The recent FDA Roadmap shows that regulators expect the pharmaceutical industry to transition away from animal tests. Scientists’ need for drug development insights without animals has spurred greater interest in New Approach Methodologies (NAMs), such as in silico modeling and in vitro assays like organ-on-a-chip.
This webinar explored how Human-on-a-Chip (HoC) systems—combined with physiologically-based pharmacokinetic (PBPK) modeling—enable a powerful, human-relevant approach to predicting safety and efficacy in drug development. Speakers showed how HoC data can be translated into in vivo outcomes using biosimulation, with case studies illustrating regulatory and program-level impact.
Who should watch this recording:
- R&D and translational leaders in biotech and pharma
- Toxicologists and DMPK scientists
- Clinical pharmacologists and regulatory professionals
- Modeling & simulation experts
What you’ll learn:
- Understand how HoC platforms build on organ-on-a-chip technology and function as NAMs aligned with the FDA roadmap
- Explore how PBPK modeling interprets and extrapolates HoC data for critical scientific insights
- Review case studies demonstrating animal-replacement potential
- Gain practical guidance on implementing NAMs in regulatory submissions
