2024 - Rome - Italy

2024 - Rome - Italy

Thirty-second meeting, 26-28 June, 2024

Register/submit abstract

Below are listed all satellite meetings scheduled to take place in the frame of PAGE Meeting.
The organizing companies are presented in alphabetical order.

 

Calvagone

On June 25 Calvagone will be running a 1-day workshop on e-Campsis, an intuitive web application to set-up and run PK/PD simulations, and to communicate simulation results in an interactive way.

As a participant you will get free access to e-Campsis pro. You will learn how to:

-          Import a model from various sources (Campsis, model library, NONMEM)
-          Set up a trial design
-          Bootstrap covariates from an external source (e.g. NHANES)
-          Simulate specific individuals, a population or a clinical trial with uncertainty
-          Explore what-if scenarios thanks to the built-in scenario creator
-          Stratify and visualize the results with customizable plots
-          Post-process the results, derive useful metrics and summary statistics and generate HTML tables in a few clicks
-          Create forest plots in an intuitive manner to assess the impact of covariates
-          Make a sensitivity analysis effortlessly and understand the limitations of your model

You will also learn how to reproduce the simulations offline in R thanks to the open-source package campsis.

The following registration fee applies for this 1-day workshop:

Industry:  €300 excl. VAT
Academic: €150 excl. VAT
Student:   €100 excl. VAT

The fee includes the workshop material, lunch and coffee breaks as well as temporary access to e-Campsis pro for 2 months. On top of it you will get a 50% discount on the annual subscription fee.

Only  limited knowledge of R is required, since all hands-on exercises will be done in the web application. Participants should bring their own laptop.

Please click on the link below to register.
https://calvagone.github.io/workshop_page.html

PS: If you already want to familiarize yourself with e-Campsis before the workshop, feel free to explore the free version at https://e-campsis.com 


ICON

Advanced Features of NONMEM 7 Workshop for PAGE 2024

Date:  Monday, 24nd June, 2024
Time: 09:00 - 17:45
Location:  Rome, Italy
Timezone: (GMT +1:00) Central European Time

A one-day in person NONMEM 7 course will be presented by ICON at the PAGE 2024 Conference

A one-day NONMEM 7.5 course will be presented by ICON at the PAGE 2024 Conference. 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.  

Finch Studio, a companion workbench/user-interface for NONMEM, will be introduced. Participants will learn how to use Finch Studio for exploratory data analysis, control stream building and editing, and running and evaluating NONMEM models.

Presenters: Robert Bauer, PhD,Brian Sadler, PhD, and Mohamed Ismail, PharmD/MS.

For additional information and agenda, please go to Workshop: Advanced NONMEM 7.5 (iconplc.com)

Fees: $600 for Industry, $300 for Academia/Government, $150 for Students

For more information and registration. contact Andreea Ancuta at IDSSOFTWARE@iconplc.com


EPSS

Educational Pharmacometrics Summer Symposium

The third Educational Pharmacometrics Summer Symposium (EPSS) will take place on 25 June 2024, at the 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. 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. 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 2024 meeting); abstract submission deadline is 26 May 2024.

The participation is free of charge. Light lunch will be provided. Based on last years’ positive feedback, register early to avoid missing out: link (open until 26 May 2024). For more information, please email EPSS2024@gmail.com.

This event is supported by Boehringer Ingelheim and Pharmetheus.


 

Leiden University

Copulas for covariate simulation in R

Copulas can be used to estimate covariate distributions and relationships and simulate new patient covariate sets. Recently, we proposed this method for covariate simulation in a previous PAGE talk and recent paper. Sign up to find out what the copula is and to learn how to use it on your own data.

