What is PAGE?

We represent a community with a shared interest in data analysis using the population approach.

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 Clinical Research LLC 
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.
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.
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.
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.
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.
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.
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.
Calvagone
A new name with familiar faces. At Calvagone we provide model-based consulting services with the aim to quantify drug, disease and trial information and to aid clients in efficient drug development and regulatory decisions. Our team consists of consultants with a wide experience in programming, mathematics, pharmacology, pharmacometrics and drug development, and a strong commitment to support clients at each step of the drug development process with a fitted and timely approach that will address key development questions and result in an optimal understanding of clinical trial results.
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.
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.
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.
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.
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.
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.
PD-value
specializes in translational PK-PD services. PD-values believe in getting more value out of your data using biomarkers, the value of PD. With more 15+ years of experience in both research/discovery and clinical development teams, from lead finding to registration, an unique perspective is offered in terms of modeling and simulation technical expertise, but also in strategic development consultancy. Clinical and research activities are supported by translation from animal to man, and from healthy to diseased, with a focus an integrated decision making and always with an eye for adding value to your projects!
Vantage Research
provides Quantitative Systems Pharmacology (QSP) Consulting and Services. With a multidisciplinary scientific staff comprising of model development engineers, and biologists with deep experience in the life sciences areas, Vantage caters to BioPharma R&D teams that look for model informed decision making approaches to take critical decisions at various stages of drug development lifecycle. We are proudly associated with several global BioPharma companies, spanning a variety of therapeutic areas including Diabetes, Immuno-Oncology, AutoImmune Disorders, Hypertension, Anaemia, Sepsis and Opthalmology.
InSysBio
is one of the pioneers in Quantitative System Pharmacology (QSP) modeling for drug research and development and has been working on the market for more than 10 years. Our team continuously improves methods and tools for biological modeling and develops QSP platforms and software. Innovative approach applied by InSysBio has already become a part of the drug development process implemented by our strategic partners. Nowadays there are more than 100 completed projects in collaboration with leaders of pharmaceutical industry in various therapeutic areas including Immuno-Oncology, Neuroscience, Inflammation and Immunology, Diabetes, Cardiovascular, Renal and Metabolic diseases.
IntiQuan
is a consulting company providing services and solutions for impactful model-informed drug development. We partner with pharmacometrics organizations, biotechs and investors to extend their resources, provide quantitative expertise and leverage the power of data for better decision making. We are proactive about improving the efficiency and quality of daily scientific work, and we share our solutions with customers and the community. Our clients tell us that they appreciate how our deliverables are self-sufficient, fully reproducible and performed in the most efficient manner. Our team has an extensive experience from big pharma, biotechs and academia, and strong technical background in pharmacometrics, general modeling & simulation, systems biology, medicine and physics.
esqLABS
is a CRO providing consulting for physiologically-based pharmacokinetics/pharmacodynamics (PBPK/PD) modeling and simulation with, and contract software development for, the Open Systems Pharmacology Suite (OSP Suite with PK-Sim® and MoBi®). esqLABS is an active member and strong supporter of the OSP community. The esqLABS portfolio includes standard PBPK applications, development of sophisticated Quantitative Systems Pharmacology disease platforms (e.g. the Diabetes Platform), and training on PBPK and QSP with the OSP Suite.
Rosa & Co. LLC
Drug development research using customized, focused drug-disease simulation platforms (PhysioPD™ Research). This research complements the expertise and experience of researchers and clinicians, guides more effective experimental and trial design, and enables deeper understanding of empirical data. PhysioPD Research enables dramatically more effective learning about the connection of drug and disease mechanisms to relevant preclinical and clinical outcomes and supports more confident decisions at all stages in research and development.
Parexel
offers wide expertise in clinical PK/PD, pharmacometrics, and model-informed drug discovery and development (MID3) across all clinical phases from translational sciences for First- Time-in-Human (FTIH) studies to marketed products. Parexel pharmacometricians and clinical pharmacologists who are based around the world offer seamless integration of services across numerous therapeutic indications, and provide expertise in the strategic implementation of modeling & simulation services to driving drug development decision-making. These offerings allow our experts to help clients to optimize the time and cost of bringing drugs to market. We are committed to delivering the highest quality service and meeting all aspects of regulatory compliance.

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)

Top