Washington, DC 

April 13-14, 2022 

2022 Conference Agenda

The full agenda for this event has not yet been announced. Please join our mailing list or re-visit this page in the coming days for updates to the agenda.

WORKSHOP: Biomarker Discovery for Microbiome-related Diseases using Precision Taxonomy
Emerging associations of the microbiome across a wide spectrum of health and diseases (350+) and tremendous success of fecal microbiota transplantation (FMT) in alleviating recurrent Clostridium difficile infection led the microbiome as a potentially modifiable factor amenable to targeting by therapeutics. Therefore, a deeper understanding of the microbiome’s association with underlying molecular causes becomes crucial for the discovery and development of novel preventive and therapeutic strategies. However, as the microbiome is a vast and complex ecosystem, new technologies and platforms are needed to effectively map the microbiome at the molecular level, and enable effective biomarker discovery. The workshop will focus on microbiota-based biomarker discovery through data- and database-driven taxonomy, the new bacterial species concept and standard, and the use of expert validated reference databases with 3000+ new species. The workshop will also uncover some effective strategies to improve results for R&D, pre-clinical, and validation studies as well as increase the likelihood of desired outcomes with more rigor and reliability.
Workshop Take Aways:
♦ Hands-on experiences with discovery of therapeutics and companion diagnostics using EzBiome’s Precision Taxonomy Discovery Platform
♦ Understand precision taxonomy and how to effectively leverage it to uncover biomarkers unseen by traditional approaches
♦ Learn strategies to improve the likelihood of the desired outcome in microbiome studies with more rigor and reliability
Special Note: No bioinformatics or scripting knowledge is needed, just bring your laptop, please.
Nur A. Hasan, Ph.D., MBA, Chief Executive Officer, EZBiome Inc.

The Role of Our Gut Microbiota in Neurological Health and Disease
With an ever-increasing ageing population, neurodegenerative diseases are on the rise and this trend is projected to continue. In all the research carried out, one fundamental question lingers: What causes neurodegeneration? Delving deeper into understanding the environmental factor component of these complex neurological diseases is therefore pertinent. The microbiome – an ecosystem of bacteria living on and inside us— is no longer seen as a predominantly opportunistic collection of microbes that had simply found a convenient environmental niche in which to live. An increasing body of evidence points to the importance of the gut-microbiota-brain axis in certain neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS). In this talk, Dr. Blacher will describe his research into the dynamic connection between our gut and out brain, providing ample evidence that this is an important and burgeoning field of study. 
Eran Blacher, Ph.D., Postdoctoral Fellow, Department of Neurology & Neurological Sciences, Stanford School of Medicine

Revolutionary Options for Oral Colonic Targeting for Sensitive Drug Products and Other Microbiome Therapeutics
Oral delivery targeting release in the distal areas of the gastro-intestinal tract (GIT) have presented challenges in the developing microbiome therapeutic space for some time. To date, this issue has primarily been addressed by utilization of advanced complex formulation techniques that involve release using pH dependent, pH dependent accelerated and/or microbial dependent options. However, these modalities fall short because the unit processes in manufacturing such as granulation and coating expose the microbiome to heat and moisture to which they are sensitive and would degrade or have a lower shelf life. Improved techniques that allow for delivery of acid / moisture / temperature labile molecules, such as nucleotides, peptides and live biotherapeutics, would be an improvement over current techniques and address these hurdles by a simple manufacturing technique without exposure to heat or moisture and avoid degradation in the stomach acidic environment. During this presentation, we will review one such improvement utilizing vegetarian “functional” hard capsules and review data demonstrating this modality which provides improved specific release profiles, and reduces the complexity in manufacturing time and risk, for effective targeting of sites including the mid-to-upper small intestine and colon. 
Kamlesh Oza, Ph.D., Head, Technical Sales and Formulation and Application Services, North America Evonik

