The Consortium brings together major pharmaceutical companies to work in collaboration with C-Path and the U.S. Food and Drug Administration (FDA). The Consortium's objective is to enable the exchange of knowledge and resources to improve drug safety.
The Resolver system will be used by the Consortium as a central data management and analysis system as it develops standards for the qualification of tests to evaluate the safety and toxicity of drugs submitted for FDA approval.
The Consortium was established by C-Path and currently has 16 members: Abbott Laboratories, Amgen, Inc., AstraZeneca Pharmaceuticals, L.P., Boehringer-Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline, Iconix Biosciences, Inc., Johnson & Johnson Pharmaceutical Research & Development, LLC, Merck & Co., Inc., Genomics Institute of the Novartis Research Foundation, Pfizer Global Research & Development, Roche Palo Alto Pharmaceuticals, sanofi-aventis U.S., Inc., Schering Plough Research Institute, and Wyeth Pharmaceuticals, Inc. Scientists from the FDA and its European counterpart, the European Agency for the Evaluation of Medicinal Products (EMEA), also participate as advisors.
C-Path is a publicly funded nonprofit research and education institute, which serves to create and support collaborations among industry, academic, and governmental scientists that advance the FDA’s Critical Path Initiative. This initiative is an FDA endeavor to help modernize the process for the development of medical products, including drugs, diagnostics and medical devices.
"In collaboration with the FDA, we are making a rigorous effort to apply new knowledge and scientific expertise to improve the drug development process," said William B. Mattes, Ph.D., director of C-Path’s Predictive Safety Testing Consortium.
"The Resolver system has already played an important role in analyzing and maintaining gene expression data for the FDA's Voluntary Genomics Data Submission program. Based on the reputation and performance of the Resolver system, the Consortium determined that it will be a valuable tool for managing the toxicity and safety biomarker data of the Consortium," Mattes continued.
“It is an honor for the Resolver system to be chosen by The Critical Path Institute’s Predictive Safety Testing Consortium to support this international effort," said Yelena Shevelenko, vice president and general manger of Rosetta Biosoftware. "The use of the Resolver system by members of the Consortium will provide us with additional input to drive the direction of our product and stimulate continuous enhancements to address the needs of our customers.”