Translating Causation To Treatment - Reviewing The Microbiome's Role In Drug Development

Advancing Standards For Translational Microbiome Research In Therapeutic Development

As the vast quantity of microbiome research continues to be translated into therapeutic, biomarker and diagnostic applications, the development of standard operating procedures continues to be crucial to ensure the reproducibility and regulatory approval of these products. The purpose of this theme will be to review the importance of creating standards to ensure the long-term viability of microbiome-based products within the pharmaceutical industry to allow for greater comparability and reproducibility between studies without dampening cutting edge scientific innovation.

8.30

Introducing the Microbiome Therapeutics Innovation Group – Building a Collective Voice to Enhance the Regulatory, Investment and Commercial Success of Microbiome-Based Therapeutics

 

 

Thomas J. DesRosier
Chief Legal Officer & Secretary
Seres Therapeutics

9.00

Improving Microbiome Work Flow Standards To Overcome Regulatory Hurdles And Accelerate Product Development

 

 

Representative from NIST invited. More details to be announced after Government Shutdown

9.30

Panel Discussion - Developing Industry Standards For The Microbiome-Based Therapeutics

 

 

Panellists to be Confirmed Shortly - Please Check Back with Us Soon

10.00

Powering Microbiome Discovery With Big Data

 

 

Dan Knights
Chief Executive Officer
CoreBiome

10.30

Morning Refreshments and Speed Networking

STREAM A: DISCOVERY PLATFORMS &
PRE-CLINICAL DEVELOPMENT OF
MICROBIOME-BASED THERAPEUTICS

STREAM B: MANUFACTURING, CLINICAL
DEVELOPMENT & COMMERCIALIZATION OF
MICROBIOME-BASED THERAPEUTICS

STREAM C: MICRONIOME BIOMARKERS, BIONFORMATICS & THERAPEUTIC RESPONSE

SUBTRACTIVE MICROBIOME APPROACHES DISCOVERY & DEVELOPMENT
DEVELOPMENT

MEASURING THE IMPORTANCE OF
ENGRAFTMENT FOR MICROBIOME-BASED THERAPEUTICS

USING ARTIFICIAL INTELLIGENCE TO TACKLE
THE COMPLEXITY OF MICROBIOME DATA
Dat

11.30 - Immunotherapeutic Approaches to Selective Modulation of Microbiomes

Julius Goepp
Chief Executive Officer
Translational Medicine in Immunology
Scaled Microbiomics

12.00 - Customized Phage Therapies for Chronic Disease

Assaf Oron
Chief Business Officer
BiomX

11.30 - An Exclusive Metabolic Niche Enables Strain Engraftment in the Gut Microbiota

Liz Shepherd
Co-Founder
Novome Biotechnologies

11.30 - Incorporating Microbiome and Clinical Data to Develop Predictive Algorithms as a Marker of Response to IBD Treatment

Ashwin Ananthakrishnan MD
Associate Professor of Medicine
Massachusetts General Hospital

12.00 - Combining Genomic, Metabolomic Data with Machine Learning to Identify New Targets from the Human Microbiome

Nathan Magarvey
Founder
Adapsyn Bioscience

GENETICALLY ENGINEERED BACTERIA DISCOVERY & DEVELOPMENT
DEVELOPMENT

PHARMACEUTICAL PERSPECTIVES & PARTNERSHIP STRATEGIES FOR MICROBIOME-BASED THERAPEUTICS

12.30 - A Prototype Biomarker for Microbiome Rehabilitation in Patients with Clostridium Difficile Infections: Application to a Clinical Trial of a Lyophilized, Non-Frozen, Oral, Microbiota-Based Drug rbx7455

Ken Blount
Chief Scientific Officer
Rebiotix

12.30 - Development of a Novel IBD Therapeutic Using Engineered Clostridium

Ben Bradley,
Head of Partnerships & Licensing
CHAIN Biotech

12.00 - Panel Discussion – New Perspectives On Pharmaceutical & Biotech Partnerships In The Microbiome

