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Wearable Injectors and Connected Devices USA
September 9 - September 10, 2024
Wearable Injectors and Connected Devices USA

SAE Media Group’s Inaugural
Wearable Injectors and Connected Devices USA
September 9 - 10 2024 | Boston, MA
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SAE Media Group are proud to announce their 2nd Annual Wearable Injectors and Connected Devices USA Conference taking place on the 9th and 10th of September 2024.


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.


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 2024!

 

FEATURED SPEAKERS

Deep S Bhattacharya

Deep S Bhattacharya

Principal Scientist, Formulation and Process Development - Biotherapeutics, Pfizer
Martin McLoughlin

Martin McLoughlin

Head of Device Development, Bristol Myers Squibb
Paul Upham

Paul Upham

Global Head of Smart Devices, Roche-Genentech
Sudhakar Garad

Sudhakar Garad

Global Head of Chemical and Pharmaceutical Profiling, Novartis
Theresa Scheuble

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson

Ajit D'Souza

Senior Director, Combination Product Development & Manufacturing, Kiniksa Pharmaceuticals
Ajit D'Souza

Ajit D’Souza is the Sr. Director of Combination Drug Product Development and Manufacturing at Kiniksa Pharmaceuticals where he directs the development of formulations, devices and manufacturing processes. Ajit has earned a PhD in Pharmaceutical Chemistry from the University of Kansas, a Professional Certificate in Systems Engineering at MIT xPRO and an MBA. He has spent majority of his career in functional and program leadership roles, developing drug formulations, medical devices for drug delivery and combination products.

Deep S Bhattacharya

Principal Scientist, Formulation and Process Development - Biotherapeutics, Pfizer
Deep S Bhattacharya

Deep is an ambitious results-oriented CMC drug product pharmaceutical professional, currently working as Principal Scientist Formulation and Process Development at Pfizer. He has 6+ experience in formulation/biopharmaceutical sciences (mAbs, fusion proteins, recombinant proteins, mRNA modalities), and product development, resulting in multiple regulatory submissions (IND and BLAs) and cross-functional collaborations across the organization.

Jamie Tsung

Head of DP Formulation, CMC, 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.

Karen Lowitz

Associate Director, Regulatory CMC Devices & Combination Product, Biogen
Karen Lowitz

My career began in New Jersey at Merck as a research biologist. After eight years, I changed direction and moved into Regulatory Affairs. In 2009, I relocated to beautiful Colorado. Most of my professional time was with Terumo BCT supporting blood collection and cell processing devices, and I had the opportunity to travel to Japan, Northern Ireland, Vietnam, and India. Last year, I joined Biogen to work on a clinical phase therapy to be presented in multiple drug/device combinations for commercialization. Regulation of combination products is ever evolving, which is why it is exciting to work in this space.

Liem Nguyen

Associate Principle Scientist- Device Program Lead, Merck
Liem Nguyen

Ling Zheng

Director - Device Development, 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 developing electro-mechanical on-body injectors.

Martin McLoughlin

Head of Device Development, Bristol Myers Squibb
Martin McLoughlin

Matt Marber

Senior Usability Engineer, Novo Nordisk
Matt Marber

Matt Marber (he/him) is a Senior Usability Engineer at Novo Nordisk where he applies human factors engineering to the development of combination products. He has experience planning, managing, and conducting usability tests throughout the device development process, with most of his experience in executing successful HF validation tests. Prior to joining Novo Nordisk, he worked as a consultant at Emergo by UL and PA Consulting. He received his BS in Engineering Psychology and his MS in Human Factors, both from Tufts University.

