Conference Day One

Wednesday, May 17

8:00 am
Registration & Welcome Coffee

8:45 am
Chair’s Opening Remarks

Exploiting Nasal Drug Delivery Therapeutic Potentials

9:00 am Opening Address: Physiologic Determinants Governing Delivery & Efficacy for Nasal Therapeutics

  • Robert Thorne Head of Postdoctoral Program & Fellow, Denali Therapeutics, University of Minnesota


  • Key examples of approved nasal drugs, vaccines and formulations: lessons learned from past experience
  • Understanding the physiology of the olfactory and nasal respiratory mucosa to appreciate their affect on nasal delivery locally, to the bloodstream and to the brain
  • Understanding potential use of the nasal route for the next wave of treatment for CNS delivery

Providing Regulatory Clarity to Accelerate Novel Nasal Formulation & Delivery

9:30 am Acceleration of Nasal Drug Product Development: Increase Efficiency while Ensuring Quality

  • Maria Smith Director - Application & Business Development, Proveris Scientific Corporation


  • Adding automation to a quality by design approach
  • Screening device and formulation combinations to identify the best pairing
  • Uses for automated actuation and spray characterization in development and quality control

10:00 am Panel Discussion: Krishna Subramanian Providing Regulatory Clarity to Accelerate Nasal Combinational Product Development
Led by:

  • Krishna Subramanian Vice President & Head of Non-clinical Translational Science, Seelos Therapeutics Inc.
  • Maria Smith Director - Application & Business Development, Proveris Scientific Corporation
  • Ross Walenga Chemical Engineer, Office of Generic Drugs, FDA
  • Robert Thorne Head of Postdoctoral Program & Fellow, Denali Therapeutics, University of Minnesota


The need for regulatory clarity on aspects such as patient usability and technical device requirements are crucial to accelerate approvals of nasal combinational products.

During this panel, we will hear experts discuss and share their experience in:

  • Incorporating safety study and demonstrating the right data package for regulatory agencies’ approvals
  • Performing a robust human factors and usability study for your combination product, and ensuring device performance – what’s the best practice?
  • How can scientists collaborate with device teams to support bridging study, in particular for on-market product for device change control?

10:45 am
Speed Networking & Morning Refreshments

Advancing Nasal Formulation for Topical, Systemic & Nose-to-Brain Delivery

11:45 am Exploring Systemic Nasal Delivery: Device & Formulation


  • Overview of systemic nasal drug delivery and impact of device reliability and formulation selection 
  • Case study demonstrating use of in silico PBPK modelling to optimize regional targeted deposition to achieve maximum absorption
  • Case study on reformulating existing epilepsy drug to an intranasal powder including preclinical PK data

12:15 pm Novel Formulation Strategies to Achieve Successful Nasal Drug Delivery

  • Debanjan Das Senior Associate Director & Science Fellow - Global Research & Development, Bayer U.S. LLC


  • Formulation-driven nasal drug delivery objectives
  • Mucoadhesive drug delivery systems to achieve prolonged action
  • Special formulations to achieve drug delivery to the CNS

12:45 pm
Networking Lunch

1:45 pm Developing Novel Nasal Formulations to Achieve Bioavailability for Systemic Delivery


  • Understanding the challenges associated with the nasal anatomy to achieve effective systemic delivery
  • Applying novel formulation strategies to improve bioavailability for systemic delivery
  • Utilizing absorption enhancers to improve bioavailability

2:15 pm Novel Formulation Strategies to Utilize Nose-to-Brain Delivery for CNS Indications

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


  • Proposing formulation strategies for macromolecular access to the CNS
  • Overcoming extracellular or intracellular transport challenges to streamline effective routes to the CNS
  • Evaluating safety and toxicological challenges of nasal formulation strategies to accelerate drug approvals for CNS indications

2:45 pm Tiziana Life Sciences’ Intranasal Delivery Clinical Updates in MS Patients

3:15 pm
Afternoon Refreshments

3:45 pm A Novel Intranasal Field-Deliverable Drug: Device Combination for the Acute Treatment of Concussion


  • Utilizing a spray-dried nanoparticle powdered formulation to increase stability and eliminate cumbersome cold chain protocols
  • Developing an intranasal field delivery system to directly target the brain and reduce the immediate pathological cascade of inflammation and swelling
  • Harnessing a breath propelled device to provide efficient delivery to the brain

4:15 pm COVID-19 Antiviral Nasal Spray Journey: Lessons Learned


  • Creating a hostile environment in the nasal cavity to maximize antiviral effects
  • Appreciating key regulatory challenges in the real world for nasal spray market approval
  • A retrospective look at a bench to shelf antiviral nasal spray to facilitate future nasal combinational product development

4:45 pm Roundtable Discussion: Evaluating the Suitability of APIs to Facilitate the Development of Innovative Nasal Formulations for Next Generation Disease Indications


Utilizing the nasal space as an effective drug delivey route for next generation disease indications demands novel payloads with highly potent APIs.

This roundtable gives the opportunity for the industry to understand key APIs that can be utilized for successful nasal formulations so bioavailabilty and efficacy can be achieved following delivery through the nasal route.

5:30 pm
Chair’s Closing Remarks & End of Day One