A Targeted, Point of Care Solution for Microbiome Analysis
In order for the microbiome field to realize its promise to revolutionize health and wellness, we must translate both diagnostic and therapeutic discoveries out of the lab and into the clinic. Floragraph is advancing this promise in two ways: 1. Developing technology that make microbiome analysis simple, reproducible, rapid and accessible, and 2. Creating novel panels of rationally designed microbiomarkers, empirically validated for significance in disease. We will present preliminary results of biomarker validation in early detection and characterization of necrotizing enterocolitis (NEC) in stool samples from very low birthweight infants in the NICU.
Alicia Scheffer-Wong, Ph.D., Founder & CEO, Floragraph

The Skin is NOT the Gut: Optimizing DNA Extractions and Amplicon Sequencing for the Skin Microbiome
Most of the methods used in skin microbiome research have been borrowed from the gut field, often with little to no validation or optimization for skin microbes. I will discuss why this is problematic, with laboratory and clinical examples, as well as data-backed solutions for working with this distinctive community. Hint: I think we’ve been missing a lot!
Kelly N. Haas, Ph.D., Post Doctoral Scholar, Dermatology Department, University of California Davis

Type 1 Diabetes: Primary Prevention Therapeutic Programs and First Pre-Autoantibody Biomarker Based on Association Between Autoimmunity and Dynamics of Amyloid-Producing E. Coli
We used a longitudinal microbiome analysis from Type 1 diabetic, HLA-susceptible children from birth to 3 years and analyzed it with an algorithm paying specific attention to gut amyloid-producing bacteria. Our analysis revealed an association between the development of autoantibodies in children with HLA-conferred susceptibility and significant (p<0.05) association between initially high gut amyloid-producing E. coli abundance among other things. Discovery of this new etiology and the mechanisms leading to autoimmunity in T1D that allowed us to develop novel biomarkers and a first-in-class diagnosis program of T1D in HLA-susceptible hosts.
George Tetz, MD, Ph.D., Chief Executive Officer, Human Microbiology Institute

Developing Products to Unlock the Promise of the Microbiome in Health and Disease: A Novel Approach, Challenges and Common Opportunities
As the scientific knowledge of the microbiome grows and the tools to study it evolve so too does our understanding of the organ and its link to health and disease. Therapies directed at the microbiome organ are the next wave of medicines to be developed not only to treat diseases but also to maintain health and wellness. A number of different ways to target the microbiome are being developed, but there are also common learnings and knowledge that can inform the entire field as it continues to advance.In this presentation, Alison Lawton will discuss Kaleido’s unique chemistry-driven approach to leveraging the potential of the microbiome organ, and outline opportunities the field can address together to facilitate the development of safe and effective products aimed at targeting the microbiome.
Alison Lawton, Chief Executive Officer, Kaleido Biosciences

Rapid Product Development: From Concept to Consumer Product
This talk will discuss BioCollective’s Approach to Rapid Probiotic/Prebiotic Prototyping using BioFlux™ Metabolic Modeling, existing extensive library of GRAS organisms/supply chain relationships, and small batch GMP production partners. Some of the most difficult challenges in formula development are:
• US Regulatory - GRAS status vs. new organisms (many organisms have similar functions - modeling can identify alternatives to deliver identical function with an already approved organism)
• Production - small batch photo-type product development, many vendors are already at maximum capacity and won’t do small production runs for prototyping-types
• Production - moving from small batch to scaled production
• Optimization - Organisms work as guilds, understanding the most synergistic combination can be simplified through metabolic modeling that closely mimics wet lab experiments
Martha Carlin, Chief Executive Officer, The BioCollective

Panel Session: Probiotics: Aligning Science and Government Regulatory Requirements on a Path to Market
In this panel session, the following topics will be covered:
• What traits to look for when selecting strains for probiotic applications - how to select beneficial strains
• FDA regulatory path (GRAS) for probiotics
• How to progress product candidates from in vitro and in vivo testing into clinical investigation
• Interpretation of the clinical microbiome/probiotic data
Moderator: Mead Johnson Nutrition

The Human Microbiome: Towards Future Diagnostic and Clinical Solutions
The Human microbiome is a highly sophisticated system, much like the circulatory and immune systems, playing multiple roles within the human body. The most straightforward analysis of GI tract microbial compositions, “normal” and “deviated” (in case of various diseases) – is performed through sequencing of stool-derived DNA/RNA. The challenges associated with this approach include: stabilization of nucleic acids in the biological samples, minimization of bias upon DNA/RNA purification and sequencing, depletion of PCR inhibitors, process automation, and rapid “sample-to-answer”. All of these issues - and strategies around them - will be discussed in details. Ms. Jasti will overview the complete arsenal of tools enabling microbiota exploration, and highlight examples of workflow application towards studying effects of probiotics and diet on gastrointestinal tract bacterial populations, and rapid detection of pathogenic species.
Madhu Jasti, Scientist III R&D, Thermo Fisher Scientific

