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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;

FEATURED SPEAKERS

Alicia Douglas

Alicia Douglas

Human Factors Lead, Merck
Anthony Coston

Anthony Coston

Technical Lead, Biogen
E Guan

E Guan

Head of Injection Systems, Takeda
Jamie Tsung

Jamie Tsung

Head of DP formulation, Alnylam
Jessica Mastropietro

Jessica Mastropietro

Device Development Engineer, Regeneron Pharmaceuticals Inc
Jessica Wilkerson

Jessica Wilkerson

Cyber Policy Advisor and Medical Device Cybersecurity Team Lead, FDA
Leya Bergquist

Leya Bergquist

Associate Director, UserWise
Ling Zheng

Ling Zheng

Assoicate Director, Alexion Pharmaceuticals Inc
Paul Upham

Paul Upham

Head, Smart Devices, Roche-Genentech
Simon Wilson

Simon Wilson

Device Development Lead, Pfizer
Sujani Nannapaneni

Sujani Nannapaneni

Senior Principal Research Scientist, Human Factors, AbbVie, Inc

Alexandra Benbadis

Usability Leader, Sanofi
Alexandra Benbadis

Alexandra is a passionate human factors (HF) professional who loves everything about combination product usability. At Sanofi, she serves as the HF subject matter expert on several programs and advocates for implementing creative HF strategies, which are rooted in her strong understanding of applying HF principles to developing safe and effective combination products. Before working at Sanofi, Alexandra was a Senior Human Factors Specialist at Emergo by UL, where she was responsible for planning, managing, and conducting usability tests throughout the product development process. She has both a bachelor’s degree and master’s degree in human factors engineering from Tufts University.

 

Alicia Douglas

Human Factors Lead, Merck
Alicia Douglas

Alicia, a graduate of the University of Maryland, with a B.S in Bio-engineering, is a knowledgeable and passionate Human Factors leader. She has 16 years of experience in Pharmaceutical, Medical Device and Consumer Healthcare Industry. Throughout her career she has been focusing on devices and combination products within Oral Care to Oncology area. With a strong background in human factors, product development, and design controls she loves learn and present on these topics for devices and combination products.

Anthony Coston

Technical Lead, Biogen
Anthony Coston

Attila Antalfy

Device Development Lead, Pfizer
Attila Antalfy

Catharine Strom

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

Catharine is a Director of Global Regulatory Affairs for Device and Combination Products at Sanofi where she is responsible for developing and executing innovative regulatory strategies for injectable products. She has 20+ years of regulatory experience supporting clinicial and commerical activities for pharmaceuticals, medical devices and combinations products. For the past 5 years, she has focused on understanding and influencing the evolving combination product regulatory landscape through participation in industry groups such as the Combination Products Coalition. She has a BS in Biomedical Engineering and MS in Regulatory Science both from the University of Southern California.

 

Christine Lynn Lanning

Distinguished Scientist, Device Area Leader, Merck & Co., Inc
Christine Lynn Lanning

Dr. Christine Lynn Lanning is a Distinguished Scientist in Nonclinical Drug Safety at Merck. She has a PhD from Duke University in Pharmacology/Toxicology and has been at Merck over 24 years gaining experience in both nonclinical drug safety and the safety of medical device/combination products. In her current role, she oversees the biocompatibility of Merck’s medical devices/combination products in development and those on the market. She has supported a variety of drug delivery devices including prefilled syringes, inhalers, oral administration kits, auto- and onbody injectors. She has authored over 200 scientific reports and 60 regulatory submissions/Health Authority responses.


 

E Guan

Head of Injection Systems, Takeda
E Guan

E is a passionate leader in building device development capabilities and improving combination product development processes. He is savvy in delivery device technology assessment, combination product development, manufacture process development, commercial scale-up and life cycle management. E currently holds the position of Head of Injection Systems at Takeda. Previously he was Director of device development with AstraZeneca. He built a very strong device team and managed multiple combination product programs in the therapeutic areas of respiratory, inflammation, autoimmune, cardiovascular, renal and metabolic diseases. Prior to AstraZeneca, he was device lead with Janssen Pharmaceuticals and Becton Dickinson, where he led and launched/relaunched a few injection device or combination product programs.
E obtained his Bachelor and PhD degrees in mechanical engineering and a master’s degree in polymer physics.
 

Jamie Tsung

Head of DP formulation, Alnylam
Jamie Tsung

Dr. Jamie Tsung received her Ph.D. in pharmaceutical sciences from the University of Connecticut. Currently, she is an Associate Director at Alnylam Pharmaceuticals. Prior to Alnylam, she worked for Momenta, Shire, Baxter, and UCB. Her biopharmaceutical experience spans preclinical to marketed products, integrating formulation, characterization, processing technology, regulatory, and quality control providing a valuable perspective and creative approach to product development.

Jeanne Greathouse

Global Director Healthcare, BSI Group
Jeanne Greathouse

Paving the way for healthy futures through scaling digital trust solutions across the globe, Jeanne is passionate to work with key clients and industry partners to develop holistic solutions, strategies, and programs in digital health. She has worked with the MedTech and Life Sciences industry for over 15 years to accelerate client and healthcare ecosystem innovation, with the goal of improving patients’ and consumers’ quality of life.

