U.S. Food and Drug Administration | Module 7 – Case Study 7: QSP Modeling to Predict Safety & Efficacy @US_FDA | Uploaded 2 months ago | Updated 2 hours ago
Dr. Kamau Pierre, with the Translational Disease Modeling Group at Sanofi, discusses how Quantitaive Systems Pharmacology (QSP) models were utilized to predict the safety & efficacy of a trispecific T-cell engager antibody for multiple myeloma before the first-in-human (FIH) study. Modeling and simulations were used to support the FIH study.
This module is part of the educational series “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients”. The educational content was developed for regulatory scientists by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. As part of Multidisciplinary Education and Exchange initiatives, CDER’s Quantitative Medicine Center of Excellence is making this resource accessible to all, supporting community-wide educational enrichment.
Disclaimer: The presentations in this educational series reflect the views of the presenters and should not be construed to represent FDA’s views or policies.
Dr. Kamau Pierre, with the Translational Disease Modeling Group at Sanofi, discusses how Quantitaive Systems Pharmacology (QSP) models were utilized to predict the safety & efficacy of a trispecific T-cell engager antibody for multiple myeloma before the first-in-human (FIH) study. Modeling and simulations were used to support the FIH study.
This module is part of the educational series “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients”. The educational content was developed for regulatory scientists by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. As part of Multidisciplinary Education and Exchange initiatives, CDER’s Quantitative Medicine Center of Excellence is making this resource accessible to all, supporting community-wide educational enrichment.
Disclaimer: The presentations in this educational series reflect the views of the presenters and should not be construed to represent FDA’s views or policies.
