Pharsight Corporation Enters into Cooperative Research and Development Agreement with FDA

Strategic Insights -

Pharsight Corporation, a leading provider of software and strategic services designed to optimize clinical drug development, has entered into a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). This collaboration directly supports the 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.

Key Takeaways:

  • Pharsight will collaborate with FDA using Pharsight software for the analysis, visualization, storage, reporting, and review of pharmacokinetic pharmacodynamic data.
  • The collaboration aims to develop Pharsight Knowledgebase Server (PKS) into a repository for data needed for modeling and simulation, support Clinical Data Interchange Standards Consortium (CDISC) data formats, and interact with other FDA databases.
  • Pharsight will utilize the FDA's feedback from the collaboration to further develop and customize PKS to meet industry analysis requirements and further develop Drug Model Explorer (DMX) to support Agency-sponsor interactions for the visualization and communication of model-based product profiles.
  • The partnership has been dubbed a "concrete evidence of the FDA's commitment to the Critical Path Initiative" by Dr. Robert Powell, Head of Pharmacometrics in FDA's Office of Clinical Pharmacology.
  • Pharsight's tools will help FDA in applying model-based drug development skills to regulatory decisions, recommendations, and knowledge sharing.
  • The FDA believes that these tools will help them in evaluating and employing them and encourages further innovation in this area.

Statistics:

  • Pharsight will make available a comprehensive suite of software tools, including PKS, PKS Validation Suite, WinNonlin Validation Suite, DMX, and Trial Simulator.
  • The collaboration will focus on reviewing clinical trial data, especially for clinical pharmacology and clinical safety reviews.
  • The partnership is expected to improve the efficiency of the drug product development process.
  • The FDA's Critical Path Initiative aims to increase the use of drug-disease modeling and simulation to improve the development process.

Sources:

  • Pharsight Corporation (Source: OTC Bulletin Board)
  • Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER)
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Securities and Exchange Commission (SEC)
  • EVC Group (phone contacts: Douglas Sherk or Jennifer Beugelmans)
  • Pharsight Corporation website (http://www.pharsight.com)