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April 11 - 13, 2017

Boston, MA USA

Translating the Microbiome From the Bench to Bedside: Challenges and Opportunities in Developing bioTherapeutics and Diagnostics

Conference Agenda

 
 
PRE-CONFERENCE WORKSHOPS
 
APRIL 11, 2017
 
2:30 pm Workshop I
Navigating the Challenges of Studying the Microbiome in Mouse Models: Design, Execution and Utility
Interacting with other workshop participants and leaders in the field, you will leave with improved knowledge of mouse translational study design, execution and utility in drug discovery applications.   FULL WORKSHOP DESCRIPTION
Alexander Maue, Ph.D., Associate Director Microbiome Products and Services, Taconic Biosciences
 
2:30 pm Workshop II
Clinical Metagenomics to Address Changing Landscape of Infectious Diseases – Challenges and Opportunities
The workshop will offer the entire clinical metagenomics workflow, its use for broad range pathogen detection, identification of community resistome, analytical sensitivity and specificity, and interpretation of data in clinical perspective.   FULL WORKSHOP DESCRIPTION
Nur A. Hasan, Ph.D., MBA, Adjunct Associate Professor, Center for Bioinformatics and Computational Biology, University of Maryland Institute of Advanced Computer Studies, Vice President, CosmosID Inc.
 
5:30 pm Welcome Cocktail Reception
 
MAIN SESSION
 
APRIL 12, 2017
 

7:00 am Registration/Continental Breakfast

7:45 am Chairperson’s Opening Remarks

Mollie Roth, JD, Managing Partner, PGx Consulting 

8:00 am Keynote Address: Invisible Influence: Precision Microbiome Medicine
The human microbiome is quickly being recognized as a dynamic part of the human ecosystem, and research is starting to demonstrate that using ecology to understand this ecosystem has profound benefits for patient wellness. The immune system controls our interaction with the microbial world, and yet the microbial communities in our bodies are central to modulating the immune response. Changes in the human microbiome have substantial influence on a range of complex conditions and disease states.
We will discuss evidence of these mechanisms of interaction and how we have started to disturb the delicate balance of the immune-microbe equilibrium, impacting the development and function of our immune systems. Central to this disturbance is the distance we have placed between our children and the microbial world, which has been demonstrated to have a substantial influence on their physiological, immunological, neurological and even endocrinological development. Applying new strategies to identify how the microbial ecosystem correlates with disease states and treatment efficacy through Microbiome-Wide Association Studies (MWAS) is altering the trajectory of precision medicine, and providing a new framework for facilitating patient care.
Jack Gilbert, Ph.D., Faculty Director, The Microbiome Center, Professor, Department of Surgery, The University of Chicago, Senior Scientist (Adjunct), The Marine Biological Laboratory, Group Leader in Microbial Ecology, Argonne National Laboratory
 
8:30 am Partnering and Research Models of Big Pharma with the Microbiome
In this presentation, Mr. Clerval will discuss the different partnership and investment models big pharma are employing in the microbiome space and consider how best to utilize research approaches, internal expertise and business models to develop a successful pharma-biotech relationship. We will also consider the future dynamics of big pharma to facilitate new partnerships and research models.
Rodolphe Clerval, Chief Business Officer, Enterome
 
9:00 am NIBR and Challenges in Microbiome Research in Big Pharma
The evidence connecting the human microbiota with health and disease states has captured the attention of the public, triggered government-funded research initiatives, and garnered attention from biotech and pharma companies. While correlative observations have enabled researchers to put forward several provocative hypotheses there exists a dearth of mechanistic understanding. The Chemical Biology & Therapeutics Department within NIBR has built a pre-clinical microbiome research program focused on 1) uncovering small molecule mediators of disease-relevant microbe/ host interactions, and 2) identifying new pharmacological targets that assimilate microbiome-derived signals. Our program leverages significant internal expertise in the areas of: computational biology, anaerobic microbiology, natural products chemistry, synthetic biology, immunobiology, high-throughput screening, and target ID/ validation. Central to our mission is an open framework that embraces external collaboration with academic and clinical researchers and provokes internal disease area experts to engage in microbiome-focused studies. 
Henry Haiser, Ph.D., Investigator III, Novartis Institutes for BioMedical Research (NIBR)
 