By the end of this workshop you will

  • have a theoretical understanding of (vine) copulas;
  • understand the estimation process of copulas on data;
  • be able to fit a copula on data and simulate from the copula;
  • be able to visualize and evaluate the fit of the copula and simulated populations;
  • be able to use simulated covariates in a population PK/PD simulation

Prerequisites: We expect you to have previous experience in R and bring your laptop with an installation of R.
Date: Tuesday, 25th June, 2024
Time: 13:00 – 17:00
Fees: €150 for industry, €75 for academics
Registration: link

More information: laurazwep.com/copulas-for-covariate-simulation-in-r


Metrum Research Group

Explore MeRGE: the Metrum Research Group Ecosystem

Join MetrumRG for a hands-on workshop exploring open-source pharmacometric tools on June 25. Enrich your skills in one day!

MeRGE is a suite of freely-available, open-source tools for scalable, reproducible pharmacometric workflows. MeRGE consists of individual but interconnected R packages that support scalability and reproducibility during:

  • Project setup
  • Data assembly
  • Data exploration
  • Model development, execution, and evaluation
  • Simulation
  • Reporting

Click here to learn more about MeRGE including an illustrative example and sample codes.

Registration fee: $150 Students / $375 Academic or Regulatory /  $750 Industry

Requirements for Attendees:

  • All participants are required to bring a laptop and ensure access to either the Chrome or Safari web browser
  • Knowledge and experience in PK modeling and the use of R

Click here to register

 


Pharmetheus AB

Workshop 1: Physiologically-based absorption modeling with the OSP Suite (PK-Sim®, MoBi®)

Do you want to increase your capabilities to support decision making in drug development with PBPK and absorption modeling? This workshop teaches you how to use and leverage the Open Systems Pharmacology (OSP) suite (also known as PK-Sim® and MoBi®) for modeling of absorption after different routes of administration utilizing the standardized and well-established whole body PBPK model provided in PK-Sim® and the open modeling possibilities in MoBi®.

Several relevant OSP techniques are highlighted,such as: Creating and leveraging PK-Sim structures, model establishment strategies, R-based processes, applying available absorption model implementations, and how to approach custom development via MoBi. The goal is to give participants (beginners to advanced users) a solid foundation to apply PK-Sim® and MoBi® in future projects.

The workshop is 2 days and covers:

  • Learning the fundamentals in PK-Sim
  • Learning the fundamentals in MoBi
  • Setting up a PBPK model in PK-Sim for oral absorption
  • How to approach subcutaneous, lung, dermal and ocular absorption modeling in MoBi
  • Using WB-PBPK-absorption models to establish an IVIVR
  • Informing bioavailability study design using virtual populations
  • Addressing bioequivalence via virtual trials 
  • Strategies to use WB-PBPK-absorption models to evaluate an administration route switch

The target audience are scientists with a modeling background and a basic understanding of the overall drug development process.

Workshop tutors:

Erik Sjögren, Principal Consultant & PBPK-QSP platform scientific lead
Tobias Kanacher, Senior Consultant
Gianluca Selvaggio, Senior Consultant
Additional tutors may be added if there is a large number of participants

In addition to the ordinary program, the Pharmetheus tutors are happy to schedule shorter, individual free of charge, speed-consulting sessions  to support the participants on related topics.

Date: Monday 24th June - Tuesday, 25th June, 2024
Time: 09:00 – 17:00
Place: Ergife Palace Hotel & Conference Center

Fee: Commercial/ Industry € 1200, Academia/ Government € 600, Students € 300.
All fees are excl. VAT.

The fee includes coffee breaks and lunch for both days.
Register here

 

Workshop 2: An introduction to probabilistic decisions support in drug development

Are you looking to improve decision making in drug development? This workshop introduces how Model-Informed-Drug-Development (MIDD) principles can be applied to facilitate probability-based decision making in drug development. The workshop covers a number of relevant concepts such as power, assurance, probability of pharmacological success (PoPS), probability of technical success (PTS), and probability of technical and regulatory success (PTRS). Important requirements for the basis of such probability predictions, including fit-for-purpose models and clinical trial simulations, are also highlighted. In addition to basic theory, with regards to these topics, the workshop includes relevant case-studies and practical recommendations on efficient communication of MIDD approaches from tutors with extensive experience in this area.

