Pharsight Consulting Services applies quantitative models to decision making
ST. LOUIS, MO – 2013 年 02 月 13 日 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through clinical development, published a new white paper that summarizes its involvement and support of eleven drug approvals over the past 24 months.
Certara’s Pharsight Consulting Services is the largest group in the world focused on model-based drug development to support informed decision making and regulatory support of drug approvals based on a quantitative framework. Pharsight Consulting Services offers support from early preclinical PK modeling, to dose-response and exposure-response analysis of safety and efficacy endpoints, to regulatory reporting, as well as trial and program strategy. Pharsight Consulting Services provided support for several of these approvals by being present at the FDA Advisory Board Meeting to present findings and address questions.
“We are very pleased to support our sponsors in their quest to get new drugs approved,” said JF Marier, Vice President and Lead Scientist, Pharsight Consulting Services. “We have partnered with these sponsors for several years in some cases and are very happy for them and their patients who are now receiving much needed therapies.”
Pharsight Consulting Services continues to expand its expertise in the areas of cardiac safety, pediatrics and orphan drugs, as well as therapeutic areas such as oncology, virology and CNS. “Pharsight Consulting Services is working on several more projects that can possibly lead to additional drug approvals over the next 12 to 24 months. The regulatory agencies have embraced Model-Based Drug Development via the Critical Path Initiative and it is gratifying to see their efforts starting to pay off,” said Dr. Daniel Weiner, SVP and GM of Certara.
Certara is dedicated to improving human health through a broad spectrum of software products and consulting services, from molecular discovery through clinical development, with special focus on supporting translational approaches to drug development. Certara was formed by uniting industry leaders Tripos, provider of innovative scientific software solutions and services enabling life science researchers to improve the efficiency of molecular discovery; Simcyp, a research-based company providing predictive pharmacokinetic and pharmacodynamics tools, workshops, and consultancy services; and Pharsight Corporation, provider of software and scientific consulting services to improve productivity and decision-making in preclinical and clinical drug development. Each Certara family brand has a primary focus on a key phase within the drug discovery and development process; combined, they offer a unique set of capabilities for modeling, analysis, and simulation with scientific informatics that can enable the cross-disciplinary approaches necessary for translational science initiatives. For more information about our consulting capabilities, visit www.certara.com/consulting.