9:30 am Commercializing Microbiome-based Therapeutics - Inordinate Potential and Challenges
Arpita Maiti, Ph.D., Director, External R&D Innovation, Inflammation & Immunology, Pfizer

10:00 am Refreshment/Poster Viewing/Networking Break

10:30 am Mice as Translational Models: Planning a Fecal Microbiota Transplantation Study
The presentation will cover practical considerations and pitfalls when planning experiments using gnotobiotic mice generated by fecal microbiota transplantation. Different sampling and handling strategies of the transplant, choice of mouse recipient, and the potential impact of environmental factors on the outcome will be highlighted. Example protocols will be discussed and the latest advances in the field reviewed.
Randi Lundberg, DVM, Application Scientist, Taconic Biosciences
 
11:00 am Rebiotix: Leading the Pack
This presentation will highlight the opportunities and pitfalls of creating a drug candidate in a newly developing microbiome drug space.
Lee Jones, Founder, President and CEO, Rebiotix
 
11:30 am Panel Discussion: Microbiome and the Media
The excitement around the microbiome is palpable from the number of pubmed publications to the number of magazine articles in this “new science.” As excitement builds, the gap between what is actually being discovered and what is being reported continues to widen. As we’ve seen historically, hype and unrealistic timelines can result in disappointment, frustration and premature withdrawal of funding. We all see the train coming, but is our only option to brace ourselves? In this panel discussion, we will explore potential proactive ways that we, as an invested community can shape how our science is translated. Audience participation and polling will be included!
MODERATOR: 
Colleen Cutcliffe, Ph.D., Co-Founder and CEO, Whole Biome
 
PANELISTS:
Taylor Milsal, Managing Director, Cotor, Inc.
Emeran Mayer, MD, Ph.D., Director, UCLA Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, Co-Director, CURE: Digestive Diseases Research Center, Professor of Medicine, Psychiatry, Biobehavioral Sciences, Digestive Diseases/Gastroenterology and Physiology, UCLA, David Geffen School of Medicine, 
David Ewing Duncan, Co-Founder and CEO, ARC Programs, Founder and Host, BioAgenda, Founding Director, Center of Life Science Policy, UC Berkeley, Correspondent, The Atlantic
Robin Farmanfarmaian, Vice President, BD, ActavalonInvestor & Vice President, BD, Invicta Medical 
Matthew Niederhuber, Graduate Student, University of North Carolina - Chapel Hill

12:15 pm Lunch

1:15 pm Eligobiotics: Sequence-Specific Antimicrobials for Microbiome Editing
In recent years, a growing body of research has linked the complex microbial ecologies that inhabit our bodies to diseases ranging from obesity to cancer. However, the ability to directly test hypotheses and to treat microbiome imbalances is hindered by the limited tools we have to manipulate these systems. Broad-spectrum antibiotics that wipe out half of our gut flora and fecal transplants are akin to conducting heart surgery with a shotgun or weeding your garden with gasoline.
We use our synthetic biology platform, which combines CRISPR/Cas system with engineered phage capsids, to develop “eligobiotics”: a new generation of highly precise antimicrobials. We can program our eligobiotics to eliminate bacteria based on the genetic sequences they carry in their genome. As opposed to traditional antibiotics, our sequence-specific antimicrobials can therefore discriminate between close bacterial strains and selectively eradicate harmful bacteria from the microbiome while sparing the beneficial ones.
Xavier Duportet, Chief Executive Officer, Eligo Biosciences
 
1:45 pm Tools to Improve the Reproducibility of Microbiome Sequencing
Microbiome profiling, the characterization of the identity and function of all microbes within a given environment, is a growing and emerging dimension of human health research. Understanding which microbes alleviate or exacerbate health outcomes and how they achieve these results is key to maximizing the utility of microbiome research in human biology. Microbiome profiling largely refers to surveying the 16S rRNA gene common to all bacteria, but profiling comes with its own set of challenges, including the need to improve taxonomic resolution to assess strain-level insights, gain functional insight from taxonomic information, and generation of reproducible results. This presentation will discuss the tools and methods that Second Genome employs to address these challenges to ensure the ability to confidently and reproducibly characterize the microbiome, including hardware and software development and application of vetted laboratory protocols and best practices. By identifying key organisms and their functions using these approaches, novel insights are gained for deepening our understanding of disease, developing microbiome-based diagnostics and uncovering new therapeutic targets.
Cheryl-Emiliane Chow, Ph.D., Bioinformatics Scientist,, Second Genome Solutions
 
