Conference Day One

8:25 am Check-In & Light Breakfast

8:55 am Chair’s Opening Remarks

Creating Easy-to-Scale Projects to Become an Attractive Acquisition Prospect for Investors

9:00 am Navigating Investment Pathways for Startup Companies Within the Nasal Space

  • Ryan Kole Co-Founder, Beyond Barriers Therapeutics

Synopsis

  • Emphasis on presenting strong preclinical and early clinical data that demonstrate the safety, efficacy, and unique benefits of the intranasal drug, showcasing its potential for market success
  • Discussion of the importance of articulating a compelling value proposition that outlines the product’s competitive advantages, potential market impact, and alignment with current healthcare trends
  • Insights into building strategic partnerships with industry leaders and highlighting any existing funding or collaborations that enhance credibility

9:30 am Roundtable: Exploring Strategies Employed From Starting a Drug Company to Successful Exit

Synopsis

  • Overview of key initial steps in building a nasal drug company, including identifying niche markets, developing a unique value proposition, and securing initial funding
  • Effective strategies for navigating regulatory pathways and clinical trials specific to nasal drug delivery, ensuring compliance, and accelerating product development
  • Crafting a strategic exit plan, including identifying potential acquirers, forming partnerships with larger pharmaceutical companies, and positioning the company for maximum valuation at exit

10:00 am Panel: Examining the Venture Capitalist Criteria for Intranasal Delivery Startup Investments

Synopsis

  • How venture capitalists assess the market size, unmet needs, and competitive dynamics of the intranasal delivery sector to gauge the potential for growth and return on investment
  • Insights into the importance of demonstrating unique technology, strong intellectual property, and innovative approaches in drug formulation and delivery that set the startup apart from competitors
  • Emphasis on the necessity of having a capable management team with relevant experience and a clear, executable business plan, including regulatory pathways and commercialization strategies, to instill investor confidence

10:30 am Speed Networking

Synopsis

This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. Get face-to-face time with many of the nasal formulation and delivery experts to establish meaningful business relationships.

11:00 am Morning Break & Networking

11:30 am Demonstrating Value to Venture Capitalists to Secure Investment for Intranasal Drug Development

Synopsis

  • Examine investor due diligence with patient advocacy
  • Best practices for investors to understand the relationship between advocacy organizations and KOLs
  • Understanding the role that these different groups play in the valuation of new products

12:00 pm Keep It Simple Stupid: Making Intranasal Biologic Drugs for Population Scale Access

  • Brian Finrow Founder & Chief Executive Officer, Lumen Bioscience

Synopsis

  • GMP scalability and COGS once made intranasal biologics impossible
  • New technology makes this feasible today, unlocking key advantages in development costs, commercial viability, and equitable access
  • How to think about optimally balancing the tradeoffs between safety, purity, and developability

12:30 pm Lunch & Networking

Increasing Drug Bioavailability in Target Regions to Maximize Drug Utility

1:30 pm Enhancing Bioavailability of Nasal Drugs to Maximise Drug Retention in the Brain

Synopsis

  • Discussion of innovative formulation approaches designed to facilitate direct drug transport to the brain while minimizing systemic absorption into the bloodstream
  • Examination of techniques to optimize the intranasal delivery route, including device design and administration protocols, to enhance localized drug retention
  • Ways to assess the distribution of drugs in the brain versus systemic circulation, guiding formulation adjustments to improve overall bioavailability and therapeutic efficacy

2:00 pm Enhancing Bioavailability of Nasal Drugs to Maximize Drug Retention in Systemic Targets

Synopsis

  • Increase bioavailability and retention for targeted efficacy
  • Explore pathways to enhance systemic absorption
  • Strategies to reduce nasal clearance for sustained drug impact

2:30 pm Afternoon Break & Networking

3:00 pm Roundtable: Exploring the Effects of Drugs on the Nasal Membranes Before Reaching the Target Region

Synopsis

  • Analysis of how various excipients and formulation components influence the integrity and permeability of nasal membranes
  • Discussion on the interactions between drugs and nasal mucosa, including potential irritation or toxicity
  • Overview of methodologies, such as in vitro models and histological evaluations, used to study the effects of drugs on nasal membranes

3:30 pm Bridging Pre-Clinical & Early Human Studies With Clinical Design

Synopsis

  • Case-study led insights on current clinical development program
  • Design of clinical trials and how this is linked back to delivery
  • Ways to optimize these methods

4:00 pm Chair’s Closing Remarks