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Pharsight Events Archive

Pharsight is pleased to provide archived presentations and case studies for viewing at your convenience from its modeling and simulation seminar series and from online webcasts.

Seminars and Workshops

Online Events (Webcasts)

 

Seminars and Workshops

Best Practice Strategies and Technology for Maximizing Your Probability of Drug Development Success
May 2, 2011 (Munich, Germany) and May 4, 2011 (Paris, France)

Combining PK/PD Data Analysis with an On-Demand Data Repository
April 22, 2010 (Copenhagen, Denmark)

Pharsight PK/PD Analysis and Reporting in the Drug Development Lifecycle
September 9, 2008 (Boston, Massachusetts)

Pitfalls and Challenges in Bridging from Preclinical to Phase I
September 4, 2008 (Burlingame, California)

European Modeling and Simulation Seminar
May 30, 2008 (Paris, France)

How 20 Major Companies and FDA Have Leveraged WinNonlin® to
Build Compliant and Productive PK Workflows

March 13, 2007 (Burlingame, California)

How 20 Major Companies and FDA Have Leveraged WinNonlin® to
Build Compliant and Productive PK Workflows

March 7, 2007 (East Brunswick, New Jersey)

Challenges in the Adoption of Modeling and Simulation to Support Model-Based Drug Development: An Interactive Workshop
September 6, 2006 (Brussels, Belgium)

Online Events (Webcasts)

The following online events are available for review or audio-video replay:

Consulting Services

 

Modeling and Simulation in Pediatric Drug Development: Applications of "Top-Down" and "Bottom-Up" Approaches to Optimize Trial Design and Support Dosing Rationale

Model-Based Drug Development in Multiple Sclerosis: Integrating Disease, Drug and Market Data for Improved Decision Making

Modeling of the Tumor Growth-Survival Link During Anti-Cancer Treatment

Criteria for FDA's Acceptance of Results from Pharmacometrics Approaches

Combining Technology and PK/PD Expertise to Optimize Drug Development:
A New Era for Collaborative Environments in Translational Medicine

Pharsight's Critical Path Approach for Development of Generic Products

Saving Time and Money With Better Preclinical Planning

Population PK/PD Modeling: The Pharsight Approach

IVIVC Applications and Case Studies

The Clinical Utility Index®: A Method for Balancing Efficacy and Safety in Drug Development Decision Making

Mechanistic Models to Simulate Dose Response of IgE Suppression Following Dosing of Anti-IgE Monoclonal Antibodies

Optimizing Oncology Development with Modeling and Simulation

Combatting Clinical Attrition With Quantitative Translational Medicine

Using the Clinical Utility Index® (CUI®) to Inform Dose Selection Decisions: Integrated Modeling and Simulation Approach in Alzheimer's Disease

Portable Concepts for HCV & HIV Drug-Disease Modeling and Prediction

Modeling and Simulation of QTc Prolongation

Dose Optimization Case Studies

Using Biomarker and Literature Data in Type II Diabetes

Quantitative Approaches for Predicting First-in-Man Dosing Regimens

Perspectives on Modeling & Simulation and FDA's Critical Path Initiative

Modeling & Simulation to Foster Collaborative Decision-Making

Modeling & Simulation to Support Strategic CNS Product Management

Modeling & Decision Analysis to Support Formulation and Trial Strategies

Modeling & Simulation to Support HIV Drug Development Decisions

Model-Based Meta-Analysis for Integration of Data from Multiple Sources

Software Products


QRPEM: A Quasi-Random Parametric EM Method


What's New in Phoenix 1.3


Enhanced Reporting Capabilities for Phoenix® WinNonlin® Users with New AutoPilot™ Toolkit for Phoenix®

Criteria for FDA's Acceptance of Results from Pharmacometrics Approaches

Introducing Phoenix® Connect™ 1.2 for Compliant Pipelining

Introducing the IVIVC™ Toolkit 2.0 for Phoenix® WinNonlin®

The First Fully Integrated Population PK/PD Modeling Tool: 
Phoenix® NLME™ 1.1

The State-Of-The-Art Software Platform for PK/PD Modeling:
Phoenix® WinNonlin® 6.2

Pharsight Knowledgebase Server™: A Compliant Solution for Efficient Creation, Storage and Reuse of Pharmacometric Models

Overview of Validation and the Phoenix WinNonlin Validation Suite

New Tools for High Throughput Preclinical/Tox Analysis and Reporting

Comparing Models within Phoenix NLME

Migration Pathways to Phoenix NLME for WinNonlin Classic Users

Introducing Phoenix NLME?

