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.

WORKSHOP DETAILS

Link to IPAC-RS event page

DATES

Wednesday - Thursday, September 4-5, 2024

AGENDA OUTLINE

Day1

• Inhaled Nasal Biologics
• Regulatory Landscape
• Testing Requirements For Protein Biologics Therapies
• Pre-Clinical Toxicology
• Testing of Nasal Oligonucleotides and mRNA Products
• Relevance of Aggregates in the Lung
• Particle Precision
  
• Breakouts
• Networking Reception

Day 2

• Excipients for Large molecules: Parenterals to Inhaled and Nasal
• Spray Drying of Biologics
• A Platform Approach to Spray Dried, Thermostable, Mucosal Vaccines
• Influence of Device on Aqueous Stability
• Collection and Detection (Compendial) Strategies for Inhaled Biologics
• Panel Discussion - Key CMC, Analytical Issues, Gaps to address
  

Link to preliminary program

IN-PERSON OPTION LOCATION

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

VIRTUAL OPTION

Zoom Webinar; Virtual information will be sent out prior to the start of the workshop.

HYBRID EVENT DETAILS

The Workshop will be a hybrid event (in-person and virtual). Not available on September 4-5, 2024? No problem. Be sure to register for the Workshop even if you can't attend it live. All registered Attendees will receive access to On Demand recordings (for 30 days) after the hybrid Workshop has concluded so you can view/review sessions at your convenience. Attending the Workshop IN-PERSON will enable you to get the most out of the experience, but we don't want you to miss out on the presentations from our excellent speakers.

PLEASE NOTE: Virtual attendees will not have access to the Breakout session on Day 1, only access to the plenary sessions.

DIRECTIONS/PARKING/HOTEL ACCOMODATIONS

Download a copy of the Workshop Logistics for hotel recommendations, directions, and parking information. REGISTRATION REGISTRATION CLOSING The Registration site will close at 3 pm ET on Wednesday, August 28, 2024. If you wish to register after that date, please contact the IPAC-RS Secretariat prior to the Workshop start on September 4, 2024 to make the appropriate arrangements. Late inquiries may result in delayed access to the start of the event.

LIMITED IN-PERSON REGISTRATION

In-Person Registration is limited. Please be sure to register early. In-person registration will close when the room capacity has been reached. REGISTRATION FEES (Fees for in-person registrations include complimentary breakfast and lunch on each day and the networking reception the evening of Day 1.) Click here to register.

WORKSHOP MATERIALS

A Workshop brochure is available to share with interested colleagues. Download a copy here. A draft Workshop program can be downloaded here (as of 6/6/24).

QUESTIONS

Please contact the IPAC-RS Secretariat if you have any questions at dede.godstrey@faegredrinker.com or +1 (202) 230-5607.