Olga Marchenko is Vice President at Quintiles Inc. She is a head of the Center for Statistics in Drug Development under Quintiles Innovation Unit. A leading expert working on adaptive design methodology, she provides strategic leadership for design and analysis of clinical trials.
PRESENTER
(S):
Jose Pinheiro, Janssen Research & Development, LLC, United States
Prior to joining Johnson & Johnson PRD as Senior Director of Adaptive Designs José Pinheiro worked at Bell Labs and Novartis Pharmaceuticals. He has been involved in methodological development in dose-finding, adaptive designs and mixed models.
Donald Berry, The University of Texas, United States
Dr. Gaydos has a PhD in Mathematical Statistics & leads the Clinical Trials Optimization Team within Advanced Analytics at Eli Lilly. She chairs the DIA Adaptive Designs Scientific Working Group & is a fellow of the American Statistical Association.
Description
In this session, the presenters will share their experience and ideas on how modeling and simulation can increase clinical program success and enable program teams to make better decisions through the drug development process.
Learning Objectives: Recognize the value of modeling and simulations Use modeling and simulation to make decisions through the program development process Discuss the use of innovative designs.