Predictive Cardiac Safety and Efficacy with human-relevant cardiomyocyte models

Clyde are attending ACT to engage with toxicologists regarding their human stem cell derived cardiomyocyte safety assay (CellOPTIQ). The pharmaceutical industry has entered a new challenging phase, where political pressures have set about a roadmap for the reduction of animal experimentation, replacing them with in vitro human assay alternatives (NAMs).

Clyde Biosciences, a leading CRO specialising in in vitro human cardiomyocyte safety and heart failure studies, has proudly completed its 300th client study—a major milestone reflecting over a decade of scientific partnership with pharmaceutical companies, biotechs, and regulatory agencies worldwide.

Professor Godfrey Smith, Chief Scientific Officer at Clyde Biosciences will be presenting both a talk and a poster at the Safety Pharmacology Society’s Annual Conference in Utrecht, Netherlands (13–15 October 2025). His presentation will highlight Clyde's collaborative work with major pharmaceutical companies, regulatory agencies, and hiPSC cardiomyocyte providers to develop and validate new approach methodologies (NAMs) for cardiovascular safety assessment. 

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.

Gossamer 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.

Clyde 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.

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.

Clyde Biosciences (Clyde) today announced that the major NC3Rs Crackit Inpulse study demonstrated the accuracy of its CellOPTIQ® technology in predicting the cardiac side-effect risk of drugs. Clyde’s platform provided the majority of data in this large study, a collaboration amongst Clyde’s laboratory, GSK, and Professor Chris Denning at Nottingham University..’ […]

Clyde Biosciences is delighted to announce it has demonstrated superiority over the legacy MEA system in the recent international CiPA study. Initiated by the FDA and by the Health and Environment Sciences Institute, the CiPA study pitted Clyde Biosciences’ CellOPTIQ system against the established micro-electrode array. The results of the study confirmed that Clyde Biosciences’ […]

The Clyde Biosciences team are delighted to have been shortlisted for an award in February’s Scottish Life Sciences Awards. One of three finalists in the Innovative Collaboration award, Clyde has been recognised for its contribution to a global initiative designed to improve the way drugs are assessed for cardiac safety. The initiative, known as CiPA […]