The microbiome R&D is an emerging area of science that is starting to prove its importance. A PubMed search on the term “human microbiome” yielded 300 citations in 2003, 4,498 citations in 2013, and 20,223 citations in 2016. 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 like inflammation, metabolic disorders, gut disorders, obesity, Type 2 Diabetes, autoimmune disorders, inflammatory bowel disease, neurodevelopmental disorders and more. There is great promise in correlating the microbiome compositions with these diseases and using the microbiome as a tool for therapeutic development.
This two-part meeting provides interactive sessions and panel discussions with leading researchers and thought leaders who will discuss how their work in this field has and will continue to have tremendous impact in generating personalized diagnostics and therapeutics to improve disease treatment and human health.
Part Two of the Targeting the Microbiome Track, taking place September 21-22, 2016, features microbiome and biopharma companies discussing the potential of translational interventions and novel therapeutic targets based on microbiome R&D. Case studies will explore how to use the microbiome as a tool for therapeutic, diagnostic and product development. We will also explore issues around microbiome patent eligibility and legal changes that will have a major impact on microbiome research in the next several years.
We expect an audience of approximately 100-125 attendees comprised of the following profile: Directors, Managers, Researchers, and Scientists from Pharma, Biotechs, Academia, Government and Healthcare Organizations working in Microbiology, Immunology, Clinical Pathology, Metagenomics, Food Science & Technology, Genome Sciences & Systems Biology, Computational Biology, Pathology, Microbial Genomics, Molecular Biology, and Therapeutic Innovation
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Wednesday, September 21
11:20 am Conference Registration Open
11:25 Enjoy Lunch on Your Own
2:40 Refreshment Break in the Exhibit Hall with Poster Viewing
3:20 Chairperson’s Opening Remarks
3:35 Correction of Microbiome Dysbiosis by Specifically-Targeted Antimicrobial Peptides (STAMP)
Brian Varnum, Chief Development Officer, R&D, C3 Jian, Inc.
The Specifically-Targeted Antimicrobial Peptide (STAMP) platform generates pathogen-specific drugs that target bacteria that drive dysbioses. Effective elimination of these organisms results in a microbiome reengineered to a healthy ecological state. Dysbiosis of microbiome communities has recently been implicated in several chronic diseases, such as dental caries, antibiotic-associated diarrhea, obesity, and IBD. Animal models and clinical studies have validated the STAMP platform, demonstrating remodeling of microbial communities. Updates to several STAMP development programs will be presented.
4:05 Skin Microbiome
Larry Weiss, M.D., CMO, AOBiome, LLC
AOBiome is exploring the role of Ammonia Oxidizing Bacteria (AOB) as an ancestral human skin commensal. The company is developing live topical therapeutic and cosmetic formulations on Nitrosomonas Eutropha for the prevention and treatment of inflammatory disorders of the skin.
4:35 Sponsored Presentation (Opportunity Available)
5:05 Refreshment Break in the Exhibit Hall with Poster Viewing
5:40 Rescuing the Infant Gut Microbiome
David Kyle, CEO, Evolve Biosystems, Inc.
The healthy human gut microbiome is a rich and diverse ecology throughout most of our lives. However, in one critical time period early in our development – from birth to weaning – the natural gut microbiome is remarkable in that it is dominated up to 80% by a single species: Bifidobactrium infantis (B. infantis). The presence of this single species is a consequence of its unique ability to consume the complex oligosaccharides (soluble fiber) found in in human milk. Unfortunately, the prevalence of the natural gut microbial phenotype in infants has been decreasing dramatically over the last 50 years in industrialized countries. We believe that the loss of this keystone species is due to the unintended consequences of the extensive use of antibiotics, the increasing use of infant formula, and Cesarean section births. Along with this precipitous loss of the natural gut microbiome phenotype in babies, there is a growing pandemic of lifelong metabolic and inflammatory disorders such as asthma, atopy, IBD, food allergies, Type I Diabetes, and obesity. Although these observations have not been directly linked, clinical research does indicate that the newborn immune system and early metabolic program are highly influenced by the gut microbiota. We have established that the infant’s natural gut phenotype (high in B. infantis) is dramatically different from that of the dysbiotic infant (little or no B. infantis) and that through a controlled supplementation with B. infantis, we can rescue the natural gut phenotype in babies regardless of their mode of delivery or nutrition. More importantly, we have shown that this natural gut phenotype is maintained long after supplementation ceases as long as those babies continue to receive breast milk as their primary source of nutrition.
