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

Morning Coffee & Registration

Chairperson Opening Remarks

Optimizing Drug Target Validation & Candidate Selection- Crosstalk between the Microbiome & the Host


It’s clear that research in the human microbiome has already redefined our understanding of human
health and disease. Using sophisticated science, the microbiome can provide alternative approaches
to known targets, as well as elucidate new targets. The purpose of this theme will be to demonstrate
novel research that substantiates the link between microbial diversity/function with gastrointestinal,
metabolic, neurological and cancer diseases.

Unraveling Microbiome Signatures for Drug Design: Clinical Immune Modulation by Microbiome Therapeutics

Microbiome Tools & Trends for the Pharmaceutical Industry

  • Julie Cope Director Scientific Operations, Diversigen


  • Delivering actionable results through ideal study design in microbiome projects
  • Industry standards on quality are nascent and expanding
  • Analyzing the microbiome across disease states

The Gut Microbiome, Immunity and Allergic Disease

  • Cathryn Nagler Bunning Food Allergy Professor, University of Chicago, President, ClostraBio

What Microbiome Systems Biology Can Tell About Mechanism


  • Studies have shown associations between host disorders and microbiome compositions
    without indicating underlying mechanisms
  • Demonstrating how integrative systems biology and ultra-high resolution microbiomics
    can provide important clues to identify key mechanistic links
  • Outlining how advances in integrative systems biology can indicate function to
    previously uncharacterized proteins

Speed Networking


This session is the ideal opportunity to get face-to-face time with many of the brightest
minds working with microbiome-based therapeutics. Benchmark against the industry
leaders and establish meaningful business relationships to pursue for the rest of the
conference and beyond.

Morning Refreshments

Bugs as Drugs Discovery & Identification

New research in NGS and multi-omic technologies is
expected to greatly assist with the accurate mining of
the animal microbiome to help identify new industrial
applications within nutrition, in-feed additives and
pharmaceuticals. The purpose of this theme will be to
review how researchers are applying new technologies to
accelerate discovery and development.

11.30 Leveraging Reverse Translation to Develop Microbial Therapies

  • How broad spectrum- microbial interventions such as FMT show proven safety profiles across a range of therapeutic areas
  • Outlining how Finch Group use machine learning to mine high-throughput molecular data generated from FMT trials to identify bacteria associated with positive clinical outcomes
  • Translating these targets to create rationally selected bacterial cocktails, such as FIN-524 for the treatment of IBD

Mark Smith, CEO, Finch Group Therapeutics

11.50 Next Generation Microbiome Profiling Bullet Points

  • LoopSeq™ microbiome profiling is the first long-read, high-resolution microbiome sequencing technology that uses existing Illumina sequencers
  • LoopSeq™ technology introduces single-molecule counting for improved microbiome species abundance quantification
  • LoopSeq™ simplifies microbiome sequencing workflows by enabling ‘one pot’, multiplexed sample preparation of up to 96 samples

Tuval Ben-Yehezkel, CEO, Loop Genomics

12.00 Novel Therapeutic Approaches Targeting the Microbiome in Metabolic Diseases

  • Understanding the role of the gut microbiome in metabolic diseases
  • From clinic and medical food to microbiome-targeted drugs
  • Discussing the challenges of strain identification and culture of LBPs

Jean Luc- Treillou, CEO, LNC Therapeutics

12.20 Delivery, Survival, Engraftment & Activity of LBPs in the Gastrointestinal Tract

  • Validated in-vitro technology platforms are a key tool for the pre-clinical work in LBPs development
  • The SHIME® is an enabling technology which allows an integrated simulation of the full GI tract, including lumen, mucosa and host
  • The SHIME® allows you to investigate the mechanism of action of LBPs in areas of the gut, which are not easily accessible, generating data complementary to in vivo studies

Massimo Mazorati, Director Business Development,

CMC/Manufacturing & Scale-Up

As companies prepare to scale from early phase
product development to commercial scale microbiome
therapeutics, challenges around guidelines and best
practice relating to CMC/Manufacturing that ensure
microbiome-based products are produced to
GMP-compliant standards. The purpose of this theme
will be to review the current industry thinking on

