Anna Nowocin
Head of Cellular Immunology Medicines & Healthcare Products Regulatory Agency (MHRA)
Seminars
Thursday 25th September 2025
Extended Q&A & Fireside Discussion: Harmonizing the Exosome & Extra-Cellular Vesicle Regulatory Landscape Towards Better Definitions, Practices & Guidelines for Therapeutic Success
9:30 am
- What are the current gaps in knowledge of submissions, and what can we learn from current therapeutic progress in the clinic?
- How does the current regulatory guidance provide clarity on CMC changes for exosome-based therapeutics?
- How can the exosome biopharma industry and regulators continue to support each other to ensure global harmony and better therapeutics to patients faster?
Thursday 25th September 2025
Biological Standardization & Development of Reference Reagents & Bioactivity Assays for Extracellular Vesicles
9:00 am
- Bioactivity/potency testing considerations for complex Biotherapeutics and ATMPs
- Bioactivity reference materials development
- Process optimisation for manufacturing of MSC-EVs bioactivity standards
BRAND NEW SESSION
