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Wearable Injectors and Connected Devices UK
14 October - 15 October 2024
Wearable Injectors and Connected Devices UK

SAE Media Group's 5th Annual Conference
Wearable Injectors and Connected Devices
14th-15th October, 2024 | London, UK
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SAE Media Group’s 5th Annual Wearable Injectors and Connected Devices Conference will explore on-body device design and development whilst also engaging in the latest advances in connectivity and digital health applications for wearable devices with industry perspectives from big pharma representatives. The conference will consider key developments in the wearable injectors field, including the enhanced demand for on-body injectors and digitalised health as the need for at home self-administration and routes for delivery of time-dependent, high volume and viscous drugs grow.

The conference will also cover key regulatory updates such as guidance on MDR requirements from regulatory and notified bodies, and the importance of considering user-experience and developing patient-centric devices. The two-day conference will bring you high-quality insights and industry connections on the latest advances in wearable injectors and connectivity, and a platform for exchanging ideas.
 

FEATURED SPEAKERS

Andrew Chapman

Andrew Chapman

Senior Director, AstraZeneca
Berna Kosekaya

Berna Kosekaya

Regulatory Professional, Novo Nordisk
Charles  Potter

Charles Potter

Technical Project Leader, Chiesi Ltd
Christian Proff

Christian Proff

Senior Verification Engineer, Roche
Esther Grandal Delgado

Esther Grandal Delgado

Senior Regulatory Affairs Professional, Novo Nordisk
Fausto Artico

Fausto Artico

Global R&D Data and AI Strategy Leader, Argenx
Julian Dixon

Julian Dixon

Former Senior Director, Human Factors, AstraZeneca
Marion Briggs

Marion Briggs

Circular Economy Expert, Airfield Consulting
Scott Ewan

Scott Ewan

MediPhorum - Program Manager, Biophorum
Soren Skov

Soren Skov

Senior Human Factors Engineer, Roche

Andrew Chapman

Senior Director, AstraZeneca
Andrew Chapman

Berna Kosekaya

Regulatory Professional, Novo Nordisk
Berna Kosekaya

Berna Kosekaya is an expert in regulatory affairs at Novo Nordisk, where she is responsible for driving global submissions for the combination products portfolio within a dynamic regulatory landscape. With a robust background as a pharmacist holding a Ph.D. in pharmacology, she brings a wealth of knowledge and expertise to her role. Her career journey includes pivotal roles within the national medicines agency of Turkiye. With over 8 years of regulatory experience spanning diverse product portfolios, her current focus is on navigating the complexities of combination products with precision and efficiency.

Blake Green

Director Regulatory Affairs, Amgen
Blake  Green

Charles Potter

Technical Project Leader, Chiesi Ltd
Charles  Potter

Christian Proff

Senior Verification Engineer, Roche
Christian Proff

Dr. Christian Proff is a materials scientist with degrees from Chalmers, Gothenburg (S) and Darmstadt (D) Universities of Technology and a PhD from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory) and Switzerland (Paul-Scherrer-Institut). Within Device and Packaging Development at F. Hoffmann - La Roche he is working in Verification Engineering since 2018 on improvements in CCI testing and development of new device test methods.

Edwin Lyons

Associate Director – Head of Device Engineering, CSL Behring
Edwin Lyons

Edwin is the head of Device Engineering in the ‘Drug Delivery Systems’ group in CSL Behring. Edwin has over 20 years experience in the design and development of drug-device combination products and a diverse range of medical devices. Edwin has a M.Eng.Sc in Biomedical Engineering from the University of Galway, Ireland and an M.B.A from Loughborough University, UK. Edwin is an active member of the BioPhorum ‘Essential Drug Delivery Outputs (EDDO)’ workstream that is a cross-industry collaboration to consider the interpretation, identification, and control of EDDOs for drug delivery systems.

Esther Grandal Delgado

Senior Regulatory Affairs Professional, Novo Nordisk
Esther Grandal Delgado

Esther Grandal Delgado is a seasoned regulatory professional, specialized in medical devices and primary packaging solutions. With a master’s degree in chemistry and over 25 years of experience in the chemical industry, she has been instrumental in steering companies through intricate regulatory frameworks to achieve product certifications with strategic insight. Her global career has endowed her with a vast knowledge and a comprehensive regulatory perspective. Presently, she tackles the complex challenges of primary packaging, an aspect of the medical device industry that has transitioned from being underestimated to being recognized as a critical interface affecting regulatory strategies in the initial stages of medical developments.

