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PFS & Injectable Drug Devices East Coast
April 27 - April 29, 2026
PFS & Injectable Drug Devices East Coast

FREE TO ATTEND FOR PHARMA AND BIOTECH

SAE Media Group's 13th Annual Pre-Filled Syringes and Injectable Drug Devices East Coast Conference will return to Boston in April 2026, continuing as a premier event for the latest innovations in injectable drug delivery.

As part of SAE’s leading PFS Series, the 2026 conference will once again bring together top experts, industry leaders, and innovators for a three-days of key insights and networking. The conference will feature a comprehensive pre-conference focus day dedicated to advancements in device design, followed by a dynamic two-day main conference featuring keynote plenaries, interactive panel discussions, and specialized topic streams covering the most pressing industry challenges and breakthrough solutions:

  • Device Innovations for Large Volume and Novel Drug Product Delivery
  • Advancing Sustainability in the Injectable Device Industry
  • Primary Packaging: Ensuring Safe, Stable, and Biocompatible Combination Products
  • Patient-Driven Device Design

What attendees can expect:

  • FREE Attendance for Pharma & Biotech Experts*
  • Dedicated Content Streams & Interactive Roundtables
  • 400+ Attendees
  • 65+ Big Pharma & Biotech Companies in the Room
  • 35+ Exhibitors & Sponsors
  • 40+ Expert Speakers From the Likes Of:
    AstraZeneca | Eli Lilly | Genentech | Biogen | Merck | Gilead | Pfizer | Takeda | Bristol Myers Squibb
    Johnson & Johnson | AbbVie | Kailera Therapeutics | Teva Pharmaceuticals | Alexion | Astria Therapeutics | Ionis Pharmaceuticals … and many more!

This must-attend event provides invaluable insights for professionals looking to enhance their injectable device portfolios while fostering meaningful connections with key stakeholders across the field. We look forward to welcoming you to Boston in April 2026!

FEATURED SPEAKERS

Aditya Sukthankar

Aditya Sukthankar

Associate Director - GRA Device Lead - Specialty Care Devices and Combination products, Sanofi
Adrienne Fletcher

Adrienne Fletcher

Director, Packaging and Device Strategy and Innovation, Johnson & Johnson
Alicia Douglas

Alicia Douglas

Human Factors Lead, Principal Scientist, Merck
Amardeep Hoonjan

Amardeep Hoonjan

Director Device R&D Lead, Biocompatibility Group, AbbVie
Amin Sedighiamiri

Amin Sedighiamiri

Senior Director, Device Development and Technology, Merck
Amy Wise

Amy Wise

Associate Director, RA Emerging Technologies, Combination Products, and Devices, AbbVie
Ashish Pokharel

Ashish Pokharel

Senior Device Engineer, AstraZeneca
Brittany Conrad

Brittany Conrad

Senior Human Factors Engineer, Pfizer Inc.
Christina Van Geen Hoven

Christina Van Geen Hoven

Director and Portfolio Project Lead, Pfizer
Chuck Ventura

Chuck Ventura

Chief Executive Officer, Ventura Solutions
David Vazquez

David Vazquez

Sr Director of Digital & Device Technical Operations, Pfizer
Doug Bakan

Doug Bakan

Chief Technology Officer, Kailera Therapeutics
Duncan Paterson

Duncan Paterson

Senior Director, AstraZeneca
Edward Hatton

Edward Hatton

Director Quality Assurance, External Manufacturing, Amneal Pharmaceuticals
Ellie Rundell

Ellie Rundell

Usability Leader, Sanofi
Javad Eshraghi

Javad Eshraghi

Senior Advisor, Eli Lilly and Company
Jayne Gavrity

Jayne Gavrity

Senior Device Engineer, AstraZeneca
Johanna Schoss

Johanna Schoss

Principal Human Factors Engineer, Biogen
Kevin Maloney

Kevin Maloney

Senior Director, Biologics Drug Product Development, Biogen
Khaudeja Bano

Khaudeja Bano

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

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Lisa Ray

Lisa Ray

Executive Director Program Management - Delivery, Device & Connected Solutions, Eli Lilly and Company
Mark DeStefano

