Conference Day Two

Thursday, May 18

8:30 am
Morning Networking Coffee

9:15 am
Chair’s Opening Remarks

Establishing Successful Pre-Clinical Models for Novel & Generic Nasal Drug Products to Accelarate Approvals For Next Generation Disease Indications

9:30 am Characterizing Regional Drug Delivery Within the Nasal Airways


  • Regulatory guidance for nasal spray drug product characterization studies
  • Using nasal airway geometries for in vitro and in silico methods
  • Establishing in vitro methods for characterizing delivery of nasal powders

10:00 am Delivering saRNA Intranasally – Is this a Possibility?

  • Anna Blakney Assistant Professor, University of British Columbia


  • Formulation approach of saRNA vs mRNA – and why should we consider nasal route of administration?
  • Preliminary data comparing saRNA intranasal vs intramuscular delivery – pros and cons
  • What’s next to widen therapeutic window?

10:30 am
Morning Refreshments & Networking Break

11:00 am Comparison & Lesson Learned between Inhalation vs Nasal Formulation

  • Tian Wu Head of Pharmaceutics, AffaMed Therapeutics


  • Novel approach to formulating a drug for nasal vs inhaled delivery – what are the parameters and excipient considerations?
  • Peptide vs biologics, and biophysiological pathway mechanism – getting it right first time
  • Solid vs liquid? The pros and cons as well as increasing retention time

11:30 am Utilizing In Vitro & In Silico Methods to Accelerate Product Development for Generic Nasal Drug Products

  • Ross Walenga Chemical Engineer, Office of Generic Drugs, FDA


  • Identify regulatory challenges associated with generic nasal drug products in the U.S.
  • Realistic in vitro nasal models to better understand bioequivalence of generic drug products
  • Building computational fluid dynamics and physiologically based pharmacokinetic models for nose-to-brain drug delivery

12:00 pm
Networking Lunch

Novel Nasal Delivery Mechanisms For Next Generation Disease Indications

1:15 pm Targeting the Upper Nasal Space to Access the Olfactory Epithelium & Improve Bioavailability

  • Stephen Shrewsbury Independent Consultant, Former Chief Medical Officer, Shrewd Consulting LLC, Impel Pharmaceuticals Inc.


  • Propelling drug delivery to the upper nasal space to maximize systemic and CNS bioavailability
  • Delivering directly to the upper nasal space to avoid mucociliary clearance
  • Reducing formulation requirements to simplify development and reduce potential toxicity

1:45 pm Fireside Chat: Understanding the Potential and Limitations of Nasal Drug Delivery for Chronic CNS Indications
Panellists: Whitney Binder, Stephen Shrewsbury


Given the direct access to the brain through the olfactory region in the upper nasal space, the potential of utilizing the nasal route for next generation of CNS indications has become an exciting area of interest for industry leaders in the field.

Hear perspectives from both pioneering and next generation experts as they discuss the opportunities of utilizing the nose-to-brain pathway for game changing CNS therapeutics.

2:30 pm
Chair’s Closing Remarks

2:35 pm End of Summit