Mark Smith
Chief Executive Officer
Finch Therapeutics Group

Mike Romanos
Chief Executive Officer
Microbiotica

Henry Rath
SVP Corporate Development
Seres Therapeutics

13.00 - Presentation Title TBC, Please Check back With us Soon

Helena Cowley
CEO
Captozyme

13.00

Lunch and Networking

14.50 - Engineering Therapeutic Bacteria to Robustly Colonize the Gut

Wes Whitaker,
Co-Founder and CEO
Novome Biotechnologies

CLINICAL DESIGN & DEVELOPMENT CONTINUED

USING ARTIFICIAL INTELLIGENCE TO TACKLE THE COMPLEXITY OF MICROBIOME DATA

GENERATING & TRANSLATING ANIMAL STUDIES TO HUMANS

14.50 - Clinical Trial Design Challenges & Considerations for a Novel Synbiotic in Patients with Type 2 Diabetes

Colleen Cutcliffe
Co-Founder & Chief Executive Officer
Whole Biome

14.50 - Biomarker and Bioinformatic Rationale for Microbiome Drug Development in Cancer

Jennifer Wortman
Senior Director, Bioinformatics
Seres Therapeutics

15.20 - Panel Discussion - Exploring the Utility of In-Vivo Models for Translational Microbiome Research

Esi Lamouse-Smith
Director Early Development Translational Medicine in Immunology
Janssen Pharmaceuticals

Lynn Bry MD
Director
Massachusetts Host-Microbiome Center

GENERATING & TRANSLATING ANIMAL STUDIES TO HUMANS

15.20 - Matrisys Bio – Phase 2 Clinical Updates and New Developments

Mark Wilson
President & Chief Executive Officer
MatriSys Bioscience

15.50 - The Human Microbiome and IBS

Mark Pimentel MD
Director of MAST Program
Cedars-Sinai

16.20 - Standardising the Process of Clinical Trial Design and Capsule Development for Microbiome-Based Therapeutics

Alexander Khoruts MD
Medical Director
University of Minnesota Microbiota Therapeutics/span>

15.20 - Panel Discussion: Reviewing the Role of the Human Microbiome in Biomarker Discovery & Development

Jennifer Wortman
Senior Director, Bioinformatics
Seres Therapeutics

Matthew Henn
EVP Microbiome R&D
Seres Therapeutics

Gerard Honig
Translational Research Manager
Crohn’s & Colitis Foundation

Glennda Smithson
Director, Translational Biomarker Research (Immunology)
Takeda

MICROBIOME LEADERS OF TOMORROW – LATE BREAKING ABSTRACTS

16.20 - Standardising the Process of Clinical Trial Design and Capsule Development for Microbiome-Based Therapeutics

Alexander Khoruts MD
Medical Director

University of Minnesota Microbiota Therapeutics/span>

CHALLENGES IN MICROBIOME BIOINFORMATICS & DATA INTEGRATION

15.50 - Actobiotics®, Lactococcus-Based Biopharmaceuticals for Expression and Local Delivery of Therapeutics at Target Sites

Lothar Steidler
Chief Technology Officer
ActoBio Therapeutics

16.05 - Harnessing Whole Community Microbiome Transfer to Develop and Advance Novel Medicinal Products

James McIlroy
Founder & Chief Business Office
Enterobiotix

16.20 - Obtaining Hidden & Novel Small Molecules of the Microbiome

Ross Youngs
CEO
Biosortia Pharmaceuticals

16.35 - Presentation Title TBC, Please Check Back With us Soon

15.50 - Bioinformatic Analysis of Microbial Communities for Novel LBP Discovery

Daniel van der Lelie
Chief Scientific Officer
Gusto Global

16.20 - Understanding Precision Metagnomics to Assess Human Biology, Disease and Diagnostics

Rita Colwell
Distinguished University Professor
University of Maryland

16.50

Close of 4th Microbiome Movement - Drug Development Summit 2019