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iSAEC Partners with Catholic Health Initiatives

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The International Severe Adverse Event Consortium (iSAEC) will partner with the non-profit health organization Catholic Health Initiatives (CHI) to enroll subjects for studies to identify genetic markers for three drug-induced adverse events.

The consortium said today that it will collaborate with CHI's Center for Translational Research business unit to combine research capabilities and clinical data warehouses aimed at building research cohorts associated with hepatoxicity, serious skin rashes, and acute hypersensitivity syndrome.

Based in Englewood, Colo., CHI's health system operates 72 hospitals; 40 facilities for long-term care, assisted, and residential-living facilities; community health organizations; and home health agencies in 19 states.

iSAEC is a private partnership of pharmaceutical and life sciences companies, the US Food and Drug Administration, the Wellcome Trust, and other academic research institutions, working together to discover and confirm genetic markers for predicting severe adverse events.

The collaboration will support the development of SAENet, an iSAEC-led research initiative involving large teaching and community hospitals aimed at securing well-characterized SAE cases for use in research of the genetic basis of adverse responses to drugs.

"Our efforts to date on drug-induced immunologic SAEs traditionally leveraged academic networks with research subject recruitment across a limited number of hospitals," iSAEC Chairman Arthur Holden said in a statement.

"By working with the CTR and other large sophisticated providers, all of whom have outstanding clinical research capabilities, we hope to open up a new, more scalable research channel for enrollment of subjects into this vital research. Our goal is to increase the breadth and diversity of patient participation to provide our clinical research collaborators with larger, more developed research cohorts in a more efficient and effective manner," said Holden.

The first phase of the CTR collaboration is expected to last around two years, according to iSAEC.