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IPAC-RS Workshop:  
Inhaled Biologics: Preparing for
a Future Beyond Small
Molecules

Wednesday - Thursday, September 4-5, 2024
Hybrid Event
Washington, DC

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.

The main objective of this workshop is to identify gaps in the current regulatory science of inhaled & nasal biologics and to consider ways to address those gaps collaboratively, through targeted initiatives to be pursued after the workshop.  


As such, in-person or virtual participation by all potential collaborators is strongly encouraged.   The proceedings will not be recorded. 
 

WORKSHOP DETAILS

Dates:

 

Wednesday - Thurdsay, September 4-5, 2024

In-Person Option Location: 

 

Office of IPAC-RS Secretariat - Faegre Drinker Biddle & Reath - 1500 K Street, N.W., 11th Floor, Washington, DC 20005

Virtual Option: 

 

Zoom Webinar

Hotel Accomodations: 

 

Recommendations are available here.

REGISTRATION

Registration to open in Spring 2024.

NOTE:  In-Person participation is limited.  Be sure to register early to save your spot!

WORKSHOP MATERIALS

A Save the Date Flyer is available to share with interested colleagues.  Download a copy here.

A draft Workshop program will be available shortly.

QUESTIONS

Please contact the IPAC-RS Secretariat if you have any questions at info@ipacrs.org or +1 (202) 230-5607.

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