Paul Carlson
Principal Investigator US Food & Drug Administration (FDA)
Seminars
Wednesday 11th November 2026
Roundtable Discussion: Engaging the FDA Proactively to Access Tailored Regulatory Guidance & Accelerate Microbiome Therapeutic Development
1:45 pm
- Addressing common misconceptions about FDA regulatory support availability to help microbiome companies access existing flexible guidance frameworks suited to complex biological products
- Implementing proactive FDA engagement strategies including early pre-IND/BLA meetings and ongoing dialogue to secure product-specific guidance and prevent costly late-stage regulatory surprises
- Sharing company experiences navigating FDA interactions to build collective understanding of how tailored regulatory conversations accelerate development timelines for diverse microbiome therapeutic modalities
Wednesday 11th November 2026
Challenging Standardization Assumptions to Embrace Flexible Development Strategies & Improve FDA Engagement for Microbiome Products
3:15 pm
- Addressing misconceptions around FDA regulatory expectations to demonstrate that flexible, product-specific approaches are preferred over rigid standardization frameworks for complex microbiome products
- Examining why standardizing assays and release specifications across highly variable live biotherapeutic products is impractical and how product-specific strategies accelerate development timelines
- Encouraging open sharing of assay approaches and development experiences across the industry to build collective knowledge and enable more practical regulatory strategies for diverse microbiome products
