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SAE Media Group’s Inaugural
Wearable Injectors and Connected Devices USA
September 13 - 14  2023 | Boston, MA
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SAE Media Group are proud to announce the Inaugural Wearable Injectors and Connected Devices USA Conference taking place on the 13th and 14th of September 2023.


Following the success of the Wearable Injectors and Connected Devices Europe conference, SAE Media Group will be bringing the conference to Boston to cater to Big Pharma, Biotech and Device Developers in the USA.
 

As the need for at home self-administration and routes for delivery of time-dependent and high-volume drug delivery grows, on-body injectors and connected devices hold great opportunity. The conference will delve into on-body device design and development, latest advances in connectivity and digital integration of wearable devices, and opportunities for enhancement of user-interface through human factors case studies. The conference will also address challenges in regulations surrounding wearable injectors and connected devices with case studies and an FDA keynote on cybersecurity.


As part of SAE Media Group’s leading Injectable series of conferences, we bring together high-level experts from big pharma and device developers to network and share knowledge to advance R&D. The two-day conference will not only bring you high-quality key insights needed to enhance your wearable devices and connected product portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in September 2023!
 

  • Discover the latest advances in wearable injector design and development as well as emerging technologies for improved drug delivery
  • Understand and gain insight into the regulations surrounding electronic devices and wearable injectors such as labelling requirements and clinical study expectations
  • Delve into the digital integration of medical devices for improved user experience and strategies to ensure connected ecosystems are safe with an FDA Cybersecurity update
  • Benchmark against connected injector case studies and gain insight into key considerations during development such as battery selection
  • Engage in the latest strategies for implementing user centricity into device design to meet patient needs and increase adherence
  • Device Developers
  • Combination Product Developers
  • Smart Packaging Developers and Designers
  • Smart Device Developers 
  • Drug- Delivery Developers
  • Connected/Digital Health Developers

Previous attendees of our Injectable series of conferences:

Alexion Pharmaceuticals; Alnylam; Amgen; AstraZeneca; BAUMANN SPRINGS LTD; Baumann Springs USA Inc.; BD; BD Medical - Pharmaceutical Systems; Biogen; Bristol Myers Squibb; BSI; BSI Group; Celanese; Clexio Biosciences; Coherus Biosciences; Corning, Inc.; CP Pathways LLC; Credence MedSystems; Datwyler Pharma Packaging Belgium; Elcam E3d ACAL Ltd; Eli Lilly and Company / DDCS; EPiWatch; Fruh Verpackungstechnik AG; Genentech; GERRESHEIMER AG; Gerresheimer Buende GmbH; Glenmark Pharmaceuticals Inc.; Groupe Jbt; Haselmeier, Inc; Johnson & Johnson; Kaleo, Inc.; Kokoku Rubber Inc.; Kokoku Rubber, Inc.; Lyndra Therapeutics; Merck & Co., Inc; Merck / MRL Device Development; Merck and Co; Nipro PharmaPackaging Americas Corporation; Novartis; Nye Lubricants; Office of Combination Products, FDA; Owen Mumford; Pfizer; Pharmacircle; PHC Corporation; PHC Corporation of North America; Polyplastics US; RAUMEDIC, Inc.; Regeneron; Regeneron Pharmaceuticals; Rx Bandz; Sagentia Innovation; Sanofi; Sanofi US; Schott North America, Inc.; Schreiner Medipharm; SHL - Pharma; Steri-Tek; SureMed Technologies, Inc.; Takeda; Terumo Solutions; UserWise, Inc.; Vertex; W.L. Gore & Associates, Inc.; Weiss-Aug Company Inc; West Pharmaceutical Services; West Pharmaceutical Services, Inc.; Zeon Specialty Materials ; Zeon Specialty Materials Inc; Zwickroell; ZwickRoell GmbH & Co.KG;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Paul Upham

Paul Upham, Head, Smart Devices, Roche/Genentech
View Bio

9:10 Moving Towards Subcutaneous Delivery: Developing Wearable Injection Devices for Large Volume Drug Delivery

