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ACoP 2025 Workshops & Tutorials

October 17, 2025

8:00 am - 5:00 pm 

ICON: New and Advanced Features of NONMEM 7.6 Workshop
Description: New and Advanced Features of NONMEM 7.6 WorkshopWorkshop Outline/Description: Advanced NONMEM 7.6 course will be presented by ICON at ACOP 2025. This in-person workshop covers the description and use of features in NONMEM 7. Workshop attendees will be instructed how to specify gradient precision and how to use the FAST algorithm (new in NM 7.4) for FOCE, how to use the Monte Carlo importance sampling, stochastic approximation expectation-maximization methods, and full Bayesian methods such as Gibbs sampling and Hamiltonian no-U turn sampling (new in NM 7.4). Parallel computing and dynamic memory allocation for efficient memory usage will be described, symbolic references to thetas, etas, and sigmas, priors to sigmas, MonteCarlo search algorithms to improve FOCE estimation, built-in individual weighted residuals, bootstrap tools for simulation, and automatic stabilization against numerical exceptions.  Learn to use abbreviated code features for easier modeling of inter-occasion variability, modeling additional mixed effects levels for grouping individuals, such as inter-clinical site variability, and using the DO loop feature in abbreviated code, useful for handling multiple bolus doses in models that use the analytical absorption function for multiple transit compartments. Optimal clinical design and evaluation tool is available, as well as delay differential equation solvers.

Presenters: Brian Sandler, Robert Bauer* (*presenting remotely)

Certara: QSP at Scale with Certara IQ
Description: With hundreds of FDA and EMA submissions supported by QSP models, QSP has finally come of age. The now proven high return of investment from QSP has led to every major pharma company, and a significant number of biotechs investing in QSP groups or partnering with QSP vendors. However, the vast majority of preclinical and clinical programs are still not supported by QSP. At this point we see this not as a limitation of the value of QSP but as a challenge for implementing QSP at scale. This workshop will unveil Certara IQ, an innovative QSP environment that enables the scaling of QSP from only supporting a small minority of projects, to supporting the entire pipeline. We will focus on four key decision points in the drug development pipeline:

• New Target Feasibility
• Determining Best in Class Properties
• First In Human Dose Projection
• Recommended Phase 2 Dose

For each we will demonstrate how to use Certara IQ to efficiently answer these questions with worked practical examples.

Presenters: Joshua F. Apgar, Andrew Matteson, Sasha Sherman, David Flowers

Simulations Plus: From PK-PD Models to Simulations: A Hands-On Workshop using MonolixSuite (Day 1)
Description: This two-day interactive workshop will guide you through population PK-PD modeling, advanced model development strategies, and simulations using MonolixSuite. With hands-on exercises and discussions, it will provide practical skills to build, refine, and apply models effectively in your daily work. A temporary MonolixSuite license is included to continue applying what you learn beyond the workshop.Prior experience with MonolixSuite is not required.
What You Will Learn :

• Build and diagnose PK-PD models in Monolix including data visualization, model definition and estimation.
• Optimize complex models understand the methods and algorithms behind each task and the impact of their settings.
• Set up simulation scenarios and efficiently answer "what if" questions using Simulx from comparing different dosing regimens and the impact of patient variability, to simulating clinical trial scenarios.
• Improve efficiency in modeling workflows
• Apply best practices and automatization tools to streamline your work.

Join us to enhance your modeling and simulation skills and use MonolixSuite confidently in your projects!

Presenters: Monika Twarogowska, Frano Mihaljevic

 
Pumas-AI: Model-Informed Drug Development: Powered by Pumas (Day 1)
Description: Model-Informed Drug Development: Powered by Pumas. This workshop will focus on drug development questions that pharmacometric analyses are uniquely well-positioned to address. The workshop will begin with a brief overview of the MIDD landscape, considerations for developing a MIDD plan, and the capabilities of Pumas software to execute on the plan. These topics will be illustrated by 3 case studies, which are motivated by historical examples of challenging questions that could not have been addressed using directly observed data. They will also demonstrate the effective communication of results, and the impact on drug development decisions.

The case studies include: (1) Selecting Phase 3 dosage regimens, including those for which clinical data are not available, (2) Assessment of probability of Phase 3 technical success, when the endpoint and study duration are different from the Phase 2 dose-ranging study, and (3) Optimization of a complex dose titration posology based on models of safety and efficacy.

Presenters: Amit Roy, Andreas Noack, Mike Tagen, and Vijay Ivaturi

Building Scalable PBPK-QSP Models: Modularization in MoBi® for OSP Suite V12
Description: The latest OSP Suite V12 introduces a modularization approach that enhances the flexibility, scalability, and efficiency of QSP modeling and integrations with PBPK. This full-day hands-on workshop will equip participants with the skills to leverage modular workflows in MoBi to build, extend, and refine PBPK-QSP models like never before.

