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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.

AUDIENCE PROFILE
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

Final Agenda


RECOMMENDED ALL ACCESS PACKAGE:

• September 19 Short Course: Designing Peptide Therapeutics for Specific PPIs

• September 19 Short Course: Using IP Landscape Studies to Improve Your Confidence While Navigating a Crowded IP and Technology Space

• September 20-21 Conference: Targeting the Microbiome - Part 1

• September 21-22 Conference: Targeting the Microbiome - Part 2


Day 1 | Day 2 | Download Brochure


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


POTENTIAL OF TRANSLATIONAL INTERVENTIONS AND NOVEL THERAPEUTIC TARGETS BASED ON MICROBIOME R&D

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 STAMP platform generates pathogen-specific drugs that target bacteria that drive dysbiosis. 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. 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.

From birth to weaning, the natural infant gut microbiome is dominated by Bifidobacterium infantis. However, the prevalence of this species has decreased dramatically over the last 50 years due to the unintended consequences of modern medical and nutritional practices, and may have long term health consequences. Here we demonstrate the ability to rescue the natural infant gut microbiome by supplementation with Bifidobacterium infantis in breast-fed infants.

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

Day 1 | Day 2 | Download Brochure


Thursday, September 22

7:30 am Registration Open and Morning Coffee


POTENTIAL OF TRANSLATIONAL INTERVENTIONS AND NOVEL THERAPEUTIC TARGETS BASED ON MICROBIOME R&D

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.

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.

The presentation will discuss two lead candidates in Phase II clinical trials and Phase III program development: 1) SYN-010 intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of IBS-C, and 2) SYN-004 designed to protect the gut microbiome from the unintended effects of certain commonly used IV beta-lactam antibiotics for the prevention of C. difficile infection and 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


POTENTIAL OF TRANSLATIONAL INTERVENTIONS AND NOVEL THERAPEUTIC TARGETS BASED ON MICROBIOME R&D

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 has been implicated in C. difficile (CDI). Fecal microbiota transplantation (FMT) has demonstrated high efficacy for preventing recurrence but has limitations. This talk discusses the delivery of an oral room-temperature stable microbiota-based drug that may provide a number of advantages in terms of dosing and therapy access and updates on a clinical study program encompassing 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.


KEYNOTE SESSION: MICROBIOME-PATENT ELIGIBILITY

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

Many microbiome-related inventions may fall under 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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