Thursday, 2 April 2020
An Intensive 3-day Workshop on Model-informed Drug Development
Certara-Simcyp Hands-on Workshop
Masoud Jamei, Mano Chetty, Certara UK Ltd, Simcyp Division
This tailored workshop on in vitro-in vivo extrapolation of metabolism, transport, and biopharmaceutics includes hands-on exercises using the industry standard Simcyp Population-based Simulator for PBPK modelling, formulation development, and DDI predictions. This workshop is intended for scientists working in discovery DMPK, metabolism, transporters, DDI, and formulation development areas of research.
Model-informed drug development has been identified by the FDA as a valuable tool to improve efficiency in drug development and tackle high costs and low success rates . Therefore, this workshop is relevant to students, scientists and managers working in the fields of drug metabolism, ADME, clinical pharmacology, pharmacokinetics, PBPK and PK/PD, in industry, regulatory bodies and research institutes. The course provides a solid grounding in model-informed approaches and is not aimed solely at individuals who have hands-on experience.
The Simcyp Simulator is freely available to approved academic institutions and other not for -profit organizations for research and teaching purposes. Attending this event satisfies the workshop attendance condition of the Simcyp academic licences.
Students £50 / R1000
Academia/Government/Non-profit £150 / R3000
Industry £260 / R5000
Saturday, 4 April 2020
A 2-Day Introductory Workshop In Population PK Data Analysis With NONMEM®
Joel S. Owen, Cognigen Corporation, a Simulations Plus Company and Union University, College of Pharmacy, Jackson, TN
Aksana Jones, Cognigen Corporation, a Simulations Plus Company
Kayla Andrews, Gates Medical Research Institute
This introductory population PK training workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program and to provide the foundation for understanding the basics of NONMEM coding and interpretation of NONMEM output. Participants will gain an appreciation for the essentials of accurate and sufficient data collection and learn how to proactively plan in order to maximize study effectiveness. The KIWI™ Pharmacometric Communication Platform will be used in conjunction with NONMEM to facilitate code writing, finding errors, comparing output from different models, and generating point-and-click model diagnostics.
$1200 / R18000 (Commercial and industry)
$600 / R9000 (Government and Academia)
$50 / R800 (Students)
15 Seats will be reserved until February 28, 2020 for tuition waivers for participants from low and middle income countries.
Sunday, 5 April 2020
2-day workshop – Pharmacometric modelling & simulation with Pumas.jl
Vijay Ivaturi, University of Maryland School of Pharmacy
Joga Gobburu, University of Maryland School of Pharmacy
Pharmaceutical Modelling and Simulation (Pumas) is a domain-specific extension of the Julia differential equation solver libraries for performing analyses of pharmacometric models. We will start by showing users how to implement PK/PD models with complex dosing schedules and incorporating population models. Then we will turn to the process of estimating population parameters from data. Next, the capability of Pumas to perform common pre-clinical and clinical data analytics work flows such as Non-compartmental analysis (NCA), In vitro- in vivo correlation (IVIVC), Bio-equivalence (BE) and Clinical Trial Design (CTS) will be introduced. This workshop will be a mix of demonstration and hands-on work where participants will be able to download the Pumas software and perform the analysis in real-time. At the end of the workshop, participants will have an overview of the Pumas toolkit and its utility in modern age computing.
$25 / R400
Modelling delays in pharmacokinetics and pharmacodynamics using NONMEM®
Wojciech Krzyzanski, University at Buffalo
Gilbert Koch, University Children´s Hospital in Basel Switzerland
The course will provide an overview of biological systems exhibiting delays, concepts of lifespan driven pharmacodynamic response, modelling of cell maturation, transduction delays, and nonlinear mixed effect lifespan models. Delay differential equations (DDEs) will be introduced and implemented in NONMEM pre-release version 7.5. The course will consist of both lectures and hands-on computer exercises. Source code for DDE based PK/PD models and data will be provided to the participants.
$200 / R3000 (regular)
$100 / R1500 (academia/government)
$50 / R800 (students)
PKPD modelling of large molecules (biologics and biosimilars)
Chiara Zecchin, GlaxoSmithKline
Nieves Velez de Mendizabal, Eli Lilly and Company
Emmanuel Chigutsa, Eli Lilly and Company
The purpose of the workshop is to equip attendees with the theoretical and practical aspects for modelling monoclonal antibodies (mAbs), bi-specific antibodies and biosimilars. The focus would be pharmacokinetics of mAbs and bi-specific antibodies including minimal PBPK modelling, target mediated drug disposition (TMDD), extrapolation of cell-surface receptor occupancy and immunogenicity. The schedule would be short lectures followed by hands-on modelling and simulation exercises. Participants will be given NONMEM control streams and test datasets to use as a basis for future practical implementation. Basic knowledge of NONMEM and general PKPD principles will be assumed.
