Welcome to the Population Approach Group in Europe

Satellite events

2023 Annual European Fútbol Pharmacometrics Collective

Date: Wednesday 28 June 2023
Location: Ciudad Deportiva de La Torre, A Coruña, Spain

As you are aware, the football tournament has become a tradition during PAGE meetings. This year as we are meeting again, there will be an opportunity for anyone who is interested to play and watch the futball match(es). Watching modelers play futball is a special kind of spectator event :-).

The event is organized by Certara and is free of charge. All conference attendees are welcome to register and join the festivities. The tournament is planned for the evening of Wednesday June 28th and all female and male players of any skill level are encouraged to participate; all players/spectators are welcome for the evening fun but will be limited to those who have registered; registration will be closed on June 2, 2023.

The event will be held at local Spanish fields (Ciudad Deportiva de La Torre) for football and at a local restaurant (La Caseta, tentatively) for food/drinks and to celebrate survival after a multi hour event. Transportation, meal, and light drinks will be provided for all players and spectators who signed up. T-Shirts will be provided for soccer players.

Advanced Features of NONMEM 7.5 Workshop

Date: Monday, 26th June, 2023
Time: 09:00 - 17:00
Location: A Coruña, Spain
Timezone: (GMT +1:00) Central European Time
Presenters: Robert Bauer, PhD & Brian Sadler, PhD
Fees: $500 for Industry, $250 for Academia/Government, $100 for Students

A one-day NONMEM 7.5 course will be presented by ICON at the PAGE 2023 Convention. This one-day, in-person, workshop will cover 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, and will also be instructed on 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 also be described as well as 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. Also, learn to use new 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. New in NONMEM 7.5: Optimal clinical design and evaluation tool is available, as well as delay differential equation solvers. The features of PDx-Pop 5.3, the graphical interface for NONMEM 7, will also be demonstrated.

View the full agenda here. Contact Lisa Wilhelm-Lear for more information and registration.

AI-based Surrogates from Quantitative Systems Pharmacology Models

The analysis of Quantitative Systems Pharmacology models typically requires a great number of simulations after sampling parameter values and/or evaluating different dosing schedules.

To speed up the evaluation of numerous scenarios, AI-based surrogate models can be trained on existing simulation or clinical data to predict quantities of interest.

In this half-day workshop, we will use SimBiology and MATLAB to:

Generate simulation data to train AI models
Explore Global Sensitivity Analysis and Feature Ranking techniques to reduce the number of parameters to consider
Train a regression model to predict simulation endpoints
Train a classifier to predict on/off outcomes (e.g., responder/non-responder)
Train Deep Learning networks such as Recurrent Neural Networks, Physics-Informed Neural Networks or Neural ODEs to predict time courses.

Day/Time: June 27, 1-5 pm

Materials Provided by Sponsor:

30-day software trial for SimBiology, MATLAB and AI toolboxes
Access to MATLAB Online (no installation required)
Access to the training materials

Requirements for attendees:

Prior experience with MATLAB.

No fees for this workshop. Registration here.

Building Effective Visualizations for Pharmacometric Models (VACHETTE)

Date: Tuesday 27 June 2023
Time: 13:00 – 17:00
Location: Palexco, A Coruña, Spain
Facilitators: Jos Lommerse, Jeffrey R. Sachs, Anna Largajolli, S.Y. Amy Cheung, Nele Mueller-Plock (full bios)
Cost: $50 (students: $30) – discount available if booked together with CAR-T course

Visualization of pharmacometrics models and data is often central to effectively informing drug discovery and development decisions. A previously published method (V²ACHER^a) yielded an intuitive, clear visual overlay of data for certain GNLS, GLM, and NLME models, allowing an integrated display (in a single plot) of model predictions and data from different groups (i.e. across covariate-value-defined subgroups).

This four-hour, hands-on tutorial will teach you how to use VACHETTE^b, an improved and automated method enabling improved visualizations for PMX models with covariates, improving assessment and communication of model fit for both modelers and non-modelers. VACHETTE can also be applied to overlay data and models or for visual predictive checks (VPC), often yielding improved interpretability compared to traditional trellis plots, VPC, or pcVPC.

