APRIL 21-23, 2020

BOSTON, MA USA

The Official Blog of the Annual Translational Microbiome Conference

The official blog of the Annual Translational Microbiome Conference provides readers with information, insight and analysis regarding the microbiome.
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New Tools are Needed to Drive Microbiome Research to the Next Level

These microbiome insights are brought to you by Dr. Peter Christey of GALT, Inc., and Arrowhead Publishers. Dr. Christey will be presenting "Driving the Tidal Wave of Microbiome Discovery - a Next Generation Platform for Exploring the Microbiome" at Arrowhead's 4th Annual Translational Microbiome Conference, 18th-20th April, 2018.

I so much enjoy microbiome meetings and continue to be blown away by the speed at which the field is developing and the innovative work being presented. However, there is a sense of frustration with many of the presentations and publications we see in the literature. You would have seen them - studies where samples are taken from healthy patients, samples are taken from diseased patients, next generation sequencing of the microbiome is performed and the results are compared. We get shown lots of charts showing that population x goes up, population y goes down. Then of course PCoA and other statistical charts are presented to demonstrate some point or other. All during the presentation I'm waiting for the punch-line, the insight that helps me understand what is going on. What is the microbiome doing? Who are the key actors? How are they impacting the disease state? What is the underlying biology, chemistry here? Data and insights that quench my curiosity. But no, the presentation ends once the sequencing data analysis is complete - we are left with that empty feeling that something is going on, but it is beyond our ability to understand.

Sequencing is an incredibly powerful tool that has helped illuminate the wonderful complexity and richness of the microbiome. It's one of the few, if not the only, research tools we currently have that scales to the complexity of the microbial systems we are studying. But is it enough? I feel we are doing the equivalent of trying to cure cancer solely by sequencing a million tumor samples. Cancer is being defeated by insights derived from multiple avenues of investigation, including clinical trials, epidemiological data, analysis of the underlying genetics and, critically, wet lab work dissecting the core biological mechanisms and pathways. Wet lab work is critical to test hypotheses and new ideas under controlled conditions - the path to getting from correlation to mechanism. Then we can seriously develop informed interventions to improve the human condition.

Microbiome wet lab work is constrained by the current toolset. Mainstream microbiology technologies were invented over 100 years ago. Core tasks, such as isolating target microbes, creating comprehensive strain collections or studying model ecosystems, are often difficult or impractical. We need new tools to drive microbiome research to the next level.

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Key Innovations in Microbiome Therapeutics: Translating the Science into the Clinic

These microbiome insights brought to you by Dana Barberio, Principal at Edge BioScience Communications and Arrowhead Publishers and Conferences.

These are glamourous times for the microbiome space. The microbiome has captured the heart of the media, and this red hot scientific area has spawned intense attention from researchers, courtship by investors and a myriad of unique business opportunities and partnerships among companies ranging in size from small start-ups to global pharmaceutical companies. Multiple companies with therapeutics in clinical trials are jockeying for position in a heated race to market, many with their lead candidate targeting Clostridium difficile (C. diff), and with a wide variety of other applications in the queue. Key players in both the scientific and business side of the microbiome space will be gathered together at Arrowhead Publishers’ 3rd Annual Translational Microbiome Conference, taking place in Boston, Massachusetts April 11th-13th 2017. Let’s capture an eagle eye view of that conference by looking at recent advances in the microbiome space, and some of the key topics represented at the conference.


Scientists are rapidly discovering the microbiome’s sophisticated and widespread network of interactions that affect human metabolism, neurology, the immune system and skin. The microbiome plays a role in radically different areas of health, such as nutrition, early childhood, hygiene, infectious disease and chronic health conditions. There is evidence that dysbiosis in the gut is a factor in an astounding array of conditions and diseases: inflammatory bowel disease (IBD), atopy, asthma, cancer, obesity, Type 2 Diabetes, fatty liver disease, and neurological disorders.

Hot Areas of Scientific Research
While investors, companies and the media are currently having a love affair with the microbiome (I decline to call it ‘hype’), arguably the science has yet to live up to the expectations. But the scientific foundation is gradually being constructed and is forthcoming with many recent studies. A January 2017 small scale clinical study of Autism Spectrum Disorder provided evidence of improved ASD symptoms resulting from Microbiota Transfer Therapy. A Dec 2016 Caltech study in a mouse model of Parkinson’s disease established that gut bacteria not only contribute to the disease, but apparently play a causal role. There are future market opportunities for treatment of anxiety, depression, and autism that may evolve from an understanding of the science behind gut-brain interactions. Emeran Meyer, MD and professor at UCLA, discusses these topics in his book “The Mind-Gut Connection: How the Hidden Conversation Within Our Bodies Impacts Our Mood, Our Choices, and Our Overall Health.”


IBD has been linked for decades with dysbiosis in the gut microbiome, and more recently scientists have been gaining a deeper understanding. Laying a foundation for defining the mechanisms for this was a March 2014 study by Dirk Gevers of Janssen Human Microbiome Institute with a multi-cohort study comprehensively defining the microbiome diversity landscape of Crohn’s Disease and identification of potential biomarkers. A February 2017 study provided evidence that IBD can be distinguished as two subtypes with distinct microbial signatures, as Crohn’s Disease and Ulcerative Colitis. These microbiome signatures are critical in the development of therapeutic targets.


