2016 Lisboa, Portugal

What is PAGE?

1. The Community

PAGE represents a community with a shared interest in data analysis using the population approach. It is a non-profit organisation (company limited by guarantee) with registered office in England and Wales. If you want to be a part of this community then please register by clicking on my profile on your left. If you have entered your personal information before at this web-site but no longer know your password, it can be mailed to you automatically using the my profile link. If you've both changed your e-mail address and do not know your password, please contact Rik Schoemaker (rs@page-meeting.org); do not create a new profile!

2. The Meeting

Each year a meeting is held in June at a different European location. The upcoming meeting will be held in Budapest, Hungary, from 6 to 9 June 2017. Registration will not open until half January 2017, but if you want to be kept informed, update or create your profile (see above).

3. The Online Journal

This web-site is also home of the official online journal PAGE. Abstracts of the Annual Meeting of the Population Approach Group in Europe. ISSN 1871-6032. All the abstracts for the past PAGE meetings can be accessed online through either the search function on the left or by going to the relevant PAGE meeting. Each abstract is formally and uniformly referenced as indicated when viewing the abstract. The web site is maintained by PAGE. Most of the content on this site is contributed by individual authors in the form of abstracts, papers, presentations, posters and so on as submitted for PAGE meetings. As such these materials are copyright of the individual authors or their institutions. Users of this site can search for these materials through the PAGE web site and may view and download them for their own private research or study. If you wish to reuse materials you must first obtain permission from the submitting author, who is linked to the abstract. Please note that no material is subjected to a formal peer review process.

4. The Mobile platform

Abstract-viewer Apps for the upcoming meeting are available for free download in an iPhone and an Android version. Additionally, a mobile version of the PAGE web-site is available at m.page-meeting.org.

5. The PAGE pictures

Pictures of previous PAGE meetings can be found in our Picasa Web Album.
  


Links to other Population Approach Resources

Fellow groups and conferences

ISoP
is the International Society of Pharmacometrics and its mission is the promotion and advancement of the discipline of pharmacometrics, through Integration, Innovation, and Impact: quantitative integration of multisource data and knowledge of clinical, biomedical, biological, engineering, statistical, and mathematical concepts, resulting in continuous methodological and technological innovation enhancing scientific understanding and knowledge, which in turn has an impact on discovery, research, development, approval, and utilization of new therapies.
ACoP
is the American Conference on Pharmacometrics, organized annually by ISoP, and will be held in the Hyatt Bellevue in Bellevue, Washington, from October 23rd to October 26th, 2016.
WCoP
is the second World Conference on Pharmacometrics (WCoP) and will be held in Brisbane, Australia from 21 to 24 August 2016.
PKUK
is a non-profit organisation with annual meetings providing an open forum for discussing all PKPD issues in drug development as well as clinical implications of PKPD studies.
PODE
provides annual workshops on the theory of optimum experimental design for non-linear mixed effects models and its applications in drug development. 
UPSS
is the Uppsala Pharmacometric Summer School intended for PhD students from all around the world. The next edition will be held 8-19 August, 2016 and the topics are PKPD modeling of continuous and categorical data in NONMEM7 and covariate model building. The program includes lectures and hands-on sessions, student group work and presentations. Instructors are Prof. Mats Karlsson and colleagues from the Uppsala Pharmacometric Research Group.

Parameter estimation software

NONMEM® software from ICON Development Solutions

Phoenix NLME™
is Certara's powerful new data processing and modeling software for population PK/PD analysis. Phoenix NLME 1.0 includes flexible tools to create models from an extensive built-in library of models, graphically, or via user-supplied code. Features include graphical workflows that integrate data preparation, model selection and generation of tables and figures, and parallelized model estimation engines designed to take advantage of significant speed gains available on modern computers running multiple processors. Phoenix NLME 1.0 can be optionally configured to connect with a drug development organization's computer grids and clusters.
BUGS
is a general-purpose program for Bayesian statistical analysis. BUGS version 0.6 can handle a wide range of models including linear mixed-effect models. The 1.4 version of WinBUGS is currently available and is capable of fitting non-linear mixed effect models; a specialist Windows interface for PK modelling (PKBUGS) is included.
MONOLIX
is a program that implements the SAEM algorithm for estimation in nonlinear mixed-effects models with several nice new features: library of usual PK and PD models as well as discrete data models, additional graphical output, enhanced interface, handling of measurements below limit of quantification, MLXTRAN language for easy model description, etc. Available as a MATLAB program or as a stand-alone executable version that does not require MATLAB.

