Exploring a Regulatory Perspective on Advancing Biomarkers for Neurodegenerative Diseases
Time: 3:45 pm
day: Track B - Day 2 pm 2
- Overview of the potential use of biomarkers for drug development for neurodegenerative conditions
- Experience on EMA Qualification of novel methodologies (biomarkers)
- Genetic markers for neurodegenerative conditions
- Evaluating approaches of using biomarkers for enrichment purposes in clinical trials
- Where does the field need to put more efforts to develop biomarkers that will be able to help us test new hypothesis across neurodegenerative diseases?
- What is the regulatory willingness to accept such biomarkers, what do we need to see in order to validate biomarker endpoint as a primary endpoint for an approval as opposed to a clinical effect?