Conference Day 1

A PROMISING FORWARD LOOK INTO THE MICROBIOME FIELD

8:20 am Chair’s Opening Remarks

8:30 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?

9:30 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

10:00 am New Frontiers in Microbiome Therapeutics: Inhaled Live Biotherapeutics for Chronic Lung Diseases

  • Vivek Lal Founder & CEO , Alveolus Bio & ResBiotic

Synopsis

Download the full event guide for more information.

10:30 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

11:00 am Morning Break, Refreshments & Structured Speed Networking

11:26 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

11:30 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

12:00 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

12:30 pm Heterogeneity in On- and Off-target Statin Responses Explained by Variation in the Human gut Microbiome

  • Sean Gibbons Assistant Professor, Institute Systems Biology

Synopsis

  • Statins are the most prescribed drug in the developed world, with hundreds of millions of users worldwide
  • Prior work has shown that gut commensal bacteria can metabolize many drugs in vitro, including statins
  • Genomic variation is known to modulate the efficacy of statins, but little is known about how the gut microbiome might modulate in vivo host responses
  • We show how variation in the gut microbiome can explain variation in statin efficacy and in statin side effects, and this variation is orthogonal to the variation explained by the dominant human genetic loci associated with statin responses

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

11:30 am 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

Synopsis

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12:00 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

12:30 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

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

11:30 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

12:00 pm Creating a Metabolomics Pipeline for Investigating Microbiome-host Interactions

  • Shuo Han Postdoctoral Research Fellow in Microbiology and Immunology, Stanford 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

12:30 pm Manufacturing Strategies to Broadly Access Biological Breadth of the Microbiome

Synopsis

Download the full event guide for more information.

1:00 pm Lunch & Networking

2:00 pm Hear the Ever Evolving Research Surrounding New Indications in Pre-clinical Development at Siolta Therapeutics

Synopsis

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2:30 pm Microbiome Considerations in Preclinical Animal Modeling

  • Caitlin SL Parello Senior Scientist II, Associate Director of Research Operations, Biomodels

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

3:00 pm What can we Learn From FMT Murine Models?

Synopsis

  • Multiple variables affect FMT murine models, including sex and cage effect, and controlling these factors may lead to more consistent results
  • Post human to mouse FMT, a subset of human bacteria can establish in mice. The abundance after FMT correlated with abundance in the inocula with more variability in low abundance OTUs
  • Three Clostridia species correlated with tumor response in R-FMT mice treated with anti-PD-L1 antibody, along with Multiple T and NK cell immune pathways

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

2:00 pm Uncover How the Gut-brain Axis is Proving to Successfully Provide Clinical Progress

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

Synopsis

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2:30 pm Incorporation of Metabolomics in a Multi-Omics Microbiome Analysis – A tool for Clinical Research

  • Yakov Ginzburg R&D manager, Microbiome MetabolomicsTechnologies, Millipore Sigma

Synopsis

  • Microbiome research around the mechanism leading to health and disease conditions has increased drastically
  • Incorporation of different *omics* approaches is necessary for such research
  • Incorporation of Metabolomics as a microbiome analysis tool has become more common
  • Since the methods vary widely between different studies and labs, the results are often incomparable
  • Standardization is crucial for translating the scientific finding into clinical practice

3:00 pm Learn Insights Into the Link Between GI Tumors & the Microbiome

Synopsis

  • Microbiome is associated with response to ICI therapy in GI tumor patients
  • Cross reactive antigens (CRAgs) between microbiota and tumor are associated with patient response to ICI therapy
  • CRAgs quality, such as overlap with virulence factors, are associated with patient response

3:30 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

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?

2:30 pm Development of Microbiome Drug Products

Synopsis

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3:00 pm Development of a Novel Live Biotherapeutic Product for the Prevention of CDI

  • Bharat Dixit VP, Biopharmaceutical Development & Manufacturing, Artugen Therapeutics

Synopsis

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3:30 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

4:00 pm Afternoon Break & Networking

4:30 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

4:40 pm Targeting the Microbiome with Synthetic Glycans for Improved Disease Outcomes

Synopsis

  • Synthetic glycans driving microbiome composition and functional output
  • How recent insights in mode of action enable innovation
  • Clinical study with KB295 in ulcerative colitis

4:30 pm Paving the Way of Blood & Tissue Microbiome Research

Synopsis

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4:40 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 Scale Up & GMP Manufacture of LBPs

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

4:40 pm Translating Microbiome Data For Efficacious Product Development

Synopsis

  • Key product developments insights to be had from analyzing microbiome data
  • BIOHM has had success in translating raw microbiome insights into commercialized products
  • Significant opportunities around AI applications to microbiome data

5:10 pm Close of Day One

6:00 pm Drinks Reception