Pharsight
Corporation (OTC Bulletin Board: PHRS), a leading provider of software,
strategic consulting, and regulatory services for optimizing clinical drug
development, 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 Regulatory Decisions: Data/models
of Diseases, Drugs, Placebo, Baseline, and Dropouts."
"As outlined in FDA's Critical Path Initiative, model-based drug
development offers an important approach to improving drug development
knowledge management and decision-making," said Shawn O'Connor, president,
chief executive officer, and chairman of Pharsight. "We are pleased that
FDA has shared their NSCLC survival model with the public to describe prior
knowledge in this area. With our unmatched collective modeling expertise,
Pharsight scientists are uniquely positioned to help our clients build,
adapt, and extend drug-disease models in their own development programs.
Over the past three years, we have supported more than 30 oncology programs
and modeling initiatives for industry clients, from pre-clinical to Phase
III and covering critical issues in trial design, dose selection, and
development strategy. We look forward to collaborating with our client to
share feedback with FDA, and to contributing to ongoing industry
discussions on opportunities for sharing drug-disease models to support
quantitative decision-making in clinical development."
About Pharsight Corporation
Pharsight Corporation develops and markets integrated products and
services that enable pharmaceutical and biotechnology companies to achieve
significant and enduring improvements in the development and use of
therapeutic products. Pharsight's goal is to help customers reduce the
time, cost and risk of drug development, as well as optimize the
post-approval marketing and use of pharmaceutical products.
Pharsight's approach enhances the fundamental element of drug
development success: strong decision-making. By adopting the Pharsight
approach, customers acquire a new decision-making process with the
potential to systematically improve every level and phase of their business
and scientific processes. Pharsight Corporation is headquartered in
Mountain View, California. Information about Pharsight is available at
pharsight.
Registered Trademarks and Trademarks
Pharsight is a registered trademark of Pharsight Corporation. All other
brand or product names mentioned in this documentation are trademarks or
registered trademarks of their respective companies or organizations.
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