June 20-22, 2018
Boston, MA

Join The Microbiome Movement

Day One
Thursday June 21, 2018

Day Two
Friday June 22, 2018

Chair’s Opening Remarks

Biomarkers for Personalized Microbiome Diagnostics – Guiding Therapeutic Decisions


As our knowledge of the microbiome’s impact on health and disease continues to increase, one
application area of the microbiome has remained fairly understudied: it’s role as guidance for
treatment monitoring and prediction of response of known therapeutics. In the near future, clinically
relevant microbiome biomarkers could help with the diagnosis of disease, help predict the outcome of
treatment options as well establish personalized therapeutics based on the microbiome. The purpose
of this theme will be to review the research going into the development of microbiome diagnostics
through growing clinical evidence for more sophisticated patient stratification.

Prioritizing Indications for Microbiome Therapeutics: Where do we go after C.difficile and UC?


  • Identifying the next priority indications for microbiome therapeutics
  • Understanding and expanding the causality toolkit for microbiome drug discovery
  • Selecting patients: will companion diagnostics be the key?

Powering Microbiome Discovery with Big Data


  • Many microbiome studies are under-powered or low resolution. Actionable microbiome
    discovery requires careful study design, larger sample sizes, and high-resolution data
  • With advances in informatics, shallow shotgun sequencing provides far higher
    resolution than 16S sequencing for the same cost
  • For the first time, researchers can affordably profile species and functional variation in
    large, dense longitudinal studies

Using the “Microbiome Health Index” to Identify Indicators for Microbiome Restoration

Precision Discovery of Novel Biomarkers Based on Deep Microbiome Analysis

Application of Multivalent Vaccine Manufacturing Testing Schemes in cGMP Characterization of Microbiome Defined Drug Products


  • Navigation through the microbiome regulatory process can be based on testing
    schemes established in multivalent manufacturing programs
  • Environmental Monitoring (EM) program design requires additional processes for
    microbiome product manufacturing
  • Implementation of anaerobic best practices is critical in the accurate characterization
    of microbiome drug products

Morning Refreshments & Networking

Gut-Brain Axis to Develop Therapeutics

Emerging data suggests that there is a link between
changes in the gut microbiome and neurological disease
and disorders. The purpose of this theme will be to outline
recent scientific advances in unravelling the gut-brain
connections and potential pathways to harness these
findings for novel therapeutic approaches

11.30 Targeting the Gut Microbiome to Treat Neurological Conditions: Elucidating a Causal Relationship Between the Gut & Disease

  • Harnessing the link between the gut microbiome and CNS using a suite of in vitro and in vivo approaches to develop a new class of therapeutics in ASD and Parkinson’s
  • A discussion of AB-1224, a first-in class commensal bacteria-based intervention for the treatment ASD and a summary of promising preclinical data
  • Reviewing the current hallmarks of success and looking to the future

David Donabedian, CEO, Axial Biotherapeutics

11.50 GABA Modulating Bacteria of the Human Gut Microbiota

  • Identification of the first bacterium from the human microbiota completely dependent on GABA for growth
  • Using this organism to identify and culture a panel of diverse GABA-producing bacteria
  • GABA production and consumption capabilities are widespread throughout the microbiota, suggesting these organisms can modulate levels of this important neurotransmitter

Phil Strandwitz, Co-Founder & CEO, Holobiome

Late Stage Clinical Development of Microbiome-Based Therapeutics

As organizations scale into late-stage clinical
development, it’s important to consider the challenges
that lie ahead. The purpose of this theme will be to review
current progress at this stage and review solutions that
will accelerate clinical development.

11.30 Curating Massive Amounts of Biological Material & Phenotypic Data for Efficient & Reproducible Microbiome Discovery

  • Of the enormous pre-clinical and clinical developments in the microbiome, what proportion have generated real insight?
  • How are leading investigators collecting biological samples in a standardized way to aggregate data, compare clinical trials and reproduce results?
  • What solutions are currently available to conduct population scale research that lead to meaningful insights?

