PhysioStim to expand range of cardiovascular safety studies
PhysioStim is a preclinical CRO that was founded by Dr. Marie Le Grand in the southern French Tarn Department. The company has received international recognition for its expertise in cardiac electrophysiology and preclinical safety studies. To expand its reach and complete its range of services and assays, PhysioStim is expected to team up with another CRO from across the Channel.
A wide range of study models for preclinical cardiotoxicity
PhysioStim offers a wide range of services to validate preclinical R&D for drug development for international pharmaceutical and biotechnology companies. The company’s electrophysiology experts provide in vitro and ex vivo models for preclinical cardiac safety studies, such as human cardiac ion channels, human cardiomyocytes, isolated perfused hearts… They master a range of vital technologies (patch-clamp, intracellular microelectrode, Langendorff, contractility studies…) to evaluate a specific compound’s risk for cardiotoxicity at an early R&D stage. To complete their range of cardiovascular safety studies, the team also collaborates with a strict selection of top level pharmacology and toxicology partners (in vivo models) and offers expertise in analytics to provide highly-skilled advice.
GLP-certified expertise in regulatory study guidelines
PhysioStim obtained its first Good Laboratory Practice certification from the French National Drug Agency AFSSAPS in 2001. The company was awarded a grade A level certification in 2003, which has been extended ever since. The company’s daily focus lies on regulatory safety studies that are required in the official ICH S7A & S7B guidelines. These guidelines tackle the cardiac safety studies required before validating drug R&D projects in the preclinical phase (before phase 1). The current ICH guidelines should soon be updated through the CiPA initiative, which stands for “Comprehensive in vitro Proarrhythmia Assays”.
CiPA and the Center of Excellence
At PhysioStim, the upcoming changes in regulation have sparked the idea to combine forces with another, complementary, CRO to provide a truly extensive range of cardiac safety studies. The CRO in question is located across the Channel and has highly skilled expertise in the same area, using complementary techniques and technology.
“Our goal is to create a European Center of Excellence for cardiac safety pharmacology by bringing two expert electrophysiology teams together. Thanks to this alliance, we will be able to offer standard as well as customized study models in order to adequately answer all our customers' needs very early in the R&D process. We will also provide strategic advice to optimize lead candidates, which will reduce R&D lead time and costs”
On October 9 & 10, 2017, Marie Le Grand and Richard Printemps, PhysioStim’s Scientific Director, will attend the Biopharma Outsourcing vol3 B4B-Connection to present their services and projects.
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