Conference Day Two

9:00 am Coffee & Light Breakfast

9:25 am Chair’s Opening Remarks

Translational Modelling for Nasal Drug Delivery to Maximize Practical Drug Applications

9:30 am Quantifying Nasal Drug Delivery in Humans Through Translational Evidence From Pre-Clinical to Clinical Settings

  • Larry Brown Executive Vice President & Chief Scientific Officer, Noveome Biotherapeutics

Synopsis

  • Exploring advanced imaging modalities and biomarker analyses used to measure drug distribution and quantify the extent of nasal delivery in human subjects
  • Discussion on the critical pathways and methodologies that bridge preclinical findings with clinical applications
  • Presentation of case studies demonstrating successful nasal delivery, highlighting key results, challenges faced, and lessons learned

10:00 am Assessing Nasal Drug Delivery in Humans: Bridging Preclinical Insights to Clinical Applications

  • Krishna Subramanian Vice President, Head of Non-clinical &Translational Science, Seelos Therapeutics

Synopsis

  • Examining cutting-edge imaging techniques and biomarker analysis for evaluating drug distribution and nasal delivery efficacy in humans
  • Discussing essential methodologies and pathways that connect preclinical evidence to clinical trial outcomes
  • Reviewing case studies showcasing successful nasal drug delivery, focusing on key findings, challenges, and practical takeaways

10:30 am Roundtable: Innovations and Challenges in Mucoadhesive Systems for Nasal Drug Delivery

Synopsis

  • Discussing advancements in mucoadhesive technologies to enhance nasal drug retention and absorption
  • Identifying challenges related to formulation, adhesion, and patient tolerability
  • Exploring regulatory considerations and testing methods for mucoadhesive-based nasal formulations

11:00 am Break & Networking

11:30 am 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

12:00 pm Transnasal Minimally Invasive Trigeminal Interventions

Synopsis

  • Trigeminal nerve pathways and their anatomical connections to the brain, highlighting how nasal drug delivery can leverage these routes for targeted delivery
  • Combination of Radiologic and Endoscopic Video assisted Large Language Models (AI) to maximize the efficacy of N2B drug delivery
  • Current research and clinical applications utilizing trigeminal nerve, NALT, Eustachian Tube pathways for drug delivery, emphasizing their potential in enhancing therapeutic outcomes

12:30 pm Lunch Break & Networking

Determining the Efficacy of Delivery Devices to Improve Target Region Delivery

1:30 pm Navigating Olfera’s Brain Drug Delivery Platform to Examine Optimization of Delivery of Challenging Modalities

  • Parnian Lak Founder & Chief Executive Officer, Olfera

Synopsis

  • OChip, an in vitro screening tool
  • Olfactory prodrugs for brain drug delivery
  • Delivery of challenging modalities

2:00 pm Roundtable: Evaluating How Changes to Formulation Can Influence Decisions Around Delivery Devices

Synopsis

  • Modifications in formulation, such as viscosity and particle size, affect compatibility with different delivery devices
  • Examination of how formulation changes can enhance delivery efficiency and patient experience, leading to decisions on device design
  • Insights into the regulatory implications of formulation changes on device selection

2:30 pm Optimizing Regulatory Guidance for Powder Nasal Delivery Formulation & Devices

  • Laura Andrade Associate Director - Research, Development & Innovation, Insud Pharma

Synopsis

  • Overview of the key regulatory bodies and their guidelines specific to powder nasal delivery systems
  • Best practices for ensuring that both formulation and delivery devices meet regulatory standards, focusing on stability testing, quality control, and consistency in dosing
  • Strategies for streamlining the regulatory approval process, including early engagement with regulatory agencies, comprehensive documentation, and addressing common pitfalls in nasal powder delivery submissions

3:00 pm Chair’s Closing Remarks