Support software

Xpose 4
is a model building aid for population analysis using NONMEM®. Xpose produces various plots and analyses to facilitate data set checkout, goodness-of-fit analysis, model exploration and visualization, model diagnostics, candidate covariate identification and model comparison.  Xpose 4 is written in the programming language R and allows for integration into nearly any model building platform. New functionality in Xpose 4 allows the user to create simulation based reference diagnostics, compute the conditional weighted residuals and modify standard Xpose graphics to create publication quality figures.
Perl-speaks-NONMEM (PsN)
is a collection of Perl modules and programs aiding in the development of non-linear mixed effect models using NONMEM®. The functionality ranges from simpler tasks such as parameter estimate extraction from output files, data file sub setting and resampling, to advanced computer-intensive statistical methods. PsN includes both stand-alone tools as well as development libraries for method developers.
Metrum Institute Open-Source Tools
Metrum Institute, a non-profit organization, develops open-source modeling and simulation software tools as a service to the M&S community. See this link for more information and to download tools such as, NMQual, MIfuns, bugsParallel, bugsPKPDmodelLibrary and SASxport. Metrum Institute also participates in training, education and applied academic M&S research efforts.
Wings for NONMEM
WFN is a set of DOS batch command files and awk scripts to help NONMEM® users be more productive. The first version of WFN (Wheels for NONMEM) was written in 1989 at UC San Francisco. The unix csh and awk scripts evolved and were eventually ported to DOS in order to support NONMEM as part of the RIDO (Right Dose First Time) project.
Census 2
is a comprehensive project manager for NONMEM, providing detailed summary, comparison and overview of the runs comprising a given project, including the display of output data and post-run processing. The new version is a complete rewrite of Census from the ground up. In addition to adding cross-platform support, Census 2 incorporates a number of interface changes, including flexible run tagging and filtering, report output in HTML and LaTeX, a portable database file format, full support for NONMEM 7.2 (including support for multiple estimation steps), and too many others to mention.
Pirana
is a modeling environment for NONMEM and PsN, and provides an easy-to-use toolkit for both novice and advanced modelers. Pirana can be used to run, manage and edit models, interpret output, and manage NONMEM installations. It supports modeling on a local system and on computer clusters, and is easily extendible with custom scripts, and integrates smoothly with R, Xpose, Excel and other software. Pirana supports all NONMEM versions and runs on Windows, Linux and Mac OSX. Pirana is free for academic use, the purchase of a commercial license is required for use in industry and consulting. 
PFIM
is a collection of R functions for population designs evaluation and optimisation. It is based on the expression of the Fisher information matrix in nonlinear mixed effects models. The recent versions are PFIM Interface 2.1, for single response models which includes a graphical user interface, and PFIM 3.0 for multiple response models. Several new features are proposed. A library of usual PK models is available and other models can be written using an analytical form or using a differential equations system. Regarding optimisation, it can be performed using either the Simplex algorithm or the Fedorov-Wynn algorithm.
WinPOPT
is standalone software for the optimal design of population PK and PKPD studies. The software runs on a Windows platform either as standalone or over a network. WinPOPT contains a library of PK models and offers flexibility in the input of user-defined models. Design and technical support are available.
Simcyp (A Certara Company)
is a simulation and data analysis tool for PB-PK-PD applications associated with small and large therapeutic molecules. It offers a database with multiple system parameters related to physiology, biology, genetics and anatomy for specific disease groups and defined age bands in humans and experimental animals. Simcyp is widely used by over 25 leading pharmaceutical companies for model-based drug development; from discovery to late clinical phases. All simulations are stochastic; however either individual or POPPK analyses can be applied for fitting data. The user-friendly interface is designed to facilitate access of various levels of expertise in nonlinear mixed effects approaches.
PK-Sim®
is a unique software tool for whole-body physiologically-based pharmacokinetic (PBPK) modeling and simulation. In particular it allows the straight forward construction of highly specific PK models that may be used to summarize the existing data and to extract the most information out of the experimental results generated thus far.
NIMROD
is a Fortran program  (Normal approximation Inference in Models with Random effects based on Ordinary Differential equations) devoted to the estimation in Ordinary Differential Equations (ODE) models with random effects. Although maximum likelihood based approaches are valuable options, both numerical and identifiability issues favor a Bayesian approach which can incorporate prior knowledge in a flexible way. NIMROD estimations relies on a normal approximation of the posterior that can be obtained by computing the maximum of the posterior distribution (MAP) by maximizing a penalized likelihood. NIMROD can be downloaded freely together with libraries for Pharmacokinetics and HIV models. 
Simulations Plus
is the industry leader in simulation and modeling software and consulting services. GastroPlus™ sets the standard for PBPK/PD modeling for oral (immediate and controlled release formulations), intravenous, ocular, pulmonary, and inhalation delivery in human and animals plus powerful IVIVC, virtual population simulations, and DDI capabilities. DDDPlus™ offers the mechanistic simulation of in vitro dissolution experiments for different dosage forms and media. MembranePlus™ unlocks important information from your in vitro permeability assay studies. And the ADMET Design Suite™, consisting of ADMET Predictor™, MedChem Studio™, and MedChem Designer™, provides chemists with an unprecedented capability to data mine compound libraries, quickly design new molecules, and see how changes in structures affect over 130 ADME-Tox properties from the industry’s #1-ranked QSAR property prediction software. 

