Collaboration is vital to support innovation in the microbiome arena and ensure that products get to patients as swiftly as possible. This interactive workshop, featuring short presentations and roundtable discussions, allows you to connect with like-minded individuals to overcome some of the key bottlenecks in the regulation of microbiome-based drugs, including: clinical trial design, endpoint and biomarker selection, use of expedited review pathways and product nomenclature.

Establishing an early-stage vision for bioprocessing developments of live biotherapeutic products from a datacentric perspective

• Understanding the optimum CMC and understanding assay appropriateness for specific live biotherapeutic formulas.
• Applying a targeted approach for CMC and assay development that reflects the regulatory landscape
• The importance of integrating technical expertise and regulatory understanding

This presentation will provide an overview of regulatory considerations for microbiome-based product development in pediatric populations. Scientific and ethical issues for microbiome product development will be discussed in the context of relevant regulatory guidances. Pediatric Research Equity Act (PREA) requirements, 21 CFR Subpart D (Additional Safeguards for Children), and informed consent for this population will be highlighted. Important resources to consider when including pediatric populations in microbiome trials will be provided.

Collaboration is vital to support innovation in the microbiome arena and ensure that products get to patients as swiftly as possible. This interactive workshop, featuring short presentations and roundtable discussions, allows you to connect with like-minded individuals to overcome some of the key bottlenecks in the regulation of microbiome-based drugs, including: clinical trial design, endpoint and biomarker selection, use of expedited review pathways and product nomenclature.