Empowering Translational Research Outcomes with Precision Microbiome Analysis & AI
The microbiome has a critical role in human health, with systemic links throughout the entire body, making it a rich source of opportunities to improve the diagnosis, management, and treatment of disease. Through an optimized platform for end-to-end microbiome analysis, Microba Life Sciences is discovering novel signals and using advanced data science and AI to identify species and functional features associated with health or disease. By precisely and comprehensively measuring the microbiome, including previously unseen species, Microba’s analysis platform is empowering translational researchers to harness the microbiome for innovative products, therapies, and diagnostic opportunities. Using data from Microba’s internal research and development programs, this presentation will demonstrate the impact of this approach for biomarker and therapeutic discovery based on a deeper understanding of the gut microbiome and how these organisms are driving human health. 
Lutz Krause, Ph.D., Associate Professor/Chief Scientific Officer, Queensland University/Microba Life Sciencese

The Oral Microbiome as a Platform for Personalized Oral Health Care and Therapeutics Discovery
Decades of research have identified dysbiosis of the oral microbiome as a key driver of oral disease, and recent research suggests oral pathogens may also play a role in chronic systemic conditions. This presentation will explore oral microbiome testing as a novel diagnostic for predicting patients’ risk of oral disease and a platform for therapeutics discovery. 
David Lin, Ph.D., Co-Founder & Chief Scientific Officer, Bristle

Type 1 Diabetes, Obesity and the Gut Microbiome
This talk will provide an overview of the effect of obesity on type 1 diabetes and its management followed by the interaction between the gut microbiome and type 1 diabetes. We will then show some preliminary data and discuss potential options for intervention.  
Heba Ismail, Ph.D., Assistant Professor of Pediatrics, Indiana University School of Medicine

Intersystems Biology: the Next Frontier of Novel Medicines
We are a system of systems, human and non-human. By unlocking the next frontier of Intersystems Biology, we can harness the power of these constant interspecies molecular exchanges to promote and sustain life. This talk will explore how Senda Biosciences, Inc. is mining millennia of co-evolution for the development of new therapies.  
Mark Umbarger, Ph.D., VP Head of Discovery, Senda Biosciences

Positioning Women’s Health Center Stage in Microbiota-based Drug Development
Women’s health continues to be under-represented when compared to other basic science and clinical areas of research. At Ferring, we are passionate about reproductive medicine, maternal and women’s health, and over one third of our research and development investment goes toward finding innovative treatments. The vaginal microbiome is central to women’s health and wellness, and our next-generation drug development pipeline includes microbiota-based therapeutics targeting common conditions in women. Here we provide an overview of our program to develop live biotherapeutics (LBP) and highlight some of the challenges that accompany LBP drug development. Furthermore, due to gender-related differences some indications disproportionately affect women. We summarize the impact of microbiota restoring therapies on incidence of recurrent urinary tract infections and the potential of microbiota-based solutions to address this condition that afflicts women of all ages.  
Heidi Hau, Ph.D., Director Translational Biology, Rebiotix Inc., A Ferring Company

Cancer and Microbiome: A New Era for Precision Oncology
Recently tissue and circulating microbiomes have been identified as key players in oncology. They can be used as a new avenue for drug discovery and/or therapy modulation. Micronoma's team has established the potential value of circulating microbiome as an early-stage cancer diagnostic tool. Applying the lessons learned from genomics to metagenomics will be key to ensuring a prompt adoption of these new methods for precision medicine.  
Sandrine Miller-Montgomery, Ph.D., President & CEO, Micronoma

Microbiome Based Therapies for Lung Diseases: Opportunities and Challenges
Much science in respiratory medicine now points towards the significant role of microbial dysbiosis in the pathophysiology of lung diseases. From the perspective of a physician scientist and microbiome entrepreneur, this talk will focus on emerging translational and basic science research which demonstrates how changes in the microbiome, may affect pulmonary disease conditions. In addition, this talk will address development of novel pulmonary focussed microbiome-based therapeutics, and the opportunities and challenges that surround the field.  
Vivek Lal, MD, FAAP, Founder, President and CEO/Director, Pulmonary Microbiome Lab, Resbiotic/University of Alabama Birmingham

