Conference Day Two - June 6, 2024
8:30 am Morning Check In
9:15 am Chair’s Opening Remarks
Maximizing Treatment Efficacy: Achieving Seamless Device-Formulation Compatibility
9:30 am [CASE STUDY]Optimization of Compound Delivery Through Different Devices
Synopsis
- Discussing how the FDA sees the administered dose as the dose placed into the device, stressing the need to optimize compound delivery for accurate dosing
- Highlighting the importance of low delivery efficiency in some devices and its impact on safety margins, raising concerns about the effectiveness of the delivered drug
- Exploring how breath-actuated devices improve bioavailability, understanding how these advancements contribute to enhanced drug delivery efficiency and improved patient outcomes
10:00 am Session Details To Be Confirmed
10:30 am Morning Break
Next Generation Therapeutic Applications, Modalities & Innovations for Future Development
11:30 am [CASE STUDY] Enhancing Local Drug Delivery for Complex Respiratory Conditions: Nebulization Tactics for Managing Pulmonary Fibrosis
Synopsis
- Exploring innovations in understanding and measuring local drug dose delivery in the lungs
- Examining the nebulization strategies to understand critical factors for successful delivery and treatment in various lung diseases related to pulmonary fibrosis
- Improving disease management, exploring these innovations and strategies to facilitate more effective drug delivery to the lungs, and improving patient quality of life in pulmonary fibrosis and related lung diseases
12:00 pm [NEW DATA] Optimizing Lipid Nanoparticles for Enhanced CRISPR/Cas9 Gene Editing in Lung Tumor Cells and Exploring the Potential for Inhalation
Synopsis
- Exploring innovative therapeutic approaches for persistent global health challenges posed by lung cancer, showcasing the potential of CRISPR/Cas9 LNPs in targeting specific lung tumor genes for gene editing
- Detailing the screening of formulations, physicochemical characterization, and successful enhancement of gene editing efficiency targeting a specific lung cancer mutation
- Exploring the potential of CRISPR/Cas9-LNPs as inhalable formulations for targeting lung cancer and addressing the challenges associated with the preparation and characterization
12:30 pm Lunch Break
1:30 pm Exploring the Successes and Failures of Inhaled Surfactant in the Utility of Current Surfactant Aerosol Delivery Systems
Synopsis
- With the exception of FDA approvals for surfactant delivery for pre-term infants and neonates, this therapeutic modality has not delivered consistent results in the management of surfactant deficiency conditions
- Addressing barriers: what has hindered the addition of surfactant delivery to the therapeutic armamentarium?
- Enhancing aerosol delivery: what enhancements are needed to make surfactant a valuable treatment across various diseases like ARDS and COPD?
2:00 pm Revolutionizing Respiratory Treatment: Breakthrough Inhaled Biotherapeutics and Delivery Platform
Synopsis
- Innovating the future of respiratory care: pioneering groundbreaking inhaled biotherapeutics, revolutionizing treatment for respiratory conditions
- Evaluating our unique inhaled biologics delivery platform and penetration to distal lung regions, maximizing therapeutic impact where it’s needed most
- Powered by innovation and support: with backing from an NIH SBIR grant, we’re poised to bring our cutting-edge treatments to clinical trials, leading the charge against COPD, IPF, BPD, and beyond
2:30 pm Afternoon Networking Break
3:30 pm Session Details To Be Confirmed
4:00 pm Roundtable Discussion: Enhancing Safety, Efficacy, and Quality Assessment of Inhalation Delivery through Advanced Tools and Regulatory Insights
Synopsis
- Addressing the increasing complexity of modern medicines and the need for advanced tools to assess safety, efficacy, and overall product quality
- Exploring various guideline-recommended aspects, including toxicology, impurity profiling, traceability of ingredients, and end-to-end processes, giving a comprehensive overview of the regulatory landscape
- Delving into the exploration of new databases and techniques for evaluating and predicting the safety and efficacy of pharmaceutical products, reflecting a forwardlooking approach in drug development