“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 The Microbiome’s Role in Gastrointestinal Cancers
Synopsis
- Exploring the Microbiome & Colorectal Cancer: How gut microbiota modulate colorectal cancer risk and progression, evaluating the influence of microbial metabolites (e.g., butyrate) on tumor microenvironment and elucidating microbiome interactions with immunotherapy and chemotherapy response
- Other GI Cancers (Pancreatic, Gastric & Esophageal): exploring key microbiome-driven mechanisms in upper GI cancers, the role of bacterial dysbiosis in inflammation and tumorigenesis, and exploring current and emerging microbiome-targeted therapeutic strategies
- Translating Microbiome Research into Oncology Practice: including strategies for microbiome modulation, the potential for microbiome-based biomarkers in GI cancer detection and challenges and future directions in integrating microbiome science into cancer care
9:30 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
10:00 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!
10:30 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
11:00 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
11:30 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
12:00 pm 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
11:00 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
11:30 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
12:00 pm 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
12:30 pm Networking Lunch
12:55 pm
Announcing the Winner of the Start-Up Showcase!
Use Data to Drive Innovation in Microbiome Research & Development
1:00 pm Clinical & Translational Insights from Microbiome Modulation Trials at MD Anderson
Synopsis
- Exploring key clinical and translational insights gained from a variety of microbiome modulation trials at MD Anderson, highlighting their impact on cancer treatment and patient outcomes
- Discussing the major findings from these trials, including how microbiome composition influences therapy response and potential strategies for leveraging microbial interventions
- Outlining the next steps in research and clinical application, focusing on the challenges and opportunities in translating microbiome science into precision cancer care
1:30 pm Leveraging AI & Big Data in Microbiome Drug Discovery
Synopsis
- Analyzing gut microbiome data is incredibly challenging due to the wide variation in microbial ecosystems found in the gut and due to the incredible explosion of scientific papers linking the gut microbiome to various diseases and health conditions (now more than two thousand peer-reviewed studies per month in PubMed). For the first time, large language models (a form of AI) offer us the ability to synthesize all of the world’s scientific knowledge to fully analyze gut microbiome data for an individual.
- The extraction of the complete published scientific knowledge of the microbiome makes it possible to develop a microbiome digital twin that can be used to digitally simulate the effects of different interventions on a trial subject with a known microbiome and predict drug therapeutic efficacy prior to treatment in the trial
- This AI technology for both analysis and digital twinning unlocks new opportunities and avenues for drug targets, therapeutic development, clinical trial design, patient recruitment and biomarker development
Translating Microbiome Learnings to Women’s Health & Gut-Brain Axis for CNS Indications
1:30 pm Learnings from Clinical Development with MH002 in IBD and Translation to LBP Development for Parkinson’s Disease
Synopsis
- Reviewing Phase 2 clinical data of MH002, a next-generation microbiome therapy utilizing MRM Health’s CORAL® Technology, combining six commensal strains for targeted action in Ulcerative Colitis (UC) and Pouchitis
- Lessons learned and highlights on its ability to restore gut microbiome balance and improve clinical outcomes
- Translation of knowhow from clinical program to develop LBPs for Parkinson’s Disease; update on preclinical data
2:00 pm Afternoon Networking Break
Harnessing the Potential of Inhaled Microbiome Therapies in Respiratory Disease Treatment
2:30 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
3:00 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