Service providers

Certara Strategic Consulting
Now the largest and most comprehensive model-based drug development and strategic pharmacometrics organization, Certara Strategic Consulting brings together the resources of Certara’s leading consulting group, Pharsight Consulting Services (PCS) with scientific powerhouse Quantitative Solutions Inc. The newly formed Certara® Strategic Consulting delivers value by integrating advanced modeling and simulation approaches into the most crucial drug development deliverables—to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience working on thousands of key modeling and simulation projects on behalf of hundreds of biopharm companies, Certara Strategic Consulting brings its track record of success and a broad range of expertise to each assignment. Our team of more than 70 scientists, consultants and industry professionals can strengthen both your pharmacometric capacity and capabilities to quantitatively inform internal decisions and improve the probability of success of regulatory interactions. We can provide you with additional resources and specific expertise to support you along the full value chain from data-management, to analysis and interpretation and subsequent integration in reporting and filings.
ICON 
is committed to providing the most advanced analysis methods and tools for the pharmaceutical industry through continued enhancements to the NONMEM® software, the industry standard for population pharmacokinetic/ pharmacodynamics analysis; ensuring pharmaceutical companies may continue to use this trusted analysis tool, incorporating classical as well as new analysis algorithms for present day pharmaceutical development. In addition, PDx-Pop®, a graphical interface working in concert with NONMEM®, integrates with existing tools and its own automated methods to expedite the population modeling and analysis, providing optimal flexibility and increased efficiency and functionality.
SGS Exprimo NV
is a European consulting company with the emphasis of its activities focussed towards the application of quantitative, model based approaches at all stages of pharmaceutical development. Services offered include pharmacokinetic analysis and reporting, population PK/PD modelling as well as advanced drug-disease modelling and clinical trial simulations. All work is conducted to appropriate GCP or regulatory requirements.
Cognigen Corporation
is the industry leader in pharmacometric analysis. Close collaboration with our clients and a systematic approach to model-based drug development are the foundations of our success. Cognigen’s reputation for excellence stems from our highly experienced interdisciplinary teams, which combine reliability, integrity, and scientific acumen to deliver superior service.
Occams
provides high-quality strategic services to clients in the pharmaceutical industry. We derive our name from the principle known as Occam’s razor: when multiple explanations are equally capable of describing the outcome, the least complex solution is preferred. Make no mistake: we deliver complex state-of-the-art modelling, but our many years of experience in academia, regulatory agencies, industry, at CROs, and in providing consultancy services to the pharmaceutical industry have honed our ability to ask and answer the key questions in drug development clearly and efficiently without being distracted by side issues.
EMF Consulting
is a group of pharmaceutical consultants who provide a wide range of drug development services. We offer consulting as members of a development team, we offer our expertise in the design, conduct, analysis and reporting of studies, we provide data sciences logistics, and write regulatory documents and PKPD modelling training. Since March 2013, EMF Consulting is part of the PhinC Development group.
PhinC Development
is a services company specializing in the early phase development of candidate drugs. It offers two types of research services. The first type is "integrated" operational support for biotech company R&D teams, providing them with all the tools (methodological, scientific and regulatory) to hand to make informed decisions and thereby effectively design their development plan. The second is carrying out statistical and pharmacometrics analyses (MBDD principle, Model-Based Drug Development), with the goal of getting the most from the key development steps and allowing time and money savings.
LAP&P Consultants
provides interdisciplinary support on advanced pharmacokinetic and pharmacodynamic analyses to solve complex problems in preclinical and clinical drug development. LAP&P has a professional infrastructure for advanced PK/PD analyses and reporting for the pharmaceutical industry, based on the most recent developments in academic science. Services include Mixed Effect (population) analysis, Physiologically Based Pharmacokinetic (PB-PK) Modelling, disease progression analysis and clinical trial simulations.
