The agency is considering using seven biomarkers that signal kidney injury when found in the uring of test subjects in hopes of moving drugs to market faster and reducing patient risk, The San Francisco Chronicle writes. And an announcement is expected any day, according to one FDA official.

“Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety,” Ray Woosley, ceo the nonprofit Critical Path Institute, which is working with the FDA to safely speed drug development, tells the paper.

Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animal reactions aren’t always the best predictor of whether substances will be safe for humans, the paper notes. Of course, drugs that are harmless to animals can hurt humans, and vice versa. If a drug that is toxic to the kidneys passes animal tests today, the damage might not show up until it is too late. “Using current tests, you have lost about 70 percent of the kidney function before you pick it up,” William Mattes, director of toxicology at the Critical Path Institute in Tucson, tells the Chron.

The new biomarker process has the potential to save a patient’s kidneys. Pharma’s ultimate goal is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.

So far, 17 drugmakers have joined the research into biomarkers at the Critical Path Institute, including Bristol-Myers Squibb, Glaxo, Johnson & Johnson, Merck and Pfizer, although they contribute expertise, not funding, according to Woosley.

Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests. “This qualification process allows the industry to have an accurate view of the application of these biomarkers in drug development. They are not replacing anything that is done today. But the goal, as we gather more and more information, is to eventually be able to include them in clinical trials,” Federico Goodsaid, senior staff scientist at the genomics group at the FDA Office of Clinical Pharmacology, tells the paper.

Goodsaid is responsible for the development of the FDA’s biomarker qualification pilot process, which began about a year ago when 23 potential biomarkers for kidney damage were submitted to the federal agency. The evaluation process at the Critical Path Institute has since selected the seven most efficient ones.

Named for the risky period when a drug is taken from the preclinical stage into clinical trials, the Critical Path Institute was founded two years ago by the FDA in collaboration with University of Arizona and Menlo Park’s SRI International to break a worrying trend in the industry: In the past decade, the number of innovative therapies submitted for FDA approval dropped by 50 percent, but the cost of drug development increased dramatically, the paper notes.

What makes the institute unique is that FDA is a co-founder. The European Medicines Agency also participates as an adviser. The agency is expected to qualify the seven biomarker testing method simultaneously with FDA. “This is the first time they have coordinated their decisions,” Mattes says.

Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit public interest organization, supports the use of biomarkers as long as they are properly validated. But he is critical of the FDA’s attitude toward present drug safety tests. “Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA,” he tells the paper.

He cites two recent examples of drugs in trouble, both of which showed toxicity in laboratory animals: the diabetes drug Avandia from GlaxoSmithKline and Vytorin from Schering-Plough and Merck, a cholesterol-lowering medication. “Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used,” Wolfe tells the Chron.

The official announcement of the qualification of the seven biomarkers for kidney injury is expected from the FDA any day. “It is in a very advanced stage of that process,” Goodsaid tells the Chron. “We should have some news soon.”

Source: The San Francisco Chronicle