Explore the Agenda
Workshop A
9:00 am Navigating Global Regulatory Expectations: Practical Strategies for Preclinical Toxicology & IND Success
This practical, discussion-driven workshop brings together regulatory experts clarify evolving expectations for preclinical packages, the use of NAMs, in vitro models, and AI- enabled approaches, and the realities of preparing an IND for multiple global markets.
Through real case studies, both successful and challenged, participants will gain a clear understanding of how to position innovative toxicology data for regulatory acceptance.
- Current FDA Expectations & Global Alignment: Insights from FDA representatives and regulatory experts on IND readiness, emerging trends, and how to ensure early- stage toxicology programs map cleanly to U.S., EU, and APAC requirements.
- Using NAMs, In Vitro Models & AI in Regulatory Filings: Real case studies, successful and unsuccessful, showing how alternative assays and computational approaches were positioned, justified, and reviewed, including instances of regulator pushback.
- Building a Multi-Market Regulatory Strategy from Day One: Designing preclinical packages that meet multiple agencies’ expectations, bridging data gaps, and knowing when to consult your regulatory team.
- Expert Insights from Industry & Consultants: Addressing pitfalls, how to support IND strategy, and how early engagement with regulators can de-risk development.
12:00 pm Lunch Break
Workshop B
1:00 pm Enhancing Translation of Toxicity Across Preclinical & Clinical Teams for Better Informed In Vitro Decision Making
Bridging the gap between early in vitro safety signals and real-world clinical outcomes remains a critical challenge, particularly as more programs rely on advanced in vitro models to guide decision making. This interactive workshop brings together case-driven perspectives from small molecules and complex biologics to show how translational alignment, validation standards, and clinical feedback loops can strengthen confidence in in vitro-driven safety strategies.
- Define what “good enough” validation looks like for ADC- and radio conjugate specific in vitro models
- Distinguish between models built for mechanistic understanding versus those intended to support regulatory toxicology decisions
- Address modality-specific challenges such as payload-driven toxicity, target expression, and off-target exposure
- Share practical lessons on aligning preclinical model outputs with clinical safety expectations for high-risk, high-value programs
- Apply GI organoids for early compound screening to identify diarrhoea liability before candidate selection
- Translate organoid-derived signals into quantitative clinical risk predictions to inform dose and progression decisions
- Understand how ad hoc mechanistic profiling using organoids is evolving to explain toxicity drivers and refine compound optimization