Another hot area is in the immunotherapy space: predicting patient response and modulating gut bacteria to optimize treatment. Research at MD Anderson Cancer Center in February of 2017 implicated gut bacteria in melanoma patients’ response to PD1 checkpoint inhibitor immunotherapy. Patients that responded to the immunotherapy had a greater diversity of gut bacteria and larger numbers of a specific bacteria than those who did not respond.


With a partnership that will translate microbiome research in immunotherapy into the commercial space, Bristol Myers-Squibb and Enterome entered into an immuno-oncology focused partnership in November of 2016 for the discovery and development of microbiome-derived drug targets and biomarkers to be used in cancer therapeutics and companion diagnostics.


We’ll hear more about these topics at the conference.

Areas with Great Market Potential
From a January 2017 review article by University of Chicago’s Jack Gilbert (conference keynote speaker) and Thomas Kuntz, a hot area in need of more research is in drug response and interaction, as there are already more than 60 drugs known to interact with the microbiome. Enhancement of personalized treatment in a clinical setting will involve a deeper understanding of bacteria’s role in drug metabolism and host variation to drug response, in particular as it corresponds to an individual’s microbiome (and host ‘omes’). For example, a March 2014 study found genes in the gut bacteria Eggerthella lenta that can be used as predictive microbial biomarkers for inactivation of the cardiac drug digoxin, with potential application in studying drug pharmacokinetics and clinical interventions.


Another area with large market potential according to Gilbert and Kuntz is in addressing alternatives to the widespread overuse of broad-spectrum antibiotics and the resulting health-endangering spread of bacterial resistance. One alternative involves targeting specific bacterial pathogens or enzymes with precision antibiotics and therapies. Multiple companies are focused in this area, including Eligo BioscienceSecond GenomeAvidBioticsC3J Therapeutics, and EpiBiome, all of whom have platforms which selectively kill off harmful bacteria while protecting commensal bacteria.


Of course, precision prebiotics and probiotics are another hot focus area, which may involve a systems biology/bioinformatics approach such as used by Seres TherapeuticsEvelo BioSciencesMetabiomics and others.

Empowering Deep Level Understanding with Big Data
If you consider the complexity of genomic and environmental factors such as lifestyle, diet, toxins, polypharmacy, metabolomics, and the gut microbiome, it’s clear that we need some high level bioinformatics to interpret the enormous amount of data for translation into the clinic.
Microbiome-based precision medicine will stem from a deep level understanding of the mechanisms involved in the complexities of host-microbiome interactions. The ultimate level of analysis may come through a systems biology paradigm, which uses mathematical/computational models to analyze large datasets and simulate system behavior with network-based analyses of the interactions between different types of ‘omics’ data (such as genomics, transcriptomics, proteomics and metabolomics), providing novel insight into complex biological systems, new biomarkers and enhanced drug discovery and development. For example, a March 2017 article proposes an ‘omics’-based precision medicine approach for elucidating genomic and metabolic interactions in the microbiome-gut-liver axis. These Big Data practices are expected to transform clinical practice.


Jack Gilbert, one of the keynote speakers at the conference, has a brand-new startup, Gusto, which produces formulations of probiotics. They use a computational modeling platform, GUST+, which predicts bacterial interactions and their effect on the immune system and human health by compiling data from human studies and running thousands of simulations.


One technical hurdle faced in the microbiome therapeutics space is in securing precise taxonomic assignments for bacteria based on sequence alignments, which is a computational challenge for both 16S and shotgun libraries, due to the short Next Gen Sequencing read lengths. This creates an obstacle for identification of reliable clinical biomarkers and hinders follow-up experiments. James White of Resphera BioSciences, at the conference, will discuss a novel approach for high-resolution microbiome profiling of 16S sequence data, which provides accurate species-level characterization.

Databases and Specimen Collection
In the case of Fecal Microbiota Transplantation, the rapid entry into clinical practice preceded the science. The FMT National Registry, a public-private collaboration, was established as a database of clinical and patient-reported outcomes intended to establish the short- and long-term safety and efficacy of FMT.
Another organization, The BioCollective, provides a resource for obtaining human fecal specimens paired with data for use in microbiome research and development, eliminating the need for researchers to recruit individuals for studies.

Frontrunners in Clinical Trials
As leaders in the field rapidly uncover the mechanisms driving the microbiome’s role in disease, the foundation is being established for capitalizing on the science in order to decrease disease and improve health. Farthest along in clinical trials is Rebiotix, with a drug candidate, RBX2660, for recurrent Clostridium difficile in Phase 3 trials. Their Microbiota Restoration Therapy (MRT) platform, which targets other diseases as well, delivers a broad spectrum of live microbes into a patient’s intestinal tract for rehabilitation of the microbiome.


At the conference, we will hear first-hand from a few of the companies in the trenches of clinical trials - Rebiotix, Seres Therapeutics and Vedanta Biosciences - on regulatory considerations, customer expectations, messaging implications, and other critical factors involved in developing and launching microbiome therapeutics.


