Understanding what is needed from sponsors to efficiently progress through the IND submission process without delay. Landscape overview of regulatory demands at each stage of clinical progression to obtain consistency and safety.

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.

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

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.

• Considerations for reducing the intensiveness of resource consumption during early bioprocessing developments.
• Prioritization of the fundamental variables of bioprocessing developments to accelerate effective product development.
• Discussing ‘good to haves’ vs ‘essentials’ in the development of live biotherapeutic products without impeding quality.

Characterizing the considerations for capsule drug delivery of GEMMs demonstrating long-term patterns of bacterial engraftment. Identifying the bacterial communities successfully engrafted through genomic methods.

• PharmaBiome's NicheMap™ technology maps bacteria into functional niches taking into account the relevant complex context of intestinal microbiota
• The NicheMap™ provides an evidence-based selection rationale for strains that make up out metabolically interacting LBP consortia
• We produce these ecologically engineered consortia using cocultivation with PharmaBiome's C3 technology
• The NicheMap™ and C3 produce consortia with strong control over pharmacokinetics and pharmacodynamics

• Discussing the application of in-silico simulation (CarbonMirror Platform) to bioprocessing
• Understanding the limitations and benefits of in-silico simulation, choosing the optimum conditions for maximum yield and tackling biofilms