PKS Online? ? Access to PKS from Anywhere at Anytime

Introducing Phoenix Connect?

A Comparison of Phoenix? WinNonlin® 6.0 and WinNonlin®5.2.1

Introducing Phoenix? WinNonlin® 6.0

Pharsight's Preclinical Automation Framework

Using Pharsight Trial Simulator? for Improved Trial Design

Improving PK/PD Workflow Integration: Pharsight Knowledgebase Server?

Perspectives on Modeling & Simulation and FDA's Critical Path Initiative

Computer System Validation and Pharsight Validation Products


Modeling and Simulation in Pediatric Drug Development

Date: October 9, 2012
Time: 11:00am - 12:00pm EDT
Speakers:  JF Marier, PhD, FCP, Vice President and Lead Scientist, Pharsight Consulting Services, part of Certara; Trevor Johnson, PhD, Principal Scientist, Simcyp Limited, part of Certara

This webinar presents general principles of modeling and simulation to optimize pediatric trial design and support dosing rationale to ensure adequate safety and efficacy of treatments intended for pediatric use. Both "top-down" PK/PD approaches and "bottom-up" physiologically based pharmacokinetic (PBPK) approaches will be discussed as part of a modeling framework to better understand and predict complex drug and system dynamics.

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Model-Based Drug Development in Multiple Sclerosis  

Date: September 12, 2012
Time: 11:00am - 12:00pm EDT
Speaker:  Francois Mercier, Ph.D., Senior Scientist

This webinar covers the strategic use and value of modeling and simulation as a tool to integrate and rationalize data, knowledge, and expertise in Multiple Sclerosis (MS), taking sphingosine 1-phosphate receptor (S1Pr) modulators as a case study. Dr. Mercier addresses three important decisions in clinical development of MS treatments: Which patients? Which dose(s)? Which competitors? Additionally, model-based approaches to support development of new compounds for the treatment of relapsing/remitting MS, primary progressive MS and other related neurodegenerative diseases are discussed.

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QRPEM: A Quasi-Random Parametric EM Method  

Date: May 10, 2012
Time: 11:00am - 12:00pm EDT
Speaker:  Bob Leary, Ph.D., Fellow

Monte Carlo (MC) parametric EM algorithms such as MCPEM and SAEM have become increasingly popular alternatives to traditional FO, FOCE and LAPLACE parametric algorithms for population PK/PD analyses. The EM methods offer a variety of advantages in terms of robustness, accuracy, reliability, and sometimes speed. QRPEM (Quasi-Random Parametric EM), a new implementation of an importance sampling based parametric EM algorithm, has recently been added to the Pharsight Phoenix NLME software platform in the latest 1.3 release. QRPEM differs fundamentally from MCPEM algorithms in that sampling of the posterior distributions is based on "quasi-random" sequences rather than the more usual pseudo-random sequences. Additionally, the Phoenix NLME implementation of QRPEM utilizes the SIR (Sampling-Importance-Resampling) algorithm as an accelerant for cases where mu-modeling is not or cannot be used.

In this webinar, we will provide an overview of QRPEM and how it differs from MCPEM and SAEM, and also from FO, FOCE, and LAPLACE. We will show that the theoretical advantage of QR relative to MC sampling is indeed achieved in practice through a variety of examples and test results. We also will discuss the SIR algorithm, a feature that is unique to Phoenix NLME QRPEM, and show its remarkable effectiveness for many classes of models.

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What's New in Phoenix® 1.3  

Date: May 3, 2012
Time: 11:00am - 12:00pm EDT
Speaker:  Ana Henry, M.S., Director, Product Management

This webinar presents and demonstrate the new features of recent release of Phoenix 1.3 (Phoenix WinNonlin 6.3, Phoenix NLME 1.2, Phoenix Connect 1.3, IVIVC Toolkit 2.1 for Phoenix WinNonlin). Some key developments in this release include 64-bit version of Phoenix, the QRPEM algorithm in Phoenix NLME, support to edit scripts in the native 3rd party Graphic User Interphase in Phoenix Connect, the new PsN plug-in in Phoenix Connect, new remote computing solutions on non-windows servers and many other improvements on data handling, project organization, templates and efficiency.