Mark DeStefano

Global Technology Innovation, Combination Products and Device Research & Development, Teva Pharmaceuticals
Mark Howansky

Mark Howansky

VP, Device Development & Commercialization, Viridian Therapeutics
Mayumi Bowen

Mayumi Bowen

Senior Principal Engineer, Genentech, A Member of the Roche Group
Merin Kalapurackal

Merin Kalapurackal

Engineer, Device Development, Bristol Myers Squibb
Monica Swinney

Monica Swinney

Sr. Director & Head, Drug Delivery Innovation & New Product Planning, Gilead Sciences
Ning Yu

Ning Yu

Vice President, Device and Combination Product Development, Astria Therapeutics
Prasad Peri

Prasad Peri

AVP Regualtory Affairs Connected Delivery, Devices and Digital Health, Eli Lilly
Richard Braga

Richard Braga

Device SRM/CDMO Lead, Takeda Pharmaceuticals
Roy Wang

Roy Wang

Associate Director, Device Development & Manufacturing, Viridian Therapeutics
Senior Representative

Senior Representative

, Immunovant
Sharmad Joshi

Sharmad Joshi

Senior Engineer II Device Development, Alexion
Shirish Ingawale

Shirish Ingawale

Director, Device & Combination Product Development, Takeda Pharmaceutical Company Limited
Shruti Parikh

Shruti Parikh

Director, Product Design, Takeda
Sriram Natarjaan

Sriram Natarjaan

Sr. Manager, Product Quality Management, Johnson & Johnson
Subhi Saadeh

Subhi Saadeh

Associate Director - MDCP QA, Gilead
Sujit Basu

Sujit Basu

Vice President & Head, Pharmaceutical Development, Ionis Pharmaceuticals
Theresa Scheuble

Theresa Scheuble

Director R&D Drug Delivery Systems, Johnson & Johnson

Aditya Sukthankar

Associate Director - GRA Device Lead - Specialty Care Devices and Combination products, Sanofi
Aditya Sukthankar

Adrienne Fletcher

Director, Packaging and Device Strategy and Innovation, Johnson & Johnson
Adrienne Fletcher

Alicia Douglas

Human Factors Lead, Principal Scientist, Merck
Alicia Douglas

Althena Medical - Senior Representative

, Althena Medical
Althena Medical - Senior Representative

Amardeep Hoonjan

Director Device R&D Lead, Biocompatibility Group, AbbVie
Amardeep Hoonjan

Amin Sedighiamiri

Senior Director, Device Development and Technology, Merck
Amin Sedighiamiri

Amy Wise

Associate Director, RA Emerging Technologies, Combination Products, and Devices, AbbVie
Amy Wise

Ashish Pokharel

Senior Device Engineer, AstraZeneca
Ashish Pokharel

Brittany Conrad

Senior Human Factors Engineer, Pfizer Inc.
Brittany Conrad

Cambridge Design Partnership Ltd - Senior Representative

, Cambridge Design Partnership Ltd
Cambridge Design Partnership Ltd - Senior Representative

CCL Healthcare - Senior Representative

, CCL Healthcare
CCL Healthcare - Senior Representative

Christina Van Geen Hoven

Director and Portfolio Project Lead, Pfizer
Christina Van Geen Hoven

Chuck Ventura

Chief Executive Officer, Ventura Solutions
Chuck Ventura

Credence MedSystems, Inc. - Senior Representative

, Credence MedSystems, Inc.
Credence MedSystems, Inc. - Senior Representative

Crux Product Design - Senior Representative

, Crux Product Design
Crux Product Design - Senior Representative

David Vazquez

Sr Director of Digital & Device Technical Operations, Pfizer
David Vazquez

Doug Bakan

Chief Technology Officer, Kailera Therapeutics
Doug Bakan

Duncan Paterson

Senior Director, AstraZeneca
Duncan Paterson

EdgeOne Medical - Senior Representative

, EdgeOne Medical
EdgeOne Medical - Senior Representative

Edward Hatton

Director Quality Assurance, External Manufacturing, Amneal Pharmaceuticals
Edward Hatton

