Exhibitors

ACoP 2009 Exhibitors

The AEgis Technologies Group

acslX is used in a diverse range of applications in biological modeling including: classical compartmental PK/PD, physiologically-based PK, population PK/PD, disease modeling, systems biology, virtual tissues and organs, and IVIVC.

acslX is intuitive

  • Models are constructed using either a simple equation-based language, or by composing models diagrammatically using "blocks" of pre-built model components
  • Parameter estimation, sensitivity analysis, and Monte Carlo analysis studies are designed using a simple wizard-based user interface
  • Scripts for controlling simulation runs and performing complex analyses can also be created using a Matlab-like scripting language
  • Models can be constructed using the PBPK/PK/PD toolkit of pre-built simulation blocks, and an SBML import utility is provided for automatically generating acslX models from SBML

acslX is flexible

  • acslX supports a wide range of robust algorithms for the numerical solution of ordinary differential equations, differential algebraic equations, delay differential equations, and discrete event behavior
  • Analyses include a robust parameter estimation engine supporting maximum likelihood and nonlinear weighted least-squares techniques; global and local sensitivity analysis; conventional Monte Carlo analyses; and a statistical modeling language for user-defined Bayesian inference studies
  • acslX models can be executed and analyzed in a variety of environments, including acslX itself, Microsoft Excel, Mathwork's Simulink/Matlab, and the freely available acslX Calc. Data import/export from Microsoft Access and Excel is easily performed

acslX is fast

  • Models are compiled into executable binary code ensuring the fastest possible performance and support for extremely large or complex models
  • Cluster computing extensions are provided to parallelize analyses in acslX, and cloud-hosted versions of acslX applications are available

acslX is open

  • Models supplied with acslX are open and transparent, meaning the model code can be inspected and modified
  • Many of the analyses used in acslX are implemented as M scripts, which can also be inspected and modified by end-users
  • Open software interfaces are provided throughout the system for extending the capabilities of the acslX environment in a variety of ways

acslX is affordable

  • Licenses for acslX start at $500
  • The acslX Calc application for running and analyzing simulations created in acslX is freely downloadable and redistributable
  • Corporate site licenses start at $7500
  • acslX is completely free for educational use

For over 30 years, acslX and its predecessor ACSL have provided scientists and engineers with a powerful and flexible software environment for modeling, simulation and analysis of complex nonlinear biological systems and data.

More information about acslX is available at www.acslX.com, 800-647-ACSL or [email protected].

Bayer Technology Services relies on mechanistic modeling of biological systems and their interaction with pharmaceuticals to gain comprehensive understanding of complex dynamical processes involved and, thus, to support decision making along the pharma research and development process.

Bayer Technology Services offers software products for predictive simulation of drug behavior and modeling of cellular pathways as well as professional consulting services, integrating many years of in-house and external market experience.

The Bayer Technology Services software products are fully integrated into one Computational Systems Biology Software Suite (CoSBiSS), which represents a user-friendly and flexible software package for mechanistic modeling and simulation in pharma research and drug development:

  • PK-Sim® The comprehensive software tool for whole-body physiologically based pharmacokinetic modeling.
  • MoBi® The systems biology software tool for multiscale physiological modeling and simulation.
  • MoBi® Toolbox for MATLAB® The advanced tool integrating multiscale physiological modeling and simulation with technical computing.
  • MoBi® Toolbox for R The advanced tool integrating multiscale physiological modeling and simulation with statistical computing.

Bayer Technology Services efficiently executes application projects in pharma research and life sciences due to its unique software platform and its broad experience gained in more than 100 application projects executed in following areas:

Drug Discovery Support

  • Target Identification & Validation
  • Biomarker Analysis
  • Proof-of-Mechanism

Drug Development Support

  • Species Extrapolation
  • Extrapolation to Special Populations
  • Proof-of-Concept
  • Bioequivalence Studies

www.systems-biology.com
[email protected]

Entelos (www.entelos.com) PhysioLab® platforms enable modelers to manage what is quantitatively known and unknown about disease processes, PK/PD, and patient responses to standard and novel treatment combinations, to better inform decision-makers through the robust prediction of clinical outcomes. Our cross-disciplinary teams of Ph.D. scientists and engineers use state-of-the-art PhysioLab technology to conduct in silico R&D in collaboration with our clients' clinical, pharmacometric, and preclinical experts.

