Roundtable discussion: Navigating Evolving Regulatory Expectations for ADC Toxicity Models – Bridging In Vivo/Vitro Approaches
Time: 1:30 pm
day: Scientific Program Day Two
Details:
Join this roundtable discussion to gain a better understanding of what is currently approved by regulatory agencies, how they are adopting to new safety models, and how we can navigate regulatory challenges with ADC toxicity models.
- What models are currently approved by regulatory agencies (FDA, EMA, etc.) for ADC safety assessments?
- Are there species-specific limitations when evaluating ocular, pulmonary, or systemic toxicities – and how can we improve predictability of these toxicities while meeting regulatory requirements?
- How are FDA and EMA responding to the adoption of humanized in vitro models for ADC safety testing?
- What validation criteria are required for in vitro models to be considered acceptable alternatives to traditional in vivo models?
