8:00 am Registration & Morning Coffee

8:50 am Chairperson Opening Remarks

(Continuation of Yesterday’s Theme) Translating Basic Microbiome Science into Therapeutic or Nutritional Targets Through Pre-Clinical Models

9:00 am Microbiome-Derived Live Biotherapeutics to Target the Gut-Brain Axis

Synopsis

• Overviewing 4D Pharma’s MicroRx discovery platforms designed to specifically target neurodegenerative diseases such as Parkinson’s Disease
• Demonstrating preclinical data on how 4D Pharma LBP candidates affect gutbrain communication and how bacterial metabolites affect pathways involved in neuroinflammation, neuroprotection and neurodifferentiation
• Sharing additional data on how specific LBPs can influence neuro-behavioural conditions such as autism spectrum disorders

9:30 am TREG-modulating Therapeutics for the Treatment of Multiple Sclerosis

Synopsis

• Symbiotix Biotherapies has been developing a novel class of molecular therapeutics based on molecules derived from gut microbiota
• These molecules function via a first-in-class mechanism that results in activation of regulatory T cells, and we have been exploring therapeutic application to MS and other immune-mediated conditions
• We have completed upstream and downstream process development for our lead program, SYMB-104, and are moving towards human clinical testing

10:00 am Addressing Oral Systemic Inflammation via Precision Biotherapeutic Pharmabiome Intervention Directed Against Porphyromonas gingivalis

  • Peter Nara Chief Scientific Officer & Founder , Keystone Bio

Synopsis

• A peripheral Keystone Pathogen is capable of establishing a dysbiotic altered microbiome
• Keystone pathogens can significantly alter host responses and disease processes both locally and distally within the body
• Targeted precision biotherapeutics to keystone pathogens may represent a novel and important means of ameliorating multiple disease conditions and allow for re-establishment of a more normal microbiome

10:30 am Networking & Morning Refreshments

Harnessing Clinical Experience to Inform In-Human Study Design & Microbiome-Based Product Development

Synopsis

Permeation of microbiome science into the healthcare and pharmaceutical industries has meant that more investigators are integrating the collection of microbiome samples throughout in-human clinical trials. However, in many cases this has been done retrospectively. This theme will harness clinical experience on how to design prospective trials that collect and analyze microbiome data, what to do with retrospectively collected microbiome data and considerations on microbiome v disease-specific endpoints so that you can plan a trial that has clinically relevant endpoints.

11:00 am Discussing Challenges in Clinical Trial Design – Lessons Learned from RCTs of Fecal Transplant in Mood Disorders

  • Valerie Taylor Department Chair of Psychiatry & Scientist, University of Calgary & Hotchkiss Brain Institute

Synopsis

• Overviewing the clinical evidence translating GBA work in to the area of mental health treatment
• Discussing pragmatic challenges designing clinical trials targeting the GBA

11:30 am Sharing Clinical Data that Identifies Gut Microbiota Biomarkers Associated with Improved Clinical Response in Alzheimer’s Disease Patients Treated with ANAVEX®2-73

Synopsis

• Linking high-levels of two gut microbiota families to improved responses with ANAVEX®2-73
• Outlining how and why ANAVEX®2-73 may have a beneficial homeostatic effect on brain-gut microbiota axis

12:00 pm Clinical Experience of Targeting Alpha Synuclein in Enteric Nerves Produced in Response to Infection Over the Life Course to Treat Parkinson’s Disease

Synopsis

• Exploring the underlying pathogenic pathways linking alpha synuclein and the enteric nervous system resulting from the aggregate impact of infection over the life course
• Demonstrating clinical activity of ENT-01 in the treatment of Parkinson’s Disease
• Ensuring clinical success – key takeaways for getting products into the clinic

12:30 pm Lunch & Networking

1:30 pm Clinical Study Design Considerations for the Testing of Gut Retentive Products, such as AB-2004, in the Neurological Disease Setting

Action Session – How Can We Transform the Way We Design Clinical Study Programs that are Investigating the Microbiome-GBA?

Synopsis

Interact with your peers in small groups in an ‘Action’ Session – we’ve heard about clinical case studies and had a chance to dig deeper and understand what has facilitated clinical progress so far. But what are we going to change when we get back to our organizations?

2:00 pm What Will You Now Change About Your Approach to R&D Planning When the Ultimate End Goals are to Inform Clinical Investigation & Improve Patient Outcomes?

Highlighting Organizations that Provide Support to Projects Targeting the Microbiome Gut-Brain Axis

Synopsis

As we face the global public health challenge of an ageing population, it is vital to assess the funding opportunities to help turn microbiome gut-brain axis R&D into a clinical reality. The purpose of this theme is to highlight organizations that provide funding and support projects targeting the microbiome gut-brain axis.

2:30 pm Advancing Parkinson’s Disease Research through Funding and Collaborative Team Building

  • Nicole Polinski Senior Associate Director, Research Programs, The Michael J. Fox Foundation for Parkinson's Research

Synopsis

• Overviewing the MJFF funding programs and additional resources MJFF provides to support Parkinson’s disease research
• Highlighting our experience with building collaborative groups comprised of different stakeholders to move Parkinson’s Disease research forward
• Touching on MJFF’s involvement in Parkinson’s disease-related microbiome studies and our current goals as they pertain to supporting this area of research

Speed Learning: R&D Setbacks & Leaps Forward from Research & Industry Leaders that are Shaking Up the Microbiome-GBA Space

Synopsis

Uncover the story behind setbacks and leaps forward from those conducting research and product development for gut-brain related disorders in a quick-fire session. Each table will be hosted by a Neurogastroenterology leader who will share the secrets of their most high-impact leap forward in microbiome GBA research and implications for biomarker identification, product development or public health policy. You then get the opportunity to question the host before moving on to the next table. Stories to be shared include:

1. Learnings from A Commercial Product Development Journey in the Microbiome Gut Brain Axis Space

Zain Kassam
Executive VP of Clinical Development & Translational Medicine
Finch Therapeutics

2. Inspiring Cross-Functional Thinking in Mutli-Disciplinary Teams to Ensure Microbiome Gut-Brain Research Project Success

 

 

3. Building Partnerships/Collaborations & Setting Expectations on Both Sides to Achieve R&D Goals

Phil Strandwitz
Co-Founder & CEO
Holobiome

3:45 pm Chairperson’s Closing Remarks

4:00 pm End of 3rd Microbiome Movement – Gut-Brain Axis Summit