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Session 6: Bridging Statistics and Pharmacometrics: Informing Drug Development Decisions Through Model-Based Approaches
Session Chair(s)
Frank Bretz, PhD
Distinguished Quantitative Research Scientist, Novartis , Switzerland
Clinical drug development remains a mostly empirical, costly enterprise, in which decision-making is often based on qualitative assessment of risk-benefit, without systematically leveraging all the relevant data collected throughout the development program. Quantification of risk and combination of information from different sources across time using model-based approaches may modernize drug research towards a better informed drug development process. Such a shift in paradigm requires a close collaboration between biostatisticians and pharmacometricians. These disciplines share many common quantitative elements and are much more specialized and offer many capabilities that each individual discipline does not have. Speakers will share their experiences on opportunities and challenges when fostering the new model-based drug development paradigm in their organizations.
Speaker(s)
Thomas E. Gwise, PhD
Division Director, Division of Biometrics IX, OTS, CDER, FDA, United States
Session Co-Chair
Joan Buenconsejo, PhD, MPH
Head of Cardiovascular and Neuroscience Biostatistics , Bristol Myers Squibb, United States
Moderator
Peter A. Milligan, PhD
Head of Pharmacometrics, Pfizer Global Research & Development, United Kingdom
Introduction to Model Informed Drug Discovery and Development (MID3) Good Practice Guidelines: Current Status and Challenges
Margaret Gamalo, PhD
Vice President, Statistics Therapeutic Area Head, Pfizer Inc, United States
Structural Approach to Pediatric Extrapolation Through Bayesian Modeling
Lian Ma, PhD
Pharmacometrics Reviewer, CDER, FDA, United States
Application of Semi-Mechanistic Pharmacokinetic-Pharmacodynamic Model in Dose Selection for Medical Countermeasures Initiative Product Developed Under Animal Rule: Case Study of Pegfilgrastim
Eric Gibson, PhD
VP, Global Head Biostatistical Sciences and Pharmacometrics, Novartis Pharmaceuticals Corporation, United States
An Extrapolation Approach for Pediatric Development in Transplantation
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