Online Program

Saturday, February 20
CS22 Modeling and Simulation Sat, Feb 20, 11:00 AM - 12:30 PM

Applications of Modeling and Simulation to a Hepatitis Compound Development (303110)

*Donghan Luo, Johnson & Johnson 

Keywords: modeling and simulation, sample size, predictive modeling, Bayesian decision analysis

Modeling and simulation (M&S) is an important tool to aid compound development across different stages from early phase 2 to confirmatory phase 3 studies in pharmaceutical industry. M&S can be particularly useful in the following areas: bridging a surrogate endpoint to primary endpoint through predictive modeling; study assumptions validation; population extrapolation; viral dynamic modeling; and Bayesian decision analysis at the interim data review for potential adaptive elements such as sample size and population selection. In this presentation, case studies from a recent successful development of a hepatitis C product in these areas of M&S are to be discussed and the impact and potential pitfalls will be elaborated. These case studies are from real world statistical practice with a practical approach which may be applicable to other disease areas.