Conference Day Two

Thursday | March 14, 2024

Event Live!

Event Live!

8:00 am Morning Coffee & Networking

8:45 am Chair’s Opening Remarks

Leveraging Cutting Edge Devices & Compatibility for Complex Therapeutic Indications

9:00 am Panel Discussion: Extrapolating Neurological Indications with the Greatest Potential to Leverage Intranasal Administration

  • Laleh Golshahi Engineering Foundation (Endowed) Associate Professor, Mechanical Engineering & Pharmaceutical Engineering, Virgina Commonwealth University
  • Andrew Martin Professor, Mechanical and Biomedical Engineering, University of Alberta
  • Robert Thorne Denali Fellow, Head of Postdoc Program, Denali Therapeutics
  • Krishna Subramanian Vice President & Head of Non-Clinical & Translational Science, Seelos Therapeutics

Synopsis

  • Empowering opioid overdose, bipolar disorder, anxiety, depression and more with the potential advantages of nasal formulations, such as increased specificity and enhanced potency
  • Brainstorming innovative approaches for quantifying subjective metrics like migraine pain relief, anosmia reduction, taste enhancement, and mood improvement for robust quality control
  • Delving into anticipated advancements, concerning challenges and expected priorities across the ever-expanding nasal delivery landscape

9:30 am Proveris Lab’s Guide to the Effects of Product Development on Nasal Spray Performance

Synopsis

  • Understanding the importance of human realistic testing
  • The impact of viscosity and other factors on nasal deposition
  • The effect of product changes on performance

10:00 am Aligning Device-Formulation Compatibility for CNS Indications

Synopsis

  • Delving into cutting-edge unique method of tracking brain delivery using magnetic resonance spectroscopy for confidence in delivery accuracy
  • Leveraging devices to gain access to the CNS for multiple indications across Parkinson’s, Concussion, MS, and Stroke for optimized patient experience
  • Gaining highly efficient nose-to-brain delivery bypassing the blood brain barrier with specialized formulations and intranasal devices

10:30 am Morning Break & Networking

11:00 am Strategic Approach and CMC Considerations for a Novel Pediatric Nasal Vaccine Development

  • Lillian Li CMC Product and Device Lead, Sanofi Pasteur

Synopsis

  • Unveiling the roadmap and key elements for a novel nasal vaccine product development, encompassing both formulation and intranasal delivery device
  • Exploring challenges, CMC, and regulatory considerations. Sharing insights with valuable tools applied from recent successful experiences with a new vaccine candidate, spanning from pre-clinical stages to Phase 3 development for accelerating and de-risking the novel vaccine development process
  • Touching upon some future perspectives in nasal delivery

Developing a Robust Analytical Toolbox Tailored to Nasal Delivery

11:30 am Adapting In Vitro Tests for Nasal Sprays to Accommodate Novel Therapeutics

  • Andrew Martin Professor, Mechanical and Biomedical Engineering, University of Alberta

Synopsis

  • Investigating regional deposition for nasal drug delivery and its implications for existing and novel therapies
  • Evaluating the applicability of established and compendial in vitro tests in evaluating targeted drug delivery to the nasal cavity
  • Case examples in the development of liquid and powder nasal vaccine formulations

12:00 pm Adapting to Evolving Needs: Tailoring Spray Characteristics for a Versatile Market

  • Marcel Sachs Product Line Manager, Healthcare, Silgan Dispensing

Synopsis

  • Versatility is needed to adopt spray systems, target specific novel regions, and adapt to different formulations
  • How Silgan’s BE Program makes us an effective partner for bringing products to market
  • Gemini BE, an adaptable and effective nasal pump for versatile formula performance

12:30 pm Networking Lunch

1:30 pm Roundtable Discussion: Improving on Animal Models: Modern Screening Methods in Nasal Drug Development

Synopsis

  • Highlighting the challenges posed by small animals in nasal drug development and the need for alternatives with more translatability
  • Comparing a range of promising options, including 3D organoids, lab-grown nasal epithelia, 3D printed models, nasal cast models, and primate models
  • Examining the remaining issues associated with these substitutes, such as the metabolism of nasal casts and the absence of vasculature in lab grown epithelia

2:00 pm Navigating the Challenges in Pediatric Intranasal Drug Delivery

  • Laleh Golshahi Engineering Foundation (Endowed) Associate Professor, Mechanical Engineering & Pharmaceutical Engineering, Virgina Commonwealth University

Synopsis

  • Introducing a robust biosimilar in vitro platform for in parallel evaluation of bioequivalence of combination suspension nasal drug products in adults and pediatric human subjects
  • Highlighting strategies to achieve precision in targeting using a set of adult and pediatric nasal casts, reflecting the impact of age, gender, and ethnicity, with enhanced sensitivity to device, formulation, and user-related variables 
  • Highlighting recent correlations to tailor physicochemical characteristics for intranasal delivery of large and small molecule APIs and vaccines

2:30 pm Afternoon Break & Networking

Enhancing Patient-Centric Outcomes with Nasal Delivery for Novel Therapeutic Areas

3:00 pm Unlocking the Potential of Nasal Delivery of Psychedelics for Enhanced Therapeutic Impact

Synopsis

  • Amplifying potency with intranasal delivery of psychedelics, exemplified by 5-methoxyDMT, and exploring its advantages, including high cellular penetration and avoiding the first-pass metabolism
  • Investigating the potential of single-use nasal administration to accelerate speed of onset, ease of self-administration, increasing safety and accessibility for psychiatric patients and on the field during combat
  • Delving into the emerging therapeutic possibilities of nasal administration for other psychedelics and highlighting the importance of patient-centric advantages

3:30 pm Developing Nasal Formulations for Novel Indications – Acute Suicidal Ideation

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

Synopsis

  • Understanding molecule PKPD and dose selection
  • Administering your API intravenously vs nasally and the impact on your molecule for optimal results
  • Evaluating toxicological challenges of intranasal CNS formulations for accelerated approval

4:00 pm Assessing Intranasal Drug Delivery for Acute Neurological Conditions

Synopsis

  • Utilizing concussion as a model for targeted intranasal drug delivery in acute neuro conditions
  • Sharing PK data and more from Phase I trials ahead of Phase II, including CSF vs. Blood concentration
  • Understanding the potential of spray-dried, lightweight device products for easy, safe actuation on-field

4:30 pm Chair’s Closing Remarks

4:45 pm End of Summit