All Timings Below in Central European Time

8:30 am Virtual Registration & Networking

Morning Plenary – Microbiome Leaders Industry Review

9:00 am European Microbiome Leaders Panel Discussion

Synopsis

• What are the current strategies to take microbiome-based therapeutics to market?
• What role will partnerships play in future therapeutic strategies?
• What can public institutions and regulators to do to support the microbiome sector?
• What tools can be utilised to reveal causation and molecular mechanism of microbiome-based therapeutics?
• Given the status of the microbiome, where do you see the industry developing in five years?

9:45 am Lightning-Round Discussions 1: Partnerships and Collaboration

Synopsis

Following on from our Leader’s Panel where our CXOs touched on the future of collaboration in the space, join three, three-minute quick-fire discussions to share opinions with your peers on these three topics:
1. Introduction – who you are and what you’re hoping to get out of the next two days of discussions
2. In your experience, what role have partnerships played in your work in the microbiome space?
3. What tools/services have aided your microbiome work so far, and are the other tools/services you are interested in finding out more about for this year?
This morning’s panelists will all be in the discussions, so this is another chance to ask them follow up questions in a more intimate setting!

9:55 am Meeting the Maturing Supply Needs of the Microbiome Sector

Synopsis

• Assessment of the growth in the microbiome space
• Solutions to meet the process development and clinical needs of the sector
• Investing to support the commercial supply needs of the sector

10:25 am Lightning-Round Discussions 2: The Future of the Microbiome Therapeutics Space

Synopsis

Three further, three-minute quick-fire discussions to share opinions with your peers on these three questions:
1. In your opinion, what will be the main change to the microbiome industry in the next five years?
2. What challenges do you think that the growth of the Microbiome space will cause for your work in the next five years?
3. Which, in your opinion, are the top three companies to watch?

10:35 am Solving LBP Manufacturing Challenges: Introducing Bacthera and Industry Changing Downstream Technologies

Synopsis

• From lab to market: introducing de-risking end-to-end CMC solutions for LBP developing companies
• Spotlighting downstream technologies enabling reduced process time, excellent scalability and superior viability, when compared to industry standards

11:05 am Morning Refreshments and Speed Networking

Stream A: Discovery & Pre-Clinical Development of Microbiome-Based Therapeutics

Complexities of Discovering Novel Live Biotherapeutics

As the predominant microbiome-targeting drug modality, LBPs have the promise of providing the same efficacy as FMTs but with more characterised mechanisms and safety profiles. This theme will continue to put the spotlight on LBP case studies that impact gut microbiome composition and reverse disease phenotypes whilst also providing new insights to the challenges of developing these drug products.

Stream B: Clinical Development & Manufacturing of Microbiome-Based Therapeutics

Clinical Trial Design & Evaluating PK/PD

Given the heterogeneity of gut microbiome signatures from person to person, research questions in translational microbiome studies have become substantially more complex than their counterparts in basic science. This theme will provide insight into the key study design considerations when developing a microbiome-based therapeutic to help inform and progress through early and late-phase clinical trials.

11:30 MRM Health – the Next Level in Optimized Consortia Development

Sam Possemiers, CEO, MRM Health

11:30 Harnessing the Potential of the Keystone Bacteria Christensenella into Ground- Breaking Live Biotherapeutic Products

• Substantial efficacy on obesity and associated metabolic disorders demonstrated
in preclinical models
• Design of Phase 1 clinical trial
• Towards other major chronic target diseases

Georges Rawadi, CEO, YSOPIA Bioscience

12:00 Delivery, Survival, Engraftment & Activity of LBPs in the GI Tract

• Sharing how validated in-vitro technology platforms are a key tool for the preclinical work in LBPs development
• Exploring how the SHIME system enables integrated simulation of the full GI track, including lumen, mucosa and host
• Investigating the MoAs of LBPs in areas of the gut, which are not easily accessible, generating data complementary to in vivo studies


Aurelien Baudot, Head of Business Development, ProDigest

12:00 Outlining Enterome’s Onco-Mimics Program: Microbiome-Derived Immunotherapy for Treatment of Cancers

• Clarifying how targeting novel antigens called oncomimics can induce cytotoxic T-cell response against tumors in combination with checkpoint inhibitors
• Understanding how EO2401 can be used in patients with Glioblastoma Multiforme (GBM)


Gregoire Chevalier, Scientific Affairs Manager, Enterome

Overcoming Development Challenges

12:30 Development of Microbiome Drug Products

Maireadh Pedersen, CEO, Quay Pharma

12:30 MicroRx Single Strain Live-Biotherapeutics: POC Clinical Data and Future Considerations

- From preclinical models to proof of concept in patients
- Next phase of clinical development
- Second generation MicroRx LBPs and new target diseases

Dr. Imke Mulder, Research Director, 4D Pharma

13:00 Lunch and Networking

13:00 Lunch and Networking

14:00 Introducing Exeliom Biosciences


• Exeliom Biosciences was founded as a lean organization by a pioneer team in the field of translational microbiome research
• Exeliom Biosciences aims at bringing microbiome to the traditional pharma by developing a microbial therapy based on a single strain of Faecalibacterium prausnitzii
• "Human discovery first" is Exeliom Biosciences' guiding principle


Mathilde Antoine,
Operations Manager, Exeliom Biosciences

Clinical Learnings of Live Biotherapeutics

As microbiome researchers prepare for the first FDA-approved therapeutic, there are several significant learnings from ongoing clinical trials that can be leveraged to support the next generation of microbiome-based therapeutics. This theme will aim to provide new insight into the learnings and outcomes of the most high-profile clinical trials in industry.

