Conference Day 1

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A PROMISING FORWARD LOOK INTO THE MICROBIOME FIELD

8:00 am Chair’s Opening Remarks

8:15 am Microbiome Fireside Leaders Chat: A Forward Look

Synopsis

  • How do you perceive the overall role of the microbiome? How has this changed in the past 12 months?
  • What is missing from the microbiome area of drug discovery?
  • What are the gaps that both investors and drug developers must see, that we need to bring from other parts of biotech R&D?
  • How is a microbiome-therapeutic going to complete against other drugs in the field?

9:05 am Overcoming Challenges Associated with Performing Bioburden & Other Purity Tests for Microbiome Based Therapeutics

  • Yvonne Nyavor Principal Scientist, Microbiome, Boston Analytical

Synopsis

  • Microbiome therapeutic products are changing the future of medicine as we know it. Bioburden and other tests for purity of therapeutic products are required by regulatory agencies in order to ensure the safety of patients
  • However, these tests often have challenges due to the fact that most microbiome based therapeutics are composed of live biotherapeutic organisms. This presentation will dive into the microbial tests for purity that are commonly conducted for microbiome based therapeutics, the common issues observed during execution of these tests and how to overcome these challenges

9:35 am New Frontiers in Microbiome Therapeutics: Inhaled Live Biotherapeutics for Chronic Lung Diseases

  • Vivek Lal Founder & CEO , Alveolus Bio, Inc.

Synopsis

Download the full event guide for more information.

10:05 am Investing in the Analytical Methods & Facilities for the Future of Live Biotherapeutic Products

  • Jeffrey Heiser Senior Director, Head of Process Development and Analytical Development, Arranta Bio

Synopsis

  • As an increasing number of Live Biotherapeutic Products move through clinical trials to commercialization, there is a growing need for more advanced analytical methods to characterize drug substance and drug product, establish CQAs, and ensure process control
  • Facility design is instrumental to product purity and quality and contributes greatly to a smooth regulatory approval
  • Investing in analytics and facility design to help bring therapies to patients

10:35 am Morning Break, Refreshments & Structured Speed Networking

11:35 am

TRACK A:
UNDERSTANDING MICROBIOME FUNCTIONALITY TO UNCOVER PRECLINICAL DEVELOPMENT

Learn the approaches & platforms being harnessed to identify new therapeutic targets to see how you can incorporate the latest scientific findings into your own product pipeline

11:35 am How Comfortable are you with your Preclinical Design?

Synopsis

  • What is still missing to fully encapsulate microbiome functionality?
  • Is preclinical development positioned correctly in order to carve the way for clinical development?
  • Insights into the use of microbiome metrics to inform clinical development

12:05 pm Microbiome Multi-Omics – Combining Metagenomics and Metabolomics Promotes Microbiome Research

Synopsis

  • The incorporation of targeted Metabolomics as a microbiome analysis tool has become a leading tool to understand the functional interaction between the microbiota and their host or environment.
  • Integrating amplicon or shotgun metagenomic analysis, together with targeted metabolomics, can provide new insights into this interaction. Here using a novel multi-omics approach, we optimized high-throughput methods for taxonomically and functionally characterizing diverse microbial communities in the combination with profiling analysis of the metabolites occupying their microbial environment.
  • Our multi-omics solution includes an easy-to-use web bioinformatics platform, M-CAMPTM (Microbiome Computational Analysis for Multi-omics Profiling), which will enhance the power of your data and accelerate microbiome research.

12:35 pm AstraZeneca & the Lung Microbiome

Synopsis

  • The role of the lung microbiome in chronic lung disease
  • Can we harness the microbiome for target discovery?
  • Case study in bridging animal models and experimental medicine data for target discovery

TRACK B:
GETTING INTO THE CLINIC TO CLINICAL CASE STUDIES

Listen to the exciting clinical case studies surrounding the microbiome, as well as advice on clinical assessment, safety & getting your program into the clinic

11:35 am Uncover How the Gut-brain Axis is Proving to Successfully Provide Clinical Progress

  • Alessio Fasano Professor and Director of the Mucosal Immunology and Biology Research Center,, Massachusetts General Hospital

Synopsis

Download the full event guide for more information.

