Grand Rapids’ ClinXus on leading edge of clinical trials for better, safer drugs

By: Deborah Johnson Wood

For the first time, ClinXus, a Grand Rapids-based life sciences alliance, is in line for early stage clinical drug trials that monitor critical biomarkers in patients. Those biomarkers indicate, on a molecular level, whether disease is present and progressing or responding to the drugs being tested. Pysicians can also assess a patient’s responses to the medication.

The opportunity for the early stage trials came about because ClinXus recently joined the Critical Path Institute’s Predictive Safety Testing Consortium. Consortium members collaborate on research and support the Food and Drug Administration and its European equivalent, the European Medicines Agency.

Currently it takes an estimated 10 years and a billion dollars to bring a drug to market. The consortium hopes to bring better, safer drugs to market faster.

For example, if pharmaceutical companies find a drug is toxic to animals, they will stop production and never test it on humans. But because tests in animals don’t translate well to humans, there is a chance that continuing the trial could produce a safe and effective drug for humans.

“If we discover a biomarker that is shown to predict drug toxicity in a preclinical model, through the PSTC the biomarkers are being qualified to determine if we can potentially use the drug in human trials,” says Craig Webb, ClinXus board president and Van Andel Institute senior scientific investigator.

Theoretically, those trials should be safer because researchers will monitor the patient’s biomarkers to determine safety and effect early.

“We’re in the meetings with the FDA, talking about what we need to do to move these trials forward and no one else in West Michigan has that luxury,” Webb says. “We’ll be getting clinical trials here that typically we would wait for 10 years to get them handed to us.”

Source: Craig Webb, ClinXus and Van Andel Institute

Deborah Johnson Wood is development news editor for Rapid Growth Media. She can be contacted at [email protected].