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Wearable Injectors and Connected Devices USA
September 8 - September 9, 2025
Wearable Injectors and Connected Devices USA

Engage in the Latest Innovations and Developments in Wearable Injectors and Connected Devices This September in Boston!

SAE Media Group’s 3rd Annual Wearable Injectors and Connected Devices USA Conference will return to Boston for 2025 on the 8th and 9th of September, bringing you the latest advances in connected on body drug delivery.

Join leading experts from the injectable drug delivery and digital health sectors for a two-day exploration of the latest advancements in the field. Dive into sessions on large-volume drug delivery technologies, digital integration, and user-centric design, featuring expert insights, real-world case studies, and opportunities for collaboration.

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.

Don’t miss out on this attend event in September 2025!
 

FEATURED SPEAKERS

Anjana Wills

Anjana Wills

Head of Device Combination Products and Software Quality, AstraZeneca
Cheng Yang

Cheng Yang

Digital Diagnostics Lead, Drug Product and Device Development, R&D, Takeda
Cindy Tritton

Cindy Tritton

Project Lead, Senior Engineer III, Technical Development , Biogen
Deep Bhattacharya

Deep Bhattacharya

Principal Scientist Formulation and Process Development - Biotherapeutics, Pfizer
Ellie Younger

Ellie Younger

Associate Principal Engineer, AstraZeneca
George Currier

George Currier

Senior Principal Scientist, Device Development, Bristol Myers Squibb
Harry Jiang

Harry Jiang

Device Engineering Lead, Alexion Pharmaceuticals
Khaudeja Bano

Khaudeja Bano

Vice President - Global Head of Device Quality, Roche-Genentech
Lipa Shah

Lipa Shah

Director Science and Technology, Novartis Pharmaceuticals Inc
Mark Harycki

Mark Harycki

Senior Director, Device Portfolio and Program Management, Eli Lilly and Company
Michael Price

Michael Price

Associate Director, Human Factors, AstraZeneca
Paul Upham

Paul Upham

Global Head of Smart Devices, Roche-Genentech
Prasad Peri

Prasad Peri

AVP Regualtory Affairs Connected Delivery, Devices and Digital Health, Eli Lilly
Sharmad Joshi

Sharmad Joshi

Senior Engineer II Device Development, Alexion AstraZeneca Rare Disease
Shruti Parikh

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Sriram Natarjaan

Sriram Natarjaan

Sr. Manager, Product Quality Management, Johnson & Johnson
Yvette Appleby

Yvette Appleby

Senior Manager, Digital Health & PMO, Pfizer

Anjana Wills

Head of Device Combination Products and Software Quality, AstraZeneca
Anjana Wills

Cheng Yang

Digital Diagnostics Lead, Drug Product and Device Development, R&D, Takeda
Cheng Yang

Dr. Cheng Yang is the Digital Diagnostics Lead at Takeda’s Global R&D organization, based in Boston. He leads the global strategy and development of digital diagnostic devices and AI/ML-enabled software for disease diagnosis, screening, and treatment monitoring. Holding a Ph.D. in Analytical Chemistry and a Master’s in AI/ML, Dr. Yang has driven cross-functional initiatives linking diagnostics with therapeutic products. His work includes point-of-care tools, companion diagnostics, and AI-powered imaging and screening solutions. He also represents Takeda in the EU IHI-funded SEARCH consortium, advancing the use of synthetic health data to support the development and deployment of next-generation e-health solutions.

Cindy Tritton

Project Lead, Senior Engineer III, Technical Development , Biogen
Cindy Tritton

Confirmed Senior Representative

, BioPhorum
Confirmed Senior Representative

Deep Bhattacharya

Principal Scientist Formulation and Process Development - Biotherapeutics, Pfizer
Deep 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.

Ellie Younger

Associate Principal Engineer, AstraZeneca
Ellie Younger

George Currier

Senior Principal Scientist, Device Development, Bristol Myers Squibb
George Currier

George is a Senior Principal Scientist in the Device Development group at Bristol Myers Squibb. He holds a Master of Science degree in Mechanical Engineering from Stevens Institute of Technology. Over the past 11 years at BMS, George has held roles in product strategy, as well as combination product development. He has led device innovation initiatives with development partners and has served as the Device Development lead for combination product development programs.

Harry Jiang

Device Engineering Lead, Alexion Pharmaceuticals
Harry Jiang

Harry obtained a Master of Science degree in Chemical Engineering from the University of Maine at Orono. His medical device career started at Bayer Healthcare Diabetes care division in Indiana 20 years age. After seven plus years at Bayer, Harry moved to the Boston area and continued working in the medical device and diagnostic industries including an OBI startup. He is currently with Alexion Pharmaceuticals, a AZ rare disease unit as a device engineering lead working on drug and device combination products.

