2022 Conference Agenda

Thursday, April 14, 2022

7:30 AM
Registration/Continental Breakfast
8:25 AM
Chairperson's Opening Remarks
Mollie Roth, JD, Chairperson, The Annual Translational Microbiome Conference
8:30 AM

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

9:00 AM

The Vaginal Microbiome DTC Women's Health
The vaginal microbiome is a critical component of female health. More than 30% of people with vaginas suffer from imbalances in the microbiome (e.g. bacterial vaginosis, yeast infections, and recurrent UTIs) that drastically affect our quality of life. Additionally, research has uncovered groundbreaking links between the vaginal microbiome and infertility, HIV risk, preterm birth, gynecologic cancers, and more. Evvy’s longitudinal, metagenomic testing is unlocking personalized definitions of health and disease in the vagina — and providing women with education and insights about their vaginal health along the way. This talk will highlight opportunities to leverage the vaginal microbiome to positively impact women’s health outcomes across the board.
Priyanka Jain, Co-Founder & CEO, Evvy

9:30 AM

Metatranscriptomics: Challenges and Advances Toward Achieving Mechanism-Driven Insights
Metatranscriptomic profiling captures snapshots of a microbial community's entire RNA profile. Characterizing gene expression profiles at the community- and individual-microbe levels allows us to understand microbial-community function and gain new mechanism-driven insights. Advances in ribosomal depletion technologies, sequencing platforms, informatics algorithms, and the expansion of reference databases have set the stage for the scaling of metatranscriptomic sequencing. For the last two years, Diversigen’s team of scientists has worked diligently to address these challenges, developing and implementing a validated metatranscriptomic profiling pipeline to deliver accurate insights into the activities of microbial communities. This presentation will address the challenges, advances, and opportunities of this re-emerging space.
Emily Hollister, Ph.D., Director, R&D, Computational Biology, Diversigen

10:00 AM
Refreshment Break
10:30 AM

Innovative Microbiome and Multi-Omics Analysis Techniques and Case Studies
Microbiome research has advanced rapidly over the past decade and continues to do so as the cost of metagenomics methods drops. Concurrently, integration of multiple ‘omics data types into metagenomics studies is increasingly being recognized as important in elucidating the role of the microbiota but doing so can be challenging. In this presentation we show the methods used by CosmosID to address these challenges and produce customized analyses addressing specific research questions.
Manoj Dadlani, Ph.D., Chief Executive Officer, Cosmos ID

11:00 AM

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., Principal Scientist - Microbiome, Boston Analytical

11:30 PM

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, Dr. Oza 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 & Formulation & Application Services - North America, Evonik

12:00 PM

Luncheon

1:15 PM

Characterization and Data Sharing of a True Diversity Microbiome Reference
The gut microbiome plays a critical role in human health. Because of this, thousands of fecal samples are processed and sequenced every month by academic and industry labs across the globe. Along with these studies comes vast amounts of NGS data and associated metadata required to better understand complex microbial communities and their interplay with human health and disease. The ability to reliably compare these data is of utmost importance as it helps researchers to confirm accuracy and identify differences between workflows, which improves inter-lab and inter-study comparisons. By having all sequencing data integrated with associated metadata, the sharing and reuse of data will be far more practical and the ability of researchers to draw meaningful comparisons across disparate datasets will be sincerely increased. There is, therefore, a need for publicly available databases, such as the ZymoBIOMICS™ Fecal Reference Database, which has been created as a repository for sequencing data and metadata of the fecal reference material. Publicly sharing sequencing data will promote transparency in scientific research and encourages the replication and confirmation of results. The importance of meaningful research comes from its dissemination and availability.
Raul J. Cano, Ph.D., Chief Scientific Officer, The BioCollective

1:45 PM

Standards for Microbiome Measurements to Support Innovation in Microbiome-Targeted Therapeutics and Diagnostics
Appreciation for the role of microbes in our lives has been growing rapidly, but the measurement science needed to understand and fully exploit microbial systems has developed at a much slower pace than the industries dependent on them demands. NIST is developing standards for microbiome measurements that will enable federal, academic, and industry labs to reliably reproduce and advance each other's results. Microbiome standards will support research investigations and commercial translation of microbiome science by providing measurement assurance tools: standardized protocols, reference materials, validated measurements and critically evaluated reference data.
Scott Jackson, Ph.D., Leader, Complex Microbial Systems Group, NIST (National Institute of Standards & Technology)

2:15 PM
Panel Session: A New FDA Classification for Microbiome Sample Collection Devices: a Big Leap in Standardization (Sponsored by DNAGenotek)
In 2021, the FDA authorized its first sample collection device for use in microbiome-based analyses - DNA Genotek’s OMNIgene.GUT Dx collection device. This has led to the creation of a new product classification for microbiome collection methods allowing them to be recognized as regulated devices to preserve and stabilize relative abundances of microbiome nucleic acids in clinical samples. This is a significant step towards the robust standardization of methods that has been sought-after by the microbiome community since its inception. This panel will discuss:
  • How do technology developers, regulatory bodies and standards organizations collaborate to achieve these scientific milestones?
  • How does a new regulatory framework help support ongoing research and development and accelerate discovery in the microbiome space?
  • Sample collection is only the first step. How will other technologies within the microbiome workflow follow suit?
  • What does this mean for the potential introduction of diagnostic testing and the use of microbiome data in clinical trials?
Moderator: Rafal Iwasiow, Ph.D., Vice President, Innovation & Technology, OraSure Technologies - Molecular Solutions
Panelists:
Scott Jackson, Ph.D., Leader, Complex Microbial Systems Group, NIST (National Institute of Standards & Technology)
Areta Kupchyk, Partner, Co-Chair, Administrative Law Department and FDA Practice, Foley Hoag LLP
Lisa Cunden, Ph.D., Senior Scientist, Metagenomics, Invitae
Rajita Menon, Ph.D., Associate Director, Modeling & Statistics, Vedanta Biosciences
3:00 PM

End of Conference

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