Translating Causation To Treatment - Reviewing The Microbiome's Role In Drug Development
APPLICATIONS IN THERAPEUTICS, NUTRITION AND DIAGNOSTICS
Registration & Morning Coffee
Chairperson Opening Remarks
Shionogi & Japan Microbiome Consortium
Live-BioTherapeutic Discovery, Clinical Development & Manufacturing
We have begun to develop more characterised therapeutic candidates based on single-strain organisms or a precise consortia of organisms, termed LBPs. LBPs have the promise of providing the same efficacy as FMTs but with a more characterised, and therefore predictable safety profile. Currently, there has been a growing body of the use of LBPs across a variety of disease phenotypes, including IBD, Diabetes, Cancer, Autism and many more. The purpose of this theme will be to review cutting-edge case studies on the use of LBPs to reverse disease phenotypes driven by an unwanted dysbiosis in the human microbiome.
Developing Microbiome into a Medicine
Founder and CEO
Genome and Company
Bacillus Spore-Based Oral Biotherapeutics
GI 310, a Novel Long-Acting Ige Trap-Fc Fusion Protein that Elicits Therapeutic Synergy in Combination with a Microbiome Agent for the Treatment of Food Allergy
Yang Bo Gie
The Asian Gut Microbiome: A New Therapeutics Discovery Opportunity
Morning Coffee & Refreshments Break
AI Approaches to Microbiome-Based Drug Development in China
VP, Research & Product Development
Microbiome-Based Biomarker Discovery – Patient Stratification Tools
As molecular biomarkers continue to become an important component to diagnose disease and predicting response to treatment, the human microbiome has become a rich source for novel biomarker discovery across broad range of disease phenotypes. The purpose of this theme will be to review current efforts in biomarker discovery and applications within the drug development and diagnostic industry.
Development of Endometrial Microbiome Testing for
Lunch Break & Networking
POLICY, REGULATION & INVESTMENT
Since the establishment of the Human Microbiome Project (HMP) and MetaHIT in 2008, there have been a growing number of global initiatives funded by government, academia and private organisations that look to accelerate translational microbiome research by exchanging methodologies, promoting standardisation and exchange ideas for the future applicability of this cutting-edge science. The purpose of this theme will be to highlight the successful efforts that are happening in the Asia-Pacific region as it relates to cooperating on microbiome-based research and the outcomes of these partnerships.
Introduction and Overview to the Korea Gut Microbiome Society Initiatives
Wang-Jun Lee MD
CEO & Chairman
Introduction of the Asian Microbiome Project: Study on Correlation among Diet, Gut Microbiota and Overall Health of Asian People
Lee Yuan Kun
National University of
Regulatory Frameworks for Microbiome-Based Products
As microbiome-based therapies constitute a novel paradigm in modern medicine, a robust regulatory framework that
addresses key safety and CMC issues should be evaluated for safe implementation of these treatments to patients in need.
Despite the rise in notoriety across the pharmaceutical industry, only a few regulatory agencies have provided clarity over the
regulatory hurdles when developing a microbiome-based therapeutic. The purpose of this theme will be to outline how leading
regulatory bodies in Asia and Internationally are currently reviewing microbiome candidates whilst highlighting successful IND
applications for emerging and well established microbiome companies.
Current Regulation of Microbiome-Based Therapeutics in Korea