Panel Discussion: Given Recent Failures, How Can we Tailor ALS Clinical Trials to Successfully Meet Regulatory Expectations
Time: 1:30 pm
day: Conference Day One Track B PM
Details:
- Outlining the approval path for sporadic and familial ALS: is it the same for different modalities? What is the regulatory bar for approving this?
- Harnessing innovative trial design
- Cross comparing diverging requirements for different regulatory agencies including the FDA, EMA and more
- Establishing clear, patient-relevant endpoints and leveraging biomarkers to demonstrate efficacy
- Critically identifying stumbling blocks in IND and BLA packages to circumvent late-stage failures and pitfalls in drug development
