The drug discovery industry is undergoing a significant shift towards New Approach Methodologies (NAMs) that provide more predictive, human-relevant data while reducing reliance on traditional animal models. Regulatory agencies, pharmaceutical companies and biotechnology organisations are increasingly incorporating NAMs into non-clinical development to improve decision-making, strengthen evidence packages and support the development of safer medicines. As the industry moves towards more predictive, human-relevant approaches, organisations are seeking partners that can help them implement NAMs effectively and generate data that supports confident development decisions.
At Metrion, we help clients integrate human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) assays into modern cardiac safety assessment strategies through advanced electrophysiology and human-relevant in vitro models. By combining clinically relevant cellular models with deep expertise in cardiac ion channel pharmacology, we can generate high-quality electrophysiology data that provide mechanistic insight into cardiac ion channel function and proarrhythmic risk, helping clients make more informed development decisions.
For many organisations, adopting these approaches provides a competitive advantage through earlier identification of potential cardiac liabilities, improved confidence in candidate selection, and the potential to shorten development timelines while reducing costly late-stage failures.
New Approach Methodologies (NAMs) encompass a broad range of innovative technologies designed to improve the prediction of human biological responses. These approaches include human cell-based assays, advanced in vitro models, computational methods and integrated testing strategies that can complement or, in some cases, reduce reliance on traditional animal studies.
In cardiac safety assessment, NAMs provide an opportunity to evaluate compound effects using human-derived systems that better reflect human cardiac electrophysiology and ion channel pharmacology than many traditional experimental models.
Cardiac safety remains one of the most critical areas of risk assessment during drug development. Unexpected cardiovascular liabilities can lead to programme delays, regulatory challenges and costly late-stage attrition.
Traditional approaches remain essential components of non-clinical development but they may not always accurately predict human-specific cardiac responses. Human-relevant NAMs, especially human induced pluripotent stem cell (hiPSC) derived cardiomyocytes can help address this challenge by providing insight into compound effects on cardiac ion channels and electrophysiological function earlier in development.
By incorporating NAMs into cardiac safety strategies, drug developers can:
Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs), combined with optical voltage imaging, provide a powerful platform for evaluating integrated multichannel cardiac effects in a human-relevant model. In our study, concentration-dependent changes in action potential waveforms reflected known ion channel pharmacology and distinguished compounds with similar action potential prolongation but different underlying mechanisms. When integrated with automated patch clamp data, this approach provides deeper mechanistic insight into proarrhythmic risk and demonstrates how complementary NAMs can strengthen modern cardiac safety assessment.
Download our poster: Action Potential Waveform Analysis in Human iPSC-Cardiomyocytes Enables Mechanistic Assessment of Multichannel Cardiac Effects.
Metrion combines deep ion channel expertise in ion channels with industry-leading electrophysiology capabilities to help clients implement modern, human-relevant cardiac safety assessment strategies.
Our capabilities include:
Human induced pluripotent stem cell (hiPSC)-derived cardiomyocytes provide a physiologically relevant model for evaluating drug-induced effects on cardiac electrophysiology. Identifying potential cardiac liabilities early is essential for reducing risk during drug development.
Our hiPSC-derived cardiomyocyte assay, performed using the VOLTA optical platform, provides clinically relevant data to help predict the effects of novel compounds on cardiac electrophysiology, including the assessment of QTc and QRS prolongation before clinical studies begin.
By generating translational safety data at an early stage, the assay enables more confident decision-making when prioritising compounds. Early identification of cardiac safety concerns helps minimise late-stage attrition, reducing development costs and accelerating the progression of the most promising candidates. Read more about our clinically translatable hiPSC cardiomyocyte assays.
Assessment of key cardiac ion channels remains an essential component of cardiac safety evaluation. Metrion provides specialist ion channel screening services, including hERG screening and broader cardiac ion channel profiling, to identify potential electrophysiological liabilities and support mechanistic understanding of observed safety signals. Read more about our cardiac safety screening services.
Our electrophysiology experts provide detailed investigations into compound effects on ion channel function and cardiac electrophysiology, helping clients understand the mechanisms underpinning observed safety signals and supporting informed development decisions.
As regulatory expectations evolve, drug developers are increasingly seeking ways to strengthen their non-clinical evidence packages with more predictive and mechanistically informative data.
Metrion's NAMs-enabled cardiac safety capabilities can contribute valuable supporting evidence for IND-enabling programmes by:
Our goal is to help clients generate the data they need to make robust development decisions while building confidence in programme progression.
Metrion is recognised globally for its expertise in ion channels, electrophysiology and cardiac safety assessment.
By partnering with Metrion, clients gain access to:
We help organisations future-proof their cardiac safety strategies by generating the human-relevant, mechanistic data needed to de-risk programmes, strengthen regulatory packages and accelerate the development of safer medicines.
NAMs are innovative scientific approaches that improve the prediction of human biological responses using technologies such as human cell-based assays, advanced in vitro models, computational modelling and integrated testing strategies.
NAMs can provide more human-relevant and mechanistically informative data, helping researchers identify cardiac liabilities earlier and make better-informed development decisions.
Not currently. NAMs are generally used alongside established safety pharmacology approaches to provide complementary data and strengthen overall risk assessment strategies. Their role continues to evolve as regulatory acceptance increases.
NAMs can provide human-relevant mechanistic data that complements traditional non-clinical studies and may help reduce reliance on animal-intensive testing approaches. By generating earlier insight into compound safety and efficacy, NAMs can support more informed decision-making and contribute to leaner development programmes.
Metrion provides human-relevant cardiac safety assays, ion channel screening and electrophysiology expertise that help clients generate high-quality data for modern cardiac safety assessment programmes.
Human-relevant mechanistic data generated using NAMs can provide valuable supporting evidence within broader non-clinical development programmes and help increase confidence in regulatory submissions.
Biologic modalities may offer opportunities to achieve levels of subtype selectivity that can be difficult to obtain using traditional small molecules, particularly across closely related ion channel family members. This may enable more precise modulation of disease-relevant targets while potentially reducing unwanted off-target activity.
We’re proud to introduce two scientific leaders whose expertise is helping advance ion channel drug discovery and pain research: Eddy Stevens, PhD, Chief Scientific Officer, and Tony Rush, PhD, Director of Neuroscience and Commercial Operations.