Khaudeja Bano

Vice President - Global Head of Device Quality, Roche-Genentech
Khaudeja Bano

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.
 

Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, AbbVie Inc and Amgen. Her career includes global medical / clinical
and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.


She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Lipa Shah

Director Science and Technology, Novartis Pharmaceuticals Inc
Lipa Shah

Lipa Shah is Director Science and Technology in Technical Research and Development at Novartis, Cambridge. She leads the Novel Delivery Technologies (NDT) team which engages to implement novel drug technologies to bring value to the drug products. In 18+ years at Novartis, she has held diverse roles in leading and supporting the development of assets from early development to clinical phase projects and innovation space. Lipa has her PhD in Pharmaceutical Sciences from Northeastern University, Boston.

Mark Harycki

Senior Director, Device Portfolio and Program Management, Eli Lilly and Company
Mark Harycki

Mark W. Harycki is a seasoned professional with expertise in pharmaceutical and medical device development. He has a strong background in clinical trials, dry product processing, parenteral processing, device assembly, packaging, and distribution. Mark specializes in a wide range of medical devices, including insulin pens, auto injectors, large volume injectors and stents. He has served as a senior advisor, overseeing device development programs from inception to submission approval. His expertise spans lean manufacturing, project oversight, budgetary planning, quality system auditing, process development, supplier management, and product line transfers. Currently, Mark is a Senior Director, Device Portfolio and Program Management, in Device and Connected Solutions at Eli Lilly and Company. He has led various submissions and approvals, including dry products, oral suspension, insulin pens, and immunology devices.


 

Michael Price

Associate Director, Human Factors, AstraZeneca
Michael Price

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.

 

Prasad Peri

AVP Regualtory Affairs Connected Delivery, Devices and Digital Health, Eli Lilly
Prasad Peri

Sharmad Joshi

Senior Engineer II Device Development, Alexion AstraZeneca Rare Disease
Sharmad Joshi

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Shruti Parikh

Shruti Parikh is the Packaging Design Lead, Takeda Pharmaceuticals based out of Massachusetts, USA, where she is leading and building Industrial Design, Sustainable Design and Patient-Centric Design capabilities across the company.
As the design lead in packaging development Shruti and her team works towards the remit to integrate design across the company’s consumer, medical device, and pharmaceuticals sectors. In addition to helping improve the lives of the patients using Takeda products every day, the Design team is also focused on improving the environmental impact by reducing the carbon footprint of Takeda packaging.
Specifically, Shruti is passionate about challenging people and organizations to think differently. She loves to dig into global macro trends and translate its potential to redesign products and systems. Impatient for action, she wants to help build an inclusive future that allows us all to thrive socially, ecologically and economically. She is an advocate for a circular economy and is constantly looking to connect with individuals who believe they too can make a positive impact in the world.
 

Sriram Natarjaan

Sr. Manager, Product Quality Management, Johnson & Johnson
Sriram Natarjaan

Yvette Appleby

Senior Manager, Digital Health & PMO, Pfizer
Yvette Appleby

Yvette Appleby, RAC, CSM, CAPM, CSPO, is a seasoned professional with a robust background in regulatory affairs and project management focused on software as a medical device. She holds a master’s degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. Currently, she serves as a Senior Manager at Pfizer, where she manages the assessment process for all medical software designed, developed, or promoted by or on behalf of Pfizer. In her role, Yvette also supports business strategy and solution delivery initiatives. Yvette is also a certified Scrum Master and Product Owner.

Conference agenda

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8:00

Registration & Coffee

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9:00

Chair's Opening Remarks

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

clock

9:10

Opening Address: Future Proofing Your Injectable Device Portfolios

  • Outlining key considerations for the evolving ecosystem for injectable devices including, diagnostics, SaMD and digital therapeutics
  • Exploring the global regulatory landscape evolutions for combination product reporting and recommendations
  • Best practices for ensuring safety and quality, and taking a risk-based approach
  • Khaudeja Bano, Vice President - Global Head of Device Quality, Roche-Genentech

    clock

    9:50

    Developing Phase Appropriate Requirements for Combination Products

  • Understanding the impact of performance claims vs convenience features
  • Phase appropriate design control considerations throughout the lifecycle
  • User needs commensurate with lifecycle phase
  • Opportunities to leverage industry knowledge and experience
  • Anjana Wills

    Anjana Wills, Head of Device Combination Products and Software Quality, AstraZeneca

    Michael Price

    Michael Price, Associate Director, Human Factors, AstraZeneca

    clock

    10:30

    Morning Coffee

    clock

    11:00

    Overview of a Device Connected Submission

    Mark Harycki, Senior Director, Device Portfolio and Program Management, Eli Lilly and Company

