Julie Batal

Company: bluebird bio

Job title: Vice President - Regulatory Science

Seminars:

Navigating Regulatory Complexities: Lessons from Bluebird Bio’s Approach to Gene Therapy Approval 9:30 am

How to define and select surrogate endpoints that accurately reflect clinical benefit in rare disease gene therapies Strategies for engaging with the FDA to gain agreement on surrogate endpoints Collaborating closely with regulatory agencies to address unique gene therapy challenges and achieve approvals, including lessons learned from early submissions and the company’s proactive responses to…Read more

day: Conference Day Two pt 1