Jessica Eisenstatt

Company: AstraZeneca

Job title: CMC Regulatory Affairs Associate Director

Bio:

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 Researcher/Reviewer at the FDA as an IOTF fellow in the former Division of Cell and Gene Therapy where she reviewed the quality information of cell and tissue therapy INTERACTs, pre-INDs, and INDs. Her experience at the FDA and at AstraZeneca provides insight on agency interactions from both sides.

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