The workshop will include lectures and hands-on exercises. Participants can also bring their own examples. The VACHETTE tutorial will use an open-source R package developed by Certara that will be freely available shortly.

a. Lommerse J, et al. CPT Pharmacometrics Syst Pharmacol. 2021;10(9):1092-1106.
b. Sachs JR, et al., ACoP13 (2022) PMX-502 [www.go-acop.org/?abstract=502]

Certara Workshop: An Introduction to CAR-T Population Kinetic Analysis

Date: Tuesday 27 June 2023
Time: 08:00 – 12:00
Location: Palexco, A Coruña, Spain
Facilitators: Mirjam Trame and Stephen Duffull
Cost: $300 (academics: $150; students: $30) – discount available if booked together with VACHETTE course

This hands-on workshop will provide an introduction to CAR-T population kinetic analysis and CAR-T concepts including:

therapeutic utility and challenges in drug development of CAR-T initiatives
the basis for understanding the cellular kinetics of CAR-T cells
models that have been used to describe the kinetics of CAR-T cells and typical inferences
CAR-T cell kinetic modelling

The workshop consists of lectures and interactive hands-on sessions using NONMEM and R. During the hands-on session participants will have the opportunity to explore CAR-T cell data and key features of cellular kinetics as well as fit base models to cellular kinetic data in order to understand the nuances of CAR-T cell kinetic modeling for autologous and allogenic CAR-T cell therapies.

It is expected that participants will bring their own devices and have access to and familiarity with NONMEM and R.

Educational Pharmacometrics Summer Symposium

The second Educational Pharmacometrics Summer Symposium (EPSS) will take place on 27 June 2023, at the University of A Coruña, close to PAGE venue. This free one-day symposium will bring together experts and professionals in the field of pharmacometrics (PMx) to give an overview of what pharmacometrics is and how it can contribute to model-informed drug development and therapy individualisation (programme). The symposium is an excellent opportunity to gain valuable knowledge about PMx, PMx-related career possibilities, establish professional relationships, and present your work.

The symposium will begin with a brief introduction to PMx, followed by a discussion on the use of PMx in drug development, covering preclinical and clinical applications, and also give an introduction to mechanistic models. After lunch and networking, the use of PMx to optimise and personalise treatment will be presented, followed by PMx case studies, based on submitted student abstracts. The symposium will conclude with a short group work session.

The symposium is intended for MSc/PhD students from all natural sciences, postdocs, and others with an interest in pharmacometrics, such as, clinical pharmacists, clinicians, mathematicians, statisticians, or colleagues from industry.

Students/postdocs may apply to present their original PMx-related work as a part of the symposium (submitted abstract should not exceed 4,500 characters, including spaces, and may be the same as for the PAGE 2023 meeting); abstract submission deadline is 31 May 2023.

The participation is free of charge and limited to 70 participants. Light lunch and coffee will be provided. Based on last year’s very positive feedback, register early to avoid missing out: link (open until 31 May 2023). For more information, please email 2ndEPSS@gmail.com.

This event is supported by University of Navarra, Boehringer Ingelheim and Pharmetheus.

Exposure-response modeling for binary & time-to-event data using R and Stan

Date & time: June 26 · 12pm - June 27 · 5pm CEST
Location: Palexco, A Coruña, Spain
Instructors: Jonathan French, ScD & Jim Rogers, PhD
Cost: $642.09 (Industry), $321.96 (Academia/Government/Nonprofit), $161.90 (Students)

Time-to-event models with time-varying hazard have broad applicability to a range of complex exposure-response questions, including those involving adverse events and time to response for efficacy variables. In this course, we build toward understanding of such models in three stages, proceeding from (non-time-to-event) generalized linear models such as logistic regression to general time-to-event concepts, and finally to an in-depth treatment of implementation and interpretation for time-to-event models with time-varying hazard. Course content related to model implementation will similarly follow a progression from R model formula syntax to brms and finally to user-written Stan code.

