FDA-Pharsight CRADA
Pharsight® 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). The Pharsight CRADA 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.
The CRADA marks Pharsight's continuing and active involvement in the Critical Path Initiative. Over the past several years, Pharsight scientists have been invited to speak at FDA and have advised the Office Clinical Pharmacology and Biopharmaceutics (OCPB) on modeling and dosing issues. In 2005, the Agency made use of Pharsight's Trial Simulator™ software as part of a modeling effort related to an undisclosed anti-HIV drug, in preparation for an end-of-Phase IIa meeting.
The new agreement continues a history of collaboration with FDA on new technologies to support the drug development process. In 2001, Pharsight signed a three-year CRADA with CDER to address evolving industry and regulatory needs for population PK/PD (pharmacokinetic/pharmacodynamic) modeling and clinical trial simulation.
Products Covered
Under the terms of the CRADA, Pharsight will provide the FDA with software for the analysis, visualization, storage, reporting and review of PK/PD data. The specific Pharsight products covered by the CRADA include:
- Pharsight Knowledgebase Server™ (PKS™)
- PKS Validation Suite™
- WinNonlin®
- WinNonlin Validation Suite™
- Pharsight Trial Simulator™
- WinNonMix®
- Drug Model Explorer® (DMX®)
FDA will use the Pharsight tools to review clinical trial data, especially for clinical pharmacology and clinical safety reviews, and will provide feedback to Pharsight.
The purpose of the collaboration is to develop 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. Pharsight will utilize the FDA’s feedback from the collaboration to further develop and customize PKS to meet industry data management and analysis requirements, and to further develop DMX to support Agency-sponsor interactions for the visualization and communication of model-based product profiles.