“High quality presentations, well attended by representatives of all stages of development, many opportunities for interaction”
Senior Director, R&D Strategic Lead, Gastrointestinal & Microbiome, Ferring Pharmaceuticals
7:30 am Morning Check-In – Served with coffee + light breakfast
Synopsis
served with coffee and a light breakfast
7:55 am Chair’s Opening Remarks
Advancing Standards, Collaboration & Innovation in Microbiome Research
8:00 am Roundtable: Advancing Microbiome Therapeutics: Insights from the MTIG and EMIH Collaboration
Synopsis
- How can harmonized regulatory frameworks benefit microbiome therapeutics across different regions, and what specific steps can be taken to achieve this harmonization?
- What innovative strategies can be employed to accelerate the development of microbiome-based therapies through international collaboration, and how can these strategies be effectively implemented?
- How can expanding access to microbiome therapies benefit the economy and healthcare systems, and what measures are necessary to ensure equitable access to these innovative treatments?
8:30 am Regulatory Considerations for Microbiome-Based Therapeutics
Synopsis
- 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 requirements
9:00 am Panel Discussion: Evaluating Translational Success in Microbiome Drug Development
Synopsis
- Highlighting translational gaps and strategies to overcome these
- Unpacking regulatory expectations on mechanisms of action
9:30 am Start-Up Showcase
Synopsis
Start-Up Showcase Immerse yourself in a showcase of cutting-edge research and technologies as short-listed microbiome start-ups unveil their unique approaches to drug development.
You, and a judging panel of experts, will meet the brilliant minds behind microbiome start-ups, understanding their expertise, commercial strategies for success and passion that drives their mission to revolutionize today’s drug development landscape.
With prizes at stake, join us for a dynamic session where microbiome start-ups take center stage and a panel of VC’s and investors decide who to award as the winner of the Microbiome Movement Start-Up Showcase 2025!
Interested in getting involved?
- Apply to Share Your Preclinical Program & Access Your Discounted Start-Up Delegate Pass
- Shortlisted Companies Present Their Technologies to the Who’s Who of the Microbiome Therapeutics Industry
- The 2025 Winner Receives A Free Pass to Attend Next Years’ Summit & a Speaking Position!
10:00 am Morning Networking Break
Synopsis
An opportunity to network, discuss and collaborate with like-minded leaders
Advancing GI & Infectious Diseases Track
Progressing Microbiome Therapeutics for GI & Infectious Diseases Beyond C.Difficile
10:30 am Breakthrough in GI-Derived Bloodstream Infection Reduction: SER-155’s FDA Designation
Synopsis
- Highlighting the significant reduction in bacterial bloodstream infections demonstrated in Phase 1b trials of SER-155 and its impact on patient outcomes
- Discussing the significance of FDA breakthrough therapy designation and fast track status for expedited development and regulatory collaboration
- Exploring the future development plans for SER-155, including its potential applications in various high-risk patient populations
11:00 am KeepBio: A Microbiome-Targeted Therapy to Reduce Healthcare-Associated Infections
Synopsis
- Synbiotic approaches lead to reproducible changes in patient microbiomes
- Working to leverage glycan-microbe specificity drives decolonization in pathogendominated patients
- Commercializing rapidly and bringing innovation to bedsides safely
11:30 am Advancing Microbiome Therapeutics: The Role of Co-cultured Therapies in Ulcerative Colitis & Beyond
Synopsis
- Evaluating the promise of co-cultured microbiome therapies.
- Emergent function of diverse consortia
- Exploring a case study of the development of a co-cultured therapy for ulcerative colitis
- Highlighting regulatory and manufacturing challenges and solutions
Expanding Pipelines with New Indications Track
Harnessing Probiotics to Modulate the Microbiome: Next-Gen Innovations & Engineered Solutions for Microbiome Resilience
10:30 am Advancing Next-Generation Probiotics: Translating FitBiomics’ Clinical & Preclinical Data into Performance and Health Innovations
Synopsis
- Harnessing the Gut Microbiome for Human Performance – Exploring FitBiomics’ latest clinical and preclinical data on next-generation probiotics derived from elite athletes and their potential to enhance metabolism, endurance, and recovery
- Bridging the Gap Between Preclinical Insights and Clinical Validation – Lessons learned from translating microbiome-based discoveries into human trials, including biomarker-driven approaches to assess efficacy
- Mechanisms of Action: Understanding How Novel Probiotics Drive Health Benefits – Unpacking the functional impact of specific microbial strains on gut health, immune modulation, and systemic health improvements
- Regulatory & Commercialization Strategies for Microbiome-Based Interventions – Addressing the path from research to real-world applications, including regulatory considerations, consumer adoption, and future innovation in the probiotics space
11:00 am Diet & Lifestyle Factors that Influence Spore Levels & Stability Over Time
Synopsis
- Environmental factors such as diet and lifestyle influence the donor microbiota
- Exploring how these factors associate with spore levels across individuals
- Evaluating factors that influence stability of spore levels over time within donors
11:30 am Engineering Probiotics for the Management of Antibiotic Impacts on the Gut Microbiome
Synopsis
- Critical unmet need in healthcare: exploring how common antibiotic treatments can disrupt beneficial gut bacteria, leading to potential health issues
- Introduction to FLR-101, an engineered yeast strain designed to produce enzymes that locally degrade specific antibiotics in the gut, thereby managing impacts to the microbiome without compromising the efficacy of the treatment
- Regulatory Strategy and Medical Food Classification: Discussing Florey's unique approach to navigating regulatory pathways by developing FLR-101 as a medical food, aiming for efficient market entry and broad accessibility
- Future Directions in Engineered Probiotics: Outlining plans for expanding the application of Florey's synthetic biology platform to develop additional probiotics targeting various health conditions influenced by the gut microbiome
12:00 pm Networking Lunch
12:55 pm
Announcing the Winner of the Start-Up Showcase!
