New Partnership for Comprehensive In Vitro Cardiac Safety Assessment

PhysioStim & ACEA Biosciences announce partnership

A hi-tech alliance to measure preclinical cardiac safety in vitro

ACEA Biosciences and PhysioStim will work together to provide comprehensive in vitro cardiac safety and toxicity assessment services for pharmaceutical and biotechnology companies in Europe.

Press release

ACEA Biosciences Inc. (ACEA), now a part of Agilent Technologies, is a pioneer in the development and commercialization of high performance, cutting-edge cell analysis platforms for life science research. Today, ACEA Biosciences and PhysioStim, a leading European CRO with GLP-certified expertise in cardiovascular pharmacology and electrophysiology, are announcing a partnership to provide comprehensive in vitro cardiac safety and toxicity assessment services for pharmaceutical and biotechnology companies in Europe.

Measuring the cardiac liability of pharmaceutical compounds

Cardiac liability of pharmaceutical compounds is a pervasive issue in drug development that needs to be carefully managed and mitigated. PhysioStim will adopt and incorporate ACEA’s xCELLigence RTCA CardioECR system as an important part of its service offerings together with human induced pluripotent stem cells (hi-PSCs), to assess the cardiac liability of pharmaceutical compounds and biologics on cardiomyocyte contractility, integrated ion-channel activity and longer-term viability, and structural toxicity.

PhysioStim, an expert CRO for preclinical cardiac screening

PhysioStim is one of Europe’s most recognized and reliable CROs offering electrophysiological studies, preclinical resources, and dedicated expertise in evaluating compounds under GLP (Good Laboratory Practices), in accordance with the International Conference of Harmonization (ICH) S7A and S7B guidelines for cardiac safety assessment. More recently, PhysioStim has taken steps to be aligned with the upcoming FDA-sponsored Comprehensive In Vitro Pro-Arrhythmia (CiPA) initiative guidelines. As part of this initiative, compounds are ranked for their pro-arrhythmic liability using a suite of approaches including the screening of compounds against critical cardiac ion channels expressed recombinantly in non-cardiac cell lines, using in silico methodology and utilizing human-derived cardiomyocytes, such as hiPSCs.

ACEA, a pioneer in real time cell assessment

ACEA is the developer of xCELLigence RTCA products with more than 3,000 installations spanning academia, industry and government laboratories. The xCELLigence CardioECR system combines high- frequency measurement of cellular impedance with multi-electrode array technology to simultaneously assess cardiomyocyte contractility, viability, and electrophysiology. The system has distinctive features such as enhanced impedance data acquisition rate (everyone millisecond), simultaneous recording of contractility and electrophysiology and electrical pacing feature all in a microtiter plate format which makes it amenable and attractive for the screening of compounds which may have cardiac liability. The CardioECR system was one of the few selected technologies which were utilized in the validation of compounds as part of the CiPA initiative.

A hi-tech partnership for CIPA-compliant cardiac screening

We are continuing to build our service capabilities with more predictive assays for assessment of cardiac liability, and incorporation ACEA’s CardioECR system is an example of how we are aligning ourselves for the future with the CiPA guidelines,” stated Dr. Marie Le Grand, CEO of PhysioStim. “The fact that the CardioECR system is not only able to assess integrated ion channel activity in hiPSCs, but also contractility and viability is an added advantage which will allow us to screen compounds for cardiac liability with more confidence.

As part of this partnership, ACEA will direct and refer all service requests in Europe on the CardioECR system to PhysioStim.

We are happy to work with world-class electrophysiologists and scientists at PhysioStim to better serve our existing customers and those clients that are eager to learn more about the potential cardiac liability of their compounds,” stated Dr. Abassi, VP of Business Development at ACEA.

About PhysioStim

PhysioStim is an independent preclinical CRO with high-level expertise in the field of cardiovascular pharmacology and electrophysiology. The company was founded in 2000 by Dr. Marie Le Grand, who is the current CEO, and is located in Lautrec in Southern France. PhysioStim aims to address the growing need of the pharmaceutical industry and biotech companies to conduct high-quality preclinical assays and studies. Over the years, PhysioStim has grown into a highly-valued team that rises to the challenge of designing and conducting high-quality studies for drug development and derisking of compounds.

About ACEA Biosciences

Founded in 2002, ACEA Biosciences, Inc., now a part of Agilent Technologies, is a pioneer in the development and commercialization of high performance, cutting-edge cell analysis platforms for life science research. Researchers are advancing their studies utilizing over 3,000 placed instruments for broad and diverse applications. The technology has been cited in over 2000 peer-reviewed publications. ACEA’s xCELLigence impedance-based, label-free, real time cell analysis system and NovoCyte flow cytometers are used in pre-clinical drug discovery and development, toxicity, safety pharmacology, and basic academic research.

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