Paul Upham

Global Head of Smart Devices, Roche-Genentech
Paul Upham

Paul is the Global 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 Petrochenko

Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals
Peter Petrochenko

Peter Petrochenko, PhD, is an Associate Director, CMC and Combination Product Regulatory Affairs at Regeneron Pharmaceuticals. Dr. Petrochenko is responsible for combination product development from early clinical use through post-marketing. Dr. Petrochenko spent almost a decade at the US FDA in at both CDER and CDRH as an NSF Scholar-in-residence and a Senior Staff Fellow, authored several FDA guidance documents. His work at the FDA has been recognized with the FDA Outstanding Intercenter Scientific Collaboration Award. Dr. Petrochenko graduated with a BS with Distinction and a PhD in Biomedical Engineering from UNC-Chapel Hill and received several scholarships and NSF funds.

Samir Shah

Director, Regulatory CMC, Devices and Therapeutics, AstraZeneca
Samir Shah

Dr. Shah guides teams on regulatory strategies to achieve worldwide approval of drug/device/software combination products. 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.

Stephen Gianelis

Senior Director, Digital Health Operations, Teva Pharmaceuticals
Stephen Gianelis

Stephen Gianelis currently serves as the Senior Director of Digital Health Operations at Teva Pharmaceuticals and boasts an illustrious career spanning over two decades in the healthcare technology sector. Throughout his journey, he has amassed invaluable expertise, honed at distinguished firms such as Ximedica and Proven Process Medical Devices. His proficiency traverses a diverse spectrum, encompassing implantable drug delivery products, robotic surgical devices, injection products, wearables, and cutting-edge digital health technologies.
Stephen stands as a beacon of success, having thrived in roles ranging from engineering to senior leadership. He is currently pursuing his Master of Business Administration at Fitchburg State University and he holds a degree in Mechanical Engineering Technology from Northeastern University.
Beyond his corporate endeavors, Stephen is an entrepreneur and podcaster. He consistently melds his technical acumen with strategic foresight to drive innovation in the realm of healthcare technology.
 

Sudhakar Garad

Global Head of Chemical and Pharmaceutical Profiling, Novartis
Sudhakar Garad

Sudhakar Garad received his Ph.D. from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr, M.S Nagarsenker. Soon after completion of his Ph.D., he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his Ph.D., he was selected as a post-doctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers with Dr. Robin Bogner. After his post-doctoral fellowship, he worked with Vertex pharmaceutical for a period of three years as Senior Investigator in formulation development group. After Vertex, he joined Novartis as a Group Head. He worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Sudhakar is working as a Global head of Chemical and Pharmaceutical profiling (Pre-formulation/Novel Drug Delivery) and Technical R and D, Biopharmaceutics Head at Novartis. His primary role is collaborating with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies for poorly soluble molecules to expedite molecules into tox and clinical studies. He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). As Biopharmaceutics head he looks after entire portfolio with physical form, formulation process changes which impacts BA/BE. He has many publications, book chapters and patents. In last 22 years of his career, he has selected more than 250 new chemical entities in clinical studies across dozen disease areas (CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration.

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson
Theresa Scheuble

Theresa Scheuble is Head of Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.
Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.
 

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 wearable injectors space, focused on the development, implementation and application of wearable injectors and connected devices.
  • The only conference discussing wearable injectors and connected devices together.

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 for wearable injectors, and develop a network with the key stake-holders in the market.
  • Delve into the world of digital health and connectivity for the healthcare sector, and discuss the future of connectivity for wearables.
  • 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 event is the only conference that discusses both wearable injectors and connected devices in one event. Over two days, we bring together executives within the pharmaceutical industry to discuss the opportunities and challenges that face on-body devices, and to collaborate on the future of the industry. The event provides and intimate environment to speak with experts and peers to learn from each other’s experiences, and to meet with a variety of solutions providers working to supplement the industry.
 

sponsors

Conference agenda

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8:00

Registration & Coffee

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9:00

Chair's Opening Remarks

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9:10

Industry Perspective On Design Considerations For Large Volume And Highly Viscous Injection-Based Delivery Systems

Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson

  • The evolution of at home drug delivery devices
  • Overview of wearable injector options
  • Patient and end user considerations when developing large volume and highly viscous delivery systems.
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    9:50

