Conference Day Two - June 6, 2024

8:00 am Registration & Morning Networking

8:45 am Chair’s Opening Remarks

  • Joshua Ziel Chief Operating Officer, Aerami Therapeutics

Maximizing Treatment Efficacy: Achieving Seamless Device-Formulation Compatibility

9:00 am Navigating Techniques for the Optimization and Translation of Inhaled Molecules: From LO to IND


  • Gaining insights into pharmacokinetic and pharmacodynamic models and methods that enhance the discovery and development of inhaled molecules
  • Assessing how defining optimal ADME properties can significantly improve therapeutic outcomes
  • Discovering translational approaches that progress from LO to first-in-human studies, accelerating the pathway to clinical trials

9:30 am [CASE STUDY]Optimization of Compound Delivery Through Different Devices

  • Joshua Ziel Chief Operating Officer, Aerami Therapeutics


  • 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 How to Maximize the Likelihood of Regulatory Approval for Novel Drug Device Combination Products


  • Learning how to navigate the regulatory landscapes of the EU and US to ensure your novel drug-device combination products gain swift approval, accelerating market entry and revenue generation
  • Discovering strategies to address the primary hurdles faced by development teams in meeting regulatory standards, ensuring smooth compliance and minimizing delays in approval processes
  • Delving into the intricacies of the EU Medical Device Regulation (MDR) to streamline the conformity assessment procedure, facilitating efficient approval pathways

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

  • Samiran De Director - Product Development, Avalyn Pharma


  • 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

  • Simone Carneiro Postdoctoral Fellow, Ludwig Maximilians University Munich


  • 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 Inhaled Extracellular Vesicle Therapeutics for Respiratory Diseases – Optimisation and Characterisation


  • Delving into essential characterisation of extracellular vesicles to assess the impact of the administration method
  • Assessing current roadblocks in preclinical models due to lack of relevant methods of administration
  • Investigating extracellular vesicle surface modification for improved targeted delivery to the lung

2:00 pm Revolutionizing Respiratory Treatment: Breakthrough Inhaled Biotherapeutics and Delivery Platform

  • Vivek Lal Founder, Executive Chairman & Chief Scientific Officer, Alveolus Bio


  • 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

3:00 pm Exploring the Successes and Failures of Inhaled Surfactant in the Utility of Current Surfactant Aerosol Delivery Systems


  • 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?

3:30 pm Roundtable Discussion: Optimizing Precision Drug Delivery to the Lung Using Lipid Nanoparticles

  • Chun Yang Senior Director - Antibody Engineering and Drug Delivery, Nitto BioPharma Inc.


  • Explore the core LNP technology for precision lung delivery, highlighting advantages in bioavailability, stability, and enhanced patient compliance through reduced side effects
  • Examine critical design factors for LNPs for inhalation, such as surface charge, lipid composition, and payload encapsulation, to optimize deposition in the pulmonary system
  • Discuss translation of LNP lung delivery from bench to bedside, addressing challenges in stability, scalability, device compatibility, and regulatory hurdles to ensure efficacy and patient safety

4:15 pm Chair’s Closing Remarks

  • Joshua Ziel Chief Operating Officer, Aerami Therapeutics

4:30 pm End of Summit