Ellie Rundell

Usability Leader, Sanofi
Ellie Rundell

Gerresheimer - Senior Representative

, Gerresheimer
Gerresheimer - Senior Representative

Haselmeier GmbH - Senior Representative

, Haselmeier GmbH
Haselmeier GmbH - Senior Representative

Instron - Senior Representative

, Instron
Instron - Senior Representative

Javad Eshraghi

Senior Advisor, Eli Lilly and Company
Javad Eshraghi

Jayne Gavrity

Senior Device Engineer, AstraZeneca
Jayne Gavrity

Johanna Schoss

Principal Human Factors Engineer, Biogen
Johanna Schoss

Kevin Maloney

Senior Director, Biologics Drug Product Development, Biogen
Kevin Maloney

Khaudeja Bano

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

Kindeva - Senior Representative

, Kindeva
Kindeva - Senior Representative

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Kinsuk Shah

Lisa Ray

Executive Director Program Management - Delivery, Device & Connected Solutions, Eli Lilly and Company
Lisa Ray

Mark DeStefano

Global Technology Innovation, Combination Products and Device Research & Development, Teva Pharmaceuticals
Mark DeStefano

Mark Howansky

VP, Device Development & Commercialization, Viridian Therapeutics
Mark Howansky

Mayumi Bowen

Senior Principal Engineer, Genentech, A Member of the Roche Group
Mayumi Bowen

Merin Kalapurackal

Engineer, Device Development, Bristol Myers Squibb
Merin Kalapurackal

Mitsubishi Gas Chemical Company, Inc - Senior Representative

, Mitsubishi Gas Chemical Company, Inc
Mitsubishi Gas Chemical Company, Inc - Senior Representative

Monica Swinney

Sr. Director & Head, Drug Delivery Innovation & New Product Planning, Gilead Sciences
Monica Swinney

Ning Yu

Vice President, Device and Combination Product Development, Astria Therapeutics
Ning Yu

Prasad Peri

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

Richard Braga

Device SRM/CDMO Lead, Takeda Pharmaceuticals
Richard Braga

Roy Wang

Associate Director, Device Development & Manufacturing, Viridian Therapeutics
Roy Wang

Schreiner MediPharm - Senior Representative

, Schreiner MediPharm
Schreiner MediPharm - Senior Representative

Senior Representative

, Immunovant
Senior Representative

Sharmad Joshi

Senior Engineer II Device Development, Alexion
Sharmad Joshi

Shirish Ingawale

Director, Device & Combination Product Development, Takeda Pharmaceutical Company Limited
Shirish Ingawale

SHL Medical - Senior Representative

, SHL Medical AG
SHL Medical - Senior Representative

Shruti Parikh

Director, Product Design, Takeda
Shruti Parikh

Sriram Natarjaan

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

Stevanato Group - Senior Representative

, Stevanato Group
Stevanato Group - Senior Representative

Subhi Saadeh

Associate Director - MDCP QA, Gilead
Subhi Saadeh

Sujit Basu

Vice President & Head, Pharmaceutical Development, Ionis Pharmaceuticals
Sujit Basu

Suttons Creek - Senior Representative

, Suttons Creek
Suttons Creek - Senior Representative

Theresa Scheuble

Director R&D Drug Delivery Systems, Johnson & Johnson
Theresa Scheuble

West Pharmaceutical Services - Senior Representative

, West Pharmaceutical Services
West Pharmaceutical Services - Senior Representative

Zeon - Senior Representative

, Zeon
Zeon - Senior Representative

sponsors

Conference agenda

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8:00

Registration & Coffee

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8:50

Chair's Opening Remarks

Kinsuk Shah

Kinsuk Shah, Sr. AD Combination Product Steward, Boehringer Ingelheim

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9:00

Keeping up with the Evolving Drug Delivery Landscape, Looking to the Future and Beyond