$25 / R400
Monday, 6 April 2020
Hands-on Pharmacometric Design and Power Analysis for Clinical Trials
Rob ter Heine, Elin Svensson, Stijn van Beek
Vera Bukkems, Radboud Institute for Health Sciences, Radboud University Medical Center
The objective of the course is to provide tools enabling the design of adequately powered studied aimed for model-based analysis. There will be lectures and hands-on examples using stochastic simulation and estimation as well as monte carlo mapped power procedures for power and sample size calculations in clinical trials. The workshop has been given three times earlier in Nijmegen, the Netherlands with very positive response from participants.
$150 / R2250 – Participants from non LMIC
$25 / R400 – Participants from LMIC
Open source PBPK modelling with the OSPSuite (PK-Sim® & MoBi®) for MIDD
Erik Sjögren, Pharmetheus, Uppsala, Sweden
Tobias Kanacher, Pharmetheus, Hagnau, Germany
The workshop will feature PBPK modelling with the Open Systems Pharmacology suite (OSPS) also known as PK-Sim® and MoBi®. The goals are:
- Getting an introduction to the open source PBPK software PK-Sim® & MoBi® and it’s use for small molecule for investigations in clinical drug development.
- Learn how to do age dependent extrapolation with PBPK models (very young or very old populations).
- Learn how to model complex DDIs.
$25 / R400
Interactive and animated web graphics in Pharmacometrics
Samer Mouksassi, Certara, Université de Montréal, Lebanese American University
Merck Sharp & Dohme, USA
Interactive R Shiny web apps are now part of our standard pharmacometrics communication and reporting efforts. These web apps can be even more effective when we leverage modern web tools built to enable mouse hover actions, automatic resizing, on-demand details, stop-play animations and more. This tutorial will focus on modern web graphics tools like plotly, rbokeh, trelliscopejs for effective and fluid communication. Examples using gganimate (gifs) that communicate uncertainty, hypothetical outcome plots, and dynamic prediction of survival will be illustrated. The attendees will leave with a battery of scripts and tools that transform bring static plots into life.
$25 / R400
Population PKPD modelling in R
Anne Kümmel, IntiQuan GmbH
IntiQuan is running a full day hands-on workshop on NLME modelling workflow from data exploration, parameter estimation, and reporting in the R environment using our IQR Tools R package. The major topics covered are:
- Data exploration with graphs and summary tables
- Defining structural model and parameter estimation settings (including IIV/BSV, covariance, and covariate models)
- NLME parameter estimation in NONMEM, MONOLIX, and NLMIXR
- Model evaluation based on goodness-of-fit plots and VPCs
- Model simulation
Standard: €500 / R7850
Government and Academia: €300 / R4700
Students: €100 / R1560
An open-source Pharmacometrics’s workflow in R: from exploration (xGx) to model building (nlmixr) and diagnostics (ggPMX)
Workshop target audience:
Pharmacometricians/modelers with basic knowledge on model building, evaluation and qualification. Basic knowledge of writing, executing R scripts is advantageous.
Fariba Khanshan, Novartis Pharmacometrics, Cambridge, USA
Matt Fidler, Novartis Pharmacometrics, Fort Worth, USA
Irina Baltcheva, Novartis Pharmacometrics, Basel, Switzerland
The workshop will provide a tutorial on three open–source R packages currently under development at Novartis, supporting the pharmacometrics workflow in exploring and modelling clinical data:
- Exploration of the data using the Exploratory Graphics (xGx) package, available on GitHub (https://opensource.nibr.com/xgx/).
- Population PK and PKPD modelling of the data using nlmixr (www.nlmixr.org). nlmixr builds on the ODE solving in the RxODE package, by implementing parameter estimation algorithms like nlme, SAEM and FOCE with interaction.
- Model building and validation using ggPMX, a library of reproducible diagnostic plots available on CRAN and on Github (https://github.com/ggPMXdevelopment/ggPMX).
The combination of the three open-source R packages provides the pharmacometrics modelling community the opportunity to reduce the learning curve needed to become proficient on each of the different tasks using a stepwise framework.
$25 / R400