Pharmetheus
offers consulting services with emphasis on the application of pharmacometric approaches to support drug development decisions. The company was founded in 2012 in Uppsala, Sweden, as a spin-off to the Pharmacometrics Research Group at Uppsala University. Pharmetheus provides strategic advice and technical expertise in most therapeutic areas and focuses on delivery of on-time, high quality work according to the latest regulatory guidelines. The team of consultants and advisors, with wide experience in the area of Model Based Drug Development, is dedicated to developing fit-for-purpose models and analyses to answer the research questions of our clients.
Mango Solutions Ltd
is a UK based data analysis company.  Operating globally, we assist our customers in a number of different markets by delivering high performance data analysis solutions. Mango Solutions can help you to embed the power of sometimes complex statistical analysis directly into the decision making process; turning data into powerful information to support business decisions and putting powerful analysis tools into the hands of end users. Working professionally and effectively, we are happy to engage in a variety of work- from data analysis training to application development - meeting your specific needs. 
The Laboratory of Applied Pharmacokinetics and Bioinformatics (LAPKB)
is a pharmacometric resource for optimal study and control of pharmacokinetic/pharmacodynamic systems and for individualized drug therapy and personalized medicine. Our research activities include: application of stochastic control theory to the design of optimal dosage regimens; improved methods for population pharmacokinetic modeling; investigation of process and measurement noise in the clinical environment; evaluation of alternative parameterizations of pharmacokinetic models; optimal monitoring strategies for pharmacokinetic studies, and clinical trials. We produce two freely available software tools: 1) Pmetrics - a non-parametric and parametric population modeling and simulation package for R; 2) BestDose - a Windows executable program for multiple-model Bayesian adaptive control of individual patient therapeutic drug dosing to achieve target concentrations with maximum accuracy and precision. An R package for BestDose is available by special request.
Metrum Research Group LLC
provides contract services aimed at enhancing biomedical R&D through quantitative modeling and simulation. Our collaborations with pharma/biotech industries are characterized by cutting-edge science, transfer of knowledge, quality deliverables and innovative, strategic application of M&S technologies. MetrumRG employs a full-time scientific staff with extensive experience in quantitative M&S. Our work is performed in and managed under quality assurance systems and our secured, managed computing infrastructure provides continuous and robust support for critical client projects.
Accelrys
develops and commercialises scientific business intelligence software and solutions that help accelerate science for clients in the Life Sciences, Energy, Chemicals, Aerospace, and Consumer Packaged Goods industries. Our solutions are used by biologists, chemists, materials scientists, IT and business professionals to aggregate, analyse, simulate, and visualise scientific data.  Our scientifically aware platform and predictive science tools help clients conduct experiments in-silico, make informed decisions, and reduce times for product development.
Arlenda
is a consulting company specialized in Applied “Modeling and Statistics” for translational sciences and Model-based Drug Development. With experts in pharmacokinetics and (Bayesian) statistics, it allows to make optimal use of PK-PD models to design and analyse clinical trials in early phases. Arlenda offers an integrated suite of services including statistical and PK analyses and reporting, TFLs production, SAP, DAP and PIP writing,  clinical trials predictions, adaptive design set up and conduct in accordance with GCP requirements.
DruDevO
With 20+ years of experience in modeling and simulation we specialize in consultancy for DRUg DEVelopment Optimization using M&S methods. Based on the experience in this field we have also developed a time saving NONMEM interface which also links Windows to Linux/Mosix systems. We comply with GCP and 21 CRF 11 guidelines.
Next Level Solutions
is a consulting company focusing on rapid turnaround population pk/pd analysis. We apply proprietary methods and high performance computing to standard population pk/pd software resulting in more robust solutions on a shorter timeline.
QuantPharm LLC
