Partnership provides pharmacometric biosimulation solutions for multiple FDA centers
PRINCETON, NJ – Nov. 2, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that the United States Food and Drug Administration (FDA) has outfitted its pharmacometrics teams with Certara’s Phoenix® software. Phoenix is the industry’s premier software platform for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data.
Certara’s partnership with the FDA dates back to 2001, when its Pharsight division (pharmacometric biosimulation software) formed a Cooperative Research and Development Agreement (CRADA) with the FDA Center for Drug Evaluation and Research (CDER). That CRADA directly supported the FDA’s Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug development process.
“We are extremely proud of our partnership with FDA, which not only includes the expanded use of Phoenix software for PK/PD, but leverages the Simcyp® Simulator for physiologically-based PK (PBPK) in regulatory review,” said Certara Chief Executive Officer Edmundo Muniz, M.D., Ph.D. “We routinely meet with the agency to collaborate and educate one another on the ever-increasing applications for biosimulation in drug development. Today’s announcement affirms the agency’s commitment to achieving its Critical Path Initiative goals via innovative technology.”
FDA has purchased almost 300 Phoenix licenses of Phoenix WinNonlin, Phoenix NLME and additional Phoenix tools for use across multiple divisions, including the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine, Center for Tobacco Products, Center for Food Safety and Applied Nutrition, Office of Generic Drugs, and Office of New Drug Products.
In its recently-published paper, Catalyzing the Critical Path Initiative: FDA’s Progress in Drug Development Activities, the agency identified computer-based predictive models for safety, efficacy, and disease progression as a key innovation toward improving health. Specifically, the article says, “Modeling and simulation [M/S] tools for drug exposure and its response have been useful in both pre- and post-market settings when questions related to safety and efficacy of therapeutic products arise. M/S has served as a useful predictive tool for dose selection for pivotal trials, dosing in select populations such as pediatrics, optimization of dose and dosing regimen in a subset patient population, prediction of efficacy and dosing in unstudied patient population in clinical trials, characterizing exposure and dose-related QT interval prolongation, and including PBPK modeling in predicting drug-drug interactions.”
Certaraはバイオシミュレーション技術対応のグローバルな医薬品開発会社です。Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable superior drug development and regulatory decision-making through biosimulation, thus increasing R&D productivity and commercial value. For more information, visit www.certara.com.
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions