Brian Taubenheim
Chief Operations Officer Belhaven Biopharma
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
Building Development-Ready Nasal Combination Products: Lessons Learned from Advancing a Powder-Based Emergency Therapy
4:30 pm
- 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
