CEO
• Understand how microbiome investment is set to change in 2021 in light of COVID-19 and Rebiotix’s positive phase 3 clinical results.
• Asses what makes a successful microbiome company and delve into the reasons Seventure invested in Enterome, MaaT Pharma, Targedys, LNC and Vedanta and what they’re looking for in terms of (pre)clinical data for future investment in microbiome companies.
Director, Gastroenterology Drug Discovery, Microbiome Research
CFO
Associate Director, Research and Innovation
Our panellists assess what pharma and VCs look for when investing in biotechs from a data and business point of view, so that you can:
• Analyse how strategic partnership deals between biotech companies and Pharma are structured.
• Understand the data you need to attract investment and how this differs in preclinical vs clinical data.
• Discover how your company can secure funding for pre-clinical and phase 1/2 clinical trials.
MD - Assistant Professor of Medicine
Chief Executive Officer
CBO
CEO
Chief Scientific Officer
Founder & Chief Innovation Officer
With big pharma investing in a verity of immune checkpoint inhibitor combination therapies (oncolytic viruses, combinations of checkpoint inhibitors, microbiome-based therapies) where does the microbiome stand vs other combo therapy types and what does the microbiome industry need to do to ‘win’ this battle vs other combo therapy types?
MD - Assistant Professor of Medicine
• Discover how the composition of the intestinal microbiome effect PD-1 checkpoint inhibition therapy. Is it causal or a correlation?
• Learn how to modulate the gut microbiome using FMT to improve response to Pd-1 checkpoint inhibition therapy from.
• What is the mechanistic understanding of the gut microbiome’s role in checkpoint inhibition and how does it differ in responders vs nonresponders?
• Understand the future clinical study plans to improve mechanism of action.
Founder & Chief Innovation Officer
• PMP is a rapid, detailed, accurate and high throughput microbiome profiling tool that makes that fulfills the requirements for microbiome-based Precision Medicine in a clinical setting.
• Learn about preliminary results of using PMP to distinguish between UC and CD in children with IBD.
• Application of PMP in cancer treatment in general and ImmuneOncology specifically.
Team Lead
• 4D pharma present their preclinical data demonstrating the ability of LBPs to offer a novel approach to immuno-oncology in monotherapy and combination settings through strong immunostimulatory profiles.
• Assess the selected LBP candidates that inhibit tumour growth across multiple preclinical models and how these could be applied
clinically in the future.
• Learn how 4D pharma were able to characterise the bioactive molecules involved in molecular mechanisms of action and develop drugs to target immuno-oncology.
Bioinformatician
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Carbohydrates are key metabolites that shape and fuel the microbiome, and carbohydrate active enzymes (CAZymes) are the repertoire of genes necessary for their metabolism.
Join us to understand how Prescient Metabiomics is implementing CAZyme characterization in their clinical studies and how you can apply their approaches to your pipeline.
Assistant Professor
In this session we’ll cover the impact of horizontal gene transfer on microbiome targeting and suppress virulence and alter metabolism at a population level through strain admixture.
VP Science and Technology
Operations Manager
Chief Business Development Officer
CEO
Co-Founder
Microbiome Expert
External innovation and Partnering Lead Dermatology
Global Category R&D Manager Hygiene Personal Care
Chief Data Scientist
Head of Biodata Innovation
Associate Director - Host Cell Biology
Review existing clinical data describing the impact of microbiota transplantation on gut microbiota composition and GI/behavioral symptoms of ASD
Review the known mechanisms linking the gut microbiota composition and function to core and peripheral symptoms of ASD
Discuss the novel challenges of developing a microbiome therapeutic for a complex disorder such as ASD
Associate Professor
• Using shotgun metatranscriptomics and metagenomics to map taxa of healthy vs early stage Parkinson’s patients revealed 40 distinct taxa with altered abundance, including clusters of specific Lactobacilli.
• The approach also revealed shifts in functional transcriptional networks of oral bacteria and the human host.
• This approach thus facilitates identification of biomarkers that may help improve the accuracy of Parkinson’s diagnosis, and indicate potential therapeutic opportunities.
• Current work is expanding the human studies and using in vitro and in vivo mouse models to investigate the possible manipulation of the microbiome to improve Parkinson’s related symptoms.
VP Business Development
Director of R&D
Alliance Manager
Director, Technology Expansion
- Understand the current mechanistic understanding of RBX2600 in recurrent Clostridioides difficile infections
- Latest phase 2a/b clinical data covering mechanism of action and metabolomic impact of the RBX2600 in recurrent C. difficile infection.
- Phase 2a/b clinical trial design and lessons learned from the studies so far
Primary Reviewer
Founder and Chief Executive Officer
With Rebiotix’s positive initial phase 3 clinical results, this is the perfect opportunity to ask the FDA direct questions regarding the future of microbiome-based therapies and the route to market approval:
• With multiple modalities being used to modulate the gut microbiota, what biomarkers do you needed to be measured to determine PK and PD?
• How do we measure the safety and efficacy of microbiome modulating drugs?
