Conference Day One | Wednesday, 29th January, 2025
7:30 am Morning Registration, Light Breakfast & Welcome Coffee
8:25 am Chair’s Opening Remarks
Leveraging Clinical Data to Pave the Way for Future Novel Therapeutic Interventions Addressing Unmet Needs
8:30 am Clinical Updates from Phase 2a Studies with Optimised Consortia Therapeutic MH002 in Ulcerative Colitis & Pouchitis
Synopsis
- MH002, a 6-strain consortia therapeutic designed, optimised and manufactured through MRM Health’s CORAL® technology, is the most advanced live biotherapeutic in clinical development for Ulcerative Colitis and Pouchitis
- Having completed full analysis, sharing additional insights of MH002’s activity
- Sharing microbiome and engraftment data, for the mechanism of action of MH002
9:00 am Microbiome Products (LBP & NGP) Development and Manufacturing
Synopsis
- Biose industrie is a pharmaceutical CDMO with development and industrial manufacturing & analytical capabilities
- In 2024 we manufactured 149 genus of strains in our bioreactors and encapsulation / Tableting / liquid filing capabilities
- We are specialized from phase I to phase III and commercial manufacturing with new NGP and commensal strictly anaerobic strains
- We run from R&D batch to Regulatory filing for worldwide applications
9:30 am Leveraging Key Proof-Of-Concept Discoveries from Clinical Data in Onco-Haematology to Uncover Future Microbiome Research Directions
Synopsis
- Gain insights into key mechanisms of action derived from clinical trials in oncohematology
- Understand how these findings are opening pathways for novel microbiome-based interventions
- Explore how proof-of-concept discoveries are guiding future directions for microbiome research in oncology
9:30 am Positive Phase 3 Results Data in hemato-oncology for MaaT013 in Acute Graft-versus-Host Disease, a first for the microbiome industry in oncology
Synopsis
- Discover the unprecedented efficacy of MaaT013 as a third-line treatment for gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD)
- Learn how MaaT013’s durable response rates translate into prolonged survival outcomes
- Explore the impact on MaaT Pharma’s growth strategy and future market opportunities
10:00 am Morning Networking Break
Synopsis
Meet and connect with your peers in this dedicated networking session
Addressing Standardisation to Inform Design & Controls for Clinical Consistency
11:00 am Targeting Unmet Clinical Needs in Medically Vulnerable Patient Populations: SER-155 Phase 1b Trial Results in Allo-HSCT Patients
Synopsis
- Leveraging a Phase 1b clinical trial strategy to evaluate safety and drug pharmacology, as well as obtain insights on clinical efficacy
- SER-155 safety was well-tolerated in both open-label patient cohort and placebo-controlled cohort
- Observation of significant reduction in both bacterial bloodstream infections (BSIs) and systemic antibiotic exposure with expected drug pharmacokinetics, as well as lower incidence of febrile neutropenia
11:30 am Addressing Patient Recruitment Challenges in Microbiome Drug Development: Approach from Ongoing Phase I Trial of BMC128 in Combination with Nivolumab
Synopsis
- Defining patient populations to support the investigation of safety and tolerability of BMC128 in combination with nivolumab, an anti-PD1 immune checkpoint inhibitor, in patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC)
- Patient identification processes, supporting preliminary findings of positive evidence of cancer therapies leveraging gut microbiota
- Additional update on preclinical IBS programme to identify promising bacterial compositions through computational analysis, with ongoing optimisation to finalise the most effective combination
12:00 pm Panel Discussion: Establishing Standards in Microbiome Clinical Studies to Enable Confidence in Comparable Data
Synopsis
- Uncover perspectives on the challenges in ensuring clinical data reproducibility, including the evaluation of current methods and studies to data
- Where does the industry see opportunities to harmonise study designs and protocols to support data interpretation?