Theresa Scheuble

Theresa Scheuble, Director R&D Drug Delivery Systems, Johnson & Johnson

  • Exploring the foundation of combination products
  • Reviewing the evolving landscape and advancements in drug delivery
  • Highlighting non-traditional routes of administration
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    9:30

    Session Reserved for Sponsor

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    10:00

    Quality by Design: Enhancing Safety, Efficacy & Manufacturability of Your Device

    Khaudeja Bano

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

  • Reviewing the QbD framework and its impact on device development with real-world case study insights
  • Embedding safety and performance early through structured design
  • Streamlining manufacturing by aligning design and process controls
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    10:30

    Morning Networking Break

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    11:00

    Digital twins for dual chamber prefilled syringe autoinjectors - faster decisions, fewer builds and predict performance more accurately

    Ashish Pokharel

    Ashish Pokharel, Senior Device Engineer, AstraZeneca

  • Why digital twins? Where it pays off?
  • Case study on modelling for predicting performance of dual chamber PFS in an autoinjector - reduce builds and set specs
  • Playbook for future programs
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    11:30

    Session Reserved for Cambridge Design Partnership

    Cambridge Design Partnership Ltd - Senior Representative

    Cambridge Design Partnership Ltd - Senior Representative, , Cambridge Design Partnership Ltd

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    12:00

    Panel Discussion: Integration of Quality by Design (QbD) and design controls in device development

  • Current State of the Industry: The BioPharma sector is advancing in its use of QbD and design controls, but maturity levels vary widely - highlighting gaps in how CQAs, control strategies, and design inputs are interconnected across organizations
  • Why Integration Is Important: Stronger integration between QbD principles and design control is essential to reduce development friction, enable clearer alignment across cross-functional teams, and create a more consistent foundation for device–drug combination product quality
  • Benefits of Integration: A unified framework and shared training can streamline development, enhance risk management, and improve regulatory readiness - ultimately accelerating innovation while supporting sustainability and robust product performance
  • David Vazquez

    David Vazquez , Sr Director of Digital & Device Technical Operations, Pfizer

    Chuck Ventura

    Chuck Ventura, Chief Executive Officer, Ventura Solutions

    Shirish Ingawale

    Shirish Ingawale, Director, Device & Combination Product Development, Takeda Pharmaceutical Company Limited

    Khaudeja Bano

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

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    12:30

    Networking Lunch

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    13:30

    Navigating ISO 10993: Biocompatibility Requirements for Combination Products

    Amardeep Hoonjan

    Amardeep Hoonjan, Director Device R&D Lead, Biocompatibility Group, AbbVie

  • Understanding the latest ISO 10993 updates and their implications for device components in combination products
  • What manufacturers must do to remain compliant under the revised biocompatibility framework
  • Designing for the Future: How upcoming product designs should integrate biocompatibility considerations early in development
  • Practical Insights: Lessons from real-world projects where teams ensured biocompatibility alignment before launch
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    14:00

    Session Reserved for Stevanato Group

    Stevanato Group - Senior Representative

    Stevanato Group - Senior Representative, , Stevanato Group

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    14:30

    Strategic Approaches in Brain-Targeted Drug Delivery: Overcoming Barriers and Fostering Collaborative Innovation

    Mayumi Bowen

    Mayumi Bowen, Senior Principal Engineer, Genentech, A Member of the Roche Group

  • Addressing obstacles and innovative solutions for navigating the blood-brain barrier
  • Rethinking conventional methods of drug delivery for neurological disorders
  • Regulatory frameworks and phase-appropriate approaches for brain-targeted delivery systems
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    15:00

    DMS: Graveyard, or Treasure Trove? Rethinking the Lifecycle of Usability Data

    Ellie Rundell

    Ellie Rundell, Usability Leader, Sanofi

  • Exploring how usability insights from formative and validation studies often get buried in DMS archives, despite their potential value across similar combination products
  • Discuss how adopting a platform mindset - structuring studies, datasheets, and reports with consideration towards future use - and emerging AI tools could help surface patterns, reduce redundancy, and make usability data a strategic asset rather than a regulatory artifact
  • Goal is to spark conversation around long-term insight mining
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    15:30

