Explore the Agenda
8:30 am Morning Coffee & Networking
8:55 am Chair’s Opening Remarks
Clarifying Regulatory Distinction & Market Positioning Across Microbiome Modalities to Enable Credible Clinical & Commercial Pathways
9:00 am Optimizing LBP & FMT Commercialization Models to Identifying Sustainable Microbiome Growth Strategies
- Evaluating consumer commercialization approaches to identifying scalable market adoption strategies for LBP & FMT developers
- Assessing reimbursement-driven therapeutic models to determining long-term revenue generation opportunities across microbiome markets
- Identifying customer engagement techniques to strengthening awareness, retention & downstream therapeutic demand
Advancing Rigorous Translational Strategies to Deliver Clinically Validated Microbiome Therapies
9:45 am Transitioning from Observational Data to Causal Evidence to Strengthen Clinical & Regulatory Credibility
- Implementing longitudinal and interventional study designs to move beyond correlation and establish causative links required for clinical validation
- Prioritising investment into complex, large-scale trials to demonstrate sustained therapeutic impact across chronic indications and long-term outcomes
- Integrating multi-disciplinary capabilities and datasets to build rigorous, evidence-driven development strategies that support regulatory approval
10:15 am Transitioning from Observational to Causal Evidence to Strengthen Preventive Medicine Credibility for Probiotics & Prebiotics
- Challenging the bias toward curative medicine by demonstrating how probiotics and prebiotics deliver measurable preventive health benefits including cognitive decline prevention and gut microbiota restoration
- Addressing regulatory gaps created by insufficient evidence standards that allow unsubstantiated probiotic claims to undermine scientifically credible preventive microbiome interventions
- Improving scientific communication of existing probiotic and prebiotic research to build clinical and regulatory credibility for preventive medicine applications in mainstream healthcare
10:45 am Morning Refreshment Break & Networking
Decoding Complex Microbiome Mechanisms & Translational Biology to Enable Targeted & Differentiated Therapeutic Development
11:15 am Advancing Mechanistic Understanding of Microbiome Therapeutics Through Pharmacokinetics & Engraftment Analysis to Demonstrate Clinical Credibility
- Examining mechanism of action data from microbiome therapeutic programs to build evidence-based narratives that strengthen regulatory and pharma partnership credibility
- Leveraging pharmacokinetic and engraftment data from clinical trials to deepen process understanding and demonstrate reproducible therapeutic activity in target indications
- Applying mechanistic insights from donor-derived and defined consortium programs to inform next-generation microbiome therapeutic development strategies
11:45 am Decoding Bidirectional Host-Microbiota Interactions to Engineer Synthetic Mucins & Improve Live Biotherapeutic Engraftment
- Examining host mechanisms regulating microbiota through mucosal barrier signaling to identify key interactions governing microbial behavior and community composition
- Investigating how microbiota degrade and interact with mucus signals to understand bidirectional communication pathways driving healthy and dysbiotic microbiome states
- Leveraging synthetic mucin technology to re-engineer host-microbiota signaling and improve live biotherapeutic engraftment and phenotypic modulation at mucosal sites
12:15 pm Leveraging Microbiota Transplant Therapy to Modulate the Gut-Brain Axis
- Explaining the contribution of gut microbiota to neurologic symptoms
- Use a pharmacological framework in the development of fecal microbiota live biotherapeutic products
- Present clinical evidence of durable therapeutic benefits of targeting the gut microbiome with microbiota transplant therapy
12:45 pm Lunch Break & Networking
Navigating Evolving Regulatory Frameworks to De‑Risk Microbiome Therapeutic Development & Investment
1:45 pm Panel Discussion: Sharing Regulatory Navigation Strategies Across Global Agencies to Reduce Uncertainty & Accelerate Clinical Progression
- 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
2:45 pm Afternoon Break & Refreshments
3:15 pm Challenging Standardization Assumptions to Embrace Flexible Development Strategies & Improve FDA Engagement for Microbiome Products
- 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
Spearheading Novel Microbiome Opportunities to Unlock Scalable Therapeutic & Commercial Value
3:45 pm Expanding Microbiome Therapeutics Strategies to Unlock European Market Opportunities & Overcoming Regulatory Hurdles
- Understanding critical US and EU market regulatory differences, including SoHO, to streamline market entry and avoid delays
- Navigating complexities of establishing European trial sites and novel regulatory pathways to de-risk therapeutic development investment effectively
- Outlining key strategies for successfully introducing an approved US drug into the European market to ensure effective penetration