Synopsis

Served with coffee + light breakfast

Synopsis

To drive microbiome-based therapeutics forward, we must address the critical gaps in data collection, statistical analysis, and validation. This workshop brings together key experts to discuss:

• Standardizing Sample Collection & Processing: Learn how improved chemistry and sequencing methods can enhance reproducibility, with insights from NIST and industry leaders
• The Impact of Biostatistics on Decision-Making: Understand how inadequate statistical analysis can mislead research and drug development, and explore biostatistical solutions tailored for microbiome studies
• Resolving Discrepancies in Bioinformatics Analyses: Examine case studies demonstrating how different computational methods yield varying conclusions from the same microbiome dataset
• Validating Microbiome-Based Biomarkers: Explore successful case studies where microbiome sequencing has been validated for diagnostic and therapeutic applications
• Engage in interactive discussions and gain practical strategies for improving microbiome data reliability, ensuring stronger translational success for therapeutics

Synopsis

As microbiome-based therapeutics move closer to regulatory pathways, overcoming data variability and establishing robust biomarkers is essential. This workshop will explore:

• Defining and Validating Microbiome Biomarkers: Discover best practices for developing clinically meaningful biomarkers and linking them to regulatory endpoints
• AI and Big Data in Microbiome Research: Learn how AI-driven analytics and spatial biology are shaping the next generation of microbiome-based therapeutics
• Regulatory Considerations for Microbiome Drug Development:
• Navigate the evolving FDA landscape and understand what it will take to translate microbiome biomarkers into approvable clinical endpoints
• Investor and Industry Perspectives: Gain insights from investors and industry leaders on which microbiome innovations hold the greatest potential for commercialization

Join this deep dive into the intersection of microbiome data science, regulatory strategy, and commercialization to accelerate your therapeutic pipeline.