Paul Carlson
Principal Investigator US Food & Drug Administration (FDA)
Dr. Paul Carlson is a Principal Investigator at the FDA, where he conducts both research and regulatory reviews. He leads a research lab focused on studying C. diff pathogenesis and nutrient acquisition to inform the development of live biotherapeutic products.
Dr. Carlson is a recognized expert in the scientific and regulatory landscapes of microbiome-based therapeutics, including LBPs and FMTs. A veteran speaker, he has presented at this conference for nearly a decade, sharing his insights on the challenges and opportunities in the field, from product development to navigating the regulatory pathway.
Seminars
Wednesday 11th November 2026
Panel Discussion: Sharing Regulatory Navigation Strategies Across Global Agencies to Reduce Uncertainty & Accelerate Clinical Progression
1:45 pm
- Benchmarking regulatory pathways used across FDA, EMA & national authorities to clarify expectations and reduce trial approval uncertainty
- Comparing real-world regulatory interactions including key questions, feedback loops & submission strategies to strengthen future applications
- Identifying common pitfalls in CMC, trial design & product characterisation to proactively mitigate delays in regulatory approval processes
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
