Conference Day Two
9:00 am Coffee & Light Breakfast
9:25 am Chair’s Opening Remarks
Translational Modelling for Nasal Drug Delivery to Maximize Practical Drug Applications
9:30 am Quantifying Nasal Drug Delivery in Humans Through Translational Evidence From Pre-Clinical to Clinical Settings
Synopsis
- Exploring advanced imaging modalities and biomarker analyses used to measure drug distribution and quantify the extent of nasal delivery in human subjects
- Discussion on the critical pathways and methodologies that bridge preclinical findings with clinical applications
- Presentation of case studies demonstrating successful nasal delivery, highlighting key results, challenges faced, and lessons learned
10:00 am Assessing Nasal Drug Delivery in Humans: Bridging Preclinical Insights to Clinical Applications
Synopsis
- Examining cutting-edge imaging techniques and biomarker analysis for evaluating drug distribution and nasal delivery efficacy in humans
- Discussing essential methodologies and pathways that connect preclinical evidence to clinical trial outcomes
- Reviewing case studies showcasing successful nasal drug delivery, focusing on key findings, challenges, and practical takeaways
10:30 am Roundtable: Innovations and Challenges in Mucoadhesive Systems for Nasal Drug Delivery
Synopsis
- Discussing advancements in mucoadhesive technologies to enhance nasal drug retention and absorption
- Identifying challenges related to formulation, adhesion, and patient tolerability
- Exploring regulatory considerations and testing methods for mucoadhesive-based nasal formulations
11:00 am Break & Networking
11:30 am Keep It Simple Stupid: Making Intranasal Biologic Drugs for Population Scale Access
Synopsis
- GMP scalability and COGS once made intranasal biologics impossible
- New technology makes this feasible today, unlocking key advantages in development costs, commercial viability, and equitable access
- How to think about optimally balancing the tradeoffs between safety, purity, and developability
12:00 pm Transnasal Minimally Invasive Trigeminal Interventions
Synopsis
- Trigeminal nerve pathways and their anatomical connections to the brain, highlighting how nasal drug delivery can leverage these routes for targeted delivery
- Combination of Radiologic and Endoscopic Video assisted Large Language Models (AI) to maximize the efficacy of N2B drug delivery
- Current research and clinical applications utilizing trigeminal nerve, NALT, Eustachian Tube pathways for drug delivery, emphasizing their potential in enhancing therapeutic outcomes
12:30 pm Lunch Break & Networking
Determining the Efficacy of Delivery Devices to Improve Target Region Delivery
1:30 pm Navigating Olfera’s Brain Drug Delivery Platform to Examine Optimization of Delivery of Challenging Modalities
Synopsis
- OChip, an in vitro screening tool
- Olfactory prodrugs for brain drug delivery
- Delivery of challenging modalities
2:00 pm Roundtable: Evaluating How Changes to Formulation Can Influence Decisions Around Delivery Devices
Synopsis
- Modifications in formulation, such as viscosity and particle size, affect compatibility with different delivery devices
- Examination of how formulation changes can enhance delivery efficiency and patient experience, leading to decisions on device design
- Insights into the regulatory implications of formulation changes on device selection
2:30 pm Optimizing Regulatory Guidance for Powder Nasal Delivery Formulation & Devices
Synopsis
- Overview of the key regulatory bodies and their guidelines specific to powder nasal delivery systems
- Best practices for ensuring that both formulation and delivery devices meet regulatory standards, focusing on stability testing, quality control, and consistency in dosing
- Strategies for streamlining the regulatory approval process, including early engagement with regulatory agencies, comprehensive documentation, and addressing common pitfalls in nasal powder delivery submissions