Conference Day One, 31st January, 2024

7:30 am Morning Registration & Networking

8:20 am Chair’s Opening Remarks

8:29 am
ANALYSING THE MICROBIOME INNOVATION & BUSINESS CLIMATE TO DETERMINE STRATEGIES FOR ADVANCE YOUR THERAPEUTIC PIPELINE & ACCELERATE THE NEXT APPROVAL

8:30 am A Development Journey: Navigating the Challenges & Opportunities in Medical Interventions

Synopsis

  • Applying medications to life-threatening disease in premature infants including NEC and sepsis
  • Considering product quality for a highly vulnerable patient population with the ambition for IBP-9414 to become the world’s first approved medication for premature infants
  • Examining the data from the largest randomized controlled trial in the premature infants ever

9:00 am LBP Drug Development & Manufacturing : CMC Challenges

Synopsis

  • Appreciating that clinical LBP manufacturing is not an easy journey : many challenges are encountered along the path because of the nature of the living organisms we are interested in
  • Describing the challenges encountered and the solutions we bring to help our clients to take lab organism to a real GMP product accepted for use in the clinic by the FDA

9:30 am Panel Discussion: Hearing Investment Perspectives to Navigate the Current Investment Climate & Take Part in a Reverse Pitch Opportunity

Synopsis

  • Uncovering the hottest areas of investment in the microbiome world to understand which features of a business attract funds
  • Exploring how you can transform your development plans to attract more investment
  • Partake in a reverse pitch sessions, giving you the chance to ask these investment experts your burning questions

10:15 am The Journey from Concept to Commercial Success

Synopsis

  • Reviewing a case study on the collaborative efforts required on the way to commercializing the first, and only, orally administered microbiome therapeutic
  • Discussing how a CDMO with a broad network, specialized expertise, and a collaborative mindset is critical to successfully navigating the pathway from clinical entry to commercial launch

10:45 am Speed Networking & Morning Break

11:44 am
TRANSLATIONAL TRACK

11:45 am Expanding Our Mechanistic Understanding for the Role of the Microbiome in Immuno- Oncology

Synopsis

  • Advancing two consortia into the clinic: MB310 in ulcerative colitis and MB097 in advanced melanoma with pembrolizuma
  • Selecting of strains comprising each consortium were due to strong associations with positive outcomes in clinical trials rather than mechanism
  • Exploring translational data which demonstrates the multiple mechanisms by which these bacteria impact host responses linked to disease pathology

12:15 pm Paving the Regulatory Footpath: Current Perspectives & Future Considerations

Synopsis

  • Working around integrating technical development within a regulated environment across CMC, preclinical to clinical stage
  • Establishing regulatory strategies in an environment where there’s a lack of frameworks and guidelines
  • Revealing future visions for microbiome regulations and preparing for long term initiatives

12:45 pm Mechanistic Insights from a Phase 2a Study with MH002, an Optimised Consortia Therapeutic Evaluated in Ulcerative Colitis Patients

Synopsis

  • Outlining MH002, a 6-strain consortia therapeutic designed, optimised and manufactured through MRM Health’s CORAL® technology, the most advanced live biotherapeutic in clinical development for Ulcerative Colitis and Pouchitis
  • Receiving first-time insight on the translation of the mechanism of action of MH002 in activity in Ulcerative Colitis patients – results from a placebo-controlled randomized Phase 2a study

11:44 am
ENABLING TECHNOLOGIES TRACK

11:45 am Exploring Challenges for CMC with Microbiome Ecosystem Native & Co-Cultured Products

Synopsis

  • Outlining MaaT Pharma’s differentiated and innovative process
  • Creating product versatility with production adhering to the highest pharmaceutical standards (cGMP)
  • Presenting MaaT Pharma’s fully integrated manufacturing and development platform for a streamlined product development, scaleup and GMP process

12:15 pm Panel Discussion: Regulatory Perspectives on Engineered Microbes

Synopsis

  • Defining your product and understanding which regulatory guidelines apply where
  • Exploring biocontainment considerations
  • Revealing agencies’ advice

12:45 pm Microbes & Cancer: Allies or Enemies

Synopsis

  • Outlining cancer biology and interactions with microbes
  • Exploring microbes and cancer prevention
  • Uncovering microbes and cancer therapy

