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 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 Strategic Business Decisions & Effective Fundraising for Biotech Companies
Synopsis
- Strategies to position your biotech for investment success
- Strategic decision making in fundraising
- Building and managing relationships and expectations with investors
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 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
2:30 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