June 3
Human Gut Microbiome (EDT Timezone)
Welcome and Opening Remarks
Investment & Strategic Partnerships
Isabelle de Cremoux | Seventure
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.

Jessica Schneider | Takeda Pharmaceuticals
Director, Gastroenterology Drug Discovery, Microbiome Research
Greg Perry | Finch Therapeutics
CFO
Gerard Honig | Crohn’s and Colitis Foundation
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.

Microbiome in Oncology
OPEN ROUNDTABLE DISCUSSION: Defining Clinical Endpoints in Microbiome/Oncology Clinical Studies.
Diwakar Davar | University of Pittsburgh
Assistant Professor
Julius Goepp | Scaled Microbiomics
CEO
Assaf Oron | BiomX
CBO
Mike Romanos | Microbiota
CEO
Johan Van Hylckama Vlieg | Kaleido
CSO
Morten Isaksen | Bio-Me
CEO

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?

Diwakar Davar | University of Pittsburgh
Assistant Professor

• 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.

Morten Isaksen | Bio-Me
CEO

• 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.

Delphine Lauté-Caly | 4D Pharma
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.

Eric Smith | Diversigen
Bioinformatician
  • 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.

Skin Microbiome (EDT Timezone)
8:45 AM EDT
Welcome and Opening Remarks
Leadership and Innovation
Julia Oh | The Jackson Laboratory
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.

INDUSTRY KEYNOTE: Microbiome and Skin Current Status and Future Opportunities
Sam Samaras | Unilever
VP Science and Technology
Labskin Virtual Clinical Trials, saving time and money on R&D
Alex Chapman | Labskin
Head of Operations
Paul Ryan | Labskin
Chief Business Development Officer
ROUNDTABLE 1: How do you validate the claims that you make on your skin microbiome products
Kristin Neumann | MyMicrobiome
Co-Founder
ROUNDTABLE 2: Combining data analysis methodology for in depth skin microbiome understanding
Mingxun Wang | Ometa Labs
CEO
EXECUTIVE PANEL – Explore and Overcome the Hurdles that are Limiting the Translation and Commercialization of the Skin Microbiome
Kimberly Capone | J&J
Head – Microbiome Platform
Stefanie Tang | Bayer Consumer Health
External innovation and Partnering Lead Dermatology
Sarah De Szalay | RB
Global Category R&D Manager Hygiene Personal Care
Digital life sciences R&D - rethinking microbiome-based product claims
Radouane Oudrhiri | Eagle Genomics
Chief Data Scientist
Sven Sewitz | Eagle Genomics
Head of Biodata Innovation
June 4
Human Gut Microbiome (EDT Timezone)
Gut-Brain-Axis
Chris Weidenmaier | Finch Therapeutics
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

Frank Middleton | Upstate Medical University
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.

ROUNDTABLE DISCUSSION: Using NGS To Determine Causality and Identify Drug Targets in Microbiome-Based Therapeutics.
Karen Woodward | Shoreline Biome
VP Business Development
Dawn Gratalo | Shoreline Biome
Director of R&D
Agnieszka Piotrowska | ARDIGEN
Alliance Manager
Heidi Hau | Rebiotix Inc
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
     
Regulatory Challenges
Qun Wang | FDA
Primary Reviewer
Nikole Kimes | Siolta
Founder & CEO

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?

Neurological Diseases
Ali Keshavarzian | Rush Medical College
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.
Manufacturing
Dan Couto | Vedanta Biosciences
COO
Bharat Dixit | Artugen Therapeutics
VP, Biopharmaceutical Development & Manufacturing
Adrien Nivoliez | Biose Industrie
CEO
Sarah Garant | Seres Therapeutics, Inc
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?

Christopher Missling | Anavex Life Sciences Corp
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.

Skin Microbiome (EDT Timezone)
Modulating the Skin Microbiome
Jay Tiesman | P&G
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.

Maya Ivanjesku | LaFlore Probiotic Skincare
Chief Scientific Officer

Understanding how to tackle and overcome the formulation and commercialization challenges in developing products for the skin microbiome

Commercializing the skin microbiome
Anneleen Cornelissen | Lysando
Head of Microbiology

- Destabilize bacterial cell walls to implement selective removal of undesirable microbial species

Alternative Approaches to the skin microbiome
ROUNDTABLE 2: Challenges of developing novel therapeutics to target the skin microbiome
Eva Berkes | Quorum Innovations
Chief Scientific Officer
ROUNDTABLE 1: Common language: terminology for the skin microbiome and the claims that come from this
Larry Weiss | Symbiome
CEO and Founder
Raja Sivamani | UC Davis
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

Nick Monsul | Quorum Innovations
CEO & Co-Founder

- Exploring functionalized nanoparticles and their role in human barrier protection - Determining POSSIBLE mechanisms of live bacterial defence

Skyler Stein | Gladskin USA
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

June 5
Human Gut Microbiome (EDT Timezone)
9:00 AM EDT
Lucille Yanckello | University of Kentucky
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. 

9:00 AM EDT
Gregory Lambert | TargEDys
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.

9:00 AM EDT
Laurent Chesnel | Artugen Therapeutics
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

9:00 AM EDT
Peter Nara | Keystone Bio
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.
 

9:00 AM EDT
Gerard Honig | Crohn’s and Colitis Foundation
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.

9:00 AM EDT
Serguei Fetissov | TargEDys
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.

9:00 AM EDT
Assaf Oron | BiomX
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.

9:00 AM EDT
Romain Daillere | Gustave Roussy
Research Scientist - Engineer

• 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
 

9:00 AM EDT
Assaf Oron | BiomX
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

9:00 AM EDT
Nicole McKnight | Stellate Therapeutics
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.

9:00 AM EDT
Julius Goepp | Scaled Microbiomics
CEO

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

9:00 AM EDT
Imke Mulder | 4D Parma Research Ltd.
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?

9:00 AM EDT
Fyza Shaikh | John Hopkins School of Medicine
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.

9:00 AM EDT
Mingyang Song | Harvard Medical School
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.
 

9:00 AM EDT
Bret Wallace | Symberix, Inc
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

Skin Microbiome (EDT Timezone)
Commercializing the skin microbiome
Steven Rosenfeld | Columbia Probiotics
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

Marie Drago | Gallinee
Founder
  • 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
Elsa Jungman | ELSI Beauty
CEO and Founder

- 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.   

Substantiating Advertising Claims: Perspectives from The National Advertising Division
La Toya Sutton | NAD
Attorney
Personalized Skin Therapies Through Gut Microbiome Modulation
Momo Vuyisich | Viome
Founder & Chief Science Officer
Jennifer Stansbury | The Benchmarking Company
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