Panel Discussion: Regulatory Addressing of Ongoing Complex Safety Concerns

Time: 1:30 pm
day: Immunogenicity Discussion Day

Details:

  • 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 confer no functional side effects

Speakers: