2024 - Rome - Italy

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

Basel University 

Workshop on OptiDose: computing optimal dosing regimens in NONMEM

OptiDose is an optimization algorithm which allows to compute the optimal dosing regimen to achieve a given therapeutic goal for any pharmacometrics model. It will be demonstrated how the OptiDose concept can be implemented in NONMEM with standard commands. In addition, it will be shown how to include safety and efficacy considerations in the optimization process. We will provide examples on the individual level, e.g., for therapeutic drug monitoring, and on the population level, e.g., to determine a one-size-fits-all dose for a certain percentage of patients. The workshop participant will learn how to formulate their own optimal dosing questions and how to implement and solve them in NONMEM.

Instructors:
Freya Bachmann (University of Konstanz, Germany)
Dominic Bräm (University Children’s Hospital Basel, Switzerland)
Gilbert Koch (University Children’s Hospital Basel, Switzerland)

Date:
Tuesday 25 June 2024

Agenda:
10:00 – 10:45: Introduction to OptiDose
10:45 – 11:30: Guided hands-on
11:30 – 13:00: Lunch break
13:00 – 14:00: Hands-on for individual dose optimization
14:00 – 14:30: Dose optimization on the population level
14:30 – 15:00: Coffee break
15:00 – 16:00: Hands-on for population dose optimization

Pricing:
Academia 125 Euro ($137.5 US)
Industry 325 Euro ($357.5 US) 

For more information please send an email to gilbert.koch@ukbb.ch
For registration please send an email to 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 (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 to optimise and personalise treatment. After lunch and networking, the use of PMx in drug development, covering preclinical and clinical applications, will be presented, followed by PMx case studies, which will be 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, Pharmetheus and University of Pavia.

esqLABS GmbH

Workshop 1: OSP Suite (PK-Sim®, MoBi®) WORKSHOP 1: Biologics (ADC) PBPK/PD and Small Molecule DDI

esqLABS will provide hands-on training on the most sought-after topics in physiologically-based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) modeling using PK-Sim® and MoBi® (OSP-Suite). The first workshop will cover practices for protein/antibody PBPK and PD modeling for antibody-drug-conjugates (ADCs) for the treatment of tumor growth accounting for target-mediated drug disposition (TMDD). In the afternoon, it will provide in-depth training on how to leverage the OSP-Suite Software and Model Library for PBPK-based assessments of drug-drug interactions (DDI).

Learning objectives:

1. Develop, extend, and customize PBPK models with a focus on biologics to simulate disease mechanisms and drug effects (PBPK/PD or PBPK-QSP models) using PK-Sim® and MoBi®.
2. Gain experience with hands-on exercises with a protein/antibody PBPK model for ADCs for the treatment of tumor growth accounting for TMDD kinetics.
3. Explore how to simulate the PK of a drug and its metabolite and the metabolizing enzyme for DDI.
4. Learn how to work with the OSP Suite Model Template Database
5. Learn how to define Parent-Metabolite and Drug-Interaction kinetics
6. Learn about regulatory requirements for the execution and reporting of PBPK-based DDI assessments

While the workshop does not require prior experience with PK-Sim® and MoBi®, many topics will interest even advanced users.

Workshop Instructors:

• Dr. Stephan Schaller (CEO and Lead Scientist)
• Dr. Wilbert De Witte (Principal Scientist)
• Pavel Balazki (Software Lead)

Date: Monday, 24th June 2024
Time: 09:00 – 17:00
Location: Ergife Hotel
Fee: 500 EUR (+tax) for industry, 300 EUR (+tax) for academia & non-profit, and 150 EUR (+tax) for students.

The fee includes coffee breaks and lunch for both days.

For more details and information on how to register, please visit our webshop (Workshop 1 (PAGE 2024) – esqLABS GmbH) or contact us via email (training@esqlabs.com).

-> The registered participants will be given a free voucher to access our upcoming course on OSP R & esqlabsR frameworks! More about them here. 

Workshop 2: OSP Suite (PK-Sim®, MoBi®) WORKSHOP 2: PBBM - Formulation development and virtual Bioequivalence

The second workshop brought by the team at esqLABS will present the principles and applications of physiologically based biopharmaceutics modeling (PBBM) and oral drug absorption with hands-on examples in PK-Sim® and MoBi® (OSP-Suite).

Learning objectives: 

1. Gain insight into the mechanistic absorption modeling with PK-Sim®.
2. Apply PBBM to predict dissolution behavior and optimize drug formulations for improved oral absorption.
3. Learn about the in vitro-in vivo correlation (IVIVC) concept and its significance in pharmaceutical development and regulatory applications.
4. Explore methods and approaches for establishing IVIVC relationships to predict in vivo drug behavior from in vitro data.
5. Understand the concepts of dissolution-safe space and virtual bioequivalence.
6. Engage with hands-on exercises to get practical experience running Virtual Bioequivalence with PK-Sim® and R. 

