WEDNESDAY, JUNE 30 | 8.30 - 17.35 EDT
Industry Leaders Plenary Discussion
8:30 am Morning Coffee
8:55 am Chair’s Opening Remarks
9:00 am Industry Leaders Panel Discussion
Synopsis
• What have been the most exciting developments within the past 12 months?
• What does the path of approval and the commercialization of these products look like?
• If C.difficle and consortia-based therapeutics was the low-hanging fruit, what is the next area of microbiome research?
• How can the focus be turned to incorporating the patient first?
• What are the biggest challenges the field will face over the next 3 years?
10:00am Lightning Discussion 1: Biggest Lessons From the Past 12 Months
Synopsis
Following on from our Industry Leader’s Discussion, where our expert faculty would have touched on the biggest challenges they have recently faced, this is your opportunity to join your peers for three, five minute quick fire discussion to share your thoughts on:
• What has been your biggest challenge in the last year?
• What have you learnt that will help you resolve that challenge in the future?
10:15 am Microbiome Endgame: Preparing Microbiome Products for Regulatory Requirements Through cGMP Program Design
Synopsis
• Hear a case-study example of Boston Analytical showcasing their manufacturing expertise
• Leveraging their in-house technologies to guide clients through the cGMP regulatory landscape
10:45 am Developing Bacterial Consortia Therapeutics for Infectious and Inflammatory Disease Targets
Synopsis
• Providing an update on Seres’ clinical and pre-clinical pipeline
• Discussing candidates including SER-109, which in a Phase 3 Clinical Trial led to a statistically significant reduction in C.difficile recurrence
11:15 am Shotgun Sequencing & Strain-Level Analysis: Study Design for Pre-Clinical & Clinical Development
Synopsis
• Discussing CosmosID’s sequencing capabilities
• Showcasing Pre-Clinical and Clinical Examples Case Studies
11:45am Lightning Networking 2: What are you hoping to achieve from this meeting?
Synopsis
Another opportunity for three, five minute discussions focussing on the next two days of content:
• What is the one thing that you are looking at getting out of this meeting?
• What services would you be most learn more about?
TRACK A: UNDERSTANDING MICROBIOME FUNCTIONALITY & PRE-CLINICAL DEVELOPMENT
Understanding Mechanisms & Functions of Live Biotherapeutics
12:00 pm Health Through Diversity: Designing Microbial Consortia for Lasting Benefit
Synopsis
• General introduction of Federation Bio platforms
• Discussion of the advantage of a microbial community approach over traditional therapeutic modalities
• Results of our lead program in secondary hyperoxaluria, including in vivo study data
12:30 pm Examining the Role of the Microbiome in Metabolic Disease
Synopsis
• Discussing how to establish causation, rather than correlation with your research
• Delve into understanding the mechanisms linking the microbiome to phenotype
• Discuss whether FMT can be used as an effective treatment?
TRACK B: CLINICAL TRANSLATION & MANUFACTURING OF MICROBIOME THERAPEUTICS
Leveraging Lessons from the Clinic to Guide Future Success
12:00 pm Forging a New Frontier – Driving Clinical Development of RBX2660, a Novel Live Biotherapeutic
Synopsis
• Clinical development challenging; even more so with the introduction of a novel approach to treatments via a live biotherapeutic
• Rebiotix, a Ferring Company, was the first company to approach the US FDA with a microbiota-based formulation to evaluated as a standardized, stabilized therapeutic option for recurrent C. difficile infection
• These learnings and personal connections have helped us build the leading clinical development program in the world. To date, the company has executed 6 clinical trials with over 900 patients for its leading investigational therapeutic, RBX2660
12:30 pm Protecting and Preserving the Intestinal Microbiota From Antibiotic-Induced Dysbiosis With dav132, a Novel Colon-Targeted Adsorbent: An Effective and Safe Solution for Cancer Patients
Synopsis
• DAV132, a first-in-class chemical product that sequesters and inactivates antibiotics circulating in the colon is able to preserve patients’ intestinal microbiota without impacting antibiotics’ plasma pharmacokinetics and efficacy, in a Phase 2 clinical study
• The understanding of DAV132 mode of action in humans is reinforced by a series of clinical studies conducted in healthy subjects and including microbiota analyses
• Additional work showing the importance of protecting the microbiota of cancer patients treated with immune checkpoint inhibitors will also be presented
TRACK C: MICROBIOME BIOMARKERS, PATIENT STRATIFICATION & DIAGNOSTICS
Exploring Approaches to Biomarker Discovery
12:00 pm Xmarker – A Novel Platform to Discover Microbiome Based Biomarkers
Synopsis
• A high resolution accurate non-referenced based approached to analyse metagenomic data
• Rapid discovery enabled through a cloud based platfrom within a few months
• Identification of metagenomic based signatures for IBD and liver diseases
12:30 pm The Strategic Role of Microbiome Biomarkers in Diagnostics & Therapeutics
Synopsis
• Microbiome-derived biomarkers are unique as they can be altered by external intervention, they are modulatable
• Biomarker and therapeutic development are linked through the microbiome
• Selecting for or against certain biomarkers lead to separate stratification and therapeutic strategies
1:00pm Lunch / Demo Area
Synopsis
Use this break in proceedings to make some lunch and coffee and head across to the Demo Area to connect with our Event Partners
1:45 pm Presentation Reserved for Event Partner
Synopsis
For more information, contact; partner@microbiome-movement.com
2:15 pm Live Biotherapeutics to Treat and Prevent Chronic Lung Infections
Synopsis
• LBPs as anti-infectives administered direct to the lungs offer many advantages over small molecules
• Aeruguard: review of a LBP for Psuedomonas & Staph lung infections including effects on the gut
