8:20 am Chair’s Opening Remarks
Bringing the Cutting-Edge from the Clinic: Redefining Standards in Disease Management
8:30 am Clinical & Mechanistic Insights From Phase 2a Studies with Optimized Consortia Therapeutic MH002 in Ulcerative Colitis & Pouchitis as Basis for Future Pipeline Development
Synopsis
- MH002, a 6-strain consortia therapeutic designed, optimized and manufactured through MRM Health’s CORAL® technology, is the most advanced live biotherapeutic in clinical development for Ulcerative Colitis and Pouchitis
- Receive integrated insight on the translation of the mechanism of action of MH002 in activity in both Ulcerative Colitis and Pouchitis patients
- Explore how insights from different clinical studies can lead to synergistic and accelerated pipeline development
9:00 am Presentation Reserved for Biose Industrie
9:30 am Final Results from PUNCH CD3-OLS, an Open-Label Clinical Trial of REBYOTA (Fecal Microbiota Live-jslm) in Patients with Recurrent C. Difficile Infection
Synopsis
- Topline results will be presented from the largest (n=697 treated) single study of REBYOTA
- Safety and efficacy will be presented for the study population and subgroups of interest (IBD and Immunosuppressed patients)
- Results provide further evidence that REBYOTA is safe and well tolerated in a variety of patients with recurrent C. diff infection
10:00 am Presentation Reserved for Clinical Microbiomics | MSOmics | Cosmos ID
10:30 am Structured Networking Break
Synopsis
Make the most of this morning networking session to reconnect with your industry and meet fellow microbiome pioneers. Use this opportunity effectively connect with cross-industry stakeholders and form important connections for expediting your platform development!
Novel R&D & Translation to the Clinic
Track Chair: David Lubkowicz, Head, Strain Engineering & Characterization and HCU Program Lead, previously Synlogic Therapeutics
Track Chair: David Lubkowicz, Head, Strain Engineering & Characterization and HCU Program Lead, previously Synlogic Therapeutics
Improving Our Mechanistic Understanding of the Microbiome: Identifying Disease Drivers & Early Pipeline Decision Making
11:30 am Mechanistic Microbiome: How New Mechanisms & Small Molecules Can Reignite the Microbiome Field
Synopsis
- Discovery of key enzymatic activities in the IBD gut microbiome
- IND enabling studies for small molecule inhibitors of gut microbial enzymes and their multidisease applicability
- Discovery and preclinical validation of a key missing metabolite from the ASD gut microbiome
12:00 pm Evolution of Novel Synthetic Biology-Derived Oral Immunotherapies
Synopsis
- Leveraging novel microbiome-regulated immune pathways
- Applications for synthetic biology engineering
- Improving immunotherapy
Manufacturing Microbiome-Altering Modalities
Track Chair: Adam Wilkinson, Vice President of Pre-Clinical Development, Microbiotica
Track Chair: Adam Wilkinson, Vice President of Pre-Clinical Development, Microbiotica
Technical Advancements Maximising Yields & CMC Output as Microbiome Therapeutics Advance
11:30 am Beyond Single Strain: Improved Process Development in an Era of Greater Complexities of Microbiome Therapies
Synopsis
- Learn how fermentation process is being modified to maintain product consistency across single strain and consortia formulations
- How are processes being optimised to hold product uniformity, looking at media development and lyophilisation
- What advancements in manufacturing technologies and quality control are being implementing to address the added complexities introduced by diverse microbial compositions?
12:00 pm Presentation Reserved for List Labs
12:30 pm Lunch & Networking
Generating Robust Translational Data: Paving the Path for Success in the Clinic
1:30 pm EXE-346 Live Biotherapeutic – A “Food To Drug” Conversion
Synopsis
- EXE-346 is a high dose probiotic blend intended for the treatment of excessive stool frequency in patients with an ileal pouch anal anastomosis
- The same formulation in a lower potency has been commercialized as a non-drug product for over 20 years under several consumer brand names
- The presentation will summarize the evolution of this product from “food to drug” and explore the benefits and pitfalls of pursing a drug approval strategy with historically nondrug probiotics
2:00 pm Presentation Reserved for One Codex
Microbial Quality Control for Safe & Efficacious Therapeutic Development
1:30 pm Best Practices for Assay Development for Live Biotherapeutics
Synopsis
- How can sponsors better align processes to meet regulatory body quality expectations?
- What are todays’ best practice for implementing robust analytical methods which meet regulatory scrutiny and support approval of material quality?
- What industry successes can others learn from to plan efficient pathways towards regulatory clearance?
2:00 pm Presentation Reserved for Sacco System
2:30 pm Scientific Poster Session
Synopsis
The learning & networking continues! Join us for our NEW scientific poster session, providing an opportunity to connect with peers, fostering new relationships, and a platform for showcasing your work, while also allowing you to explore cutting-edge contributions across drug discovery to clinical trial updates.
Currently in the Clinic from C.Difficile & Beyond: Promising Industry Pipelines Actively Progressing
Afternoon Chair: Dan Brownell, Head of R&D, AOBiome
Afternoon Chair: Dan Brownell, Head of R&D, AOBiome
3:00 pm Data Driven Decision Making: Trends in Microbiome Drug Development and Market Landscape Review
Synopsis
- Gain exclusive insights into the current state of play for microbiome drug development with a deep dive into the progression of the preclinical and clinical landscapes
- Delve into the array of indications being targeted today, with insight on which therapeutic modalities gaining traction and indications capturing industry attention
- Align your pipeline strategy with key industry leaders in the US and across the globe where investment and collaborations are shaping the future of microbiome drug development
3:30 pm Advancing a Non-Infectious Disease Indication Through Clinical Development
Synopsis
- Explore a clinical case study demonstrating how microbiome drug development is progressing for diseases beyond infectious
- Key milestones and challenges encountered to underscore efficacy demonstration in non-infectious targets
- Uncover patient outcomes and clinical markers demonstrating the therapeutic impact of microbiome modulation in a novel therapeutic context
4:00 pm Start-Up Showcase
Synopsis
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 2024!
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 2024 Winner Receives A Free Pass to Attend Next Years’ Summit & a Speaking Position!
- Find out more here