Agenda At A Glance

Agenda At A Glance

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

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

The gut microbiome continues to be at the fore front of medical research and both the industrial and academic communities expect that insights gained from microorganisms will soon become a critical component of health management across a gamut of critical indications. However, the biggest hurdle in translating promising gut microbiome research into effective therapeutic candidates is demonstrating the causative role of human microbiome in disease pathology. Although there are a growing number of microbiome-based candidates showing promising results in both pre-clinical and clinical settings, the approaches that are likely to have well-validated mechanisms of action are limited. The purpose of this theme will be to review the current thinking in approaching the human microbiome mechanistically and understanding both the academic and industrial perspectives on this important topic.

8.30

Microbiome Industry Leaders Panel Discussion

 

 

Bernat Olle
CEO
Vedanta Biosciences

Colleen Cutcliffe
CEO
Whole Biome

Eric Shaff
EVP & CEO
Seres Therapeutics

Ken Blount
Chief Scientific Officer
Rebiotix

Alison Lawton
CEO
Kaleido Biosciences

9.30

Healthy Infants Harbour Intestinal Bacteria That Protect Against Food Allergy

 

 

Cathryn Nagler
Bunning Food Allergy
Professor
University of Chicago

10.00

Microbiome Tools & Trends for the Pharmaceutical Industry

 

 

Julia Cope
Director of Scientific
Operations
Diversigen

10.30

Shotgun Sequencing & Strain-Level Analysis: Study Design for Pre-Clinical & Clinical Development

 

 

Nur Hasan
Chief Scientific Officer
CosmosID

11.00

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

Introduction & Purpose: Prior to Clinical Validation, translational microbiome researchers look to leverage cutting edge pre-clinical models to identifymicrobiomederived targets that can be pursued for therapeutic development. The purpose of this stream will be to explore the discovery and pre-clinical assessment of microbiome-based therapeutics across the critical product modalities and disease phenotypes.

Introduction & Purpose: Although there has been significant progress both commercially and academically, there is still much we do not know about the microbiome and its role in disease causation. The purpose of this stream will be to review the critical product development challenges when bringing a microbiome-based therapeutic candidate to market. biomarker discovery and applications within the 

Introduction & Purpose: As molecular biomarkers continue to become an important component to diagnosing disease and predicting response to treatment, the human microbiome has become a rich source for biomarker discovery across a broad range of disease phenotypes. The purpose of this stream will be to review efforts in biomarker discovery and applications within the drug development and diagnostic industry.

LIVEBIOTHERAPEUTIC DISCOVERY & DEVELOPMENT

MANUFACTURING THE MICROBIOME/
FORMULATION AND DELIVERY

MICROBIOME BIOMARKER DISCOVERY
& DEVELOPMENT IN IBD

12.00 - A Preclinical Assessment of a Rationally Designed LBP

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

12.30 - Translating Probiotic Research into LBP Drug Programs

Nigel Titford
Chief Executive Officer
Biogaia Pharma

12.00 - Panel Discussion - Manufacturing and Scaling LBPs

Adrien Nivoliez
Chief Executive Officer
biose industrie

Bharat Dixit
VP Bioprocess & Analytical Development
Finch Therapeutics Group

Chris Reyes
CSO
Bloom Science

12.00 - Microbiome-based Biomarkers for Inflammatory Bowel Diseases: Opportunities to Accelerate Drug Development and Improve Clinical Outcomes

Gerard Honig
Translational Research Manager
Crohn’s & Colitis Foundation

12.30 - Utilizing Microbiome-Derived Biomarker to Assess PK/PD and Support the Development of Rationally Designed LBPs

Matthew Henn
EVP Microbiome R&D
Seres Therapeutics

13.00 - Developing Microbial Therapies to Prevent and Treat Human Disease and Allergies

Greg Mckenzie
Chief Scientific Officer
ConsortiaTX

12.30 - CMC Development for a Full Spectrum Microbiota Product

Bharat Dixit
VP Bioprocess & Analytical Development
Finch Therapeutics Group

13.00 - Microbiome-derived Biomarker Initiatives at Janssen Pharmaceuticals to Evaluate the Success of VE202