Prerequisites

Familiarity with R, including tidyverse programming style

Introductory level knowledge of maximum likelihood and Bayesian modeling

Helpful, but not necessary, to have some prior exposure to Stan

Learning Objectives

Describe confounded exposure-response
Analyze binary data (exploratory analysis and modeling using R and Stan)
Analyze time-to-event data (exploratory analysis and parametric modeling using R and Stan)
Interpret TTE models with continuously time-varying hazard

GastroPlus Workshop: Population Simulation and Virtual Bioequivalence - Concepts, Tips, Applications, and Regulatory Impact

Tuesday 27 June 2023 – 09:00 – 13:00
Fees: $125 for industry, $50 for students

A properly conducted Virtual BE (vBE) can significantly impact your drug development process. To maximize its benefits, it is important to understand how populations are generated in GastroPlus and how to appropriately set up a Virtual BE.

By the end of the workshop, you will have gained an understanding of:

How populations are generated within GastroPlus: considering health status, age, gender, and ethnicities
Setting up a vBE: theoretical and practical (hands-on) perspectives, key considerations, results interpretation, and possible additional post-processing in R
The regulatory impact of vBE on drug development: examining its potential to optimize or even replace clinical trials

Registration.

EsqLABS workshop on (advanced) PBPK and QSP modelling in PK-Sim and MoBi

Join esqLABS on June 26th and 27th for a dynamic 1 or 2-day workshop showcasing the latest innovations in physiologically-based pharmacokinetics (PBPK) and quantitative systems pharmacology (QSP) modelling. This workshop will feature hands-on training using PK-Sim and MoBi (OSP-Suite, www.open-systems-pharmacology.org), and will focus on cutting-edge topics such as FcRn inhibitors, sweeping proteins, Protein-Drug Conjugates, bispecifics, and more.

Day 1 will provide an essential introduction to mechanistic modelling and it will cover the necessary steps for ADC tumor growth inhibition. Day 2 will explore advanced modelling on novel modalities. You can attend both days or choose to participate on either day. Plus, with both in-person and virtual satellite attendance options, you can experience the workshop from anywhere.

With only 25 in-person seats available, secure your spot for € 75/225/450 per day for students/academia/industry before May 1st, or € 125/300/550 per day for late registration. Attendees will receive access to our online training courses for this workshop and a 50% discount on access to all other courses. Online seats are also available for € 0/75/150 per day for students/academia/industry. Please note, this option does not include online course materials, but you will receive a 50% discount on access to all online training materials.

Don’t miss out on this opportunity to enhance your knowledge and skills in PBPK and QSP modelling. Register for our workshop today through our web shop:
Day 1: Workshop Day 1 (PAGE 2023)
Day 2: Workshop Day 2 (PAGE 2023)
or contact us via email for more information.

Hands on jinko: the first end-to-end in silico trial platform that translates biomedical knowledge into actionable QSP models

Tuesday 27 June 2023 – 15:00 – 17:30 CEST
Facilitators: Simon Arsène, Eulalie Courcelles and Jim Bosley
Location: A Coruña, Spain
Free entry

What is knowledge based modeling under the lens of in silico clinical trials? This workshop will provide an overview of jinko with a hands-on demonstration of the platform from scientific extracts from the literature to actual clinical trial simulation. We'll then showcase jinko's capabilities in setting up reference scenarios, generating virtual populations, and defining in silico trial protocols. We’ll finish by an illustration of one of jinko's advanced modeling features, which allows to subsample a virtual population to match target distributions, and a short introduction to the model edition capabilities, soon to be released. This workshop provides an ideal platform for researchers, clinicians, regulatory professionals, and industry experts to exchange knowledge, share experiences, and foster collaborations in the field of quantitative system pharmacology and in silico clinical trials. By harnessing the power of modeling and simulation, we can revolutionize the way clinical research is conducted, ultimately leading to accelerated innovation, improved patient outcomes, and a more efficient and sustainable healthcare ecosystem. Register here!

