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Follow on Google News | Critical Path Institute Secures Regulatory Support For Kidney Safety BiomarkersBy: Critical Path Institute “This Letter of Support intends to encourage scientists to collect data from exploratory studies, which may lead to qualification of these types of biomarkers,” The kidney safety biomarkers, osteopontin (OPN) and neutrophil gelatinase-associated lipocalin (NGAL), are proteins that can be measured in urine. Higher levels of OPN and NGAL could indicate the kidneys are being damaged and result in a loss of kidney function. “We are pleased to continue our work with the FDA, academia, and industry on identifying tools, processes, and methods to improve the drug development process,” said Martha Brumfield, Ph.D., president and chief executive officer of C-Path. “With this Letter of Support, the FDA has opened doors that encourage the generation of necessary, rigorous clinical data to determine if these biomarkers hold clinical utility.” The FDA’s Letter of Support indicates that a biomarker has strong potential for use in humans and warrants additional exploration and gathering of data. The FDA granted the Letter of Support for OPN and NGAL to encourage their use in both nonclinical and exploratory clinical studies as markers of proximal renal tubule degeneration/ “What’s notable is that the collaborative efforts of the PSTC and FDA have led to the Letter of Support, a mechanism to benefit the clinical qualification of new Drug Development Tools,” said Jonathan Phillips, Ph.D., head of translational safety biomarkers at Boehringer Ingelheim Pharmaceuticals, Inc. The Letter of Support for OPN and NGAL is posted on the FDA DDT website (http://www.fda.gov/ About the Critical Path Institute The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the U.S. Food and Drug Administration (FDA). C-Path’ End
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