2022 - Ljubljana - Slovenia

2022 - Ljubljana - Slovenia

Thirtieth meeting, 28 June - 1 July, 2022

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Satellite meetings and virtual events

Advanced Features of NONMEM 7.5 Workshop for PAGE 2022

A one-day NONMEM 7.5 course will be presented by ICON at the PAGE 2022 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.

Date: Monday, 27th June, 2022
Time: 09:00 - 17:00
Location: Ljubljana, Slovenia
Timezone: (GMT +1:00) Central European Time
Presenters: Robert Bauer, PhD
View the Full Agenda
Fees: $500 for Industry, $250 for Academia/Government, $100 for Students
Contact Lisa Wilhelm at: Lisa.Wilhelm@iconplc.com for more information and registration.

An open-source Pharmacometrician’s workflow in R: from exploration (xGx) to model building (nlmixr) and diagnostics (ggPMX)

The nlmixrggPMX and xGx development teams will present a one-day in-person tutorial on three open–source R packages, supporting the pharmacometrics workflow in exploring and modeling clinical data. Covered will be exploration of the data using the Exploratory Graphics (xGx) package; nonlinear mixed-effects population PK and PKPD modeling of the data using nlmixr package, which provides a range of efficient parameter estimation methods; and model building and validation using ggPMX, a library of reproducible diagnostic plots.

During the workshop, participants will have the opportunity to become familiar with the packages with extensive hands-on sessions, which will follow initial lectures on xGx, ggPMX, and nlmixr. First, through a question-based approach, xGx helps to uncover useful insights that can be revealed without complex modelling and to identify aspects of the data that may be explored further. Next, nlmixr is used for building a population model refined by the exploration of the data to characterize the dose-exposure-response relationship. Finally, model evaluation, validation and reporting is driven by ggPMX. Model diagnostic plots help in selecting the model describing the data most accurately.

Date: Tuesday, 28th June, 2022
Time: 08:00 - 17:00
Location: Ljubljana, Slovenia
Timezone: (GMT +1:00) Central European Time
View the Full Agenda
Fees: $150 for industry, $100 for academia/government/non-profit, $50 for Students
Maximum participants: 60
Please visit https://afea.eventsair.com/page2022/novartissatellite to sign up.

Efficient and reproducible non-compartmental analysis in R

IntiQuan will present a 3 hour interactive webinar entitled “Efficient and reproducible non-compartmental analysis in R”. In this workshop, participants will learn to how to conduct non-compartmental analyses (NCA) using the freely available and open source R package IQnca (https://iqnca.intiquan.com/) in a script-based manner. IQnca‘s functionality covers data import from usual sources (ADaM data, WinNonLin inputs datasets), graphical assessment of the data, conducting NCA with various options, and generation of tables, listings, and figures. The functionality will be introduced on slides and illustrated on a case example. During hands-on sessions, the participants have the opportunity to conduct a provided or an own example case under the guidance of the presenter. Basic knowledge of NCA principles and R is of advantage. The webinar is free of charge but registration is needed. Follow this link for details and registration.

Forest plots in practical use: Implementation and interpretation

Interested in communicating the impact of covariates in pharmacometrics models? Join this one day workshop led by Pharmetheus' experts Niclas Jonsson, Ph.D., Joakim Nyberg, Ph.D. on Tuesday 28th June 2022 (09:00-17:00 CEST/GMT+2), in connection to PAGE, in Ljubljana, Slovenia.

  • With this 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, implemented in NONMEM and PsN.
  • 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.

Find more information and register to the workshop here. For questions, contact info@pharmetheus.com.

From PBPK to PBFTPK (physiologically-based finite time pharmacokinetic) models

Athena Research Center is organizing a one-day seminar focusing on physiologically-based pharmacokinetic (PBPK) modeling and the recently developed physiologically-based finite time pharmacokinetic (PBFTPK) models.  There is a great deal of interest on this topic across academia, industry and regulators, as reflected by a new draft guidance by FDA. The program of the seminar and registration details can be found here. To register, please click here.

Introduction to Campsis, an open-source platform to set-up and run PK/PD simulations

Calvagone is running a 1-day hands-on course on Campsis on Tuesday 28th of June 2022.

This course is an opportunity to discover Campsis, a new, intuitive, and open-source platform to set-up and run your model-based PK/PD simulations with ease. Campsis is built on top of the R packages RxODE and mrgsolve, and provides an abstraction layer over the underlying processes of writing a model, assembling a dataset and running a simulation with one of these packages, at the user’s choice.

To begin with, the participants will be trained, through hands-on exercises, on the basic use of Campsis: model implementation from literature, dataset creation based on given protocol, drug formulation and population characteristics and, eventually, the execution of simple PK simulations (typical profile/specific individuals/population). Additional Campsis-specific features like the management of scenarios or the bootstrap of covariates will then also be shown and put into practice.

