Clyde Founders contribute to FDA/HESI CiPA publication

 

It has been long established that a hERG assay is not a sufficient predictor for pro-arrythmic actions of a drug (Gintant, 2011; Lu et al., 2008). Since 2013, the FDA has led an initiative designed to validate the use of hiPSC cardiomyocytes in an assay to improve prediction of drug-induced pro-arrhythmic risk (Comprehensive invitro Pro-arrythmia Assay – CiPA).

This initiative has stimulated the use if iPSC-cardiomyocytes in industrial work and a growing number of regulatory filings now contain data from iPSC cardiomyocytes. Many of the large pharmaceuticals currently submit hiPSC cardiomyocyte data as part of their IND submission and in this most recent publication a cross-industry group including two senior Clyde employees have come together to specify the best practices for the CiPA assay.

https://www.sciencedirect.com/science/article/pii/S0273230020301823?via%3Dihub

If you require a CiPA cardiovascular assay for regulatory filing;

  • Clyde is the only CRO with a FDA validated hiPSC cardiomyocyte CIPA assay

  • Clyde’s CiPA assay follows all the recommended published best practices

  • Clyde have been actively supporting regulatory filings since 2016

 
Mark Bryant