Klaudia Kuranda

Company: Spark Therapeutics

Job title: Head of Immunology


Panel Discussion: Regulatory Addressing of Ongoing Complex Safety Concerns 1:30 pm

An overview of the most common safety concerns flagged by CBER Leveraging early CBER interaction to set up for success at the pre-IND stage Strategies the FDA are looking for to mitigate against AAV vector safety risks Top tips for demonstrating product safety with regulatory filings Advocating for different safety monitoring pathways where antibody responses…Read more

day: Immunogenicity Discussion Day

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