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Companies, regulators team up for drug testing

Regulators, scientists at 17 companies and academic researchers have teamed up in a new international experiment to find agreed-upon ways to test new drugs in the lab and eventually in people.

The hope is to find a few simple measures that will tell whether a drug is likely to cause serious side-effects, and then share them among drug developers and regulators, members of the team reported in the journal Nature Biotechnology on Monday.

The group, called the Predictive Safety Testing Consortium, chose a panel of biomarkers -- proteins that indicate disease or injury -- to predict kidney injury from experimental drugs.

The unprecedented collaboration includes the U.S. Food and Drug Administration and the European Medicines Agency, and the hope is to streamline the approval process as well.

"Better biomarkers will allow drug developers to make more informed decisions about which products to move forward in testing, the doses at which they should be used, and ways to design clinical trials that will provide clear information about product benefit and safety," Dr. Joseph Bonventre of Brigham and Women's Hospital and Harvard Medical School in Boston and colleagues wrote in a commentary.

The group chose seven potential biomarkers in urine to detect specific kidney injuries in rats.

Up to a third of new drugs in development are abandoned because they damage some organ in lab animals, but Bonventre said this is often unjustified, giving the Bristol Myers Squibb AIDS drug Sustiva, known generically as efavirenz, as an example.

Sustiva kills kidney cells in rats, but not in monkeys or humans, Bonventre wrote. The drug, an important part of the arsenal used against AIDS, could have been abandoned.

Frank Dieterle of the Novartis Institutes for BioMedical Research in Basel, Switzerland and colleagues noted that two biomarkers called serum creatinine, or SCr, and blood urea nitrogen, or BUN, are currently used to measure kidney damage, but they are not very accurate.

"This is the first report to use a broad panel of urinary biomarker values to demonstrate that renal injury can be monitored at both the point where toxicity begins and when it reverses after the withdrawal of treatment," they wrote in one of the series of reports in the journal.

Frank Sistare of Merck Research Laboratories in West Point, Pennsylvania and colleagues said the collaboration saved everyone time and trouble.

"Agreement to the use of pre-existing study samples accelerated experimental progress and saved over $4 million in estimated animal, human and other associated study expenses," they wrote.

David Warnock of the University of Alabama at Birmingham and colleagues said the collaboration should also simplify new drug approvals.

"Until now, both the FDA and EMEA required pharmaceutical companies to submit the results of renal toxicity biomarker qualification tests separately," they wrote.

"The successful collaboration of fiercely competitive pharmaceutical companies (overcoming substantial intellectual property barriers) with scientists from academia and regulatory bodies is particularly notable," they added.