11.30 Quality & GMP Aspects of Manufacturing Live Biotherapeutic Products – a CMO Quality Perspective

  • Defining the product (cell bank characteristics, recombinant or not, API or Finished Product, Dosage Form)
  • Food or drug?
  • Addressing GMP manufacturing challenges (early clinical trial material)

Jason Ryan, Senior Scientist, Luina Bio 

11.40 Panel Presentation : Manufacturing & Scaling Microbiome-Based Therapeutics

  • What are the common challenges with manufacturing LBPS? How are organizations modulating capabilities to accommodate for that?
  • How to successfully interact with global regulatory agencies to meet guidelines and optimize production.Are new standards required to ensure GMP and safety of samples?
  • How are organizations thinking about scaling manufacturing as they progress through clinical development? What are the greatest hurdles associated with this?
  • What are the most successful case-studies that organizations can learn from?

Bharat Dixit, VP Bioprocess Development &
Manufacturing, Finch Group Therapeutics
Daniel Couto, CTO, Vedanta Biosciences
Dick Schwartz, SVP Process Development &
Manufacturing, Synlogic Therapeutics
Adrien Nivoliez, CEO, Biose Industrie

12.10 Development of Oral Live Bio-therapeutic Products – a CDMOs perspective

  • Key CMC considerations for the development of an LBT product
  • Critical factors affecting timelines when outsourcing GMP manufacturing activities of LBT drug products
  • Incorporating ‘quality’ (systems and regulations) into early phase dosage form design of LBT products

Mike Frodsham, Pharmaceutical Development
Manager, Quay Pharma

Lunch & Networking

Introduction and Purpose:
Often cited as “Drugs from Bugs”, many researchers are
either identifying and characterizing microbial by-products
that modulate host function or introduce compounds
that act on known pathways, known as “microbiome
mimics” that can be applied as a viable therapeutic.

Due to the unknown regulatory and manufacturing requirements
for cocktail-based therapeutics, many organizations are
exploring these novel methodologies to modify microbiome
composition and structure. The purpose of this theme will be
to review how organizations are discovering and validating
new therapeutics based on these techniques.

13.40 Drugs from Bugs – Using Metagenomic Dataset Delivers Druggable Targets

  • Using the human microbiome as a source of bioactives and novel targets
  • Outlining quantitative and functional metagenomics to identify novel therapeutics
  • Gut-restricted therapeutics

Christoph Bonny, Chief Scientific Officer, Enterome

14.00 Microbial Metabolites That Modulate Host Functions

  • Building a pre-clinical microbiome program to uncover small molecule mediators of disease relevant microbe/ host interactions
  • Identifying new pharmacological targets that assimilate microbiome-derived signals
  • Opening a framework that embraces external collaborations with academic and clinical researchers

Henry Haiser, Investigator III, Novartis Institutes for
Biomedical Research

14.20 Gut Microbe-Targeted Non-Lethal Therapeutics for Cardiometabolic Diseases

Stanley Hazen, Head of Preventative Cardiology and Rehabilitation, Cleveland Clinic


14.40 Developing Clostridum-Based Microbial Therapeutics for the Treatment of Chronic Gut- Related Diseases

Ben Bradley, Technology Innovation Lead, CHAIN
Biotechnology Ltd

Telling the Perfect Pre-Clinical Story for Microbiome-Based Therapeutics

Introduction and Purpose:
Prior to entering clinical development, organizations aim to
create viable pre-clinical packages that consist of valuable
in-vivo and computational results that demonstrate
efficacy and provide clues to potential modes of action.
The purpose of this theme will be to review what preclinical
development means in microbiome-based drug
development and how research may redefine our definition
of this concept.

15.00 Panel Discussion – The Supporting Role of the Pre-Clinical CRO when Conducting Microbiome Research

  • What are the critical pre-clinical challenges that will hinder the power of the microbiome in drug development?
  • When thinking about different modalities, how do organizations have to consider study design, dosing regimes, efficacy results?
  • Does this industry need in-vivo/in-vitro models? Are there any “gold standard” models?
  • How do researchers design optimal pre-clinical packages for different recipients (investors, regulators)? Are the hallmarks for success different?

