� The Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC), which includes Grand Rapids-based ClinXus, has identified seven new tests to assess the safety of new drugs in development, specifically to monitor the drugs' effects on the kidneys. The U.S. Food and Drug Administration (FDA) and its equivalent in Europe, the European Medicines Agency (EMEA), recently approved the consumption of these tests in the preclinical phase of drug development, as easily as the use of five of the tests in some cases bridging pre-clinical and Phase I clinical studies.
The tests measure the levels of seven key proteins or "biomarkers" base in pee that crapper provide extra information around drug-induced damage to kidney cells, as well known as renal perniciousness. Currently, researchers and clinicians typically look for changes in serum creatinine and blood urea nitrogen (BUN), but these may only show up after the onset of kidney injury, which can buoy be permanent.
According to William Mattes, Ph.D., C-Path's director of the PSTC, "Using current kidney tests that were developed over 100 geezerhood ago, 70 percent of kidney office must be lost before damage can be detected. The new approved biomarkers are far more sensitive and specific for drug-induced kidney damage."
Many of the newly approved biomarkers are not new to the research and clinical community. But the deficiency of specific scientific "rules" or standards about their utility has prevented companies from victimisation them for fear that data from the studies could further delay the FDA and EMEA approval process. By quantifying biomarker information and getting approval to utilisation the tests from these regulatory bodies, the PSTC has eliminated a significant barrier to the drug development work.
The side by side steps are to gather more information to backing using these tests more than broadly in clinical studies, and eventually to make approval to use some or all of the biomarkers to help guidebook medical deciding.
"ClinXus has always been dedicated to introducing molecular biomarkers into the clinical trial sue," said ClinXus Board President Craig P. Webb, Ph.D., Van Andel Institute scientific investigator and director of translational medicine. "Our role in the next phase of the Critical Path's PSTC endeavour will be to ease the clinical evaluation of these new biomarkers and diagnostic tests."
This is the most significant achievement to-date of the PSTC, which was created in 2006 to identify improved methods to test the safety of new drugs in development and bring life-saving drugs to the FDA more quickly and safely. The collaboration involves over 200 scientists from the xVI largest pharmaceutical companies, not-for-profit research organizations, and advisors from the FDA and the EMEA. ClinXus, a community-based clinical research alliance focused on innovative devices/medicines, became the first not-for-profit to join the PSTC earlier this year.
ClinXus was formed in July, 2006 to establish innovative clinical tryout designs that are chiefly biomarker goaded and to increase admittance to clinical research and emerging technologies provided by member organizations, enhancing patient care and establishing West Michigan as a national destination for innovative clinical research. The alliance's vI founding members include Grand Valley Medical Specialists, Grand Valley State University, Jasper Clinical Research & Development, Saint Mary's Health Care, Spectrum Health and Van Andel Institute.
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