This IPAC-RS Workshop will serve as a meeting place for industry and regulatory thought leaders to consider the burgeoning field of pulmonary and nasal delivery of biologics.  In developing these types of products, the general principles of pharmaceutical aerosol generation for safe and effective delivery to the respiratory tract need to be combined with the approaches and techniques suitable for large, complex, and generally fragile entities that fall under the umbrella of biologics.
 

The Workshop speakers and attendees will discuss the practical and regulatory considerations regarding analytical method
establishment, formulation design and development, device selection, manufacturing, stability, characterization, and control of inhaled and nasal large molecule formulations. Discussions will include proteins and peptides, oligonucleotides, DNAs and RNAs, antibodies, phages and other novel modalities. 

Through podium presentations from expert speakers and roundtable discussions, attendees will identify current gaps in regulatory science and outline areas that could be addressed through collaborative initiatives among interested stakeholders in follow-up to the Workshop.