Partnerships and Regulation
While the scientific and technical resources are critical, we will also hear about the equally critical business side - the role of partnerships as well as regulatory and patent issues.

Since probiotics have widespread acceptance by clinicians and the general population, microbiome therapeutics is at an enviable jumping off point for some microbiome companies. However, the FDA is of course involved in prescription products. The criteria for FDA approval involve defining bacterial colonization, what effect colonization has and how fast it occurs, and the pharmacokinetics/ pharmacodynamics, among other factors. This is for live bacteria. The addition of genetic manipulation adds another level of complexity in gaining approval.


Big Pharma has taken a huge interest in the microbiome space, with numerous partnerships. Among those leading the way was a partnership in 2014 between Second Genome and Pfizer, in which the two companies engaged in a large observational study with the goal of gaining a better understanding of the connection between obesity, metabolic disorders and the microbiome. Three major pharma investment funds have invested in Second Genome. Second Genome is partnering with Monsanto in applying big data science, bioinformatics and machine learning to drive discovery of microbiome-based solutions that can help farmers better manage on-farm challenges.


In 2015, Janssen and Vedanta Biosciences struck a deal involving Vedanta’s out-license of its most advanced clinical candidate VE202: a mix of bacteria from the Clostridia subspecies that are a potential treatment for several IBD disorders: Crohn’s disease and ulcerative colitis.


Most recently, in November of 2016, the aforementioned Bristol Meyers-Squibb and Enterome established an immuno-oncology focused partnership.


Join us to hear more on all of these topics and the many exciting opportunities and challenges in the microbiome space at Arrowhead Publishers’ 3rd Annual Translational Microbiome Conference. We will see you there!

 

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The Mike Rowe of the Microbiome Space

By Martha Carlin, Chief Executive Revolutionary, The BioCollective

In every industry there are dirty jobs that must be done to fuel the business.  Business Insider recently published “Small World: 20+ Startups Targeting the Microbiome” a review of just some of the exciting new microbiome ventures that are primarily focused in four key areas - diagnostics, genomics, dietary supplements, and intestinal health/disease targeted therapies.[1] These ventures use convenient and available samples for their initial R&D obtained from relationships with universities, hospitals and friends and family. When a promising discovery is made from that initial research, it may be necessary to test it on a larger and more representative population and this is where the The BioCollective comes in. 

Everybody poops.[2] But nobody wants to have to “deal with it.” One of the biggest barriers to accelerating microbiome research is getting a sample from everyone doing their duty! (or dooty depending on the age of your audience!) So we approached the problem from the Pooper’s perspective. We created a kit that is easy to use in the comfort of your home, ick-free and even a little bit fun. There is no scooping, probing, dipping or mixing needed. There are no messy plastic “hats,” bowls or containers to be disposed of. The process is seamless with nothing left behind, so to speak. Our BioCollector patent-pending design collects the entire sample, keeping it viable and ready to leverage into any number of research pipelines. Once the live sample reaches our lab, it is divided into smaller portions and cryopreserved enabling many types of research on the same sample. One sample can generate data from phage to fungi and culture. We are much more than DNA! 

Subject recruitment and sample collection is one of the top five cost drivers in research, but when we do the “dirty job” of providing samples to support microbiome research we can save thousands of dollars from the process. The BioCollective has made pooping a fun and profitable way to participate in microbiome research. We use engaging and innovative ways to get people of all ages and walks of life to become members of The BioCollective with the goal of building a microbiome resource full of samples that are actually representative of the US population. We go beyond the narrow and limited population of WEIRD (white, educated, industrialized, rich and democrat)!

In exchange for providing a sample to aid in research members receive a share of revenue from sample sales and feedback on where their sample is being used. We also provide the member with options for learning what’s in their gut from a basic 16S analysis to whole genome sequencing.  For the super curious, we can provide specialty analysis such as metabolomics, 18S and transcriptomics through our sequencing partners.  

Learn more about what we do and how you can become an active participant in the field of microbiome research at Arrowhead’s 3rd Annual Translational Microbiome Conference, being held April 12-13, 2017 in Boston, MA.

 

[1] https://www.cbinsights.com/blog/microbiome-startups-market-map-company-list/

[2] This is fact, and for an excellent read on this subject, may we suggest “Everyone Poops,” by Taro Gomi, https://www.amazon.com/Everyone-Turtleback-School-Library-Binding/dp/0613685725

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Tailoring Microbiome Interventions: The Intersection of Precision Medicine and the Microbiome

By Carrie Brodmerkel, Senior Director, Systems Pharmacology & Biomarkers, Janssen R&D

The microbiome gets a lot of press these days, from leading scientific journals such as Science publishing a special issue “Microbiota at Work” in April, 1 to articles about fecal microbiome transplants in major newspapers like the Washington Post.2 Many articles tout the need for a healthy gut microbiome and that the diversity of the gut microbiome is what maintains not just gut health but overall health. But for all of the hype, what do we really know about what a healthy microbiome looks like? What do we really know about the impact of the microbiome on health and disease? Is there a universal definition of a healthy microbiome or is it more likely that the each person has his or her own unique healthy gut microbiome?

