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SAE Media Group’s Inaugural Respiratory Drug Delivery will be coming to London in November 2023 to bring together big pharma, device developers and innovative biotech to discuss emerging trends and innovations within respiratory drug delivery device development. The conference will bring the opportunity for experts to discuss emerging trends and innovations in the inhalator drug delivery space.

With an increasing need for respiratory medicines and pulmonary delivery providing an alternative to common routes of delivery such as injection and oral administration, there have been significant advances in nasal and inhalation devices in recent years.

Why Attend? 

The conference is set to explore the design and development of respiratory drug delivery devices, opportunities for enhancing the patient experience and the digital integration of inhaler devices. Furthermore, with the growing need for circular economy, the conference will assess case studies of sustainable approaches for device life cycle management and packaging. The conference will also address challenges in regulations with case studies on labelling and best practices for successful submissions.


This is the only event that will:

Bring you the key insights needed to expand you device portfolio and the opportunity to network with senior players throughout the industry. We hope to welcome you to this must attend event in November 2023.
 

  • Discover the latest approaches to enable sustainability for respiratory devices with a case study on an inhaler platform with a near-zero carbon footprint propellant
  • Benchmark against connected inhaler case studies and gain insight into how digital integration can enable better patient experience and adherence
  • Explore key drug formulation and biopharmaceutical considerations for efficient delivery to the respiratory system with key insights from AstraZeneca on biopharmaceutic modelling
  • Delve into the latest strategies to enhance patient usability for increased correct device use and better health outcomes
  • Hear from the MHRA, BSI and GSK on the latest regulatory requirements for respiratory devices, including Article 117, and ensuring legacy devices are in line with updated regulations
     

Directors, Heads of Departments and Managers for the following areas:

  • Device Development
  • Device Engineering
  • Combination Product Development
  • Drug Delivery Devices
  • Primary Packaging Development
  • Digital Health
  • Novel Drug Product Formulation
  • Drug Product Development
  • Regulatory Affairs
  • Medical Affairs

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

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9:10

Streamlining product development through correct CMC practices and regulatory governance

Ryan Noble

Ryan Noble, Associate Director, GlaxoSmithKline

  • Key considerations for drug product strategies from pre-NME to post-NDA/MAA approval, including Life Cycle Management (LCM)
  • A review of current European regulatory guidance for drug delivery devices and lessons from MDR implementation
  • Strengthening device optimisation with a review of article 117 and available EMA guidance
  • Future labelling requirements and next steps in regulatory guidance
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    9:50

    Navigating Regulations in the Respiratory Field

    Orla Ni Ogain, Pharmaceutical Assessor, MHRA

  • Reviewing the most important regulatory updates
  • Comparison of international guidelines for inhaled products: oral and nasal
  • Guidance on best practices for a successful application and approval
  • clock

    10:30

    Morning Coffee

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    11:00

    Inhaled Drugs and Extrapolation strategy- Do we know enough?

    Niyati Prasad, Chief Medical Officer, Enterprise Therapeutics

  • Inhaled drugs and their impact on lung deposition by age
  • Extrapolation strategy in paediatrics
  • clock

    11:40

    Utilising Device Performance Data for User-Driven Devices

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

  • Approaches for producing numeric values for forces required to operate inhalers
  • Understanding usability several patient populations
  • Case study on research on actuation forces
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    12:20

    Networking Lunch

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    13:20

    SmartTrack™: An Alternative Pathway to the development of Dry Powder Inhalers

    Lucas Silva, Senior Specialist, Nanopharm Ltd

  • SmartTrack™ Platform: combination of in vitro and in silico methodologies to accelerate and de-risk drug product development.
  • In vitro tools used to generate clinically relevant results
  • In silico approach employing Rapid Deposition Analysis & Computational Fluid Dynamics
  • Presentation of 2 Case Studies
  • High Payload Dry Powder Inhaler Development utilising the Orbital device.
  • Bioequivalence of two tiotropium dry powder inhalers and the utility of realistic impactor testing.
     
  • clock

    14:00

    Digital Inhaler Case Study – and lessons from Aircraft Crashes!

    Mark Milton-Edwards, Head of Health Solutions, Teva Pharmaceuticals

  • Healthcare Lessons can be learnt from outside Healthcare
  • Real-World User Design and enduring needs must be clearly defined
  • Machine Learning & Prospective Research can be used to predict attacks
  • Validation pathway for digital inhaler product and best practises for gaining regulatory approval
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    14:40

    Afternoon Tea

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    15:10

    Conformity assessment challenges for digital health and connected medical devices

    Abtin Rad, Global Director Digitization, TUV SUD Product Service GmbH

  • Software life cycle aspects and connected medical devices
  • How to ensure security and privacy for active medical devices
  • Implementing artificial intelligence in medical devices under state of the art
  • clock

    15:50

    Panel Discussion: Present and Future Opportunities in Respiratory Devices

  • Re-inventing inhalers for a digital age
  • Main challenges in developing respiratory devices and what can be done to overcome them
  • Regulatory uncertainties and how can collaboration in industry drive innovation forward
  • Mark Milton-Edwards, Head of Health Solutions, Teva Pharmaceuticals

    Abtin Rad, Global Director Digitization, TUV SUD Product Service GmbH

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

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    16:30

    Chair’s Closing Remarks and Close of Day One

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

    clock

    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

    clock

    9:10

    Pharmaceutical Transition to Low Environmental Impact pMDI

    David Lechuga Ballesteros, Head of Innovation, AstraZeneca Pharmaceuticals

  • Outlining roadmap to reduce environmental impact
  • Insight into producing new pDMI platform with a near-zerocarbon footprint propellant
  • Comparative performance of current hydrofluoroalkane propellants to products with next generation propellants
  • clock

