasai

Hidefumi Kasai

Japan Manager, Consulting Service

Certara G.K., Japan

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.

Speaker(s)

Bill R. Prucka, PhD

Overview of Program Level Modeling and Simulation

Bill R. Prucka, PhD

Eli Lilly and Company, United States

Director, Innovation Computational Statistics

Vladimir  Dragalin, PhD

Role of Statistics in MID3

Vladimir Dragalin, PhD

Janssen R&D, at Johnson & Johnson, United States

Vice President, Scientific Fellow

Atsunori  Kaibara, PhD

Modeling & Simulation - Role, Process, and Organization in Astellas

Atsunori Kaibara, PhD

Eli Lilly Japan K.K., Japan

Principal Scientist, PKPD & PMx,Medicines Development Unit Japan

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