Aptar Pharma & Propeller Health (Room C7)
The Future of Connected Medicines: Promise and Potential Pitfalls
Introduction: While effective respiratory medications are often available, patient adherence is known to be low. Some estimates suggest that just 1 out of every 5 patients in the US are compliant with the medication plans prescribed by their physician. This lack of adherence leads to a lack of disease control often associated with diminished quality of life, exacerbations, costly emergency room and inpatient visits that burden the healthcare system, both with respect to resource utilization and cost.
Description: This workshop will discuss the future of connected medicines, including benefits to patients, providers, pharma and payers, and potential challenges to achieving scale. The session will include real-world learnings from Propeller and Aptar Pharma, and perspectives from leading US payers, provider organizations, pharmacy benefit managers and pharmaceutical companies. The data will focus on implementation for asthma and COPD.
Outcome for Participants: Participants will have the opportunity to participate in an interactive discussion on unmet needs and current/future requirements of digital inhaled drug delivery devices. They will also leave with a better understanding of the implementation and adoption challenges for connected medicines and what the future might hold.
Biocorp (Room C3)
Using Connected Compliance Monitoring Solutions in the Context of Clinical Trials for New Respiratory Medicines
Introduction: This workshop will describe new connected solutions used to remotely monitor clinical trials for respiratory medicines. Such solutions are designed to capture treatment information directly on the respiratory device and collect patient’s feedback through a questionnaire available on a dedicated app.
Description: This workshop will feature a presentation of Biocorp’s technical solution with a live demonstration and introduce some real-life use cases. It will also address regulatory and technical aspects of remote clinical trials using connected devices. Advantages such as conducting more clinical trials, increasing quantity and quality of data collected, avoiding reporting errors, ensuring patient compliance and optimal use of the solution will be reviewed. Conducting clinical trials in this way does not require patients to attend a clinical facility and collect feedback through individual interviews.
Outcome for Participants: This workshop will enable participants to understand the benefits of connected compliance monitoring solutions in the context of clinical trials and how such an approach can be implemented in the most effective way. Looking forward, one can see how the next steps will involve migrating from a single phase of a clinical study to a phase of commercial use or at least educating the patient when prescribing the device or a new therapy.
Emergo (Room D1)
Inhaler Use in Real Life: Using Human Factors to Understand Risk and Critical Design Attributes
Introduction: It is widely accepted that inhaler technique is poor, and that this causes sub-optimal dosing which in turn reduces symptom control. However, very little is known about what types of use error affect lung deposition. If you are developing a new inhaler or dose counter, regulators such as FDA expect manufacturers to show that the intended users can use a proposed new inhaler correctly; to do this, human factors methods are essential for design validation.
Description: In this workshop, case studies will be used to show how human factors methods can be applied to novel inhalers being submitted for first-time regulatory approvals. In addition, studies related to generic inhalers, including demonstrating equivalent inhaler use to the reference product and the necessary human factor methods to apply use will be made clear.
Outcome for Participants: This workshop will educate participants on the key human factor activities essential in order to understand risk, critical design attributes and also how to aid successful regulatory approvals of inhaled products in any marketplace.
FLUIDDA (Room C5)
FRI Deposition: Next Generation Aerosol Deposition and Delivery Optimization
Introduction: Functional Respiratory Imaging (FRI) deposition technology is based on CT imaging, and uses segmentation and computational fluid dynamics (CFD) calculations to provide regional deposition metrics of inhaled products. FRI’s patient specific nature and core characteristics make it an ideal alternative to scintigraphy, providing similar results in a more time and cost-effective manner.
Description: This workshop will introduce the different building blocks of FRI aerosol deposition analysis including patient-specific 3D airway geometry modeling, inhaler characteristics and CFD simulations to model lung deposition. Combining these 3 blocks in the correct way allows for a fast and versatile evaluation of lung deposition, while maintaining the patient specific characteristics of in vivo scintigraphy. Lastly, we will focus on the validity of FRI aerosol deposition by showing the correspondence between simulated results and in-patient scintigraphy.
Outcome for Participants: Attendees will gain insight into the methods and choices behind FRI deposition and guidance through examples that highlight the practical details of an FRI deposition evaluation. Participants will leave with an understanding of the capabilities and the variety of options that are available with FRI deposition studies.
