Paul Carlson

Company: US Food & Drug Administration (FDA)

Job title: Principal Investigator

Seminars:

Regulatory Considerations for Microbiome-Based Therapeutics 8:30 am

Interpreting the latest FDA guidance on LBPs, FMT-based therapies, and the shifting regulatory framework for microbiome drugs Addressing key hurdles in clinical trial design, potency validation, and manufacturing standards to meet FDA expectations Preparing for future regulatory trends with insights on accelerated approval pathways, real-world data integration, and evolving safety requirementsRead more

day: Conference Day Two, 7:30 - 10:00