Pre-Conference Workshop Day
Tuesday June 20, 2023

09:00 – 11:30
Workshop A

Developing Robust Pre-Clinical Models for Translatable & Predictive Results in Clinic

Workshop Leader: Pavan Muttil

  • Pavan Muttil Associate Professor and Vice-Chair, University of New Mexico


The lack of translatability in our current preclinical models for inhaled delivery is currently

playing a role in reduced progression into the clinic. Efforts are being driven toward

understanding the inhalation delivery development to create predictive preclinical models

that regulatory authorities will accept.

This workshop will explore in vivo and in vitro methods to help you to overcome your

preclinical translatability challenges and progress your inhalation product confidently into

the clinic.

Join this workshop to understand:

  • Considerations with rodent models: obligatory nose breathers and other differentiators
  • Role of different delivery devices used to deliver drugs and biologics, including nose-only, whole-body, and intratracheal administration systems; each of these devices works with varying mechanisms of aerosolization
  • The role of small and large animal models in preclinical studies
  • How can we recapitulate the lung anatomy and physiology, anatomy, physiology, and cell types accurately cell types accurately
  • How do different models go through proof-of-concept studies?
  • What does the FDA think about in terms of these different models e.g. organ-on-chip or in vitro assay

11:30 – 12:30

12:30– 15:00
Workshop B

Using the Lungs as a Way to Treat Other Organs – Systemic Diseases

Workshop Leader: Vivek Gupta

  • Vivek Gupta Assistant Professor & Dean for Graduate Education & Research, Industrial Pharmacy, Saint Johns University


While the inhalation route of administration is most commonly associated with targeted

lung delivery for your pulmonary conditions, an array of advantages can be seen across

non-pulmonary conditions such as cardiovascular.

Rather than looking at the lungs as your end target, this particular organ offers a different

point of entry to the body over intravenous, intramuscular, or even oral delivery. This carries

great potential and a vast array of advantages.

Join this workshop to maximize your knowledge on:

  • Exploring the lung as an easy point of entry that has not been evaluated enough
  • Utilizing inhalation to reduce metabolism of your molecule, avoid the liver, dose at higher volumes with limited side effects
  • Reformulating metabolically unstable formulations for inhaled delivery
  • Structure of the lung: does its veiny structure and large volume offer advantages for systemic delivery?
  • Potential risk factors: immune response and safety concerns