Donald Stanski and David Boulton, AstraZeneca, “The Role of Quantitative Clinical Pharmacology in Drug Development”
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Bio
“The Role of Quantitative Clinical Pharmacology in Drug Development”
Don Stanski joined AstraZeneca in early 2014 as Global Head of Quantitative Clinical Pharmacology. He received his MD from the University of Calgary and his clinical anesthesiology residency at Massachusetts General Hospital, Boston, followed by research training in clinical pharmacology/ pharmacometrics from the late Lewis B. Sheiner at the University of California, San Francisco. He joined Stanford University in 1979 developing a clinical pharmacology and pharmacometric academic research program for anesthetic/analgesic drugs. In 1992 he became Chairman of the Department of Anesthesia. He retired emeritus from Stanford in 2005. He spent two years as a senior scientific advisor at the FDA then joined Novartis. He built an integrated Modeling and Simulation program at Novartis over the next eight years, prior to joining AstraZeneca. Don works out of AstraZeneca’s Gaithersburg, MD site.
Dave Boulton joined AstraZeneca in early 2015. He is the Late-Phase Metabolics Franchise Lead for Quantitative Clinical Pharmacology where he is accountable for anti-diabetic and anti-hyperkalemic medicines. He received his BPharm and PhD from the University of Otago, New Zealand, with an internship between his degrees qualifying him as a licensed Pharmacist. This was followed by 4 years of postdoctoral training at the Medical University of South Carolina, Charleston, SC. Dave then joined Bristol-Myers Squibb where for 14 years he worked as an individual contributor and later in leadership roles as a Clinical Pharmacologist in a number of therapeutic areas and in all phases of drug development. Dave works out of AstraZeneca’s Gaithersburg, MD site.
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Abstract
“The Role of Quantitative Clinical Pharmacology in Drug Development”
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.
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