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Webinar Q&A


Enhanced Reporting Capabilities for Phoenix® WinNonlin® Users with New AutoPilot™ Toolkit for Phoenix® 

Date: July 19, 2011
Time: 11:00am - 12:00pm EDT
Speaker:  Dr. Peter Schaefer, Director, Product Management

PK Automation, the automated generation of PK output, including tables, listings, and figures, is an efficient way to reduce the reporting effort for clinical studies. Pharsight has led the automation trend by providing a highly configurable and powerful PK Automation product ? WinNonlin AutoPilot.  These capabilities are now available for Phoenix WinNonlin, with the release of the AutoPilot Toolkit 2.0 for Phoenix, which gives users the power to create report-quality tables and graphs from the NCA output in Phoenix projects. The integrated Automation File Explorer allows users to easily transfer AutoPilot generated output into Word documents or PowerPoint presentations.  This webinar will demonstrate the critical features of AutoPilot Toolkit for Phoenix and the benefits Phoenix WinNonlin users can achieve by implementing. Additionally, we will show the improvements over the ?legacy? version of AutoPilot resulting from the integration into the Phoenix platform.

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Modeling of the Tumor Growth-Survival Link During Anti-Cancer Treatment
An AAPS eLearning Series Webinar

Date: June 30, 2011
Time: 12:30pm - 2:00pm EDT
Speaker:  Rene Bruno, PhD, Managing Dir., Consulting Services, Europe

Join this webinar for an introduction to a modeling framework being developed to simulate clinical response in oncology trials. Simulations support the use of change in tumor size as a primary endpoint. These models incorporate drug- and disease-specific parameters that can be informed by early clinical data (Phase 1b, 2) and prior information (preclinical, historical or public-domain Phase III data or models) in the disease of interest (e.g. breast cancer, NSCLC). Case studies will illustrate how drug-disease models and clinical trial simulations offer a powerful science-based quantitative approach to predict expected drug profiles and support oncology drug development decisions.

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Criteria for FDA's Acceptance of Results from Pharmacometrics Approaches
An AAPS eLearning Series Webinar

Date: June 2, 2011
Time: 12:45pm - 2:15pm EDT
Speaker:  Jogarao Gobburu, PhD, Division of Pharmacometrics, OCP/US FDA
Moderator: Dan Weiner, PhD, Pharsight

Join this webinar for a historical perspective of modeling and simulation (M&S) submissions to FDA, and for insights on strategies to increase the likelihood that M&S results will be acceptable to FDA for review. Questions addressed include: What should be addressed in the submission? For which approaches has FDA received training, and what if a sponsor wants to perform M&S based on some other approach? How are reviewers assigned to specific submissions, and is there a checklist of things they look for? The webinar will include an interactive question and answer session.

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Introducing Phoenix® Connect™ 1.2 for Compliant Pipelining

Date: May 18, 2011
Time: 11:00am - 12:00pm EDT
Speaker:  Erin Guinan, Senior Director, Deployment & Automation Services

Join this webinar to learn how Phoenix Connect can be used to integrate third party tools into your PK/PD modeling workflows. During this webinar you will learn how to import data from ODBC data sources; create graphical workflows that integrate NONMEM, S+, R, SAS, SigmaPlot, PsN and Xpose; store, share and reuse graphical workflows to save up to 75% of your time on the next analysis. You will see how all of these operations can be performed in a single, integrated, regulatory compliant software tool.


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Introducing the IVIVC™ Toolkit 2.0 for Phoenix® WinNonlin®

Date: May 4, 2011
Time: 11:00am - 12:00pm EDT
Speaker:  Jason Chittenden, M.S., Director, Product Development

Join this webinar to learn how the IVIVC Toolkit can improve your bioavailability and bioequivalence studies. During this webinar you will learn how to create correlations via the use of an IVIVC Wizard; perform numerical convolution and deconvolution; create tables and figures, including Levy plots; predict pharmacokinetics from new in vitro data. You will see how all of these operations can be performed in a single, integrated, regulatory compliant software tool.

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The First Fully Integrated Population PK/PD Modeling Tool:
Phoenix® NLME™ 1.1

Date: April 26, 2011
Time: 11:00am - 12:00pm EDT
Speaker:  Emily Colby, DrPH Candidate, Scientific Consultant

Join this webinar to learn how Phoenix NLME can support your population PK/PD modeling needs. During this webinar you will learn how to import and merge data to create modeling ready data sets; perform covariate selection, bootstrapping and post-predictive checks; select from among a range of computational engines; create report ready tables and plots; export data in several standard data formats; and finally, create and reuse graphical workflow templates, saving up to 75% of your time on the next analysis. You will see how all of these operations can be performed in a single, integrated, regulatory compliant software tool.

