Karolina Kopańska
Postdoctoctoral Resercher Center for Alternatives to Animal Testing (CAAT)
Seminars
Thursday 14th May 2026
VICT3R: Building Trust in Virtual Animal Models to Reduce, Refine, Risk the Cost & Animal Use in Toxicology
1:15 pm
- Overview of VICT3R and Virtual Control Groups (VCGs): rationale in the context of current global regulatory changes, and how using statistical methods and AI on historical control data can reduce animal use by up to 25%, supporting ethical innovation in toxicology
- Qualification strategy to demonstrate scientific validity, robustness, and reproducibility of studies including VCGs – examples from reanalysed legacy studies and ongoing prospective studies with industry partners and CROs
- Regulatory engagement and leveraging global partnerships to translate VCG qualification results into scientific opinions and internationally harmonised guidance documents – overview of our interactions with EMA, FDA, and OECD, and the role of the Scientific and Regulatory Advisory Board
Wednesday 13th May 2026
Panel Discussion: Regulatory & Pharma Expectations in the Adoption of NAMs: IQ MPS Affiliate Perspective
3:00 pm
- How pharma teams are collaborating within IQ MPS Affiliate to progress simple and complex in vitro NAM platforms toward regulatory acceptance
- Review insights from recent FDA publication on submitted NAM case examples and reviewer feedback – what works and what can be improved (need for well-articulated context-of-use)
- Where AI-enabled validation initiatives like VICT3R can strengthen confidence by benchmarking prediction accuracy against real clinical outcomes
- Gain practical guidance for integrating in vitro and in silico NAMs into toxicology packages without over-claiming translatability
- What industry needs from consortia, regulators, and data-sharing frameworks to accelerate adoption of novel platforms covering diverse mechanisms of injury
