FDA Utilizes Pharsight Consultants During Model Development

Pharsight Corporation, a leading provider of software and strategic services designed to optimize clinical drug development, announced today that the U.S. Food and Drug Administration (FDA) has utilized Pharsight’s scientific input in the development of an anti-HIV drug model.

In preparation for a recent End of Phase IIa (EOPIIa) meeting with a company in the process of developing an anti-HIV drug, the FDA used quantitative-based modeling and simulation in an effort to engineer the best clinical trial design for the late Phase II and Phase III programs.  To assist in constructing this model utilizing Pharsight’s Trial Simulator(TM) program, the FDA used Pharsight scientific staff as consultants, who were able to provide specific expertise in the model development process.

In a March 2004 report entitled “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products” the FDA discussed the challenges of the current medical development process, which has become inefficient and costly, and which has resulted in a drastic slowdown in innovative medical therapies that have recently been submitted for approval. To address these issues, the FDA has established The Critical Path Initiative, which strives to identify and prioritize the most pressing development problems and the areas that provide the greatest opportunities for public health benefits.

As part of its Critical Path Initiative the FDA has recently instituted the EOPIIa program, which enables the FDA to provide sponsors of clinical trials with valuable input earlier in the drug development cycle.  Prior to the program’s establishment, sponsors typically met with the FDA at the end of Phase II clinical trials, which was often too late for the FDA to have a meaningful impact on the design of the Phase III program.

“We were honored to provide the FDA with critical support and input for their modeling and simulation efforts,” said Shawn O’Connor, president and chief executive officer of Pharsight.  “We have amassed a large collection of data that supports our theory that utilizing quantitative-based modeling and simulation during drug development greatly increases the productivity and efficiency of the process.   We believe that the FDA’s desire to build drug models to better their understanding of the drug development process validates the value of our methodology and modeling approach.”

About Pharsight Corporation
Pharsight Corporation is a leading provider of software products and consulting services that help pharmaceutical and biopharmaceutical companies improve and accelerate their decision-making in drug development and commercialization. By integrating scientific, clinical and business decision criteria into a dynamic, model-based methodology, Pharsight helps its customers optimize the value of their drug development programs and portfolios from discovery to post-launch marketing and any point in between.  Pharsight’s computer-based drug-disease models, dynamic predictive market models, clinical trial simulation and advanced valuation models create a continuously evolving view of its customers’ development efforts and product portfolios. Pharsight’s range of software offerings includes the Drug Model Explorer(TM) Web Server (DMX(TM)), Pharsight Knowledgebase Server(TM) (PKS(TM)), PKS Reporter(TM), Trial Simulator(TM), and WinNonlin(R) and WinNonMix(R) modeling tools.  Related software services include pharmacokinetic automation services and training courses.  Information about Pharsight is available on the World Wide Web at http://www.pharsight.com .

NOTE:  Pharsight, WinNonLin and WinNonMix, Pharsight Knowledgebase Server, PKS, Drug Model Explorer, DMX, PKS Reporter and Trial Simulator are registered trademarks or trademarks of Pharsight Corporation.