Panel Session: Enhancing the Power of the Microbiome Through Partnership
Partnership in any business is a crucial component to success. In the growing arena of microbiome therapeutics, partnerships between scientific, clinical, governmental and corporate teams lend credibility, flexibility and speed to the development of novel technologies. Join in the discussion about how partnerships can accelerate the microbiome field and push the boundaries of innovation to help a broader class of patients.
Moderator: Edward Burd, Ph.D., Head of Regulatory Affairs, Rebiotix

Microbial Signatures of Gut Wellness Through Multi-Study Integratlon of Human Stool Metagenomes
In this presentation, Dr. Sung will present results from a meta-analysis on an integrated, multi-cohort dataset of 4,347 publicly available stool metagenomes from healthy and non-healthy cohorts. Using probabilistic approaches that identifies frequent patterns across individual microbiome samples, I will show a set of microbial species and functions consistently observed within the healthy population, but not as frequent in disease. From these results, a gut microbiome health index, composed of multi-dimensional microbiome information, was developed to quantitatively assess the health status of a human gut.
Jaeyun Sung, Ph.D., Assistant Professor of Surgery, College of Medicine, Senior Associate Consultant I, Division of Surgery Research, Mayo Clinic

Microbial life at Scale: Applications, Analytics and Lessons Learned From the Food Supply Chain
This presentation will detail the work IBM Research has done with the Sequencing the Food Supply Chain Consortium to analyze food microbiomes to understand pathogens, community dynamics, and ingredient authentication using deep sequencing. We will also detail some of the challenges and solutions we've generated in applications, analytics, and reference data repositories to study microbial life at scale.
Kristen L. Beck, Ph.D., Research Staff Member, Sequencing the Food Supply Chain, Almaden Research Center, IBM

The First 1000 Days: Babies, Nutrition and Gut Health
Every time an infant is born marks the start of a new symbiosis between a human host and microbial communities that are essential for health. Microbial colonization patterns are partly determined by gestational age, delivery method, feeding practices, and many other, still poorly understood factors. There are numerous challenges in trying to deliver technology platforms to analyze the gut health and to optimize nutrition of preterm infants in the neonatal ICU and beyond. In this presentation, we will talk about the challenges in sample acquisition and processing, data analysis, and technical standards, both focused on our specific goals, as well as in the setting of current hopes and hypes of the microbiome field.
Elisabeth Bik, Ph.D., Director of Science, Astarte Medical

Biological, Chemical and Spatial Drivers of Microbiota Structure and Function: Therapeutic Implications
While fecal microbiota transplantation is highly effective for the treatment of recurrent Clostridium difficile infection, development of the next generation of therapeutics requires a deep mechanistic understanding of the dynamic host-microbiota relationship, as well as the inter- and intra-species relationships within the microbial community. We describe several basic research studies that are designed to elucidate the underlying biological, chemical, and spatial mechanisms that drive these relationships, the links to host physiology, and implications for microbial therapeutics.
Elliot Friedman, Ph.D., Senior Research Investigator, Division of Gastroenterology, Technical Director, Microbial Culture & Metabolomics Core, PennCHOP Microbiome Program, Perelman School of Medicine, University of Pennsylvania

New Modeling Tools to Predict Dynamics of Microbial Ecologies
This session will describe an ongoing collaboration between the Bucci Lab and Vedanta Biosciences to develop and experimentally validate new modeling tools to predict dynamics of microbial ecologies. The speakers will also present a specific application of the tools in the optimization of rationally designed bacterial consortia drugs.
Vanni Bucci, Ph.D., Assistant Professor, University of Massachusetts Dartmouth
Bernat Olle, Ph.D., Chief Executive Officer, Vedanta Biosciences

From Conceptualization to Launch: A Case Study of a GI Microbiome Modulator
Perhaps no other rapidly emerging space of innovation so confounds and comingles the disparate industries of nutrition and pharmaceuticals, as does the field of the microbiome. A collision of sorts is occurring now and will unfold over the coming years between the nutritional industry’s notions of the microbiome and the resultant emerging products with those of the pharmaceutical sector. Neither side seems fully prepared for the inevitable challenges and yet the prospects for breakthroughs and benefit are sufficiently high for strong optimism and commitment to the sector. The scientific insight and conceptualization of a potential therapy translated into a plan for scientific validation and regulatory compliance frequently runs in parallel with overcoming the hurdles of financing, and eventually, to product positioning, launch, marketing campaigns and consumer response. Such a life-cycle of any novel genre of product is usually tortuous and perhaps this has never been truer than with the emergent class of microbiome-derived products. The product life-cycle of one particular GI microbiome modulator will be reviewed in the context of these challenges from both the nutritional and pharmaceutical industry point of view.
Dale Pfost, Ph.D., Chief Executive Officer, MicroBiome Therapeutics, General Partner, Advent Life Sciences