    Creating a Desirable and Usable Product from Early Device Development

    Matt Marber, Senior Usability Engineer, Novo Nordisk

  • Making the case for a wearable injector, using patient preferences to drive innovation.
  • The importance of integrating human factors studies into early device development to reduce delays.
  • Ensuring collaboration for device development: integrating human factor concerns into early-stage development to optimise usability.
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    10:30

    Morning Coffee

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    11:00

    Streamlining Drug/Device Combination Product Development Collaboration

    Ajit D'Souza, Senior Director, Combination Product Development & Manufacturing, Kiniksa Pharmaceuticals

  • 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

    11:40

    A Risk-Based Approach To Design Controls To Support Pivotal Clinical Studies In The Development Of A Novel Drug-Device Combination Product

    Karen Lowitz, Associate Director, Regulatory CMC Devices & Combination Product, Biogen

  • Device development is an iterative process in which design and requirements are refined as the product moves through design control phases. Device design and requirements continue to be confirmed when a novel device is introduced into clinical studies to support a combination drug/device therapy. 
  • Using a risk-based approach, it is possible to support clinical release of combination products using a limited set of requirements as appropriate for the clinical phase (i.e Phase 1 healthy volunteers vs. Phase 3 patient population).
  • Using a risk-based approach, it is possible to support clinical use of a novel device in a combination therapy for which design changes may be implemented prior to commercialization.
  • Using a risk-based approach to combination product device design and verification requirements allows sponsors to move into clinical studies earlier while ensuring test product safety and effectiveness.
  • clock

    12:20

    Networking Lunch

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    13:20

    The Regulatory Challenge: Strategies for Bringing Wearables To The Market

    Peter Petrochenko, Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals

    What regulatory strategies should we be employing during device development to streamline submissions?
    Navigating uncertainties throughout the device approval process
    Strategies for collecting data and evidence during the device development process
    Managing conflicting requirements of global regulatory agencies and industry news for harmonisation
     

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    14:00

    Formulation Approaches to Understanding High Concentration, High Volume Drug Development

    Deep S Bhattacharya, Principal Scientist, Formulation and Process Development - Biotherapeutics, Pfizer

  • Current paradigms around these products in the subcutaneous spaces.
  • Drug product development from a more biophysical lens.
  • Challenges and opportunities around higher concentration subcutaneous injection and formulation focus areas.
     
  • clock

    14:40

    Afternoon Tea

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    15:10

    Review of Formulation Strategy, Based on The Commercial Product

    Jamie Tsung, Head of DP Formulation, CMC, Alnylam

  • Formulation considerations when developing drug delivery devices
  • CMC challenges when developing the wearable products
  • In use stability strategies for wearable injectors
     
  • clock

    15:50

    Designing A Molecule With A Delivery And A Device In Mind

    Sudhakar Garad, Global Head of Chemical and Pharmaceutical Profiling, Novartis

  • Strong collaboration between a formulator, a device engineer and a chemist
  • Knowledge on pre-clinical and clinical doses
  • Input from pharmacokinetics scientist along with toxicologist
  • Collective wisdom leads to faster pipeline and outcome
     
  • clock

    16:30

    Chair’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    clock

    9:10

    Connectivity, Usability and Necessity: Creating A Balance

    Paul Upham, Global Head of Smart Devices, Roche-Genentech

  • When should we involve software in a device, and when should we not? Considering factors such as treatment regularity, sensors, adherence.
  • In challenging to deliver drugs, how can connectivity improve adherence and reduce risk of at home treatment?
  • Software and app development as a part of the device development process – when should it be integrated and how?
  • How do we manage the risk of software being outdated when the device hits the market?
     
