Session Abstract – PMWC 2020 Silicon Valley


Understanding mechanism of action and translating microbiome science into commercially viable therapeutics remains the biggest challenge in this emerging field. With that said, pharma and biotech across many different therapeutic indications and modalities are united in this global effort to bring novel microbiome-based therapies and diagnostics into the clinical domain. This session will include some of the most impactful and promising areas of the microbiome field:

  • Fecal Microbiota Transplantation (FMT)
    To date, FMT, or the transfer of donor feces containing gut microbiota from a healthy individual to restore microbial diversity in patients, has been used for the treatment of patients with chronic gastrointestinal infections and inflammatory bowel diseases. Now there is great interest in its therapeutic potential for other applications. This session will explore the use of FMT for IBD, IBS, metabolic syndrome, neurodevelopmental disorders, and autoimmune diseases, among others.
    - Tor Savidge, Baylor College of Medicine
  • Microbiome Profiling through “Omics” Methods
    Advances in sequencing and analysis tools have provided unprecedented insight and resolution into the microbiome and is enabling researchers and clinicians to monitor shifts in the microbiome-- from taxonomic profiling to metabolomics and proteomics. This session will uncover some of the latest and most advanced tools for microbiome analysis and where the current trends are taking the industry next.
    - Sandrine M. Miller-Montgomery, UCSD
    - Manoj Dadlani, COSMOSID
    - Martha Carlin, The BioCollective
    - Lihi Segal, DayTwo
    - Gregory Michelotti, Metabolon
    - Sanjay Joshi, Dell EMC
    - Morten Isaksen, Bio-Me AS
  • The Skin Microbiome
    Human skin is populated by diverse bacteria and there is increasing evidence that resident bacteria play a key role initiating immune responses in numerous diseases. This session will look at techniques to modulate the skin microbiome composition as a therapeutic option in diseases affecting the skin such as psoriasis and acne vulgaris.
    - Mark S. Wilson, MatriSys Bioscience
    - Larry Weiss, Persona Biome, Inc.
  • Microbiome Modulation by Diet
    Advances in microbiome research are spurring the development of new therapeutics for a variety of diseases. This session will explore recent discoveries in gut microbiome interventions for promoting human health and combating disease. These approaches include microbiome modulation or direct impact on the host through nutritional intervention, either by prebiotics or by individualized diets.
    - Colleen Cutcliffe, Pendulum Therapeutics
  • Gastroenterology & the Microbiome
    This session will take the perspective of the clinician, as the microbiome approaches the clinic and will focus on how novel microbiome science can be communicated to classically trained gastroenterologists and other clinicians, in order to prepare them to bring these practices to patients.
    - Haroldo Magarinos, BioVital Health
  • Regulatory Affairs & Standardization
    Uniform, rigorous, and unbiased experimental and regulatory approaches, similar to the careful and stringent testing and approval processes practiced in other human interventions, will allow the safe and efficacious long-term integration of microbiome-based therapies into the treatment of a variety of different diseases. This session will address the standardization work done to date and what the next big challenges are to be addressed.
    - Scott A. Jackson, NIST
  • Pre-Clinical & Clinical Development
    A new and exciting aspect of mirobiome research focuses on personalization of interventions, as well as harnessing the inherent individualized variability in microbiomes and other physiological features. This session will aim to provide insight into best practices and the pitfalls to avoid.
    - Nikole Kimes, Siolta Therapeutics
    - Mary Conrad, Axial Therapeutics
    - Jackie Papkoff, Assembly Biosciences

 Session Chair Profile

CEO, CosmosID

Biography
Prior to CosmosID, Mr. Dadlani served as a partner at Applied Value Group, a management consulting and investment firm, and was co-founder and CEO at Rasa Industries, Ltd., a leading beverage manufacturing company. Mr. Dadlani has substantial experience in strategy, M&A, supply chain management, product development, marketing and business development. Mr. Dadlani received his Bachelor’s and Master’s degrees in Biological Engineering from Cornell University. Services offered by CosmosID’s CLIA and GLP certified laboratory cover the entire workflow from study design to sample collection, extraction, library preparation, sequencing, data analysis and publication support. CosmosID’s cloud-based metagenomics application offers user-friendly access to the largest curated databases for microbial genomics, antimicrobial resistance and virulence data and has been independently validated to return metagenomic analyses at strain level resolution with industry-leading sensitivity and precision.


