Workshop Leader: Pavan Muttil
Time: 9:00 am
day: Pre-Conference Workshop Day
Details:
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