Jessica Mastropietro

Device Development Engineer, Regeneron Pharmaceuticals Inc
Jessica Mastropietro

Jessie Mastropietro is a Device Development Engineer within New Technologies Management, Combination Product Development at Regeneron Pharmaceuticals. She is responsible for analyzing and interpreting drug delivery system industry trends, competitive landscapes, and user needs to drive device strategy. She also characterizes devices through technical assessments and conducts user studies to inform and develop the drug delivery system portfolio. Jessie previously worked in product development to bring both primary container components and combination products from design input to commercialization.


Jessie graduated with BS and MEng degrees in Biomedical Engineering from Rensselaer Polytechnic Institute in Troy, NY.
 

Jessica Wilkerson

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

Jessica Wilkerson is a Senior Cyber Policy Advisor and the Medical Device Cybersecurity Team Lead within the All-Hazards Readiness, Response, and Cybersecurity (ARC) team in the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). As part of ARC, she examines issues and develops policy related to medical device cybersecurity. Previously, she spent a year as a partial detail to the Office of the National Cyber Director (ONCD), representing medical device and health sector cybersecurity equities within the Executive Office of the President. She also worked as the Cybersecurity Research Director for the Linux Foundation, and spent over five years as a congressional staffer with the House Committee on Energy and Commerce, covering cybersecurity issues in the telecommunications, commercial, energy, and health sectors. As part of that work, she examined issues related to coordinated vulnerability disclosure, software supply-chain transparency, legacy technology risks, and cybersecurity governance models, among others. She received a B.A. in Policy Studies and minors in Computer Science and Mathematics from Syracuse University, and a J.D. from the Catholic University of America’s Columbus School of Law.

Leya Bergquist

Associate Director, UserWise
Leya Bergquist

Leya Bergquist is currently Associate Director, Human Factors Engineering at UserWise, a consultancy that helps medical device and combination product manufacturers and start-ups design safe and easy-to-use medical products.

Leya regularly works on human factors submission strategy and compliance documentation for FDA Human Factors Guidance and international standards related to usability engineering (e.g. IEC 62366-1, IEC 60601-1-6, and ISO 14971) for home and hospital use products.

Leya has been working the medical device industry for more than 20 years with experience in design controls, risk analysis, and V&V. She has focused on human factors engineering for the last 6 years.

 

Ling Zheng

Assoicate Director, Alexion Pharmaceuticals Inc
Ling Zheng

Ling Zheng is a device development lead at Alexion Pharmaceuticals, AstraZeneca’s Rare Disease Unit. She is currently working on developing drug delivery devices for combination products. She has many years of experience working on wearable injectors with focus on electrical and software design and development. She has hands-on experience on primary battery selection for wearable devices, including power budget management and battery characterization.

Paul Upham

Head, Smart Devices, Roche-Genentech
Paul Upham

Paul is the Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.
Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.

Paul was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.

Paul’s prior experience includes 10 years in BD’s Diabetes Care business. Paul was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

Paul holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.
 

Peter Dorski

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

Peter Dorski is an Associate Director, CMC Regulatory Affairs at Janssen, at Pharmaceutical Companies of Johnson and Johnson. He has worked within the pharmaceutical and combination products industry for over 10 years, driving regulatory strategies based on industry best practices for global/major market product development and supporting advancement of complex, innovative delivery systems using leading-edge therapies.


Within the pharma industry, Peter works to understand and influence the continuously evolving regulatory landscape surrounding combination products to serve industry stakeholders and patients. Peter holds a BS in microbiology from The Ohio State University and an MS in Health Sciences from The George Washington University.
 

Samir Shah

Director, AstraZeneca
Samir Shah

Dr. Shah guides teams on regulatory strategies to achieve worldwide approval of drug/device/software combination products. His approvals include the first three smart/digital inhalers, the DIGIHALERS. Currently at AstraZeneca, he previously worked at Teva. Prior to joining regulatory, he formulated respiratory products as a scientist at Merck. Dr. Shah earned his B.S. from Case Western Reserve University in Polymer Science Engineering and a PhD in Biomedical Engineering from Wake Forest University School of Medicine/Virginia Tech. He enjoys sharing tips on using technology to learn faster, improve productivity, and visualize complex ideas, all crucial to achieving regulatory success with software and electronics.

Simon Wilson

Device Development Lead, Pfizer
Simon Wilson

Simon has spent over 30 years developing a wide range of products since graduating with a degree in Engineering Product Design. These have included consumer goods, handheld computers and mobile communications devices as well as a stint at a major London design consultancy. He joined Pfizer’s Cambridge based Device Centre of Excellence, DCoE, in 2007.

 
Whilst working for Pfizer, Simon has managed parenteral device development projects through from initial concept to clinical trials and beyond. Simon has worked on several digitally ‘connected’ device projects, helping to liaise between teams developing devices and mobile apps or other digital elements.
 

Sujani Nannapaneni

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

Sujani Nannapaneni is a Human Factors Senior Principal Research Scientist at AbbVie. In her role, she is responsible with human factors studies and documentation of FDA submissions. She has been working in Human Factors for the last 10 years and has over 23 years of experience working in various capacities within the pharmaceutical and biotechnology industry.

 

 

Sponsors

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


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


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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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