Day Two

• Explore how powder formulations can overcome stability limitations associated with traditional liquid products while simplifying storage, transportation, and long-term product performance
• Understand how formulation and device design influence deposition, absorption, and pharmacodynamic performance, including lessons learned from clinical development
• Learn how developers are overcoming regulatory, manufacturing, and product development challenges when advancing powder-based intranasal products toward commercialization

• Explore how intranasal delivery is creating new opportunities for immune modulation, infectious disease prevention, and treatment beyond traditional symptomatic therapies
• Understand how local nasal delivery can improve therapeutic effectiveness while reducing systemic exposure and minimizing development challenges associated with conventional administration routes
• Evaluate emerging strategies being used to address antimicrobial resistance and respiratory health through innovative intranasal therapeutic platforms

• Develop a framework for selecting the most appropriate formulation approach based on molecule characteristics, target indication, and delivery objectives
• Understand the trade-offs between powders, liquids, nanoparticles, and enhanced formulations when balancing efficacy, manufacturability, stability, and patient experience
• Avoid costly reformulation and development delays by aligning formulation strategy with long-term clinical, regulatory, and commercial goals

• Explore how next-generation biologic modalities can overcome traditional delivery barriers to enable effective intranasal administration while maintaining therapeutic activity
• Understand how intranasal biologics can leverage local mucosal immunity to provide differentiated therapeutic benefits across infectious disease and other emerging applications
• Learn from the development of novel biologic platforms and the scientific, translational, and regulatory considerations required to progress these therapies toward clinical success

• Explore how nanoparticle-enabled delivery systems can overcome absorption barriers associated with peptides and biologics while minimizing systemic exposure
• Understand how intranasal GLP-1 delivery may create differentiated therapeutic profiles by targeting CNS pathways while potentially reducing gastrointestinal side effects
• Learn how developers are balancing bioavailability, manufacturability, safety, and scalability when advancing next-generation peptide therapies

• Identify the characteristics that make preclinical intranasal models predictive of human deposition, uptake, and therapeutic outcomes
• Explore current limitations of animal, in vitro, and translational models when evaluating olfactory and trigeminal delivery pathways
• Learn how emerging technologies and model innovations may improve confidence in candidate selection and reduce clinical development risk

• Explore the unique challenges associated with evaluating powder-based intranasal products in preclinical studies, including administration techniques, dose accuracy, and reproducibility across animal models
• Understand the strengths and limitations of commonly used preclinical approaches for assessing safety, pharmacokinetics, deposition, and product performance when developing nasal powders
• Review practical strategies developers are using to generate more relevant preclinical data and improve confidence when progressing powder-based products toward clinical development

Where the Industry Solves Its Biggest Nasal Challenges Together

At the start of the session, attendees will be invited to submit the single biggest obstacle they are currently facing via a live poll. Whether it's demonstrating nose-to-brain delivery, improving clinical translation, overcoming bioavailability limitations, selecting the right device strategy, navigating regulatory uncertainty, or progressing next-generation biologics, every challenge is welcome.

We'll consolidate the responses into the most common themes and divide attendees into facilitated discussion groups to explore practical solutions together.

Each group will work through three key questions:

• What is the root cause of this challenge and why does it continue to persist across the industry?
• What approaches have been attempted so far, and why have they succeeded or failed?
• What is the single highest-impact action the industry could take to overcome this challenge?

Facilitated by the Chair.