Navigating Accelerated Approval of Gene Therapies: The Role of Regulatory Processes & Biomarkers
Time: 12:00 pm
day: Day 1 - Regulatory 2
Details:
• A detailed examination of recent updates in regulatory processes aimed at expediting gene therapy approvals, including insights from successful case studies
• Exploration of what makes biomarkers compelling for accelerated approvals, focusing on attributes such as sensitivity, specificity, and relevance to disease progression
• A review of gene therapy approvals where biomarkers played a pivotal role, highlighting strategies used to meet the criteria for expedited pathways