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The State-Of-The-Art Software Platform for PK/PD Modeling:
Phoenix® WinNonlin® 6.2

Date: April 13, 2011
Time: 11:00am - 12:00pm EDT
Speaker:  Ana Henry, M.S., Director, Product Management & Desktop Products

Join this webinar to learn how Phoenix WinNonlin can support your NCA and PK/PD modeling needs. During this webinar you will learn how to import and merge data to create modeling ready data sets; calculate standard PK parameters; create report ready tables and plots; export data in several standard data formats; and finally, create and reuse graphical workflow templates, saving up to 75% of your time on the next analysis. You will see how all of these operations can be performed in a single, integrated, regulatory compliant software tool.

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Pharsight Knowledgebase Server™ (PKS™): A Compliant Solution for Efficient Creation, Storage and Reuse of Pharmacometric Models

Date: December 14, 2010
Time: 11:00am - 12:00pm EST
Speaker: Daniel Weiner, PhD, Vice President and Chief Technology Officer

Modeling and simulation departments are increasingly supporting regulatory submissions with pharmacometric models. Pharsight’s PKS repository (already deployed in 25 companies and FDA) addresses the challenges of and opportunities for efficient creation, storage and reuse of pharmacometric models. This webinar provides an overview and demonstration of how PKS, combined with Phoenix destkop analytical tools, enables interoperability between SAS, S-PLUS, NONMEM, and CDISC data sources.

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The Clinical Utility Index: A Method for Balancing Efficacy and Safety in Drug Development Decision Making

Date: September 23, 2010
Time: 11:00am - 12:00pm EDT
Speaker: TJ Carrothers, ScD, Senior Scientist

Every drug has benefits and risks, and these often result in counteracting attributes when drug development decisions are being made. The Clinical Utility Index (CUI), as well as other related quantitative decision-analytic tools, offers product teams a systematic and transparent approach for quantifying the subjective preferences underlying these decisions.

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Mechanistic Models to Simulate Dose Response of IgE Suppression Following Dosing of Anti-IgE Monoclonal Antibodies
An AAPS eLearning Series Webinar

Date: August 5, 2010
Time: 12:30pm - 2:00pm EDT
Speaker: Pascal Chanu, PharmD, Senior Scientist

The purpose of this webinar is to provide an overview of biomarkers, highlighting critical concepts such as: the characteristics of target versus mechanism biomarkers, biomarker assay issues, and the role of constructing and validating mechanistic PK-PD models for translational research.

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Overview of Validation and the Phoenix WinNonlin Validation Suite

Dates: July 7 & 22, 2010
Time: 10:00am - 11:00am EDT
Speaker: Debra Fontana, Quality Assurance Manager

This webinar provides an overview of the reasons for computer system validation, how it is performed, and how Pharsight validation products assist in the completion of validation activities. The session also includes a tour of Pharsight’s recently released Phoenix WinNonlin Validation Suite product, which significantly reduces the time, effort, and cost of on-site validation.

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New Tools for High Throughput Preclinical/Tox Analysis and Reporting

Date: May 12, 2010
Time: 11:00am - 12:00pm EST
Speaker: Anne-Louise Menard, M.Sc., Associate Scientist

This webinar demonstrates the use of new workflow tools in Phoenix, Pharsight's desktop analysis and modeling platform, for efficient preclinical PK data management, analysis, modeling, and preparation of tables, figures, and listings within a single integrated environment.

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Comparing Models within Phoenix NLME

Date: December 1, 2009
Time: 11:00am - 12:00pm EST
Speaker: Ana Henry, M.S., Director of Product Management Desktop Products

This webinar introduces the ‘Phoenix Model Comparer’ object within Phoenix NLME, which provides the capability to compare results of population models, combine comparison results within a spreadsheet, compare plots side by side, and to perform log-likelihood ratio tests for nested models.

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Migration Pathways to Phoenix NLME? for WinNonlin Classic Users

Date: November 17, 2009
Time: 11:00am - 12:00pm EST
Speaker: Ana Henry, M.S., Director of Product Management Desktop Products

This webinar provides an introduction on how WinNonlin 5x users can begin transitioning to Phoenix NLME. It covers an overview of the differences between using WinNonlin 5 classical PK models and how to write them as Phoenix WinNonlin models when doing individual modeling. A live demonstration illustrates the transition from an individual Phoenix model to a population-based model. The webinar also demon-strates how results from NCA or other WinNonlin classical models can be used as initial estimates for population modeling. Steps for translating ASCII model to PML code are also reviewed.

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Introducing Phoenix NLME?