 Speaker Profile

Ph.D., Executive Director, Center for Microbiome Innovation, Professor of Practice, Bioengineering, UCSD

Biography
Dr. Sandrine Miller-Montgomery’s team is focused on expanding industry and academic collaborations of microbiome research in the consumer world as well as enabling major clinical breakthroughs. Previously, she led MO BIO Laboratories, now a QIAGEN Company, having started as their director of sales and marketing where her team contributed to the consistent business growth resulting in its acquisition by QIAGEN. She has held global marketing management positions at large companies such as Abbott Laboratories, Illumina, and Invitrogen (now part of Thermo Fisher), and originally came from France in 2000 to join Genset in their R&D department. Sandrine received both her PharmD and her PhD in Life Science from the University of Bordeaux (France), with an emphasis in molecular biology, biology of aging, and thrombosis and hemostasis.

Talk
Personalization Of Microbiome Analysis: Why A Longitudinal Multi-Omics And Flobal Approach Is A Must?
Unlike genome, microbiome is highly affected by many parameters such as environment, or diet. We have to study personalized microbiome within a comparable population database to gather proper insights. We will present multi-omics data (including human and food microbiome) that highlight this complex but necessary to address challenge.


 Speaker Profile

Ph.D., Associate Professor, Department of Pathology & Immunology, Baylor College of Medicine

Biography
Dr. Savidge's research interests include studying microbial-neuroimmune interactions in the gastrointestinal tract and nervous systems. This work has established new disease susceptibility biomarkers to Clostridium difficile infection and Fecal Microbiota Transplantation failure, as well as identifying new precision-based microbial therapy for recurrent C. difficile infection based on population-scale metagenomics and functional microbiome analysis.

Talk
Recurrent C. Difficile Infection In Adults And Children: Precision-Based Diagnosis And Aicrobiota Therapy
This talk will cover Dr. Savidge's research on predicting patient susceptibility to C. difficile infection and clinical fecal microbiota treatment failures. His lab is also utilizing population-scale omics data to rationally design new microbial therapy for recurrent C. difficile infection.


 Speaker Profile

CEO & Founder, The BioCollective

Biography
Martha began her career with Arthur Andersen after graduating with honors from the University of Kentucky with a BS in accounting. Early training at Andersen included a process called “transaction flow review” an approach to complex systems thinking. This process maps the flow of transactions in a business to identify weak points and systemic risks. Martha has applied this systems-based thinking throughout her career solving complex problems. In 2002, her husband was diagnosed with PD and she applied her systems expertise to understanding this complex disease. Martha is a self-taught scientist who studied across many fields from plant and soils biology, nutrition, chemistry, molecular biology, infectious disease, genetics, epigenetics, proteins, to neuroscience in search of connections. TBC has built an innovation engine for the microbome. They have a sample base of subjects age 1 to 102, fostered collaboration in PD microbiome research, and developed a strain bank of 2,000+ species of bacteria.

Talk
Uses And Challenges Of Microbiome Data In Personalized And Population Medicine
This session will discuss the potential of metagenomic microbiome data in personalized medicine, including in the potential identification of emerging population infection disease. We will cover the basics of metagenomic data - bacteria, fungi, viruses, and protists as well as antibiotic resistance and virulence genes and their implications in treatment and pathogenicity. Additionally, we will discuss gaps in physician training, changing perspectives needed in infectious disease and the difficulty in translating single rather than time series samples for effective diagnostics.


 Speaker Profile

LL.B, MBA, CEO, Co-Founder, DayTwo

Biography
Lihi co-founded DayTwo in 2015 to bring personalized blood sugar control into the consumer mainstream. She is experienced in the analytical techniques needed to turn this scientific discovery into workable solutions for individuals, having been COO and CFO of Sisense, a provider of business intelligence and analytics software, before starting DayTwo. For more than ten years prior to that she has held senior roles in a number of IT led businesses, from startups to large public enterprises. She is a certified Lawyer, has an LLB from the Tel-Aviv University and an MBA from Northwestern University, USA.

Talk
Glycemic Control & Diabetes Remission: Enabled Via Gut Microbiome Profiling
By better understanding patients, we can provide more personalized care. DayTwo is now profiling 50 clinical measures of patients, including gut-microbiome to help enable people with Type II diabetes attain glycemic control. Using Food-As-Medicine, we can now match nutrition and diet to an individuals gut-profile to help them balance blood sugar, and maintain a carb-friendly lifestyle.