A study published in 2015 in Science Advances studied the fecal, oral and skin microbiome of an Amerindian tribe, the Yanomami, who were completely isolated from the Western world.3 The researchers found that the Yanomami had the highest levels of human microbial diversity ever reported. They also don’t suffer from Western diseases like cardiovascular and metabolic disease or autoimmune and inflammatory diseases. Does this infer that gut microbial diversity equates to better health and less disease? That has not yet been proven and it may be that the microbiome in this tribe works in conjunction with a far different lifestyle and lack of chemical and pharmaceutical impacts and interventions to support a lack of disease. Still it drives the question of whether personalized cocktails of microbes will be needed to achieve optimal gut health for a given individual or group of individuals with similar microbiomes?

This collision of microbiome research and the precision medicine space, and the potential need for patient selection and personalization of microbiome therapies, will play out as microbial based therapeutics begin to hit the clinic. Evidence supporting this need already exists from fecal microbial transplant studies in C. difficile and inflammatory bowel disease where the response rates in an unselected population of patients leaves opportunity for improvement. Efforts to understand the functional effects of the microbes that inhabit the human gut and determining which promote health and which promote disease will be essential in unraveling the microbial communities necessary to promote health at the population or cohort level.

Hear more about Janssen’s efforts to define patient stratification strategies and personalized medicine in the age of microbial-based therapeutics at Arrowhead’s 3rd Annual Translational Microbiome Conference, being held April 12-13, 2017 in Boston, MA. For more information, visit: http://www.microbiomeconference.com

1 Science Magazine April 2016 http://science.sciencemag.org/content/352/6285

2 https://www.washingtonpost.com/news/speaking-of-science/wp/2016/04/28/scientists-think-theyve-found-the-secret-to-better-poop-transplants/?utm_term=.91f00d298c91

3 http://advances.sciencemag.org/content/1/3/e1500183.

Interestingly, despite their isolation and no known exposure to antibiotics, it was found that the tribe harbored bacteria that carried functional antibiotic resistance genes, including those that confer resistance to synthetic antibiotics and are syntenic with mobilization elements.

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Interview with Mollie Roth: Executive Director of The Microbiome Coalition (TMBC)

 

Interview with Mollie Roth, JD

Executive Director of The Microbiome Coalition (TMBC)

 

What is The Microbiome Coalition and what’s its goal?

The Microbiome Coalition (TMBC) represents a variety of commercial entities working toward commercial success in the microbiome field, united by their desire to promote greater public understanding of the role of the microbiome in human health and wellness, and the desire to advance appropriate regulation, needed investment and required infrastructure.

Recognizing that a shift in how microbiome based medicine and research is implemented will not happen simply because a body of scientific evidence suggests it should, TMBC has identified key goals to support and advance the industry, including: Education, Regulatory Engagement and Standards. You can learn more about what we are doing on all three fronts at http://www.themicrobiomecoalition.com/

 

How did TMBC come to be formed? 

Although I started my career as a litigator for the pharmaceutical industry, I have always had an affinity for making business run better. I spent 10 years working with a precision medicine consulting company helping pharma drug development teams understand how to co-develop and launch companion diagnostics.

In early 2013, I started working as a consultant in the microbiome space and became interested not only in the vast body of research that was happening across multiple industries – pharmaceutical, diagnostic, consumer products and nutrition – but in the challenges for companies to become a commercial success. Many of the hurdles and challenges this industry faces mirror exactly the experience in the precision medicine field – an unclear regulatory path, unclear business models, a lack of standards, differing reference databases among others.

It was my opinion, based on my experience in the precision medicine field, that a coalition of companies in this space could better address and overcome these challenges than any one company could. Thankfully the founding companies agreed with me and TMBC was born.

 

You said one of TMBC's goals pertains to standards, is there a problem with standards in the microbiome space?

In scientific research, standards allow for and ensure quality in research and the generation of quality evidence that can be compared across researchers and companies. Absent uniform standards, the quality of scientific research can be uneven and lacking in credibility, making it difficult to make confident, concrete assertions or predictions regarding evidence for improving practice or consumer outcomes.

For example, in the precision medicine space, we saw the lack of standards cause issues when it became apparent that there were no standardized practices for how samples being used to generate clinical data for diagnostic tests were handled. There are a number of groups already hard at work on two distinct standards issues in the microbiome space – how samples are handled and sequenced as well as how the vast volume of information generated in this space is processed. 

TMBC will serve as a clearinghouse for these activities already underway and will bring these disparate groups to the table to ensure they are engaging with each other so the industry ends up with a set of conformed standards, rather than numerous sets of non-interoperable standards.

 

What companies formed TMBC?

The founding companies are a visionary set of innovators who quickly understood the need for a coalition of companies working toward commercial success in the microbiome space and have provided seed support and substantial resources to get the coalition off the ground. They include AOBiome, Whole Biome, CosmosID, Abbott Nutrition, The Mayo Clinic, Diversigen and Second Genome.