Entelos has helped its pharmaceutical partners to:

  • Save time and reduce patient requirements for clinical trials
  • Determine the optimal dose for a clinical trial
  • Compare efficacy of new compounds and combinations to standards of care
  • Advance complex clinical strategies to meet efficacy, regulatory, and marketing requirements
  • Identify compound/target advantages to support competitive differentiation claims
  • Discover novel biomarker panels
  • Translate results from preclinical experiments to clinical studies and results

Key features of the PhysioLab platforms and software tools include:

Virtual Patients and Populations are a key part of the PhysioLab technology, enabling the exploration of the full range of patient variability and alternate mechanistic hypotheses all layered on top of the core PhysioLab model. Virtual populations are designed to mirror real clinical populations and are then utilized for running simulated clinical trials and biomarker analyses.

Parameter and Simulation Management is optimized for efficiency in the software thus enabling high throughput and batch simulation runs for evaluation of variant PK, uncertainty in pharmacodynamics, and population variation. The results are stored in an Oracle® database and can be exported for analysis in other tools (e.g., Microsoft® Excel®, SAS®, Spotfire®) and an API enables interfacing with MATLAB and custom scripting.

Integrated Documentation allows data, modeling rationale, and parameter value sources to be annotated within the model and shared between users. This capability supports a corporate knowledge base by providing a knowledge management platform, as well as a learning tool for new users.

PhysioLab platforms are available in the following areas:

  • Cardiovascular - Atherosclerosis, Cholesterol, Hypertension/RAAS
  • Metabolism - Type 2 Diabetes, Obesity
  • Respiratory - Asthma
  • Autoimmune - Rheumatoid Arthritis, Type 1 Diabetes
  • Hematopoiesis - Anemia
  • Skin Sensitization

GVK Biosciences, Asia's leading Contract Research Organization, delivers customized innovative and value added services with speed and quality to leading Pharma, biotech and other companies in the area of Life Sciences.

In order to increase the success rate in Clinical Studies, a number of novel and innovative approaches such as PK/PD modeling of clinical data or the usage of Biomarkers are being followed in the recent past. GVK BIO has been offering customized services in both these areas. We have a unique Clinical Biomarker online database (www.gobiomdb.com). In PK/PD modeling and Simulation studies we offer manually curated Clinical Pharmacology databases for a number of Therapeutic areas/indications. These databases and associated custom curation process offer:

  • Predictive modeling tools provide invaluable information to better streamline the drug development process
  • Modeling approaches prove useful in determining relationships between biomarker responses, drug levels, and dosing regimens of new drugs faster and at a lower cost.
  • We build and maintain indication specific clinical trial outcome databases to support simulation and modeling efforts

GVK BIO provides premier quality customized services that are regarded by our clients as highly effective.

Novartis accredits "The partnership with GVK Bio for data extraction and populating the spreadsheet has been established and has proved very effective" - Population Approach Group Europe (PAGE), June 23-26, 2009.

GVK BIO has also partnered with Quantitative Solutions, a modeling and simulation consultancy to the pharmaceutical and biotech industry, to market the existing QS clinical outcomes databases and to develop/market additional databases in high value disease areas.

  • The databases capture summary level data for the clinical safety and efficacy outcomes from publicly available data sources. Models derived from them can be used to characterize the probability distribution of clinical efficacy and tolerability as a function of various treatment and patient factors.
  • The databases can help companies conduct comparative efficacy and safety analysis, link/scale biomarkers to clinical outcomes, predict/improve trial outcome, and develop product differentiation strategies.
  • The databases are supported by customization and M&S consulting services provided by GVK Bio and QS, respectively, to ensure maximum flexibility and benefits to our clients

In the future GVK BIO plans to expand its services from data curation to data analytics, providing modeling and simulation services to support drug development decision making.

ICON Development Solutions specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. With global clinical pharmacology and bioanalytical capabilities, ICON offers industry-leading solutions in early-phase clinical research, bioanalytical/immunoassay, biomarkers, PK/PD modeling & simulation and the full range of support services. Our multi-disciplinary experts incorporate scientific excellence and product development strategy in all that we do -- with the experience to address the most demanding drug development challenges with an unyielding focus on completing clinical studies on time, on budget and with the quality that will withstand the most vigorous scrutiny.

ICON Development Solutions is proud to announce the release of NONMEM® 7, the Software that has facilitated the analysis of data for pharmaceutical research and development for the last 30 years; the Gold Standard for population Pharmacokinetic / Pharmacodynamic analysis.

NONMEM® 7 is the only program that offers all of these methods under one roof:

  • FO
  • FOCE
  • ITS
  • Importance Sampling EM
  • SAEM
  • MCMC Bayesian Analysis

Other improvements found in NONMEM® 7 include: Improved incidence of completion when using the multiple problem feature; three stage hierarchical Markov Chain Monte Carlo (MCMC) methods; improved efficiency and incidence of success in problems using the classical NONMEM® method and many more that you will get to experience with your new software. NONMEM® 7 also provides a comprehensive tool-kit in an easier to use package to facilitate population-based data analyses, and improves the rate of success of analyzing complex PK/PD models.