While the workshop does not require prior experience with PK-Sim® and MoBi®, many topics will interest even advanced users.

Workshop Instructors:

• Dr. Marco Siccardi (Principal Scientist)
• Dr. Wilbert De Witte (Principal Scientist)
• Dr. Mariana Guimarães (Scientist)

Date: Tuesday, 25th June 2024
Time: 09:00 – 16:30
Location: Ergife Hotel
Fee: 500 EUR (+tax) for industry, 300 EUR (+tax) for academia & non-profit, and 150 EUR (+tax) for students.

The fee includes coffee breaks and lunch for both days.

For more details and information on how to register, please visit our webshop (Workshop 2 (PAGE 2024) – esqLABS GmbH) or contact us via email (training@esqlabs.com).

-> The registered participants will be given a free voucher to access our upcoming course on OSP R & esqlabsR frameworks! More about them here.

ICON

Advanced Features of NONMEM 7 Workshop for PAGE 2024

Date:  Monday, 24^nd 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

InSysBio

Workshop on InSysBio Immune Response Template (IRT): IRT templates export, edition and merge with existing projects for QSP platform development.  

IRT is a Quantitative Systems Pharmacology (QSP) platform of immune system that contains base models of cells and cytokines processes and their parameters. IRT allows to export any part of the platform pre-developed equations and use it for the new QSP platform creation. Also, parts of the IRT platform may be integrated with existing projects and models using Heta compiler.  

At this workshop we will demonstrate how to speed up development and improve the existing model by adding prepared templates from IRT. Open-source model, developed without IRT templates usage, will be merged with the IRT submodel template to extend the QSP project and introduce more detailed mechanistic description of the immune process. The open-source model will be used “as is” in its original format to save our time. With Heta compiler usage, the result will be translated into format compatible with simulation software. 

In frames of this workshop, you will familiarize yourself with: 

• IRT template export and edition 
• IRT template merge with pre-developed QSP model 
• Heta compiler to convert QSP model formats into each other 

Workshop Instructor: Veronika Musatova (Head of IRT development team)

Date: Tuesday 25^th June 2024
Time: 11:00 – 14:00
Location: Ergife Hotel
The workshop is free of charge. Coffee break will be provided.

Register here

ISoP

Modeling Delays in Pharmacokinetics and Pharmacodynamics

Date: June 25^th
Time: 8am-4pm
Location:  Ergife Palace Hotel, Largo Lorenzo Mossa, 8, 00165 Roma RM, Italy 

Instructors: Wojciech Krzyzanski, Gilbert Koch, Robert Bauer, Johannes Schropp

Registration fees: students ($80), ISoP members ($160), regular fee ($320)

Mathematical and Computational Sciences Special Interest Group of 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.

-> For course information visit https://sites.google.com/site/delaysinpkpd .

-> To register visit https://insp.memberclicks.net/mcsworkshop2024

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

MathWorks 

Global Sensitivity Analysis with SimBiology®

Sensitivity analysis lets you explore the effects of variations in model quantities on a model response. You can use the analysis to identify key pathways and parameters or validate preexisting knowledge on influential model quantities.

Local sensitivity analysis (LSA) analyzes the effect of one model parameter at a time, keeping the other parameters fixed. In global sensitivity analysis (GSA), on the other hand, model inputs are varied together to simultaneously evaluate the relative contributions of each quantity with respect to a model response. Thus, GSA can be used to understand which model inputs drive the model response across the entire input space and inform parameter calibration strategy.

SimBiology® provides the following methods to perform GSA: Calculation of Sobol Indices, Multiparametric GSA (MPGSA), and Elementary Effects (EE).

In this half-day workshop, we will introduce the Global Sensitivity Analysis (GSA) functionality in MATLAB/SimBiology and discuss:

• The differences between Local and Global Sensitivity analysis when it is appropriate to apply each method,
• How to perform Local and Global Sensitivity Analysis with SimBiology,
• How Sobol-indices, Multiparametric GSA, and Elementary Effects are calculated and differences between methods - Interpretation of the results,
• How to choose your sample size for these GSA methods.

This workshop is free of charge for all attendees.

