May 2010 archive

Brigham Renal Division Research at the Center of an International Effort to Identify Next Generation Biomarkers to Screen Kidney Toxicity

Press Release - May 14, 2010

Brigham Renal Division Research at the Center of an International Effort to Identify Next Generation Biomarkers to Screen Kidney Toxicity 

Boston, MA – The kidney is one of the primary targets for toxicity of drugs. Two serum biomarkers, serum creatinine (SCr) and blood urea nitrogen (BUN), are commonly used to detect kidney toxicity in preclinical and clinical studies and in routine clinical care. Both, however, have severe limitations relating to sensitivity and specificity.

New research from the laboratories of Vishal S. Vaidya, a Faculty in the Renal Division at Brigham and Women’s Hospital (BWH) and Assistant Professor of Medicine at HMS and Joseph V. Bonventre, the Samuel A. Levine Professor of Medicine, Health Sciences and Technology at HMS and chief of the renal division at BWH in collaboration with the Predictive Safety Testing Consortium, has resulted in the approval of Kidney Injury Molecule-1 (Kim-1) as a highly sensitive and specific marker of drug-induced kidney injury by both the FDA and EMA and is expected to greatly facilitate evaluation of tubular toxicity in certain preclinical and clinical settings.

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Posted by Vishal Vaidya on Fri, 14 May 2010

Biomarkers for kidney damage should speed drug development

Drug-safety indicators are the first fruits of a collaboration between academia, industry and regulators.

Brendan Borrell (Published online 10 May 2010 | Nature | doi:10.1038/news.2010.232)

Drug-makers have come up with a new set of tools to determine if a promising therapy might damage the kidneys. In the latest issue ofNature Biotechnology, researchers describe the validation of seven specific biomarkers for kidney damage that are found in urine1,2,3,4. It is hoped that these will accelerate drug development from animal safety studies to human clinical trials. The biomarkers are the first major results of a collaboration between pharmaceutical companies, regulatory agencies and academic scientists that was formed in response to a worrying lack of promising drugs in the development pipeline. "In drug development, what one wants to do is fail early on so you can put your resources into drugs that are more likely to succeed," says Carl Peck, former head of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) in Silver Spring, Maryland, who is now at the Center for Drug Development Science, run by the University of California, San Francisco. Peck, who was not involved in the research, estimates that the biomarkers could speed drug development by one to three years.

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Posted by Vishal Vaidya on Mon, 10 May 2010