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Osteoporosis and Bone Disorders: A Showcase for Model-based Drug Development
Wednesday, November 14
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-547-L04
This session will showcase the application of model-based drug development, including disease progression modeling and drop-out modeling in long-term trials, in one specific therapeutic area: osteoporosis. Speakers will provide clinical research experience on the role of M&S in drug development for osteoporosis medications; illustrate the role of modeling and simulation (M&S) in drug development in osteoporosis and bone disorders with emphasis on the synergy between biostatistics and clinical pharmacology; comment on the role and attitude of regulators towards use of M&S in drug development; emphasize the clinical potential or realized value in osteoporosis drug development; and comment on the overall statistical issues, beyond the particular therapeutic area of osteoporosis.
Moderators
Goonaseelan (Colin) Pillai, Ph.D.
Novartis Pharma AG
Jean-Louis Steimer, Ph.D.
Novartis Pharma AG
Bone Turnover Markers in the PK/PD of Osteoporosis Drugs
Serge Cremers, Ph.D.
Columbia University
Linking PK/PD of a Biomarker to Outcome Events – Application to Osteoporosis
Nicholas H. Holford, Ph.D.
The University of Auckland
A Population PK Model of Balicatib, a Cathepsin K Inhibitor and a PK/PD Model for Changes in Rapid and Slow Bone Biomarkers
Nitin Kaila, Ph.D.
Novartis Pharmaceuticals Corporation