  • clock

    9:50

    SaMD and Digital Health – From Concept to Market

    Stephen Gianelis, Senior Director, Digital Health Operations, Teva Pharmaceuticals

  • What are the unique challenges with bringing SaMD and digital health products to market? 
  • How do we integrate new digital technologies with healthcare systems appropriately?
  • Clinical trials or studies for digital products – best practices.
  • Ensuring patient usability and training when designing digital products for at home use.
     
  • clock

    10:30

    Morning Coffee

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    11:00

    Regulatory Updates for Software and Medical Devices

    Samir Shah, Director, Regulatory CMC, Devices and Therapeutics, AstraZeneca

  • Cyber security guidance – digital remote health
  • An update on SaMD regulations, in the US and Internationally
  • The roadblocks in digital health, from regulatory requirements to health data security
  •  
  • clock

    11:40

    Digital Technology as Device Usability Enabler for Pulmonary Drug Delivery

  • High incidence of handling error during administration of inhalation therapies are still reported.
  • Development of inhalation products that do not consider the physical needs of patients will fail.
  • Inhalation devices must be developed directly with patients from early stage up to commercialization, including feedback post market launch.
  • Patient-centric drug product design combined with digital technology can increase the success rates of inhalation therapies.
  • clock

    12:20

    Networking Lunch

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    13:20

    On-Body Injectors: Opportunities and Challenges

    Ling Zheng, Director - Device Development, Alexion Pharmaceuticals Inc

  • Why is there a need for on body injectors?
  • Why are there such a limited number of on body injectors on the market?
  • The challenges: from design and manufacturing to final approval. 
  • Post-market supply – managing commercial supply of components, and potential need for a design change.
     
  • clock

    14:00

    Building the Business Case for Wearable Injectors

    Liem Nguyen

    Liem Nguyen, Associate Principle Scientist- Device Program Lead, Merck

  • What are your considerations for your company when you identify a wearable injector.
  • Strategies for identifying how compatible your drug product and device are.
  • Building partnerships between device manufacturers and pharmaceutical companies.
     
  • clock

    14:40

    Afternoon Tea

    clock

    15:10

    Innovation for Wearable Drug Delivery Devices: What Next?

    Martin McLoughlin

    Martin McLoughlin, Head of Device Development, Bristol Myers Squibb

  • What steps does the industry need to make to foster innovation in drug delivery research and development.
  • What lessons can we learn from past devices to strengthen the case for newer developments?
  • The pharmaceutical perspective – what are we looking for in a wearable device?
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    15:50

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

  • Materials – how can we balance costs and scalability with performance?
  • Adherence matters: acknowledging training factors in order to increase usability across the patient population.
  • Streamlining approval processes while maintaining accurate and relevant evidence collection. Can we see harmonisation develop internationally?
  • 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?
     
  • Paul Upham, Global Head of Smart Devices, Roche-Genentech

    Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson

    Martin McLoughlin

    Martin McLoughlin, Head of Device Development, Bristol Myers Squibb

    clock

    16:30

    Chair’s Closing Remarks and Close of Day Two


    Senior Director, Combination Product Development & Manufacturing
    Kiniksa Pharmaceuticals
    Principal Scientist, Formulation and Process Development - Biotherapeutics
    Pfizer
    Head of DP Formulation, CMC
    Alnylam
    Associate Director, Regulatory CMC Devices & Combination Product
    Biogen
    Associate Principle Scientist- Device Program Lead
    Merck
    Director - Device Development
    Alexion Pharmaceuticals Inc
    Head of Device Development
    Bristol Myers Squibb
    Senior Usability Engineer
    Novo Nordisk
    Global Head of Smart Devices
    Roche-Genentech
    Associate Director, Regulatory Strategy
    Regeneron Pharmaceuticals
    Director, Regulatory CMC, Devices and Therapeutics
    AstraZeneca
    Senior Director, Digital Health Operations
    Teva Pharmaceuticals
    Global Head of Chemical and Pharmaceutical Profiling
    Novartis
    Head of Design & Innovation
    Johnson & Johnson

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