 

How important are collaborations in the microbiome space?

 As incredibly important as they are in any area of new scientific research!

There are literally hundreds of small startup companies making incredibly exciting discoveries with regard to the microbiome, but without the resources or global reach to complete their research or get products approved and launched. Collaborations with larger companies, carefully crafted to ensure a win-win, are not only vital but imperative to move this space forward.

Further, now that we are a few years into the “age of the microbiome” we are starting to see a convergence between microbiome therapies and precision medicine, as companies consider how patients might need to be stratified based on their microbiome to determine who best to treat. The business models of how pharma and diagnostic companies can best collaborate and work together will continue to be vitally important as these two spaces continue to merge.

 

Is membership in TMBC open and to whom?

Membership in TMBC is open and we welcome any company, association or individual with an interest in advancing the commercial viability of microbiome based therapies, diagnostics, consumer or nutrition products to address and improve human health and wellness. You can learn more about membership options at http://www.themicrobiomecoalition.com/become-a-member/

 

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Banking Your Personal Biome

(Guest Bloggers, Sasha Lieberman, Nonprofit Management Fellow and Carolyn Edelstein, Director of Policy and Global Partnerships, OpenBiome)

Mark Smith and James Burgess were inspired to found OpenBiome after a family friend who had suffered with repeated C. difficile infections shared his story of having to resort to performing a DIY fecal transplant at home. Since its founding in 2012, OpenBiome has been committed to enabling safe access to fecal microbiota transplantation (FMT) by providing rigorously screened, ready-to-use microbiota preparations for use in FMT and by catalyzing research into the human microbiome.

This year, OpenBiome launched PersonalBiome, a pilot service that allows individuals who are at risk of contracting C. diff to preserve a copy of their healthy microbiome. In the event that these individuals do end up experiencing recurrent C. diff infections, participants can retrieve their sample from their PersonalBiome bank to repopulate their gut with their own healthy microbial community. PersonalBiome pushes OpenBiome’s mission to provide safe microbiota treatments from its pool of universal stool donors forward by expanding the available options for repopulating the gut microbiome following a C. diff infection.

In some ways, the service resembles that of private umbilical cord blood banking. A practice that began in the early 1990s, cord blood banking is now undertaken by a network of over 100 cord blood banks and transplant centers that have stored over 400,000 units of cord blood worldwide. The vast majority of banked cord blood is for use by unrelated donors, but private banks have arisen to give families the option of storing their own cord blood, a service that is most useful for those with family members who have a current or potential need for a stem cell transplant.

Current FDA regulations governing FMT only permit physicians to treat patients with FMT outside of a clinical trial, if the patient experiences repeated, unresolvable C. diff. These regulations apply equally to one’s own stool as well as stool from a universal bank. However, co-founder and executive director James Burgess, featured in this recent FastCompany article about the PersonalBiome pilot project, envisions a future in which high-risk patients can bank their microbiomes to help prevent and treat other microbiome-associated diseases.

Individuals who would like to learn more about participating in the PersonalBiome pilot launch should contact This email address is being protected from spambots. You need JavaScript enabled to view it., or visit www.openbiome.org/personalbiome. To learn more about OpenBiome and what we do, visit www.openbiome.org.

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Our events give attendees a conference experience that encompasses learning, networking and professional growth. We strive to facilitate connections. At our events, attendees, speakers, sponsors and exhibitors have opportunities to network and then to utilize those connections to further their professional goals. At Arrowhead Publishers, our focus is on bringing life sciences industry professionals together to help move research forward. Learn more about us at www.arrowheadpublishers.com.

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This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Office of Continuing Medical Education of the University of Virginia School of Medicine and Arrowhead Publishers. The Office of Continuing Medical Education of the University of Virginia School of Medicine is accredited by the ACCME to provide continuing medical education for physicians

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The University of Virginia School of Medicine, as accredited provider, awards 8 hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)TM ) to a participant who successfully completes this educational activity. The University of Virginia School of Medicine maintains a record of participation for six (6) years.

Shahram Lavasani, Ph.D.

Founder, Chief Executive Officer and Chief Scientific Officer
Immune Biotech

Shahram Lavasani is an international keynote speaker and entrepreneur in the field of the microbiome. He received his PhD in Immunology from Lund University in Sweden while studying the immunoregulation and immunotherapies in multiple sclerosis (MS). With more than two decades of teaching and research expertise on Gut-Brain axis, he has pioneered research in MS by demonstrating gut inflammation and barrier dysfunction and introduced microbiota-based therapies using probiotic bacterial consortia. He is the founder of ImmuneBiotech developing novel microbiome therapeutics. The company has access to a proprietary lactobacilli library and advanced selection technologies to design nutritional formulations for optimal management of the diseases. ImmuneBiotech´s first product GutMagnificTM has been designed to address the underlying causes of IBS and successfully launched to European market in October 2019.

Scott Jackson, Ph.D.

Group Leader, Complex Microbial Systems
NIST (National Institute of Standards & Technology

In this current role, Scott is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies, developing reference materials and reference methods, and developing in vitro tools that allow us to better understand microbial community resilience and evolution.

