Conference Day 2
Thursday, June 30 2023


8:20 am Chair’s Opening Remarks

8:30 am International Spotlight: A new initiative for Microbiome Based Drug Discovery Ecosystem Creation in Japan as one of Government Funded Programs

  • Jun Terauchi Steering Committee Chair, Metagen Therapeutics


  • Outlining the program which is aimed to create a microbiome-based drug discovery ecosystem in Japan
  • Navigating the regulatory and CMC/manufacturing activities to overcome the bottleneck of the MBDD, especially for LBPs
  • Detailing this public / private partnership program,funded by the Japan Agency for Medical Research and Development inviting more than 30 organizations

9:00 am The Power of PoC: Quick Insights into the Unknown


  • Understand why today’s financial challenges require unusual methods to generate convincing data for investors
  • Using proof-of-concept (PoC) studies as a tool to de-risk the CMC development and generate data without overspending your budget
  • Discover how PoC-studies are designed at CDMOs, such as Bacthera, and in which fields of CMC development are they most powerful

9:30 am Panel Discussion: Global Regulatory Perspectives: US, Asia & Europe Perspectives


  • Ensuring vigilance for side effects for FMT and LBPs
  • Exploring pathways towards approval nutritional vs live biotherapeutics, what does the future hold?
  • Navigating nuances in the regulatory process for therapeutics that aren’t systemically absorbed

10:00 am Developing Microbiome Based Therapeutics: Leveraging Technology and Product Innovation to DevelopCharacterization Plans


  • Delving into some of the challenges facing the characterization of microbiome based drug products, potential approaches for dealing with these challenges
  • Exploring the future of the microbiome drug development space
  • Outlining how the microbiome-based therapeutics industry can evolve to take its place as an important asset to healthcare

10:30 am
Morning Break & Speed Networking

Track A: Discovery & Preclinical

11:30 am Measuring Microbiome Interactions En Masse to Learn How to Restore Microbiome Functions for Health


  • Discover how Concerto Biosciences builds beneficial microbial communities that heal disease in our bodies and our environment
  • Presenting present Concerto’s ground-breaking discovery platform, kChip, which produces and measures half a million microbial combinations each day, revealing new treatment strategies to restore damaged microbiomes
  • Discussing applications of kChip to discover beneficial microbial communities byproducts that can redefine how we address diseases in women’s health, skin health, and the human gut

12:00 pm Interactive Roundtable Discussions Chair-Philip Strandwitz,


  • As more indications are being explored than ever before and more microbiome-based therapeutic developers are entering the clinic, it’s time to go back to basics and disucss how to design R&D to set up for a successful late stage program. We will discuss:
  • The importance in having a robust and clear MoA in securing investment
  • Where are the pitfalls in R&D that add challenges later down the line

12:30 pm The SuperDonorTM Technology – a Scalable & Customizable Alternative to FMT

  • Lior Weissman Vice President of Research & Development, MyBiotics


  • Using the SuperDonorTM technology, MyBiotics team can select and produce in scale a desired microbial profile while maintaining very high similarity to the origin
  • MyBiotics’ ability to culture and maintain such resemblance to the source has been applied as a discovery and screening system
  • Generation of large sets of data on microbial population dynamics in samples from patients and healthy subjects

Track B: Translation & Clinical

11:30 am Precision Modulation of Dysbiotic Microbiomes With a Synbiotic of Human Milk Sugars & B. infantis Reshapes Gut Microbial Composition & Metabolites


  • Presenting a synbiotic product comprised of donor-derived human milk oligosaccharides and Bifidobacterium longum subsp. infantis.
  • Demonstrating that engraftment and microbiome changes are predictable, controllable, and reversible.
  • Exploring data from animal models and human trials showing the utility of this product for repairing dysbiosis in adults, ready for IND filing

12:00 pm Interactive Roundtable Discussions


We know that therapeutic insights from the human microbiome require successful collaborations across basic science, clinical expertise, and industry partners. With that in mind, this unique collaborative format will look to current clinical challenges relates to the development of microbiome-based therapeutics.

  • Diversity and inclusions in clinical trials and the impact on clinical results
  • What really is a placebo in microbiome-therapeutic research?
  • Why aren’t more products being commercialised and exploring key challenges here

12:30 pm Panel Discussion: Getting into the Clinic


  • Navigating challenges in entering the clinic
  • Patient stratification, interindividual variation & more
  • Attracting and working with investors

Track C: Manufacturing & Process Development
Chair- Aaron Cowley, Chief Scientific Officer, Arranta Bio

11:30 am The Design, Manufacturing & Clinical Application of a Metabolically Complete Gut Microbiome Therapy for Enteric Hyperoxaluria


  • Defining and designing a metabolically complete gut microbiome
  • Outlining enteric hyperoxaluria and how this microbiome therapy can function in the patient population
  • Manufacturing and clinical testing strategy for a first in-class microbiome therapy

12:00 pm Leveraging Experience and Process Flexibility to Support the Development & Manufacturing of Novel Microbiome Therapeutic Products from Clinic to Commercial Launch


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

12:30 pm Perfecting Your Products with Greater Efficiency and Innovation


  • Exploring the extensive global sales force and global manufacturing capabilities, including twelve manufacturing plants worldwide
  • Outlining the innovative, solution-oriented approaches towards customers