Date: October 22, 2009
Time: 11:00am - 12:00pm EST
Speaker: Daniel Weiner, Ph.D., Sr. Vice President & CTO

This webinar provides an overview and demonstration of Phoenix NLME 1.0, the next generation population modeling application. The demonstration will focus on the major features of Phoenix NLME 1.0, including: its outstanding pre- and post-processing data management tools; a look at the range of optimization engines available; how to build models using NLME’s built-in library, graphical modeling tool, or by coding with text; how to compare various models; as well as its integration with Phoenix? WinNonlin® and Phoenix Connect?.

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Optimizing Oncology Development with Modeling and Simulation

Date: October 14, 2009
Time: 11:00am - 12:00pm EST
Speaker: Rene Bruno, Ph.D., Managing Dir., Strategic Consulting Services, Europe

This webinar introduces a causal drug-disease modeling framework to predict clinical endpoints and support oncology drug development. Several case studies will illustrate how to enhance learning from early clinical data by using all available information and therefore, reducing uncertainty in understanding of drug response that contributes to better decision-making and design of later phase trials. Case examples and discussion topics include: Use of model-based approaches to achieve a more informative analysis of clinical trial data; designing Phase II studies to assess dose response and schedule dependence; dose response simulations to support dose selection and label; use of the FDA NSCLC modeling framework to simulate expected survival and Phase III trials.

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PKS Online? - Access to PKS From Anywhere at Anytime

Date: August 11, 2009
Time: 11:00am - 12:00pm EST
Speaker: Peter Schaefer, Ph.D., Director of Product Management

This webinar introduces PKS Online, an Internet-accessible implementation of PKS that provides productivity benefits for PK/PD data management, analysis and reporting tasks, in addition to compliance with existing FDA Electronic Records/Electronic Signatures regulations. For PKS Online, Pharsight has partnered with a leader in the Software-as-a-Service arena to bring the benefits of PKS to every desktop without the need to invest time and money into deploying PKS in a company’s IT environment. Using a standard desktop computer and a standard network connection, users can access PKS Online through a secured channel from virtually anywhere and at anytime.

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Combatting Clinical Attrition With Quantitative Translational Medicine

Date: July 23, 2009
Time: 11:00am - 12:00pm EST
Speaker: Jonathan K. Wagg, M.D., Ph.D., Senior Scientist

This webinar defines and discusses the emerging discipline of Translational Medicine from the perspective of regulatory authorities. The problem of late stage attrition and the potential role of Translational Medicine to improve success rates for clinical development programs is also covered. This sets the context for a more detailed discussion of the field and of the related, emerging field of quantitative Translational Medicine as an upstream extension of the current model-based drug development paradigm typically applied to the clinical phases of drug development. Opportunities facing this emerging discipline are also outlined.

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Introducing Phoenix Connect? 1.0

Date: July 1, 2009
Time: 11:00am - 12:00pm EST
Speaker: Jason Chittenden, M.S., Director of Product Quality

This webinar provides an overview and demonstration of how Phoenix Connect enables interoperability between SAS, S-PLUS, NONMEM, and CDISC data sources while providing scientists the rich features of the Phoenix platform. The demonstration features several specific examples of how Phoenix Connect can be used to enhance the efficiency of data management, analysis, and modeling tasks.

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A Comparison of Phoenix? WinNonlin® 6.0 and WinNonlin® 5.2.1

Date: June 16, 2009
Time: 11:00am - 12:00pm EST
Speaker: Ana Henry, M.S., Director of Product Management

This webinar provides a detailed comparison of Phoenix WinNonlin 6.0 and WinNonlin 5.2.1 within the context of a standard noncompartmental pharmacokinetic analysis.  The comparison covers creating graphs, running an NCA analysis, and generating tables.  The presentation also demonstrates how to refresh out of synch workflows and how to reuse previous workflows using new datasets via the new Phoenix WinNonlin 6.0 template feature. 

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Introducing Phoenix? WinNonlin® 6.0

Date: June 11, 2009
Time: 11:00am - 12:00pm EST
Speaker: Daniel Weiner, Ph.D., Sr. Vice President & CTO

This webinar provides an overview and demonstration of Phoenix WinNonlin 6.0, the next generation of the industry standard software tool for PK/PD modeling and noncompartmental analysis. The demonstration covers the major features of Phoenix WinNonlin 6.0, including: new workflow functionality for easy visual creation and reuse of PK/PD analyses, data visualization tools and high quality graphics, enhanced modeling capabilities, and a new underlying architecture to facilitate integration with third-party modeling and analysis tools.

