Cardiac and vascular safety liabilities using totality of evidence approach

US-FDA recommend integration of both preclinical (S7B) and clinical (E14) data to improve risk assessment, reduce reliance on TQT clinical studies, streamlined drug-development, simplified decision-making processes, effective risk-communication.

About this webinar

Cardiac safety and vascular safety are crucial components of the evaluation of potential risks and adverse effects associated with new medications on the cardiovascular system.

Eurofins Discovery preclinical studies utilize in vitro assays and biomarker assays to evaluate comprehensive cardiac and vascular safety assessment. This integrated approach helps to identify and manage potential risks associated with clinical candidate drugs, and allowing for earlier decision making before clinical trial entry.

By leveraging Eurofins Discovery’s expertise in preclinical assessments and staying current with the latest regulatory guidelines, we help to ensure cardiac and vascular safety evaluation of new drug candidates ultimately improves patient care and safety.

Key Takeaways

  • We will discuss recent updates emphasizing the importance of integrating nonclinical (S7B) and clinical (E14) data as a comprehensive evidence-based approach to safety assessment.
  • Eurofins Discovery’s nonclinical study use of the best in vitro practices for cardiac ion channel evaluation (FDA, March 2022) for assessing cardiac safety will be shown.
  • The evaluation of phenotypic biomarker modulation in Eurofins Discovery nonclinical vascular safety evaluation studies will be used to illustrate the adverse effects of valdecoxib and rofecoxib, and relative lack of adverse effects of celecoxib.

Our speaker

Dr Muthukrishnan Renganathan., Senior Study Director Ion Channels, Eurofins

Muthukrishnan is a Principal Scientist and Senior Study Director of Ion Channel Services at Eurofins Discovery, where he is responsible for all activities relating to in vitro cardiac safety evaluation, as well as studies on ion channels as drug targets. He has over 20 years of industrial drug discovery experience. His main area of expertise is ion channel functional assessment and high-throughput cardiac safety evaluation in early drug discovery, including assay development and validation.

Prior to joining Eurofins Discovery in 2009, Dr. Renganathan worked at Boehringer Ingelheim as Principal Scientist in early cardiac safety screening, and worked at ChanTest as a Study Director for GLP cardiac repolarization studies for IND submission to FDA.