Anthony Coston

Anthony Coston, Technical Lead, Biogen

  • Strategies establishing optimal volume range for an on-body device
  • Assessing the impact of viscosity on injection force and best driving mechanisms for use
  • Maximising therapeutic effect, patient tolerance and user acceptability
  • Case studies on wearable device development
  • Insight into developing and commercialising of a portfolio of device and combination products
  • 9:50 Early-Stage Research: Best Strategies for Understanding Injection Device Needs in Patients

    Jessica Mastropietro

    Jessica Mastropietro, Device Development Engineer, Regeneron Pharmaceuticals Inc
    View Bio

  • The importance of meeting and understanding the specific challenges for patients with extra difficulties to design usable devices
  • Assessing the value of patient needs research at the early stage of device development
  • Best practices for maximising usability when designing and developing devices
  • Key insights and takeaways from findings from qualitative user research
  • Examining FDA guidance ‘applying human factors and usability engineering to medical devices’
  • 10:30 Morning Coffee

    11:00 Case study on SMARTCLIC® Development: A Smart Auto-Injector

    Claire Everitt

    Claire Everitt, Design Engineering Team Lead, Pfizer
    View Bio

  • Key drivers and benefits of smart injectors 
  • Evolution of SMARTCLIC’s design, graphical user interface and packaging through preference and usability studies
  • Challenges faced during development of SMARTCLIC: learnings and takeaways to apply to connected injector development
  • Validation of the SMARTCLIC® auto-injector and strategies for successfully gaining regulatory approval
     
  • 11:40 PANEL DISCUSSION: Enabling Successful Delivery of Drugs with Wearable Injectors and Emerging Technologies

  • What are the current biggest challenges and how can we overcome these?
  • How can teams across device and drug development work together to ensure speed to clinic?
  • As we look to advance technology and innovations, how can we ensure stakeholder buy-in for the evolution of the injectables landscape?
  • Looking into the future: what can we expect from industry and vendors?
     
  • E Guan

    E Guan, Head of Injection Systems, Takeda
    View Bio

    Christine Lynn Lanning

    Christine Lynn Lanning, Distinguished Scientist, Merck & Co., Inc
    View Bio

    Jessica Mastropietro

    Jessica Mastropietro, Device Development Engineer, Regeneron Pharmaceuticals Inc
    View Bio

    Paul Upham

    Paul Upham, Head, Smart Devices, Roche/Genentech
    View Bio

    Anthony Coston

    Anthony Coston, Technical Lead, Biogen

    12:20 Networking Lunch

    13:20 De-risking combination product development for large volume biologics: a device partner’s perspective

    Adam Kalbermatten

    Adam Kalbermatten, Vice President of Commercial Development, BD
    View Bio

  • Making and executing a compelling business case for any new combination product can be a challenge. Balancing trade-offs of time, investment and innovation to commercialize a combination product and achieve market uptake requires close collaboration with experts both internally and externally.
  • Transitioning drugs from intravenous (IV) to subcutaneous (SC) delivery brings new requirements and impacts program considerations for combination product development. In this session, we identify trade-offs that pharma weighs to de-risk combination product developments involving large volume subcutaneous (LVSC) delivery.
  • Key issues can include: understanding the patient experience throughout the injection process with LVSC delivery, reducing risk of use variability to gain market confidence in successfully delivering LVSC formulations, leveraging partner capabilities, insights and data to inform combination product trade-offs and program risks, manufacturability of the combination product including the delivery system and integration into the pharmaceutical operation’s network, exploring the value of drug delivery technology used consistently from clinical development into commercial use.
  • Examples of how these issues can impact a combination product development program will be explored along with the functional experts that can be engaged.

