2026 MIDD Webinar Series | Practical Optimal Design for Clinical Trials in a Model-Informed Drug Development Framework

Includes a Live Web Event on 05/28/2026 at 12:00 PM (EDT)

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This talk will cover how to evaluate and optimize clinical trial designs using the Fisher Information Matrix (FIM), as implemented in tools like NONMEM's $DESIGN and PopED. While clinical trial simulation is a powerful approach for assessing design characteristics, such as model identifiability, parameter precision, and even type I error and power, FIM-based evaluation offers a faster alternative that enables exploration of many more designs and makes true design optimization feasible. A number of examples will be presented to show how design evaluation and optimization can be useful in a model-informed drug development context. Robust design techniques that account for uncertainty in models and model parameters will also be discussed.

The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.

Andrew Hooker, PhD, ISOP member

Professor of Pharmacometrics

Uppsala University

Andrew C. Hooker, PhD, is a Professor of Pharmacometrics at Uppsala University, Sweden. Andrew received a BS in Physics with a Mathematics Minor at the University of Colorado and received a Masters and then a PhD in Bioengineering from the University of Washington, Seattle. Andrew joined the faculty at Uppsala University in 2006. His research ranges between methodological and applied pharmacometrics, including: optimal (adaptive) experimental design, methodological problems associated with building, evaluating and using pharmacometric models (including using models for bioequivalence evaluation) and the development and use of PKPD models in a range of therapeutic areas and drug classes. Andrew is a co-developer of a number of software programs including Xpose, PsN, Pharmpy and the optimal design program PopED. Andrew has published over 90 papers in peer reviewed journals, supervised 12 students to their PhD degree and mentored 11 post-docs. In 2012, he co-founded the model-informed drug development consultancy company Pharmetheus.