About the webinar

Testing for developmental toxicity according to the current guidelines requires large numbers of animals, making these tests very resource intensive, time-consuming, and ethically debatable. The recent ICH S5 (R3) guideline on developmental and reproductive toxicology proposes using alternative assays as part of an integrated testing strategy to minimize the use of animals.

We developed ReproTracker as an alternative in vitro assay to assess developmental toxicity. ReproTracker is a human induced pluripotent stem cell (hiPSC)-based biomarker assay that mimics the differentiation of early embryonic development. The assay is based on the differentiation of hiPSCs into three germ layer-specific cell types, hepatocytes, cardiomyocytes, and neural rosettes.

During the webinar, we will show how ReproTracker fits in as an alternative assay under ICH S5 (R3) guidelines and highlight a few cases that point out the added value of the assay over the conventional testing battery.

In this webinar, you will learn about:

– The ReproTracker assay and how it works.
– New regulatory opportunities for alternative developmental toxicity tests.
– The applicability domain of the ReproTracker assay.