• Mybacguard: review of a LBP for Non-tuberculous Mycobacterial (NTM) lung infections
Advancing Pre-Clinical Model Development to Improve Translatability
2:45 pm Pre-Clinical Animal Models to Understand the Influence of the Microbiome on the Host-Immune System
Synopsis
• Evaluation of the influence of antibiotic treatment on vaccine outcome in murine and non-human primate models
• Use of germ-free murine models to understand mechanisms of microbial entities that can influence the host immune system
• Characterizing global immune cell pathways modulated in murine models of dysbiosis
3:15 pm Next Generation Microbiome Profiling
Synopsis
• LoopSeq™ microbiome profiling is the first longread, high-resolution microbiome sequencing technology that uses existing Illumina sequencers
• LoopSeq™ technology introduces single-molecule counting for improved microbiome species abundance quantification
• LoopSeq™ simplifies microbiome sequencing workflows by enabling ‘one pot’, multiplexed sample preparation of up to 96 samples
1:45 pm Development of Microbiome Drug Products
Synopsis
• Discussing Quay Pharma’s expertise in formulation
• Learn how Quay Pharma’s formulation strategy can rapidly and effectively to First in Man studies
2:15 pm A Human-First Discovery Approach: Leveraging Clinical Data to Identify Microbial Communities Driving Positive Clinical Outcomes
Synopsis
• 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
Scaling-Up Microbiome Manufacturing to Reach Clinical Demands
2:45 pm Presentation Reserved for Event Partner
Synopsis
For more information, contact; partner@microbiome-movement.com
3:15 pm Overcoming Obstacles in the Development of Live Biotherapeutic Products
Synopsis
• Discussing GMP capabilities to manufacture LBPs, bacterial products and proteins
• Understanding how List Laboratories can scale-up cGMP manufacturing for Phase 1 and 2 clinical supply
1:45 pm Presentation Reserved for Event Partner
Synopsis
For more information, contact; partner@microbiome-movement.com
2:15 pm Panel Discussion – What Are We Looking for in a Microbiome Biomarker?
Synopsis
• Are we striving for a universally accepted biomarker? Is this achievable?
• Do we look for a marker of health, or a marker of disease?
• What is the FDA guidelines for microbiome-based biomarkers?
• How can biomarkers be used to intervene in health before disease sets in?
3:05 pm Presentation Reserved for Event Partner
Synopsis
For more information, contact; partner@microbiome-movement.com
3:15 pm The Blood Microbiome: New Source of Biomarkers for Infectious and Cardiometabolic Diseases
Synopsis
• Using a stringent contamination-aware approach, Vaiomer has developed advanced and robust pipelines to qualitatively and quantitatively characterize blood and tissue microbiomes, thanks
to 16S RNA gene sequencing and qPCR
• Vaiomer has demonstrated the existence of highly diversified blood microbiome in healthy human donors and shown the associations between changes in the blood microbiome and different noninfectious diseases
• These associations help to understand the role of bacterial translocation in the diseases and find new source of diagnostic and companion biomarkers
3:25pm Afternoon Virtual Networking & Coffee
Leveraging Small Molecules to Modulate the Microbiome
4:00 pm Synthetic Glycans to Optimize Microbiome Composition & Function for Therapeutic Outcomes
Synopsis
• Synthetic glycans as targeted modulators of microbiome composition and metabolic output
• Human centric discovery through ex-vivo screening and non-clinical studies
• Translational clinical studies
4:30 pm Expanding the Drug Discovery Space With Predicted Metabolite-Target Interactions
Synopsis
• Drug discovery requires to go beyond statistical association of metabolites with disease state
• Mullti’omics cohorts and publicly available data allow computational approaches to infer novel drug targets
• This study uncovered more than 900 metabolite host receptor pairs that can be useful to design treatments for inflammatory bowel disease (after experimental validation)
5:00 pm Inventing Medicine by Accessing the Microbiome Dark Matter
Synopsis
• The “dark matter” of human microbiome is highly valuable for drug discovery, yet remains largely inaccessible
• The methods and challenges in unlocking the microbiome dark matter
• DeepBiome’s platform and its progress
Effectively Designing & Executing Clinical Trails
4:00 pm Presentation Reserved for Event Partner
Synopsis
For more information, contact; partner@microbiome-movement.com
4:10 pm Designing & Executing Microbiome-Therapeutic Clinical Trials
Synopsis
• How do you design an FMT clinical trial?
• What considerations should be made when executing a trial?
4:40 pm Short Refreshment Break
5:00 pm Oral Microbiome Breakout Session
Synopsis
• Provide an overview of the oral microbiome
• Give an insight into BrickBuilt Therapeutics Inc.
• Discuss future directions and possibilities involving the oral microbiome
Application of Biomarkers in the Discovery of New Drugs and in Clinical Development
4:00 pm Biomarkers to Evaluate Microbiome Therapeutic Drug Pharmacokinetics & Pharmacodynamics
Synopsis
• Harnessing microbiome biomarkers to understand PK/PD of a microbiome therapeutic
• Using this information to inform the drug development pipeline
4:30 pm Biomarker Assay Development Considerations for Microbiome Therapies
Synopsis
• Microbiome drugs necessitate thinking about PK and PD in non-traditional ways
• Dynamics of microbial engraftment and timing of measurement are important for understanding PK
• Demonstrating the expected functionality of constituent microbes is an additional PD considerations in addition to quantifying host effects
5:00 pm Respiratory Microbiome Breakout Session
Synopsis
• This will be a discussion led session, and will provide an overview of the science of the respiratory microbiome, discuss the current challenges of working in this area with a view to unlocking the opportunities of this exciting area