Explore the Agenda
8:00 am Morning Coffee & Check-in
Workshop A
9:00 am Navigating Regulatory Pathways for Intranasal Drugs to Achieve Efficient, Risk-Reduced Product Development
As interest in intranasal therapeutics accelerates, spanning systemic delivery, local nasal treatments, and emerging nose-to-brain approaches, regulatory expectations have become increasingly complex and highly product-specific. Intranasal drugs no longer follow a single pathway, mechanism of action, target tissue, or delivery method.
This has shaped what evidence regulators require. Designed for teams developing and bringing intranasal products to market, this hands-on workshop, led by senior regulatory experts with direct experience navigating FDA and EMA submissions, will cut through the complexity by blending case examples with practical frameworks. Participants will gain clarity on how to design development programs that are compliant, efficient, and
approval ready.
This workshop will explore:
- Regulatory Expectations Across Modalities: Understand what FDA and EMA require for intranasal drugs, and where the grey areas lie
- Designing Evidence Packages that Accelerate Approval: Learn how to strategically plan compatibility studies, human factors assessments, PK/PD work, and device performance data to support smoother submissions
- Avoiding Common Pitfalls in Nasal Drug Development: Explore real-world missteps in formulation, device selection, safety data, and early study design that slow development, and learn how to proactively mitigate them
12:00 pm Networking & Light Lunch
Workshop B
1:00 pm Building an Investment-Ready Intranasal Program
Securing funding for intranasal therapeutics has never been more competitive. As investors become increasingly selective and funding tightens, developers must show not only strong science but also a compelling commercial narrative, differentiated positioning, and evidence of de-risking across development. Designed for biotech founders, R&D leaders, program directors, and BD teams advancing novel intranasal modalities, this interactive workshop, led by active biotech investors and seasoned fundraisers, will help participants transform their programs into investment-ready opportunities. Through practical frameworks and real-world insights from successful
raises, attendees will learn how to communicate scientific value, articulate a credible regulatory and commercial pathway, and craft a compelling story that resonates with venture capital, angels, and strategic partners.
This workshop will explore:
- Crafting a Compelling Scientific and Commercial Narrative: Learn to communicate the therapeutic rationale, unmet need, differentiation, and market opportunity behind your nasal product
- De-Risking Strategies that Matter to Investors: Understand what funders actually look for
- Positioning for Funding Success: Benefit from networking and group project activities, ending in a Shark Tank–style competition