Clyde will be updating delegates on the recent changes to ICH-S7B/E14 and how hiPSc cardiomyocytes can help fulfil regulatory compliance and also reduce late stage cardiovascular safety failures.
Read MoreGossamer Bio, Inc., one of Clyde’s clients, has recently published a series of case studies to highlight the benefits of hiPSC cardiomyocytes for early identification of a broad set of cardiovascular liabilities. These case studies show that hiPSC-CM assay can assess drug-induced negative inotropy as well as electrical conduction alterations.
Read MoreClyde Biosciences is the leading in vitro cardiomyocyte safety provider with a track record in developing fully validated safety assays to help solve industry wide challenges regarding cardiovascular liabilities beyond that of hERG. Working with the FDA and large pharmas, Clyde has been instrumental in developing next generation assays for pro arrhythmic risk (CiPA Assay) and negative inotropy (CRACKIT). This publication in the Journal of Cardiovascular Pharmacology highlights our excitation-coupling assay for the parallel assessment of voltage and contractility effects using hiPSC cardiomyocytes.
Read MoreIt 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.
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