Explore the Agenda
8:00 am Check in & Morning Coffee
8:50 am Chair’s Opening Remarks
Honing Potency Assays to Improve Biological Relevance & In-depth Understanding of Your Therapeutic’s Efficacy
9:00 am Developing Robust & Reproducible Potency Assays to Address Variability in Biologics & Assay Standardisation
- Managing biological variability in exosome preparations through well-defined reference standards and controls
- Implementing cell-based and functional assays with high sensitivity and reproducibility across manufacturing batches
- Establishing assay validation frameworks to ensure robustness, precision, and regulatory compliance
9:30 am Defining Potency Assays for Exosome Therapeutics to Link Mechanism of Action to Measurable Biological Activity & Better Understand Product CQAs
- Establishing potency assays that reflect the proposed mechanism of action, including immunomodulation, angiogenesis or tissue repair
- Moving beyond surrogate markers to functional readouts that capture biologically relevant exosome activity
- Correlating in vitro potency with in vivo efficacy to support clinical translation and dose justification
10:00 am Extracellular Vesicles from Microbial Cells for Clinical Applications
- Establishing in process controls upstream to monitor yield and quality
- Providing analytics acceptable to regulatory authorities
- Proactively developing potency assays that reflect the proposed mechanism of action, including stability, integrity and immunomodulation
10:30 am Morning Break
Evaluating the Applications of Exosomes For Various Indications & How Analytical Testing Can Help Improve Understanding of Key Quality Metrics
11:30 am Extracellular Vesicles From Human Cerebral Endothelial Cells Exposed to Oxygen-Glucose Deprivation Exhibit Potent Activity Against Hepatocellular Carcinoma
- Understanding why EVs from hCEC cells exposed to OGD deprivation express potent activity against hepatocellular cell lines
- Identifying how EVs from hCEC cell exposed to OGD deprivation express potent activity against a wide array of cancer cell lines
- Evaluating why EVs from hCEC cells exposed to OGD deprivation have no activity against benign cells
12:00 pm Analyzing Real World Exosomes from Lab to the Clinic to Understanding Clinical & Analytical Experience
- Reviewing case reports from current exosome-based therapeutics
- Understanding the benefits of exosomes in high-cost diseases
- Identifying the accessibility in manufacturing & analysis to better understand your exosomes
12:30 pm Lunch
Standardising Exosome & EV Analysis to Improve Consistency of Data & Streamline Testing Timelines
1:30 pm Engineering Programmable Natural Nanoparticles for Organ-Targeted Delivery: Immunology to CNS Therapeutics
- NNP Design AI: AI-guided engineering for DDS design
- NNP Manufacturing: Scalable production and analytical development of engineered NNPs
- Brain-Targeted and Immunology-Targeted Natural Nanoparticle Platforms
2:30 pm Roundtable Discussion- Examining Regulatory Alignment & Validation of Analytical Methods for Exosome Therapeutics to Build Confidence in Clinical Grade Manufacturing
- Aligning analytical validation with regulatory expectations for accuracy, precision, specificity, and robustness in complex biologics
- Integrating analytical standardisation into GMP workflows for batch release and comparability assessments
- Supporting regulatory submissions with validated, reproducible datasets that demonstrate consistent product quality and safety