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
- Imke Mulder Director of Research, 4D Pharma
09.35 Application of Multivalent Vaccine Manufacturing Testing Schemes in cGMP Characterisation of Microbiome Defined Drug Products
- Jeffrey Heiser Director of Microbiology, Boston Analytical
10.05 Comfort Break
10.20 Advancing Cancer Immunotherapy Candidates Based on Microbiome-Derived LBPs that Stimulate the Immune System
- Bruce Roberts Chief Scientific Officer, Vedanta Biosciences
10.40 Utilising Phage to Improve Immuno-Oncology Therapy
- Assaf Oron Chief Business Officer, BiomX
11.00 Morning Refreshments & Networking
11.40 Designing Non-GMO Hybrid Microbes as Live Biotherapeutics
Jeanette Mucha, Co-Founder and CEO, Scibac
12.00 Engineered “Bugs as Drugs” for the Skin: A Novel Approach for Skin Therapeutics
Travis Whitfill, Chief Scientific Officer, Azitra
Phage Therapy Identification & Development
12.20 Phage Therapies for Chronic Diseases Such as IBD and Liver Disease
Assaf Oron, Chief Business Officer, BiomX
12.40 Modulating Human Microbiome: Bacteriophages and Their Practical Applications
Alexander Sulakvelidze, EVP & Chief Scientist, Intralytix
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
- 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?
Benjamin Hadida, Chief Executive Officer, Nextbiotix
Denise Kelly, Investment Advisor, Seventure Partners
Georges Rawadi, Chief Executive Officer, LNC Therapeutics
Cheryl Zimberlin, Associate, Merck Ventures
Henry Rath, SVP, Corporate Development, Seres Therapeutics
13.00 Lunch & Networking
Overcoming Regulatory Challenges for Microbiome-Based Therapeutics
14.00 Overcoming Regulatory Challenges for Microbiome-Based Therapeutics
- Magali Cordaillat-Simmons Scientific and Regulatory Affairs Director, Pharmabiotic Research Institute
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?