Rakesh Dixit
President & Chief Executive Officer Bionavigen
Rakesh Dixit is a seasoned biotechnology executive and scientific leader with extensive experience in biologics, drug development, and translational sciences. He currently serves as Chief Scientific Officer at TMAB Therapeutics and co-founder, President, and CSO of Regio Biosciences, an AstraZeneca spin-off focused on innovative therapies targeting cardio-metabolic diseases and cancer. He is also President and CEO of Bionavigen, a consultancy specializing in biologics and advanced therapeutics. Previously, he held senior leadership roles at MedImmune and AstraZeneca, overseeing global biologics safety assessment. Dr. Dixit earned his Ph.D. in Toxicology from Case Western Reserve University School of Medicine.
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.