2:15 pm The Fecal Microbiota Transplant National Registry 
These are exciting times in the microbiome field, as we are just beginning to understand the role of the gut microbiota in health and disease. FMT is a unique case study in which rapid adoption of the clinical practice has preceded the science. The FMT National Registry is collecting clinical and patient-reported outcomes in FMT with the goal of defining the practice in the U.S. and determining the short- and long-term safety and efficacy of the procedure. This public private collaboration between the American Gastroenterological Association (AGA), in partnership with the Crohn’s and Colitis Foundation of America, Infectious Diseases Society of America, and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition with funding from the National Institute of Allergy and Infectious Diseases, along with OpenBiome and American Gut, will provide the vehicle with which individual clinicians and their patients can contribute to the research and development of this important therapy.
Gary Wu, MD, Ferdinand G. Weisbrod Professor in Gastroenterology, Perlman School of Medicine, University of Pennsylvania, Co-PI, AGA Fecal Microbiota National Registry
 
2:45 pm Next Generation Microbial Therapeutics: Challenges in Transforming the Therapeutic Landscape for Atopy and Asthma
Siolta Therapeutics is an early-stage biotech pursuing next generation microbial therapeutics aimed at the prevention and treatment of inflammatory diseases. Our current research and development is focused on the rational design of a mixed-species therapeutic microbial consortium to treat airway inflammation. We are concurrently working towards a future in which the microbiome can help drive patient stratification and tailored microbial therapeutics. We face numerous regulatory, manufacturing, and scientific challenges that require the implementation of innovative solutions.
Nikole Kimes, Ph.D., Co-Founder and Vice President, Siolta Therapeutics
 
3:15 pm Networking/Poster Viewing/Refreshment Break
 
3:45 pm Panel Discussion: Is Pharma Finally Getting on Board the Microbiome Train?
There has been a lot of talk, but little actual deal activity from pharma companies on the microbiome. Vedanta’s outlicense of its most advanced clinical candidate to Janssen is still an interesting benchmark for the industry and three major pharma venture funds have invested in Second Genome. More recently, BMS’ deal with Enterome in immune-oncology is noteworthy. We will have dealmakers from both emerging microbiome companies as well as biopharma to discuss the deal outlook for 2017.  
MODERATOR:
Mohan S. Iyer, Chief Business Officer, Second Genome
 
PANELISTS:
Pierre Belichard, Ph.D., Chief Executive Officer, Enterome
Micah Mackison, Vice President, Corporate Development & Strategy, Assembly Biosciences, Inc.
Arpita Maiti, Ph.D., Director, External R&D Innovation, Inflammation & Immunology, Pfizer
 
4:30 pm Bacterial Based Predictive Diagnostic for Endometrial Cancer
Marina Walther-Antonio, Ph.D., Associate Consultant, Division of Surgery Research and Department of Obstetrics & Gynecology, Assistant Professor of Surgery, College of Medicine, Department of Surgery, Mayo Clinic
 
5:00 pm Doing the Dirty Jobs to Accelerate Microbiome Research
Martha will tell us about what inspired her to start The BioCollective and the challenges she faces in getting this essential "Dirty Job" of microbiome research done. She will describe how The BioCollective, a direct-to-consumer bioscience company, provides high-quality human biospecimens paired with meta data to advance microbiome research and development and how this microbiome marketplace eliminates the need for individual research scientists to recruit people for their studies (subject recruitment can be 20 percent of a total research budget) saving precious research dollars and time. The microbiome is more than just bacterial DNA and Martha will illustrate the many research pipelines for live microbiome biospecimens.
Martha Carlin, Chief Executive Revolutionary, The BioCollective
 
