Explore the Agenda
8:00 am Morning Coffee and Check-in
8:55 am Chair’s Opening Remarks
Ensuring Safe, Compliant & Measurable Nose-to-Brain Delivery for CNS Therapeutics
9:00 am Regulatory Perspectives on Nose-to-Brain Delivery Pathways to Accelerate Safe and Compliant CNS Drug Development
- Clarify regulatory expectations for intranasal drugs targeting the CNS
- Explore how FDA and EMA evaluate device/formulation combination products for safety and efficacy
- Provide guidance for designing preclinical and clinical packages to support regulatory approval
9:30 am Session Reserved for Medpharm
10:00 am Reimagining Rare Disease Treatment Through Intranasal Delivery to Transform Patient Experience
- Human Impact of Rare Disease: Framing unmet needs through the lived experience of patients and families
- Why Nasal Delivery Changes the Paradigm: Lessons from neurology showing how intranasal routes can replace invasive administration
- ASOs and the Nose-to-Brain Opportunity: Exploring why intranasal delivery may unlock safer, more practical CNS access
10:30 am Morning Break
Translating Preclinical Nasal Models to Predict Human Clinical Outcomes for Safer and More Effective Therapeutics
11:30 am Predictive Animal Models for Nasal Drug Absorption and Distribution for CNS Applications
- Examine the value and limitations of current models for nasal drug delivery
- Explore anatomical and physiological differences that impact translation from animal studies to humans
- Understand strategies to increase predictive power, through novel technology including nasal casts
12:00 pm Session Reserved for Intertek
12:10 pm Leveraging Organoids and Innovative Models to Predict Clinical Outcomes
- Explore the use of organoid systems to study local toxicity, deposition, and absorption patterns
- Examine how these models informed dosing, formulation, and delivery strategies for clinical trials
- Highlight lessons learned and best practices for integrating preclinical models into development programs
12:40 pm Experimental Models to Quantify, Predict & De-Risk Brain Delivery
- Reviewing current experimental evidence and biological mechanisms governing nose-to-brain transport and brain parenchyma exposure
- Benchmarking in vitro brain tissue models against animal and emerging human in vivo PK/PD data to strengthen preclinical translation
- Exploring how advanced brain models and experimental datasets can inform predictive tools, formulation strategy, and future clinical study design
1:10 pm Lunch Break
Transforming Therapeutics Through Intranasal Delivery of Advanced Modalities: Overcoming Formulation Barriers to Maximise Efficacy and Patient Impact
2:00 pm Optimizing Carriers for Nasal Nucleic Acid Delivery and Lipid Nanoparticles to Improve Delivery Efficiency and Maximize Therapeutic Effect
- Deep dive into lipid nanoparticle (LNP) technologies for RNA and oligonucleotide delivery
- Exploring novel mechanisms of action and key design considerations influencing delivery performance
- Landscape overview of current and emerging approaches in intranasal nucleic acid delivery
2:30 pm Exploring Powder-Based Intranasal Delivery as a Platform for Systemic Therapeutics
- Compare powder versus liquid intranasal delivery, highlighting how deeper nasal deposition, increased surface area, and richer vascular access can drive faster and higher systemic absorption
- Explore the critical challenges of particle size distribution, particle shape, and limited large-scale manufacturing capacity, and how proprietary formulation strategies can address them
- Advancing powder-based naloxone and epinephrine programs, including device considerations, scalability planning, and where innovation is still needed across delivery technologies and manufacturing infrastructure
3:00 pm Intranasal Delivery of a Novel Synthetic Small-Molecule Antibiotic Using Nanocarriers
- Trace the journey from honey-derived antimicrobial activity to a scalable, water-soluble synthetic small molecule designed for intranasal delivery
- Explore how intranasal administration enables early intervention against viral infections that trigger secondary bacterial disease, with implications for resistance management
- Learn how nanocarrier delivery supports sustained local release, minimizes systemic exposure, and enables safe degradation into non-cytotoxic components after therapeutic action