Brian Taubenheim
Chief Operations Officer Belhaven Biopharma
Brian Taubenheim has built his career by effectively combining science, business, and project management to achieve successful outcomes in complex and regulated environments. He has worked for small and large organizations in numerous leadership positions, participating on the executive leadership teams and being responsible for setting strategic objectives and translating those into executable operational plans. In his current role at Belhaven, Brian was tasked with assembling the required multidisciplinary team to develop a combination product and oversees product development and business operations.
Seminars
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
- 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