H&T Presspart (Room D2)
The Future Challenges Facing Respiratory Drug Delivery: Stability and Effective Delivery of Complex Molecules and Combinations Meeting Patient Needs
Introduction: Patient adherence is becoming a critical need for today’s respiratory medicines. In addition, device manufacturers are becoming more aware of the need to deliver the medication to the targeted site of action. In order to meet these expectations one must target key factors such as consistent dose delivery, satisfactory aerosol performance, human factor studies and cost effectiveness.
Description: This workshop will review possible solutions to overcome some of these challenges using pMDI (plasma coated canisters, dose counting solutions) and DPI (PowdAir Plus capsule-based Inhaler) technologies to deliver complex drug formulations and drug combinations to meet market requirements.
Outcome for Participants: This workshop will provide attendees with an overview of the different approaches available and how engineering excellence can come together to design and deliver the most effective and economical device.
Harro Höfliger (Room D3)
Challenges in the Development Process for Soft Mist Inhaler Design, Manufacturing and Scale-Up
Introduction: A Soft Mist Inhaler (SMI) is a relatively new type of propellant free liquid inhaler, originally developed successfully by Boehringer Ingelheim. The device functions by forcing a metered dose of drug solution through a unique and precisely engineered nozzle. This creates a slower-moving, longer-lasting mist, reducing the need for breath-actuation or coordination. The success and acceptance of SMIs in the market place is now triggering development of analogous devices and technologies to compete with the original innovator product.
Description: This workshop will review the technologies related to nebulization and soft mist inhalers. The unique situation in the market will be discussed in relation to various technologies and ongoing developments. The key challenges of successfully developing a SMI delivery system will be described from a manufacturing standpoint. This will include an insight into the do’s and don’ts for soft mist inhaler systems with regard to logistics, design and production technologies.
Outcome for Participants: The workshop participants will be educated on the current trends in SMIs and the optimization of SMI technology to manufacture new innovative or re-engineered inhaler devices.
Hovione (Room F7)
Bridging Particle Engineering, Formulation and Device Development
Introduction: A successful dry powder formulation arises from a fine balance between multiple factors: particle properties, particle interactions in a formulation and resulting powder behavior, and device efficiency. A scientific approach in particle engineering, formulation and device design, supported by the right characterization toolbox, is key to achieving the target product profile across the life cycle of a product.
Description:The workshop will review traditional and advanced formulation approaches for inhalation and nasal delivery, coupling key aspects across particle engineering as well as formulation and device design. Case studies will be presented focused on the interaction between traditional carrier-based formulation components and the final outcome in terms of aerodynamic performance, manufacturability and expected lung dose. Further case studies will look at carrier-free formulations for DPIs and for nasal applications, advanced particle engineering technologies applicable to labile biomolecules and finally design optimization of a cost-effective capsule-based inhaler and device development targeting high dose delivery.
Outcome for Participants: Participants will leave with a greater understanding of how to develop and characterize scalable inhalation and nasal powder formulations as well as inhalation devices incorporating lean tools such as modeling, as well as advanced analytical characterization of particles and formulations.
IMA (Room C2)
Manufacturing DPIs: An Engineering Perspective
Introduction: When developing new pharmaceutical products in DPI form, industrial manufacturing aspects must be considered from the very beginning to shorten the scale-up and optimization of the final manufacturing process to achieve more efficient and cost-effective production. Precise micro-dosing, weight control, containment measures and ease of device assembly are all issues that must be faced at an early stage.
Description: This workshop will delve into processing and assembly aspects such as direct weight control performed in-line on each single capsule or device, both before and after filling, absence of mechanical powder compression for improved airway intake and accurate micro-dosing and automatic feedback and adjustment. Proof of principle studies at an early stage for highly flexible and precise inhaler assembly aligned with design for manufacturing (DFM) will also be reviewed. The Minima tabletop capsule filler will be demonstrated, a system that can be used for efficient inhalation product optimization, as it mimics the same process and dosing parameters as high-volume production machines.
Outcome for Participants: The workshop provides attendees with an opportunity to see the technical solutions available for manufacturing DPIs and to understand how to address the various challenges linked to DPI engineering and delivery.