• What will be required from the FDA in terms of standardisation of these measurement methods? How will Rebiotix’s positive phase 3 results impact this?
Professor, Department of Internal Medicine, Division of Digestive Diseases and Nutrition
- Understand the role of the gut microbiota in neurological disorders and the application of dietary changes to prevent disease progression.
- Discover the microbiome derived metabolites involved in Parkinson’s and the key biomarker’s measured.
Chief Operating Officer
VP, Biopharmaceutical Development & Manufacturing
CEO
Executive Director, CMC Manufacturing
• Understand how our speakers are controlling the costs of goods for LBPs in phase 1 and 2.
• Assess the latest methods to avoid pathogen presence in final LBP product.
• In-house or CDMO? With manufacturing not being a core competency of microbiome companies, what are the implications of both business models and which is best for your company?
• How can you implement better analytics for quality control (including PCR and flow cytometry) to replace classical approaches like microscopy and CFU count?
PhD - President & CEO
• Discover the correlations between the gut microbiota and response to the drug in Alzheimer’s patients.
• Assess the mechanism of action of the drug from 2020 phase 2b/3 clinical data from 450 Alzheimer’s patients.
• Analyze the genomic biomarkers used in the study to determine efficacy and apply to your own discovery pipeline.
• Understand how and why the high levels of two specific microbial families improve ANAVEX2-73 response in Alzheimer’s patients.
Genomics Group Lead
Develop robust molecular tools for understanding genomic interaction and utilize it for research on areas including the skin and scalp. Understand the human:microbe interaction at the genome level and gain new insights into how we can optimize our co-existence.
Chief Scientific Officer
Understanding how to tackle and overcome the formulation and commercialization challenges in developing products for the skin microbiome
Head of Microbiology
- Destabilize bacterial cell walls to implement selective removal of undesirable microbial species
Chief Scientific Officer
CEO and Founder
Associate Professor
- Assess the impact that oral probiotics can have on the production of lipids on the skin - Explore the communication network linking the immune, endocrine, and metabolic systems
CEO & Co-Founder
- Exploring functionalized nanoparticles and their role in human barrier protection - Determining POSSIBLE mechanisms of live bacterial defence
President
- How the endolysin approach differs from probiotics, prebiotics and, postbiotics - Comparison of endolysin and antibiotic effects on skin bacteria in treatments for common skin conditions
MD
• A bioinformatics platform that improves on existing pipelines by standardizing critical preprocessing and downstream analysis tools, enabling comprehensive evaluations of taxonomic and functional signals across sequencing datasets.
• Identification of novel bacterial signatures associated with clinical responses that could potentially be used as biomarkers in patients undergoing treatment with checkpoint inhibitors.
Director
• Introduce the role of enteric bacterial beta-glucuronidases (GUS) in triggering lower GI toxicities associated with prescription medications
• Demonstrate that GUS-targeting, small-molecule drugs can prevent these medication-induced lower GI injuries, such as chemotherapyinduced diarrhea
• Reveal the inter-individual variability among the ~300 GUS orthologs that make up the “GUSome” in the human gut microbiome
• Discuss the GUSome as a case study on the unique challenges of developing microbiome-targeting drugs
• Demonstrate the utility of a stool-based functional assay to assess patient-relevant GUSome function
• Disclose how the assay can be developed as a companion diagnostic to potentially identify patients who are responsive to GUSometargeted drugs
Assistant Professor
• Assessing whether post-diagnosis fiber intake correlates with improved survival rates in a 1500 strong cohort of colorectal cancer patients.
• Understand how observational data was leveraged and linked to metagenomic and metatranscriptomic data.
• Learn how a multi-omics approach was used and how the lessons learned can be used in future studies.
Research Director
• The poly-pharmaceutical nature of LBPs offers new therapeutic avenues to treat multifactorial disease such as Parkinson’s Disease.
• What are the LBP candidates with complementary activities that protect against specific neurodegenerative readouts and the latest understanding of their mechanisms of action?
• What are the bacterial metabolites (including short-chain fatty acids) that influence gut-brain axis communication at multiple levels and how do they operate in molecular mechanisms?
PhD Student
• Assess the microbial taxonomic data and system-wide metabolomics data, investigating the impact of dietary inulin on the metabolites and species present in mice.
• Understand how the mouse model was designed to include a human AP0E4 gene and why this is relevant to Alzheimer’s Disease.
• Discover the therapeutic potential of inulin in reducing neuroinflammation and the inflammatory biomarkers used to measure this.
Chief Operating Officer
• AMA-101: An example of a small molecule drug against Parkinson’s disease.
• Preclinical data demonstrating the AMA-101’s mechanism of action.
• The unique set of metabolites that are produced by a healthy gut microbiota and the maintenance of health and their mechanistic importance in Parkinson’s disease.
• Utilising Amabiotic’s microbiome indication screening process for small molecule drug discovery.
• How microbiome-derived diagnostics can pave the way for personalized medicines to treat gut-brain disorders such as Parkinson’s.