    Afternoon Networking Break

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    16:00

    Beyond “connectivity”: Practical Digital Innovations that Improve Self-Injection Experience

    Amin Sedighiamiri

    Amin Sedighiamiri, Senior Director, Device Development and Technology, Merck

  • Define value in digital for patients. What matters most: Reduce errors, improve adherence or streamline onboarding?
  • “Simple wins” in the development lifecycle: Low-friction digital features for combination products that scale
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    16:00

    Optimizing External Collaboration in Injectable Drug Delivery

    Richard Braga

    Richard Braga, Device SRM/CDMO Lead, Takeda Pharmaceuticals

  • How pharma companies can build strategic partnerships with CDMOs and device developers to streamline product development, drive innovation, and enable scalability
  • Strategies to harmonize goals and operations, fostering resilient, high-performance collaborations that deliver sustainable value
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    16:00

    Building a Robust Combination Product Ecosystem

    Mark Howansky

    Mark Howansky, VP, Device Development & Commercialization, Viridian Therapeutics

  • Design Controls and Program Optionality: How do regulatory, quality, and design control requirements shape early decisions and documentation strategies?
  • Integrating Human Factors, Design Controls, and Aggressive Timelines: What proven approaches ensure usability and reliability while meeting accelerated development schedules?
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    16:00

    Platform Solutions in BioPharma Device Development: Opportunities and Challenges

    Shirish Ingawale

    Shirish Ingawale, Director, Device & Combination Product Development, Takeda Pharmaceutical Company Limited

  • From Practice to Strategy: Key lessons from case studies and the operational, sustainability, and portfolio level value of platform driven approaches
  • Future Outlook: Industry collaborations, evolving guidance, AI integration, and supplier perspectives shaping next-generation platforms
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    17:30

    Chair’s Closing Remarks and Close of Focus Day

    Kinsuk Shah

    Kinsuk Shah, Sr. AD Combination Product Steward, Boehringer Ingelheim

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    7:30

    Registration & Coffee

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    8:00

    Chair's Opening Remarks

    Mark DeStefano

    Mark DeStefano, Global Technology Innovation, Combination Products and Device Research & Development, Teva Pharmaceuticals

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    8:05

    Strategic Foresight in Drug Delivery: Planning for Innovation, Scale, and Patient Impact

    Monica Swinney

    Monica Swinney, Sr. Director & Head, Drug Delivery Innovation & New Product Planning, Gilead Sciences

  • Bridging early planning with long-term device strategy with insights into how upstream planning decisions shape downstream success in platform selection, lifecycle management, and patient outcomes
  • Aligning innovation with commercial and clinical realities with strategies Gilead utilizes for balancing cutting-edge delivery formats with scalability, regulatory readiness, and therapeutic relevance
  • Leveraging cross-functional insights to future-proof development with practical approaches for integrating R&D, regulatory, and supply chain perspectives to de-risk device innovation
  • Translating market signals into actionable platform strategy: exploring how real-world data and unmet needs inform device design choices and portfolio prioritization
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    8:35

    Advancing Use of Platforms for Development and Regulatory Submissions

    Amy Wise

    Amy Wise, Associate Director, RA Emerging Technologies, Combination Products, and Devices, AbbVie

  • Principles for developing the platform
  • Modular device concept platform
  • Bridging and reuse of platform concept
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    9:00

    Session Reserved for Lead Sponsor Crux Product Design

    Crux Product Design - Senior Representative

    Crux Product Design - Senior Representative, , Crux Product Design

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    9:30

    Leading the Next Wave of Obesity Treatments

    Doug Bakan

    Doug Bakan, Chief Technology Officer, Kailera Therapeutics

  • Overview of Kailera’s mission, therapeutic focus, and approach to obesity treatment
  • Pipeline Highlights: Summary of key assets and clinical progress
  • Exploring why GLP-1 and related mechanisms are pivotal for improving outcomes in obesity and metabolic disease
  • Impact on Patient Population: Addressing unmet needs and long-term benefits of innovative drug therapies for weight management
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    10:00