Strategies for Approaching FDA for Your First Clinical Trial
This talk will address common questions and concerns related to FDA Pre-IND meetings, including what the process is for requesting a meeting, when to approach FDA, what types of content to include and how to frame questions, and what types of outcomes can be expected.
Nicole Rempel, MS, MBA, Director of Regulatory & Strategic Development, Clinipace

The Asian Gut Microbiome: A New Therapeutics Discovery Opportunity
Almost 90 percent of the current translational microbiome research is focused on the Western gut microbiome. AsiaBiome has created the first horizontally integrated microbiome discovery platform in Asia. The company is linking together a microbiota bank, clinical network, and R&D discovery platform to launch microbiome products for both the Asia and global markets. They have strategic partnerships with Hong Kong University and the Genome Institute of Singapore. In this presentation Jonathan will discuss the following:
• How is the Asian gut microbiome different than the Western gut microbiome
• How does fecal microbiota transplant yield new drug discovery opportunities
• How the Asian gut microbes work in global population
Jonathan Krive, Co-Founder, CEO, AsiaBiome

Statistical and Computational Tools for Functional Microbiome
Human microbiome research is quickly moving towards functional microbiomics in order to understand how microbes in the human gut affect host immunity and physiology, disease initiation and treatment outcome. Alterations in microbiome-associated metabolite levels and small molecules may explain such associations. In this presentation, I will describe several new machine learning methods for (1) predicting and quantifying metabolic potentials of a microbial community using shotgun metagenomics data, (2) understanding the complex network of interactions between the intestinal mucosal immune system and the microbiome by integrating CyTOF and shotgun data. I will demonstrate the insights we gain from applying these methods to study IBD, infant early growth dynamics and effects of diet on host metabolism.
Hongzhe Li, Ph.D., Professor of Biostatistics and Statistics, Chair, Graduate Program in Biostatistics, Director, Center for Statistics in Big Data, University of Pennsylvania

Beyond Bacteria: Harnessing the Virome to Improve Our Understanding of Human Health and Inform Diagnostic and Therapeutic Applications
Although the human microbiome consists of broad diversity of bacteria, archaea, viruses, fungi, and small eukaryotes, the majority of human microbiome studies have limited their focus to bacteria. Viruses represent the most abundant group of organisms living in and on our bodies and are known to influence health and disease. Although our broader understanding of the virome is still being shaped, recent studies suggest that the human virome has the potential to be harnessed for both diagnostic and therapeutic applications. This presentation will address the challenges associated with virome sequencing and highlight virome applications.
Emily Hollister, Ph.D., VP, Information Technology & Analytics, Diversigen

Of Microbes and Monoamines: Stepping Stones from Dysbiosis to Psychiatric Disease
The microbiome is a rich target for drug discovery and therapeutic intervention, but in order for targeted approaches to be realized, a mechanistic understanding of the role of various microbial taxa is necessary. In an article recently accepted for publication at Trends in Neurosciences, S.D. Skolnick and Dr. Nigel Greig highlight three promising but largely overlooked metabolic pathways from the microbiome that have the potential to influence psychiatric and neurodevelopmental health. In this presentation, these pathways and their implications will be outlined in a manner appropriate for those with any level of neuroscience expertise, from layman to expert. Prospective research and challenges will be presented, and possible solutions discussed..
Stephen Skolnick, Translational Gerontology Branch, National Institutes on Aging, National Institutes of Health

What are Endolysins and How Can They Improve Skin Health?
Skyler Stein, Head of Gladskin, USA, Micreos

Supporting Infant Development by Supporting the Developing Microbiota
Arthur Ouwehand, Ph.D., Technical Fellow and Research Manager, DuPont Nutrition & Health

Presentation to be Announced
Nancy Caralla, Founding President, Executive Director, C Diff Foundation

Panel Session: Confronting False Truths: On the Way to an IND, Is It Best to Avoid the FDA or Engage Early and Often?
There is a pervasive belief that engaging the FDA about your IND and clinical trial plans is something to be avoided lest you get locked into an approach you would prefer not to take. This panel brings together experts in the field of live biotherapeutic products (LBPs) that have first-hand knowledge working with the FDA to dispel this false narrative. Actual experience suggests that engaging early and often at the reviewer level actually allows the opportunity to walk through your thinking before you have gotten too far afield and have to invest more time and money in revising your approach or backtracking from it.
Moderator: Nikole Kimes, Ph.D., Founder and Chief Scientific Officer, Siolta Therapeutics