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Institute for Computational Medicine Distinguished Seminar Series 2016-2017
February 6, 2017 @ 11:00 am - 12:00 pm
The Role of Quantitative Clinical Pharmacology in Drug Development
Dr. Donald R. Stanski
Global Head of Quantitative Clinical Pharmacology
Dr. David W. Boulton
Late-Phase Metabolics Franchise Lead for Quantitative Clinical Pharmacology
Dr. Stanski will discuss the integration and quantitative modelling of data and disease information over the research and development spectrum to generate knowledge that informs clinical drug development and underpins business decisions which is the core mission of the Quantitative Clinical Pharmacology (QCP) Department at AstraZeneca (AZ). This framework ensures the right patient gets the right dose at the right time with optimized trial designs and clearly identified proof of mechanisms. The organizational structure and role of the QCP in the drug development process at AstraZeneca will be outlined. The role of Clinical Pharmacology and Pharmacology scientists in the R&D process will be discussed. Dr. Boulton will provide an example of integrated model-based approaches to answering key clinical questions for AZ’s sodium-glucose linked co-transporter-2 (SGLT-2) inhibitor, dapagliflozin, which is approved for type 2 diabetes mellitus but is now being proposed as a new treatment for heart failure and chronic kidney disease. The QCP-driven modeling approach uses quantitative systems pharmacology, longitudinal pharmacometric, pharmacokinetic/pharmacodynamic, and model-based meta-analysis approaches to provide the organization with a scientific basis on which to invest in these potential new indications without having to conduct expensive and time-consuming Phase 2b studies.
Clark Hall 110 (Homewood Campus)
Video-teleconferenced to Traylor 709 (Medicine Campus)
Lunch will be provided at 12:00 PM (Homewood location only)