    Session Reserved for Gold Sponsor Suttons Creek

    Suttons Creek - Senior Representative

    Suttons Creek - Senior Representative, , Suttons Creek

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    10:30

    Morning Networking Break

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    11:00

    Fireside Chat: Driving Innovation: Gaining Stakeholder Alignment for Emerging and Existing Technologies

    Engaging Stakeholders Effectively: Strategies to secure cross-functional alignment and leadership support for innovation initiatives
    Technology Scouting Challenges: Common pitfalls when establishing structured processes for identifying and evaluating emerging technologies
    Building Proactive Organizational Frameworks: Implementing a sustainable, scalable approach for technology adoption

    Subhi Saadeh

    Subhi Saadeh, Associate Director - MDCP QA, Gilead

    Kindeva - Senior Representative

    Kindeva - Senior Representative, , Kindeva

    Crux Product Design - Senior Representative

    Crux Product Design - Senior Representative, , Crux Product Design

    Theresa Scheuble

    Theresa Scheuble, Director R&D Drug Delivery Systems, Johnson & Johnson

    Sujit Basu

    Sujit Basu, Vice President & Head, Pharmaceutical Development, Ionis Pharmaceuticals

    Mark Howansky

    Mark Howansky, VP, Device Development & Commercialization, Viridian Therapeutics

    Mark DeStefano

    Mark DeStefano, Global Technology Innovation, Combination Products and Device Research & Development, Teva Pharmaceuticals

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    11:30

    Session Reserved for Gold Sponsor Instron

    Instron - Senior Representative

    Instron - Senior Representative, , Instron

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    12:00

    Industry Perspectives on Delivery Device Circularity

    Duncan Paterson

    Duncan Paterson, Senior Director, AstraZeneca

  • Opportunities and challenges with injection device take-back and recycling
  • Current state of the industry with injection device circularity
  • Future outlook for circularity for injection devices
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    12:30

    Session Reserved for Gold Sponsor Althena Medical

    Althena Medical - Senior Representative

    Althena Medical - Senior Representative, , Althena Medical

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    13:00

    Human Factors in the Post Market Space

    Alicia Douglas

    Alicia Douglas, Human Factors Lead, Principal Scientist, Merck

  • Strategies for enabling lifecycle decisions based on usability and safety
  • Bringing learnings from post market into development – Platform approach
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    13:30

    Networking Lunch

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    14:30

    Chair’s Opening Remarks

    Amin Sedighiamiri

    Amin Sedighiamiri, Senior Director, Device Development and Technology, Merck

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    14:40

    Stream Opening Panel Discussion: Large Volume Delivery Devices: Handheld, On Body, or Near Body delivery systems?

  • Decision frameworks and trade-offs as biologics move to higher volumes and at-home administration
  • Clinical and patient factors that drive platform choice: dose frequency, injection duration, tolerability, etc
  • Where each platform is winning today and why
  • Amin Sedighiamiri

    Amin Sedighiamiri, Senior Director, Device Development and Technology, Merck

    Mark DeStefano

    Mark DeStefano, Global Technology Innovation, Combination Products and Device Research & Development, Teva Pharmaceuticals

    Alicia Douglas

    Alicia Douglas, Human Factors Lead, Principal Scientist, Merck

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    15:10

    Session Reserved for Credence MedSystems

    Credence MedSystems, Inc. - Senior Representative

    Credence MedSystems, Inc. - Senior Representative, , Credence MedSystems, Inc.

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    15:40

    Combination Product Development from the Biologics Formulation and Fill-Finish Perspective

    Kevin Maloney

    Kevin Maloney, Senior Director, Biologics Drug Product Development, Biogen

  • What good looks like for a combination product protein formulation
  • High-dose/high-volume products; what are the challenges?
  • Value of integrating CMC Development across Drug Substance, Drug Product, and Device
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    16:10

    Afternoon Networking Break

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    16:40

    Global Device Regulatory Submission Strategies for On-body Delivery Systems

    Aditya Sukthankar

    Aditya Sukthankar, Associate Director - GRA Device Lead - Specialty Care Devices and Combination products, Sanofi

