Navigating the Next Steps in Neurodegenerative Therapies: Assessing Drug Safety, Regulations & Progressing Through Trials to Get Protein Degrader Drugs to Clinic to Improve the Treatment of CNS Disease
Time: 9:30 am
day: Conference Day One
Details:
- In vitro and in vivo safety and toxicity profiling – overview of the methodologies able to assess safety, toxicity and off-target effects as well as selecting appropriate biomarkers for progressing to clinical trials
- Current regulatory landscape for protein degrader therapies – regulatory requirements and guidelines that need to be met to get approval for use as drugs
- Challenges that novel protein degradation drugs for neurodegenerative diseases face in the approval process – preclinical study design and navigating the FDA/EMA regulatory pathways
