FDA and Pharsight continue to collaborate under CRADA

Pharsight Corporation has provided an update on its Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER).

The CRADA collaboration directly supports FDA's Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug product development process.

Since the initiation of the five-year CRADA in June 2006, Pharsight has successfully worked with FDA to install Pharsight(R) Knowledgebase Server(TM) (PKS(TM)) into the Agency's IT environment. PKS is a market-leading, high- productivity, regulatory-compliant enterprise data repository that manages modeling and simulation data. Pharsight has conducted training classes for FDA staff on PKS and has also trained FDA staff on WinNonlin(R) and Trial Simulator(TM), which FDA had previously installed. Pharsight has also introduced Drug Model Explorer(R) (DMX(R)) to FDA.

Importantly, Pharsight has worked with FDA to streamline the process of loading data from New Drug Applications (NDAs) into PKS by integrating the FDA's internal data management tools with Pharsight's PKS data connector technology. This integration allows FDA reviewers to build analysis datasets from NDAs submitted in Clinical Data Interchange Standards Consortium (CDISC) and non-CDISC formats. These analysis datasets can then be imported into WinNonlin or PKS. FDA expects to use these installed Pharsight tools to review clinical trial data, especially for clinical pharmacology and clinical safety reviews, and will provide feedback to Pharsight.

"We remain excited about our ongoing collaboration with FDA and reaching our common goal of developing PKS into a repository for the vast amount of data needed for modeling and simulation projects," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "We look forward to FDA's feedback on our other software tools, which should provide valuable insight as we continue to introduce enhancements to our existing products and launch new innovative tools. Currently, we are utilizing the Agency's feedback to further customize PKS to meet industry data management and analysis needs. We believe that our software tools offer tremendous value to drug developers and believe that FDA's positive engagement in our CRADA underscores this belief. Pharsight has already gained valuable insights by interacting with FDA through our CRADA and expects to continue to benefit from this relationship in the future."

Under the terms of the five-year CRADA, initiated in June 2006, Pharsight is collaborating with FDA using Pharsight software for the analysis, visualization, storage, reporting and review of pharmacokinetic/pharmacodynamic (PK/PD) data. A focal point of the collaboration is to develop Pharsight's enterprise PK/PD data management system, PKS, into a repository for the data needed for modeling and simulation, support Clinical Data Interchange Standards Consortium (CDISC) data formats, and interact with other FDA databases.