1:15 pm Lunch Break & Networking

2:15 pm Boosting Cancer Immunotherapy With Next Generation Co-Cultured Product

Synopsis

  • Outlining MET-C product generation, driven by predictive AI and by state-of-the-art proprietary in vitro and in vivo validation
  • Presenting preclinical data for ground-breaking co-culture donor independent for first MaaT03X asset, a full synthetic microbiome capsule

2:45 pm Panel Discussion: Microbiome, Dosing & Toxicity – Regulatory Lessons Learned & Questions Still Remaining

  • Selin Bolca Dir Operations and Development, MRM Health
  • Celine Druart Microbiome Project Manager, Pharmabiotic Research Institute (PRI)
  • Karine Roget Chief Scientific Officer, Nexbiome
  • Sophie Mathys Head of Regulatory Affairs and Quality Assurance, PharmaBiome AG

Synopsis

  • Exploring engraftment and microbiome-therapeutic efficacy
  • Outlining challenges in determining dosing
  • Navigating toxicity concerns

2:15 pm AI Implementation for Microbiome Secondary Metabolites Discovery & Therapeutics

Synopsis

  • Using deep learning to refine microbiome natural product structure prediction from gene sets
  • Enabling high-throughput categorization of natural products using chemoinformatics
  • Exploring a therapeutic natural product discovery from patient microbiome

2:45 pm A High-Throughput Screening Approach to Study Effects of a Multi-Strain Product in the Colon Using Rapid Metabolic Fingerprinting

Synopsis

  • Assessment of metabolic impact of SymproveTM treatment in 1600 experimental conditions enables an in-depth evaluation of treatment efficacy
  • Miniaturized colonic simulations (Colon-on-a-Plate®) coupled to rapid metabolic fingerprinting (LA-REIMS) effective for high-throughput applications
  • By targeting thousands of metabolites in a single analysis, novel LA-REIMS technology provides significantly higher resolution as compared to traditional techniques

3:15 pm Poster Session & Networking

Synopsis

Take a break from the formal presentations and join your peers in the microbiome field by presenting your work in our dedicated microbiome poster session. This is the perfect opportunity to discuss, debate and display your work in the field!

3:59 pm
UNCOVERING NEW CLINICAL DATA & NOVEL MICROBIOME-TARGETING TECHNOLOGIES TO REVEAL NEW HORIZONS FOR THE FIELD

4:00 pm Current Approaches, Challenges & Opportunities to Establish Microbiome as a Risk Assessment Tool

Synopsis

  • Exploring how exposures to xenobiotics may impact the gastrointestinal barrier and lead to disruptions in the abundance and function of microbiome
  • Discussing ongoing approaches, challenges, and opportunities to establish science-based minimum standards for conducting risk assessment of such products
  • Using animal and non-animal models

4:30 pm Technology Showcase: Organisations Take Spotlight to Share Their Technological Innovations in Quick Fire Rounds

Synopsis

As more and more companies are progressing their pipelines through to the clinic and generating exciting data, we have also seen advancements in the technologies that are underpinning microbiome research. From precision bacterial engineering to integrated -omics analyses, such advancements in technologies have stimulated a new wave of microbiome innovation. We welcome three early-stage organisations to the stage to share their innovations!

4:35 pm Building a Platform for Target Discovery in Heterogeneous Stock Laboratory Rats

Synopsis

  • Outlining the “Heterogeneous Stock” population of laboratory rats: a resource for target discovery
  • Evaluating the information content of different microbiome sequencing and profiling approaches.
  • Developing computational pipelines for the identification of causal relationships
  • between microbiome and host phenotypes
  • Leveraging allo-coprophagy, a natural behaviour of rats, to identify microbial therapeutics suitable for oral delivery

4:50 pm Triggering Anti-Tumour Immune Responses Against Cancer Through Bacteria-Based Therapy

Synopsis

  • Development of LBP to treat cancer
  • Identification of mechanism of action of our bacteria
  • Development of a small molecule therapy based on the identified mechanism of action

5:05 pm Engineering the Human Skin Microbiome to Modulate Sebum Production to Supply Long-term Therapies Within the Skin

Synopsis

  • Exploring how Synflora equips the most abundant skin microbe Cutibacterium acnes with enhanced capabilities to benefit human health.
  • Uncovering proof of concept in acne vulgaris, showing efficient engineering of this bacterium
  • Accelerating in vivo production of a sebum modulator

5:20 pm Q&A

5:30 pm Chair’s Closing Remarks

5:40 pm End of Conference Day One