29-31 January, 2019

Paris, France

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Day One
Tuesday, 30th January 2018

Day Two
Wednesday, 31st January 2018

07.50
Morning Coffee and Registration

08.50
Chair’s Opening Remarks


TARGETED FORMULATION, CMC MANUFACTURING & SCALE-UP STRATEGIES: HOW TO DEVELOP A LIVE MICROBIAL PRODUCT


Synopsis

Introduction and Purpose:
As companies prepare to scale from early phase product development to commercial scale microbiome therapeutics, challenges around guidelines and best practice relating to formulation and CMC that ensure microbiome-based products are produced to GMP-compliant standards. The purpose of this theme will be to review the current industry thinking on manufacturing.

09.00
Panel Presentation: Manufacturing the Microbiome – An Industry Perspective

  • John Aunins EVP of Manufacturing and Chief Technology Officer , Seres Therapeutics
  • Richard Schwartz SVP Process Development and Manufacturing, Synlogic
  • Jeff Dubuisson Deputy Manager, Pharmaceutical Development, MaaT Pharma

Synopsis

  • How does modality impact manufacturing approach?
  • How can companies manage cost and scalability?
  • How to maintain product characterization throughout the development lifecycle of a microbiome-based therapeutic?
  • What are the benefits of building in-house manufacturing capabilities?

10.00
Quality and GMP Aspects of Manufacturing Live Biotherapeutic Products – a CMO Quality Perspective

Synopsis

  • Defining the product (cell bank characteristics, recombinant or not, API or Finished Product, Dosage Form)
  • Food or Drug?
  • GMP Manufacturing challenges (early clinical trial material)

10.10
Oral Delivery of Live Bio-Therapeutics: Drug Product Development for FIM Studies

Synopsis

  • Key CMC considerations for the development of an LBT product.
  • Critical factors affecting timelines when outsourcing GMP manufacturing activities of LBT drug products.
  • Incorporating ‘Quality’ (systems and regulations) into early phase dosage form design of LBT products.


SUBTRACTIVE THERAPIES IN THE MICROBIOME – BACTERIOPHAGES


Synopsis

Introduction and Purpose:
Bacteriophage-based therapies focus on using phage to target highlight specific strains of bacteria. Despite the promise, phage therapies currently lack the rigorous prod of efficacy, clinical evidence and regulatory approval in the US preventing widespread use. The purpose of this theme will be to review current practice in development bacteriophage-based therapies.

10.20
Novel Approaches for Microbiome Modulation Addressing IBD, Cancer and Acne

Synopsis

  • Utilization of phage, either native or synthetically modified, to eradicate specific bacteria provides a promising novel therapeutic approach
  • BiomX provides a novel approach to IBD through eradicating specific inflammatory enhancing, antibiotic-resistant bacteria
  • Demonstrating promising pre-clinical results for BX001 phage therapy for acne, expecting to enter human trials in 2018

10.50
Modulating Human Microbiome: Bacteriophages and Their Practical Applications

Synopsis

  • Bacteriophages are bacterial viruses that are arguably the oldest  and most ubiquitous organisms on Earth
  • Phages are very specific: they only attack their targeted bacterial hosts, and they cannot infect human cells or other eukaryotic cells. Moreover, phages only lyse strains or subgroups of strains of their targeted bacterial species, which makes targeted bacterial killing possible
  • Lytic phages may serve as a platform technology for developing a new class of drugs (and/or nutritional supplements) for improving human health via targeted microbiome modulation

11.20
Morning Refreshments and Networking


INNOVATION POWER-HOUR: START-UPS IN THE MICROBIOME


Synopsis

Introduction and Purpose:
Emerging start-ups in the human microbiome are using a variety of novel strategies to target microbial communities across different sites to treat a multitude of complex diseases. The purpose of this theme will be to showcase novel methods to target the microbiome from the companies beginning their microbiome journey.

11.50
Novel Approaches to an Ancient Therapeutic Strategy

Synopsis

  • Establishing a GMP facility for FMT-based therapeutics
  • Commercialising a microbiota based medicinal product in the United Kingdom
  • Development of a closed GMP-compliant processing system for enhancing faecal donations

 

12.10
Precision Discovery of Novel Bacterial Therapeutics and Biomarkers Based on Deep Microbiome Analysis

Synopsis

  • Gut bacteria have an important role as herapeutics and as biomarkers of
    immunotherapy response
  • Strain-level precision is required in identification of gut bacteria associated with
    patient phenotype in clinical studies
  • Microbiotica uses state of the art precision metagenomics based on its proprietary
    reference genome database and software

12.30
Harnessing the Vaginal Microbiome in Contraceptive Development

Synopsis

  • Vaginal Microbiome Cycle-Based Changes Can Be Exploited In Contraception;
  • Local Production Of Anti-Sperm Agents By Engineered Commensals Can Be Accomplished On A Cycle-By-Cycle Basis
  • Preclinical Studies Demonstrate High Efficacy And Complete Reversibility

 

12.50
Lunch and Networking


THE LARGE PHARMA PERSPECTIVE ON MICROBIOME-BASED DRUG DEVELOPMENT


Synopsis

Introduction and Purpose:
A number of pharmaceutical companies have now committed to microbiome-based drug development whilst others remain interested. With multiple industry collaborations now announced, pharmaceutical resources may play a critical role in the success of these products. The purpose of this theme will be to review what leading pharmaceutical companies look for in this emerging space and how utilization of pharmaceutical resources may accelerate the microbiome field.

13.50
The Microbiome: Translating Research into Discovery

14.20
Gut Microbiota Composition, Short-Chain Fatty Acids and Regulatory T-Cell – Are We Ready to Translate into Therapeutics?

Synopsis

  • Understanding the role of changing gut microbiota in the development of regulatory T-cell population during the early life
  • From Microbiome to therapeutics
  • The use of microbiota analysis for the development of personalised treatments in allergic and respiratory diseases

14.50
Respiratory Tract and Gut Microbiomes in Precision Medicine for Respiratory Diseases

  • Jim Brown Director, Computational Biology & Senior Fellow, GSK

Synopsis

  • Recent studies suggest that lung microbiome dynamics plays a key role in the severity of chronic obstructive pulmonary disease (COPD)
  • In this presentation, lung microbiome analyses of three large, longitudinal COPD patient cohorts (COPDMAP, BEAT and AERIS studies) will be discussed
  • In addition, novel chemogenomic analysis approaches to identify potential immunomodulator activity from gut bacterial metabolites will be described
  • Collectively, these approaches are aimed at the development precision diagnostics and therapeutics for the treatment of chronic respiratory diseases

15.20
Panel Presentation: Committing to the Therapeutic Potential of the Microbiome – Resources for Results

  • Dirk Gevers Global Head, JHMI, Janssen Research and Development
  • Kristin Wannerberger Director R&D Alliance Management, Ferring Pharmaceuticals
  • Jim Brown Director, Computational Biology & Senior Fellow, GSK
  • Outi Vaarala VP Head of Lung Immunity, AstraZeneca
  • Olga Danilchanka Microbiome Lead; Exploratory Science Center (ESC), MSD
  • Henry Haiser Investigator III, Novartis Institutes of Biomedical Research

Synopsis

  • Discussing what scientific breakthroughs in the human microbiome are most exciting with therapeutic applications
  • How can pharmaceutical companies best use their resources to accelerate the microbiome field?
  • Which resources are most useful for emerging organizations?
  • What are the biggest risk factors when harnessing the microbiome for therapeutic applications?

16.05
Chair’s closing remarks

16.15
End of Conference Day 2