Basic and applied biomedical research from the Human Microbiome Project and other independent studies prove that a disruption of a stable microbiome ecosystem results in dysbiosis. This imbalance leads to chronic disease and health conditions. There is great promise in correlating the microbiome compositions with these diseases and using the microbiome as a tool for therapeutic development. Cambridge Healthtech Institute’s 4^th Annual Targeting the Microbiome tracks both the scientific and clinical progress being made to discover and develop microbiome-derived biomarkers, drug targets, and bioactive molecules as potential treatments for chronic disease and health conditions. Through interactive sessions and panel discussions, leading researchers and thought leaders will explore how the microbiome can become a potential point of intervention to impact progression to disease.

Final Agenda

Thursday, September 27

11:50 am Conference Registration Open (Foyer)

12:20 pm Plenary Keynote Program (Constitution Ballroom)

2:00 Refreshment Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)

Targeting the Microbiome in Obesity and Metabolic Disorders
Berkeley

2:45 Welcome Remarks

Cindy Crowninshield, RDN, LDN, HHC, Senior Conference Director, Cambridge Healthtech Institute

2:50 Chairperson’s Opening Remarks

2:55 Targeting the Human Host-Microbiome Interface in Metabolic Disease
James R. Brown, MSc, PhD, GSK Senior Fellow and Director in Computational Biology for Infectious Disease and Oncology, GlaxoSmithKline, Collegeville PA
Recent studies have highlighted the role of gastrointestinal tract microbial communities in metabolic health and disease. The microbiome, the collective genomic and metabolic potential of the gut microbiota, has a key role in many chronic diseases through its mitigation of host immune-inflammatory responses. In this presentation, we provide a pharmaceutical industry perspective on the importance of the gut microbiome in metabolic and inflammatory diseases, its impact on drug pharmacology and the promise and challenges of exploiting human host-microbiome cross-talk pathways and networks for novel therapeutic targets.

3:25 Gut Microbiome Mediates Sex Differences in the Obesity and Metabolic Syndrome in Mice

Kanakaraju “Raj” Kaliannan, MD, Instructor, Medicine, Harvard Medical School; Senior Research Fellow, Laboratory for Lipid Medicine and Technology (LLMT), Massachusetts General Hospital

Gut microbiome mediates sex differences in the obesity and metabolic syndrome. Estrogen or estrogen-like compounds-induced elevated intestinal alkaline phosphatase levels and subsequent gut microbiome changes lower bacterial lipopolysaccharide production and gut permeability, resulting in reduced metabolic endotoxemia and systemic low-grade chronic inflammation with subsequent reduction in the susceptibility to develop western-diet-induced metabolic syndrome in estrogen treated males and post-menopausal women.

3:55 Small Molecules at the Intersection of Health and Microbiota

Karen DeBalsi, PhD, Senior Study, Director, Metabolon

Metabolites serve as a language that mediates cross-species relationships and Metabolon’s unbiased global metabolomics approach provides a great tool to decipher the complex biological story. This talk will cover how one can best leverage this technology to address their microbiome research questions as supported by case studies.

4:25 Refreshment Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)

Targeting the Microbiome in Oral Health & Nutrition
Berkeley

5:00 The Oral Microbiome as a Gateway to Systemic Health

Bonnie Feldman, DDS, MBA, Digital Health Analyst and Chief Growth Officer, DrBonnie360

The oral cavity is home to an immensely diverse microbiome: an estimated 20 billion microbes (more than 700 species) live in our mouths, with distinct populations predominating in different oral habitats. The status of our oral microbiome and health may provide an early indicator of systemic diseases such as diabetes, heart disease, stroke, rheumatoid arthritis and other autoimmune diseases. As advances in big data analytics, next-generation sequencing, and systems immunology advance our knowledge about the human microbiome, our understanding of and approach toward oral health, systemic immunity, and systemic health will also evolve. Learn about the latest research connecting the oral microbiome and gut with chronic and autoimmune diseases and systemic health.

5:30 Nutrition and the Gut Microbiome: Where Are We Now? Where Are We Going?

Leigh A. Frame, PhD, MHS, Program Director, Integrative Medicine, The George Washington University School of Medicine and Health Sciences

When the gut microbiome (gBiome) is in an unhealthy state, an individual is in dysbiosis, which may be related to their diet and its nutritional value. The role of nutrition and the gBiome in health and disease has rapidly grown with the understanding of each, their interactions, and the links to gastrointestinal disease, obesity, and chronic disease. In the last decade, the availability of affordable next-generation sequencing and gnotobiotics (germ-free animal models) has facilitated a major advancement in our understanding of the gBiome and the interaction with nutrition.

6:00 Oral Blis - Streptococcus salivarius Probiotics to Promote a Healthy Oral Microbiome

John Hale, PhD, Chief Technology Officer, Blis Technologies Ltd

Streptococcus salivarius is a commonly-occurring commensal bacterium found both exclusively in humans. S. salivarius strains K12 and M18 have been characterized and developed as probiotics providing many benefits to consumers by promoting microbial equilibrium. This talk will present examples of how application of these probiotics has led to the promotion of improved health. Future studies embracing microbiome technology will further validate the specific roles probiotics have in improving oral health.

6:30 Dinner Short Course Registration (Foyer)

9:30 Close of Day

Friday, September 28

7:00 am Registration Open (Foyer)

7:30 Interactive Breakfast Breakout Discussion Groups

Grab a cup of coffee and join a breakout discussion group. These are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.