Microbiome Chemistry Small Molecules

Many researchers are identifying microbial by-products that modulate host function and have therapeutic efficacy. Due to the unknown regulatory and manufacturing requirements for Live Biotherapeutics, researchers are keen to explore microbiome-targeting small molecules due to their close alignment to traditional pharmacology. The purpose of this theme will be to review the potential of microbiome-targeted therapeutics derived from chemistry, not live organisms.

14:00 Prevention of Recurrent Clostridium Difficile Following Treatment with Microbiota based Therapy: Clinical Results and Considerations

• Demonstrating how RBX2660 was efficacious for the prevention of rCDI with longterm durability at 6 months post-treatment
• Evaluating consistency with other ongoing clinical studies
• Exploring clinical trial design and considerations when working with LBP products

Ken Blount, CSO, Rebiotix

14:30 A Novel Approach to Prebiotic Based Therapeutics


• Prebiotics as a co-intervention
• The potential SCFA’s to impact therapeutic efficacy
• The importance of gut health diagnostics in the development and personalisation


Kristofer Cook,
CEO & Co-Founder, Carbiotix

15:00 Developing Microbiome-derived Molecules for the Treatment of Neurodegeneration


• Stellate Therapeutics’ microbiome-derived medicine platform spans discovery and screening to production and biomarker identification and has generated a portfolio of characterized drug candidates
• STL-101 is a potential first-in-class small molecule for the treatment of Parkinson’s and Alzheimer’s disease that acts through neuroprotection
• Microbiome-molecules are an ideal source for potential new treatments because they are endogenous and therefore less likely to be toxic and are also potential biomarkers to stratify patients for trials


Nicole McKnight,
CEO, Stellate Therapeutics

15:30 From Computational Predictions to Preclinical Performance

• Reporting new positive pre-clinical results with Biomica’s rationally-designed consortia in our immune-oncology program
• Initiating a new program on Biomica’s pipeline- utilizing functional microbiome analysis for targeting abdominal hypersensitivity in IBS

Shiri Meshner, VP R&D, Biomica

14:30 A Human-First Discovery Approach: Leveraging Clinical Data to Identify Microbial Communities Driving Positive Clinical Outcomes

• Utilizing data from human microbiota transplantation studies and machine learning to develop novel microbiome therapeutics and retire risk early
• Applying a Human-First Discovery approach to the development of microbiome therapeutics for a diverse range of conditions, such as inflammatory bowel disease and autism spectrum disorder


Zain Kassam,
CMO, Finch Therapeutics

15:00 C difficile Infection and Microbiome Therapeutics: The Importance of Understanding Your Disease Target


• Highlight the importance of diagnostic assay selection in a subjective disease
• Review potential confounders in study trial design that may impact outcomes
• Highlight how a thorough understanding of the natural history of disease may impact selection of microbiome endpoints


Matt Henn,
CSO, Seres Therapeutics

15:30 Data Directed Discovery of Microbiome Derived Therapeutics


• Presenting how big data in combination with machine learning can be applied for the rational discovery of microbiome-derived therapeutics
• Applying this novel approach to IBD which has helped identify new biological leads which have shown to supress key inflammatory pathways
• Developing new therapeutic leads for other indications, including metabolic diseases, GI conditions and psychiatric disorders


Lutz Kraus, Head of Data-Mining and Artificial Intelligence, Microba

16:00 Refreshments Break

 

15:40 Refreshments Break

 

4:30 pm Microbiome Endgame: Preparing Microbiome Products for Regulatory Requirements Through cGMP Program Design

5:00 pm Magnifying the Human Gut Microbiome

  • Rob Finn Head of Microbiome Informatics Team , European Bioinformatics Institute

Synopsis

• Background to EBI’s 5000+ species collection of metagenome-assembled genomes (MAGs) for the human gut, the largest of its kind globally
• Understand the resources available for you to use
• Contextualise your isolate genomes against this human catalogue

5:30 pm Collaboration Roundtable Discussions

Synopsis

• We know that therapeutic insights from the human microbiome require successful collaborations across basic science, clinical expertise, and industry partners. With that in mind, this unique collaborative format will look to provide disease specific knowledge as it relates to the development of microbiome-based therapeutics and help further identify new solutions.

Roundtable A: IBD and the Human Microbiome
Roundtable B: Metabolic Disease and the Human Microbiome
Roundtable C: Cancer and the Human Microbiome
Roundtable D: Neurodegenerative Disease and the Human Microbiome
Roundtable E: Women’s Health and the Human Microbiome

6:00 pm End of Conference Day 1