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
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
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
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
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
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
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