Led by ESQlabs scientists, attendees will start with a simple two-compartment model to grasp the fundamentals of modularization before diving into a real-world case study: modeling an ADC modality for tumor treatment. Participants will:

• Develop a PBPK model for the large molecule and small molecule payload.
• Modularization 1: adding a Target-Mediated Drug Disposition reaction network as a reaction extension module.
• Modularization 2: adding a tumor organ as a physiological extension module.
• Modularization 3: Implement a pharmacodynamic effect extension module to simulate tumor growth inhibition.
• Work with separate modules to demonstrate how modular workflows streamline model management, reuse, and extension.

Attendees will master the new modular approach in MoBi, learning how to build and manage complex models in a structured way. While automated model qualification will be touched upon as an outlook, the focus will be on hands-on modeling and modularization techniques that enhance collaboration, transparency, and reusability in PBPK-QSP modeling.

Presenters: Dr. Stephan Schaller, Dr. Wilbert de Witte

U of Buffalo/ICON: Modeling Delays in Pharmacokinetics and Pharmacodynamics using NONMEM
Description: The course will provide an overview of biological systems exhibiting delays, concepts of lifespan driven pharmacodynamic response, modelling of cell maturation, transduction delays, and nonlinear mixed-effect lifespan models. Delay differential equations (DDEs) will be introduced and implemented in NONMEM version 7.5. The course will consist of both lectures and hands-on computer exercises. Source codes for DDE based PK/PD models and data will be provided to the participants. For course information visit https://sites.google.com/site/delaysinpkpd

Presenters: Wojciech Krzyzanski, Johannes Schropp, Robert Bauer

October 18, 2025

8:00 am - 5:00 pm 

Simulations Plus: From PK-PD Models to Simulations: A Hands-On Workshop using MonolixSuite (Day 2)
Description: This two-day interactive workshop will guide you through population PK-PD modeling, advanced model development strategies, and simulations using MonolixSuite. With hands-on exercises and discussions, it will provide practical skills to build, refine, and apply models effectively in your daily work. A temporary MonolixSuite license is included to continue applying what you learn beyond the workshop.Prior experience with MonolixSuite is not required.

What You Will Learn :

• Build and diagnose PK-PD models in Monolix, including data visualization, model definition and estimation.
• Optimize complex models understand the methods and algorithms behind each task and the impact of their settings.
• Set up simulation scenarios and efficiently answer "what if" questions using Simulx, from comparing different dosing regimens and the impact of patient variability, to simulating clinical trial scenarios.
• Improve efficiency in modeling workflows - apply best practices and automatization tools to streamline your work.

Join us to enhance your modeling and simulation skills and use MonolixSuite confidently in your projects!

Presenters: Monika Twarogowska, Frano Mihaljevic

Pumas AI: Model-Informed Drug Development: Powered by Pumas (Day 2)
Description: Model-Informed Drug Development: Powered by Pumas. This workshop will focus on drug development questions that pharmacometric analyses are uniquely well-positioned to address. The workshop will begin with a brief overview of the MIDD landscape, considerations for developing a MIDD plan, and the capabilities of Pumas software to execute on the plan. These topics will be illustrated by 3 case studies, which are motivated by historical examples of challenging questions that could not have been addressed using directly observed data. They will also demonstrate the effective communication of results, and the impact on drug development decisions.

The case studies include: (1) Selecting Phase 3 dosage regimens, including those for which clinical data are not available, (2) Assessment of probability of Phase 3 technical success, when the endpoint and study duration are different from the Phase 2 dose-ranging study, and (3) Optimization of a complex dose titration posology based on models of safety and efficacy.

Presenters: Amit Roy, Andreas Noack, Mike Tagen, and Vijay Ivaturi

Pharmetheus: FREM in practical use: Implementation and interpretation
This workshop provides theoretical insights and hands-on training (using R, NONMEM, and PsN) in applying the Full Random Effects Model (FREM) to integrate covariate data into your modeling process effectively for robust decision-making in pharmacometrics.

By the end of this workshop, participants will:
● Understand the fundamentals of the FREM methodology.
● Gain hands-on experience implementing FREM for model-based decision-making in various pharmacometric contexts.
● Learn to interpret and apply FREM results to improve modeling and decision-making processes.

It is intended for scientists with a modeling background and a basic understanding of the drug development process. It is particularly suited for professionals in pharmacokinetics, biopharmaceutics, and regulatory science.

Presenters: Niclas Jonsson, Joakim Nyberg 

Simulations Plus: End-to-end clinical trial modeling with the Thales QSP software platform
Description: This workshop provides an in-depth introduction to Thales, a cloud-based quantitative systems pharmacology (QSP) modeling platform with a focus on simulating virtual clinical trials. The 1-day session includes both lectures and hands-on exercises, aimed at familiarizing participants with the platform's core functionalities and its use in translational and clinical modeling contexts. Lectures will cover key features of the platform, specifically highlighting standardization of model representation, fitting, and validation. Emphasis will be placed on the platform's native support of virtual populations and ability to simultaneously optimize data spanning numerous therapeutic interventions, as well as the suite of integrated software tools that enable the design and execution of virtual clinical trials. Finally, the workshop will conclude with a preview of how Thales integrates AI, giving a glimpse into the future of QSP modeling. Practical sessions will allow participants to apply these concepts directly, using case-based examples relevant to current needs in model-informed drug development. Users will gain first-hand experience using the cloud-based platform in setting up simulations, using peripheral tools, and interpreting model outputs. The workshop is intended for modelers and scientists with experience working in QSP and interest in an end-to-end modeling platform for virtual trial simulation.