Lisa Gamwell, Microbiome Product Manager, DNA

11.40 Protecting the Gut Microbiome from Antibiotics

  • Ribaxamase (SYN-004) is designed to degrade residual beta lactam antibiotics in the GI tract and protect the microbiome from antibiotic mediated side effects
  • In a Phase 2b clinical trial, Ribaxamase (SYN-004) significantly reduced the risk of CDI and protected the microbiome from antibiotic mediated changes, including the expansion of the resistome
  • The translation of successful clinical trials to animal modeling and new drugs development will also be discussed

Christian Furlan Freguia, Director of Research,
Synthetic Biologics

12.00 Human Microbiota: Proof of Concept to Production

  • General overview of live microbial production processes
  • Step by step process description with emphasis on process development
  • Considerations prior/ during tech transfer focusing on specific requirements for pharma (GMP) production

Isil Tuzun Weber, Process Engineer, SynCo Bio Partners

Lunch & Networking

Subtractive Microbiome Therapeutics Discovery & Identification


Broad based subtractive approaches through the use of antibiotics can lead to unintended reduction of
commensal bacteria, causing the patient to become vulnerable to chronic disease, including C.Difficile
infection. Subtractive based therapies, including bacteriophages, focus on targeting highly specific
strains of bacteria through the use of breakthrough technology. The purpose of this theme will be
to review current practice in the discovery and pre-clinical development of subtractive therapeutic
microbiome strategies that treat disease.

Symbiotic Drugs For Good Bugs Gone Bad


  • Exploring how gut bacteria are involved in xenobiotic metabolism, sometimes causing severe GI
  • Symberix has designed small molecule drugs (termed “Symbiotic Drugs”) which
    selectively eliminate harmful bacterial activity without killing enteric bacteria
  • Demonstrating that these Symbiotic Drugs improve the clinical efficacy and
    reduce toxicities of existing drugs

A New Approach to Therapeutic Durability and Integration


  • Reviewing the challenges of subtractive methods in microbiome therapies to achieve
    clinically relevant results
  • Challenging the ‘bottoms-up” approach of investigating these therapies to identify
    clinically observable and relevant biome-wide changes
  • Exploring Bioplx’s “top-down” approach by beginning with hypotheses driven by
    clinically observable phenomenon to pursue MoA elucidation and engineer the
    microbiome across a range of disease conditions including MRSA

Presentation Title To Be Confirmed: Please Check Back With Us Soon

Using Synthetic Biology for Targeted Antimicrobials & Microbiome Engineering


  • How to design mechanisms that adapt to pathogen resistance
  • Addressing the main challenges associated with treating microbiome imbalances with the limited
    tools the community has at their disposal
  • Demonstrating the value of sequence-specific antimicrobials that can selectively
    eradicate harmful bacteria from the microbiome

Afternoon Refreshments & Networking

Innovation Power-Hour: Breakthrough Ideas in Microbiome Drug Development


Emerging start-ups in the human microbiome are continuing to apply pioneering research and apply
that information to create new therapeutics across a variety of complex disease states. The purpose of
this theme will be to showcase novel methods to target the microbiome from the companies beginning
their microbiome journey.

What is the Role of Biofilms in Human Microbiome Discovery?

  • Eva Berkes Chief Scientific Officer, Quorum Innovations


  • Outlining the underestimated clinical relevance in the disease treatment and
    microbiome drug discovery paradigms
  • Why biofilms can be difficult to grow and do not fit within a developed diagnostic or
    regulatory rubric
  • Discussing the relationship between biofilms, human disease and their applications to
    microbiome drug discovery

Pharmacological Mimicry of the Gastric Bypass Microbiome to Treat Obesity

  • David Beno Chief Scientific Officer, Xeno Biosciences


  • Proposing the “air hypothesis” as a mechanism to explain the profound weight loss and
    associated microbiome shifts observed after gastric bypass surgery
  • Creating XEN-101, a first-in-class, oral anti-obesity medicine that demonstrates
    substantial weigh loss and corresponding shifts in the gut microbiome
  • Exploration of early preclinical and clinical pilot efficacy data

Known Unknowns – An Outsiders Perspective On The Cost Of Being at The Forefront Of Biotech’s New Chapter


  • Sharing the impact of being an outsider and an amateur in the space and the cost
    plated on two young biotech founders
  • Exploring the costs of working in an industry filled with uncertainty
  • Pushing forward new forms of medicine that have been recently slowed by speculation
    and regulations

Chairperson Closing Remarks

Close of Summit