Inhalation & Respiratory Drug Delivery | Wearable Injectors & Connected Devices

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  • Day 0

    October 05, 2022

  • Day 1

    October 06, 2022

  • Day 2

    October 07, 2022

  • ➡️ Inhalation products have many different requirements, which need to be considered when selecting the delivery device.
    ➡️ SMI provide a patient friendly, cost-effective alternative to existing delivery devices.
    ➡️ Soft mist inhaler performance and case studies
    Inhalation & Respiratory Drug Delivery

  • ➡️ Innovative solution of an eFlow technology nebulizer with Wifi and Bluetooth connectivity
    ➡️ App for the patient and a dashboard for the physicians and therapists
    ➡️ First experiences with this solution
    Wearable Injectors & Connected Devices

  • ➡️ Inhalation methodology particularly for non-clinical species has always had an air of mysticism and complexity about it. This presentation will provide the understanding that will effective development and regulatory submission for inhalation delivered products.
    Inhalation & Respiratory Drug Delivery

  • ➡️ Overview of the ISO 18562 standard and its application to the safety evaluation of breathing gas pathways of medical devices.
    ➡️ Strategy for achieving the requirements laid out in the new standard.
    ➡️ ISO 10993, which covers biological evaluation of medical devices, does not sufficiently address the biological evaluation of the gas pathways of medical devices. ISO 18562 addresses the risk of potentially hazardous substances being conveyed to the patient by the gas stream in three ways:
    1) Emission of particulate matter into the gas stream;
    2) Emission of volatile organic compounds into the gas stream;
    3) Substances leached by liquid water condensing into gas pathways of medical devices.
    In this presentation, we will discuss what this new standard entails and the methods used to meet the testing needs outlined in ISO 18562.
    Wearable Injectors & Connected Devices

  • ➡️ Importance for formulators to be collaborative with capsule manufacturers.
    ➡️ Establish if a capsule can empty too well. Performance criteria and comparisons of legacy products vs new developments.
    ➡️ Customizing capsules: raw materials, plasticizers, internal lubricants, weight ranges and other considerations.
    Inhalation & Respiratory Drug Delivery

  • ➡️ EU: navigate through EUMDR and applicable legislative requirements
    ➡️ US: consolidate FDA expectations
    ➡️ Evaluation of connectivity solutions from RA perspective
    Wearable Injectors & Connected Devices

  • ➡️ Remote patient monitoring tools
    ➡️ Virtual Asthma Coaching
    ➡️ Smart Asthma Inhalers
    Inhalation & Respiratory Drug Delivery

  • Collaboration and Simplification to Accelerate Device Development and Drug Delivery
    Wearable Injectors & Connected Devices

  • Artificial Intelligence/Machine Learning in Dry Powder Inhalers in the Digitalization Era: Current Status and Future Perspectives
    Inhalation & Respiratory Drug Delivery

  • ➡️ The Chronic Cough Challenge (Healthcare Need, Worsening Trends)
    ➡️ Current non-Respiratory Therapies (Market Size, Opportunity for Innovation)
    ➡️ Gefapixant (the P2X3 target, challenges with the oral route, opportunity)
    ➡️ Monitoring Cough with Digital Technologies (Quantification, Regulation, Insurance)
    ➡️ The Nocion Approach to Respiratory Treatment (Science, Data, Path to Market)
    ➡️ The Airway Hydration Solution to CC Management (Science, Data, Path to Market)
    Inhalation & Respiratory Drug Delivery

  • ➡️ Liquid Crystal Polymers (LCP) are best-in-class thermoplastics for thin-wall and micro- injection molding useful for high-volume manufacture of miniaturized medical devices.
    ➡️ LCP expands design capabilities enabling smaller structures and integration of electronic circuitry into structural components.
    ➡️ Vectra® MT® LCP from Celanese has a long clinical history in registered Class II and III medical devices.
    Wearable Injectors & Connected Devices

  • ➡️ Faster, safer and user freindly by design, human factor and clinical studies demonstrating the benefits of a needle-free auto-injector, ZENEO Terbutaline for Asthma exacerbations.
    Wearable Injectors & Connected Devices

  • A luxurious Gala dinner with live music
    Inhalation & Respiratory Drug Delivery
    Wearable Injectors & Connected Devices
    Location to be announced

  • ➡️ Healthcare is moving out of the clinical and into the home environment thereby increasing the need for and pertinence of developing safe and user-friendly digital medical solutions, software as a medical device (SaMD), or smart medical devices. However, lay users who are often the intended users of such development efforts, do not have the same level of (clinical) knowledge as healthcare professionals (HCPs), which impacts device interactions and may lead to different or more harmful use errors compared to devices being exclusively used by HCPs. Applying human factors engineering methods will help to ensure that smart medical devices are not only safer but also usable in the hands of the lay user.
    ➡️ Attendees will be provided with sufficient content that enables them to:
    • Understand how human factors engineering activities reduce harmful user errors, and improve devices’ use-safety and usability
    • Apply best practices for designing and evaluating smart medical devices
    • Learn about common use errors, as well as pitfalls and how to avoid them when designing and evaluating smart medical devices
    Wearable Injectors & Connected Devices

  • ➡️ Will inhalation device digitalization play a role with respect to sustainability?
    Inhalation & Respiratory Drug Delivery

  • ➡️ Current biocompatibility requirements for inhaled drug-device combination product therapies, including newer regulatory requirements.
    ➡️ Strategies to satisfy biocompatibility endpoints.
    ➡️ Challenges for inhaled drug-device combination products including bridging strategies for older devices.
    Inhalation & Respiratory Drug Delivery

  • ➡️ Topic to be announced
    Inhalation & Respiratory Drug Delivery

  • ➡️ Orbital is a unit dose dry powder for inhaler (DPI) capable of delivering up to 400 mg to the lungs. Orbital has potential for broad applications across the inhaled drug delivery market. Several papers has been published on the performance of this DPI, particularly on the management of Cystic Fibrosis. Young et al., reported in 2013 an aerodynamic performance comparison between Orbital and RS01, loading both devices with spray dried ciprofloxacin. Multi Stage Liquid Impinger deposition showed a much better performance with more cohesive powders for Orbital compared to RS01 (67.1% versus 46.5% of Fine Particle Fraction, FPF) [Young et al., 2013].
    ➡️ In order to assess the performance of this device different model formulations have been prepared and characterized, employing various manufacturing processes: spray drying, low shear blending and the novel thin layer fluidization. Performance of Orbital device and formulation combination was studied employing realistic aerodynamic particle size distribution testing together with in silico regional deposition modeling. These tests are part of Nanopharm's SmartTrack, a collection of in vitro tools that generate clinical relevant data for orally inhaled and nasal drug products.
    ➡️ The study is still on-going and will be completed in July 2022. However, the results collected until now showed a better performance in terms of realistic FPF for Orbital compared to RS01: FPF of a spray dried formulation of amikacin was between 22.6-24.3% for all the different Orbital device assembly versus 17.0% for RS01 and 39.2-46.9% for Orbital compared to 37.4% for RS01 when these were loaded with a high payload fluticasone propionate low shear blend.
    Inhalation & Respiratory Drug Delivery