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Application of Modeling in Drug Development and Registration
April 12, 2018 @ 8:00 am - 4:00 pm
8:00 – 8:30 am
Registration and Continental Breakfast
8:30 – 8:45 am
Welcome
8:45 – 9:30 am
The Use of Quantitative Pharmacology to Drive Clinical Drug Development Decision Making
Mike Tortorici, CSL Behring
9:30 – 10:15 am
Pharmacometrics in Drug Development: Examples from HIV and HCV
Larissa Wenning, Merck
10:15 – 10:45 am
Coffee
10:45 – 11:30 am
How Quantitative Sciences Based on Translating From Pre-Clinical Data Can Inform on Drug Development and Decision Making
Cecilia Fosser, Cytel
11:30 – 12:15 pm
Application of Quantitative Systems Pharmacology (QSP) Modeling in Early Drug Development: Case Studies from Dermatology and Immuno-inflammation
Loveleena Bansal, GSK
12:15 – 1:15 pm
Lunch
1:15 – 2:00 pm
Modeling Membranes, Metabolism, and Transporters in a Continuous Intestinal Absorption Model
Ken Korzekwa, Temple University
2:00 – 2:15 pm
Coffee Break
2:15 – 3:00 pm
Role of Quantitative Sciences in the Development of Large Molecules
Ana Hazra, Janssen
3:00 – 3:45 pm
Integrated Pharmacokinetic/Pharmacodynamic Analysis in Facilitating the First-in-Human Starting Dose Selection of Biologics
Zheng Yang, BMS
3:45 pm
Closing