Lonza (Room F1)
Technology Selection for Capsule-Based Inhalation Product Development
Introduction: Particle engineering in dry powder inhaler product development utilizing capsule-based devices is gaining interest driven by a trend towards higher dose formulations and increasing interest in both large molecule and combination products utilizing DPI delivery. Spray drying offers processing and formulation benefits for these new products versus traditional carrier-based formulation approaches based on jet milling platforms. Capsule-based devices can provide the additional benefit of faster development compared to alternative inhaler designs.
Description: This session will look at critical factors in choosing a DPI formulation approach including spray drying vs jet milling and achieving mix and mill in a single step via co-micronization and jet milling. Formulation options using spray drying will be reviewed as well as capsule customization in order to optimize performance and stability of the finished product. Is an off-the-shelf (device) option right for your application? This interactive workshop will utilize examples and case studies to answer the above question and others from the participants.
Outcome for Participants: Attendees will understand how to perform technology selection to help shape their product development strategy and understand how DPI capsule selection and customization contribute to overall product performance.
Mexichem (Room F3)
HFA 152a - The Next Chapter in the Story of the MDI?
Introduction: Global warming and the introduction of related new international regulations on HFA gases have resulted in the development and availability of P152a HFA as a proposed new propellant for MDIs. For anyone involved in this transition of HFA gases in their pMDI products, it will be essential to understand all the challenges likely to emerge over the coming years.
Description: The workshop will consist of several sub-presentations covering the following subject areas:
- Environmental regulations (EU F Gas & Kigali Amendment to Montreal Protocol)
- P152a as an alternative MDI propellant (physical properties, cost, availability, sustainability & formulation)
- Safety studies (toxicology & flammability risk assessment)
- Impact on other key MDI components (including valves & cans)
- P152a MDI production process (hardware, flammability & building layouts).
Outcome for Participants: Attendees will leave with a much better understanding of the implications around the potential introduction of the new HFA propellant on their MDI products and get a glimpse of the exciting and challenging times ahead.
Proveris Scientific (Room F5)
Control Strategy for pMDI Development and Release Testing: Factors that Impact pMDI Performance
Introduction: As a drug-device combination product, the development process of pressurized metered dose inhalers (pMDIs) is quite challenging, and involves device, formulation, as well as user-device interaction. This workshop will introduce a series of automated actuation systems into the pMDI development and production workflow, as well as spray characterization tools to evaluate in vitro performance and provide indicators of pre-pulmonary deposition.
Description: This workshop will include a presentation to outline the steps from early stage pMDI development, through to production release testing. A case study outlining how to determine and control critical actuation and shaking parameters that affect product performance will be reviewed. Attendees will have the opportunity to offer potential problems encountered during pMDI development and the instructors will provide feedback and discuss solutions.
Outcome for Participants: Attendees will gain an understanding of the importance of designing and controlling the actuation process to achieve more robust and reproducible in vitro results as well as insights into utilizing controlled pMDI workflows to ensure repeatability, reduce testing variabilities, minimize out-of-specification (OOS) and increase efficiency in pMDI development and release testing.
Qualicaps (Room F6)
The Performance of Hard Shell Capsules for Use in Dry Powder Inhalers
Introduction: The performance of dry powder inhalers depends on the complex inter-connection between drugs and excipients, formulations, capsules, device design and patient inhalation capacity and technique. In the case of capsule-based DPIs, the capsule also plays an important role, not only in the packaging of the formulation, but also in powder aerosolization and dispersion of the drug during inhalation.
Description: This workshop discusses some of the established and emerging methods that can be used to characterize hard shell capsules and their performance in DPIs. Participants will be given the opportunity to view and discuss the data that can be produced by imaging technologies, such as optical coherence tomography (OCT) and computerized tomography (CT) scanning equipment. A range of capsule formulations will be compared and contrasted to enable participants to understand how small changes in formulation can influence the properties of the hard shell capsule.
Outcome for Participants: Participants will develop a better understanding of the differences between capsule formulations and the potential role of novel testing and imaging methods to analyze hard shell capsules to ensure their quality and performance in the hands of users.
