Grand Rapids Researchers Take Part in International Coalition to Speed and Improve Research on Kidney Disease
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Grand Rapids Researchers Take Part in International Coalition to Speed and Improve Research on Kidney Disease
Grand Rapids, Mich., - May 20, 2010 - Every game has rules. For scientists, identifying biomarkers which can be used to identify disease at the earliest stages represents one of the most basic rules in the drug development game. This process includes developing consensus on language and terms that can be used by other researchers and regulators to speed development of potential therapies.
A study published this week in a special issue of the scientific journal Nature Biotechnology was co-authored by Grand Rapids-based researchers from ClinXus, Innovative Analytics, and the Van Andel Institute along with colleagues from the pharmaceutical and biotechnology industry. The researchers worked together to identify seven new biomarkers that can be used to assess safety and potential clinical effects in kidney disease. Researchers also proposed common terminology and procedures to guide
future scientists.
Researchers included ClinXus executive director and chief medical officer William Baer, M.D., Pharm.D., Matthew Schipper Ph. D., biostatistician, clinical at Innovative Analytics and Craig Webb, Ph.D., director of the Program of Translational Medicine at the Van Andel Research Institute.
"Each time science advances our understanding of how certain molecular biomarkers work, we take another step toward modernizing how drugs are developed," said Baer. "Researchers could use these new biomarkers to support decisions to advance or suspend development because they can objectively evaluate whether superior standards of performance have been met. What's more, those decisions could be made much earlier in the development process, saving valuable time and research money."
Because the kidney is exposed to high levels of medicine in the human body, monitoring kidney safety is critical to drug development. Compounds that damage kidney tissue cannot generally proceed to later-stage human trials.
"This focus presents the first formal results of the Predictive Testing Safety Consortium, a community-wide effort involving industry, non-profit institutions and regulators to qualify seven nephrotoxicity biomarkers in the preclinical and ultimately clinical settings," said Webb. "In gathering and analyzing these data, the consortium has taken
the first steps in outlining a generic path for regulatory qualification of biomarkers in general."
The study compared biomarkers to current standard indicators of kidney impairment. Biomarkers that outperformed those standard tests for monitoring kidney safety were identified and proposed for use by regulatory authorities as clinical trials progress to early use in humans.
"Including regulatory authorities in this process was crucial," said Baer. "Because all promising therapies are evaluated by regulatory authorities, it is imperative that the research on a compound is agreed to as acceptable by those authorities. This research lays the framework for that process.
"Now that the rules have been defined, scientists can begin using these new biomarkers in additional research to validate their utility as superior indicators of kidney damage in the clinical setting," he said.
ClinXus researchers participated in the study as part of the organization's membership in the Critical Path Institute's Predictive Safety Testing Consortium, a public-private partnership that includes 15 global pharmaceutical companies and ClinXus. The U.S. Food and Drug Administration, and the European EMA participated as observers and
advisors.
The Critical Path Institute has recently selected one of ClinXus' members, Jasper Clinical Research and Development, Inc., to conduct the first study in the biomarker qualification effort. This trial will involve healthy volunteers and will establish baselines and thresholds for these novel biomarkers. The next steps evolve into standard of care
based trials and then to those where adaptive decisions can be made using these as new standards in patient care.
About ClinXus
The ClinXus network of partner and community institutions represents a diverse set of clinical and support organizations. Through this collaborative alliance, we provide clinical trial sponsors the advantages of collective expertise, with particular emphasis on biomarker-driven clinical research. Network members have extensive
credentials in health care, preclinical, early clinical development (providing a smooth transition for translational-based studies), clinical research and academics, and follow guidelines for Good Clinical Practices. This in-depth expertise extends across a range of specialties such as oncology, ophthalmology, cardiovascular, inflammatory,
neurological, metabolic and endocrine medicine. State-of-the-art patient facilities and support includes a 50-bed full-service phase I clinical research unit, combined 1,500-bed hospital capacity, integrated physician network with extensive EMR utility and standardized custom sample acquisition. For more information, visit www.clinxus.org
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