WEDNESDAY, JUNE 30 | EDT
Industry Leaders Plenary Discussion
8:00 am Morning Coffee
8:35 am Chair’s Opening Remarks
8:45 am Industry Leaders Panel Discussion
Synopsis
- What are the decisions industry pioneers have made/are making to ensure progress within this novel industry?
- What are the unique characteristics of microbiome therapeutics and how can they change the paradigm of healthcare?
- Benchmarking how microbiome therapeutics compare against existing traditional approaches already on the market?
- What are the biggest challenges currently facing microbiome drug developers?
- What does the future of microbiome therapeutics look like?
9:45 am
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 challenges are you expecting to arise within the next 3 years?
10:00 am Towards a Regulatory Framework for Microbiome Based Therapeutics: Current Practice & Future Opinion
Synopsis
- Due to the novel nature of most microbiome based therapeutics, the guidance available from regulatory agencies has relied on industry and regulatory expertise.
- An overview of current regulatory testing for microbiome based therapeutics, what purpose these tests serve, and a discussion on what future regulatory testing might include
- How to best position your products in the current regulatory testing framework.
10:30 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
11:00 am Characterizing LBP Drug Substances & Drug Products for Rational Product Development
Synopsis
- Characterizing physical and chemical attributes of DS and DP
- LBP sensitivities to stresses typically encountered during Formulation and Manufacturing unit operations
11:30 am
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 Preclinical Solutions for Microbiome Investigation in Pathological Situation & Drug Development
Synopsis
• Microbiome-based therapeutics: which models, which assays?
• Drug-microbiome interactions: a requirement for efficacy and safety assessment?
• Case studies for oncology and inflammatory diseases
12:10 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
12:40 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 Leveraging Experience & Expertise to Support the Development & Manufacturing of Microbiome Therapeutic Products
Synopsis
• Utilization of Single Use Equipment in the LBP Process Flow
• Novel Dosage Forms
• Innovative Product Delivery Platforms
• Microbiome Derived Protein Products
12:10 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
12:40 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 From Microbiome Research into Clinical Practice
Synopsis
• Microbiome research has increased drastically in recent years, focusing on causation and mechanism leading to health and disease conditions
• Microbiome research is now incorporating different *omics* approaches to answer those fundamental questions
•The methods vary widely between different studies and labs and the results are often not comparable
•Standardization is crucial for translating the scientific finding into clinical practice
12:30 pm Panel Discussion – What Are We Looking for in a Microbiome Biomarker?
Synopsis
- What are the types of biomarkers and what are they used for?
- What are the unique challenges associated with microbiome biomarkers?
- What are pharma looking for as a potential diagnostic?
1:10pm 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
2:00 pm Harness the Power of Metabolomics to Advance Microbiome Drug Development
Synopsis
• Find out how metabolomics can provide a functional readout of the microbiome which can be used to complement other approaches such as genomics and proteomics and provide a deeper understanding of host-microbiome interactions and how these are impacted by disease and novel therapeutics
• Discover how the incorporation of metabolomics into drug discovery programs can assist in understanding the mechanism of action, safety, and efficacy of new and novel treatments as well as aiding in aspects important for consistent clinical outcomes such as patient stratification
• Learn about several metabolomic solutions, ranging from broad global metabolomic profiling to targeted analysis of specific microbial analytes, that can provide actionable insights to advance drug development
• Gain unique and valuable insights key to understanding the microbiome’s role in several therapeutic areas using metabolomics through discussion of select case studies
2:30 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
3:00 pm Microbiome Considerations in Preclinical Animal Modeling
Synopsis
•Introduction on the role of the microbiome in various human disease states
• Discussion of strategies for assessing microbiome effects in disease models
•Examples of microbiome influence in disease modeling
3:10 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
3:40 pm Afternoon Virtual Networking & Coffee
2:00 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
2:30 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?
3:00 pm 5 Tips for Successful Clinical Trials Implementation
3:10 pm Afternoon Virtual Networking & Coffee
2:00 pm Live Bacterial Therapeutic and Biomarker From a Clinical Microbiome Signature of Checkpoint Inhibitor Drug Response in Cancer
Synopsis
• Precision microbiome profiling plus MELRESIST study led to identification of a single clinical signature predictive of checkpoint inhibitor response across multiple melanoma and lung cancer studies
• Live bacterial therapeutic MB097, comprising 9 bacteria from this clinical signature, demonstrates efficacy in mouse models
• MB097 constituent bacteria demonstrate multiple immuno-stimulatory mechanisms in primary human immune cell assays in vitro
• MB097 is in preclinical development progressing to the clinic for treatment of patients not responding to anti-PD1s
2:30 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
3:00 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
3:30 pm Afternoon Virtual Networking & Coffee
Leveraging Small Molecules to Modulate the Microbiome
4:30 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
5:00 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)
5:30 pm End of Track A
5:00 pm Talk Details TBC
5:30 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
4:30 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
5:00 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