12:05 pm Collection, Preservation, & Storage of Microbiota Samples for Culture Recovery

Synopsis

• Discussion of BIOME-Preserve, a new storage and transport kit for collecting and culturing stool samples
• Comparison of standard HMP collection protocol for stool to BIOME-Preserve for successful culture recovery
• Culture media requirements for maximizing recovery from microbiota samples

12:35 pm Modulation Of Microbiome Bacterial Targets to Treat Human Diseases, A Case Study

  • Xin Guo Principle Scientist , Merck

Synopsis

  • Bacterial target to disease link
  • Bacterial target druggability assessment
  • Challenges in microbiome drug discover

1:05 pm Metagenomics in Clinical Trials – Setting Up For Success Considerations in Operations & Logistics

  • Mo Langhi Director, Business Development, CosmosID, Inc.

Synopsis

• Primary vs Exploratory Endpoints
• Clinical Microbiome Data Analysis & Interpretation

TRACK C:
GMP MANUFACTURING, SCALE UP AND MORE

Hear from subject experts on the major challenges regarding manufacturing and scaling up of the microbiome products, & how to overcome these through the clinic in order to move your products closer to approval and commercialization

11:35 am Key Challenges in Process Development for LBP DS Manufacturing

  • Yoshinori Hamaji Associate Scientific Director, Microbial Development , Takeda

Synopsis

  • Animal component free culture media
  • Determining the optimal harvest time
  • Quantification of live bacteria

12:05 pm Development & Manufacture of LBP’s

Synopsis

• Consideration for technology transfer and development of LBPs prior to GMP
• Assessing the scale-up considerations and challenges associated with LBPs in early clinical trial material
• Outlining viability and yield considerations throughout the manufacturing process to bulk drug product

12:35 pm Creating a Metabolomics Pipeline for Investigating Microbiome-host Interactions

  • Shuo Han Postdoctoral Research Fellow in Microbiology and Immunology, Duke University School of Medicine

Synopsis

• Creation of a metabolomics pipeline for small molecule discovery
• In vitro and in vivo applications of this pipeline on
• discovering metabolic patterns and manipulating gut
• microbial metabolites in the mouse models

1:05 pm Utilizing Metagenomics in Release Testing of LBP’s

Synopsis

• Lab Infrastructure & Validation Strategy
• Strain-Level ID & Quantification
• Quality & Compliance

1:15 pm Lunch & Networking

2:15 pm The Power of Early Intervention

Synopsis

• Challenging traditional drug development assumptions
• The role of the gut microbiome in atopic disease
• Clinical approaches to early intervention

3:00 pm Customized End to End Solutions to Explore the Microbiome in Preclinical Research

Synopsis

  • Overview of major areas of preclinical microbiome research and common questions (bugs as drugs, small molecule modification of the microbiome, FMT, humanized microbiome, germ free animals)
  • Biomodels’ approach to novel microbiome strategies in preclinical animal modeling
  • Examples of microbiome focused research concepts, study designs, and outcomes

3:30 pm Understand How Gelesis’ can Help Your Pipeline

  • Bryan Jones Senior Director, Scientific Affairs, Gelesis

Synopsis

  • Introduce Gelesis’ oral superabsorbent hydrogels (OSH) and their potential use in the treatment of metabolic disorders
  • Discuss of how OSH treatment drives compositional changes to the intestinal microbiota in pre-clinical mouse models of diet-induced obesity
  • Provide a brief overview of the human clinical data we are generating to confirm our pre-clinical observations

2:15 pm Development of a Synthetic Biotic for the Treatment of Phenylketonuria

Synopsis

• Phenylketonuria is a rare inherited disorder of Phenylalanine metabolism, with significant risk of neurocognitive impairment and high unmet need
• Our team at Synlogic has developed SYNB168, an engineered Synthetic Biotic to consume Phe in the GI tract that demonstrated fasting plasma Phe lowering in patients with PKU
• The SYNB1618 clinical data validate Synlogic’s mathematical modeling approach for the development of Synthetic Biotic medicines

3:00 pm Expediting Microbiome Biomarker Discovery using Precision Taxonomy

Synopsis

• Describe precision taxonomy and the need for “qualified” reference databases for microbiome studies
• Discuss how precision taxonomy uncovers biomarkers unseen by traditional approaches and increases the likelihood of desired outcomes in R&D, pre-clinical, and validation studies with more rigor and reliability

3:30 pm Improve Your Clinical Trial Design, Safety and Assessment

  • Nancy Dubois Associate Director, Local Safety Officer US Region + Senior Manager, Risk Evaluation and Mitigation Strategies, Alexion/AstraZeneca Rare Disease

2:00 pm PANEL: Uncover How Manufacturing & Formulation Along Your Pipeline can be Improved

Synopsis

  • How do we make sure we are maintaining a viable product when scaling up manufacturing?
  • Anaerobic vs aerobic microbes – What are the main challenges faced when working with each?
  • How can we consistently show that we are able to produce the same product and prevent result fluctuations?
  • How do we keep manufacturing at scale cost efficient?
  • What challenges do we face delivering products one they are at a large, commercial scale?

