8:30 am Morning Registration & Virtual Networking

Morning Plenary – Streamlining Regulatory Approval of Microbiome-based Therapeutics

9:00 am Development of Microbiome-Based Medicinal Products in Europe: Regulatory Considerations

  • Alice Rounet Regulatory Affairs Associate , Pharmabiotic Rese

Synopsis

• Reviewing the definitions of microbiome-based medicinal products
• Exploring specific requirements and regulatory considerations to place a microbiome-based medicinal product on the European market
• Optimizing microbiome-based drug development to guarantee regulatory success

9:30 am Regulatory and Clinical Considerations for LBPs

Synopsis

• Understanding the IND process
• Discussing current FDA review of LBPs and other microbiome-based biologics
• Reviewing the current FDA review on clinical development of LBPs

10:00 am Developing Standards for the Microbiome Field

Synopsis

• Developing the first reference reagents produced by the National Institute for Biological Standards and Control (NIBSC) for microbiome analysis by next-generation sequencing
• How these can act as global working standards and will be evaluated as candidate World Health Organization International Reference Reagents.
• Looking at the NIBSC DNA reference reagents Gut-Mix-RR and Gut-HiLo-RR and a four-measure framework for evaluation of bioinformatics tool and pipeline bias

10:30 am Meeting the Supply Needs of the Microbiome Sector

Synopsis

• Assessment of the growth in the microbiome space
• Challenges in establishing supply
• Solutions to meet the supply needs of the sector

11:00 am Morning Refreshments and Speed Networking

Stream A: DISCOVERY & PRE-CLINICAL DEVELOPMENT OF MICROBIOME-BASED THERAPEUTICS

Introducing the Era of Engineered Microbes

The recent combination of synthetic biology with the microbiome has welcomed a new drug modality that fight disease by delivering therapeutic payloads. The purpose of this theme will be to review the successes and future directions from researchers and companies who are levering the drug development potential of engineered microbes.

Stream B: CLINICAL DEVELOPMENT & MANUFACTURING OF MICROBIOME-BASED THERAPEUTICS

Manufacturing the Microbiome

As drug developers prepare to scale from early proof of concept to commercial scale therapeutics, downstream processing and formulation within the microbiome have been largely unexplored. The purpose of this theme will be to review the current industry thinking
on manufacturing and scale-up of microbiome-based therapeutics, with a focus on Live Biotherapeutics.

11:30 Developing CRISPR-based Microbiome Drugs to Selectively Eradicate Target Bacteria


• Utilizing the natural bacterial CRISPR-based adaptive immune system in a programmable fashion to kill target bacteria based on their specific genome
• Developing next-generation antibiotics harbouring DNA-based CRISPR-Guided Vectors that cause double-stranded breaks in bacterial genomes
• Precisely targeted therapeutics to the desired bacterial species or strain whilst minimizing development of resistance

Eric van der Helm, Head of Synthetic Biology & Bioinformatics, SNIPR Biome

11:30 Bottom-Up Design of Therapeutic Consortia Using Co-Cultivation


• Development of indication-specific consortia addressing key functions
• Biologically validated rules of assembly for the engineering of consortia
• Focus on the maintenance of functionality, viability, and reproducible composition in the product


Tomas de Wouters,
CEO & Co-Founder, PharmaBiome

12:00 Harnessing the Power of Synthetic Biology to Engineer and Edit the Microbiome with Surgical Precision


Examining CCBio's proprietary drug discovery platform, Zeus, which evaluates and optimises the potential of thousands of first-in-class therapeutics for the precise augmentation of your microbial ecology


Matthew Cummings,
CEO & Co-Founder, CCBio

12:00 Building a Strategic Partnership to Effectively Scale and Manufacture Microbiomebased Therapeutics

Adrien Nivoliez, CEO, Biose Industrie

12:30 Leveraging Gut Microbiota Cross-Talk with Immune System to Enhance Cancer Immunotherapy


• Extracellular ATP (eATP) as a bacterial metabolite in host-microbiota mutualism
• Adaptive modulation of intestinal immunity by inhibition of eATP signalling
• Enhancement of immune checkpoint blockade by eATP interfering biotherapeutics


Fabio Grassi,
Founder, MVBiotherapeutics

12:10 Scale Up & GMP Manufacture of LBPs


• Consideration for technology transfer and development of LBPs prior to GMP
• Assessing the scale-up considerations and challenges associated with LBPs in early clinical trial material
• Outlining viability and yield considerations throughout the manufacturing process to bulk drug product


Tina Christensen-Ram,
General Manager Quality, Luina Bio

13:00 Lunch & Networking

12:20 Collaboration Efforts and Research Directions for EU-funded Microbiome Projects