Mapping Out the Microbiome & Strategies for Manufacturing Consistency, Stability & Scalability
1:00 pm A Platform for Rationally Designing and Controlled Manufacturing of Complex Consortia Products that combine the Functional Diversity and Activity of Healthy Microbiomes with Scalable, Consistent and MoA-targeted Consortia
Synopsis
- Enabling precise identification and quantification of individual strains within complex consortia, allowing for potency assessment and process control in manufacturing
- Addressing co-culture challenges by stabilizing microbial communities through rational product design and advanced fermentation strategies
- Ensuring scalability, reproducibility, and quality control of high-diversity microbial therapeutics
- Strategically integrating strain-specific mechanisms with host-microbiome interactions
1:30 pm Advancing Assay Development for Multi-Strain Live Biotherapeutic Products
Synopsis
- The next generation of complex live biotherapeutic products demands advanced analytical approaches beyond sequencing to accurately assess potency, efficacy, and safety
- Kanvas has developed a spatial imaging platform that provides unprecedented resolution in evaluating microbial interactions and the host-microbe interface
- This technology enhances strain isolation, refines process development by characterizing strain-strain interactions, and enables more precise potency assays to meet evolving regulatory and clinical validation requirements
2:00 pm Advancing Assay Development for Multi-Strain Live Biotherapeutic Products
Synopsis
- Developing assays to evaluate the potency of multi-strain LBPs
- Key considerations for potency assay development and validation for late-stage clinical studies of LBPs
2:30 pm Panel Discussion: Scaling Up Manufacturing for Clinical Trials of LBPs
Synopsis
- Scaling up LBP production from preclinical to late-stage clinical trial quantities by maintaining microbial consistency, stability, and product quality at larger scales
- Managing the supply chain and logistics for late-stage trials by ensuring reliable and timely delivery of LBPs, including temperature-sensitive storage, transportation, and distribution to multiple clinical sites
- Navigating regulatory requirements during late-stage trials by balancing manufacturing compliance with the strict demands for clinical-grade products and preparing for commercialization
The Skin Microbiome Revolution for Advanced Dermatological Treatments
1:00 pm Development of ATR-12, an Engineered Strain of S. Epidermidis, for Netherton Syndrome
Synopsis
- Netherton syndrome is a rare, severe skin disease caused by missing LEKTI protein
- ATR-12 is an engineered strain that delivers LEKTI to the skin to treat Netherton syndrome
- Initial safety results of an ongoing Phase 1 clinical study of ATR-12 in adult Netherton syndrome patients
1:30 pm Exploring ENS-002: A Microbiome-Based Therapy for Atopic Dermatitis
Synopsis
- Targeting Staphylococcus aureus by using a combination of three microbial strains to restore balance to the skin microbiome without immune suppression
- Evaluating ENS-002’s safety and tolerability in Phase 1 clinical trials, with a focus on its impact on S. aureus abundance and atopic dermatitis symptoms
- Anticipating Phase 2 trial results, which will provide further insights into ENS-002’s efficacy and its potential to become a transformative treatment for atopic dermatitis
2:00 pm Advancing Topical Therapies & Harnessing Ammonia Oxidizing Bacteria for Skin Health
Synopsis
- Exploring the therapeutic mechanism of Ammonia Oxidizing Bacteria (AOB) in regulating inflammation and immunomodulatory activity on the skin
- Understanding how AOB treatment supports a balanced, anti- inflammatory environment and enhances skin health
- Phase 2 clinical results of B244, demonstrating significant reductions in pruritus, improvements in Atopic Dermatitis (AD), and strong durability of treatment effects in patients with mild-to-moderate AD and associated itch; Preparations for Phase 3
2:30 pm Roundtable Discussion: Future Directions for Skin Microbiome Research & Therapeutics: Unlocking New Frontiers in Dermatology
Synopsis
- Beyond Dysbiosis: Rethinking the Role of the Skin Microbiome – How do microbial communities contribute to skin health, and what are the next big questions in research?
- Advancing Microbiome-Based Therapeutics – Exploring live biotherapeutics, postbiotics, and precision skincare for conditions like eczema, acne, psoriasis, and wound healing
- Regulatory & Clinical Translation Challenges – Navigating hurdles in clinical validation, standardization, and regulatory pathways for microbiome-targeted dermatological treatments
- Personalized & AI-Driven Approaches – How AI and multi-omics technologies are shaping the future of individualized skin microbiome diagnostics and therapies
3:00 pm Afternoon Networking Break
Harnessing the Potential of Inhaled Microbiome Therapies in Respiratory Disease Treatment
3:30 pm Engineering Microbiome-Based Inhaled Therapies for Respiratory Diseases
Synopsis
- Addressing the complexities of selecting the right bacterial chassis for inhaled microbiome-based therapies to prevent rapid clearance by the immune system and respiratory physiology
- Exploring Pulmobiotics’ approach to engineering bacteria to produce human proteins like cytokines and interleukins to stimulate targeted immune responses in conditions like lung cancer
- Highlighting Pulmobiotics’ innovative use of microbiome-derived bacteria, such as their Mycoplasma pneumoniae-based candidate, to treat infectious diseases and disrupt biofilms in combination with standard antibiotics
4:00 pm Inhalation of Live Biotherapeutics (LBP) for Chronic Lung Diseases
Synopsis
- Targeting neutrophilic lung inflammation by using a inhaled Lactobacilli LBP
- Targeting neutrophilic lung inflammation by using a inhaled LBP metabolites
- Getting ready for clinical trials in COPD, IPF, BPD