Regulatory Considerations in Commercializing a Non-Antibiotic Microbiota-Based Drug Targeted for Recurrent Clostridium difficile Infection

Regulatory Considerations in Commercializing a Non-Antibiotic Microbiota-Based Drug Targeted for Recurrent Clostridium difficile Infection

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Microbiome / Microbiota
R&D and Business Collaboration Forum
October 2-3, 2014, San Digo, CA

Background

Clostridium difficile infection is the leading cause of healthcare acquired diarrhea, and is linked to perturbations of the intestinal microbiota initiated by antibiotics. Approximately, 20% to 30% of patients will go on to experience recurrence, with each additional episode predisposing to further recurrence. No drug is currently indicated for recurrent Clostridium difficile infection.