6:10 Preventing Vaginal Infections with the Live Biotherapeutic Product Gynophilus
Adrien Nivoliez, Ph.D., General Manager R&D, biose®
Live Biotherapeutic Products Gynophilus®, formulated with the strain Lactobacillus rhamnosus Lcr35®, has been specifically developed for preventing vaginal infection. The activities and the efficacies of the product are validated by many clinical data. This talk introduces two new human clinical results (Phase I, Phase III).
6:40 End of Day
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Thursday, September 22
7:30 am Registration Open and Morning Coffee
8:30 Chairperson’s Remarks
Susan Kling Finston, J.D./M.P.P., CEO, Amrita Therapeutics Ltd.
8:45 Oncobiotic™ Therapeutics
Speaker to be Announced, Evelo Biosciences
Evelo Biosciences is dedicated to transforming cancer therapy through a deep understanding of the mechanisms and biology of the cancer microbiome. Evelo is developing Oncobiotic™ therapies, derived from its Bacterial Immune Activator (BIA™) and Cancer Associated Bacteria (CAB) proprietary platforms, designed to disrupt the tumor microenvironment, activate the immune system against tumors and interfere with tumor metabolism. Founded by Flagship VentureLabs® in 2015, Evelo is the world’s first microbiome company focused on the treatment of cancer.
9:15 Targeted High Molecular Weight Protein Complexes for Microbiota Engineering
Dean Scholl, Ph.D., Director of Research, AvidBiotics Corporation
Avidocin proteins are engineered high molecular weight bacteriocins targeted to kill chosen bacterial species by manipulating the Avidocin cellular receptor binding motif. In vivo data show that Avidocin proteins can remove a targeted bacterial species from the mouse gut without disrupting normal microflora. We are developing these novel antimicrobials for microbiota engineering by selectively removing key species associated with dysbiosis and metabolic disorders.
9:45 Silencing Harmful Bacterial Activity with Non-Antibiotic Drugs
Ward Peterson, Founder & CEO, Symberix, Inc.
The gut microbiome can be pharmacologically targeted to improve human health with a new class of drugs that act on bacteria without killing them. Symberix is targeting the sugar-metabolizing GUS enzyme in gut microbiota that is responsible for causing serious intestinal injuries associated with many pain and cancer drugs. The therapeutic, regulatory and commercialization implications of “drugging the microbiome” will be discussed.
10:15 Coffee Break in the Exhibit Hall with Poster Viewing and Poster Competition Winner Announced
11:10 Protection of the Gut Microbiome from Antibiotics
Jean de Gunzburg, Ph.D., CSO, Da Volterra
Antibiotics are life-saving drugs but inflict severe damage to the gut microbiome with short and long term consequences. We have devised a product, DAV132, which delivers a powerful adsorbent to the late ileum of humans, and show in a randomized controlled study on human volunteers that its co-administration with the fluoroquinolone moxifloxacin enables to protect the gut microbiome without jeopardizing the systemic exposure to the antibiotic. Furthermore, we show the product prevents the occurrence of Clostridium difficile infections in several preclinical settings. Our data suggests that DAV132, which has the capacity to adsorb a broad spectrum of different antibiotics, may constitute a breakthrough in antibiotic treatments, by protecting the gut microbiome and preventing adverse health consequences.
11:40 Precision Medicine and Microbiome Targets: Treatment of IBS-C and Prevention of C. difficile Infections
Klaus Gottlieb, M.D., FACG, Vice President, Clinical & Regulatory Affairs, Synthetic Biologics, Inc.
Microbiome research is currently dominated by sequencing efforts and hypothesis-free discovery. To date, hypothesis-driven translational efforts, e.g., a specific microbiome-directed intervention which results in a specific clinical benefit, are few. The presentation will provide an update on two clinical programs currently in development that demonstrate it may be possible to utilize established pathomechanisms, or mechanisms of action, in an entirely new way to protect the gut microbiome while targeting pathogen-specific diseases. Lead candidates in Phase 2 clinical trials and Phase 3 program development include: 1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and 2) SYN-004 which is designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD).
12:10 pm Sponsored Presentation (Opportunity Available)
12:40 Session Break
12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:30 Refreshment Break in the Exhibit Hall with Poster Viewing
2:15 Chairperson’s Remarks
Susan Kling Finston, J.D./M.P.P., CEO, Amrita Therapeutics Ltd.
