FOCUS DAY TRACK
Bioconvergence Enabling Microbiome Platforms
Synopsis
Join this targeted focus day as we facilitate the convergence of biological sciences, data analytics and engineering principals to accelerate R&D into viable drug candidates
Assessing Effective Adoption of AI/ML to Gain Efficiencies & Refine Quality
8:30 am Shaping Our Microbiome for Lifelong Health
Synopsis
- Broadly representative human microbiome data access has been limited, and consequently has slowed progress on the development of models of human health and wellness
- Advanced genomic sequencing methods are now available to further our insight into how microbes within our bodies influence our physiology and health
- Today, we have the capabilities to economically construct comprehensive, high quality and reproducible data repositories for researchers to innovate our next generation models of human health and wellness
9:00 am Multi-Level Analysis of the Gut–Brain Axis Shows Autism Spectrum Disorder-Associated Molecular & Microbial Profiles
Synopsis
- We designed a Bayesian differential abundance algorithm that analyzed 15 studies, 25 datasets and multiple omics levels to identify links between the gut microbiome and autism
- We identified metabolic signatures spanning diet, gut metagenome and host brain transcriptome that that differentiated autistic individuals from age-sex matched neurotypical controls
- The majority of the inferred ASD-associated microbes in the meta-analysis were depleted in the Kang et al FMT study, mirroring the improvement in autistic symptoms 2 years after the intervention
Exploring Microbiome Analytical Tools
9:30 am Panel Discussion: Unravelling Barriers to Adoption of AI/ML in Microbiome Research
Synopsis
- How can we more critically assess the extent to which AI/ML technologies could transform drug development?
- What are the biggest bottlenecks to implementing novel AI, taking data quality and patient safety data into account?
- What is the current outlook of today’s novel AI technology pipelines?
- How can AI be used to address challenges surrounding trial length?
DEEP-DIVE NETWORKING WORKSHOPS
Strategic Intelligence for Portfolio Planning & Network Building
Synopsis
Data and discussions bringing you the most current microbiome ecosystem updates, paired with working sessions to strengthen your connections with key opinion leaders and field experts
8:30 am Workshop A – Defining a Strategic Roadmap for Transitioning from Successful Clinical Trials to Regulatory Approval: Phase Appropriate Regulatory Strategy
Synopsis
With regulatory approval and commercialization pivotal milestones in the microbiome drug development journey, join this workshop to benchmark best practices and engage in discussions to address:
- Designing a Phase-Appropriate Regulatory Strategy: Explore the strategic roadmap for transitioning from successful clinical trials to regulatory approval, focusing on key considerations at each stage of drug development
- Regulatory Challenges and Performance Control: Delve into the challenges of regulatory submissions and learn how to best control performance through robust planning, data analysis, and adherence to regulatory standards
- Establishing Reference Standards: Discuss the importance of reference standards and controls in ensuring accuracy in regulatory submissions, and explore practical approaches to implement them effectively
Participate in this collaborative workshop to develop a comprehensive strategic roadmap guiding you through the intricacies of the regulatory landscape. This roadmap aims to facilitate a smooth transition from successful clinical trials to regulatory approval and subsequent commercialization of your microbiome drug development program.
Featuring a Case Study: Regulatory Considerations for Microbiome-Based Therapies for Pediatric Use
Synopsis
- Provide an overview of regulatory considerations for microbiome-based product development in pediatric populations
- Discuss scientific and ethical issues to consider when including pediatric populations in clinical trials
- Provide information about important FDA resources available to product developers
10:30 am Morning Break
11:00 am Single-Cell Genomics for Resolution of Conserved Bacterial Genes & Mobile Genetic Elements of the Human Intestinal Microbiota Using Flow Cytometry
Synopsis
- A method utilizing fluorescence-activated cell sorting for isolation of single bacterial cells, amplifying their genomes, screening them by 16S rRNA gene analysis, and selecting cells for genomic sequencing to provide nearly complete coverage of bacterial genomes when applied to isolates and partial genomes of bacterial species recovered from complex communities
- Utilizing this method to uncover conserved and variable genomic regions between samples from healthy and patient samples
- Show novel organisms discovered utilizing a flow cytometric approach to probing the microbiota
11:30 am Role of the Immune T Regulatory Cells in Mood Disorders and Alzheimer’s Disease Phenotype as a Therapeutic Target in Altered Gut-Brain Axis Cross-Talking
Synopsis
- The role of the gut-brain axis in the onset and progression of degenerative conditions, including Alzheimer’s disease, will be discussed. In particular, the implication of the causative role of T-regulatory cells mediated influence on adaptive immunity in the gut-brain axis communication
- Discussion of strategies to intervene in the brain degenerative progression by targeting selected T-regulatory mediated mechanisms to mitigate abnormal brain permeability and disease progression in response to stress-induced mood/ psychological impairment associated with the onset of Alzheimer’s disease phenotype
- Discussion of novel strategies to move from preclinical observations to the clinical setting
12:00 pm Leveraging Spatial Methods & Analysis for Microbiome-Based Biological Insights
Synopsis
- A highly multiplexed FISH approach to uncover microbiome-based markers
- Investigating antibiotic recovery to identify risk through foundational bacteria
- Correlating bacterial biomarkers with recovery through spatial analysis techniques
11:00 am Workshop B – Navigating Geographic and Regulatory Variances in Microbiome Drug Development
Synopsis
As the success of microbiome drug development increasingly hinges on strategic considerations for different geographies and regulatory landscapes, this workshop offers a platform assessing clinical strategies covering:
- Designing Drug Development Programs for Varied Regulatory Environments: Uncover the intricacies of tailoring drug development programs to suit diverse geographies and regulatory environments, ensuring viability and compliance at each stage
- Essential Data Requirements for Geographic Expansion: Assess the specific data needs crucial for assessing the viability of microbiome drug development platforms in different regions, particularly US and Europe, addressing regulatory variations and market dynamics
- How to Overcome Challenges in Regulatory Diversity: Debate challenges associated with varying regulatory environments and learn how to best control and optimize drug development strategies to ensure success across different geographies
Join this interactive and synergistic learning group to craft a robust drug development strategy, considering geographic nuances and regulatory diversities. Develop insights into essential data requirements for informed decision-making and strategic planning, ultimately ensuring the success of your microbiome drug development program on a global scale.
