Marianna Stamou
Director, Project Toxicologist AstraZeneca
Seminars
Thursday 25th February 2027
Defining the Non-Clinical Safety Strategy for Next-Generation Radiopharmaceuticals
4:30 pm
- Navigate differences in non-clinical safety requirements across regulatory regions to understand what evidence is needed to progress towards FIH
- Tailor the safety strategy to the target, modality, and radioconjugate profile, rather than applying a one-size-fits-all toxicology package
- Identify the remaining safety uncertainties after IND-enabling studies and determine where additional evidence is needed to better predict clinical risk