Rakesh Dixit
Seminars
- Traditional nonclinical models often fail to predict clinical outcomes for complex ADCs, creating a need for more advanced and biologically relevant preclinical approaches.
- Novel in vitro systems can improve decision-making in drug discovery by providing better insights into key factors such as target uptake, payload characteristics, and tissue toxicity
- Integrating these systems into a broader translational strategy, along with improved species selection, biomarker use, and mechanistic data, can produce more predictive nonclinical packages and enable faster, more confident go/no-go decisions
The FDA’s landmark guidance to reduce and ultimately replace animal testing has sent shockwaves through the toxicology community. The central question asks how to build a compelling, regulator-friendly safety package without decades of historical precedent.
Join regulatory experts, translational scientists, and industry pioneers as they chart a practical path forward for implementing NAMs in ADC development by:
- Building confidence in in vitro models, evaluating how organoids, microphysiological systems, and iPSC-derived tissue panels can be benchmarked against historical clinical data for known ADC toxicities like ILD and ocular keratopathy to establish predictive thresholds that regulators will trust
- Constructing a weight-of-evidence framework, discussing how to integrate high-content imaging, computational modeling, and mechanistic biomarker data into a cohesive safety package that compensates for the absence of traditional animal toxicology endpoints
- Collaborating with regulators on validation, exploring how to engage the FDA early in the NAMs development process through pre-IND meetings and qualification programs, ensuring that novel testing strategies are aligned with agency expectations and positioned for successful adoption
While first-in-human trials remain the ultimate test, this workshop focuses on how to de-risk programs earlier. It tackles the critical industry challenge of poor translation by moving beyond standard animal models to validate new in vitro systems and design smarter, more predictive non-clinical packages. Attend this workshop to improve the probability of clinical success by:
- Evaluating the predictive value of organoids, microphysiological systems, and computational models against historical clinical data for known toxicities like ILD and ocular toxicity.
- Developing a framework for reverse translation, using clinical safety signals to refine and calibrate preclinical models for better future predictions.
- Navigating the FDA’s NAMs initiative. Discussing practical strategies for implementing New Approach Methodologies and preparing robust data packages to support regulatory submissions with reduced reliance on animal studies.