 

Mango Solutions is a privately owned data analysis company producing tailored solutions for it's customers. Based in the UK but operating globally Mango have customers on several continents and work with some of the largest companies in the world such as KPMG and BP. Mango work with the biggest companies in the pharmaceutical sector such as Pfizer, Novartis and GSK among others.

Mango have a team of mathematicians, statisticians and IT programmers who provide a range of services including:

  • Customised training courses
  • Application development services
  • Data analysis consulting
  • Support and validation of code

Mango have wide experience with technologies such as R, SAS, S-PLUS and Matlab and are able to integrate and develop these technologies to suit customer requirements. In all engagements Mango's methodology is to work closely with its customers to ensure complete satisfaction.

For more details of how we help our pharmaceutical customers please go to www.mango-solutions.com

MathWorks provides software tools for the entire PK/PD workflow, from modeling to analysis, within a single graphical environment. MathWorks PK/PD modeling environment, SimBiology®, provides point-and-click tools to make PK/PD modeling and analysis accessible, even for researchers with little to no programming experience. Built on MATLAB®, SimBiology provides direct access to an industry-tested simulation solver suite, and allows integration of PK/PD modeling with other functionality such as parallel computing, statistics, and optimization. SimBiology also allows modelers the ability to experiment with new cutting edge trends, such as integrating mechanistic and physiologically-based PK models.

Employing more than 2,000 people, The MathWorks was founded in 1984 and is headquartered in Natick, Massachusetts, with offices and representatives throughout the world. The company has been profitable every year since its inception and is privately held. Over 1,000,000 scientists and engineers in more than 100 countries, on all seven continents, use MathWorks products.

  

Metrum Institute is a nonprofit organization dedicated to solving unmet needs in biomedical research through quantitative modeling and simulation. Our efforts include applied academic research, training, education, resource sharing, and research and development efforts focused on new open-source tools and methods. For more info visit: www.metruminstitute.org

Metrum Research Group provides contract services aimed at enhancing biomedical R&D through quantitative modeling and simulation. Our collaborations with the pharma/biotech industry are characterized by cutting-edge science, transfer of knowledge, quality deliverables and innovative, strategic application of modeling and simulation technologies. For more info visit: www.metrumrg.com

Phoenix NLMETM - The Future of NLME Modeling

  • Flexible user interface allowing users to create models using library models, a graphical modeling tool, or using the new Pharsight Modeling Language (PML).
  • Many default high quality plots generated for each model run including lattice plots, q-q plots, covariate plots, conditional weighted residuals plots, histograms of etas, residual plots with LOESS and absolute LOESS trend lines, and more.
  • Parametric, FO and FOCE algorithms, including a nonparametric method. User defined log-likelihood for user-specified models.
  • Stepwise and shotgun covariate search methods, Predictive Check and Bootstrap options as well as the NLME Model Comparer which allows for the comparison of model results and plots.
  • Parallelized NLME algorithms supported by Intel's® multi-core CPU platforms increases speed (e.g.: a single run can be split up and processed by as many processors as available in your computer). With some customization, NLME can be connected to your grid or cluster.
  • Graphical workflow engine integrates data preparation, modeling and model selection, and generation of high quality tables and figures. Individual steps or a group of steps can be saved as templates to reuse with other datasets.
  • One single file contains all inputs, settings, and outputs of analyses steps. For example, data preparation, several models, and post-model processing of results are all saved under a phoenix project (i.e. one file).
  • Optional integration with Pharsight's PKSTM data management system.

Phoenix ConnectTM

  • Allows users to run a variety of third party tools under a single Phoenix project file that can be shared, rerun, changed, and even saved as part of a workflow template that can be reused later with other datasets. With Phoenix Connect, you get all of the features of the Phoenix platform (e.g. data tools, graphics, tables) but other software applications can be used to perform other type of analyses.
  • Interfaces with the following software applications:
    • Pharsight® Knowledgebase ServerTM (PKSTM)
    • PhoenixTM WinNonlin® 6.0
    • SAS® 8 & 9
    • S-Plus® 8
    • R 2.9.1
    • NONMEM® 5 & 6
    • SigmaPlot® 9.0.1, 10, 11.1
    • ODBC data sources
    • Microsoft® WordTM & Excel® 2000, XP, 2003, 2007
  • Provides the capability to import and export CDISC STDM SAS transport datasets.
  • Provides a tool to compare results of NONMEM runs including comparison of output plots.

For more information, visit www.pharsight.com

MashFrame - Mine, Analyze, Report and Share. Like never before...

MashFrame and MashObject Technology helps business users across enterprise to quickly and easily access, mine, analyze, report and share data. This is an application framework based on open XML standards allowing flexible and seamless integration with other enterprise systems, databases, document repositories, third party applications and the corporate intranet.
This framework can be used to support following Pharmacometrics related needs...

