Jessica Eisenstatt

Company: AstraZeneca

Job title: Associate Director - Chemistry, Manufacturing & Control Regulatory Affairs

Seminars:

New Tools, Old Questions: Applying FDA Initiatives & Evolving CMC Expectations in CGT 2:15 pm

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…Read more

day: Conference Day One