Explore the Agenda
8:00 am Registration & Morning Coffee
Workshop A
9:00 am Demonstrating Credible Microbiome Mechanistic & Early Clinical Evidence to Engage Pharma Partnerships Earlier
Pharma skepticism towards microbiome therapeutics, driven by past clinical failures and difficulty distinguishing robust science, has delayed partnership engagement until Phase II data. This workshop outlines how to package mechanistic insight and early clinical evidence to meet pharma expectations and unlock earlier, higher-quality partnering conversations.
Workshop highlights:
- Structuring differentiated mechanism-of-action narratives using immune, metabolic, and microbial pathways to position programs in language that resonates with pharma decision-makers.
- Aligning early clinical study design with pharma-preferred endpoints and indications to generate signals that support future regulatory and commercial success
- Positioning Phase I, translational, and biomarker datasets strategically to maintain engagement and credibility despite limited late-stage outcome data availability
- Demonstrating scientific validation across heterogeneous microbiome approaches to clearly separate high-quality programs from lower-confidence competitors in crowded pipelines
12:00 pm Lunch Break & Networking
Workshop B
1:00 pm Validating Novel Assay Technologies to Demonstrate Identity Potency & Viability for Regulatory Confidence in Microbiome-Based Therapies
Measuring complex, multi-strain microbiome products remains inconsistent, with biased culture assays, unclear regulatory expectations, and no validated industry standards. This workshop shows how to adopt novel assay technologies and build product-specific analytical strategies that demonstrate identity, potency, and viability, enabling confident regulatory interactions.
Workshop highlights:
- Assessing emerging technologies that quantify complex microbial consortia while capturing strain-level identity and live viability without biased culture workflows.
- Defining product-specific analytical strategies aligned with evolving FDA expectations to validate potency identity and release assays across development stages.
- Comparing approaches to measure multi-strain abundance and function including sequencing viability assays and synthetic biology readouts to strengthen mechanism claims.
- Walking through end-to-end processes for selecting labs piloting methods and validating assays to generate reproducible data satisfying regulators.