Ken blount
cso Rebiotix Inc., a Ferring Company
Seminars
Monday 23rd June 2025
Workshop B: Translating Microbiome Data into Actionable Biomarkers & Regulatory Approvals
1:00 pm
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.
Tuesday 24th June 2025
Pioneering the Future of Microbiome Therapeutics: Assessing Clinical Progress & Outlining Market Opportunities
8:10 am
- Evaluating clinical progress by analysing existing approvals and late-stage clinical trial candidates
- Unlocking new market opportunities in oncology, women’s health, and metabolic disorders while navigating pharma investment trends
- Assessing the current progress of incorporating advanced technologies like AI-driven microbiome analysis, synthetic biology, and scalable manufacturing to accelerate innovation
Tuesday 24th June 2025
Clinical Update on C. diff Candidate RBX2660
11:30 am
- Discussing the pivotal Phase 3 trial results of RBX2660, demonstrating its superior efficacy in reducing recurrence of Clostridioides Difficile Infection (CDI)
- Explore the significance of FDA approval and breakthrough therapy designation for RBX2660, and its impact on accelerating the development and availability of this microbiome-based therapeutic
- Future Directions and Applications: Examine the potential expansion of RBX2660’s use in other high-risk patient populations and the ongoing efforts to address unmet medical needs in gastrointestinal health