Presenters: Ryan Suderman, Cameron Meaney, Clifton Anderson

Certara: A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models
Description: Would you like to modify and tailor population PBPK models? This course will review the principles of PBPK modelling, using the Simcyp Simulator and how to use Simcyp Designer to modify existing PBPK models with your own extension and link them to custom-built PD/QSP models. We will have lectures to introduce the PBPK models to be changed and have hands-on exercises to train the customization of PBPK models with the Designer. No prior knowledge is required. Access to the Simcyp Simulator and Simcyp Designer will be provided. Participant are required to bring their own laptops as the workshop is hands-on intensive.

Presenters: Abdallah Derbalah, Felix Stader

October 22, 2025

1:00 pm - 5:00 pm 

ISoP Education Committee: Unlocking the Value of Physiologically-based Modeling for Small and Large Molecule Therapeutics: Hands-on modeling and simulation with open-source tools, R and PK-sim
Description: This hands-on session will focus on practical exercises using Physiologically-Based Pharmacokinetic (PBPK) models, offering a mechanistic approach compared to traditional models. PBPK models use physiological, anatomical, physicochemical, and metabolic parameters from in vitro, in vivo, and clinical data to predict drug behavior, making them valuable for clinical applications like trial design and drug-drug interaction analysis.
Attendees will use open-source software tools to complete exercises that strengthen their understanding of PBPK modeling for biologics and small molecules.
Key exercises include:

• Predicting the clinical pharmacokinetics (PK) of monoclonal antibodies (mAbs)
• Modeling lipid nanoparticle (LNP)-mediated delivery of mRNA in the vascular system
• Predicting mAb PK following subcutaneous administration
• Developing a minimal-PBPK model for simulating lung exposure in humans after oral administration of Ivermectin for COVID-19 treatment

Additionally, if time allows, attendees will participate in a case study exercise, discussing how they would utilize PBPK modeling output in the industry setting. This session aims to provide hands-on experience with open-source tools, improve study design understanding, and demonstrate the value of integrating PBPK models with pharmacodynamic models.
Learning Objectives:

• Understand the fundamentals of PBPK and the how the modeling approach compares to traditional mammillary or “tissue lumping” modeling.
• Apply full- and minimal- PBPK modeling approaches using open-source software, R and PK-sim, through hands-on exercises to predict drug exposure of small molecules and biologics, including monoclonal antibodies (via IV or SC administration) and mRNA.
• Understand how PBPK models can be integrated with PD models to enhance drug development.
• Practice communicating modeling analyses and results to a simulated industry team to guide drug development and inform decision-making processes.

Presenters: Gauri Rao

October 23, 2025

8:00 am - 5:00 pm 

Certara: Model-Based Meta-Analysis (MBMA): Concepts, Methodologies, and Hands-on Workshop
Description: 
MBMA motivation and methodologies (70 minutes) Motivation

Hands-on sessions (9:30am-12:00pm)

• Part 1: General meta-analysis concepts (30 minutes)
• Part 2: MBMA of binary data (60 minutes)
• Part 3: MBMA of continuous data (60 minutes)

Hands-on sessions (1:00pm - 4:00pm)

• Part 4: Data processing (45 minutes)
• Part 5: Longitudinal MBMA (60 minutes)
• Part 6: MBMA of joint endpoints (75 minutes)

Presenters: Matt Zierhut, Paul Diderichsen

Insilico Trials: Hands-On Introduction to Clinical Trial Simulation
Description: Explore an in-depth, hands-on workshop where you will discover the potential of InSilicoTrials, a platform designed to simplify and enhance clinical trial simulations. Led by our expert team, VP of R&D Daniel Roeshammar, Scientific Director Jane Knoechel, and Head of Engineering Matteo Gazzin, this workshop is tailored for professionals and students interested in model-informed drug development. Whether you're a pharmacometrician, statistician, data scientist, or pre-clinical modeler, you'll gain practical insights into how the InSilicoTrials platform can improve collaboration, streamline simulations, and accelerate decision-making in clinical trials. The platform supports seamless integration of various prominent modeling languages, including NONMEM, Python, Matlab (featuring SimBiology), and R (with packages such as rxode2, mrgsolve, and many others). It allows you to work with complex pharmacokinetic/pharmacodynamic (PK/PD) models, quantitative systems pharmacology (QSP), and even AI/machine learning models. Presenters: Daniel Roeshammar, Jane Knoechel, Matteo Gazzin