CBO
• Understand the latest 2019/2020 preclinical data describing Phage’s molecular mechanism
• Discover the key considerations for designing a phage cocktail therapy for Acne Prone Skin
• Be the first to learn about the measurable microbiota biomarkers of efficacy for phage therapies in Acne Prone Skin
Head of Preclinical Research, Co-Founder
• Understand how Everimmune harness the microbiome for the discovery of diagnostic and therapeutic tools in cancer and how the gut microbiota is key for modulating the clinical outcome of anticancer regimens
• Assess data from EverImmune’s development of oncobax-based therapeutics to improve the efficacy of anticancer treatments
CBO
• Discover how the presence of intra-tumoral F. nucleatum promotes tumor growth and treatment resistance in colorectal cancer.
• Assess the latest 2019/2020 in vivo data on how to engineer phage to target and eradicate specific bacteria (F. nucleatum) in the tumor microenvironment for therapeutic response.
• Understand the mechanisms of action of phage therapy in colorectal
cancer and the phase 1 clinical studies being designed to study these
mechanisms further.
Scientific advisor and co-founder
• How are Targedys utilising molecular mimicry to develop bacterial metabolites and small molecules to target the gut-brain axis and treat obesity?
• Understand the role of the gut microbiome in the regulation of the appetite and the accompanying data describing the molecular mechanisms and metabolites involved.
• Learn how Targedys selected the strain for their product and designed animal proof of concept trials to demonstrate efficacy.
• Discover how Targedys formulated, scaled-up and ensured the stability of the final product and the lessons learned along the way.
• Designing successful human clinical trials and consumer studies to get your product to market faster and at a lower cost.
Associate Director, Research and Innovation
• Why biomarkers are critical to address unmet patient needs and accelerate drug development in the IBD field.
• Examples of microbiome-based biomarkers for risk stratification in IBD.
• Scientific, regulatory and commercial criteria for biomarker selection in IBD drug development.
CSO
• Learn how to identify keystone pathogens using next generation sequencing techniques.
• Understand how P. Gingivitis can colonise and form bio-films in the oral microbiome, leading to systemic inflammation and manipulation of the local microbiota environment.
• Assess the preclinical data and learn how monoclonal antibodies have been developed against P. Gingivitis to prevent systemic inflammation.
• Discover how the preclinical proof of concept will be translated into phase 1 clinical trials in 2020.
VP, Research and Development
• Discover the key in vitro characteristics of ART24 related to its direct activities against C. difficile and its toxins
• Learn how the in vitro properties translate in an animal model of CDI
• Explore the in vitro and in vivo impact of ART24 exposure on the faecal microbiota
• Describe the clinical development plan for Phase 1 focussing on safety and tolerability
CEO
• How are Targedys utilising molecular mimicry to develop bacterial metabolites and small molecules to target the gut-brain axis and treat obesity?
• Understand the role of the gut microbiome in the regulation of the appetite and the accompanying data describing the molecular mechanisms and metabolites involved.
• Learn how Targedys selected the strain for their product and designed animal proof of concept trials to demonstrate efficacy.
• Discover how Targedys formulated, scaled-up and ensured the stability of the final product and the lessons learned along the way.
• Designing successful human clinical trials and consumer studies to get your product to market faster and at a lower cost.
Chief Executive Officer
This presentation will introduce passive immunotherapy for modulation of microbiome structure and dynamics, using avian immunoglobulins (IgY) as effector molecules. After a brief description of IgY as a technology, we discuss how it can be used to intervene in the myriad signaling pathways and event cascades that promote dysbiosis-induced pathology, giving as an example a pathway leading to colorectal cancer. Finally, we present two case studies on drug candidates developed by Scaled Microbiomics to prevent Travelers' Diarrhea and COVID-19, as illustrations of the speed with which the company's drug discovery platform can work
CEO
- Assess how plant stem cell extracts suppress the activity of proteases which slow down skin renewal processes - Determine long term safety implications of pre, pro and post biotics on the skin microbiome
CEO
- Quick intro of Gallinée and our credentials as a microbiome skincare company
- The role of nutrition in explaining the microbiome in beauty, and the logical transition to ingestible beauty
- How to develop a high standard probiotic supplement
- The gut skin axis: Education of the beauty consumer, how to help them navigate a new world
- Wishes for the future
- Quick intro of Gallinée and our credentials as a microbiome skincare company
- The role of nutrition in explaining the microbiome in beauty, and the logical transition to ingestible beauty
- How to develop a high standard probiotic supplement
- The gut skin axis: Education of the beauty consumer, how to help them navigate a new world
- Wishes for the future
Founder & CEO
- Understanding the impact of skincare products and hormonal changes on the microbiome and sensitive skin.
- Developing a new way to develop cosmetics to respect the skin microbiome and barrier function.
- Building an in vitro and in vivo microbiome platform through partnerships to assess the impact of cosmetics on the skin microbiome.
Attorney
Founder & Chief Science Officer
Co-Founder
- A genetic approach that could be applied to identifying skin microbiome products beneficial for different skin types - Communicate product claims about skin microbiome to the consumer