 Speaker Profile

Ph.D., CEO, Pendulum Therapeutics

Biography
Colleen has over 20 years of experience managing and leading teams in biotech, pharma and academia. Pendulum is a startup company based in San Francisco that uses biological and computational insights into the microbiome to develop interventions for a variety of health and disease conditions. Before starting Pendulum, Colleen served as the Senior Manager of Biology at Pacific Biosciences, which is where she met her two co-founders. Prior to that, Colleen was a Scientist at Elan Pharmaceuticals. Colleen completed her postdoctoral research at Northwestern’s Children’s Memorial Hospital, received her Ph.D. in Biochemistry and Molecular Biology from Johns Hopkins University and received her B.A. in Biochemistry from Wellesley College. Colleen currently resides in Menlo Park, CA with her husband, 2 daughters, 2 dogs, and 2 birds…all contributing to a diverse microbiome!

Talk
Clinical Evidence: Medical Probiotic Targeting Type 2 Diabetes
Pendulum Therapeutics (previously Whole Biome) will share the discovery, characterization, and clinical trial results for their flagship T2D product. This is the first medical probiotic specifically designed for patients with diabetes that is clinically proven to reduce A1C and postprandial glucose spikes.


 Speaker Profile

N.D., Naturopathic Physician, Human Universal Health Institute, BioVital Health

Biography
Dr. Haroldo Magarinos is a Chilean dentist with specializations in periodontics, oral medicine and implantology. After over a decade of conventional practice, Dr. Magarinos decided to pursue his passion and become a naturopathic doctor, graduating in 2018 from the Naturopathic Doctor program at the American College of Integrative Medicine. He is certified by the American Naturopathic Certification Commission and received an additional specialization in Integrative Biological Dental Medicine certified by the American Commission of Medicine and Integrative Dentistry. Dr. Magarinos has long been a strong advocate for the study of the human microbiome, with a firm belief that treating patients with dysbiosis has the power to prevent and even reverse many prevalent forms of chronic disease. His interest in this integrative field started with his own personal explorations in optimizing vitality for himself and his friends and family, which has now grown to be a professional passion.

Talk
Integrative Approach To The Human Microbiome Regulation
Considering the increased amount of evidence available regarding the huge role the microbiome plays in human health, it’s imperative to consider new and better strategies to rebalance and protect this complex and diverse ecosystem. Using nature and technology in an integrative approach, we have developed protocols that can analyze and regulate this in a comprehensive way improving multiple health conditions related to this important area of medicine.


 Speaker Profile

Ph.D., Founder & CSO, Siolta Therapeutics

Biography
Dr. Nikole Kimes is Founder and Chief Scientific Officer of Siolta Therapeutics, a San Francisco-based biotech company developing novel microbiome-focused precision strategies for the prevention and treatment of inflammatory diseases. As the lead executive driving Siolta’s early-stage development, Dr. Kimes heads a talented team of scientists, blending microbiology, immunology, and bioinformatics expertise to leverage microbiome data for the improvement of patient stratification and development of precision microbial therapeutics. An inventor of Siolta’s technology, her research in Dr. Susan Lynch’s lab at the University of California San Francisco, provided the foundation from which the translational research program at Siolta Therapeutics has developed.

Talk
Microbiome Therapeutics: Moving Beyond the Hype
Siolta Therapeutics is a clinical-stage biotech company developing live biotherapeutic products (LBPs) for the prevention and treatment of inflammatory diseases, starting with allergic diseases such as asthma. We leverage our knowledge of the developing gut microbiome and its role in immune regulation to develop microbiome-based therapeutics and diagnostics.


 Speaker Profile

Associate Director, Microbiology, Axial Biotherapeutics

Biography
Mary Conrad leads Microbiology and in vitro biology efforts at Axial Biotherapeutics, a clinical stage biopharmaceutical company harnessing the gut-brain axis to develop novel therapeutics to improve the quality of life for people with Central Nervous System diseases and disorders, including Parkinson’s Disease and Autism Spectrum Disorders. Axial utilizes a mechanism-based approach to discover CNS therapies inspired by the microbiome. Mary’s experience includes leading cross-functional teams in projects from exploratory through candidate selection stages to discover antibiotics and microbiome-targeted therapeutics, as well as building teams and drug discovery capabilities in microbiology, molecular biology, biochemistry, cell biology and the microbiome. Mary studied at Princeton University and in the department of bacteriology at the University of Wisconsin-Madison.