5:30 pm Cocktail Reception
 
APRIL 13, 2017
 
7:30 am Continental Breakfast
 
8:00 am Keynote Address: Metagenomics in Understanding Human Biology, Disease and the Environment
High-throughput sequencing, combined with high-resolution bioinformatics provides a powerful tool for microbiome studies, clinical management of infectious diseases and agricultural and environmental applications. In an era of climate change and emerging and re-emerging diseases, such tools are critical in understanding and tracking resident microbiota as well as identifying infection-inducing agents. The presentation discusses the use of metagenomics in understanding human biology, disease and the environment with prime examples of diarrheal disease, waterborne infections, and wastewater reuse.
Rita Colwell, Ph.D., Distinguished Professor, Univ. of Maryland at College Park, Johns Hopkins Univ. Bloomberg School of Public Health, President, CosmosID, Inc., Senior Advisor, Canon U.S. Life Sciences, Inc.
 
Main Track       Consumer Health Track
       
8:30 am Pervasive Selection Pressure on the Gut Microbiota: Considerations for Microbe-based Therapeutic Design
In this presentation, Dr. Parker will describe evolutionary selection pressure on the gut microbiota, giving several examples of how the microbiota rapidly and effectively responds to changing environments. In addition, environmental forces associated with Western culture that are driving the formation of an inflammatory-associated microbiota will be addressed. The potential impact of these evolutionary and environmental forces on design on microbe-based therapeutics will be highlighted.
William Parker, Ph.D., Associate Professor of Surgery, Duke University School of Medicine
                 
8:30 am The Impact of Topical Washes on Vulvovaginal Microbiome
According to international guidelines, daily gentle cleansing of the vulva is an important aspect of feminine hygiene and overall intimate health. However, there is a paucity of published medical literature related to the external vulva and how personal hygiene practices can affect it. This talk will present clinical evidence assessing the effect of an intimate wash formulation containing lactic acid on overall tolerance and impact on the vulvar microbiome. It also reviews global feminine hygiene practices and the potential benefits and risks of external feminine vulvar washes in overall feminine intimate health. Considering the increasing amount of research and data in the vulvovaginal microbiome field, should the future MECA and RCOG guidelines evolve to incorporate this very important aspect of vulvovaginal health?
Ying Chen, Ph.D., Clinical Project Manager, Equity and Claims, Reckitt Benckiser
       
9:00 am Panel Discussion: Strategies and Risks for Developing Comprehensive Patent and Licensing Strategies
This panel will discuss the specific challenges and opportunities of developing a meaningful patent portfolio for live bacterial entities and bacterially-derived products, and the difficulties of evaluating freedom to commercialize products in an uncertain field. From the licensing perspective, we will evaluate opportunities for collaboration with pharma in drug discovery and development to accelerate microbiome therapeutics development, while addressing what changes need to be made in approaches to research, clinical design and partnership models that may be necessary to create a successful pharma-biotech relationship.
MODERATOR: Greg Sieczkiewicz, JD, Ph.D., Managing Director, Chief IP Counsel, MPM Capital
 
PANELISTS: To Be Announced
   
9:00 am Targeting Chronic Health Conditions via Microbiome Induced Immunomodulation and in-situ Therapeutic Synthesis
The standard of care for most chronic health conditions today is focused on symptom management. Our recent understanding of the capabilities of the human microbiome indicates that many, if not most of these conditions arise as the result of microbiome dysbiosis. We’ll discuss how harnessing the in-situ production capabilities of the existing bacteria in a human host, rather than trying to introduce new and unproven bacteria to the local environment, has the potential of treating the most intractable and chronic health conditions today without the historically common side effects of pharmaceuticals. By delivering the substrates necessary to fuel existing bacteria, and using them as indigenous micro-factories, it is possible to trigger specific metabolic activity so as to induce in-situ production of therapeutics that can reverse chronic disease and resolve disease states without collateral damage.
Jack Oswald, Co-Founder, Chief Technology Officer and CEO, IsoThrive
       
