Evaluating the Acceptance Criteria of Fluid &
Imaging Biomarkers as Surrogate Endpoints in
Neuroscience
Evaluating Regulatory Considerations in IUO vs
RUO Assay in Neuroscience Research
- Outlining the ongoing efforts for obtaining more validated
biomarkers for neurological disorders - Exploring when and under which circumstances biomarker
data can be used as a surrogate endpoint in
neurological trials - Exploring lessons learnt from NFL in SOD-1 ALS and potential
expansion to broad ALS - Considering the requirements for drug approval using
amyloid, NFL or other novel biomarkers as surrogate
endpoints
- Differentiating between investigational use only (IUO) and
research use only (RUO) assays, when to use them within
clinical development and outlining their role in early-phase
investigational studies and regulatory scrutiny compared
with RUO assays - Transitioning to in vitro diagnostic use to highlight
implications for assay validation, regulatory approval
processes and importance of early planning to ensure
compliance with evolving regulatory standards in the CNS - Navigating different approaches globally to understand
regulatory requirements needed for global approval