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Combining Technology and PK/PD Expertise to Optimize Drug Development: A New Era for Collaborative Environments in Translational Medicine

Date: April 22, 2009
Time: 1:00pm - 2:00pm EST
Speakers: JF Marier, Ph.D., FCP, Vice President and Lead Scientist, Reporting and Analysis Services; Mark LJ Reimer, Ph.D., Senior Director, Reporting and Analysis Services

This webinar covers integrated approaches for data management, PK/PD analysis, reporting technology and automation to optimize drug development. Collaborative platforms for efficient translational medicine activities are also presented. Illustrative case studies provide an overview of approaches and tools used by Pharsight in the drug development process for: (i) preclinical analysis and modeling to support first-in-human dose selection (ii) Phase I/II study analysis to support efficient protocol design (iii) population PK/PD modeling to support progam decision-making (iv) regulatory submissions, CDISC and data transfer.

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Using the Clinical Utility Index (CUI) to Inform Dose Selection Decisions: Integrated Modeling and Simulation Approach in Alzheimer's Disease

Date: February 4, 2009
Time: 11:00am - 12:00pm EST
Speaker: Lee Hodge, MBA, Senior Scientist, Strategic Consulting Services

This webinar covers the strategic use and value of developing utility metrics that explicitly quantify tradeoffs for clinical and commercial success to support dose selection in clinical drug development. The webinar illustrates how Pharsight's quantitative framework combines development of a Clinical Utility Index (CUI) with drug-disease models to predict drug performance versus competing treatments. The presentation includes an applied case example of dose selection using CUI and discusses extensions of the model-based CUI framework to support other drug development decisions.

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Pharsight's Preclinical Automation Framework

Date: January 28, 2009
Time: 11:00am - 12:00pm EST
Speaker: Jeff Fischer, PharmD, Manager, PK Automation & Deployment Services

This webinar provides an overview and demonstration of Pharsight's Preclinical Automation Framework (PAF), a software application that provides preclinical development organizations with a systematic approach to automate preclinical PK analyses, creation of high-quality graphs and tables, and export to Microsoft Word and Powerpoint for use in regulatory and internal reports and presentations. PAF provides analysis outputs for preclinical reports in an expedited manner while increasing quality with minimal study data setup required.

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Pharsight's Critical Path Approach for Development of Generic Products

Date: November 12, 2008
Time: 10:00am - 11:00am EST
Speakers: Jean-Francois Marier, PhD, FCP, Vice President & Lead Scientist, Reporting and Analysis Services; Jean-Sébastien Brunet, MSc, Senior Associate, Statistics and Data Management, Reporting and Analysis Services.

This webinar presents state-of-the-art pharmacokinetic and statistical analyses that can be used to assess bioequivalence of locally acting and highly variable drugs. The webinar will also present multiple examples showing how Pharsight's approach can save time and money in the development of a generic product with the use of IVIVC, biowaivers, bioassay validation, short-paneled or under-recruited studies, interim analysis, sequential bioequivalence studies, and sample pooling for preliminary assessment of bioequivalence.

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Saving Time and Money With Better Preclinical Planning

Date: August 6, 2008
Time: 10:00am - 11:00am EDT
Speaker: Mark LJ Reimer, Ph.D., Senior Director, Operations and Preclinical Development, Reporting and Analysis Services

Many drug development failures can be attributed to a lack of proper planning and execution at the early preclinical assessment stages. Asking the right questions at the right time is the key to strategic drug development planning.  Drug development can be viewed as a process that proceeds through several key go/no-go 'decision gates'. This webinar will review key decisions in early stage development that drive the goals of generating viable clinical candidates, shortening the development process, and reducing attrition rates.

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Population PK/PD Modeling: The Pharsight Approach

Date: June 26, 2008
Time: 10:00am - 11:00am EDT
Speaker: Dan Weiner, Ph.D., Senior Vice President and Chief Technology Officer

Provides an overview of the approaches and tools used by the Pharsight Reporting and Analysis Services (RAS) Group for regulatory-quality population PK/PD modeling, including: analysis planning, dataset construction, base model building (structural and statistical), addition of covariates, checking of assumptions, model evaluation, parameter estimation, predictions, and sensitivity analysis.

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Portable Concepts for HCV & HIV Drug-Disease Modeling and Prediction

Date: February 28, 2008
Time: 10:00am - 11:00am PDT
Speaker: Bill Poland, Ph.D., VP and Lead Scientist, Strategic Consulting Services

Covers the use and strategic value of integrated modeling and simulation of pharmacokinetics, pharmacodynamics, adherence, and trial outcomes for HCV and HIV drugs. Despite important differences such as the potential to cure HCV and faster HCV dynamics, HCV trial outcomes can be predicted and improved by model-informed design, as for HIV.