- Learn areas of industry progression and opportunities for collaborative efforts to standardise methodologies
12:45 pm Lunch Break
Synopsis
Take this chance to meet the expert speakers, connect with your peers and explore our exhibition hall to meet fresh and familiar faces or even your next collaborator!
Lunchtime Networking Room: Pivoting from Therapeutic Development to Probiotics
Join this networking session, to meet peers with a common interest in the interplay between probiotic and LBP therapeutic development fields.
As LBPs increasingly prove safety, use this time to discuss:
- Why pivot towards or away from food supplements?
- What market pressures should developers take into consideration?
- What are the trends of today, could preventative therapeutics become a reality?
Addressing Investment & Regulatory Landscapes in Microbiome R&D to Advance Therapeutic Development
1:30 pm Regulatory Journey to Phase I for Defined Consortia LBP: Helping Biopharma Pre-Empt Challenges Navigating Regulations in Europe
Synopsis
- Visibility on preclinical requirements for taking an LBP to the clinic, and navigating lack of concordance across non-clinical safety, and CMC specifications
- Sharing how biopharma can better plan to achieve regulatory milestones
- With regulatory set-backs adding time and cost to programmes, pre-empt requirements earlier to more accurately predict timelines and costs
2:00 pm New EU SoHO Regulation & Proposed Pharmaceutical Legislation: Implications for Microbiome-Based Medicinal Product Development
Synopsis
- Human microbiome samples are now included within the scope of the new EU SoHO regulation
- Human microbiome samples used as SoHO preparation and/or starting material for the production of microbiome-based medicinal products will have to follow the standards and requirements set by this new SoHO regulation
- The upcoming new European General pharmaceutical legislation will specify the interplay between the SoHO regulation and this pharma legislation
2:30 pm Probiotic & Therapeutic Development Cross-Talk: Defining a Route Forward with Therapeutic & Commercial Potential in Mind
Synopsis
- How to leverage expertise and IP landscape awareness to de-risk drug opportunities at an early stage
- Approach to select probiotic clinical / preclinical research programmes to move into a therapeutic setting, or remain within probiotic
- BioGaia Pharma’s pharma pipeline, and approach to de-risking opportunities for internal or external development
3:00 pm Afternoon Break
Synopsis
Grab a coffee and explore our exhibition booths, networking and more!
Preclinical Showcase
Apply Here to Present Your Preclinical Programs!
Synopsis
Immerse yourself in a showcase of cutting-edge research and technologies as microbiome start-ups unveil their unique approaches to drug development. Understand their expertise, commercial strategies for success and the passion that drives their mission to revolutionise today’s drug development landscape.
3:30 pm AI-guided Design of a Synthetic Consortium for the Development of Live Biotherapeutic Products
3:40 pm Deciphering & Targeting the Virome
4:00 pm Accelerate Your LBP Towards GMP Level – The CDMO Approach
Synopsis
- What does our technology (LIBATEC® tailor-made platform) look like?
- How do we ensure that our product and process remain monoseptic?
- The key factors to be considered during development in order to accelerate a LBP process for GMP manufacturing.
4:30 pm Investor Perspectives Panel Discussion: Attractors & Detractors, Geographical Variances & Promising Innovation on the Horizon
Synopsis
- Uncover perspectives on the microbiome industry as an investment opportunity, from where there’s most excitement to challenges investors see, to align your projects with investor expectations
- Explore geographical differences in funding environments to strategically attract more investment
- Discuss the thinking behind how to re-engage large pharma in microbiome research
- Learn perspectives on market dynamics, like competition and unmet need, to secure necessary capital and move differentiated projects forward
Moderated by – Gabriela Juarez Martinez
5:00 pm Chair’s Closing Remarks
5:05 pm Networking & Scientific Poster Session
Synopsis
The learning and networking continues! This is the perfect opportunity to connect over the themes and challenges addressed throughout the day, and spark discussions and potential future collaborations with fellow microbiome R&D sharing their trailblazing research!