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Ready to change the paradigm of cardiac safety assesment?

The current regulatory FDA guidelines for cardiac safety assessment (ICH S7B) require in vitro hERG and in vivo QT analysis. However, it has become well-accepted that hERG block is not sufficiently predictive to detect arrhythmias. Thus, a comprehensive cardiomyocyte model is required for a better prediction for cardiac liability. The CiPA consortium aims to validate the use of human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CM) for implementation in regulatory testing of cardiac safety.

The results of the CiPA Pilot study have been published, which support the utility of hiPSC-cardiomyocyte assays for cardiac safety evaluation.

To read more: Results - CiPA Myocyte Pilot Study

 

 

What is CiPA?

CiPA Steering Team

CiPA is coordinated by the CiPA Steering Team and is composed of members of the following organizations:

What is CiPA?

The Comprehensive in vitro Proarrhythmia Assay (CiPA) is a novel safety screening initiative driven by HESI, the FDA and the Safety Pharmacology Society (SPS). The CiPA initiative aims to validate iPSC-derived assays solutions for the identification of cardiac arrhythmias as a side effect of pharmaceuticals with the ultimate aim to include the technology in the regulatory ICH S7B guideline.

 

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Our vision

The drug discovery & development market needs reproducible, predictive and translatable human cellular models to facilitate decisions about drug candidates in the drug discovery & development process. Safety assessment plays a key role in this decision making and creates a real need for emerging technologies based on human biology in order to increase success rates. Human stem cell-based cardiomyocyte assay solutions are revolutionizing drug safety studies. Ncardia is at the forefront of this workflow transformation.

What our experts are saying

At Ncardia we believe that stem cell technology will help to get better medicines to patients faster. Our top priority is to develop products and solutions that can be used in the pharma industry on a routine basis. Alternatively, we can provide safety assays as services. We are ready to help you implementing CiPA cardiomyocyte assays in your lab.

Ncardia has adopted stringent quality management metrics to continuously improve operations and ensure quality. We are ready for regulatory acceptance…

Read interview with Greg & Ralf

The CiPA project is unique and very important for multiple reasons. First of all, it is probably the first fully functional cardiac safety model that has been extensively validated…

Read interview with Stefan

Peer-reviewed publications

Our selection of peer reviewed publications about CiPA can be found here. This selection provides the most recent insights and developments of CiPA. For a complete overview of CiPA-related publications we refer you to: The CiPA Project Home Page

CiPA Myocyte Pilot Study

The results of the CiPA Myocyte Pilot Study have been published! We are proud that the results reported in this publication support the use of our Cor.4U® Cardiomyocytes for cardiac safety evaluation as defined by FDA/HESI/CSRC’s CiPA initiative. The CiPA initiative aims to validate iPSC-derived cardiomyocyte models and related technologies for predicting potential cardiac arrhythmia risks during pharmaceutical R&D. These data show the summarized data from the initial Myocyte Team’s blinded "Pilot Studies". These multi-site validation studies were executed in order to confirm the electrophysiological effects, as well as sensitivity, specificity and reproducibility of hiPSC-derived cardiomyocytes in response to eight well-characterized drugs across different MEA platforms, cell manufacturers, and testing sites. Concentration-dependent effects on repolarization and observations of arrhythmia-related events consistent with known ionic mechanisms of single and multi-channel blocking drugs were clearly observed in the study. These data demonstrate the predictive functionality of iPS-derived cardiomyocytes as a HTS-scalable tool for comprehensive cardiac risk assessment and have paved the way for future validation studies required for further adoption of CiPA strategies.

Read more about the CiPA Myocyte Study here.

Ncardia Posters

Download our White Paper

Our experts Ralf and Greg outline in a White Paper what CiPA and Ncardia can do for you.

Download it below:

Protocol

Interested in our CiPA protocol?

This protocol outlines how to prepare and implement our Cor.4U® Cardiomyocytes on microelectrode array (MEA) assays for CiPA implementation.

 

 

Download Protocol