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Modeling and Simulation of QTc Prolongation

Date: January 23, 2008
Time: 10:00am - 11:00am PDT
Speaker: TJ Carrothers, Sc.D., Senior Scientist, Strategic Consulting Services

Prolongation of the QT interval has emerged as an important biomarker in cardiac safety assessment in drug development. Concentration-effect modeling, as promoted by the US FDA, is an important component in assessing QT-related risk. This webinar provides an overview of modeling and simulation applications, and their associated benefits for improving drug development, both in the context of the thorough-QT study as well as in the pooled analysis of Phase I/II studies.

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Dose Optimization Case Studies

Date: December 11, 2007
Time: 11:00am - 12:00pm EST
Speaker: Dan Weiner, Ph.D., Chief Technology Officer

Covers a review of five case studies, from a variety of therapeutic domains, where PK/PD modeling and simulation was used to optimize dose selection.

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Using Pharsight Trial Simulator? for Improved Trial Design

Date: August 23, 2007
Time: 1:00pm - 2:00pm EDT (US)
Speaker: Daniel Weiner, Ph.D., Senior Vice President & Chief Technology Officer

Overview of the rationale for Computer Assisted Trial Design (CATD), CATD process and methods, and demonstration of Pharsight Trial Simulator? software.

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Improving PK/PD Workflow Integration with PKS?

Date: August 9, 2007
Time: 11:00am - 12:00pm GMT
Speaker: Simon Davis, Senior Scientific Consultant, Training and Pre-Sales

Overview and demonstration of how Pharsight Knowledgebase Server? (PKS?) provides the technical infrastructure to effectively and securely manage PK/PD data and associated analyses across development programs or indications.

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IVIVC Applications and Case Studies

Date: July 25, 2007
Time: 1:00pm - 2:00pm EDT (US)
Speakers: JF Marier, MSc, PhD, Vice President, Reporting and Analysis Services; Jason Chittenden, MS, Product Manager, WinNonlin® & IVIVC Toolkit? for WinNonlin

Overview of In Vivo-In Vitro Correlation (IVIVC) approaches, strategies and regulation; two applied IVIVC case studies; introduction to Pharsight software for conducting IVIVC analyses.

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Using Biomarker and Literature Data in Type II Diabetes

Date: May 30, 2007
Time: 1:00pm - 2:00pm EDT (US)
Speakers: Jill Fredrickson, Ph.D., Senior Scientist, Strategic Consulting Services; Todd Barbee, R.Ph., Manager of Clinical Database Services

Covers the strategic use and value of assessing, extracting and modeling public-domain scientific literature to support clinical drug development decision-making. An applied case example illustrates how development of literature-based disease models can be used to generate insights into the treatment of Type II diabetes. Beyond the case example, issues and considerations for combining public-source literature data with proprietary NCE data are discussed.

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Quantitative Approaches for Predicting First-in-Man Dosing Regimens

Date: May 21, 2007
Time: 1:00pm - 2:00pm EDT (US)
Speaker: Jonathan K. Wagg, M.D., Ph.D., Senior Scientist, Strategic Consulting Services

Covers the strategic use and value of modeling and simulation to support translational drug development decision-making.  Case examples are used to illustrate key approaches for the scaling of pharmacokinetic and pharmacodynamic data from preclinical studies and public domain data to human subjects to support first-in-man (FIM) dosing regimen design and optimization. Relevant regulatory issues and considerations are also discussed, including regulatory perspectives and current activities under FDA’s Critical Path Initiative.

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Perspectives on Modeling & Simulation and the Critical Path Initiative

Date: April 17, 2007
Time: 9:00am ? 10:00am Japan local time
Speakers: Daniel Weiner, Ph.D., Senior Vice President & Chief Technology Officer; Kunihiro Sasahara, Ph.D., Japanese Business Development, Pharsight Corporation

The webinar discusses FDA's view on the role of modeling and simulation in drug development and approval and describes how biopharmaceutical companies and FDA are building the technology and organizational infrastructure to support model-based drug development. The program covers:

  • The regulatory and commercial imperatives for modeling
  • FDA’s Critical Path Initiative
  • The evolving needs for technical infrastructure to support model-based drug development

The webinar concludes with a question and answer session on the practical challenges and considerations for implementing model-based drug development in today’s leading organizations.