The workshop covers:

  • MIDD and the current state of affairs for pharmaceutical R&D
  • Working with a Target Product Profile
  • Definition of decision criteria & Go/No-go
  • Economic risk analysis
  • Characterization and simulation of variability and uncertainty
  • Introduction of probability concepts (e.g. power, assurance, PoPS, PTS and PTRS)
  • Clinical Trial Simulation 

The target audience are scientists with a modeling and/or statistics background who have a basic understanding of the overall drug development process.

Workshop tutors:

Richard Anziano, Principal Consultant & Chief Statistician
Peter Milligan, Chief Executive Officer
Martin Bergstrand, Principal Consultant & MIDD platform science lead
Giovanni Smania, Senior Consultant, Team leader & MIDD platform business lead

In addition the Pharmetheus tutors are happy to schedule shorter individual free of charge speed-consulting sessions to support the participants on related topics.

Date: Tuesday, 25th June, 2024
Time: 09:00 – 17:00
Place: Ergife Palace Hotel & Conference Center
Fee: € 600 excl. VAT (a limited number of seats are reserved for students @ € 150 excl. VAT)

The fee includes coffee breaks and lunch.

Register Here


Pirana-RsNLME / Certara

PMX Analysis with R, NsLME, and Pirana Darwin

This is a full day workshop on June 25 that will introduce the student to PMX analyses in R using Certara’s R speaks NLME, Pirana, and Pirana Darwin.  By the end of the course, students will be able to create a pk model in R using the PML language, fit the model, perform diagnostics including VPC, and perform simulations.  In addition, students will be given an introduction to executing a machine learning model selection analysis using Pirana Darwin.  

The workshop will include lectures and hands-on exercises. Participants will be given access to a cloud environment to perform the hands-on exercises.

Click here for more details and to register: https://www.certarauniversity.com/store/3630082-page2024-workshop-pmx-analysis-in-r-using-rsnlme-and-certara-toolsets


Pumas-AI Inc

Workshop 1: Scientific Modeling Augmented by Machine Learning with DeepPumas

DeepPumas is a powerful tool that bridges the gap between mechanistic, statistical, and machine learning modeling. This hands-on workshop will introduce participants to the core concepts behind DeepPumas and its potential to transform decision-making in the healthcare space. By seamlessly embedding machine learning methodology into nonlinear mixed-effect models, DeepPumas enables the simultaneous utilization of domain-specific knowledge and available data for model identification. This workshop will give participants practical skills in hybrid mechanistic and machine learning modeling, a comprehension of how complex covariates can help forecast longitudinal outcomes, and an insight into the possible implications of this technology.

Learning Objectives:

  • Learn basic usage of the Pumas and DeepPumas software.
  • Understand simple neural networks and how to use them.
  • Understand neural-embedded dynamical systems such as Neural Ordinary Differential Equations (ODEs) and Universal Differential Equations (UDEs).
  • Learn Mixed-Effect Neural Networks (MeNets) and how to find individualizable models.
  • Learn how to integrate machine learning for prognostic factor identification in longitudinal models.
  • Understand how to compose all the above to enable a semi-mechanistic scientific machine learning approach to finding individualizable and predictive longitudinal models.
  • Get a sense of how this technology may transform the role of data and modeling in the healthcare space.

Instructors: Niklas Korsbo, PhD, Lorenzo Contento, PhD and Jose Storopoli, PhD

Click here for more details and to register: https://www.eventbrite.com/e/scientific-modeling-augmented-by-machine-learning-with-deeppumas-tickets-808028032597

Date & Time: Monday 24 June 2024, 8AM – 5PM
                      Tuesday 25 June 2024, 8AM – 5PM

 

Workshop 2: A Practical Bayesian Analysis Workflow in Pumas

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. We’ll focus on a practical and comprehensive Bayesian Workflow (arXiv:2304.04752).

