Exploring a Regulatory Perspective on Advancing Biomarkers for Neurodegenerative Diseases

Time: 3:45 pm
day: Track B - Day 2 pm 2

Details:

  • 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?

Speakers: