Irina Antonijevic
Chief Medical Officer Trace Neuroscience
Seminars
Friday 21st August 2026
Roundtable Discussion: Enabling Platform-Based Regulatory Strategy for CNS Oligonucleotides
9:30 am
- Reassessing the necessity of fully independent nonclinical toxicology packages for each candidate by examining shared chemistry, mechanism of action, and accumulated class safety data across oligonucleotide platforms
- Identifying the scientific commonalities that could justify a proportionate, risk-based regulatory approach, rather than repeating comprehensive packages where prior pharmacology and toxicology knowledge already exists
- Exploring practical strategies to align regulatory bodies around a platform framework, including early agency engagement, cross-program data integration, and clearer articulation of class-based evidence to enable streamlined, science-driven IND progression
Friday 21st August 2026
Optimizing Splice-Correcting ASO Dosing & Regulatory Strategies to Target TDP-43–Driven Neurodegenerative Diseases
11:30 am
- Discuss how a comprehensive, data-driven non-clinical development for ASOs can help optimize clinical dosing strategies, for a favorable safety profile, reducing toxicity risks and enabling a more efficient trial design
- Align non-clinical evidence with regional regulatory requirements to facilitate efficient clinical development and access to novel therapeutics for rare disease patients
- Utilize emerging clinical data and real-world insights to refine clinical trial designs and increase chance for early clinical proof-of-concept