In the second part,  the training will especially focus on clinical trial simulations and, more specifically the simulation and analysis of clinical endpoints from pharmacodynamic (PD) models. Finally, dose adaptation based on such endpoints will be demonstrated as well through the use of interruption events, another built-in feature in Campsis for stopping/resuming a simulation.

Date: Tuesday, 28th June, 2022
Time: 09:00 - 17:00
Location: Ljubljana, Slovenia
Timezone: (GMT +2:00) Central European Summer Time
Fees:  €250 for industry, €150 for academia/government/non-profit, €100 for students
Maximum participants: 40
Find more information and register for the workshop here. For questions, send an email to contact@calvagone.com.

Lixoft workshops

Lixoft will present a series of satellite workshops this year:

PBPK modelling with the OSPSuite: leveraging in vitro data for MIDD

Interested in PBPK with a focus on both IVIVE for FIH prediction and IVIVC for virtual BE trials?

Join this two day workshop led by Pharmetheus’ experts Marylore Chenel, Ph.D., Erik Sjögren, Assoc. Prof, Ph.D. and Tobias Kanacher, Ph.D., on Monday-Tuesday 27-28th of June 2022 (Starting at 09:00 CEST/GMT+2), in connection to Page in Ljubjlana, Slovenia.

  • With this workshop, you will get an in-depth understanding of PBPK informed drug development with a focus on informing first human PK prediction and Biopharmaceutics.
  • You will also learn how to leverage preclinical in vitro and in vivo data for IVIVE and First In Human (FIH) predictions.
  • Finally you will learn how to leverage in vitro dissolution data for virtual bioequivalence trials.

Find more information and register to the workshop here. For questions, contact info@pharmetheus.com.

OSP-Suite workshop

esqLABS is conducting a FREE 1-day workshop on Tuesday, June 28th, demonstrating the application of PK-Sim and MoBi (OSP-Suite, www.open-systems-pharmacology.org) for use in physiologically-based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) modeling and simulation applications as an in-person & virtual satellite event to the Meeting.

Participants will learn how to integrate qualified compound model templates to evaluate Drug-Drug-Interactions (DDIs) using PK-Sim and how to customize & extend PBPK models to develop PBPK-QSP models.

For more details and free registration, please visit our webshop (https://esqlabs.shop/products/workshop) or contact us via email (info@esqlabs.com).

Pharmacometric Modeling & Simulation with Pumas

June 27-28, 2022

Workshop Faculty from Pumas-AI, Inc.

  • Andreas Noack, PhD
  • Patrick Mogensen, PhD
  • Joga Gobburu, PhD

Pumas is a powerful tool for pharmacometrics work, with the ability to perform all PK & PD activities in one software.

This workshop will provide an overview of the Pumas toolkit and its utility in modern computing. At the end of the workshop, participants will:

  1. Gain an overview of the Pumas modelling ecosystem
  2. Learn how to perform Non-compartmental Analysis in Pumas
  3. Learn how to simulate using non-linear mixed effects models in Pumas
  4. Learn the different estimation methods and perform data analysis using Pumas NLME
  5. Learn how to perform post-processing of results for reporting

Registration and further details are available here.

Pharmacometrics: from here to where? A 1-day Educational Pharmacometrics Summer Symposium

The University of Ljubljana, Faculty of Pharmacy is organising a 1-day Educational Pharmacometrics Summer Symposium titled Pharmacometrics: from here to where? on Tuesday, 28th June 2022. The aim of this symposium is to present an overview of how Pharmacometrics (PMx) can contribute to the drug development and therapy individualisation. With speakers from academia, industry, and regulatory authorities, this event covers a broad range of PMx roles and may also be of use to those looking for the next step in their career development. Topics covered:

  1. Introduction to PMx (basic principles)
  2. The role of PMx in industry to guide drug development (pre-clinical and clinical applications)
  3. The role of PMx in the clinic (therapy personalisation & optimisation)
  4. Direct application of PMx (case-studies)

The symposium is intended for students from all natural sciences (both Master and PhD), postdocs, and others with an interest in pharmacometrics, such as clinical pharmacists, clinicians, mathematicians, statisticians, or colleagues from industry. Students or postdocs/trainees 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 meeting). The participation is free of charge and limited to 100 participants. Light lunch and coffee will be provided. To register please follow this link (open until 5th June). For more information please email us.

If you are interested in organising a satellite meeting, please contact the local organising agency AFEA SA at Pagemeeting2022@afea.gr. Please note that PAGE itself is not involved in organising satellite workshops or booking venues, etc, and satellite meetings cannot be booked through the PAGE website.

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