The Newsletter for Model-Based Drug Development
Summer 2010

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News

The Validation Suite for Phoenix® WinNonlin® is Now Available!
The Validation Suite significantly reduces the time, labor, and cost of manually validating Phoenix WinNonlin by automatically executing a standard test plan containing 184 automated test scripts that run in less than a day and generate a pass/fail Run Report. Four validation template documents are included; test plans and individual scripts can be customized. Accelerate Your Validation Efforts Now

Pharsight Presents on Clinical Utility Modeling at PaSiPhIC.
TJ Carrothers, ScD, Senior Scientist, presented at the inaugural June 14-16 Pacific Coast Statisticians and Pharmacometricians Innovation Conference (PaSiPhIC) with a talk on "The Clinical Utility Index, a Method for Balancing Efficacy and Safety in Drug Development Decision-Making." The presentation was part of a conference session on emerging topics in drug safety and pharmacometrics. View CUI Case Studies

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Events

Pharsight Contributes to PAGE 2010 in Berlin, Germany.
Pharsight scientists contributed a podium presentation and also to eight posters at the Population Approach Group in Europe (PAGE) 19th Annual Meeting in Berlin, Germany on June 8-11. Presentation and poster topics included physiology based modeling in asthma, tumor growth inhibition modeling, literature-based meta analysis, and population modeling methods. Pharsight also continued its role as a sponsor of PAGE and hosted a pre-conference workshop on Phoenix® NLME™, our powerful new data processing and modeling tools for population PK/PD analysis.
View PAGE Contributions

Phoenix Training Courses and PK/PD Methodology Workshops.
A number of Phoenix WinNonlin training courses and PK/PD modeling and methodology workshops are scheduled throughout the summer months and into the fall in the United States and Europe. View the training schedule to reserve your seat now. View Full Training and Workshop Schedule

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Success Stories

Modeling and Simulation of Clinical Tumor Progression Dynamics. This invited talk at ASCPT 2010 by Rene Bruno, PhD, Managing Director, provides a drug-disease modeling framework for predicting Phase III survival outcomes from tumor size measurements in Phase II, presents examples of survival simulations, and offers a new paradigm for using change in tumor size as a primary endpoint in Phase II studies. View ASCPT Case Study

Customer Feedback on Pharsight Collaborations.
Pharsight is committed to providing high-quality PK/PD analysis, biostatistics and regulatory reporting services that are the backbone of every submission package. We are pleased that our customers recognize this commitment and value our collab-orative approach to providing world-class expertise and technology for new drug approval. View Customer Testimonials

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Scientific Contributions

Conferences: Tumor Progression-Survival Modeling at ASCO 2010.
Laurent Claret, PhD, Senior Scientist, contributed an abstract at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting describing how a public domain drug-disease NSCLC modeling framework and phase II data can be used to support end-of-phase-II decisions and the design of phase III studies.  View ASCO Abstract
View Other Pharsight Oncology M&S Case Examples

Books: Contributed Chapter on PK/PD Biomarker Correlations.
JF Marier, PhD, FCP, VP and Lead Scientist, has co-authored a chapter on pharmacokinetic and pharmacodynamic biomarker correlations in the newly published book entitled "Biomarkers in Drug Development: A Handbook of Practice, Application and Strategy." (Wiley & Sons, 2010). View Book Details

Journals: Clinical Trial Simulations in Pediatric Populations Using Realistic Covariates (published in Clinical Pharmacology & Therapeutics).
Samer Mouksassi, PharmD, Associate Director, has collaborated with colleagues in industry and at the University of Cincinnati Children's Hospital Medical Center on an article describing how clinical trial simulations and novel modeling approaches were applied to design Phase I dosing strategies for neonates and infants with gastrointestinal disorders. View CPT Journal Abstract
View More About Pharsight Modeling in Pediatric Populations