Ling-Yang Hao
Associate Director
Janssen Pharmaceuticals

13.30 - Delivery, Survival, Engraftment & Activity of LBPs in the GI Tract

Massimo Marzorati
Chief Executive Officer
ProDigest

13.00 - Development of Oral LBPs
– a CDMOs Perspective

Mike Frodsham
Pharmaceutical Development Manager
Quay Pharma

13.30 - Scale Up & GMP Manufacture of LBPs

Tina Chritensen-Ram
Quality Manager
LuinaBio

13.30 - Commercial Speaking Position Reserved for Solution/Service Provider

Please Contact adam.harasgummer
@hansonwade.com for further details

13.40

Lunch and Networking

14.40 - Improving Cancer Treatment Through Oncobax-Based Therapeutics

Romain Daillere
Co-Founder & Head of Preclinical Research
EverImmune

EARLY STAGE CLINICAL DESIGN & DEVELOPMENT

14.40 - Presentation Title TBC, Please Check Back with Us Soon

Trevor Lawley
Chief Scientific Officer
Microbiotica

SMALL MOLECULE/METABOLITE DISCOVERY
& DEVELOPMENT

14.40 - Clinical Development and Scale-Up Considerations for a Microbiome-based Therapeutic for the Treatment of Metabolic Disease

Gregory Lambert
Chief Executive Officer
TargEDys

15.10 - Commercial Speaking Position Reserved for Solution/Service Provider - Please Contact adam.haras-gummer@hansonwade.com for Further Details

15.10 - Commercial Speaking Position Reserved for Solution/Service Provider - Please Contact adam.haras gummer@hansonwade.com for Further Details

15.10 - Clinical Validation for Microbiome Modulators

Herwig Bachmann
Group Leader Fermentation
NIZO

15.40 - A Novel Machine Learning Approach to Microbiome Based Biomarker Discovery

Assaf Oron
Chief Business Officer
BiomX

15.40 - Microbiota-Derived Metabolites to Treat Food Allergy and Prevent Food Allergen Sensitivity

John Colson
Director of Operations
ClostraBio

15.40 - Reverse Translation for Therapeutic Development in the Human Microbiome

Ulrich Thienel
Chief Medical Officer
Finch Therapeutics Group

16.10 - The Growing Role of the Gut Microbiome in Drug Metabolism

Andrew Goodman
Associate Professor
Yale University

16.10 - A Chemistry-Driven Approach to Leveraging the Potential of the Microbiome Organ to Treat Disease and Improve Human Health

Katharine Knobil MD
Chief Medical Officer and Head of R&D
Kaleido Biosciences

16.10 - Developing Microbiome-based Therapeutics for the Prevention and Treatment of
Inflammatory Diseases

Nikole Kimes
Founder & Chief Scientific Officer
Siolta Therapeutics

16.40 - Commercial Speaking Position Reserved for Solution/Service Provider
- Please Contact adam.haras-gummer@hansonwade.com for Further Details

16.40 - From Sample to Data - Considerations for Designing Microbiome Studies

Malcolm Kendall
Chief Executive Officer
Microbiome Insights

16.40 - Overcoming Hurdles in the Development of Live Biotherapeutic Products

Stacy Burns-Guydish,
Founder & VP, Biotherapeutics Development & Manufacturing
List Laboratories

16.50

Afternoon Refreshments and Networking

STREAMLINING REGULATORY APPROVAL OF MICROBIOME-BASED THERAPEUTICS

CHATHAM HOUSE RULES C-LEVEL ROUNDTABLE (INVITE ONLY)(INVITE 

As microbiome therapies constitute a novel paradigm in modern medicine, a robust regulatory framework thataddresses key safety and biocontainment issues should be evaluated for safe implementation of these treatments. 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 currently review microbiome candidates whilst highlighting successful IND applications for emerging and well established microbiome companies.

17.15 – 18.45
This theme will be an invite only session that will look to unite the leaders of the translational microbiome space to discuss the long term challenges and opportunities that still lie within this ever-growing field.

17.15

Regulatory Considerations for LBPs & Bacteriophage Therapy

 

 

Representative from FDA Invited, More Details to Be Announced after Government Shutdown

17.45

Application of Multivalent Vaccine Manufacturing Testing Schemes in cGMP Characterization of Microbiome Defined Drug Products

 

 

Jeffrey Heiser
Director Microbiology
Boston Analytical

18.15

Panel Discussion – Building Clear Regulatory Guidelines for Microbiome-based Therapeutics

 

 

Representative from FDA Invited, More Details to Be Announced after Government Shutdown

Jim Weston
SVP Regulatory Affairs
Seres Therapeutics

Susan Stewart
SVP, Regulatory Affairs & Quality
Kaleido Biosciences

Kris Piper
VP Regulatory Affairs
Finch Therapeutics Group

Edward Burd
Head of Regulatory Affairs
Rebiotix

18.45

Evening Drinks Reception and Poster Session Hosted by The Microbiome Movement

 

 

20.00

Close of Conference Day One