Rachel Clemens, Ph.D.

Commerical Innovation Manager, Life Science Lead
ISS US National Lab, Center for Advancement in Science in Space

Rachel Clemens has focused her career on advancing life science research and product development through experiments in space. In her current role as a Commercial Innovation Manager at the ISS US National Lab, she brings life science research to low earth orbit. She leads partnership development specifically with life science companies – from biotech start-ups to large pharmaceutical companies. She is eager to entertain even the craziest of ideas and passionate about finding novel solutions to Earth-bound problems.

Lynne Elmore, Ph.D.

Director, Translational Cancer Research Program
American Cancer Society

Lynne Elmore, PhD, is the director of the Translational Cancer Research program in the Extramural Grants department of the American Cancer Society (ACS). She manages a research portfolio focused on cell biology, infectious disease, the microbiome, molecular genetics, and cancer drug discovery.

Garth Ehrlich, Ph.D.

Professor of Microbiology & Immunology, Professor of Otolayngology - Head & Neck Surgery
Drexel University College of Medicine

Dr Ehrlich is Professor of Microbiology and Immunology, and Otolaryngology-Head and Neck Surgery at Drexel University College of Medicine (DUCOM) in Philadelphia, PA, USA. Dr. Ehrlich is also the founder and director of three Research Centers of Excellence in the Institute for Molecular Medicine and Infectious Disease: the Center for Genomic Sciences (CGS); the Center for Advanced Microbial Processing (CAMP); and the Center for Surgical Infections and Biofilms.

He also directs Drexel University’s Core Genomics Facility and the Meta-Omics Shared Resource for the Sidney Kimmel Cancer Center – an NCI-designated Cancer Center.

Momo Vuyisich, Ph.D.

Chief Scientific Officer
Viome

Momo Vuyisich is a co-founder and Chief Science Officer at Viome, a data-driven personalized nutrition company. Momo provides scientific leadership at Viome and his vision is to revolutionize healthcare from "symptoms management" to a true preventative medicine. He leads product development, clinical test implementation, and comprehensive clinical research portfolio.

Momo is also an Adjunct Professor at the University of New Mexico and New Mexico Tech. Before co-founding Viome in 2016, Momo spent 12 years at Los Alamos National Laboratory, where he led the Applied Genomics team, which developed the core technology used by Viome today.

Nancy Caralla

Founding President, Executive Director
C Diff Foundation

Nancy C Caralla is a three-time Clostridioides difficile infection (CDI) survivor. She has accumulated over 25 years of experience in the nursing profession blended with over 30 years in international construction management. Over the past several years, Nancy, in partnership with C Diff Foundation members, has focused on raising C. difficile awareness through education and advocating for Clostridium difficile infection prevention, treatments, clinical trials, AMR, and environmental safety worldwide. The C Diff Foundation is a non-profit organization that takes great pride in its volunteers, chairpersons, and committees.

Rachel Teitelbaum, Ph.D.

Chief Executive Officer
Hervana

Rachel Teitelbaum, PhD is the founder and Chief Executive Officer of Hervana Bio Ltd. Dr. Teitelbaum earned her Ph.D. in microbiology and immunology at the Sue Golding Graduate Division of the Albert Einstein College of Medicine. Her academic research career spans more than 15 years, with a focus on research in infectious diseases, in particular relating to the host-pathogen interface, elements of the immune response to intracellular pathogens, the development of animal models of infection and the development of vaccines, in particular for providing effective mucosal immunity. With the founding of Hervana Bio Ltd, Dr. Teitelbaum has applied some of these principles to developing a probiotic therapeutic platform in Women’s Health applications, including the development of a non-hormonal, long-acting biologic contraceptive.

Sonia Timberlake, Ph.D.

Vice President of Research
Finch Therapeutics

Dr. Sonia Timberlake is the VP of Research at Finch Therapeutics, a microbiome therapeutics company. Sonia is an expert at designing NGS-based algorithms for applications in microbial genomics, immunogenomics, and evolution. Prior to joining Finch, she built and managed AbVitro's computational algorithms and infrastructure, supporting high throughput single-cell immune phenotyping and repertoire sequencing technology. This technology platform was acquired by Juno Therapeutics, where Sonia led a multidisciplinary team to harness native adaptive immune responses for developing engineered cell therapies in oncology.

Dae-Wook Kang, Ph.D.

Assistant Professor, Department of Civil & Environmental Engineering
University of Toledo

Dr. Kang received his BS and MS in Civil and Environmental Engineering from the Seoul National University and his PhD (also in Civil and Environmental Engineering) from the University of Wisconsin-Madison. Prior to joining the University of Toledo in 2019, Dr. Kang was a research scientist in the Biodesign Swette Center for Environmental Biotechnology at the Arizona State University where he was involved in groundbreaking work to establish the relationships between human gut microbiota and autism spectrum disorders. His broad research interests are employing multi-omics technologies and bioinformatics to advance understanding of the role of microbiota on human health, environment, and engineering systems, and eventually to improve human public health and environment sustainability.

Amy Feehan, Ph.D.