     

  • 14:00 Successfully Selecting your Wearable Injector Battery

    Ling Zheng

    Ling Zheng, Assoicate Director, Alexion Pharmaceuticals Inc
    View Bio

  • Important criteria for battery selection
  • Ensuring effective power budget management
  • Exploring system power characterization and battery characterization techniques
  • 14:40 Connected Ecosystems: Overview of Connected Devices in Clinical and Commercial Applications

    Simon Wilson

    Simon Wilson, Device Development Lead, Pfizer
    View Bio

  • Exploring connected ecosystem use cases (Connected Drug Delivery, Digital Therapeutics, Digital Diagnostics etc)
  • Understanding complexities of building connected ecosystems around parenteral delivery devices
  • Optimising components in a connected ecosystem to improve patient adherence and engagement
  • Ensuring the development process is a collaborative, user-driven approach with end-to-end thinking
  • Case study on a ‘connected’ project
  • 15:20 Afternoon Tea

    15:50 Incorporating Behaviour Design for Digital Health Solutions

    Paul Upham

    Paul Upham, Head, Smart Devices, Roche/Genentech
    View Bio

  • Introduction to behavioural science and applying key principles to connected devices and digital health products
  • Leveraging behavioural science to support patients and their self-management as well as increase adherence
  • Key considerations in creating a behaviour design service in pharma
  • 16:30 Biocompatibility of Medical Device/Combination Product

    Christine Lynn Lanning

    Christine Lynn Lanning, Distinguished Scientist, Merck & Co., Inc
    View Bio

  • Overview of biocompatibility
  • Leveraging supplier information vs testing to satisfy ISO 10993 requirements
  • Case examples with a focus on on-body/wearable devices and connectivity
     
  • 17:10 Practical Drug Product Development Considerations for Wearable Injector Development

    Jamie Tsung

    Jamie Tsung, Director of Drug Product Development, Alnylam
    View Bio

  • Outlining storage challenges for primary drug containers
  • Critical design considerations: minimum waist and low depth space
  • How to control drug temperature to extend shelf life of wearable injection devices
  • 17:50 Chair’s Closing Remarks and Close of Day One

    Paul Upham

    Paul Upham, Head, Smart Devices, Roche/Genentech
    View Bio

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Paul Upham

    Paul Upham, Head, Smart Devices, Roche/Genentech
    View Bio

    9:10 Regulatory Perspectives on Wearable Injectors

    Peter Dorski

    Peter Dorski, Associate Director, Janssen, Pharmaceutical Companies of Johnson and Johnson
    View Bio

  • Optimizing CMC and bridging strategies during clinical development
  • Health authority interactions: when should they occur and what is expected?
  • Platform approaches to wearable injectors
  • Recommendations for improved guidance and harmonisation of global regulations

     

  • 9:50 What manufacturers of electronic devices should know about electromagnetic labelling regulatory requirements

    Samir Shah

    Samir Shah, Director, AstraZeneca
    View Bio

  • The many sources of labelling requirements for electrical, wireless, and smart medical devices
  • Deciphering an immunity label (so you can create your own)
  • Resources for understanding symbol requirements
  • Changes to the standard on whether such labelling could confuse privates users
  • 10:30 Morning Coffee

    11:00 Clinical Study Considerations to Support Registration of Non-integral Wearable Injectors

    Catharine Strom

    Catharine Strom, Director, Global Regulatory Affairs, Device and Combination Products, Sanofi
    View Bio

  • Determining the regulatory pathway for a non-integral wearable injector clinical trial
  • EU clinical studies and associated country-specific device clinical investigation application requirements for non-CE marked, non-integral wearable injectors
  • Coordination and logistics for drug and device clinical study applications for a single clinical trial
  • 11:40 Cybersecurity is Critical: Making Connected Medical Devices Cyber Secure

    Jessica Wilkerson

    Jessica Wilkerson, Cyber Policy Advisor and Medical Device Cybersecurity Team Lead, FDA
    View Bio