Talk
Mechanism-Based Microbiome-Inspired Drug Discovery
This talk will discuss moving beyond identifying associations between the microbiome and disease status to generating and testing hypotheses and driving mechanism-based drug discovery for microbiome-inspired targets. An example targeting GI dysfunction and associated symptoms of Autism Spectrum Disorder will be provided to illustrate potential approaches.


 Speaker Profile

Ph.D., Chief Scientific Officer, Microbiome, Assembly Biosciences, Inc.

Biography
Dr. Papkoff has worked in both pharma & biotech for over 25 years and has broad scientific strategy, executive leadership and business experience. She has deep expertise in cell biology and molecular mechanisms of disease which she has applied to therapeutic and biomarker preclinical discovery & development in oncology, inflammation and autoimmunity. Prior to joining Assembly Biosciences, Dr. Papkoff was Senior Vice President Research at Evelo Biosciences where she led the preclinical scientific team to discover, validate and nominate microbial therapeutics for clinical development in oncology indications. Prior to Evelo Dr. Papkoff was a founding member of the J&J California Innovation Center where she served as Vice President of Immunology Scientific Innovation for the Janssen Immunology Therapeutic Area focused on inflammatory and autoimmune diseases. Previously, she was CSO of CFD Therapeutics, a cancer-immunology focused antibody therapeutics company she co-founded, and held R&D leadership positions at diaDexus, Inc. and Aventis pharma.

Talk
Discovery & Development Live Microbial Therapeutic Consortia
Assembly Biosciences is engaged in discovery and development of oral live microbial biotherapeutic products that harness naturally evolved functions of gut commensal bacteria to deliver clinical benefit in a wide variety of therapeutic areas. Our rationally-selected microbial consortia target diseases modulated by gut microbe-mediated pharmacological and biological mechanisms with systemic effects.


 Speaker Profile

Ph.D., Leader, Complex Microbial Systems Group, National Institute of Standards and Technology

Biography
Scott Jackson joined NIST in May of 2014 after 11 years as a principal investigator with the FDA. At FDA, his research focused on characterizing the global genomic diversity of enteric pathogens, with applications for food safety, bioforensics and public health. At NIST, Scott is currently the leader of the Complex Microbial Systems Group in the Biosystems and Biomaterials Division. In this current role, Scott is leading 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. Scott completed his PhD research in the biochemistry and biophysics departments at The University of Maryland and Johns Hopkins University, respectfully, where he focused on the evolution of mobile genetic elements using yeast as a model genetic organism. Scott performed his undergraduate studies in Chemistry and Geology at the University of South Carolina.


 Speaker Profile

Co-founder and CEO, MatriSys Bioscience

Biography
Mr. Mark S. Wilson is the co-founder and CEO of MatriSys Bioscience. He is a broadly skilled bioentrepreneur with 30 years of experience in biopharmaceutical and diagnostics development with extensive accomplishments in pharmaceutical licensing and business development, new organization startup, strategic alliance formation with Big Pharma and Big Biotech firms, and developmental sourcing in a virtual company environment.

Talk
Therapeutics at the interface of the innate immune system and the skin microbiome
MatriSys Bioscience is commercializing skin microbiome therapeutics. We will describe the science behind the products, our product portfolio, and provide an update on our clinical developments.


 Speaker Profile

Ph.D., Professor, Department of Biology, University of Massachusetts Amherst

Biography
Margaret (Peg) Riley has championed an alternative to the current paradigm in antibiotic discovery, one that recognizes the power of targeted therapeutic interventions, resulting in lower levels of antibiotic resistance and reduced collateral damage to the microbiome. She provides “proof of principle” for this approach utilizing the diverse family of bacteriocins. These efforts have identified candidates for use in treating TB and UTI’s. Dr. Rliey and her students created a new venture, Organicin Scientific, whose mission is to develop bacteriocin-based biopesticides for use in treating bacterial disease in plants, such as citrus greening and Fire blight. She is committed to engaging the public in science and has appeared with Bill Nye in his TV shows and podcasts and created the Massachusetts Academy of Sciences in 2007. In 1991 she joined the faculty at Yale, where she was honored with the NSF Presidential Young Investigator Award and an NIH FIRST Award. In 2004 she accepted a faculty position at University of Massachusetts Amherst. Peg Riley earned her Bachelor of Arts degree in Biology from University of Massachusetts in 1981, her Ph.D. in population genetics from Harvard University, and she conducted her postdoctoral work at the University of Massachusetts.