Materials Provided by Sponsor:

Access to jinko
Handout material
Example models

Requirements for Attendees:

Laptop with browser

LAP&P Course: An interactive translational pharmacometric case study for an antibody exhibiting TMDD

In this one-day course we will specifically discuss the importance of understanding the pharmacology of monoclonal antibodies (mAbs) to make the right decisions in target-mediated drug disposition (TMDD) model development. If you want to learn more on 1) the relevance of mechanistic modelling for mAbs, 2) the considerations with regards to scaling the model for first in human (FIH) approaches, and 3) what TMDD models are, what approximations may be applicable and how to use these models for (non-) clinical data. LAP&P’s interactive course will be held on Tuesday the 27th of June 2023 (9:00 – 17:00) in A Coruña, Spain.

After a short introduction, we will directly dive into a hands-on session, in which the participants work in small groups on TMDD modelling challenges using a nlmixr2 within a shinyMixR workflow. Find more information and register for the course here. For questions, contact us.

Monolix: Introductory course on pharmacometrics modeling and simulation with MonolixSuite

Monday 26 June 2023 – entire day

If you want to start using Monolix for your popPK/PD modeling, or you have already started and want to become a more confident user, then this course is for you. We will teach you all you need to know to develop, diagnose and interpret population models for your PK/PD datasets. After a reminder on the key concepts of the population approach, we will show you how to format your dataset, do a first exploratory data visualization, set up a model in the Monolix GUI and analyze the run results. Modeling workflows and strategies will also be discussed. Finally, we will teach you how to simulate new scenarios with Simulx.

Better understanding and confidence comes from practice. You will improve it during an interactive and guided hands-on session on a typical PK/PD dataset – an opportunity to immediately apply new skills with the help from the Lixoft team of Simulations Plus.

More information and registration

Modeling Delays in Pharmacokinetics and Pharmacodynamics

Date: June 27^thTime: 9am-5pm
Location: Eurostars Atlántico, A Coruña, Spain
Instructors: Wojciech Krzyznanski, Gilbert Koch, Robert Bauer, Johannes Schropp
Registration fees: students ($75), academia ($150), regular fee ($300)

The Mathematical and Computational Sciences Special Interest Group of the International Society of Pharmacometrics will present a one day workshop on Modeling Delays in Pharmacokinetics and Pharmacodynamics using NONMEM. The course will provide an overview of biological systems exhibiting delays, concepts of lifespan driven pharmacodynamic response, modeling 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. Course information: here. Registration: here.

Monolix: Advanced course on pharmacometrics modeling with Monolix

Tuesday 27 June 2023 – entire day

This training will give you the keys to move your modeling skills to the next level. It is designed for modelers with already a good knowledge of Monolix, who wish to i) better understand the methods, the algorithms and their options, ii) learn how to implement complex models, iii) improve their strategy for model building.

The course will consist of both lectures and interactive hands-on sessions with Monolix. A dedicated Q&A session is also included. An opportunity to learn guided by the expertise of the Lixoft team of Simulations Plus!

More information and registration

Monolix: Tumor growth inhibition (TGI) modeling with MonolixSuite

Tuesday 27 June 2023 – entire day

This training will give you the keys to confidently and efficiently work on tumor growth data in Monolix and avoid common pitfalls. During this workshop, we will provide an overview of the most common TG and TGI models (included in a modular Monolix library), their key characteristics and discuss guidelines for the modeling of tumor growth and tumor growth inhibition data. Use of custom user-defined models and methods for VPC bias corrections will also be shown.

The workshop will alternate lectures and interactive hands-on sessions, using real dataset examples to show how to model tumor growth data with Monolix, including how to choose a first model depending on the data characteristics, estimate the parameters and diagnose the model. Joint modeling of PK, tumor growth and time-to-event such as survival data will also be demonstrated. An opportunity to learn guided by the expertise of the Lixoft team of Simulations Plus!