• Discussing current research breakthroughs in the microbiome sector that have been awarded EU funding
• Reviewing the trends and challenges of the microbiome in healthcare research
• Addressing future opportunities that remain untapped


Dirk Hadrich,
Policy and Programme Officer, European Commission

12:40 Building the First Private Incubator of Microbiome Biotechs


• How Nexbiome Therapeutics evaluate projects in relation to the patient’s need and progress in technology
• Introducing our process of facilitating pharmaceutical development, from discovery to product registration
• Exploring our finance engineering principles through equity and support from financial partners


Stanislas Desjonqueres, CEO, Nexbiome Therapeutics

13:10 Lunch & Networking

Subtractive Therapeutics that Target the Human Microbiome

Clinical Case Studies Continued

Broad-spectrum antibiotics can lead to unintended reduction of commensal bacteria, causing the patient to become vulnerable to chronic disease, including C.Difficile infection. Subtractive therapies that target the human microbiome can be used in a more targeted way. The purpose of this theme will be to review current practice in discovery and development of bacteriophage-based therapies and address any unique challenges when selecting a subtractive approach to modulate the immune microbiome

Clinical Case Studies Continued

14:00 Nemesis Symbiotics for Inactivation of Anti-microbial Resistance Genes in the Microbiome

• Nemesis Bioscience is developing companion DNA therapeutics and prophylactic termed Nemesis Symbiotics© to inactivate anti-microbial resistance (AMR) in bacterial pathogens
• Our Symbiotics use CRISPR/Cas RNA-guided endonuclease (RGN) technology to inactivate 8 families of beta-lactamase (bla) resistance genes
• Medical and veterinary applications of our technology include prophylactic clearing AMR genes in patients


Conrad Lichtenstein,
CSO, Nemesis Bioscience

14:00 Comparative Microbiome Study in Lean vs. Obese Population: Discovery of Novel Probiotics for Metabolic Health

• Review of DuPont’s integrative platform to discover human commensals to improve metabolic health
• Discovery of 15 candidates from which 4 strains including were assessed in-vivo
• Discussion on preclinical results and in-vivo efficacy of selected strains on T2D model


Sebastien Guer,
Technology & Innovation Leader, DuPont Nutrition & Biosciences

14:30 Delivery of Therapeutic DNA Payloads via Phage-Derived Vectors

• High-titer production of phage capsids containing therapeutic DNA payloads
• Host-range engineering of phage capsids
• Demonstration of in-vivo delivery and expression of payloads
• In-vitro and in-vivo targeted killing of bacterial strains


Xavier Duportet,
CEO, Eligo Biosciences

14:30 MaaT013 - A Dysbiosis Correcting Live Biotherapeutic for the Treatment of AcuteGraft-vs-host-Disease


• GMP requirements
• Working with CMOs
• Looking at scale up and efficiency

 

Hervé Affagard, Founder and CEO, MaaT Pharma

 

15:00 Afternoon Break & Virtual Networking

15:00 Clinical Progress in MDN


• An overview of the specific learnings and challenges


Nikhil Sharma MD,
Consultant Neurologist and Senior Clinical Researcher, UCL

15:30 Afternoon Break & Virtual Networking

Afternoon Plenary – Microbiome-based Biomarkers and Drug Response

4:00 pm Discovery of Pharmacological Agents Emitted by Intestinal Bacteria

Synopsis

Bacteria evoke changes in human cells by producing and emitting agents that can alter human gene expression networks of inflammation, transport, proliferation and metabolism. To discover these biomolecules and to develop them into drugs, a specialized platform can be industrialized to collect clinical microbiome data, conduct multi-technology meta-analysis, select candidates in a data-driven manner and efficiently prepare and screen those agents through in vitro and in vivo models of disease. Challenges and solutions will be presented using examples from ulcerative colitis, oncology and autism.

4:30 pm Rational Design of Gut Microbiome Biomarkers and LBTs to Optimize Cancer Immunotherapy curation

5:00 pm Leveraging the Microbiome to Deliver Safer and More Efficacious Drug Therapies

Synopsis

• Clinical management of chronic inflammatory diseases is frequently inefficient, with few products to help physicians select personalized treatment strategies
• Developing a highly disruptive diagnostic that uniquely draws upon the immunomodulatory role of the microbiome to predict how patients with respond to biologic drugs
• Creating report guides to help doctors select and optimized treatment plan

5:30 pm A Novel Machine Learning Approach to Microbiome Based Biomarker Discovery

Synopsis

• The need and challenges in microbiome-based biomarker discovery
• Using a novel cloud based computational approach utilizing machine learning to identify biomarkers
• Sharing examples of biomarker discovery

6:00 pm Close of Conference