  • Background: Overview of the medical device development process, focusing on mechanical and electronic integration
  • Key to success: Collaborating with suppliers for seamless integration through clear communication, early expectation setting, and adherence to quality and timelines
  • Platform strategies: Optimizing and streamlining future device-connected submissions and commercial supply for efficiency and scalability
  • clock

    11:40

    Innovations in On-Body Injector Development: Lessons from Two Large Volume Delivery Device Case Studies

    Harry Jiang, Device Engineering Lead, Alexion Pharmaceuticals

  • Outlining design strategies for on-body injectors with insights from two projects, including challenges, user-centric design, and integration with drug formulation and primary packaging
  • Delving into lessons learned in adhesive performance and user interface development from the programs
  • Key hurdles in gaining regulatory approval, and scaling manufacturing for market launch
  • clock

    12:20

    Patient Acceptance in Large Volume Drug Delivery

    Shruti Parikh, Director, Product Design, Takeda Pharmaceuticals

  • Understanding patient preferences in large volume drug delivery and reviewing key factors influencing patient acceptance, including comfort, convenience, and perceived ease of use
  • Outlining key usability considerations such as user interaction, training needs, and patient burden, and optimizing device selection and design based on this
  • Leveraging usability testing and risk assessment to enhance patient confidence and adherence
  • Strategies to ensure patients can self-administer large-volume drugs safely and effectively including labelling and training
  • clock

    13:00

    Networking Lunch

    clock

    14:00

    Advancing Subcutaneous Delivery: A High Viscosity and High-Volume Platform Technology Approach

    Cindy Tritton

    Cindy Tritton, Project Lead, Senior Engineer III, Technical Development , Biogen

  • Examine design strategies and considerations to enable efficient delivery of high-volume, high-viscosity drugs through subcutaneous administration
  • Assess patient tolerance and user acceptability of high-volume injectables, focusing on improving comfort and adherence
  • Provide an overview of current challenges faced by wearable devices in delivering larger volumes and strategies to optimize subcutaneous delivery systems for enhanced patient experience
  • Discuss emerging trends and innovations shaping the future of high-volume subcutaneous drug delivery
  • clock

    14:40

    Key Performance and Quality Considerations for Wearable Injector Development

    Sriram Natarjaan

    Sriram Natarjaan, Sr. Manager, Product Quality Management, Johnson & Johnson

  • Overview of the latest applicable standards and regulations impacting wearable injector development
  • Insights into design verification challenges and learnings to implement
  • High-viscosity formulation challenges
  • Human Factors and User preferences
  • clock

    15:20

    Design Space Considerations and Highly Accelerated Stress Screening (HASS) for Combination Products

    George Currier, Senior Principal Scientist, Device Development, Bristol Myers Squibb

  • Understanding the design space and its potential variations for device evaluation and selection
  • Applying Highly Accelerated Stress Screening (HASS) to rapidly gather insights with a limited quantity of devices
  • Leveraging learnings from HASS testing to promote focused and productive early engagement during a development program
  • clock

    16:00

    Afternoon Networking Break

    clock

    16:30

    Stability Considerations for Combination Products

    Sharmad Joshi

    Sharmad Joshi, Senior Engineer II Device Development, Alexion AstraZeneca Rare Disease

  • Impact of temperature selections for stability
  • Impact of drug product through accelerated stability on functional performance of device
  • Case study and next steps
  • clock

    17:10

    Optimising Formulation for High Concentration, High Volume Drug Development and Delivery

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

  • Examining current paradigms in subcutaneous drug delivery for these products
  • Applying a biophysical perspective to drug development
  • Navigating formulation challenges and opportunities in high concentration subcutaneous injection, highlighting key focus areas
  • clock

    17:50

    Chair’s Closing Remarks and Close of Day One

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

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chair's Opening Remarks

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

    clock

    9:10

    Understanding the Sustainability Impacts of Connected Devices and Wearable Injectors

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

  • Analysing the environmental footprint of connected devices and wearable injectors, focusing on materials, manufacturing processes, and end-of-life considerations
  • Exploring opportunities to reduce waste through sustainable design and recycling initiatives in the production of drug delivery devices
  • Reviewing the impact of connected devices in promoting sustainability through data collection, remote monitoring, and optimising patient outcomes while reducing healthcare system burdens
  • Addressing regulatory challenges and industry efforts to align wearable injectors with global sustainability goals and environmentally responsible practices
  • clock

    9:50

    Designing a product with Delivery and Device in mind: Strategies for Early Phase Development

    Lipa Shah, Director Science and Technology, Novartis Pharmaceuticals Inc

  • Integrating drug product and device strategies early in development
  • Fostering strong collaboration between formulators, device engineers, and chemists and utilising this to optimise pipeline timelines and outcomes
  • Leveraging knowledge on preclinical and clinical dosing
  • Incorporating expertise from pharmacokinetics and toxicology to enhance safety and efficacy
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Collaboration with Commercial Suppliers: Relations and Lifecyle Management

