Rodrigo Ruiz-Soto
Seminars
Wednesday 26th August 2026
Predicting Regulatory Expectations on Dose Optimization is Shaping ADC Clinical Development for Strategic Planning
4:00 pm
- Analyzing recent regulatory feedback to interpret how the FDA’s Project Optimus guidance is being applied to dose selection and toxicity mitigation strategies, providing a clear roadmap for designing Phase I dose-finding studies
- Designing clinical dose-optimization strategies for antibody–drug conjugates that balance therapeutic exposure and tolerability, to proactively address regulatory expectations
- Applying lessons from Ligachem Bio’s ADC pipeline to integrate translational toxicology, pharmacokinetics, and early safety signals into adaptive Phase I study designs
Thursday 27th August 2026
Panel Discussion: Aligning Clinical Experience with Translational Insights to Improve ADC Safety
10:00 am
The disconnect between observed clinical toxicities and preclinical predictions continues to challenge ADC development and patient management. Treatments that appear tolerable in early studies can lead to unexpected adverse events in patients, complicating dosing decisions and long-term care. Join clinicians, clinical pharmacologists, and translational experts as they explore how to integrate clinical data, PK/PD insights, and real-world evidence to better interpret safety signals and inform treatment strategies by:
- Interpreting clinical safety signals to inform treatment decisions, exploring how systematic analysis of patient-level data can support dose modifications, treatment interruptions, and proactive toxicity management in clinical practice
- Leveraging translational and pharmacokinetic insights to contextualize toxicity risk, examining how physiologically based pharmacokinetic modeling and cross-species data can help clinicians anticipate adverse events, understand variability in patient response, and apply trial learnings to real-world populations
- Applying exposure-response relationships to guide dosing in the clinic, discussing how evolving dose optimization strategies, including those aligned with Project Optimus, can move toward individualized dosing approaches that balance efficacy and safety for different patient subgroups