  1. Automated data collection and validation
  2. Data cleanup and preparation
  3. Data modeling and simulation using multiple industry standard applications
  4. Automated alerts, reports and exports
  5. Scalable framework to meet computation intensive analysis
  6. Integration with grids and cloud computing environments

This technology platform also allows programmers to rapidly build applications, reports and widgets by creating and reusing objects. It provides a lower cost and quicker to market alternative to traditional higher cost longer to market solutions.

www.mashframe.com
www.rudraya.com

With a growing team of exceptional scientists and a world-class expertise in oral drug delivery, pharmacokinetics, & pharmacodynamics, Simulations Plus is a leading developer of large scale system simulations and high quality, rapid structure-property modeling software for the pharmaceutical industry.

ADMET PredictorTM is a computer software program for advanced predictive modeling of numerous vital ADMET properties from molecular structures, including pKa, permeability, logP/logD, solubility, Vd, protein binding, BBB penetration, CYP metabolism (1A2, 2C9, 2C19, 2D6, 3A4), multiple toxicities, and simulated Fa at multiple dose levels. Additionally, via its integrated ADMET ModelerTM module, it is also capable of building predictive models of new properties from user's data. The program predictions can be further utilized as inputs for our software products GastroPlus and ClassPharmer, or used internally by a flexible screening filter ADMET Risk that can include any combination of predicted properties.

ClassPharmerTM is an intuitive cheminformatics platform supporting lead identification and prioritization, de novo design, scaffold hopping and lead optimization. The software is divided into four modules - Basic, SAR, Design, and ADMET - each of which can be licensed separately.

DDDPlusTM (Dose Disintegration and Dissolution Plus) - the world's only in vitro dissolution software for the formulation scientist - is an advanced technology computer program that models and simulates the in vitro dissolution of active pharmaceutical ingredients (API) and formulation excipients dosed as powders, tablets, and swellable or non-swellable polymer matrices under various experimental conditions.

GastroPlusTM is used by more pharmaceutical researchers than any other oral absorption/pharmacokinetic/pharmacodynamics software package. This includes nearly all of the top 20 pharmaceutical companies in the world. You, too, can benefit from the world's most powerful analytical capability for oral absorption pharmacokinetic/pharmacodynamics (combined with world-class support) at a fraction of the cost to develop and maintain an equivalent capability in-house.

Benefits of GastroPlus

  • Rapid analysis and understanding of the behavior of drug candidates in animals and human.
  • Rapid ability to test hypotheses regarding formulation, changing physicochemical parameters, fasted and fed state effects, ionization effects on solubility and absorption, and more.
  • Ability to quickly estimate the best dosing options for toxicity studies in animals.
  • Ability to fit absorption/pharmacokinetic models to Phase I data in human, and with those models, to determine optimum dosing for later phases.

Web: www.simulations-plus.com

 

TIBCO Software Inc. is a leading provider of enterprise analytics software for next generation business intelligence. TIBCO Spotfire products offer a visual and interactive experience that helps professionals quickly discover new and actionable insights in information. Distinguished by its speed to insight and adaptability to specific business challenges, Spotfire rapidly reveals unseen threats and new opportunities, creating significant economic value. Spotfire customers include industry leaders among the Global 2000 that have deployed Spotfire analytics to gain an information advantage over their competitors.

From early stage discovery research to sales force optimization, Spotfire helps the world's leading pharmaceutical companies discover new therapeutics, develop and launch them to the market, and align sales and marketing campaigns to maximize return on their enterprise information investments.

Our products include:

  • TIBCO Spotfire - Full-featured analysis environment for business professionals and business analysts
  • TIBCO Spotfire Lead Discovery - Visual and interactive environment for exploring the effects of chemical structure on biological activity
  • TIBCO Spotfire Integromics Biomarker Discovery - Advanced methods for data access, normalization, pattern detection, treatment comparison, and functional analysis for scientists analyzing genomic expression data.
  • TIBCO Spotfire S+ - Statistical analysis, graphics and programming for Windows, UNIX and Linux
  • TIBCO Spotfire Miner - Data mining software for massive data sets using visual data analysis workflows.
  • TIBCO Spotfire S+ Server - Deploy advanced analytics enterprise-wide
  • TIBCO Spotfire Clinical Graphics - Rapid definition, production and reuse of reporting graphics without programming
  • TIBCO Spotfire S+ FinMetrics - Modern and flexible analytics for powerful econometric analysis.
  • TIBCO Spotfire S+ NuOPT - Fast numerical optimization of functions of many variables.
  • TIBCO Spotfire S+ SeqTrial - Design of group sequential clinical trials.

Website: http://spotfire.tibco.com