9:45 am Networking/Poster Viewing/Refreshment Break    
9:30 am  Developing an Approach to Consumer Hygiene Practice and Products that can Maximize Protection from Infection and Minimize the Risk of Disrupting our Microbial Friends
At a time when we are dealing with the impact of massive antibiotic resistance and the continuing emergence of new pathogens, we need to be vigilant in protecting the public against infectious disease. And at the same time, there is a growing understanding of the important links between our exposure to environmental microbes, the microbiome and the establishment of a healthy immune system. As a result, it is important to develop, adopt and promote smart hygiene products and practices that can help to reduce the risk of infection and at the same time, minimize disruption to microbial friends.  
Elizabeth Scott, Ph.D., Associate Professor of Biology, Co-Director of the Center for Hygiene and Health, Simmons College
David J. Dowling, Ph.D., Project Manager, Adjuvant Discovery Program Infectious Diseases, Boston Children's Hospital, Research Fellow, Pediatrics, Harvard Medical School
       
10:15 am Translating the Microbiome
As various academic and commercial teams begin to develop interventions targeting the microbiome, we all find ourselves needing to answer 2 key questions: (1) Can we change an already existing microbial ecosystem in a predictable and desired way and (2) Can we change a person's disease or healthy state in predictable and desired ways? The keys to answering these questions lie in the interventions themselves, but also in the methods that are used to measure and monitor the microbiome. In this talk, I will share some of Whole Biome's learnings as we begin to explore the complexity of data acquisition and analytics required to enable us to answer these 2 key questions.
Colleen Cutcliffe, Ph.D., Co-Founder and CEO, Whole Biome
 
    10:00 am Networking/Poster Viewing/Refreshment Break
10:45 am High-Resolution Taxonomic Profiling to Enhance Translational Microbiome Research
Despite advancements in high-throughput DNA sequencing technologies, current microbiome analysis methods employed by the research community often suffer from insufficient taxonomic characterization. This lack of resolution hinders the identification of reliable biomarkers with clinical utility and the design of follow-up experiments. This talk will focus on a novel approach for high-resolution microbiome profiling of 16S sequence data capable of accurate species-level characterization, and we will highlight applications in the context of colorectal cancer, nosocomial infection, and detection of foodborne pathogens.
James White, Ph.D., Founder, Resphera Biosciences
   
10:30 am Panel Discussion: Time to Put the Hygiene Hypothesis to Rest?
 
MODERATOR: Joe Rubino, Director, Research and Development, Reckitt Benckiser
 
PANELISTS: Elizabeth Scott, Ph.D., Associate Professor of Biology, Co-Director of the Center for Hygiene and Health, Simmons College
 
Larry Weiss, MD, Chief Medical Officer, AOBiome
       
11:15 am Panel Discussion: Bioinformatics Tools and Genome Databases for Clinical Applications of Metagenomics
Whole genome shotgun (WGS) sequencing is increasingly becoming the method of choice for precise, high-resolution characterization of microbial communities, identifying and characterizing infection-inducing mono-microbial agent, polymicrobial community, co-infections, and/or discovering completely new disease causing agents. Many bioinformatic tools and algorithms are available for analyzing metagenomic data, however, robust bioinformatics tools that can address various challenges and concerns in complex clinical and regulatory environments are still lacking. The panel will bring together bioinformatic experts from academia, industry, and government who will present solutions to some of these challenges and interact with the audience to review and discuss critical features of bioinformatics tools, aspects of databases, and various validation framework that are needed for its clinical and public health applications.
MODERATOR: Manoj Dadlani, Chief Executive Officer, CosmosID Inc.
 
PANELISTS:

Scott Jackson, Ph.D., Group Leader, Complex Microbial Systems, National Institute of Standards and Technology (NIST) 

Sanjay Joshi, Ph.D., CTO, Healthcare & Life-Sciences, Storage Division, Dell EMC

Jonathan Jacobs, Ph.D., Senior Advisor, MRI Global
   
11:15 am Personalized Nutrition Using Gut Microbiome and Clinical Data
Elevated postprandial (post meal) blood glucose levels are a major risk factor for cardiovascular disease and development of type II diabetes, but current dietary guidelines induce high blood glucose responses in many cases, thereby accelerating development of the metabolic diseases they were intended to treat. Research from the Weizmann Institute in Israel found high variability in individual response to identical meals, with the gut microbiome being a major driver of interpersonal variability. Integrating multi-dimensional data into a machine-learning algorithm resulted in successful prediction of individualized post-meal glucose response, including the ability to predict using solely microbiome data glucose responders to each bread type. DayTwo uses and extends the algorithm to provide personalized nutrition and actionable insights that allow people to maintain normal blood sugar levels.
Lihi Segal, Co-Founder & CEO, DayTwo
     