3:00 pm Microbiome Drug Product Development – Partnering for Success

  • Ryan Wilson Head of Live Bio Program, SGS Quay Pharma

3:30 pm Continuous Drying for Microbiome Applications

3:40 pm Building a World-Class Microbial & Viral Vector Manufacturing Facility

Synopsis

  • Overview of Locus Biosciences business and history
  • Rationale for internalizing manufacturing and designing capabilties
  • Bacteriophage cocktail production for clinical trials

4:10 pm Afternoon Break & Networking

4:30 pm Identifying & Tracking Individual, Proprietary Strains is Critical to Biotherapeutic Development

Synopsis

• Reference-free genomic markers can be used to detect and monitor live biotherapeutic products in a complex microbial community
• The One Codex data platform can rapidly classify and deconvolute individual strains in a metagenomic sample

4:40 pm Keeping up with Live Biotherapeutics – a Landscape Overview of the Last 10 Years

Synopsis

• Overview of the current active preclinical and clinical landscape within live biotherapeutics and whole-ecosystem derived products
• A review of the regulatory achievements associated to trial progressions
• A discussion of discontinued or inactive projects

5:10 pm Host-microbiome Metatranscriptomic Targets for Drug Development

Synopsis

• Viome has built its ViOS platform with 350,000+ samples of host+microbiome gene expression data with associated rich phenotypes
• Viome has developed a rapid target identification method (days to weeks per indication) for defining and stratifying a large range of chronic diseases
• As an example, we show the types of host and microbiome transcripts we identified for IBD, many of which can be pursued into drug development using multiple modalities

4:30 pm Causal Effect Relationship Between Stress Induced Depression in Alzheimer’s Disease (AD) Progression Through Single Bacteria Modulating Regulatory T cell (Treg) and Th17 cells (Th17) Immunity

  • Giulio Pasinetti Saunders Family Chair and Professor of Neurology, Icahn School of Medicine at Mount Sinai

Synopsis

• Role of T cell regulation of IL-15 and IL-17 in the attenuation of Segmented Filamentous Bacteria (SFB) mediated cognitive deterioration through mitigation of mechanism associated to
anxiety and depression
• Investigation of the role of IL-17a production in the gut lamina propria in the regulation of Th17 responses in the meningeal compartment of SFB mice
• Translational studies to alleviates anxiety and depression in SFB positive mice through modulation of adaptiveimmunity, implications for novel AD therapies

5:00 pm Potentials for New Drugs or Clinical Trials Validation using Circulating Microbiome

Synopsis

• In the recent past, Microbiome tools and sciences have exploded. But this remains mostly focused on gut, oral or skin microbiome
• It is starting to be well established that tissue and plasma have an existing microbiome as well that should be mined for novel applications
• We will discuss potential implications of this novel insight for drug development

5:30 pm ONCOBAX®-AK, a game-changer Live Biotherapeutic Product for anticancer immunotherapy

Synopsis

  • The composition of the gut microbiota influences the effectiveness of anticancer immunotherapy
  • EverImmune has developed Oncobax®-AK, a breakthrough microbiome technology as oral adjuvant for anticancer immunotherapy in
  • NSCLC and RCC patients treated with ICIs, that will enter into clinics 2nd quarter 2022.
  • EverImmune has developed companion diagnosis tools to identify patients amenable to Oncobax®-AK

4:30 pm Leveraging Experience and Process Flexibility to Support the Development & Manufacturing of Novel Microbiome Therapeutic Products from Clinic to Commercial Launch

Synopsis

• Utilization of single use equipment in the LBP process flow
• Novel dosage forms
• Innovative product delivery platforms
• Microbiome derived protein products
• Path to commercial launch

4:40 pm Manufacturing Strategies to Broadly Access Biological Breadth of the Microbiome

5:10 pm Development of a Novel Live Biotherapeutic Product for the Prevention of CDI

5:40 pm Drinks Reception