More information and registration

Monolix: Target mediated drug disposition (TMDD) modeling with MonolixSuite

Tuesday 27 June 2023 – entire day

This training will give you the keys to confidently and efficiently work on TMDD data in Monolix and avoid common pitfalls. The course will provide an overview of the characteristics of the PK of therapeutic proteins, introduce TMDD modeling concepts (equations, approximations, and underlying assumptions), discuss guidelines for the development of TMDD models and examples of real datasets. Challenges specific to the modeling of TMDD will also be addressed. The workshop will alternate lectures and interactive hands-on sessions with MonolixSuite, including the exploration of the behaviour of TMDD models, and the step by step development and interpretation of a TMDD PK data set. An opportunity to learn guided by the expertise of the Lixoft team of Simulations Plus!

More information and registration

Physiologically based finite time pharmacokinetic (PBFTPK) models en route to PBPK and pharmacometrics: Emphasis on drug absorption

27th June 2023, 09:00 – 17.00
Hotel Zenit Coruña
Comandante Fontanes 19, 15003, A Coruña

The Laboratory of Biopharmaceutics-Pharmacokinetics, Department of Pharmacy, National and Kapodistrian University of Athens, organizes a one-day seminar on Tuesday, June 27, 2023 covering modelling approaches in oral drug absorption. Special emphasis is given to the novel concept of Finite Absorption Time (F.A.T.) and the relevant Physiologically Based Finite Time Pharmacokinetic (PBFTPK) models developed recently.

Registration-Fees:

Industry, CROs: €300
Academia-Government: €150
Student : €100

To view the full agenda and more information, click here. To register please click here.

Pharmetheus Workshop: Forest plots in practical use: Implementation and interpretation

Tuesday 27th of June 2023 (09:00-17:00 CEST/GMT+1) (1-day workshop)

Students: € 150 excluding VAT
Academia / Government: € 300 excluding VAT
Commercial / Industry: € 600 excluding VAT

Interested in communicating the impact of covariates in pharmacometrics models?

With this one day workshop, you will get an in-depth understanding of how Forest plots should be interpreted given the variations in which point estimates and uncertainties can be derived and reference conditions can be set up.
You will also learn how to create Forest plots in R based on output from different types of models and covariate modeling techniques.
Finally participants will get clarity on how Forest plots depend on the underlying modeling methodology and how “Full Model-like inference” can be obtained even from modeling approaches that generate parsimonious covariate models.

Join this one day workshop led by Pharmetheus' experts Niclas Jonsson, Ph.D., Joakim Nyberg, Ph.D. held in A Coruña, Spain, as a satellite meeting to PAGE.

Pharmetheus Workshop: PBPK-PD/QSP modeling with the OSPSuite (PK-Sim, MoBi)

Monday-Tuesday 26th-27th of June 2023 (09:00-17:00 CEST/GMT+1) (2-day workshop)

Students: € 300 excluding VAT
Academia / Government: € 600 excluding VAT
Commercial / Industry: € 1200 excluding VAT

Interested in combining WB-PBPK and PD/QSP models and looking for efficient means to accomplish this?

With this two-day workshop you will learn to develop whole-body physiologically based pharmacokinetic (WB-PBPK) models in PK-Sim, using case examples of pediatric and elderly population translations as well as applications to complex DDIs.
You will also acquire the necessary knowledge on how to connect them to pharmacodynamics (PD) and quantitative systems pharmacology (QSP) models and how to develop or use custom built PD/QSP models in MoBi.

Join this workshop led by Pharmetheus’ experts Assoc. Prof. Erik Sjögren, Ph.D. and Tobias Kanacher, Ph.D. held in A Coruña, Spain, as a satellite meeting to PAGE.

Pumas: Bayesian Workflow in Pumas

June 30 and July 1, 2023 (1.5 Day Course)

This hands-on workshop is designed for novices in Bayesian methods and relatively experienced individuals dealing with pharmacometrics. Pharmaceutical Modelling and Simulation (Pumas) is a domain-specific extension of the Julia differential equation solver libraries for performing analyses of pharmacometric models. Attendees will learn Bayesian methods and how to build Bayesian PKPD workflows in Pumas.