11:45 am The Acne Trial
Larry Weiss, MD, Chief Scientific Officer, AO Biome
       
12:00 pm Lunch     12:15 pm Lunch
 
1:00 pm The Microbiome: Opportunities and Challenges for Personalized Medicine
The microbiome and its role in health as well as disease has been a subject of intense study with the advent of next generation sequencing methods. In addition the demonstration of efficacy of fecal microbiota transplants in diseases such as C. difficile infection and more recently in Inflammatory Bowel Disease (IBD) lends credence to the hypothesis that restoration of a healthy microbiome can influence disease outcomes. This has ushered in a new area of opportunity for drug development and in parallel for personalized medicine. The diversity of the microbiome across individuals presents challenges for what defines a healthy or dysbiotic microbiome and how to select subjects who would be most likely to benefit from a microbial intervention. Patient stratification will likely be required in early trials which assess efficacy and safety of microbial interventions to ensure efficacy signals are not masked within a general population of diseased subjects who may or may not have a microbial community structure amenable to the microbial intervention. The implementation of this will need to overcome challenges in sample collection and extraction and real-time or just-in-time data generation to enable clinical trial enrollment. IBD is an excellent model for this as alterations in the gut microbiome are a hallmark of the disease but with significant heterogeneity amongst patients.
Carrie Brodmerkel, Ph.D., Senior Director, Systems Pharmacology & Biomarkers, Janssen R&D
 
1:30 pm Panel Discussion: The Commercial Opportunities and Challenges of Microbiome-Based Therapeutics
Microbiome-based therapeutics will offer an entirely new way to treat conditions and will be very different in their composition when compared to therapies based on more traditional small and large molecules. Will customers (physicians, P&T committees, formulary managers, patients, etc.) view MBTs as fundamentally different and, if so, how? What pre-, peri-, and post-launch issues will commercial teams (marketing, managed care, sales, market research, etc.) need to address to ensure that the therapeutic promise of MBTs translates into commercial success? This panel will discuss the regulatory considerations, customer expectations, messaging implications, and other factors involved in launching what is arguably an entirely new category of therapeutics.
MODERATOR: 
JP Benya, Vice President Commercial, Assembly Biosciences
 
PANELISTS: 
Wa’el Hashad, Executive VP and Chief Commercial Officer, Seres Therapeutics
Bernat Olle, Ph.D., Chief Executive Officer, Vedanta Biosciences
Lee Jones, Founder, President and CEO, Rebiotix
 
2:15 pm Unravelling Microbiome Signatures in the Context of Pharmacokinetics and Pharmacodynamics
In this talk Dr. Henn will discuss the challenges of developing microbiome based therapeutics and evaluating drug response in terms of Pharmacokinetics and Pharmacodynamics. 
Matt Henn, Ph.D., Senior VP, Head of Drug Discovery and Bioinformatics, Seres Therapeutics
 
2:45 pm Networking/Poster Viewing/Refreshment Break
 
3:15 pm Exploring the Microbiome to Enhance Cancer Immunotherapy
Recent scientific advances in understanding and analyzing the gut microbiome and how it impacts systemic immunity have put microbiome characterization and manipulation to enhance patient response within reach. Data generated in mouse models and in the clinic have demonstrated that the microbiome can potentially impact immunotherapy effectiveness, and may help us to understand toxicity. Armed with this knowledge, thoughtful and systematic characterization of the microbiome may help to improve outcome. Increasingly, pharmaceutical companies have looked externally for expertise in microbiome analysis and interpretation. This talk will highlight scientific observations that have increased confidence in microbiome effects on immunotherapy while also highlighting some of the most attractive characteristics of potential partners for microbiome analysis.
Bryan C. Barnhart, Ph.D., Senior Scientist 2, Bristol-Myers Squibb
 
3:45 pm Unconference
What issues would you like covered?
MODERATOR: Larry Weiss, MD, Chief Medical Officer, AOBiome
 
4:45 pm End of Conference

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