    Ellie Younger

    Ellie Younger, Associate Principal Engineer, AstraZeneca

  • Best practices for setting up an effective quality agreement
  • Implications on validation and verification
  • Dealing with changes from suppliers
  • clock

    11:40

    Advancing Platform Development for Combination Products

    Confirmed Senior Representative

    Confirmed Senior Representative, , BioPhorum

  • Exploring the challenges and opportunities in developing products that integrate drugs, devices, and biological components
  • How standardized platforms can streamline development processes, reduce costs, and ensure compliance across diverse combination products
  • Reviewing the regulatory landscape and how platform approaches can address global requirements for safety, efficacy, and quality
  • Discussing emerging tools and technologies that are driving innovation in the development and lifecycle management of combination products
  • clock

    12:20

    Networking Lunch

    clock

    13:20

    Integrating SaMD in Patient-Centric Digital Health

    Yvette Appleby, Senior Manager, Digital Health & PMO, Pfizer

  • Overview of the role of Software as a Medical Device (SaMD) in advancing digital health solutions
  • Highlighting the importance of digital health literacy in empowering patients to understand and utilize their healthcare data
  • Examining the application of data from both patient and care provider perspectives, focusing on enhancing care delivery and outcomes
  • Address barriers and enablers for the adoption of digital health tools, emphasizing strategies to foster patient and provider engagement
  • clock

    14:00

    PANEL DISCUSSION: Digital Health from Clinic to Commercialization: Navigating the steps to success

  • Leveraging digital solutions to personalize patient experiences, improve adherence, and increase retention, all for better outcomes
  • Navigating regulatory and market access challenges: key considerations for compliance, reimbursement strategies, and aligning digital health with evolving regulatory landscapes
  • Best practices for ensuring a seamless transition from clinical development to market launch, maximizing adoption, and demonstrating value to stakeholders
  • Paul Upham, Global Head of Smart Devices, Roche-Genentech

    Mark Harycki, Senior Director, Device Portfolio and Program Management, Eli Lilly and Company

    Cheng Yang, Digital Diagnostics Lead, Drug Product and Device Development, R&D, Takeda

    clock

    14:40

    Afternoon Tea

    clock

    15:10

    Advancing Digital Diagnostics as Medical Devices - From Modality to Implementation

    Cheng Yang, Digital Diagnostics Lead, Drug Product and Device Development, R&D, Takeda

  • Exploring how digital diagnostics enhance the functionality of medical devices, enabling real-time monitoring and improved patient outcomes
  • Insight into innovations in digital diagnostic and medical device integration, focusing on seamless data exchange and user-centric design
  • Future Trends in Digital Health: Highlight emerging technologies and strategies shaping the future of digital diagnostics, emphasizing their role in transforming healthcare delivery
  • clock

    15:50

    Transitioning from Drug to Device and Incorporating Connectivity

    Prasad Peri

    Prasad Peri, AVP Regualtory Affairs Connected Delivery, Devices and Digital Health, Eli Lilly

  • Insights into basics of interacting with the FDA and pre-market regulations for medical devices
  • Update from the US on combination product requirements: touching on EDDO guidance
  • Impact on manufacturers from this guidance and requirements for connected devices and related systems
  • clock

    16:30

    Chair’s Closing Remarks and Close of Day Two

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


    Head of Device Combination Products and Software Quality
    AstraZeneca
    Digital Diagnostics Lead, Drug Product and Device Development, R&D
    Takeda
    Project Lead, Senior Engineer III, Technical Development
    Biogen
    BioPhorum
    Principal Scientist Formulation and Process Development - Biotherapeutics
    Pfizer
    Associate Principal Engineer
    AstraZeneca
    Senior Principal Scientist, Device Development
    Bristol Myers Squibb
    Device Engineering Lead
    Alexion Pharmaceuticals
    Vice President - Global Head of Device Quality
    Roche-Genentech
    Director Science and Technology
    Novartis Pharmaceuticals Inc
    Senior Director, Device Portfolio and Program Management
    Eli Lilly and Company
    Associate Director, Human Factors
    AstraZeneca
    Global Head of Smart Devices
    Roche-Genentech
    AVP Regualtory Affairs Connected Delivery, Devices and Digital Health
    Eli Lilly
    Senior Engineer II Device Development
    Alexion AstraZeneca Rare Disease
    Director, Product Design
    Takeda Pharmaceuticals
    Sr. Manager, Product Quality Management
    Johnson & Johnson
    Senior Manager, Digital Health & PMO
    Pfizer

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