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
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:
Reporting and Analysis Services (RAS)
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
Using WinNonlin AutoPilot for PK Analysis and Reporting
Strategic Consulting Services (SCS)
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
PK Accelerator™: 90 Day Solution for PK Analysis, Storage and Reporting
Using Drug Model Explorer® to Communicate Model-Based Product Profiles
Using Pharsight Trial Simulator™ for Improved Trial Design
Improving PK/PD Workflow Integration: Pharsight Knowledgebase Server™
Using WinNonlin AutoPilot for PK Analysis and Reporting
Perspectives on Modeling & Simulation and FDA's Critical Path Initiative
IVIVC Toolkit for WinNonlin: Product Introduction & Demonstration
Computer System Validation and Pharsight Validation Products
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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PK Accelerator™: 90 Day Solution for PK Analysis, Storage and Reporting
Date: July 21, 2008
Time: 10:00am - 11:00am EDT
Speaker: Simon Davis, Senior Scientific Consultant, Training and Pre-Sales
PK Accelerator is a packaged software solution consisting of the Pharsight® enterprise PK/PD data management system designed for Part 11 compliance, PKS™, and associated desktop analysis and reporting tools, coupled with a rapid deployment service provided at a fixed price and scope. Adopting PK Accelerator allows small to mid-sized organizations to deploy, in as little as 90 days, Pharsight’s complete best practices solution for end-to-end pharmacokinetic analysis, storage and reporting.
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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 DMX® to Communicate Model-Based Product Profiles
Date: October 23, 2007
Time: 1:00pm - 2:00pm EDT (6pm GMT, 10am PDT)
Speaker: Klaas Prins, Ph.D., Senior Scientist, Strategic Consulting Services
Overview of how DMX software can make complex information about modeled drug effects accessible to clinical development teams to explore strategic development questions. Includes applied case study and product demonstration.
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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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Using WinNonlin AutoPilot for PK Analysis and Reporting
Date: July 31, 2007
Time: 1:00pm - 2:00pm EDT (US)
Speaker:
Joannellyn Chiu, PhD, Scientific Consultant, Training, Pre-Sales & Support
Overview and demonstration of how WinNonlin AutoPilot can automate scriptable noncompartmental analysis and reporting.
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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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IVIVC Toolkit for WinNonlin: Product Introduction & Demonstration
Date: October 25, 2006
Time: 11:00am EDT (US)
Speaker: Jason Chittenden, Product Marketing Manager
This webinar provides an overview and demonstration of the IVIVC Toolkit for WinNonlin, an add-in toolkit for WinNonlin that extends its capabilities beyond pharmacokinetic, pharmacodynamic, and non-compartmental analysis to the development and application of in vivo-in vitro correlations (IVIVC). The product overview and demonstration covers the Toolkit's enhanced deconvolution methods, numerical convolution, new plotting capability, and describes benefits of the "IVIVC Wizard" for pharmacokineticists and formulators.
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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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