Research Scientist
Ochsner Health System

Dr. Feehan is an early stage investigator who received her BS and PhD in Neuroscience from The Brain Institute at Tulane University in New Orleans. She has conducted research in humans and rodents covering topics ranging from drug development of novel endomorphin analogs for pain, to sleep and circadian rhythms research and most recently the gut-brain axis and infectious disease. Her doctoral work led to two patents for a compound that reverses both acute and chronic pain with no observable risk of addiction. She currently works as a research scientist in the Infectious Disease department at Ochsner in New Orleans designing and executing investigator-initiated clinical trials.

Sangeeta Khare, Ph.D.

Research Microbiologist, Division of Microbiology, National Center for Toxicological Research
US Food & Drug Administration

Dr. Sangeeta Khare is a Research Microbiologist in the Division of Microbiology, at National Center for Toxicological Research, Food and Drug Administration. Dr. Sangeeta Khare leads an active team with a research emphasis on host-pathogen and host-microbiome interaction during perturbations with xenobiotic agents (nanoparticles, antibiotics and other drugs, natural products and additives). The main focus of Dr. Khare’s research group is on establishing innovative parameters of host intestinal toxicity.

Julius Goepp, MD

Chief Executive Officer
Scaled Microbiomics

Dr. Goepp is the inventor of “Systems and Methods for Altering Microbiome to Reduce Disease Risk and Manifestations of Disease,” filed as a PCT patent with USPTO on August 27, 2017 and assigned to Scaled Microbiomics, LLC. He has spearheaded the development of Scaled Microbiomics to date, including developing a research team, equipping a laboratory, designing the experiments that produced supporting data on use of IgY in microbiome applications, and interpreting the results.

Ze'ev Ronai, Ph.D.

Professor
Sanford Burnham Prebys Medical Discovery Institute

Ze'ev Ronai obtained his Ph.D. in 1985 from The Hebrew University, Jerusalem Israel and performed his postdoctoral research with I.B. Weinstein at the Cancer Center of Columbia University in New York. He established the Molecular Carcinogenesis Program at the American Health Foundation in Valhalla, New York, and in 1997 moved to the Ruttenberg Cancer Center at Mount Sinai School of Medicine in New York, where he was a tenured professor up to 2005. During 2004, Dr. Ronai moved to Sanford Burnham Prebys Medical Discovery Institute (formerly known as Sanford-Burnham Medical Research Institute) in La Jolla CA, where he is a Professor. He served as the Director of the Signal Transduction Program (2005-2013), as the Deputy Director for the Cancer Center (2008-2014), and as the Scientific Director for the La Jolla site (2014-2016). He established a cancer center at the Technion in Israel (Technion Integrated Cancer Center), while maintaining his activities at SBP (2016-2018). He is currently Chief Scientific Advisor and Professor at Sanford Burnham Prebys Medical Discovery Institute (SBP), La Jolla CA.

Henrik Bjorn Nielsen, Ph.D.

Chief Scientific Officer
Clinical Microbiomics

Henrik Bjørn Nielsen, PhD, is Chief Scientific Officer (CSO) at Clinical Microbiomics where he is part of the leadership team together with the CEO and CBO. As CSO he is responsible for directing the science team and the scientific innovation, in addition to overseeing all client projects. Bjørn has an outstanding background as both group-leader at the Technical University of Denmark (DTU) and has been a frontrunner in the field of microbiome research for more than a decade. He has published more than 20 high-visibility publications within the microbiome field, covering biomedical discoveries and a series of key analysis concepts for microbiome data. Bjørn has extensive expertise in analysing, integrating and managing diverse types of data. With his experience and innovative mindset, Bjørn has played a key role in establishing Clinical Microbiomics as the leading CRO for advanced microbiome analysis.

Cecile Clavaud, Ph.D.

Project Leader in Skin Microbiome, L'Oreal Advanced Research
L'Oreal

Research and Innovation, France Dr. Clavaud's initial expertise is chemistry and biochemistry to design new radiolabelled probes for medical imaging (Commissariat à l’Energie Atomique, Saclay, FRANCE) followed by four years post doc in the Aspergillus Unit (Institut Pasteur, Paris, FRANCE) to characterize the molecular mechanisms involved in the fungal cell wall polysaccharides biosynthesis. Dr. Clavaud joined L’Oréal Research and Innovation in 2011, to work in an open innovation mode, establishing partnership with international academic experts in the skin and scalp microbiome field. At that stage, she explored the ecology of skin microbiota members (bacteria, fungi and viruses) observed in various skin physio-pathologies and body sites in order to identify key determinants involved in the interaction with skin. Since 2017, she has been involved in building a laboratory dedicated to the skin – microbiota interactions in 3D reconstructed skin models, to better understand how commensal microbiota can impact positively the skin barrier function and the skin quality. Today, she is leading transformation projects turning the recent microbiome knowledge into anti-aging applications.

Anandh Babu Pon Velayutham, Ph.D.

