2023 - A Coruña - Spain

2023 - A Coruña - Spain

Thirty-first meeting, 27-30 June, 2023

Register/submit abstract

Satellite meetings and virtual events

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, Anna Largajolli, S.Y. Amy Cheung, Nele Mueller-Plock
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 (V2ACHERa) 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 VACHETTEb, 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.

Register here. For further questions, feel free to reach out to Certara University (info@certarauniversity.com).

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.

Register here. For further questions, feel free to reach out to Certara University (info@certarauniversity.com).

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

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

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

Register here

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

Register Here

Top