Cell and Gene Therapy Regulatory Affairs Summit

Key Topics

• Reflecting on the Most Pressing Challenges & the Future of the Cell & Gene Therapy Space
• Driving Accelerated Approval by Dismantling Criteria for this Pathway to Fast-Track Cell & Gene Therapies Through Pipelines
• Pre-Clinical Challenges for Cell & Gene Therapies such as IND-Filing & Dosing to Unravel Bottlenecks & Share Experiences
• Finding Solutions to Regulatory Bottlenecks to Advance Gene Therapies Through the Clinic
• Finding Solutions to Regulatory Bottlenecks to Advance Allogeneic Cell Therapies & In Vivo Gene Editing Through the Clinic
• Utilizing Lessons Learned from Commercialized Therapies to Accelerate Clinical Products to Approval
• Supercharging Regulatory CMC by Overcoming Challenges to Ensure Safe & Efficacious Advanced Therapies
• Diving into Potency Assay Regulation to Uncover Hurdles in the Latest Regulatory Guidance
• Taking a Global Perspective in Regulatory CMC to Discuss How Raw Materials, Batch Failures, & Platform Technologies are Regulated Across the World