    9:50

    Combining sustainability with usability

    Louisa Harvey, Founder and Principal, Harvey Medical

  • Overview of global research conducted by Harvey Medical
  • Methods used and results found
  • Plans for future research
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    10:30

    Morning Coffee

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    11:00

    Particle Engineering Technologies for Inhalable Biopharmaceuticals

    Sune Klint  Andersen

    Sune Klint Andersen, Associate Director/Principal Scientist, Janssen Pharmaceutica R&D

  • Challenges for inhalable delivery of biopharmaceuticals
  • Strategies for designing stable formulations for inhalation
  • Particle engineering formulation and process technologies for inhalable biopharmaceuticals
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    11:40

    Use of physiologically-based biopharmaceutic modelling (PBBM) to evaluate in vivo comparability of inhaled drug products

    Markus Friden, Director, AstraZeneca

  • Overview of PBBM model structures and strategies for model development/parameterisation
  • Challenges of validating model predictivity for systemic and local lung pharmacokinetics
  • Case studies of successful prediction of relative bioavailability
  • Outlook on requirements for future advancement in the field
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    12:20

    Networking Lunch

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    13:20

    Developing drug design and formulation strategies to optimise retention in the lungs

  • Formulation and characterisation of dry powders for systemic delivery of therapeutic proteins
  • Validating in vivo and ex vivo models of the lungs as tools to predict pulmonary drug absorption in vivo
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    14:00

    Describing aerosol plume response to physiological conditions

    Dan Hardy, Assistant Course Manager, University Of Bristol

  • There is a lack of accurate descriptions of the state of plumes of aerosol particles when exposed to physiological conditions.
  • Phenomena such as hygroscopic growth, crystallisation and particle dissolution may all significantly change the aerodynamic properties of inhaled particles - modifying the deposition profile
  • Thus, without accurate representation of the aerosol kinetics, it is not possible to describe the deposition of particles within the lung
  • We will present accurate, time-resolved simulations of size distributions relevant to soft mist inhalers in conditions representative of inhalation
  • Such simulations reveal the range of time-scales over which hygroscopic response occurs and how these are comparable to the timescales of deposition.
  • We will then present a methodology by which the coupled processes of aerosol kinetics and deposition may be represented by integrating a deposition model (ICRP 66) with Microsol’s aerosol kinetics model.
  • With accurate and time-resolved predictions of the properties of the full particle size distribution, it is then possible to suggest modifications to the formulation properties which modulate the dynamics of hygroscopic growth and tune the deposition profile
  • clock

    14:40

    Afternoon Tea

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    15:10

    EU Regulatory Update: Software as a Medical Device

    Sandra Beltran Rodil

    Sandra Beltran Rodil, Associate Director, Regulatory Affairs, Teva Pharmaceuticals Ltd

  • Exploring the regulatory landscape for software as a medical device under the MDR (classification)
  • Engaging with a notified body
  • Looking at the lifecycle management of software as medical device
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    15:50

    EU Regulatory Update: Software as a Medical Device

    Arabe Ahmed, Medicinal Technical Specialist, BSI

  • Exploring the regulatory landscape for software as a medical device under the MDR (classifi cation)
  • Engaging with a notified body
  • Looking at the lifecycle management of software as medical device
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    16:30

    Chair’s Closing Remarks and Close of Day Two

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim


    Global Director Digitization
    TUV SUD Product Service GmbH
    Medicinal Technical Specialist
    BSI
    Assistant Course Manager
    University Of Bristol
    Head of Innovation
    AstraZeneca Pharmaceuticals
    Senior Principal Scientist
    Boehringer Ingelheim
    Founder and Principal
    Harvey Medical
    Senior Specialist
    Nanopharm Ltd
    Head of Health Solutions
    Teva Pharmaceuticals
    Director
    AstraZeneca
    Chief Medical Officer
    Enterprise Therapeutics
    Pharmaceutical Assessor
    MHRA
    Associate Director
    GlaxoSmithKline
    Associate Director, Regulatory Affairs
    Teva Pharmaceuticals Ltd
    Associate Director/Principal Scientist
    Janssen Pharmaceutica R&D

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    Sponsors


    Nanopharm

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    https://nanopharm.co.uk/

    Nanopharm, an Aptar Pharma Company, is a world leading specialist contract research organization (CRO) offering product design and development services for orally inhaled and nasal drug products (OINDPs). Nanopharm operates a fee-for-service model, helping its clients navigate the scientific, technical and regulatory challenges in developing nasal and respiratory drug products The company’s unique processing technologies and formulation development tools enable seamless translation from discovery and pre-clinical development through to clinical manufacturing. Its service offerings provide the most efficient path to success for its clients by providing an integrated drug product development service covering:

    • Advanced materials characterization and preformulation studies

    • Formulation development and device selection

    • Analytical development and aerosol performance testing

    • In silico modelling of deposition and bioavailability

    • In vitro and in silico bioequivalence studies

    • cGMP analytical and stability studies

    These services aid successful product development by understanding how material properties and processing conditions influence aerosolised product functionality and clinical performance, and therefore reduce risks and expedite drug development timelines.

    The technology platforms for advanced materials characterization, formulation & device development and in-silico modelling of in vivo behavior, have provided Nanopharm a technical competitive edge, helping it become an international market leader. For more information visit: www.nanopharm.co.uk


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    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

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    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

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    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

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    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

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    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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