Pharsight, FDA Collaborate on C-Path for Drug Development

Pharsight Corp., a provider of software and services for clinical drug development, has entered into a Cooperative Research and Development Agreement (CRADA) with the FDA Center for Drug Evaluation and Research (CDER).

Under the terms of the CRADA, Pharsight will collaborate with FDA using Pharsight software for the analysis, visualization, storage, reporting and review of pharmacokinetic/pharmacodynamic data. Pharsight will make comprehensive software tools available, including Pharsight Knowledgebase Server, PKS Validation Suite, WinNonlin Validation Suite, Drug Model Explorer and Pharsight Trial Simulator. FDA will use the Pharsight tools to review clinical trial data, namely for clinical pharmacology and clinical safety reviews, and will provide feedback to Pharsight.

The collaboration 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 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 analysis requirements, and further develop DMX to support Agency-sponsor interactions for the visualization and communication of model-based product profiles.

“This collaboration between Pharsight and FDA supports the Critical Path initiative to improve the productivity and efficiency of the drug development process,” said Shawn O’Connor, president and chief executive officer of Pharsight. “With the increasing costs of new drug development, the FDA recognizes the importance of utilizing innovative technologies, including Pharsight’s data management and modeling and simulation tools, to accelerate review and increase the number of new, safe and effective therapies available to patients.”

“This agreement is concrete evidence of the FDA’s commitment to the Critical Path Initiative,” said Dr. Robert Powell, head of pharmacometrics in FDA’s Office of Clinical Pharmacology. “We believe these tools will help us in applying model-based drug development skills to regulatory decisions, recommendations and knowledge sharing. Building the various model types (disease, placebo, dropout, drug efficacy/safety) requires software tools to acquire, preserve and share data and models in our high-speed environment. Data standardization such as CDISC and software tools is an important foundation for our work. We are looking forward to evaluating and employing these tools and we encourage further innovation in this area.”