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 Intranasal Nose to Brain Cell Secretome Delivery to Non-Human Primates and Clinical Translation From Preclinical to Clinical Settings
Synopsis
- Quantifying labeled protein techniques to measure drug distribution with biomarker analyses and exploring the therapeutic effect of intranasal delivery in human subjects
- Discussion of the critical regulatory pathways and methodologies that bridge preclinical findings to clinical applications
- Clinical case study presentation demonstrating targeted intranasal nose to brain delivery, highlighting key results, challenges faced, and lessons learned
10:00 am Effects of Particulate Matter in Unit Dose Nasal Spray Devices on Spray Performance and Mitigation Strategies for Manufacturing
Synopsis
- Potential types of particulate matter in nasal spray drug products
- Impact of particulate matter on spray performance
- Mitigation of Finished Product particulates in Manufacturing of nasal sprays
10:30 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
11:00 am Break & Networking
11:30 am The Development of Novel Spray-Dried Intranasal Neurosteroids for the Treatment of Neurological Disease
Synopsis
- Spray-dried powder formulation development of neurosteroid enantiomers
- Novel intranasal device performance with spray-dried neurosteroids
- Phase I clinical trial results following treatment of concussive brain injury with intranasal device: neurosteroid combination
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 Selecting the Optimal Delivery Device: Options, Challenges and Opportunities (Or a “Shopping List” to Consider)
Synopsis
- A increasing range of delivery technology is available for purchase or partnering representing a portfolio of options for the drug developer
- Systematic review of the product development needs, careful definition of key project-specific selection criteria and robust matching with the attributes and limitations of different systems is essential
- Significant opportunities can be realized through such a judicious approach to the combination of drug and formulation with the optimal delivery device
2:00 pm 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
2:30 pm Designing Modified Release Formulations for Nasal Administration of Local, Systemic and Targeted Drug Molecules
Synopsis
- Consideration of critical formulation parameters to design modified release (immediate & delayed) dosage forms
- Evaluation of spray characteristics for targeted deposition in internal nasal structures
- Development of in vitro nasal permeation models with PAMPA & other artificial membranes for enhanced delivery
- Formulation attributes to enhance enhanced absorption for N2B delivery in olfactory region