Fausto Artico

Global R&D Data and AI Strategy Leader, Argenx
Fausto Artico

Fausto has two PhDs (Information and Computer Science respectively), earning his second master’s and PhD at the University of California, Irvine. He also holds multiple certifications from several universities. As a Physicist, Mathematician, Engineer, Computer Scientist and High-Performance Computing (HPC) and Data Science expert, Fausto has worked on key projects at European and American commercial organisations, government institutions and with key individuals, like Nobel Prize winner Michael J Prather. He is Managing Director at Transformational Execution and he is currently working at Argenx as Global R&D Data and AI Strategy Leader.

Julian Dixon

Former Senior Director, Human Factors, AstraZeneca
Julian Dixon

After 24 years at Team Consulting supporting the development of drug delivery devices and 2 years at AstraZeneca biopharmaceutical development gaining direct experience of pharma life, Julian has returned to consulting at Clarimed. His background is in mechanical engineering and psychology. A favourite quote: “There has been an alarming increase in the number of things I know nothing about.” - Ashleigh Brilliant.

Leonel Stermann

Senior Material Development Scientist, Sanofi
Leonel Stermann

Leonel Stermann is a materials engineer by education and holds a doctorate in materials physics from University of Lyon. He developed activities on different sectors such as medical textile, metallurgy, nuclear, and pharmaceutical in Latin America and Europe. He joined Sanofi in 2022 and he is focus on primary containers and innovation, such as ultra-low temperature applications, and large volume devices.

Marco Caproni

Senior Product Specialist for Software, TÜV SÜD
Marco Caproni

Marco Caproni is Senior Product Specialist for Software and AI at TÜV SÜD Notified Body. He has more than 15 years of professional experience in the design and development of medical devices, in the area of software, extracorporeal circulation devices (such as dialysis) and has worked as software- and active medical devices-focused certification lead auditor and technical documentation assessor. As Lead Auditor, Project Handler and Technical Documentation assessor, Marco is actively driving conformity assessment activities for active medical devices customers in Italy and internationally. As Senior Product Specialist, Marco is the ultimate responsible for answering technical questions, making decision in case of unclear requirements about AI and software in general.

Marion Briggs

Circular Economy Expert, Airfield Consulting
Marion Briggs

Scott Ewan

MediPhorum - Program Manager, Biophorum
Scott Ewan

Senior Representative

, BioPhorum
Senior Representative

Soren Skov

Senior Human Factors Engineer, Roche
Soren Skov

Søren Skov is a Senior Human Factors Engineer at Roche, specializing in the development of Smart Device and Digital Health products. He is the HFE lead in the Smart Device Tech Center and a core member of the Roche Behavior Design Service. Prior to this, he led the UX and HFE activities in the development of connected medical devices and digital ecosystems at Novartis. Søren's focus on improving user experiences in healthcare is founded in an educational background in psychology and further work background in Danish design.

Why to attend:

  • 2 full days of networking opportunities.
  • 16+ sessions with 75% of speakers from big pharma companies.
  • An agenda designed for professionals within the injectables space, focused on the development, implementation and application of wearable injectors and connected devices.
  • The only conference discussing wearable injectors and connected devices together, other than our USA version of this event.

The Experience:

  • A collaborative environment for pharma, biotech and device developers to discuss the latest trends and challenges within the wearable injectors and connected device market.
  • Learn from key industry players about new technologies, strategies and processes for the development of wearable injectors.
  • Gain insights into the regulatory processes for the approval of wearable injectors and develop a greater understanding of how-to bring devices to market.
  • Create a dialogue with industry leaders and develop a network with the key stakeholders in the market.
  • Delve into the world of digital health for the healthcare sector and discuss implementation of connectivity with on-body drug delivery systems.
  • Examine the importance of usability for at home injectors, and what is needed to make a device appropriate for patient administration.

