Day One

• Explore how intranasal drug delivery has evolved over the last decade, examining the scientific, regulatory, commercial, and technological developments that are shaping the next generation of nasal therapies
• Understand the critical decisions developers must make when selecting formulations, delivery devices, and development strategies, ensuring both the therapeutic and delivery system are optimized for long-term clinical and commercial success
• Learn lessons from progressing intranasal products through development and regulatory review, identifying common development challenges, unexpected barriers, and opportunities that continue to drive innovation across the nasal delivery landscape

• Explore alternative mechanisms through which intranasal therapies may influence CNS pathways and clinical outcomes
• Understand how clinical and translational evidence can support novel nasal mechanisms without relying solely on traditional pharmacokinetic approaches
• Examine lessons learned from developing intranasal therapies targeting neurological and psychiatric disorders

• Understand the scientific rationale for targeting concussion and traumatic brain injury through intranasal direct-to-brain delivery
• Explore the challenges of generating translational, safety, and clinical evidence to support progression of a novel neurological therapy into human studies
• Learn lessons from advancing a clinical-stage intranasal program, including regulatory strategy, development planning, and building confidence in direct CNS delivery

The ideal opportunity to get face-to-face with many global nasal formulation and delivery leaders for important in-depth conversations.

• Explore how intranasal RNA therapies can enable targeted modulation of neural circuits while avoiding systemic exposure
• Understand the opportunities and challenges of delivering RNA therapeutics directly to the brain through nose-to-brain pathways
• Learn how next-generation genetic medicines may unlock new treatment approaches for cognitive, psychiatric, and neurodegenerative disorders

• Exploring how intranasal delivery can bypass the blood-brain barrier to enable direct access to the central nervous system
• Examining the opportunities and challenges of developing potent biologics for neurodegenerative diseases including Alzheimer’s, Parkinson’s, and ALS
• Understanding the scientific, clinical, and commercial considerations needed to drive broader adoption of nose-to-brain therapeutics

• Explore how targeted intranasal access to the sphenopalatine ganglion may offer an alternative approach to influencing CNS-relevant pathways beyond traditional olfactory-focused delivery strategies
• Understand the development journey from clinician-administered SPG procedures to scalable intranasal drug-device combination products capable of improving patient access and treatment convenience
• Learn how delivery strategy, formulation design, and device development must work together to support successful clinical translation, regulatory development, and future commercialization opportunities

• Explore how targeting the nasal mucosa can generate differentiated immune protection by stimulating local mucosal immunity and cellular immune responses at the site of pathogen entry as well as in serum, providing a distinct immunological profile compared to traditional systemic antibody responses achieved through injectable vaccines
• Understand the historical biases as well as scientific and development challenges associated with intranasal vaccine platforms, including achieving durable immune protection, demonstrating clinical efficacy, optimizing deposition within the nasal cavity, and building confidence in alternative immune correlates of protection
• Learn how next-generation intranasal vaccines are leveraging favorable safety profiles, needle-free administration, and mucosal and serum immune activation to improve patient acceptance, expand access, and create new opportunities for preventing infectious respiratory diseases beyond traditional vaccination approaches

• Avoid costly reformulation, redevelopment, and regulatory delays by integrating formulation, device, and combination-product strategy from the earliest stages of development rather than treating them as separate workstreams
• Understand how formulation characteristics, delivery route requirements, and device performance interact to influence product success, patient usability, manufacturability, and long-term commercial viability
• Learn practical lessons from developing integrated liquid and powder-based intranasal products, highlighting common mistakes that lead to drug-device compatibility challenges and how to prevent them

Witness some of the latest and greatest research in the nasal drug development & delivery field by drug developers, academics, service providers, and researchers in this spotlight poster session!

• Address the challenge of highly variable patient anatomy by understanding how differences in nasal geometry, airflow patterns, and target site accessibility can influence deposition, absorption, and therapeutic outcomes
• Evaluate the impact of common factors such as nasal obstruction, congestion, inflammation, and disease state on delivery performance to improve study design and patient selection strategies
• Improve confidence in clinical translation by identifying approaches to account for anatomical variability during preclinical development, device optimization, and clinical evaluation to achieve more consistent treatment outcomes across patient populations

• Understand how early integration of formulation development with device design and manufacturing capacities while meeting regulatory requirements can prevent costly late-stage redesigns, delays, and regulatory setbacks
• Explore the key development challenges associated with advancing powder-based combination products, including device reliability requirements, human factors trials, clinical development planning, and regulatory expectations
• Learn how teams can build commercially viable intranasal products by integrating patient, payer, and provider perspectives into target product profiles

• Identify the critical scientific, translational, and clinical evidence gaps that remain before nose-to brain delivery can achieve widespread regulatory acceptance and commercial adoption
• Understand what regulators still need to see regarding reproducibility, biodistribution, imaging, clinical outcomes, and direct CNS exposure before confidently supporting nose-to-brain claims
• Debate whether current preclinical models, analytical tools, imaging technologies, and translational approaches are sufficient to predict human outcomes and support development decisions
• Separate genuine scientific progress from industry hype by examining which technologies, pathways, and approaches are producing meaningful evidence versus those that continue to face significant validation challenges