is a consulting company located in Maryland, US. It specializes in development and application of advanced mathematical modeling, simulation, and data mining methods to support pharmaceutical and biotechnology industries. QuantPharmTM offers fast, efficient and high quality population analysis of pharmacokinetic and pharmacodynamic data and model-based clinical trial simulations to support all stages of drug development, from pre-clinical to Phase IV.
Cellular Statistics, LLC
Tools and services in algebraic statistics and logic for  pharmacometrics applications.
Probayes
provide ProBT© which is a powerful modeling, inference, and learning platform inheriting 10 years of experience in the domain of Bayesian probabilistic computing, and ProBT-XL which makes Bayesian models prototyping and testing easier and quicker. It provides a Microsoft Excel graphical user interface to ProBT. Use it to design Bayesian networks while taking advantage of the worksheet environment and the Bayesian programming approach.
PRI
provides a wide range of Study Design (D-optimization), Pharmacokinetic, Pharmacodynamic, and Pharmacometric services performed by internationally recognized experts with experience working within industry, academia, and FDA. The PRI team analyzes clinical trial data and provides clear concise reports allowing faster, better informed decision-making during the drug development process and ensuring fewer queries during the regulatory review process.
qPharmetra
provides efficient, effective, and decision-focused pharmacometric consulting services to Pharma and Biotechnology organizations. Our experienced, senior modeling team performs a comprehensive range of analyses in support of all phases of drug development, including population PK, PK/PD, clinical trial simulation, clinical utility analysis and reporting. Further, we have standardized and automated our work processes from initial project preparation through final project documentation. The result: efficiently generated reports and presentations providing clear guidance to internal and external stakeholders in the drug development process.
Ann Arbor Pharmacometrics Group (A2PG)
is a functional service provider specializing in model-based drug development consulting for the pharmaceutical industry. Our consulting services include population pharmacokinetic and pharmacodynamic (pop PK/PD) modeling, and model-based clinical trial simulations to support trial designs, program strategy and decision-making. 
Shafi Consultancy Ltd
is a SAS programming group specialising in producing NONMEM ready files using raw data from clinical trial databases. We have 10 years of experience in producing datasets both for PK/PD analysis and for analysis using NONMEM. Using our extensive expertise, client specific standard process are established to handle missing and dirty data, to merge different types of covariates and to produce traceability and summary tables. This ensures datasets can be produced quickly and consistently in a timely manner for analysis.
Model Answers
is a well established pharmacometric consulting company that provides services to a global client network. The team delivers a range of highly innovative solutions with an emphasis on quality, transparency and reproducibility. With live project mapping, interim results management, sophisticated operating procedures and reporting systems, clients can trust Model Answers to deliver a superior product on time.
BAST Inc Limited
is a consulting business that was founded in 1991 with the purpose to provide population PK analysis to the pharmaceutical industry. We have widened our services considerably since 2010. Now we offer, in addition to standard popPKPD services, risk and utility assessments through mechanistic modelling. Our quantitative decision support adds value to projects of biotech companies in search of additional venture capital.
Dynakin
is the sole one-stop integral provider of support in drug development, in-house, from GLP biolab to M&S pivotal strategic consulting and from GCP clinical trial to regulatory application all driven by a MBDD translational method. Dynakin’s M&S expertise applies industry standard M&S and metadata analysis within a strictly “Good Modeling Practices” environment of custom scripting and traceability. Dynakin presented the first model based PIP (EMA) and continues to participate in numerous projects for its customers faced with agencies around the world, including most of Europe, the FDA and Japan. The company also integrates a grounds up scientific software development department with a main product line of maximum likelihood and Bayesian modeling software, DynaPred®. Through its offices in Spain, Canada, France and the US, Dynakin successfully addresses complex tight timeline projects.
Kinesis Pharma
