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.

Great data visualization is more than just charts—it’s about effective communication. This session explores principles of design that make data clear, efficient, and beautiful, ensuring your audience grasps key insights at a glance. Learn how to craft visualizations that not only look good but also enhance understanding and tell a compelling story with your data.

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.

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.

An important skill for quantitative scientists within the pharmaceutical industry is the need effectively communicate complex technical information. This is especially challenging when the audience includes high-level stakeholders such as senior managers and regulatory representatives who may not have a deep technical understanding but must rely on modeling and simulation analyses to drive decision making. In this webinar, important points to consider will be discussed that can help attendees develop and deliver successful presentations that are tailored to meet the needs of the target audience and their objectives.

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.

We consider nonlinear mixed effects models including high-dimensional covariates to model individual parameters variability. The objective is to identify relevant covariates and estimate model parameters. We combine a penalized LASSO-type estimator with an eBIC model choice criterion to select the covariates of interest. Then we estimate the parameters by maximum likelihood in the reduced model. We calculate the LASSO-type penalized estimator by a weighted proximal gradient descent algorithm with an Adagrad-type adaptive step. This choice allows us in particular to consider models that do not necessarily belong to the curved exponential family. We illustrate the performance of the method in a nonlinear mixed-effects logistic growth model.

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.

In November 2024, the ICH Assembly endorsed the draft guideline entitled “M15 General Principles for Model-Informed Drug Development” and agreed to make the guideline available for public comment. This marks a major milestone for model-informed drug development (MIDD) and its maturity as a globally accepted standard for evidence generation. The draft guideline is the product of the multidisciplinary Expert Working Group (EWG) of the ICH. It establishes a harmonized assessment framework (including associated terminology) for MIDD evidence and provides an assessment table as a tool for communication. In this session, members of the ICH M15 EWG from regulatory agencies and industry will provide an overview of the draft guideline. The presentations will cover key contents of the M15 guideline, relevant perspectives, and examples.

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.