Pharsight and FDA Collaboration Continues

Pharsight and FDA Collaboration Continues:
CRADA Delivers Phoenix NLME and Phoenix Connect to Market
ST. LOUIS--(BUSINESS WIRE)--Pharsight, a market-leading provider of software and scientific services to improve productivity and decision-making in clinical drug development, today announced that it has released two new data analysis tools; Phoenix NLME and Phoenix Connect. The tools were developed via a collaborative effort between FDA and Pharsight under Pharsight's previously-announced Cooperative Research and Development Agreement (CRADA) with FDA's Center for Drug Evaluation and Research (CDER).

"Pharsight is proud to report that we have now provided Phoenix NLME and Phoenix Connect to FDA under our continuing collaboration."
."When we entered into this CRADA we agreed to provide the FDA with new software for the analysis, visualization, storage, reporting and review of pharmacokinetic and pharmacodynamic data," said Daniel Weiner, Chief Technology Officer of Pharsight. "Pharsight is proud to report that we have now provided Phoenix NLME and Phoenix Connect to FDA under our continuing collaboration."

The Phoenix suite of tools Pharsight has provided will be used by FDA, along with software products from other suppliers, to review clinical trial data, especially for clinical pharmacology and clinical safety reviews. The goal of this collaboration is to ensure that this suite of products helps meet FDA needs for Investigational New Drug Application (IND) and New Drug Application (NDA) data review and analysis.

"This collaboration reflects Pharsight's mission to provide critical tools that can meaningfully increase the productivity and efficiency of the drug development process," continued Dr. Weiner. "With the increasing costs associated with new drug development, the FDA has recognized the importance of utilizing innovative technologies to accurately assess the safety and effectiveness of potential new therapies. Pharsight believes these tools enable those abilities and looks forward to contributing to a more efficient and robust drug application and review process."

About Phoenix NLME

Phoenix NLME 1.0 is Pharsight's powerful new data processing and modeling software for population pharmacokinetic and pharmacodynamic (PK/PD) analysis. With a visual workflow engine, high quality graphics, and an easy to use graphical user interface, population PK/PD modeling has never been this accessible, flexible, and powerful. Phoenix NLME lowers the barriers to use of population-based modeling, while providing cutting edge tools that advance the science of drug development. More information about Phoenix NLME is available at www.pharsight.com.

About Phoenix Connect

Phoenix Connect increases the value of common PK/PD modeling tools by removing barriers between them. Phoenix Connect allows users to save all the work done with different 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. Phoenix Connect provides all of the features of the Phoenix platform in a stand-alone application. Phoenix Connect can help bridge the gaps that lie between the silos and systems that you depend on by creating connections between many common drug development software systems and protocols, such as: Pharsight® Knowledgebase ServerTM (PKSTM); PhoenixTM WinNonlin®; 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.

About Pharsight

Pharsight, a CertaraTM company, is a market-leading provider of software products and scientific consulting services to help pharmaceutical and biotechnology companies improve their drug development process, regulatory compliance and strategic decision-making. Established in 1995, the company's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products. Pharsight leverages expertise in its software tools and in the disciplines of pharmacology, drug and disease modeling, human genetics, biostatistics, strategic decision-making and regulatory strategy. Headquartered in St. Louis, Missouri, with more than 1200 customers worldwide, Pharsight products and services are used by all of the world's top 50 pharmaceutical firms.

About Certara

Certara is dedicated to improving human health through a broad spectrum of products and services, from molecular discovery to clinical research. Formed in 2008, Certara unites Tripos (www.tripos.com) and Pharsight Corporation (www.pharsight.com). Tripos provides innovative scientific solutions enabling life science researchers to improve the efficiency of molecular discovery. Pharsight provides software and scientific services to improve productivity and decision-making in clinical drug development. Certara focuses on reducing the barriers between the phases of research to speed discoveries in chemistry and enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products.

Registered Trademarks and Trademarks

Pharsight, Phoenix, Phoenix NLME, Phoenix WinNonlin, Phoenix Connect, Pharsight Knowledgebase Server, PKS, WinNonlin and Certara are trademarks or registered trademarks of Tripos, L.P. All other brands and product names are trademarks or registered trademarks of their respective holders.


Contacts
Pharsight
Adam Rutkin, 650-314-3752
Director of Marketing
[email protected]

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