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 and simulations for reporting.
  • Learn how to perform cross-validation and model selection.

Instructors: Jose Storopoli, PhD and Mohammed Tarek Mohammed, PhD

Click here for more details and to register: https://www.eventbrite.com/e/a-practical-bayesian-analysis-workflow-in-pumas-tickets-808001092017

Date & Time: Monday 24 June 2024, 1:30PM – 5PM
                      Tuesday 25 June 2024, 8AM – 5PM


Simcyp | Certara

Workshop 1 : A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models

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 customisation 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.

Key aspects of the course:

  • Overview of PBPK modelling, using the Simcyp Simulator.
  • Rapidly create new models in a graphical editor – the Simcyp Designer.
  • Replace PBPK model components in Simcyp with a user-defined model.
  • Adding components/modules to simcyp PBPK models.
  • Extending PBPK models for large molecules.
  • Building PBPK driven PD/QSP models.
  • Incorporate population variability into the customized models.

Date: Tuesday 25th June 2024

Time: 08:15 – 16:45

COST £200+VAT Students (Coupon Code: STUDENT24) / £400+VAT Industry

Register Here

 

Workshop 2 : A Hands-On Workshop on incorporating physiological covariates in Population based PK Predictions

Population pharmacokinetic analyses of covariates sometimes suffer from the “tobacco smoking syndrome” of early epidemiology, where known effects of smoking are not considered. Hunting for influencing covariates via standard analyses of epidemiological data either each time rediscover these effects or lose power.

In contrast, modern bottom-up Physiologically Based Pharmacokinetic (PBPK) approaches rely on prior knowledge and include known covariate effects in population-based PK predictions. This workshop introduces principles for incorporating covariates in the prediction of drug clearance and volume of distribution, and applies them to predict PK in various healthy and disease populations using PBPK.

The workshop covers the following key aspects:

  • Clinical examples of Physiological covariates affecting PK
  • How to incorporate physiological and genetic covariates within PBPK models
  • Quantifications of the impact of static and time-dependent covariates on clearance and volume of distribution predictions for healthy and disease populations
  • Covariates impacts on dose selection and study design

Date: Tuesday 25th June 2024

Time: 08:15 – 16:45

COST £200+VAT Students (Coupon Code: STUDENT24a) / £400+VAT Industry

Register Here


 

Simulations Plus

WORKSHOP 1: Introductory course for pharmacometrics modeling using Monolix® 

Whether you’re a novice in population modeling eager to start working on your PK and PK-PD projects, or an intermediate modeler aiming to boost your confidence and make strategic decisions, this 1.5-day course is tailored for you. Gain essential skills to develop, diagnose and interpret models, and efficiently use algorithms within Monolix. 

The comprehensive course includes practical, hands-on exercises to reinforce your newly acquired knowledge. No prior experience with MonolixSuite is necessary. 

  • Gain the statistical knowledge essential for understanding the population approach and interpreting results effectively.
  • Build complete Monolix projects, covering data visualization, model set up, and parameter estimation.
  • Employ various diagnostic tools to assess model goodness of fit and how to improve it.
  • Implement complex models and refine strategies for optimal model development.
  • Explore Monolix algorithms and their options.

Includes a temporary licence for the MonolixSuite. 

REGISTRATION FORM

https://lixoft.com/blog/2024/01/10/course-pharmacometrics-modeling-monolix-page2024/

WORKSHOP 2: Advanced course for pharmacometrics modeling using Monolix®  

Take your modeling skills to the next level with our advanced 1.5-day course on modeling in pharmacometrics using Monolix. Designed for modelers with intermediate knowledge of Monolix, who wish to: 

  • Deepen understanding: gain insights into the methods and algorithms behind each task and the impact of their settings.
  • Implement complex models: learn how to write and diagnose intricate models effectively such as non-standard parameter-covariate relationships or non-continuous data.
  • Optimize model building strategies: improve your approach to covariate model building  and inter-occasion variability for enhanced outcomes.

