Description
MonolixSuite Spring School:
High - Impact Pharmacometrics Case Studies
Beyond routine PKPD: TMDD, Oncology, conc-QTc, Biosimilars and MBMA
Free Online Training | March 23 - 27, 2026
Why This Training Matters
Most pharmacometric projects don’t start out as “advanced.” They become advanced the moment a standard PK model is no longer enough. When that shift happens, the questions change:
- How do you choose the right TMDD approximation for a biologic?
- How do you model tumor response when dropout is driven by progression rather than "missing-at-random"?
- What makes a conc-QTc analysis workflow truly submission-ready?
- How do regulators expect biosimilarity to be demonstrated?
- Where do you start with MBMA across multiple trials?
These approaches—TMDD, tumor growth dynamics, conc-QTc, biosimilars, and MBMA—shape critical development decisions. Yet, they often feel intimidating or reserved for specialists.
The real challenge is rarely the equations themselves. The difficulty lies in turning a complex biological problem into a structured, interpretable, and defensible analysis. Until now, mastering these workflows has been a slow process: guidance is scattered, best practices are often learned only under project pressure, and many modelers hesitate to step into areas that seem “expert-only.”
The MonolixSuiteTM Spring School is designed to make these workflows accessible through a clear, expert-guided learning path. Across five focused case studies, you will learn complete workflows — from model building and diagnostics to simulation-based decision support and standardized reporting.
The Outcome? You will leave with:
- Practical strategies for non-standard data types and challenges.
- Reusable project workflows you can apply immediately.
- The confidence to tackle complex modeling questions far beyond routine PK/PD.
How You Will Learn
The MonolixSuite™ Spring School is a modular, expert-guided and interactive course, designed to help you focus on the sessions most relevant to your work while building confidence in advanced workflows.
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Comprehensive Onboarding & Prerequisites
A full introductory Monolix course (based on previous Spring School sessions) will be available in advance, ensuring that everyone starts with a solid foundation in MonolixSuite basics. -
Five live online sessions led by MonolixSuite™ experts
Learn directly from the people who develop and apply these workflows, gaining not only software instructions but insight into best practices, scientific reasoning, and real-world decision contexts. -
Two identical 1.5-hour time slots per day + video recordings
Choose the session time that fits your schedule, participate live, ask questions, and revisit key concepts through recordings afterwards. -
Interactive Live Q&A and Safe Learning Environment
Get immediate expert answers to real-time challenges. Ask the practical questions that rarely fit into tutorials: “I tried this but it didn’t work, why?”, “Is this assumption scientifically correct?”, or “How do I justify this in a report?” -
Guided hands-on exercises with explained solutions
Reinforce each session through practical exercises, supported by dedicated solution walk-through videos, so you can replicate the workflows independently after the course. -
Comprehensive learning package
Leave with a library of presentations, datasets, and reusable Monolix projects and Quarto scripts. Use these as templates to accelerate your own project work long after the course ends.
Certificate of attendance - Demonstrate your advanced thematic training in the MIDD community.
Free temporary license for all MonolixSuite™ applications - Experiment with the software during the school, apply workflows to your data, explore advanced features, and turn learning into immediate project impact.
COURSE FORUM: Connect with an international community of modelers Join a global network of pharmacometricians working on the same challenges. Exchange best practices, discuss regulatory expectations, explore future directions, and build professional connections beyond the sessions.
Skills and Insights You Will Gain
Session 1: Target-Mediated Drug Disposition (TMDD): Navigating Complexity in Biologics
TMDD is a mechanism that can fundamentally reshape a biologic’s PK, but the variety of TMDD models can be overwhelming. In this session, you will learn how to decide between full, QE/QSS, IB, or Michaelis–Menten models based on what your data actually supports. We address the primary bottleneck—parameter identifiability—and demonstrate how Simulx exploration helps to investigate which parameters can be estimated with confidence. Through expert-guided diagnosis of real mAb case studies, you will learn to ensure that parameter uncertainty remains low enough to support reliable and valuable simulations.
Session 2: Tumor Growth Inhibition (TGI): Building Defensible Models from Imperfect Data
TGI models are the backbone of oncology development, but the real challenge lies in building analyses that remain defensible when standard diagnostics look "wrong." In this session, we move beyond basic curve-fitting to explore critical strategic decisions, such as growth model selection. You will also learn to navigate the "dropout trap," where progression-driven missing data biases standard diagnostic plots, and master specific VPC bias correction techniques. Through a guided case study, you will leave with a simulation-ready workflow for optimizing doses and schedules, even when working with imperfect clinical data.
Session 3: Concentration-QTc: Automated Workflows for Regulatory Success
Building a submission-ready C-QTc assessment involves much more than fitting a single model. In this session, you will learn the standard regulatory-expected workflow for evaluating QT liability: from baseline correction and dataset preparation to model fitting and confidence interval interpretation at clinically relevant exposures. You will also discover how to automate the entire process through an R-based workflow that generates Monolix projects, key diagnostic outputs, and standardized reports. Less standard cases such as how to handle the absence of placebo data, non-linear conc-QTc relationship or hysteresis will also be covered. By the end, you will know how to deliver a complete, reproducible C-QTc assessment that meets the highest regulatory standards.
Session 4: Biosimilars: Model-Informed Strategies for Similarity Testing
Planning biosimilarity trials is challenging because true product differences are subtle, yet study outcomes are highly sensitive to inter-individual variability and design assumptions. This session explores how the FDA and EMA evaluate biosimilars and how simulations can be used to guide biosimilarity trial design decisions. Using a pegfilgrastim case study, you will see how sensitivity analyses identify the most informative dose levels and how clinical trial simulations guide sample size and power calculations. You will leave with practical tools and scientifically defensible modeling strategies to support biosimilar development programs.
Session 5: Model-Based Meta-Analysis (MBMA): Evidence Synthesis for Decision Support
MBMA allows you to benchmark a compound against competitors and predict Phase 3 performance by integrating trial-level data from literature into a single decision framework. In this session, you will learn how to model longitudinal endpoints, handle between-study and between-arm variability, and optimize parameter estimation settings. Using real-world case studies in osteoarthritis and rheumatoid arthritis, we demonstrate how MBMA supports external benchmarking by calculating the probability of trial success. This is one of the most powerful workflows for turning existing clinical evidence into strategic, forward-looking development decisions.
Certificate
By completing/passing this course, you will attain the certificate - MXSuite Attendance
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