Pharsight Uses FDA Disease Model to Support Oncology Drug D...( Use of FDA Model in Non-Small Ce...),Health

Use of FDA Model in Non-Small Cell Lung Cancer Expected to Inform

Quantitative Predictions for Experimental Cancer Treatment

MOUNTAIN VIEW, Calif., Nov. 20 /PRNewswire-FirstCall/ -- Pharsight Corporation (OTC Bulletin Board: PHRS), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that its Strategic Consulting Services Group is using a quantitative disease model developed by the Food and Drug Administration (FDA) for non-small cell lung cancer (NSCLC) to support an oncology drug development program sponsored by one of its clients, a global pharmaceutical company.

Pharsight scientists are using FDA's publicly available model in NSCLC to perform simulations of expected survival based on tumor shrinkage for an investigational drug in early clinical studies. Pharsight scientists also expect to refine these simulations with emerging data in new clinical studies to assist with key oncology development program decisions, including optimized dose selection and improved design of survival trials.

Pharsight's collective modeling and simulation experience in oncology includes longitudinal exposure-response modeling to inform labeling decisions and test dosing strategies, allometric projections, and work with novel mechanisms.

FDA has developed several quantitative drug-disease models based on the literature and clinical trial data from sponsor submissions for drug approval. FDA does not release proprietary source data from sponsors used to develop and validate the models, but the agency has underscored its commitment to publicly sharing and further testing the models that it has developed in important disease areas, including oncology. The NSCLC model was presented by FDA scientists at a January 2007 meeting, co-sponsored by FDA and the Drug Information Association (DIA), entitled "Sharing Knowledge to Improve Clinical Drug Development and Regulator
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