Thursday, June 26, 2008: Short Courses
An additional fee is required to attend all short courses.
8:30 am - 5:00 pm
Short Course #1: Binding to the Target Ligand: Monoclonal Antibody PK/PD First Principles (Berkeley Madonna Hands-On)
An additional fee is required to attend all short courses.
The objective of this short course is to provide hands-on exposure to lecture materials surrounding the complexities of monoclonal antibody PK/PD due to saturable binding with target antigen, concentration-dependent elimination, endogenous antibody response and/or feedback regulation. Antibodies represented greater than half of U.S. FDA approvals in 2006, adding to a growing armamentarium of monoclonal antibody preparations (antibodies, antibody fragments/fusion proteins, etc.) that make up an increasingly prevalent method of substantially decreasing the problem of unmet intervention for various disease states. Although monoclonal antibodies (mAbs) constitute a major advance in therapeutics, their Pharmacokinetic (PK) and Pharmacodynamics (PD) properties remain complex and not fully understood. It has become increasingly apparent that the best way to capture and appreciate the complexities associated with antibody PK/PD is via simulations using well-described mechanistic models. This hands-on course presents case studies from the diverse group of mAb therapeutic proteins and explores PK/PD first principles from classical Langmuir/Michaelis-Menten characterization through Gaddum kinetics. Important concepts dictating PK/PD characterization including saturable binding, concentration-dependent elimination due to protective influence of FcRn, endogenous antibody response, and feedback regulation due to target availability or downstream known/unknown PD responses will be explored via simulation using various mechanistic models. Berkeley Madonna and NONMEM will be used as teaching tools. The class will be limited to 40 participants.
Moderator
Nelson L. Jumbe, Ph.D.
Genentech, Inc.
mAB Initial Dose Selection
Ivan Nestorov, Ph.D.
Zymogenetics, Inc.
Impetus for Considering Drug-target Binding for mABs
Nelson L. Jumbe, Ph.D.
Genentech, Inc.
Thermodynamics and Target Mediated Drug Disposition
Donald E. Mager, Ph.D., Pharm.D.
University at Buffalo
Turnover Processes
Philip J. Lowe, Ph.D.
Novartis Pharma AG
Modeling & Simulation with Berkeley Madonna
Robert Macey, Ph.D.
University of California, Berkeley
Mechanism Based PK/PD: Drug Development and Clinical Practice Applications
Jing Li, Ph.D.
Genentech, Inc.