In this webinar, experts explore how New Approach Methodologies can replace, reduce, or refine animal testing requirements in drug discovery and development.

Crucial Starting Material Considerations for NAM Success
Courtney Noah, PhD
VP of Scientific Affairs, BioIVT

This presentation explores the critical role of human specimen starting materials in the success of New Approach Methodologies (NAMs), and how ethical sourcing, characterization, and quality control can drive confidence, reproducibility, and regulatory acceptance.

Miniaturizing Organoid Screening for Commercial R&D
René Overmeer, PhD
Principal Scientist, HUB Organoids (part of Merck KGaA)

Patient-derived-organoids (PDOs) are valuable tools for predicting individual responses to cancer treatments. However, current screening methods require large numbers of PDOs, resulting in long turnaround times and limiting use. Our miniaturized, automated platform using patient-derived organoids enables high-quality drug screening with substantially fewer cells, accelerating the translation of in vitro results to patient-specific predictions. Integrating mini-organoids workflow reduces the time to actionable readouts to about one week, while maintaining patient-relevance and increasing throughput. This supports HUB Organoids’ goal of rapid prediction to guide selection of successful preclinical candidates.

Predicting Multi Organ Toxicity Early Using AI Enabled Transcriptomic Profiling in Human Models
Paul Walker, PhD
VP, Head of Toxicology and Innovation Efficiency, Cyprotex

High clinical attrition driven by safety and efficacy failures underscores the need for earlier, more predictive toxicology strategies. Advances in human relevant in vitro systems, new approach methodologies (NAMs), transcriptomics, and AI/ML now enable earlier, mechanistically informed toxicity screening in drug discovery.
Here, we profile organ specific clinical reference compounds across liver, cardiac, and kidney human cellular models using high throughput RNA seq. Differential expression, BMD/PoD modelling, pathway analysis, and AI/ML were applied to derive quantitative toxicity metrics. Integrating transcriptomics with NAMs provides a robust framework for early identification of multi organ toxicological liabilities.

Key Topics:

• How to manage donor variability while maintaining human relevance and reproducibility


• The importance of fit for purpose QC, standardization, and documentation


• How BioIVT’s human biospecimen capabilities help de risk NAM development from the start


• Hub Organoids’ miniaturized, automated platform for high-quality drug screening


• Evotec’s high throughput RNA seq applied to organ specific clinical reference compounds across liver, cardiac, and kidney human cellular models