Room:Constitution A

Table 4: Standards for the Microbiome Therapeutics Industry: Navigating the Regulatory Landscape

Scott A. Jackson, PhD, Leader, Complex Microbial Systems Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology

Table 5: NEW: Microbiome: Going Beyond a Gut Feeling

Madhumitha Rangesa, Department of Chemical and BioMolecular Engineering, NYU: Tandon School of Engineering; (formerly Senior Analyst, Frost & Sullivan)

• Non-gut microbiome areas like bladder, skin

TARGETING THE MICROBIOME IN AUTOIMMUNITY AND INFLAMMATORY BOWEL DISEASE
Fairfax A

8:30 Chairperson’s Remarks

Thomas Sundberg, PhD, Senior Research Scientist I, Center for Development of Therapeutics, Broad Institute of MIT and Harvard

8:35 KEYNOTE PRESENTATION: Bacterial Transformations in Autoimmune Drug Metabolism

Jason Michael Crawford, PhD, Maxine F. Singer ’57 Ph.D. Associate Professor of Chemistry and Associate Professor of Microbial Pathogenesis, Yale University

Photorhabdus asymbiotica is a gammaproteobacterial pathogen that causes systemic and severe soft tissue infections in humans. During infection, it produces tapinarof, an immunomodulatory drug developed to treat psoriasis and atopic dermatitis. We show that bacteria transform tapinarof into other novel metabolites that regulate arylhydrocarbon receptor and Nrf2 antioxidant signaling, phenotypes responsible for tapinarof’s clinical efficacy. We also show that closely related dietary metabolites associated with “alternative” IBD treatments undergo similar novel transformations.

9:05 Reverse Translation for Therapeutic Development in the Human Microbiome

Ulrich Thienel, MD, PhD, CMO, Finch Therapeutics, Inc.

A major challenge in microbiome research is interpreting correlations observed in human cohort studies or murine models. However, with the increasing abundance of clinical interventional data from experience with fecal microbiota transplantation, there is an opportunity to develop therapeutic insights directly from clinical observations. Finch Therapeutics identifies microbial therapies by observing patterns of microbial engraftment that drive clinical responses. We plan to use the patterns to develop a new generation of rationally selected microbiota therapies for Inflammatory Bowel Disease.

9:35 NOD2, Innate Immunity and the Microbiome

Klare Lazor, Graduate Student, Laboratory of Catherine Grimes, Department of Chemistry and Biochemistry, University of Delaware

The bacterial peptidoglycan is a known antibiotic target. In addition to serving as an antibiotic target, the human innate immune system uses the peptidoglycan to detect bacteria and generate an immune response. Synthetic peptidoglycan fragments, such as Muramyl Dipeptide (MDP), are known to interact with human Nucleotide-binding oligomerization domain-containing protein 2 (NOD2). However, an improper interaction is hypothesized to cause Crohn’s disease (CD). Consequently, we are developing new tools to better understand this peptidoglycan-host interaction for the design of novel antibiotics and anti-inflammatory therapies.

10:05 Coffee Break in the Exhibit Hall with Poster Viewing and Poster Competition Winner Announced (Grand Ballroom)

Commercializing Translational Applications & Microbiome Products
Berkeley

10:45 Standards for Microbiome and Metagenomics: Supporting the Commercial Translation of Microbiome Science

Scott A. Jackson, PhD, Leader, Complex Microbial Systems Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology

At NIST, we are improving microbiome science and supporting the National Microbiome Initiative by 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.

11:15 Considerations in Developing a Microbiome Therapeutic

Jeannie Rojas, PhD, MBA, Portfolio Leader, Research and Development, Janssen R&D

When developing a commercial microbiome product, the development pathway and regulatory submission strategy will be different depending on whether the product is a medical food, dietary supplement or prescription drug. Microbiome-based products are novel and available guidelines are open to interpretation. In this talk, I will walk through the process of bringing a microbiome-based therapeutic to the clinic, with emphasis on key considerations, hurdles and challenges that must be factored into the development process.

11:45 Enjoy Lunch on Your Own

1:15 Refreshment Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)

Microbiome Market, Development & Investment Opportunities
Berkeley

1:55 Chairperson’s Remarks

Keith F. Batchelder, MD, CEO and Founder, Genomic Healthcare Strategies

2:00 NEW: Human Microbiome Growth Opportunities and Predictions

Madhumitha Rangesa, Department of Chemical and BioMolecular Engineering, NYU: Tandon School of Engineering; (formerly Senior Analyst, Frost & Sullivan)

This presentation focuses on recent development in the areas of microbiome-driven therapeutics. An overview of key research groups, disease focus areas and trends will be provided. The discussion will encompass a review of select technologies, markets and products as well.

2:30 PANEL DISCUSSION: From Microbiome to Market: Exploring Business Development Opportunities and Investment Models

Keith F. Batchelder, MD, CEO and Founder, Genomic Healthcare Strategies (Moderator)

David Donabedian, PhD, Venture Partner, Longwood Fund; CEO and Co-founder of Longwood portfolio Company Axial Biotherapeutics, Inc.

Gail Javitt, JD, Member of the Firm, Healthcare and Life Sciences Practice, Epstein Becker Green

Jeannie Rojas, PhD, MBA, Portfolio Leader, Research and Development, Janssen R&D

This panel discussion is appropriate for you if you are working in research, science or industry and have questions about translation opportunities or the kinds of business and financial models that investors find attractive. We will discuss the areas of the microbiome investors are looking at and why. We will explore the global scope of microbiome and successful collaboration, reimbursement, and business investment models between science, business, healthcare, and government in bringing live microbial products to market. We will also discuss balancing venture activities, external R&D, and long-term market opportunities. Join us for a lively and interactive discussion.

4:00 Close of Conference