aims to facilitate a fast and high quality development and registration process for medicinal products through consultancy and contract research services. Kinesis’ PK/PD modeling services include: exploratory analysis for instant decision-making (e.g. dose selection and trial design), meta-analysis and model-based extrapolations. Model based extrapolations include animal to human or adult to paediatric extrapolations for dose selection and answering “What if” questions. At Kinesis-Pharma the model is not a goal in itself, but a tool to provide the answers you seek.
Alleantis
is the business development unit of a network of companies and we offer to our clients the expertise of highly specialized drug development scientists, pharmacometricians, modelers and imaging experts across various drug development stages by applying a Model-Based approach to support rational and effective drug development.
PharmacoMetrica
is a global pharmacometrics consulting company. We develop and apply a Model Based Drug Development approach to address key and strategic questions in drug development such as the evaluation of exposure-response, dose selection, trial design, in-licensing drug evaluation, disease progression, model-based meta-analysis of therapeutic area data, physiologically-based modeling and clinical trial simulation to support decision making and trial design evaluation.
Improve - Modeling and simulation platform
The main concept behind Improve is to cover control and traceability over your complete modeling and simulation workflow while retaining the simplicity and ease of use of a standard file explorer. No matter which analysis, from noncompartmental to multicompartmental models, you choose, Improve will keep track of the "who what when where and why" of your data, while you are completely free to make decisions for the analysis you want to perform and which actions you want to take within your 3rd party tool of choice. In one sentence: Whatever you perform with your data, Improve will help you to keep track of your files AND your decisions.
LYO-X
is a consulting and service company specialised in Systems Pharmacology. Our unique focus is the preclinical and clinical development of biologics. We have extensive experience in all development aspects which are unique to this class of drugs, such as PK/PD properties, target mediated disposition, optimal dose and regimen selection, MABEL and first in human dose selection. Supported formats include mAb, Fab, scFv, bi-specifics, ADC, fusion proteins, siRNA and cell based therapies. Our customers are both global pharmaceutical companies and small biotechnology companies working with highly innovative products. LYO-X is part of the Integrated Biologix (iBx) Network, a strategic partnership with Integrated Biologix Gmbh and KinDyn Consulting Ltd. The iBx Network has senior experts dedicated to biologics modelling, preclinical toxicology, assay development, PK/PD interpretation and clinical pharmacology.
Rudraya
is a Scientific Platform and Information Technology Service provider to Pharmaceutical, Biotechnology, and Healthcare organizations with core focus on High Performance Computing Platform (local or cloud based) and Clinical Outcomes Databases Platform (KEEP - Knowledge Enhancing and Enabling Platform). Rudraya is strategically located in both the US (New Jersey and Boston) and Europe (Basel) to provide services and support to global clients. Rudraya’s cloud based, regulatory compliant, and validated computing platform provides economical, flexible, and agile environment for Pharmacometrics, Genomics, Biostatistics, and Translational Medicine needs. Rudraya’s KEEP Enterprise aims to integrate and enhance clinical knowledge and enable model-based meta-analysis (MBMA) by providing the capability to quickly and securely access, share, explore, and analyze comprehensive, integrated, up-to-date clinical efficacy and safety data.

Various

A web animation
developed by Inria about the Population Approach is now available online. The objective of this animation is to explain that this approach is relevant in many fields (biology, agronomy, toxicology, pharmacology,…) and to show an application in PK modelling in a little more detail.
EMEA
The European Agency for the Evaluation of Medicinal Products.
PopDesign
is an e-mail list server for questions and comments about the design of population PK and PKPD studies. The PopDesign mailing list would be an appropriate place to ask questions and post comments about the design of any study for which nonlinear mixed effects modelling is the proposed analysis tool. Members of the list includes those who have developed nonlinear mixed effects models design software: PFIM, PFIM_OPT, PkStamp, PopDes, PopED, POPT, WinPOPT.
WikiPopix
is wiki dedicated to mixed effects models for the population approach.
Pharmacokinetic Resources
maintained by David Bourne, OUHSC College of Pharmacy. The purpose of this page is to provide links to information about the discipline of Pharmacokinetics.

Please send comments to Rik Schoemaker (rs@page-meeting.org)