Anuk Das, Head, Scientific Innovation, Janssen Human
Microbiome Institute

Mike Romanos, CEO, Microbiotica

Ian Parsons, Director Analytical Laboratories, Charles
River Laboratories

Mark Smith, CEO, Finch Group Therapeutics

Rana Samadfam, Scientific Director,
Charles River Laboratories

Introduction and Purpose:
With a number of important therapeutics entering a clinical
setting, there are still major questions surrounding best
practice in designing, scaling and progressing through
clinical trials. Without a doubt, successful in-human clinical
efficacy data will help cement the success of microbiome based
therapeutics in the future. The purpose of this theme
will be to outline industry developments when executing
clinical trials for microbiome-based therapeutics whilst
addressing the challenges that still remain in an emerging

13.40 Genome Based Comparison and Interpretation for the Development of Microbiome-Based Therapeutic Products

  • Development of potent probiotics and LBP’s require understanding of mode of action
  • Further development of new therapeutics do not only require functional strains, but also strains that are safe and manufacturable
  • Genomics research on microbiome strain collections are a good first step in identifying new high potential strains

Michiel Wels, Group Leader Microbiomics, NIZO

14.10 Translational Development and Clinical Trial Design of a Synthetic Biotic for Rare Disease

Caroline Kurtz, Head of Translational Sciences &
Product Development, Synlogic Therapeutics

14.30 You’ve Collected Your Microbiome Samples – Now What?

  • Reducing the phenomena of “garbage in” = “garbage out”
  • Key considerations in analyzing your microbiome data
  • Driving actionable results and discoveries in a controlled and reproducible way

Manoj Dadlani, CEO, CosmosID

14.40 Clinical Considerations of Rationally Designed Live Bacterial Cocktails

Bruce Roberts, Chief Scientific Officer,
Vedanta Biosciences

15.00 Panel Discussion – Clinical Development of Microbiome-based Therapeutics

  • How do organizations have to think about clinical trial design when developing a microbiome-based therapeutic? (considering patient selection, primary/ secondary endpoints and outcomes)
  • What are the key learnings from clinical programs that have been conducted for microbiome-based therapeutics?
  • In the microbiome, is clinical efficacy as valuable as MoA elucidation?

Kirk Taylor, Chief Medical Officer, Finch Group Therapeutics

Marja Puurenen, Associate Medical Director, Synlogic Therapeutics

Matt McClure, Chief Medical Officer, Second Genome

Afternoon Refreshments & Networking

Regulatory Challenges for Microbiome-Based Therapeutics


As microbiome therapies constitute a novel paradigm in recent drug development, a clear regulatory
framework that addresses key safety and biocontainment issues should be evaluated for successful
implementation. Despite the rise in notoriety across the pharmaceutical industry, only a few regulatory
agencies have provided clarity over the regulatory hurdles when developing a microbiome-based
therapeutic. The purpose of this theme will be to outline how leading regulatory bodies in the US and
EU currently review microbiome candidates across a number of modalities.

Regulatory Considerations for Live Biotherapeutic Products & Bacteriophage Therapy


  • Overview of the IND process
  • Discussing current FDA review of live biotherapeutic products and other microbiome
    based biologics
  • Discussing current FDA review of bacteriophage therapy

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

Regulatory Challenges for Registering Live Biotherapeutic Products in Europe


  • Presenting the EU regulatory bodies in Europe in relation to the pharma industry
  • Discussing the regulatory status in which probiotics were commercialized within the EU
    and how the landscape is evolving
  • Sharing the pharmaceutical regulatory framework
  • Understanding the system and how to interact with authorities in order to
    clarify the regulatory framework

Panel Presentation – Building Clear Regulatory Guidelines for Microbiome-Based Therapeutics


  • How can companies work with regulatory agencies to accelerate speed to market?
  • How do we overcome challenges in measuring purity, safety and product
    characterization when regulating microbiome-based therapeutics?
  • Food vs Pharma: What are the key considerations for making this determination
    as an organization in the microbiome?
  • How does drug modality impact regulatory guidelines?
  • What are the differences in strategy for US vs EU registration of microbiome-based
  • What are the critical considerations when working with regulators to understand key
    design elements for seamless product development?

Chairperson Closing Remarks

End of Conference Day One & Evening Drinks Reception