Stefan Braam is the Co-Founder and CEO of Ncardia. Stefan brings Ncardia over a decade of experience in stem cell technology, product development and general management. Before the appointment as CEO of Ncardia, Stefan was the CEO of Pluriomics. As co-founder and key inventor of Pluriomics/Ncardia technologies, he has been instrumental in the establishment and growth of the company. Earlier in his career, Stefan obtained a MSc and Ph.D. (both cum laude) in stem cell biology under the supervision of Prof. Dr. Mummery and obtained international experience in labs in the UK and Australia. Stefan won the NGI venture challenge (2009), the Niaba biobusiness Masterclass (2010), published in multiple leading scientific journals, is an inventor on multiple patent families, secured multiple grants and commercial research collaborations and was with increasing responsibilities instrumental in Pluriomics/Ncardia pre-seed, seed, Series A and B financing rounds.

OpenTox Euro 2019 talk: Rethinking translational predictivity using hiPSC-derived models: a retrospective analysis for cardiac liabilities

Adverse effects on the cardiovascular system are major reasons for compound attrition in late stage pre-clinical and clinical development. To avoid such failures in costly clinical phases, physiologically relevant predictive human cellular assays need to be exploited in early preclinical phases. Traditional methods have relied upon in vitro overexpressing human cell lines which lack the complexity of human cardiomyocytes. Physiologically more relevant models such as primary human cardiomyocyte cultures rapidly dedifferentiate and are not readily available for cell-based assays.  

In my presentation I will give various examples how advanced induced pluripotent stem cell (iPSC) derived cardiovascular cell-based assay systems have been developed and used in safety screening by the pharmaceutical industry. I will discuss how implementation of these cellular models for safety assessment has impacted traditional safety/tox assessment studies and how the cellular models are now more and more being utilized in early discovery to prevent late stage failures.  

Finally, I will also discuss how the regulatory validation of iPSC-derived cardiomyocyte assays for the prediction of drug induced cardiac arrhythmias by the CiPA consortium can serve as an example for the validation of any new cell based assay system in the safety tox field.