Stuart Madden
Chief Scientific Officer Neurelis
Seminars
Tuesday 2nd February 2027
Navigating Regulatory Expectations for Intranasal Products, Nose-to- Brain Therapies, & Novel Delivery Platforms
9:00 am
This interactive workshop brings together industry experts to explore evolving FDA and global regulatory expectations, providing practical guidance on building development programs that reduce regulatory risk and accelerate progress toward the clinic.
Discussion Areas:
- What evidence do regulators actually require to support nose-to-brain claims?
- Understanding FDA expectations for powders, biologics, and novel delivery technologies
- Bioequivalence vs in vitro bioequivalence pathways
- Addressing regulatory uncertainty surrounding direct CNS delivery
- Bridging conflicting expectations around animal testing, modeling, and safety packages
- Learning from successful INDs, NDAs, and regulatory interactions
- Understanding the value of systemic exposure for nose to brain delivery
- Reducing regulatory risk by aligning device reliability, human factors, and manufacturing strategy early in nasal combination product development
Wednesday 3rd February 2027
Panel Discussion: Has the Industry Finally Solved Nose-to-Brain Delivery?
5:00 pm
- 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