At the end of the workshop, participants will:

Gain an understanding of Bayesian methods
Gain an overview of the Pumas modelling interface
Learn how to specify priors for parameter values
Gain an understanding of Markov Chain Monte Carlo sampling methods
Learn how to perform Bayesian inference for models using Pumas
Learn how to perform post-processing of results for reporting
Learn how to perform cross-validation and model selection

More information and registration

Pumas: Scientific Modeling Augmented by Machine-Learning with DeepPumas

June 26 and 27, 2023 (2 Day Course)

Often scientists may not know the exact biological mechanisms dictating the data signatures. For example, which risk factors drive responders to a cancer treatment or how a biomarker is related to clinical outcomes. Current data science methods require big data, and they ignore prior knowledge of the problem at hand. Pumas-AI is poised to disrupt this. DeepPumas enables seamless integration of domain-specific knowledge and data-science methodology, reducing dependence on data size and enabling faster decision-making.

Here, we will learn, hands-on, how DeepPumas can automatically discover complex predictive factors to individualize predictions. Furthermore, we will learn how dynamical systems that model the longitudinal evolution of patient outcomes can be augmented by machine learning – enabling data-driven discovery of the underlying biology. Together, this enables effective use of data to rapidly develop models that predict individual outcomes from heterogeneous sources of patient data.

Applicable across the whole chain of drug development, from lead generation, quality by design manufacturing, clinical research, and market research to individualized patient management, DeepPumas is not an incremental improvement but a game-changer.

The workshop is split in two, where the first day is dedicated to learning the powerful Pumas software for pharmacometric modeling. During the second day, we learn about machine learning and how it can be seamlessly embedded in pharmacometric models using DeepPumas.

More information and registration

Simcyp Workshop: PBPK in Paediatric and Pregnancy Populations

This workshop will provide an overview of applying PBPK approach to describe examples of altered pharmacokinetics due to physiological changes during development in children as well as during pregnancy. Upon completion, participants should be able to understand the advantages of PBPK models in providing information in the field of perinatal pharmacology during drug development and in clinical settings. The workshop is a mixture of lectures and with hands-on exercises

Key aspects of the course:

Application of In vitro-in vivo extrapolation
Impact of key influencing covariates and their ontogenies to inform prediction of pharmacokinetics
Impact of interindividual variability
Time varying population parameters

Date: Tuesday 27th June 2022
Time: 09:00 - 16:00 (Break 10:00 / lunch 12:30)
Location: A Coruña, Spain
Cost: £100+VAT Students (Coupon Code: STUDENT23) / £200+VAT Industry

Simcyp Workshop: Simcyp Designer PBPK-QSP Focused Workshop

Learn how to develop population-PBPK driven PD/QSP models within an integrated platform. The course will review the basics of PBPK modelling using the Simcyp Simulator and builds rapidly to specialised applications where you will modify existing PBPK models with your own extensions. No prior knowledge is assumed, but you are expected to learn quickly!

You will also learn how to propagate population variability into mechanistic models of effects that can dynamically interact with the systemic distribution model.

Key aspects of the course:

Overview of PBPK modelling using the Simcyp Simulator
Generation of realistic population variability by correlated Monte Carlo sampling
Rapidly create new models in a graphical editor (Simcyp Designer)
Incorporating PBPK covariates within a user defined PD/QSP (mechanistic effect) model
Replacing a tissue compartment in Simcyp with a user defined model
Adding target mediated drug disposition (TMDD) models to tissue compartments
Extending PBPK models for therapeutic proteins
Optimise your PBPK model to a set of clinical trial data simultaneously

Date: Tuesday 27th June 2022
Time: 09:00 - 16:00 (Break 10:00 / lunch 12:30)
Location: A Coruña, Spain
Cost: £100+VAT Students (Coupon Code: STUDENT23) / £200+VAT Industry