Thursday, 2 April 2020
An Intensive 3-day Workshop on Model-informed Drug Development
Certara-Simcyp Hands-on Workshop
Sponsored by Certara UK Ltd, Simcyp Division and co-hosted by Pharmacometrics Africa, NPC
Dr Masoud Jamei, Dr 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 modeling, 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.
Saturday, 4 April 2020
A 2-Day Introductory Workshop In Population PK Data Analysis With NONMEM®
Joel S. Owen, PhD, Cognigen Corporation, a Simulations Plus Company and Union University, College of Pharmacy, Jackson, TN
Aksana Jones, MS, Cognigen Corporation, a Simulations Plus Company
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.
Role of Model Informed Drug Development (MIDD) in regulatory science
Sponsored by Critical Path Institute and co-hosted by Pharmacometrics Africa, NPC
Klaus Romero, Jagdeep Podichetty, and Jackson Burton, Critical Path Institute
The goal of this pre-conference session is to expose the audience to various MIDD methodologies and associated drug development case studies in regulatory setting. The speakers would focus on the intersection between the fields of MIDD and regulatory science. The discussion would also involve regulatory pathways for the review and endorsement of quantitative drug development platforms. The speakers would cover several state-of-the-art methodologies for MIDD, with a regulatory science focus. To provide more context to the real-world application of MIDD, speakers would provide case studies and live demos.
Sunday, 5 April 2020
2-day workshop – Pharmacometric modelling & simulation with Pumas.jl
Sponsored by University of Maryland School of Pharmacy and co-hosted by Pharmacometrics Africa, NPC
Vijay Ivaturi and 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.
Modelling delays in pharmacokinetics and pharmacodynamics using using NONMEM®
Sponsored by University of Buffalo, USA and co-hosted by Pharmacometrics Africa, NPC
Wojciech Krzyzanski, PhD, University at Buffalo
Gilbert Koch, PhD, University Children´s Hospital in Basel Switzerland.
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 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.
PKPD modeling of large molecules (biologics and biosimilars)
Sponsored by Eli Lilly & Company, GlaxoSmithKline and co-hosted by Pharmacometrics Africa, NPC
Dr Chiara Zecchin, GlaxoSmithKline
Dr. Nieves Velez de Mendizabal, Eli Lilly and Company
Dr Emmanuel Chigutsa, Eli Lilly and Company
The purpose of the workshop is to equip attendees with the theoretical and practical aspects for modeling monoclonal antibodies (mAbs), bi-specific antibodies and biosimilars. The focus would be pharmacokinetics of mAbs and bi-specific antibodies including minimal PBPK modeling, target mediated drug disposition (TMDD), extrapolation of cell-surface receptor occupancy and immunogenicity. The schedule would be short lectures followed by hands-on modeling 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.
Monday, 6 April 2020
Hands-on Pharmacometric Design and Power Analysis for Clinical Trials
Sponsored by Radboudumc Applied Pharmacometrics and co-hosted by Pharmacometrics Africa, NPC
Rob ter Heine, Elin Svensson, Stijn van Beek, and 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.
Open source PBPK modelling with the OSPSuite (PK-Sim® & MoBi®) for MIDD
Sponsored by Pharmetheus and co-hosted by Pharmacometrics Africa, NPC
Erik Sjögren, Pharmetheus, Uppsala, Sweden and 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.
Interactive and animated web graphics in Pharmacometrics
Sponsored by Certara and co-hosted by Pharmacometrics Africa, NPC
Samer Mouksassi, Certara, Université de Montréal, Lebanese American University
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.
Population PKPD modelling in R
Sponsored by IntiQuan GmbH and co-hosted by Pharmacometrics Africa, NPC
Anne Kümmel, Affiliations: 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
An open-source Pharmacometrics’s workflow in R: from exploration (xGx) to model building (nlmixr) and diagnostics (ggPMX)
Sponsored by Novartis and co-hosted by Pharmacometrics Africa, NPC
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 modeling clinical data:
- Exploration of the data using the Exploratory Graphics (xGx) package, available on GitHub (https://opensource.nibr.com/xgx/).
- Population PK and PKPD modeling 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 modeling community the opportunity to reduce the learning curve needed to become proficient on each of the different tasks using a stepwise framework.