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Microbiome Leaders Panel Discussion – Is Microbiome Causation a Reality for Patients?


Introduction and Purpose: The gut microbiome continues to be at the fore front of medical research and both the industrial and academic communities expect that insights gained from microorganisms will soon become a critical component of health management across a gamut of critical indications. However, the biggest hurdle in translating promising gut microbiome research into effective therapeutic candidates is demonstrating the causative role of human microbiome in disease pathology. Although there are a growing number of microbiome-based candidates showing promising results in both pre clinical and clinical settings, the approaches that are likely to have well-validated mechanisms of action are limited. This opening discussion will look to unite leaders from be to review the current thinking in approaching the human microbiome mechanistically and understanding what is needed to be overcome to translate novel findings into therapeutics of the future.

8:30 am Microbiome Leaders Panel Discussion

9:30 am Shotgun Sequencing & Strain-Level Analysis: Study Design for Pre-Clinical & Clinical Development

10:00 am Gut Microbiome Endgame: Ramping up cGMP Program Design to Ensure Regulatory Preparedness for Microbiome Products

10.30 Morning Refreshments and Speed Networking

Stream A: Functionality, Mechanisms & Pre-Clinical Development of Microbiome-based Therapeutics

What are the Targets, Platforms, and Challenges for Novel Live Biotherapeutics?

Introduction and Purpose:

LBPs have the promise of providing the same efficacy as FMTs but with a more characterised, and therefore predictable safety profiles. Currently, there has been a growing body of the use of LBPs across a variety of disease phenotypes, including IBD, Diabetes, Cancer, Autism and many more. The purpose of this theme will be to review cutting-edge case studies on the use of LBPs to reverse disease phenotypes driven by an unwanted dysbiosis in the human microbiome.

Stream B: Clinical Translation, Manufacturing & Commercialization of Microbiome-based Therapeutics

How Can You Demonstrate a Causative Clinical Benefit for Microbiome-based Therapeutics

Introduction and Purpose:

As a number of microbiome-based therapeutics enter a pivotal stage in clinical development, there are still major questions surrounding best practice in designing, scaling and progressing through the clinic. Successful in-human clinical efficacy data will help cement the success of microbiome-based therapeutics and continue to fuel the industry. The purpose of this theme will be to outline developments from industry and academia when executing clinical trials for therapies that aim to target the human microbiome.

11:30 Bottom-Up Design of Therapeutic Consortia Using Co-Cultivation

Thomas de Wouters, CEO & Co-Founder, PharmaBlome

11:30 Unlocking the Potential of the Microbiome: Oxalobacter Formigenes for the Treatment of Primary Hyperoxaluria

Maria Akerman, Director process R&D, Oxthera 

12:00 Novel Therapeutic Approaches Targeting the Microbiome in Metabolic Diseases

Georges Rawadi, CEO, LNC Therapeutics 

12:00 Prevention of Recurrent Clostridium Diifficule Following Treatment with Microbiota-based Therapy: Clinical Results and Considerations  

Ken Blount, CSO, Rebiotix

12:30 Developing Microbiome-Empowered Therapeutics for the treatment of immune-mediated and infectious disease

Elran Haber, CEO, Biomica Ltd.

12:30 Culturing and Scale up of Live Biotherapeutic Products

Herwig Bachmann, Expertise Group Leader Fermentation, NIZO

13:00 Delivery, Survival, Engraftment & Activity of LBPs in the GI Tract 

Aurelien Baudot, International Business Developer, ProDigest

13:00 Clinical Trial Considerations for Microbiome-targeted Therapeutics 

Andrea Doolan, CEO, Atlantia Food Clinical Trials  

13.10 Lunch and Networking

How are Microbial-Derived Metabolite Changing the Face of Microbiome Therapeutics?

Introduction and Purpose:

Many researchers are identifying and characterising microbial by-products that modulate host function and can therefore be used a viable therapeutic. Due to the unknown regulatory/manufacturing requirements for LBPs, many organizations are exploring the small molecule route as it is closely aligned to traditional pharmacology strategies. The purpose of this theme will be to review how organizations are targeting and validating new therapeutics based on by products of clinically relevant microbial species.

From Lab to Commercialization-How are Organisations Scaling and Manufacturing Microbiome-based Therapeutics?

Introduction and Purpose:

As companies prepare to scale from early phase product development to commercial scale microbiome therapeutics, challenges around guidelines and best practice relating to CMC that ensure microbiome-based products are produced to GMP-compliant standards. The purpose of this theme will be to review the current industry thinking on manufacturing and scale-up of microbiome-based therapeutics.

14:00 Mining the Microbiome for Novel Therapeutics

Kareem Barghoti, Co-Founder, VastBiome

14:00 Clinical and Manufacturing Considerations for Rationally Designed Live Bacterial Cocktails 

Bruce Roberts, CSO, Vedanta Biosciences 

What are the Limitations when Translating Animal Studies to Humans?

14:30 Harnessing Whole Community Microbiome Transfer to Develop and Advance Novel Medicinal Products

James Mcllroy, Founder & President, Enterobiotix

Introduction and Purpose: 

Prior to initial Phase 1 studies, a preliminary characterisation of a microbiome therapeutic has to be made using a combination of, in-vitro/in-silico  assays, animal models . The purpose of this theme will be to outline the most predictive preclinical strategies that address key regulatory and safety  considerations whilst guaranteeing future  clinical success.


15:00 Development of Oral LBP's- a CDMOs Perspective 

Ryan Wilson, Head of Live-Bio Programmes, Quay Pharma

15:30 Scale Up & GMP Manufacture of LBPs

Jason Ryan, Upstream Manager, Luina Bio

14:30 Intestinal microbiota dysbiosis in antibiotic-induced C. difficile infection: an example of inferences from animal studies and translation to humans 

Jean de Gunzburg, CSO, DaVolterra 

15:40 Making the Difference in LBP Drug Development and Manufacturing  

Adrien Nivoliez, CEO, biose Industrie 

15:00 The Blood Microbiome: New Source of Biomarkers for Infectious and Non-Infectious Diseases 

Alain Roulet, Laboratory Director, Vaiomer 

15:10 Early Break for Afternoon Refreshments

15.50 Afternoon Refreshments and Networking

Mastermind Session

Introduction and Purpose:

This session will facilitate in-depth discussion amongst participants in an informal setting. After splitting into groups, participants will have the opportunity to discuss three key areas that are related to the future application and success of microbiome-based therapeutics. Notes from this session will be shared with attendees after the meeting.

4:30 pm Standalone Therapy or Co-Therapy: Where is the Microbiome Most Relevant?

4:30 pm How Can Industry Partners Streamline Regulatory Guidelines for Microbiome-based Therapeutics?

4:30 pm Harnessing the Microbiome to Develop Breakthrough Diagnostic Tools

5:10 pm Chairperson Closing Remarks

17.20 Evening Drinks Reception & Scientific Poster Session Hosted by The Microbiome Movement 

Close of Conference Day One