2:20 Talk Title to be Announced
Gerard Honig, Ph.D., Founder & CEO, Symbiotic Health, Inc.
2:50 Developing a Room Temperature Stable, Orally Delivered Microbiota-Based Drug for the Prevention of Recurrent C. difficile Infection
Beth Brown, Ph.D., RPh, Director, Research and Development, Rebiotix
Disruption of the intestinal microbiota by factors such as antibiotic use has been implicated in Clostridium difficile infection (CDI). Fecal microbiota transplantation (FMT) has been demonstrated as a very effective for preventing recurrences of CDI. However, product preparation and delivery can be burdensome. A room temperature-stable microbiota-based drug that could be delivered orally in capsules could greatly simplify many aspects of the therapy for patients and physicians alike. The formulation has the potential to increase availability and access to a non-antibiotic therapy for recurrent CDI that does not disrupt the intestinal microbiota. Additionally, the drug formulation has broader applicability to other indications and disease states. This talk discusses the development and validation of an oral room-temperature stable microbiota-based drug formulation and updates on a clinical study program both for the prevention of recurrent CDI and other indications.
3:20 Session Break
3:30 Catalyzing Safe Fecal Microbiota Transplantation: From Current Practices to Future Therapies
Zain Kassam, M.D., MPH, FRCPC, CMO, OpenBiome; Gastroenterologist, Epidemiologist and Research Affiliate, MIT Center for Microbiome Informatics & Therapeutics
Fecal microbiota transplantation (FMT) is a promising emerging therapy for the treatment of recurrent C. difficile infections (rCDI). FMT has already advanced significantly from a DIY therapy using minimally screened individual donors to a highly standardized process, using universal donors subject to rigorous screening. As an example of this transformation, OpenBiome, the first public stool bank, has delivered over 11,000 treatments to over 600 hospitals in 7 countries, with less than 3% of prospective donors passing the 178-point clinical assessment and 30-item laboratory screening panel required for enrollment. The field continues to evolve rapidly with new synthetic microbial therapies under development for rCDI, and a wide range of new indications emerging as targets for microbial engineering.
4:00 The Changing Legal Landscape for Microbiome Research
John M. Conley, J.D., Ph.D., William Rand Kenan, Jr. Professor of Law, University of North Carolina, Chapel Hill; Counsel, Robinson Bradshaw & Hinson
This presentation will review three sets of legal changes that will have a major impact on microbiome research in the next several years. These changes are occurring in patent law, making it much harder to get and enforce patents on both biological substances and analytic methods; in the Common Rule for protecting human research subjects; and in the U.S. and international law of privacy.
4:30 Microbiome, Industrial Product Development and Their Patent Protection: Key Emerging Issues
Ananda Chakrabarty, Ph.D., Department of Microbiology & Immunology, University of Illinois College of Medicine
The US patent laws are in the US Constitution (Article I, section 8, clause 8) to promote the progress of science and useful arts as well as to ensure that ingenuity should receive a liberal encouragement (Thomas Jefferson, 1793). As part of such Constitutional mandate, the US Supreme Court in the case Diamond v. Chakrabarty (447 US 303, 1980) boldly declared that ‘anything under the sun that is made by man’ is patent eligible in the US so long as it meets the statutory requirement of patentability. Since then many purified products of nature which were novel, non-obvious and with great utility not recognized before, including our bacterial anticancer protein azurin, and its peptide fragment p28, have been patented. A sea change has, however, occurred since the 2012 Supreme Court’s verdict in the case Mayo Collaborative Services v. Prometheus Laboratories, Inc. and the 2013 decision on Myriad Genetics BRCA gene patents (Association for Molecular Pathology v. Myriad Genetics) on inventions involving natural process, natural phenomenon or product of nature that appear to have imposed strict limitations on what are patentable subject matters under the US patent laws. Many microbiome-related inventions may fall under such legal limitations and prevent their marketing because of lack of patent protection, as illustrated by the recent CAFC decision on Sequenom v. Ariosa Diagnostics. This talk will deal with such issues to sensitize both academic/industrial researchers and entrepreneurs on the limits of patent protection for many microbiome inventions of great practical and industrial importance.
5:00 Q&A Discussion: Patent Eligibility Issues of Microbiome Innovations
This interactive discussion will provide attendees an opportunity to explore direct questions regarding patent eligibility of microbiome innovations and IP issues involved.
5:15 Close of Conference
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