PHARSIGHT ANNOUNCES COOPERATIVE RESEARCH AGREEMENT WITH FDA FOR ITS CLINICAL TRIAL SIMULATOR AND POPULATION MODELING SOFTWARE
Goal is to collaboratively explore and enhance software tools for use in clinical trial drug development
MOUNTAIN VIEW, CA—February 13, 2001 — Pharsight Corporation, (Nasdaq:PHST) the leading provider of technologies and services for accelerating pharmaceutical development, today announced the approval of a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) to further develop products using clinical drug trial simulation and population pharmacokinetic (PK) analysis software to support the drug development process. Under the agreement, CDER and Pharsight will collaborate on future versions of Pharsight's WinNonMix® and Pharsight® Trial Simulator™ products over a three-year term. The goal of the collaboration is to address evolving industry and regulatory needs for population PK/PD (pharmacokinetic/pharmacodynamic) modeling and clinical trial simulation.
"This collaboration is expected to benefit both organizations and potentially the pharmaceutical industry as well. By combining the needs of the agency with the needs of the industry we can create better products for clinical development design and evaluation," said Daniel Weiner, Ph.D., Pharsight's senior vice president of technology deployment.
Population PK/PD studies are designed to determine important sources of variability in drug concentrations and effects among individual subjects of a target population who participate in the clinical testing of a new drug. Population PK/PD analysis makes it possible to identify relevant intrinsic and extrinsic (demographic or physiological) variables that contribute to the differences in patient blood level profiles and pharmacodynamic outcomes.
These results can be valuable in planning later phases of clinical trials. By using these software tools to better explain the measurable factors that may be related to both the change and the magnitude of change in outcomes, more appropriate directions for dosage, administration and labeling for new drugs may be achieved.
"While population modeling and trial simulation tools have become increasingly important to the pharmaceutical development process, technological advances now make it possible to develop additional user-friendly scientific software to help integrate these multiple sources of input into the planning and review processes," Weiner said. "This could enable more efficient clinical trial design and evaluation."
Pharsight will provide software products, consulting and training and will collaborate with CDER to develop software solutions.
About Pharsight Corporation
Pharsight Corporation (Nasdaq:PHST) develops and markets integrated products and services that help pharmaceutical and biotechnology companies improve the drug development process. The company's solutions combine proprietary computer-based simulation, statistical and data analysis tools with the sciences of pharmacology, drug and disease modeling, human genetics, biostatistics and strategic decision making. Pharsight Corporation is headquartered in Mountain View, California. Information about Pharsight is available on the World Wide Web at www.pharsight.com.
This press release contains forward- looking statements related to the future development of products under this CRADA and the benefits to be obtained. Actual results may differ as a result of numerous risks and uncertainties, including the risk that the collaboration may not yield expected results due to unexpected technical or other difficulties, or that customers may not perceive the benefits of the resulting products as Pharsight perceives them.
Pharsight and WinNonMix are registered trademarks, and Trial Simulator is a trademark of Pharsight Corporation.