What Are The Major Regulatory Bottlenecks for CGT Developers

Chair

John Rasko, Head of Department, Cell & Molecular Therapies, Royal Prince Alfred Hospital

9am Presentation

Omer Butt, Vice President, Regulatory Affairs, CytoImmune Therapeutics

9.15am Fireside Chat: Leveraging CMC to Reduce Bottlenecks

• Role of process characterization in platform produced gene therapies
• Aligning with FDA guidance on platform technologies (section 2503)

Lucia Fernandez, Vice President Process Development & Manufacturing, VintaBio

9.30am Panel Discussion

Joined by all session participants and Miguel Forte, Chief Executive Officer, Kiji Therapeutics, President-Elect, ISCT