Explore the Agenda

Pre-Conference Day

Tuesday, February 2

Day One

Wednesday, February 3

Day Two

Thursday, February 4

8:00 am Registration & Morning Coffee

Workshop A

9:00 am Navigating Regulatory Expectations for Intranasal Products, Nose-to- Brain Therapies, & Novel Delivery Platforms

Stuart Madden
Chief Scientific Officer, Neurelis
Brian Taubenheim
Chief Operations Officer, Belhaven Biopharma
Stephen Shrewsbury
Fractional Chief Medical Officer,, Lionbio & TransformBio

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

12:00 pm Lunch Break & Networking

Workshop B

1:00 pm From Nose-to-Brain Theory to Clinical Success: Building a Development Strategy That Investors, Regulators, & Partners Will Support

Heather Loring
Associate Director - Search & Evaluation, AstraZeneca
Jason Cook
Co-founder & Chief Executive Officer, Olfax Medical

This highly practical workshop is designed for teams looking to understand what separates successful intranasal development programs from those that fail. Through open discussion, attendees will explore how to build robust development strategies that generate confidence among investors, partners, regulators, and future commercial stakeholders.

Discussion Areas:

  • What evidence convinces investors to fund intranasal programs to de-risk programs?
  • Understanding reimbursement and commercialization requirements and avoiding common development
  • Understand how large pharma evaluates emerging intranasal technologies, platforms, and therapeutic programs when considering partnership or licensing opportunities
  • Identify the scientific, clinical, and regulatory milestones that increase confidence and help transform promising innovation into a commercially attractive asset
  • Learn how developers can reduce perceived development risk, strengthen differentiation, and build evidence packages that support productive conversations with strategic partners

4:00 pm End of Pre-Conference Workshop Day

Day One
Day Two
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