Empowering Discovery of Exciting New Biology and Transformative Therapeutics Using Precision Taxonomy
As the microbiome is a vast and complex ecosystem, new technologies and platforms are needed to effectively map the microbiome to understand its structure and function to enable effective biomarker discovery. Precision taxonomy offers a new frontier in microbiome research while defining diseases by their underlying molecular causes. The presentation will discuss the role of precision taxonomy in uncovering the data unseen by traditional microbiome analysis and demonstrates effective approaches to utilize Precision Taxonomy Discovery Platform to obtain highly confident and actionable results in microbiome analysis, which will eventually help shorten the time for discovery and development of microbiota-based therapeutics and companion diagnostics for microbiome-related diseases.
Nur A. Hasan, Ph.D., MBA, Chief Executive Officer, EZBiome Inc.

Developing Phase-appropriate Regulatory Testing Plans for Microbiome-based Therapeutics
Research and interest in the human microbiome and its therapeutic potential has led to increased growth in the number of microbiome based products under development. These therapeutics vary in origin and type, and also in disease indication. Due to the novel nature of most microbiome based therapeutics, characterization of microbiome based products for regulatory purposes relies on both regulatory guidance and industry expertise. This presentation will delve into some of the current regulatory testing for microbiome based therapeutics at different phases of development, what purpose these tests serve, and briefly discuss what considerations might be included in developing a testing and characterization plan. At the end of this presentation, attendees can expect to have a broad overview of the regulatory testing conducted on microbiome based therapeutics and how to best position their products in the regulatory testing framework.
Yvonne Nyavor, Ph.D., MBA, Principal Scientist - Microbiome, Boston Analytical

A New Patented Method for Obtaining Unique Inner-colonic Microbiome
Hygieacare® Inc. is a biomedical company that partners with gastroenterologists to provide solutions for improved GI care. The company utilizes the FDA-cleared Hygieacare system to offer two primary prescription-based services: HygiPrep® and HygiRelief®. In both services, the patients’ colon is washed by gravity-fed double filtered water that induces defecation, resulting in patients excreting their colon effluent. The microbiome of the collected effluent, HygiSample™, had been hypothesized to represent the inner-colonic microbiome and be significantly different from home-collected stool samples. In a proof-of-concept clinical trial, we collected stool and three HygiSample from up to 20 healthy patients and studied their microbiome community, including taxonomy, phylogeny, and biological gene clusters (BGCs). Briefly, of all bacterial strains detected in our study, a third were unique to the HygiSample, with a notable contribution from the different biogeographic locations. There was a clear gradient of bacterial communities along the colon, and the results were consistent between sequencing and analysis methods. In this talk, Dr. Levitan will present HygiBiome®, the research arm of Hygieacare Inc., and their business model and interests. Dr. Levitan will also present selected results from our microbiome studies showing that our patented HygiSample is currently the only way of obtaining microbiome information from within the colon, non-invasively, and without the ill effects of oral prep purgatives.
Orly Levitan, Ph.D., Chief Medical Officer, Hygieacare

Bench to Bedside: Comprehensive Microbiome Findings for Development of Precision Infectious Disease Diagnostics
In this presentation, Dr. Nagy-Szagal will discuss:
♦ Recent advances in clinical metagenomics for precision infectious disease diagnostics and surveillance
♦ Understanding the role of strain-typing and antimicrobial resistance profiling employing next-generation sequencing (NGS) to guide precision therapeutics in urinary tract infection
♦ Exploring bioinformatic tools and AI to support the use of microbial genomic data
♦ Challenges of applying cutting edge research and tools for development of a diagnostic product, standardization and compliance with regulatory requirements
Dorottya Nagy-Szakal, MD, Ph.D., Chief Medical Officer, Biotia, Research Assistant Professor, SUNY Downstate Health Sciences University

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