7:20 am Check In, Morning Coffee & Light Breakfast
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
9:00 am Microbiotica & Biose Industrie : Developing & Manufacturing Two Multi-Strain Live Biotherapeutic Products for Clinical Studies
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
10:00 am Innovative Tools & Strategies for Advancing Microbiome Therapeutic Development
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
12:00 pm Evolution of Novel Synthetic Biology-Derived Oral Immunotherapies
Manufacturing Microbiome-Altering Modalities
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
12:00 pm The Vaginal Microbiome: Sometimes, It Doesn’t Take a Village.
Synopsis
- Optimization of the manufacturing process for a robust and stable LBP product
- A novel LPB for prevention of bacterial vaginosis, preterm birth, and HIV prevention
- Successful colonization with a single strain LBP
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
2:00 pm F(AI)R Data: Not Just for Humans! Foundations for AI and ML Programs in Translational Microbiome Research
Microbial Quality Control for Safe & Efficacious Therapeutic Development
1:30 pm Best Practices for Assay Development for Live Biotherapeutics
2:00 pm Approaches Sacco System Employ to Develop Commercially Ready Manufacturing Systems
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
3:30 pm Advancing a Non-Infectious Disease Indication Through Clinical Development
4:00 pm CMC Considerations for Consortia Based LBP Programs – Streamlining Early Phase Analytics to Ensure IND Acceptance
Synopsis
· It is important to effectively characterize an LBP process to ensure IND acceptance in a timely manner.
· How do you balance phase appropriate qualification with comprehensive characterization initiatives?
· What are some of the challenges with performing stability studies on products that contain live microorganisms?
· Purity assays, such as USP <61> and <62> seem like they are easy, but can be quite challenging with LBP consortia’s contain facultative anaerobes. How do we overcome those challenges?
· Partnering with an analytical expert ensures the analytical panel utilized will be accepted by regulatory authorities.
4:30 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
5:15 pm Chair’s Closing Remarks & End of Day One
5:30 pm Networking Drinks Reception & Awarding the Winner of 2024’s Start-Up Showcase
Synopsis
Enjoy a beverage alongside your peers, as we toast the winner of the Start-Up Showcase!