Under terms of the agreement, Pharsight will provide consulting services to develop models that relate drug treatment to clinical outcome, based on identified genetic difference characteristics in the human population. The initial modeling and simulation will use information from Roche's mouse "Digital Disease" genomics discovery platform (Science. 2001 292:1814-5) to identify the genetics traits influencing drug efficacy. These models will be used to simulate clinical trials, based on the Pharsight Trial SimulatorÔ software, to explore alternative trial design, and to assess how to best incorporate genetic analysis into the trial design. Roche will identify and test the optimal design to validate the use of Pharsight's modeling and simulation methodology, linking genetic analysis with clinical drug development. The financial terms of the agreement were not disclosed.
"Much of the emphasis in genomic research has been directed toward identification of new targets for drug discovery; however, genomics can improve the efficiency of the entire drug development process, from discovery through clinical development," said Gary Peltz, M.D., Ph.D., head of genetics for the Roche Bioscience Inflammatory and Viral Diseases Unit. "Genomic research has not been widely utilized in many areas of clinical development in the pharmaceutical industry. In our collaboration with Pharsight, we expect to better understand how to link a genomics discovery platform to the clinical development of new drugs. Pharsight has the right combination of scientific expertise and simulation tools to help us explore this complex problem. This is one step toward the development of individualized healthcare from which patients will benefit by receiving treatment tailored to their specific physiology."
"Modeling and simulation is the logical bridge between the huge contributions of genomics in drug discovery and clinical drug development," said Greg Lee Ph.D., Pharsight founder and vice president of engineering. "What is particularly exciting about the Roche collaboration is that it leverages Roche's Digital Disease platform, and that it involves a prospective validation of the application to clinical development. We expect to have a quantitative demonstration of the general benefits of exploiting genetic knowledge in clinical trials. If the technology is successful at optimizing clinical trial design, then the same principles should apply to optimizing drug treatment for patients. This is the most exciting part of the collaboration: the potential for improving drug therapy by selecting the right drug, and giving it at the right dose, for the individual patient."
About Roche
Roche Bioscience is focused on the discovery and early clinical development of innovative new medicines to treat diseases including arthritis, asthma and other respiratory diseases; anxiety, depression, schizophrenia and other neuropsychiatric diseases; genitourinary diseases, osteoporosis, HIV/AIDS, and hepatitis C.
Located in the Stanford Research Park in Palo Alto, Calif., Roche Bioscience employs approximately 1,100 men and women. It is one of five worldwide research centers for the Roche Group. Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative services address the prevention, diagnosis and treatment of diseases, thus enhancing people's well-being and quality of life. More information on Roche Bioscience is available at http://paloalto.roche.com.
About Pharsight
Pharsight Corporation develops and markets products and services that help pharmaceutical and biotechnology companies improve 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 uses computer-based drug-disease models, dynamic predictive market models, clinical trial simulation and advanced valuation models to create a continuously evolving view of its customers' development efforts and product portfolios. This enables decision makers to make explicit value-driven trade-offs throughout the development and commercialization process. Pharsight Corporation is headquartered in Mountain View, California. Information about Pharsight is available on the World Wide Web at http://www.pharsight.com.
The statements in this press release regarding the benefits to be obtained from Pharsight's products and services are "forward-looking statements" that involve risks and uncertainties, including the risk that Pharsight's technology may not be successful in optimizing clinical trial design or that its benefits may not be fully realized due to unforeseen adverse results in the drug discovery and clinical development processes. For a further description of the risks and uncertainties Pharsight faces, see the reports it has filed with the Securities and Exchange Commission. Pharsight disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
