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ClinXus Joins Consortium
GRAND RAPIDS — ClinXus, a local clinical trial marketing organization, recently became the first nonprofit to join the Critical Path Institute’s Predictive Safety Testing Consortium.
Critical Path Institute supports the U.S. Food and Drug Administration with collaborative research and education programs that enable the safe acceleration of medical product development. Its Predictive Safety Testing Consortium brings pharmaceutical companies together to share and validate each other’s safety testing methods under FDA advisement and its equivalent in Europe, the European Medicines Agency.
“The PSTC has been described as a model for modernizing the development of medicinal products,” said ClinXus Board President Craig Webb, Ph.D., the Van Andel Institute’s director of translational medicine. “It allows pharmaceutical companies and partners to share knowledge and resources to bring life-saving drugs to the FDA more quickly and safely.”
Initial PSTC members included Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, Merck and Co., Novartis Pharmaceutical Corp., Pfizer, Roche Palo Alto LLC and Schering Plough Research Institute. Seven additional pharma members have joined since then.
ClinXus was founded in July 2006 by the Van Andel Institute, Spectrum Health, Saint Mary’s Health Care, Jasper Clinical Research & Development, Grand Valley Internal Medicine Specialists and Grand Valley State University. ClinXus promotes its partner institutions’ expertise and clinical research capabilities to pharmaceutical and biotech companies and institutions that want to run clinical trials on new medicines, devices and diagnostics. Its focus is to develop innovative clinical trials that are primarily biomarker-driven, involving new medicines, devices and diagnostics in all stages of testing.
William Mattes, Ph.D., director of the PSTC, noted that the consortium has made rapid progress since its inception last year.
“We have already found a number of improved tests for drug safety that can be used in the early stages of drug development,” Mattes said. “ClinXus will greatly facilitate the next phase that includes clinical evaluation of these new tests.”