Talk
Rethinking The Composition Of A Rational Antibiotic Arsenal In The Age Of The Microbiome
This talk will cover Dr. Riley's research on the development of targeted bacteriocin-based antimicrobials, whose use results in lower levels of antibiotic resistance and limits collateral damage to the microbiome. Her lab is applying these same approaches to develop bacteriocin-based biopesticides, to limit the need for anti-biotic use in food production and thus reduce the exposure of our microbiomes to food-based antibiotics.


 Speaker Profile

M.D., CEO and Founder, Persona Biome, Inc.

Biography
Prior to Persona Biome, Dr. Weiss was founding Chief Medical Officer at AOBiome where he formulated AOB-101, the first live topical biotherapeutic and ran the first successful virtual Phase IIb clinical trial. He also developed the Mother Dirt cosmetic line, including AO Mist, the first live skin probiotic. He has an extensive background in natural products chemistry, microbiology, clinical medicine, dermatology, anesthesiology, biophysics, and pharmaceutical and cosmetic product development. Dr. Weiss is board certified in Anesthesiology, has an MD from Stanford University, and a BS in Biochemistry from Cornell University. He has 14 patents and is published in the areas of chemistry, electrophysiology, clinical pharmacology, and the microbiome. Dr. Weiss is a Co-Founder of CleanWell Company.


 Speaker Profile

Industry CTO Healthcare, Dell EMC

Biography
Based in Seattle, Sanjay’s 25+ year career has spanned the entire gamut of life-sciences and healthcare from clinical and biotechnology research to healthcare informatics to medical devices to informatics. He defines himself as a “non-reductionist” with a “systems view of the world.” His current focus is a systems view of genomics, proteomics and healthcare for infrastructures and informatics. Recent experience has included data management and instruments for Electronic Medical Records; Proteomics and Flow Cytometry; FDA and HIPAA validations; Lab Information Management Systems (LIMS); Translational Genomics and Imaging. He began his career developing and building X-Ray machines. Sanjay was the recipient of a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant and consultant or co-Principal-Investigator on several NIH grants. He is actively involved in non-profit networking and educational organizations worldwide.

Talk
Time-Series Approaches To Microbiome Clinical Studies: A Machine Learning Review


 Speaker Profile

Ph.D., Associate Director, Discovery & Translational Sciences, Metabolon, Inc.

Biography
Dr. Michelotti is a biochemist with special expertise in the analysis of large metabolomics and gene expression datasets. As principle investigator of a translational research laboratory at Duke University for 15 years, Dr. Michelotti successfully attracted both federal and pharmaceutical grants. His laboratory contributed to the identification of novel G protein coupled receptor-mediated stress-response cascades that contribute to de-regulated epithelial growth responses. Collectively, this work resulted in the publication of over 70 peer reviewed publications, resulting in an h-index of 31. Dr. Michelotti joined Metabolon in 2015 to apply his expertise in signal transduction, cancer biology, and metabolism to assist investigators in the successful design and execution, and analysis of large metabolomic data sets to provide biological insight into complex human pathologies.


 Speaker Profile

Ph.D., CEO, Bio-Me

Biography
After finishing his Ph.D. in biotechnology from the University of Oslo, Morten Isaksen set up several biotech companies in Norway and the UK. He also has experience as a consultant for several biotech companies and academic TTOs. He has more than a decade of experience in the microbiome field and was instrumental in setting up Genetic Analysis (GA) and their core technology. After leaving GA, he continued to develop ideas for improved microbiome profiling technologies. This resulted in Morten founding Bio-Me in 2016. His passion to transform microbiome profiling for better clinical applications has attracted a team of highly skilled and motivated team at Bio-Me.

Talk
PMP - A Rapid, Detailed Microbiome Profiling Tool
In order to microbiome analysis to be fully implemented into Precision Medicine regimes, a rapid, detailed and high throughput technology needs to be available. This is what Bio-Me has developed in Precision Microbiome Profiling (PMP™).