12:30 pm Lunch & Networking
1:30 pm Interactive Working Group Discussion: Navigating Analytical Gaps: Fostering Innovation for Robust Assessment of Microbiome Drug Efficacy in Clinical Settings
Synopsis
Engage in a collaborative discussion to identify and comprehend the existing analytical gaps hindering the accurate assessment of microbiome drug efficacy in clinical settings. Joining this session will enable you to plan ahead to:
- Gain visibility on the breadth of analytical approaches and testing tools supporting robust data generation
- Understand the potential pathways for industry stakeholder to collectively promote the creation and validation of tools to help demonstrate safety & efficacy in target patient populations?
The Microbiome Movement: Standardization & Probiotic Data Beyond Drug Development
2:30 pm Innovative Platform Development: Validating a Novel Platform in Preclinical Models of the Microbiome in Differential Physiological States
Synopsis
- Determining technology advantages and disadvantages
- Planning funding for experiments validating technology
- Applications across different disease areas
1:30 pm Workshop C – Market Engagement: Paving a Path to Commercially Successful Microbiome Drug Development
Synopsis
With commercial viability being more pivotal than ever to secure the longevity of microbiome drug development, learn from biopharma, payer and research leaders throughout a platform facilitating discussion across:
- Evaluating Market Performance: Explore the current landscape of microbiome drugs in the market, assessing the performance of approved companies and what this means for today’s therapeutics in the pipeline
- Identifying Investment Attractors: Delve into key factors that attract investment and widespread buy-in for live biotherapeutics, examining successful cases and strategizing for future investment opportunities
- Building Early Networks for Industry Support: Discuss the importance of establishing early networks to garner industry support and enhance buy-in, fostering collaboration and knowledge exchange for the growth of microbiome modality development
Join this deep-dive to craft strategies for promoting the commercial strengths of microbiome platforms. Explore market dynamics, investment attractors, and early network-building initiatives to ensure the success and widespread adoption.
Featuring a Case Study from Yakult Netherlands: Gut Microbiota Management: A One Health Business Case & Valorization Potential
Synopsis
- The epidemiology of infectious, autoimmune and metabolic disorders: a scientific business case for the need of gut microbiota management
- Gut microbiota management by microbial intervention: challenges and strategies
- The valorization of gut microbial interventional modalities: healthcare professional acceptance and costs reduction studies
3:30 pm Afternoon Break
The Microbiome Movement: Standardization & Probiotic Data Beyond Drug Development
4:00 pm Translating Preclinical Gut-Brain Axis Research into Clinical Trials Using Prebiotic Interventions
Synopsis
- Overview of the gut-brain axis: Emerging work suggests that the gut microbiota and its metabolites play a key role in modulating brain activity and behaviour. One of the key mechanisms by which the gut microbiota influences the brain is via the production of shortchain fatty acids (SCFAs), produced during the microbial fermentation of prebiotic fibre
- How to translate preclinical gut-brain axis research into human clinicals: Most of the gutbrain axis research comes from preclinical (animal) studies, but due to the large variability between the mouse and human microbiota, preclinical observations have not always been replicated in clinical trials
- Finally, I’ll present findings from a 12-week open label parallel group RCT, where participants were randomised into a control group receiving healthy eating advice, or an intervention group receiving healthy eating advice alongside myota’s daily prebiotic supplement. At pre- and post-invention, we assessed gut microbiome profiles, inflammation, and mood, stress, and anxiety scores. This work represents a critical step in progressing gut-brain axis research from preclinical settings, to the more complex and nuanced human state
4:30 pm The Use of a Novel Dual Pro- & Post- Biotic in Adults with IBS-D: Results from a Recent (Unpublished) RCT
Synopsis
- IBS is a hugely important diagnosis, with few effective management options
- ADM recently completed a 3-arm randomized, double blind placebo controlled clinical trial in adults with IBS-D
- This talk will cover the full results, including data on IBS symptom severity, abdominal pain scores, quality of life and anxiety
4:00 pm Workshop D – Microbiome Macroeconomics: Analysing Industry Trends to Inform Microbiome Drug Development Strategy
Synopsis
With industry trends serving as crucial guideposts for strategic decision-making in microbiome drug development, seize the opportunity in this workshop to benchmark effective practices and explore:
- Trend-Informed Pipeline Strategy Beyond Drug Development: Examine the latest industry trends shaping microbiome drug development, as well as across the microbiome product field, and how these inform strategic decisions in optimizing drug pipelines
- Application and Modality Insights: Gain preliminary insights into the therapeutic applications and platforms showing promise, identifying areas of opportunity and potential for innovation
- Navigating Bottlenecks: Delve into the challenges and bottlenecks currently faced in microbiome drug development, fostering discussions on overcoming hurdles and strategizing for improved pipeline efficiency
Participate to dissect industry trends, garner valuable insights, and collectively shape a forward-thinking pipeline strategy for the success of your microbiome drug development program.