 

Who should attend:

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

  • Device Development
  • Smart Devices
  • Digital Health and Connectivity
  • Connected Devices
  • Device Engineering
  • Drug Delivery
  • Formulation for Wearables
  • Combination Product Development
  • On Body Device Development
  • Large Volume Drug Delivery
  • Regulatory Affairs
  • Medical Devices

Our Wearable Injectors and Connected Devices Conference is the only event that delves into the world of connectivity and digital healthcare through the lens of wearable drug delivery devices. Over two days, executives and leaders within the pharmaceutical industry come together to discuss and collaborate on the unique challenges that face this space. This event provides an intimate environment to network with peers and experts across the industry and learn from each other’s experiences, and to meet with solutions providers who are working hard to supplement the ever-changing industry.

sponsors

Conference agenda

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8:00

Registration & Coffee

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9:00

Co-Chair's Opening Remarks

Julian Dixon, Former Senior Director, Human Factors, AstraZeneca

Andrew Chapman

Andrew Chapman, Senior Director, AstraZeneca

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9:10

Streamlining Drug/Device Combination Product Development Collaboration

Esther Grandal Delgado, Senior Regulatory Affairs Professional, Novo Nordisk

  • Designing a device to use with a drug versus designing a drug with a device inside? Bespoke vs platform devices.
  • Large volume/high concentration drug deliveries. Considerations when making the switch from IV to subcutaneous administration.
  • Communications between drug R&D and device R&D – how do separate teams communicate and collaborate to streamline device development.
  • How has the industry progressed in making the switch from IV to subcutaneous injections
     
  • clock

    9:50

    Accelerating Progress for Large Volume Wearable Injectors

    Julian Dixon, Former Senior Director, Human Factors, AstraZeneca

  • Only two wearable injectors have made it to market over years of conversation and innovation - what is holding companies back, and what can we do to overcome this?
  • What lessons can we learn from successful devices on the market?
  • What challenges can we anticipate as the market continues to grow?
  • The importance of the story we tell alongside our technology
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Panel Discussion: Hitting the Sweet Spot: What Trade-Offs Need To Be Made For Wearable Injectors?

  • Sustainability – mechanical vs electronics, single use vs reusable, ‘real’ vs ‘perceived’ sustainability? 
  • Recyclability – should future devices be designed with recycling in mind?
  • Where is connectivity useful and where is it creating more problems than it solves? How do we decide the line between smart and overly complicated? 
  • Usability – What does the patient want / need to ensure compliance? What is the optimum frequency of injections without being a burden but so the patient remembers how and when to take their medication?
     
  • Charles  Potter

    Charles Potter, Technical Project Leader, Chiesi Ltd

    Soren Skov, Senior Human Factors Engineer, Roche

    Andrew Chapman

    Andrew Chapman, Senior Director, AstraZeneca

    clock

    11:40

    CCI Compliance Challenges After (Recent) Regulatory Updates

    Christian Proff, Senior Verification Engineer, Roche

  • USP<1207> and EU Annex 1
  • Expectations for pharmaceutical packaging development and lifecycle management
  • Details available from thorough packaging development which supports compliance to regulatory requirements
  • Typical examples we will shed light on selected aspects of individual packaging solutions
     
  • clock

    12:20

    Networking Lunch

    clock

    13:20

    The Regulatory Challenge: Fireside Chat with Blake Green

    Blake  Green

    Blake Green, Director Regulatory Affairs, Amgen

  • What regulatory strategies should we be employing during device development to streamline submissions?
  • Understanding the structure of approval bodies and navigating uncertainties throughout the device approval process.
  • Strategies for collecting useful data and evidence during the device development process.
  • Managing conflicting requirements of global regulatory agencies and industry news for harmonisation.
     
  • clock

    14:00

    Sustainability Considerations For On Body Drug Delivery Devices

    Marion Briggs

    Marion Briggs, Circular Economy Expert, Airfield Consulting

  • Single use versus reusable injectable devices: pros and cons?
  • Regulatory hurdles for reusing plastic waste from devices
  • Creating an eco-friendly injector while maintaining sterility and safety for patient use
  • Electronic waste versus plastic waste 
  • Closing a loop on circular economy – design for disassembly so we can recover these materials
  • Device cost considerations to ensure a device is feasible at market level.
  • clock

    14:40

    Afternoon Tea

    clock

    15:10

    Navigating Lifecycle Management of Integral Drug-Device Combination Products

    Berna Kosekaya, Regulatory Professional, Novo Nordisk

  • Regulatory Landscape for Drug-Device Combination Products in the EU
  • Understanding the Complexity of Integral Drug-Device Combination Products
  • Post-Authorization Device Related Changes and Their Regulatory Impact
  • Current Guidelines and Practical Considerations
  • clock

    15:50

    Chairman’s Closing Remarks and Close of Day One

    clock

    16:00

    End-of-Day-One Networking Reception

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Co-Chair's Opening Remarks

    Julian Dixon, Former Senior Director, Human Factors, AstraZeneca

    clock

    9:10

    Fireside Chat: Emerging Technologies for Health Data and AI for Connected Devices

