All Timings Below in Central European Time

Morning Plenary – Streamlining Regulatory Approval of Microbiome-based Therapeutics

8:30 am Morning Registration & Virtual Networking

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

  • Alice Rouanet Regulatory Affairs Associate , Pharmabiotic Research Institute

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 Lightning-Round Discussions 3: Regulatory Considerations

Synopsis

Following on from yesterday, Three further, three-minute quick-fire discussions to share opinions with your peers on these three questions:
1. What are the biggest regulatory uncertainties you face, that you’re hoping to find answers to at this conference?
2. Where are you currently looking for help with regulatory challenges?
3. What regulatory hurdles do you see emerging in the next five years?

9:40 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

10:10 am The Microbiome as a Companion for Therapeutical Developments

Synopsis

• Product development : safety, toxicity, efficacy
• Stool collection
• Methodological, technological and data insights

10:40 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.

11:05 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

11:05 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

11:35 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

11:35 Building a Strategic Partnership to Effectively Scale and Manufacture Microbiomebased Therapeutics

Adrien Nivoliez, CEO, Biose Industrie

12:05 EU-funding for Collaborative Microbiome Projects and Future Research Policies

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


Dirk Hadrich
, Policy and Programme Officer, European Commission

Clinical Trials

12:05 Microbiome-Drug Interactions: Clinical Trials, Biomarkers and Bioinformatics in IBD

Marcus Claesson, Lecturer, University College Cork

Onthatile Serehete, Medical Doctor - Clinical Trials, Atlantia Food Clinical Trials

12:35 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

13:05 Lunch & Demo Area

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 Guery,
Technology & Innovation Leader, DuPont Nutrition & Biosciences

14:30 Addressing microbiome-associated diseases via the targeted delivery of CRISPR and therapeutic DNA payloads

  • Eligobiotics platform enables targeted delivery of DNA payloads to the microbiome
  • Foundational inventors of CRISPR-based killing of bacteria
  • First-ever demonstration of symptoms mitigation in a disease model by delivering a CRISPR system to gut the microbiome
  • Examples of applications in skin and gut microbiome / AMR, inflammation and infectious disease

Xavier Duportet, CEO, Eligo Biosciences

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

  • Introduction to MaaT Pharma’s Microbiome ecosystem therapies platform
  • Discussion of recent results obtained in 29 patients with acute Graft versus Host Disease with MaaT013
  • Perspectives for microbiome ecosystem-based therapeutic approaches)
John Weinberg, Chief Medical Officer, MaaT Pharma

 

15:00 Iron and the Gut Microbiome: an Important Consideration for LBPs Targeted Towards
the Chronically Inflamed or Stressed Gut

• During chronic gut inflammation and/or stress, luminal levels of iron are high
• Lactobacilli and bifidobacteria, species commonly investigated for LBP potential, rarely use iron as a growth factor and are therefore rapidly out-competed in a high-iron environment
• Ferryx has identified a safe and effective strain of Streptococcus thermophilus (FX856) which increases growth rate in response to iron and has demonstrated anti-inflammatory properties


Jenny Bailey
, CEO & Co-Founder, Ferryx

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 & Speed Networking

Afternoon Plenary – Microbiome-based Biomarkers and Drug Response

4:00 pm Discovery of a Highly Predictive Microbiome Signature of Checkpoint Inhibitor Response Leads to Potent Antitumor Live Bacterial Therapeutic

4:30 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.

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