James Kelly
Chief Medical Officer Oragenics
Seminars
Wednesday 3rd February 2027
Advancing a First-in-Class Intranasal Neurosteroid for Concussion: Lessons from Clinical Development of a Direct-to-Brain Therapy
9:30 am
- 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
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
