Conference Day One - June 5, 2024
8:30 am Registration & Morning Networking
9:15 am Chair’s Opening Remarks
Exploring Next Generation Pulmonary Delivery Formulations
9:30 am Entering the Field: Overview of Inhalation Drug Development to IND
Synopsis
- Exploring inhalation delivery technologies to understand how they can enhance drug delivery efficiency and patient outcomes.
- Delving into the crucial considerations for preclinical testing, focusing on optimizing delivery methods and accurately assessing exposure and toxicity to ensure safety
- Navigating key regulatory insights for determining safe dosing, helping to streamline the IND application process and enhance compliance
10:00 am Navigating Challenges in Efficient Lung Delivery for Molecule Stability
Synopsis
- Discussing the struggle of achieving optimal delivery efficiency, addressing material loss concerns and maximizing drug concentration in the target area of the lungs
- Exploring the critical need to prevent compromise or degradation of pharmaceutical molecules during formulation, focusing on challenges posed by energy imparted during aerosolization
- Examining precision in targeting, emphasizing the importance of reaching deep into the lungs and tailoring efficiency based on the specific patient population
10:30 am Advancing Biologics Dry-Powder Inhalation: Challenges and Solutions
Synopsis
- Exploring the integration of monoclonal antibodies, vaccines, and therapeutic proteins into Dry Powder Inhalers (DPIs), assessing their suitability and potential benefits for targeted pulmonary delivery
- Delving into advanced spray drying technologies that optimize the formulation of biologics in DPIs, focusing on maintaining therapeutic integrity and bioactivity
- Examining methods to enhance the stability of biologic formulations in DPIs, preventing protein aggregation to ensure consistent and effective drug delivery
11:00 am Morning Break & Speed Networking
Synopsis
Our speed networking session offers a rapid and efficient platform for industry experts to expand their network, exchange insights, discover opportunities, and foster meaningful connections within the inhalation industry.
12:00 pm [NEW DATA]Exploring Physical Stability of Protein Powder Formulations for Inhalation
Synopsis
- Discussing the impact of solid-state properties on stability and aerosolization: evaluating how crystallinity and crystallization tendency affect stability of powder formulations for inhaled proteins
- Exploring solid form changes during storage, altering aerosol performance, and addressing the mixing of homogeneity of excipients and proteins influence on solid-state properties and stability
- Delving into advanced characterization techniques for evaluating particle surface properties and understanding molecular interactions between proteins and excipients in the powder formulation
12:30 pm Delving into ARCUS Technology for Inhaled Delivery of Pharmaceuticals
Synopsis
- Unveiling the advantages of large porous particle engineering through spray drying for enhanced drug delivery efficiency
- Achieving rapid onset of action and systemic delivery via dry powder administration for improved patient relief and management of conditions
- Minimizing inhalation effort by delivering a substantial dose in a single administration, reducing burden on patients and improving adherence
1:00 pm Networking Lunch
Advancing Pulmonary Delivery: Innovative Strategies for Inhaled Therapeutics
2:00 pm Roundtable Discussion: Navigating Delivery System Considerations
Synopsis
- Exploring the pivotal role of device selection as a primary consideration, influencing the formulation system
- Delving into challenges related to high pressure, high temperature, and manufacturing processes, emphasizing the need for overcoming physical and mechanical barriers
- Highlighting challenges posed by physical barriers like mucus and the importance of formulating strategies to neutralize negative charges within mucus networks
2:30 pm [NEW MODALITY]Peptide-Based Intracellular Delivery Strategy for Pulmonary Space
Synopsis
- Unlocking targeted pulmonary treatment with a groundbreaking peptide-based intracellular delivery strategy
- Maximizing therapeutic effectiveness through tailored delivery to airway cells across diverse animal models
- Unveiling the potential of ASO delivery to revolutionize respiratory care, ensuring precision and impactful benefits for respiratory conditions
3:00 pm Afternoon Networking Break & Poster Session
4:00 pm Optimizing Organ-Targeted Delivery: Enhancing Precision and Patient Comfort Through Tailored Delivery Systems
Synopsis
- Delving into the complexities of biologics, understanding the unique structural and property challenges they present, and learn strategies to navigate these issues effectively
- Examining the critical components required for developing inhaled biologics, including molecule specifics, formulation nuances, process intricacies, and device integration
- Identifying common gaps encountered in the development of inhaled biologics and explore potential solutions to address these challenges, paving the way for more efficient and successful product development
4:30 pm Inhalable Biologics for Treating Acute and Chronic Lung Diseases
Synopsis
- Leverage the potential of inhalable biologics using lipid-based drug delivery vehicles such as exosomes, liposomes, and lipid nanoparticles (LNPs) for precise and effective treatment
- Explore the innovative delivery of therapeutic microRNA via inhalation as a promising approach for treating acute lung injury (ALI) and idiopathic pulmonary fibrosis (IPF), offering targeted healing directly at the source
- Extend the benefits of inhalation therapy beyond lung diseases, opening new avenues for treating systemic conditions like diabetes and myocardial infarction through noninvasive, focused treatments
5:00 pm Chair’s Closing Remarks
5:30 pm Catalent Site Tour
Synopsis
We are excited to invite Next Gen Inhalation Delivery Summit attendees for an exclusive networking event at our Boston facility on Wednesday, June 5 from 5:30-7:30 PM. Bringing together inhalation community leaders, join us for an evening of good food, drinks, networking, site tours and more!
The Boston site has a rich history with 25+ years of experience in spray drying for inhalation. Initially established to manufacture insulin dry powder for inhalation manufactured by spray-drying and capsule filling, the site later expanded to support the development and commercial launch of Inbrija®. Catalent now proudly continues the site’s vision as it serves as the global center of excellence for spray drying dispersion and low humidity DPI capsule manufacturing. It also continues to produce commercial DPI products for distribution in the United States and Europe as well as develops clinical stage spray-dried and encapsulated products.
Event attendees will have an opportunity to speak to our spray drying experts and take a guided tour to get an up-close look at the state-of-the-art technology and infrastructure including best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.
We look forward to welcoming you to Catalent Boston!