28-30 January 2019
Paris, France
View Event Guide

Day One
Tuesday 29 January 2019

Day Two
Wednesday 30 January 2019

07.30
Morning Coffee & Registration

08.20
Chairperson Opening Remarks

The Role of the Human Microbiome in Predicting Cancer Immunotherapy Response

08.30
The Impact of the Intestinal Microbiota in Therapeutic Responses Against Cancer

  • Pr Laurence Zitvogel Group Leader of Tumour Immunology & Immunotherapy of Cancer, Institut Gustave Roussy

09.15
Developing Live Biotherapeutics to Target Immuno-Oncology

09.35
Application of Multivalent Vaccine Manufacturing Testing Schemes in cGMP Characterisation of Microbiome Defined Drug Products

10.05
Morning Refreshments & Networking

10.20
Advancing Cancer Immunotherapy Candidates Based on Microbiome-Derived LBPs that Stimulate the Immune System

10.40
Improving Cancer Treatment Through Oncobax-Based Therapeutics

11.00
Utilising Phage to Improve Immuno-Oncology Therapy

11.20
Morning Refreshments & Networking

11.40 Designing Non-GMO Hybrid Microbes as Live Biotherapeutics

Jeanette Mucha, Co-Founder and CEO, Scibac

12.20 Phage Therapies for Chronic Diseases Such as IBD and Liver Disease

Assaf Oron, Chief Business Officer, BiomX

12.40 Modulating the Human Microbiome: Bacteriophages and Their Practical Applications

Alexander Sulakvelidze, EVP & Chief Scientist, Intralytix

11.40

The majority of innovators in the microbiome field are small or early-stage biotechnology companies, eager to obtain financing to fuel developments. However, like other scientific breakthroughs that have seen significant venture and pharmaceutical interest, sufficient clinical trial data is not available, making it difficult to evaluate the potential of the science underlying these investments.

Through this interactive session, you will be able to better navigate the current investment landscape within the microbiome and understand how to raise funds to help launch, build and a sustain a successful microbiome therapeutics organisation.

Critical Questions to be Discussed:

  • How do start-up organisations raise funds in a field
    that isn’t validated?
  • How do you optimise R&D efforts to attract
    investment?
  • How do start-ups prepare for an IPO?
  • How do early stage microbiome start-ups raise capital in an ever-crowded space?
  • What role do strategic investors play in the success of microbiome-based therapeutics?

Denise Kelly, Investment Advisor, Seventure Partners

Georges Rawadi, Chief Executive Officer, LNC Therapeutics

Benjamin Hadida, 
Chief Executive Officer, Nextbiotix

 

13.00
Lunch & Networking

Overcoming Regulatory Challenges for Microbiome-Based Therapeutics

14.00
Overcoming Regulatory Challenges for Microbiome-Based Therapeutics

Synopsis

As microbiome therapies constitute a novel paradigm in recent drug development, a robust regulatory framework that addresses key safety and biocontainment issues should be evaluated for safe implementation. 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.

Through this interactive session, you will be able to understand how leading regulatory agencies currently, review microbiome candidates for therapeutic development whilst highlighting successful case studies for emerging and established microbiome organizations.

Critical Questions to be Discussed:

  • What are the common regulatory opinions on donor screening and reducing overall variability of samples used for the development of LBPs?
  • How does modality impact the regulatory thinking (LBP vs. small molecule versus engineered strains)?
  • What are the regulatory guidelines underpinning product characterisation/strain selection criteria?
  • What are the EU perspectives on LBPs and FMTs? What requirements do EU regulators need to accelerate product approval?
  • What are commonalities/differences in regulatory strategy for the US versus EU? What is being done to align regulatory thinking on microbiome-based therapeutics globally?
  • Once a product is approved, what are the follow up safety tests that would be required?

15.30
Chairperson Closing Remarks

15.40
Close of Conference Day Two and 3rd Microbiome Movement – Drug Development Europe 2019