Venue: Ergife Hotel
Date: 25 Jun 2024
Time: 13:00-17:00 CEST

Register Here -> Global Sensitivity Analysis with SimBiology® - MATLAB & Simulink (mathworks.com)

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 24^th June - Tuesday, 25^th 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, 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

The nlmixr2 team

The nlmixr2 team will be presenting a half-day workshop on nlmixr2 and its supporting tools at PAGE in Rome this year.

We will cover:

An introduction to rxode2 and nlmixr2 syntax, and approaches to simulation

• Nonlinear mixed-effects model model development with nlmixr2, including standard diagnostics and visual predictive checks

• A simple PK example

• Advanced capabilities of nlmixr2

• More advanced PK/PD

 We will also touch on topics like semi-automated model translation between other tools (such as NONMEM and Monolix) and nlmixr2, reporting, project tracking and other. To get the most out of the course participants should have experience with using R, as well as a basic understanding of the principles of nonlinear mixed-effects model development. Personal laptops with R and nlmixr2 pre-installed will be required for the hands-on sessions (detailed installation instructions will be provided).

nlmixr2 and its satellite packages are undergoing continuous and intensive development, and are intended to provide a complete suite of packages for pharmacometric data analysis as free, open-source software. nlmixr2 is based in R and provides robust support for parameter estimation (primarily through the SAEM and FOCE/I estimation methods) and simulation. It has been used successfully for a range of purposes in academia and in industry. More details may be found at https://nlmixr2.org/.

Workshop tutors:

• Rik Schoemaker, Owner and Senior Consultant at Occams
• Bill Denney, Owner and CEO at Human Predictions
• Matt Fidler, Director, Pharmacometrics at Novartis
• Mirjam Trame, Vice President and US Northeast Regional Lead Pharmacometrics at Certara Drug Development Solutions
• Justin Wilkins, Owner and Senior Consultant at Occams

Date:  Tuesday 25 June 2024
Time:  13:00 – 17:00
Location:  Ergife Palace Hotel & Conference Center
Cost:  €150 per participant from industry, €100 per participant from academia or

non-profit (including regulatory) and €25 per student (including VAT and coffee/tea).

Register here! 45 seats are available. 

https://www.eventbrite.nl/e/nlmixr2-workshop-tickets-867482261797?aff=ebdsoporgprofile

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

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

Simcyp | Certara

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 25^th June 2024

Time: 08:15 – 16:45

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

 University College London (UCL)

Getting the dose right first!

Regulatory perspective and impact of Project Optimus on RP2D selection in oncology

Date:     25^th June 2024
Time:     13:00-18:00 h CET
Venue:  Orange Hall, Ergife Palace Hotel
Largo Lorenzo Mossa, 8,
00165 Rome, Italy

UCL Clinical Pharmacology & Therapeutics Group together with a panel of representatives from pharmaceutical R&D, clinical oncology research, and regulatory agencies (U.S. Food and Drug Administration and European Medicines Agency) has the pleasure to invite PAGE delegates to attend this satellite event.

WHY THIS SYMPOSIUM: The objective of this public symposium is to reflect on current practices and discuss approaches for dosage optimization for medicinal products progressing in clinical development in oncological indications and provide further context for the Project Optimus initiative.

Historically, dose-finding studies for oncology drugs following 3+3 designs have been used to determine the “maximum tolerated dose" (MTD). However, this approach can lead to poorly tolerated doses for many modern medications, including targeted therapies and immunotherapies, which defy the premise that efficacy and toxicity increase monotonically with dose, in contrast to traditional cytotoxic chemotherapy.

WHAT IS GOING ON: The FDA Oncology Center of Excellence launched Project Optimus to address this issue. Project Optimus has been trying to revolutionize the paradigm of dose selection and optimization in oncology drug development since its start in 2021. The emphasis on determining the optimal dose necessitates the evaluation of modern designs, moving away from the traditional 3+3 design for dose escalation, and the evaluation of the totality of the data, including careful integration of data on the pharmacokinetics and pharmacodynamics (i.e., exposure-response relationships) as basis for the characterisation of the safety, efficacy and benefit-risk profile of novel medicinal products.

This symposium will provide a forum for discussion on expectations, best practices for dose finding, and on the role of clinical pharmacology approaches based on modelling and simulation in achieving this goal.

AGENDA: An outline of the preliminary agenda can be found here.

REGISTRATION: Participation in person or online is free of charge, but registration is mandatory due to venue capacity limitations. Delegates will be enrolled on a first-come first served basis.

You can email Salvatore D’Agate (s.d’agate@ucl.ac.uk) if you have any queries regarding the event.

Please fill in the form in this link to register. Participants are expected to submit a question, outline an issue, or share their experience with regard dose selection in oncology. These questions will support the discussion and highlight common issues faced by different stakeholders