29th January – 1st February 2018 | Paris, France

REGISTER NOW – SAVE €200

Day One
Tuesday, 30th January 2018

Day Two
Wednesday, 31st January 2018

07.50
Morning Coffee and Registration

08.50
Chair’s Opening Remarks


DEFINE ‘HEALTHY MICROBIOME’? : DISCOVERY PLATFORMS THAT DEMONSTRATE CAUSALITY AND IDENTIFY NOVEL DRUG TARGETS


Synopsis

Introduction and Purpose:
The microbiome has allowed researchers to look at health and disease in a unique way and are building discovery platforms that identify novel targets to diagnose, prevent and treat disease using microbiome-related methodology. The purpose of this theme will be to outline successful methods to tackle variability and build healthy standards.

09.00
Studying Microbiome-Host Interactions to Translate Microbiome Drugs into the Clinic

  • David Cook EVP of R&D and Chief Scientific Officer, Seres Therapeutics

Synopsis

  • Review of approaches to mine microbiological and functional information from human clinical trials
  • Using mechanistic data and pharmacological models to design and test microbiome drugs
  • Discussion of regulatory and CMC considerations for translating microbiome drugs into clinical trials

 

09.30
Definition of a Healthy Microbiome and If Disturbed – How to Shape It Back to Normal

Synopsis

  • Definition of a healthy microbiome requires prospective large-scale prospective population based studies.
  • Adjust for confounding factors when defining a normal cohort
  • Novel approaches to shape the microbiota in clinical practice

 

10.00
State-of-the-Art Functional Analysis of Microbial Communities

Synopsis

  • Understanding indications through analysis of missing functionalities in the microbiome is central to therapeutic discovery.
  • Outlining a novel development platform addresses missing functionalities and critical metabolic interdependencies between strains as drivers for the successful design of stable consortia
  • Discussing why  bioinformatics are a core competency for each stage of R&D, from early strain discoveries, isolations and characterizations through the optimization of production processes

 

10.30
Microbiome in Understanding Human Biology, Disease and Diagnostics

  • Rita Colwell Distinguished Professor, University of Maryland

10.50
Drugs from Bugs – Using Metagenomic Dataset Delivers Druggable Targets

Synopsis

  • Microbiome as a source of bioactives and novel targets
  • Quantitative and functional metagenomics
  • Gut-restricted therapeutics

 

11.20
Morning Refreshments and Speed Networking

12.20
Microbiome Research at NIBR: Microbial Metabolites That Modulate Host Functions

  • Henry Haiser Investigator III, Novartis Institutes of Biomedical Research

Synopsis

  • Building a pre-clinical microbiome program to uncover small molecule mediators of disease relevant microbe/host interactions
  • Identifying new pharmacological targets that assimilate microbiome-derived signals
  • Opening a framework that embraces external collaborations with academic and clinical researchers


TRANSLATING PRE-CLINICAL RESULTS INTO THE CLINIC: FROM PHARMACOLOGY TO SYSTEMS BIOLOGY


Synopsis

Introduction and Purpose:
The complexity of studying the human microbiome has slowed progress in the development of microbiome-based therapeutics. This has prompted efforts to develop predictive pre-clinical models to investigate host-microbiome interactions in specific diseases. The purpose of this theme will be to review preclinical strategies that address key safety considerations whilst guaranteeing translational and clinical success.

12.50
FMT-Based Discovery: From Platform to Product

Synopsis

  • New insights in design of FMT-studies
  • Building a platform to evaluate new leads
  • Systematic In-vitro and in-vivo evaluation
  • Data-mining: digging deeper pays off

 

13.20
Delivery, Survival, Engraftment and Activity of LBPs in the Gastrointestinal Tract

Synopsis

  • Validated in vitro technology platforms are a key tool for the pre-clinical work in LBPs development
  • The SHIME® is an enabling technology which allows an integrated simulation of the full GI tract, including lumen, mucosa and host
  • The SHIME® allows to investigate the mechanism of action of LBPs in areas of the gut, which are not easily accessible, generating data complementary to in vivo studies

 


CLINICAL TRIAL LEARNINGS: PREPARING FOR COMMERCIAL SCALE MICROBIOME THERAPEUTICS


Synopsis

Introduction and Purpose:
With a number of important therapeutics entering a clinical setting, there are still major questions surrounding best practice in designing, scaling and progressing through clinical trials. The purpose of this theme will be to outline industry developments when executing clinical trials for microbiome-based therapeutics.

13.30
Rollercoaster Ride for the Pioneers in Microbiome Clinical Program Development

Synopsis

  • Understand how interest and hype in the microbiome may impact clinical progress and perceptions
  • Key learnings conducting clinical programs in difficult patient populations
  • Hindsight is 20:20; predicting the future not so easy

14.00
Lunch and Networking

15.00
Clinical Development of Ribaxamse, an Oral-Beta Lactamase Intended to Protect the Gut Microbiome and Prevent C.Diificile

15.30
Preserving the Intestinal Microbiota during Antibiotic Treatments with DAV132: From Preclinical Studies in Hamsters to Phase 1 Trials in Humans

Synopsis

  • Treatment with DAV132 severely reduces the exposure of the intestinal microbiota to co-administered antibiotics, while maintaining their systemic level
  • DAV132 enables to essentially spare the intestinal microbiota from antibiotic-induced dysbiosis
  • Preserving the intestinal microbiota during antibiotic treatments in hamsters prevents the development of lethal Clostridium difficile infections

16.00
Clinical Considerations of Rationally Designed Live Bacterial Cocktails

16.20
Afternoon Refreshments and Networking


APPROACHING REGULATORY CHALLENGES IN EUROPE AND US


Synopsis

Introduction and Purpose:
When assessing and regulating microbiome-based therapeutics, there are still ongoing conversations regarding how international regulatory bodies classify and review these breakthrough products. The purpose of this theme will be to give an international perspective on regulating Live Biotherapeutic Products whilst addressing common challenges from industry when navigating a complex regulatory landscape.

16.50
The Regulatory Challenge for Registering Live Biotherapeutic Products in Europe

Synopsis

  • Presenting the EU regulatory Bodies in Europe regarding the pharma industry
  • Discussing the regulatory status in which Probiotics were commercialized within the EU and how the landscape is evolving
  • Sharing the pharmaceutical regulatory framework
  • The importance to understand the system and to interact with authorities in order to clarify the regulatory framework

17.20
Panel Presentation: Overcoming Regulatory Uncertainty to Accelerate Speed to Market

Synopsis

  • How can companies work with regulatory agencies to accelerate speed to market?
  • How do we overcome challenges in measuring purity, safety, and product characterization when regulating microbiome-based therapeutics
  • What to consider when working with international regulators to understand key design elements for seamless product development

17.50
Chair’s Closing Remarks

18.00
End of Conference Day 1 and Evening Drinks Reception