Associate Professor, Department of Nutrition and Inegrative Physiology
University of Utah

Dr. Anandh Babu Pon Velayutham is an Associate Professor in the Department of Nutrition and Integrative Physiology at the University of Utah. His research focuses on identifying novel dietary compounds for the prevention of vascular disease in diabetes and metabolic syndrome. His current research examines the vascular effects of blueberries and strawberries with special emphasis on the microbial metabolites of berry anthocyanins and the molecular signaling mechanisms involved. Dr. Velayutham's research aims to understand the causal association between dietary berries, gut microbiome and vascular health.

Sara Ferrando Martinez, Ph.D.

Research Scientist
AstraZeneca

Dr. Sara Ferrando-Martinez is a Research Scientist at AstraZeneca. Sara is an immunologist that focused on understanding the mechanisms underlying the deterioration of the immune system and how to rejuvenate and recover immune responses as a strategy for immunotherapy. Within AZ Sara is trying to uncover the link between microbiome, microbiome-related products and immune modulation and its impact in health and disease.

A. Stewart Campbell, Ph.D.

VP, Early Stage Development
Axial Biotherapeutics

Dr. Campbell brings more than 25 years of drug discovery and development experience to the team. He has built and led R&D teams involved in a variety of environments from early stage research through to advanced clinical development in small start-ups to mid-sized companies. With capable colleagues he has been fortunate to have triaged several drug candidates from discovery to clinical proof-of-concept in multiple therapeutic areas. He received a Ph.D. in Organic Chemistry from the Queen’s University, which was followed by post-doctoral research at Duke University. He has consulted for several start-up companies in multiple technology and therapeutic areas in the Greater Boston area and is co-inventor on more than 15 issued patents.

Gregg Silverman, MD

Professor of Medicine & Pathology
NYU School of Medicine

Dr. Silverman is Professor of Medicine and Pathology, Associate Director of the Division of Rheumatology, and the Director of the Laboratory of B-cell Immunobiology at the NYU School of Medicine. He is an elected member of AOA, ASCI and the Henry Kunkel Society. After training in Internal Medicine at UCSD, he was a fellow at The Scripps Research Institute in rheumatology and clinical immunology, with a focus on molecular immunology and the structural basis of immune recognition. He has authored over 160 publications and he is on the editorial board of several prestigious journals. Work in his lab is highly translational, with a special interest in B cells and the properties of autoantibodies. and more recently the contributions of the gut microbiome to autoimmune disease.

Mahmoud Ghannoum, Ph.D.

Professor, Department of Dermatology
Case Western University and University Hospitals Cleveland Medical Center

Dr Mahmoud Ghannoum received MSc in Medicinal Chemistry and PhD in Microbial Physiology from University of Technology in England, and an MBA from the Weatherhead School of Management at Case. Presently he is a tenured Professor and Director of the Integrated Microbiome Core and Center for Medical Mycology, Case Western Reserve University and University Hospitals Cleveland Medical Center (UH) where he established a multidisciplinary Center of Excellence that combines basic and translational research investigating medically important fungi from the test tube to the bedside. More recently he pioneered the studies on the fungal communities residing in our body and coined the term ‘Mycobiome”.

He is also a fellow of the Infectious Disease Society of America and past President of the Medical Mycological Society of the Americas (MMSA). In 2016, Dr Ghannoum received the Rohda Benham Award presented for his continuous outstanding and meritorious contributions to medical mycology from the Medical Mycological Society of the Americas and he also received the Freedom to Discover Award from Bristol-Myers Squibb for his work on microbial biofilms. In 2017, he was inducted as a fellow of the American Academy of Microbiology. Beside his academic career Dr. Ghannoum is an entrepreneur-scientist who launched a number of companies focusing on the treatment of biofilm infections as well as microbial dysbiosis as it relates to gut health.

Pamela Silver, Ph.D.

Elliot T. and Onie H. Adams Professor of Biochemistry and Systems Biology
Harvard Medical School

Pamela Silver received her BS in Chemistry and PhD in Biochemistry from the University of California where she was an NIH Pre-doctoral Fellow. She was a Postdoctoral Fellow at Harvard University in the Dept of Biochemistry and Molecular Biology where she was a Fellow of the American Cancer Society and The Medical Foundation. Subsequently, Pam was an Assistant Professor in the Dept of Molecular Biology at Princeton University and then moved to the Dana Farber Cancer Institute where she was a Professor in the Dept of Biological Chemistry and Molecular Pharmacology at Harvard Medical School. Pam became one of the founding members of the Department of Systems Biology at Harvard Medical School and the first Director of the Harvard University PhD Program in Systems Biology and one of the first members of the Harvard University Wyss Institute for Biologically Inspired Engineering. Her work has been recognized by an Established Investigator of the American Heart Association, a Research Scholar of the March of Dimes, an NSF Presidential Young Investigator Award, Claudia Adams Barr Investigator, an NIH MERIT award, the Philosophical Society Lecture, a Fellow of the Radcliffe Institute, and election to the American Academy of Arts and Sciences. She is among the top global influencers in Synthetic Biology and her work was named one of the top 10 breakthroughs by the World Economic Forum. She serves on numerous public and private advisory boards including the board of the Internationally Genetics Engineering Machines (iGEM) Competition, and she is the co-founder of several biotech companies.