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Computer System Validation and Pharsight Validation Products

Date: August 29, 2006
Time: 10:00am EDT (US)
Speaker: Debra Fontana, Quality Assurance Manager, Software Products Group

Covers software and computer systems validation terminology, regulations and guidelines for validating computer systems in FDA-regulated environments. The presentation covers:

  • Current status of validation requirements in FDA-regulated industries
  • Responsibilities of software vendors vs. software users with regard to validation
  • Phases of a validation life cycle model
  • Current status of 21 CFR Part 11
  • How Pharsight validation products assist in the completion of the validation life cycle

The session includes a demonstration of Pharsight’s WinNonlin Validation Suite product, which streamlines the on-site validation of WinNonlin. The Validation Suite provides a selection of automated tests, each of which runs a specific WinNonlin analysis or function and tests the results against standardized, known output, along with valuable document templates.

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Modeling & Simulation to Foster Collaborative Decision-Making

Date: June 14, 2006
Time: 11:00am EDT US
Speaker: Kevin Dykstra, Ph.D., Senior Scientist, Strategic Consulting Services

Covers how quantitative modeling and simulation (M&S) can foster collaborative decision-making across functional development team members and with senior R&D management. The term M&S is shorthand for a set of integrated methods and tools that help navigate the inherent complexity and uncertainty in clinical drug development. An applied case study illustrates:

  • How PK/PD modeling can be used to create integrated assessments of a compound's clinical utility and commercial potential
  • How tools to visualize and explore model-based product profiles can make complex information accessible to clinicians and other non-modelers
  • How the above methods and tools helped identify specific, actionable recommendations for the drug program team

Beyond the case example, issues and considerations for extending the analysis to explicitly address financial recommendations are also discussed.

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Modeling and Simulation to Support Strategic Management of CNS Product Lifecycle

Date: May 25, 2006
Time: 2:00pm EDT US (18:00 GMT)
Speaker: Bob Korsan, M.S.,M.A., Senior Scientist, Strategic Consulting Services

Covers the multi-year collaboration between Cephalon and Pharsight to use decision-focused drug-disease modeling, simulation and trial design to assist Cephalon in the development of a sequence of compounds and formulations in its flagship CNS product franchise. Provigil? and its associated products are used in the treatment of narcolepsy (NARC), obstructive sleep apnea (OSA), shift work sleep disorder (SWSD) and attention deficit hyperactivity disorder (ADHD). Case examples of modeling and simulation approaches from the collaborative engagement demonstrate:

  • How trial arms were eliminated
  • How model-based dose selection dramatically shortened time-to-market
  • How dose-regimen was tailored to improve efficacy in the face of complex pharmacodynamics
  • How Cephalon used model recommendations based on early phase trial data to proceed to confirmatory trials, manage risk and uncertainty, and provide a steady stream of evidence for the FDA to enlarge the pool of patients who gain medically significant benefit .

Beyond the case examples, issues and considerations for applying decision-focused modeling and simulation to clinical development, indication sequencing and formulation selection are also discussed.

 

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Modeling and Decision Analysis to Support Formulation Selection and Trial Sequencing

Date: April 11, 2006
Time: 10:30am ? 11:30am PDT (US)
Speaker: Bob Korsan, M.S.,M.A., Senior Scientist & Director of Decision Services

Covers the use and strategic value of integrated modeling and simulation/decision analysis (DA) to assist with important development decisions by maximizing learning and making quantitative assessments of compound/NCE value. An applied case example illustrates:

  • How modeling/DA helped recommend the choice and order of formulation development
  • How modeling/DA recommended skipping a trial to shorten development
  • How a model of market value can be applied to difficult development decisions

Beyond the case example, issues and considerations for applying integrated modeling/DA techniques to decisions ranging from compound progression to portfolio selection are also discussed.

 

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Modeling and Simulation to Support HIV Drug Development Decisions

Date: February 28, 2006
Time: 10:30am ? 11:30am PST (US)
Speaker: Bill Poland, Ph.D, Senior Scientist, Strategic Consulting Services

Covers the use and strategic value of integrated adherence-PK-PD-trial modeling and simulation for antiretrovirals approaching Phase 2 or 3 development. Case examples illustrate:

  • How modeling helped Pfizer plan Phase 2 and 3 for maraviroc
  • How benchmarking against a better understood drug can help in dose selection
  • How a model of market value can be applied to difficult development decisions

 

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Model-Based Meta-Analysis for Integration of Data from Multiple Sources

Date: February 15, 2006
Time: 11:30am ? 12:30pm EST (US)
Speaker: Bill Gillespie, Ph.D, Lead Scientist and VP, Strategic Consulting Services

Covers the use and strategic value of model-based meta-analysis to support clinical drug development decision-making, including:

  • Rationale for model-based meta-analysis
  • Overview of the data collection and modeling process
  • Illustrative case studies
  • Issues and considerations for execution and interpretation

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