    Fausto Artico, Global R&D Data and AI Strategy Leader, Argenx

  • Understanding difficulties and challenges in the healthcare sector
  • Discuss how Emerging Technologies can help you and your teams
  • Utilising connectivity for at home devices to improve adherence and safety
  • Discussing the sensitive nature of health data, and how to manage it securely
  • clock

    9:50

    The Value of Digital Healthcare for Drug Delivery Devices

    Scott Ewan

    Scott Ewan, MediPhorum - Program Manager, Biophorum

  • What benefits can be gained from digital? For the patients, the payers and the industry.
  • Clarifying the meaning of value in the drug delivery space
  • Overcoming challenges of digital healthcare within the medical device space
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Utilising Connectivity and Digital Health to Develop a Patient Friendly Device

    Soren Skov, Senior Human Factors Engineer, Roche

  • Behaviour design and digital health – how to maximise usability when designing connected devices?
  • Patient preferences beyond usability.
  • How do we smoothly integrate technology with injectable drug delivery systems?
  • Patient considerations when developing connected devices, from usability to access systems.
  • clock

    11:40

    Medical Devices & MDR Article 117

    Marco Caproni, Senior Product Specialist for Software, TÜV SÜD

  • MDR latest state of play and what happens next
  • Additional Regulations & Directives in the EU affecting your device & development
  • Security for connected devices
  • clock

    12:20

    Networking Lunch

    clock

    13:20

    The FDA Essential Drug Delivery Outputs Draft Guidance: Interpretations for On-Body Injectors

    Edwin Lyons, Associate Director – Head of Device Engineering, CSL Behring

  • An overview of MediPhorum’s collective comments on the FDA EDDO Guidance
  • Clarifying the interpretation of the guidance further to the recent MediPhorum Essential Performance Requirements reports and additional insights related to On-Body Injectors
  • A review of On-Body Injector control strategies across MediPhorum participants
  • clock

    14:00

    Characterization of needles and spikes for medical devices

    Leonel Stermann, Senior Material Development Scientist, Sanofi

  • Characterization of penetration force and bevel defects
  • Impact assessments of lab-generated defects
  • Mechanical and dimensional characterization of the cannula
  • clock

    14:40

    Afternoon Tea

    clock

    15:10

    Panel: More Than A Concept – Bringing Wearable Injectors To The Market

  • Overcoming regulatory hurdles for large volume injectors
  • Recognising the unique challenges for wearables, from human factors to health data safety
  • Developing a gold standard for clinical trials and evidence-based approval submissions
  • Working together as an industry to create an environment that nurtures innovation
     
  • Berna Kosekaya, Regulatory Professional, Novo Nordisk

    Blake  Green

    Blake Green, Director Regulatory Affairs, Amgen

    Julian Dixon, Former Senior Director, Human Factors, AstraZeneca

    clock

    16:00

    Chairman’s Closing Remarks and Close of Day Two


    Senior Director
    AstraZeneca
    Regulatory Professional
    Novo Nordisk
    Director Regulatory Affairs
    Amgen
    Technical Project Leader
    Chiesi Ltd
    Senior Verification Engineer
    Roche
    Associate Director – Head of Device Engineering
    CSL Behring
    Senior Regulatory Affairs Professional
    Novo Nordisk
    Global R&D Data and AI Strategy Leader
    Argenx
    Former Senior Director, Human Factors
    AstraZeneca
    Senior Material Development Scientist
    Sanofi
    Senior Product Specialist for Software
    TÜV SÜD
    Circular Economy Expert
    Airfield Consulting
    MediPhorum - Program Manager
    Biophorum
    BioPhorum
    Senior Human Factors Engineer
    Roche

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    Hilton London Kensington

    179-199 Holland Park Avenue
    London W11 4UL
    United Kingdom

    Hilton London Kensington

    At the heart of the Holland Park district, our hotel is 10 minutes from Westfield London shopping center. We're blocks from Shepherd's Bush Underground station, linking to central London, and Kensington Palace and Gardens are two miles from us. Enjoy 24-hour access to our fitness center.

     
    Join us in WestEleven for hearty buffet breakfast, a great way to start the day! Our Avenue Bar and Lounge serves light bites throughout the day as well as a delicious, seasonal dining menu.”
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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:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

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

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

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

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    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)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    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.

    GLOBAL CPD

    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.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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