June 20-22, 2018
Boston, MA
Only 34 Passes Remaining – Secure Yours Now

Day One
Thursday June 21, 2018

Day Two
Friday June 22, 2018

08.20
Chair’s Opening Remarks

Biomarkers for Personalized Microbiome Diagnostics – Guiding Therapeutic Decisions

Synopsis

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.

08.30
Prioritizing Indications for Microbiome Therapeutics: Where do we go after C.difficile and UC?

Synopsis

  • 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?

09.00
Powering Microbiome Discovery with Big Data

Synopsis

  • 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

09.30
Using the “Microbiome Health Index” to Identify Indicators for Microbiome Restoration

10.00
Culturing the Unculturable to Enable Precision Metagenomics

10.30
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?

Evgueni Doukhanine, Scientist, Microbiome, DNA Genotek

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

12.20
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.

13.20 Symbiotic Drugs For Good Bugs Gone Bad

  • Exploring how gut bacteria are involved in xenobiotic metabolism, sometimes causing severe GI
    toxicities
  • 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

Ward Peterson, CEO, Symberix

13.40 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

Ravi Starzl, CEO, Bioplx

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

Dean Scholl, Scientist, Pylum Biosciences

14.20 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

Xavier Duportet, CEO, Eligo Biosciences

Intellectual Property Protection for Microbiome-based Therapeutics

13.20-14.50 Microbiome Intellectual Property (IP) Masterclass: Developing an IP Strategy for Attracting Investment

You chances of being awarded investment is optimised if you can efficiently demonstrate to investors that your IP adequately underpins the business plan on which your investment-pitch is based. Through this interactive session, you will get first-hand experience of:

  • Identifying key elements in relation to IP that are examined during investor due diligence.
  • Examining the strengths and weaknesses of an example microbiome investment pitch from the perspective of a VC. This will include an analysis of how the pitch could be improved and of the value of patent claim types in the microbiome field.
  • Building up a tool-kit to enable you to analyse your own IP to ensure that you are investor-ready.

Craig Thomson, Partner, HGF Limited (European, UK and Irish Patent Attorney)

14.40
Afternoon Refreshments & Networking

Innovation Power-Hour: Breakthrough Ideas in Microbiome Drug Development

Synopsis

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.

15.10
What is the Role of Biofilms in Human Microbiome Discovery?

  • Eva Berkes Chief Scientific Officer, Quorum Innovations

Synopsis

  • 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

15.30
Pharmacological Mimicry of the Gastric Bypass Microbiome to Treat Obesity

  • David Beno Chief Scientific Officer, Xeno Biosciences

Synopsis

  • 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

15.50
Known Unknowns – An Outsiders Perspective On The Cost Of Being at The Forefront Of Biotech’s New Chapter

Synopsis

  • 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

16.10
Chairperson Closing Remarks

16.20
Close of Summit