New Tools, Old Questions: Applying FDA Initiatives & Evolving CMC Expectations in CGT

Time: 2:15 pm
day: Conference Day One

Details:

• How companies can best leverage meetings with FDA in cell and gene therapy development
• Practical implications for submission planning, regulatory flexibility, and engagement tools such as INTERACT and Type D meetings
• Uses for FDA-led programs such as Project FrontRunner, the Commissioner’s National Priority Voucher program, and RMAT designation
• What’s changing in CMC expectations: comparability, potency methods, and analytical characterization

Speakers:

Jessica Eisenstatt Jessica Eisenstatt is a CMC RA Associate Director at AstraZeneca focusing on the clinical development of biologics including CAR-T products. She previously served as a Read more