PCI 3.06.26

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Subsection - Neurodegenerative Diseases

From Depression to Deep-Learning: Leveraging iPSC and AI Platforms for Evidence-Based Depression Treatment

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Subsection - Oncology

Essential DMPK Strategies for IND Success

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Subsection - Cell and Gene Therapy

When the Gene Editing Guide is the Drug

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CiPA-Ready hiPSC Cardiomyocytes for Cardiac Safety Assessment

Drug-induced arrhythmias remain a significant challenge in pharmaceutical development, often resulting in
late-stage failure, regulatory rejection and post-market withdrawals. Traditional safety assays focused on hERG
potassium channel inhibition and QT prolongation, while effective at detecting torsadogenic compounds, frequently overestimate risk for multichannel-acting drugs and underestimate chronic structural toxicity.1,2 Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) have emerged as a superior human-relevant alternative, particularly when integrated into the Comprehensive in vitro Proarrhythmia Assay (CiPA) framework.2,3 CiPA-ready hiPSC-CM platforms offer a convergent solution that combines physiological relevance, mechanistic insight and regulatory alignment, positioning them as pivotal tools for next-generation cardiac safety assessment.1,2,3

The Need for Better Cardiac Safety Testing
Cardiovascular toxicity remains a leading cause of late-stage drug development failure and post-marketing withdrawal. Historical analyses show that 8.7% of drugs withdrawn between 1960 and 1999, and 14% withdrawn between 1953 and 2013, were due to unanticipated cardiotoxic effects.4,5 These failures span diverse therapeutic classes, antiarrhythmics like dronedarone, anticancer agents including anthracyclines, and non-cardiac drugs such as antidiabetics, fluoroquinolones and SSRIs.1,6,7,8

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