  • Introduction to the cybersecurity risks surrounding medical devices and software validation of smart devices
  • Outlining the steps that should be taken to protect patients
  • Assessing role of global regulators in reducing cyber risks and how regulations can be implemented
  • Guidance on facilitating patient access to medical device innovations while also educating them on associated risks
  • 12:20 Networking Lunch

    13:20 IoMT Wearables in Digital Health

    Jeanne Greathouse

    Jeanne Greathouse, Global Director Healthcare, BSI Group
    View Bio

  • Delving into security aspects to maintain protected health information (PHI)
  • Strategies to successfully manage PHI
  • Ensuring compliance in digital health ecosystem
  • Exploring important security considerations and steps that should be taken to protect patients
  • 14:00 Human Factors Best Practices and Considerations for Wearable Injectors

    Alexandra Benbadis

    Alexandra Benbadis, Usability Leader, Sanofi
    View Bio

  • Discussing human factors requirements within regulatory frameworks and best practises for complying with these
  • Exploring the pitfalls relating to wearable injector development and usability
  • Insight into design validation for wearable injectors and important considerations
  • Evaluating human factors studies to ensure expectations are satisfied
  • 14:40 Developing Engaging Patient and Healthcare Provider Medical Device Training

    Alicia Douglas

    Alicia Douglas, Human Factors Lead, Merck
    View Bio

  • Assessment of wearable injectors and connected devices from a two-user perspective: patient and healthcare provider
  • Designing and developing user-centric training for patients and healthcare providers
  • Implementing digital training solutions that connect with patients and caregivers and discussion of digital tools and services to support patients as well as caregiver in using the devices
  • Case study examples
  • 15:20 Afternoon Tea

    15:50 Strategies to Consider During On-Body Device Development to Meet Patients Needs

    Sujani Nannapaneni

    Sujani Nannapaneni, Senior Principal Research Scientist, Human Factors, AbbVie, Inc
    View Bio

  • On-Body Device criteria to consider evaluating during human factors research
  • Key takeaways from human factors formative user research and clinical studies
  • Leveraging human factors research for developing training materials
  • 16:30 Integration of Human Factors into the Product Life Cycle of Wearables and Connected Devices

    Leya Bergquist

    Leya Bergquist, Associate Director, UserWise
    View Bio

  • What types of human factors practices are appropriate for each stage of product development?
  • Considerations for training and training decay
  • Navigating human factors as it relates to your devices in an ecosystem
  • What to expect for human factors timelines and workload
  • 17:10 Chairman’s Closing Remarks and Close of Day Two

    +

    Vice President of Commercial Development
    BD
    Usability Leader
    Sanofi
    Human Factors Lead
    Merck
    Technical Lead
    Biogen
    Director, Global Regulatory Affairs, Device and Combination Products
    Sanofi
    Distinguished Scientist
    Merck & Co., Inc
    Design Engineering Team Lead
    Pfizer
    Head of Injection Systems
    Takeda
    Director of Drug Product Development
    Alnylam
    Global Director Healthcare
    BSI Group
    Device Development Engineer
    Regeneron Pharmaceuticals Inc
    Cyber Policy Advisor and Medical Device Cybersecurity Team Lead
    FDA
    Associate Director
    UserWise
    Assoicate Director
    Alexion Pharmaceuticals Inc
    Head, Smart Devices
    Roche/Genentech
    Associate Director
    Janssen, Pharmaceutical Companies of Johnson and Johnson
    Director
    AstraZeneca
    Device Development Lead
    Pfizer
    Senior Principal Research Scientist, Human Factors
    AbbVie, Inc

    Gold Sponsor

    Sponsors

    Exhibitors

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Sponsors and Exhibitors


    Crux

    Gold Sponsor
    http://www.cruxproductdesign.com

    Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems..


    Sponsors


    BD Medical

    Sponsors
    http://www.bd.com

    As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

    With an emphasis on patient-centered innovations and strong technical expertise, BD Medical - Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us


    Exhibitors


    ZwickRoell

    Exhibitors
    http://www.zwickroell.com

    ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    HOTEL BOOKING FORM

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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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