This course features both lectures and interactive hands-on sessions with Monolix. A dedicated Q&A session ensures your queries are addressed comprehensively.  

Includes a temporary licence for the MonolixSuite. 

REGISTRATION FORM

https://lixoft.com/blog/2024/01/10/advanced-course-modeling-monolix-page2024/

WORKSHOP 3: From simple to complex simulations in pharmacometrics using Simulx®  

Explore the world of simulations in pharmacometrics with our half-day workshop using Simulx - a simulation tool equipped with a user-friendly graphical interface and fully integrated with all MonolixSuite applications. This training will give you the keys to confidently set up simulation scenarios and efficiently answer “what if” questions.

Learn the ins and outs of simulations: 

  • Define simulation elements such as outputs, treatments, or covariates.
  • Explore your model and effective dosing regimens.
  • Simulate groups of individuals and clinical trials with uncertainty.
  • Post-process results and analyse efficacy and safety criteria. 
  • Use statistical tests to answer relevant questions. 

Whether you’re starting from scratch or building a simulation based on an existing Monolix project, this training equips you with the essential tools.  

Engage in hands-on sessions, progressing from simple to complex examples, to solidify your understanding of simulations and Simulx. Don't miss this opportunity to enhance your skills and navigate pharmacometrics with ease.

Includes a temporary licence for the MonolixSuite. 

REGISTRATION FORM

https://lixoft.com/blog/2024/01/10/simulations-in-pharmacometrics-simulx-page2024/

WORKSHOP 4: Automating pharmacometrics modeling and simulations course: scripting using lixoftConnectors

Discover the potential of workflow automation in pharmacometrics modeling and simulations with our half-day course on using lixoftConnectors. These R-API functions offer direct access to MonolixSuite applications from within R and enable you to seamlessly script complex workflows and revolutionize your approach to phamacometrics. 

What you will discover:

  • R-API functions: gain insight into the applications of lixoftConnectors to access MonolixSuite from R. 
  • Workflow automation: understand the fundamental principles of these functions and how to script modeling and simulation tasks efficiently. 
  • Integration of MonolixSuite: learn about benefits from the direct connectivity between R and MonolixSuite through lixoftConnects. 

This course is designed for professionals with at least basic knowledge about Monolix and Simulx, who seek to script their pharmacometrics workflows. It features both lectures and interactive hands-on sessions. Join us to unlock the potential of lixoftConnectors to elevate your pharmacometrics projects.

Includes a temporary licence for the MonolixSuite. 

REGISTRATION FORM

https://lixoft.com/blog/2024/01/10/automating-pharmacometrics-modeling-and-simulations-scripting-using-lixoftconnectors-page2024/

 

GPX™ Workshop: A hands-on PBPK training course using the newly released GastroPlus® platform.

Whether you are new to PBPK or you have used GastroPlus before, this workshop is for you!
During this day long training, you will gain hands-on experience on PBPK modelling with our new platform. Using its logical workflow and enhanced visualization capabilities, you will explore the powerful ability to run multiple simulations at once and fully analyze the results via default and user-defined plots. In addition, you will discover and assess the enhanced DDI capabilities to perform polypharmacy simulations with no limitations on the number of drugs evaluated.


By the end of the day, you will feel comfortable working with GPX.

You will gain knowledge on:

-          The new GPX paradigm
-          Creating GPX projects from scratch or with a template
-          Defining multiple drugs and solubilities/forms within your formulations
-          Using various run modes, including population simulations
-          Performing polypharmacy DDI assessments
-          Using the enhanced plotting capabilities

The focus of this course will be on hands-on applications using GPX, so although previous GastroPlus knowledge is not necessary, theoretical knowledge on PBPK is essential.

A temporary license to GPX with all the modules is included.

Date: Tuesday, 25th June, 2024
Time: 09:00 – 17:00
Fees: $300 for industry, $100 for academics

Registration

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