1:00 pm

2:00 pm Leveraging the Microbiome to Promote Women’s Health

  • Nikole Kimes Founder & Chief Scientific Officer, Siolta Therapeutics


  • Women’s Health is a key factor in establishing a healthy ecosystem for infant development
  • Bacterial Vaginosis impacts 30% of women of childbearing age with recurrence in up to 50%
  • Siolta is creating a synergistic consortium to address the underlying vaginal microbiome dysbiosis thought to be a key driver of Bacterial Vaginosis

2:30 pm Immunoglobulin Y Antibodies Against Cytolysin & Enterococcus Faecalis Reduce Gut Leakage & Ethanol-induced Liver Disease in Microbiota Humanized Mice


  • E. faecalis and cytolysin are important mortality predictors in alcohol-associated hepatitis patients.
  • In a precision medicine approach, we generated neutralizing IgY antibodies against cytolysin producing E. faecalis and cytolysin.
  • Targeted neutralization using these specific antibodies improves ethanol-induced liver disease in microbiota of humanized mice.
  • IgY antibody therapy offers a precise intervention to edit the microbiome without affecting the composition of the gut microbiota

3:00 pm Modulation of Intestinal Immunity & Colitis by Microbial Sphingolipids Offers a Potential New Therapeutic Target for Inflammatory Bowel Diseases

  • Bin Bao Postdoctoral Research Fellow, The President and Fellows of Harvard College


  • Exploring the mechanisms by which gut lumen sphingolipids modulate intestinal barrier function and colitis development
  • Outlining the study showing that bacterial sphingolipids interact with ILC3s to constrain ILC3- derived IL-22, and that mutant B. fragilis lacking sphingolipids alleviates DSS-induced colitis in monocolonized mice
  • Highlighting the potential therapeutic target for IBD

2:00 pm Proof-of-Concept Applications of the MICOM Modeling Platform to Rationally Engineer the Metabolic Outputs of the Microbiome

  • Sean Gibbons Associate Professor, Institute for Systems Biology


  • Developing a community-scale metabolic model of the gut microbiome, called MICOM, which can be used to build a ‘digital twin’ of the gut microbiome.
  • Leveraging MICOM to predict engraftment of nonindigenous commensal bacteria and opportunistic pathogens in individual gut microbiomes.
  • Exploring validation data that our engraftment predictions are accurate, and we provide an example for how this modeling platform could be used to design personalized probiotic cocktails that prevent or reverse pathogen colonization in the gut

2:30 pm Revealing the Clinical Outcomes of SB-121 in Autism Spectrum Disorder


  • Phase Ib Data in Patients with Autism Spectrum Disorder
  • Clinical Evidence from Objective and Subjective Measures of Behavior
  • Pre-clinical to Clinical Mechanism of Action Data

3:00 pm Outlining ATR-12 for the Treatment of Netherton Syndrome


  • Outlining ATR-12 as a novel genetically modified strain of S. epidermidis to be auxotrophic and secrete an active fragment of the full-length LEKTI protein for the treatment of Netherton syndrome (NS) patients, a rare autosomal recessive disease of the skin
  • Revealing studies that show ATR-12 secretes sufficient LEKTI to reverse the underlying causes of NS
  • Sharing the program that has been cleared by the FDA to begin a Phase 1 clinical trial in NS patients in the US

2:00 pm Process Development and Technology Transfer: Streamlining the Path to the Clinic

  • Tariq Warsi Vice President Technical Operations, Novome Biotechnologies


  • Leveraging prior process development experience to increase robustness and decrease time to tech transfer
  • Optimizing analytical and manufacturing strategies for improved product quality and reduce time to GMP

2:30 pm MH002, a 6-strain Optimized Consortium in Clinical Development for Ulcerative Colitis & Pouchitis


  • Discover how MH002 was developed through MRM Health’s proprietary CORAL® platform, allowing manufacturing of complete consortia in a single process
  • Reviewing MH002’s multifactorial mechanism-ofaction includes gut barrier restoration, mucosal healing and immunomodulation
  • Sharing a status update of both ongoing clinical trials

3:00 pm Ecological Engineering of the Gut Microbio


  • Utilizing supplemental dietary fibers to modify the composition and metabolic output of the gut microbiome in healthy individuals, two preliminary clinical trials were initiated
  • The ultimate goal of the first trial is to ameliorate colitis during cancer immunotherapy, while the motivation of the second trial is to prevent the development of graft versus host disease following bone marrow transplants.
  • Exploring the tolerance of the dietary fiber interventions and responses of the gut microbiome in the healthy and clinical cohorts

3:30 pm
Afternoon Break


4:00 pm Panel Discussion: Evaluating Current Market Dynamics to Navigate Future Investment Possibilities


  • Exploring what current investors are looking for for further buy-in during the current financial environment
  • Educating general investors on the nuances of LBT product development and understanding what will attract big pharma into future collaboration
  • Engaging with developing Asian markets

4:30 pm Role of Hematopoietic Cells in Immune Mediated Dysbiosis in Alzheimer’s Disease Modifying Strategies


  • Role of immunopoiesis in the gut-brain axis in Alzheimer’s disease and depression
  • Microbiome disruption following bone marrow transplantation in experimental Alzheimer’ disease
  • Restoration of cognitive deterioration in Alzheimer’s disease by immune mediated remodelling of gut microbiome

5:00 pm Measuring Gut Microbiome Responses in Alzheimer’s & Parkinson’s Dementia


  • Exploring gut microbiota as a source of potential biomarkers in CNS
  • Analysing ANAVEX®2-73 alzheimer’s and parkinson’s dementia clinical studies to understand microbial interactions

5:30 pm Chair’s Closing Remarks

5:40 pm
End of Conference