  • Key considerations when working with internal and external partners for developing effective collaborations for successful regulatory submissions
  • Clinical Applications Considerations
  • Pilot Coordinated Assessment Process - European Commission – Overview and Learnings
  • Clinical study documentation strategies for global harmonization of regulatory submissions
  • Marketing Applications – Navigating Pharma and Device partner regulatory submission pathways
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    17:10

    Session Reserved for EdgeOne Medical

    EdgeOne Medical - Senior Representative

    EdgeOne Medical - Senior Representative, , EdgeOne Medical

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    17:40

    Challenges in Development of Large Volume Delivery Device

    Roy Wang

    Roy Wang, Associate Director, Device Development & Manufacturing, Viridian Therapeutics

  • Drug and device landscape
  • Partnership between drug and device developers
  • Design controls, risk management
     
  • clock

    18:10

    Chair’s Closing Remarks and End of Day One

    Amin Sedighiamiri

    Amin Sedighiamiri, Senior Director, Device Development and Technology, Merck

    clock

    14:30

    Chair's Opening Remarks

    Duncan Paterson

    Duncan Paterson, Senior Director, AstraZeneca

    clock

    14:40

    Sustainability Initiatives for Injectable Devices

    Lisa Ray

    Lisa Ray, Executive Director Program Management - Delivery, Device & Connected Solutions, Eli Lilly and Company

  • Discuss why sustainability matters
  • Share vision and key objectives
  • Share device specific initiatives and global perspective
  • Discuss how to measure impact and next steps
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    15:10

    Session Reserved for Haselmeier

    Haselmeier GmbH - Senior Representative

    Haselmeier GmbH - Senior Representative, , Haselmeier GmbH

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    15:40

    Panel Discussion: Putting Sustainability into Practice in Combination Product Development

  • Sharing experiences with development programs and submissions, with a case study from Eli Lilly on a reusable device submission
  • Reviewing recent initiatives that integrate sustainability principles into the design and development of combination products, with a focus on long-term environmental impact
  • Addressing key challenges including technical, regulatory, and cultural that hinder the adoption of circular economy and sustainability models in injectable drug delivery
  • Shruti Parikh

    Shruti Parikh, Director, Product Design, Takeda

    Lisa Ray

    Lisa Ray, Executive Director Program Management - Delivery, Device & Connected Solutions, Eli Lilly and Company

    Duncan Paterson

    Duncan Paterson, Senior Director, AstraZeneca

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    16:10

    Afternoon Networking Break

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    16:40

    Framework for evaluating takeback schemes

    Jayne Gavrity

    Jayne Gavrity, Senior Device Engineer, AstraZeneca

  • Review of current state of disposal options
  • Comparing impacts of disposal methods
  • Case study on value of take back scheme
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    17:10

    Session Reserved for Sponsor

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    17:40

    Integrating Sustainability into Quality Systems and Life Cycle Management

    Sriram Natarjaan

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

  • Incorporating sustainable design principles into combination product development while maintaining regulatory compliance
  • Developing risk management frameworks that integrate sustainability objectives alongside quality and safety requirements
  • Discussing how post-market surveillance processes can monitor environmental impact throughout the product lifecycle to drive continuous improvement
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    18:10

    Chair’s Closing Remarks and End of Day One

    Duncan Paterson

    Duncan Paterson, Senior Director, AstraZeneca

    clock

    7:45

    Registration & Coffee

    clock

    8:20

    Chair's Opening Remarks

    Subhi Saadeh

    Subhi Saadeh, Associate Director - MDCP QA, Gilead

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    8:30

    Balancing Platform Innovation with Patient-Centric Drug Delivery

    Sujit Basu

    Sujit Basu, Vice President & Head, Pharmaceutical Development, Ionis Pharmaceuticals

  • Exploring how platform-based delivery systems can adapt to both rare and prevalent disease conditions
  • Ensuring that product design remains responsive to diverse patient needs across therapeutic areas
  • Balancing scalability with customization to meet contrasting demands effectively
  • Aligning platform capabilities with real-world outcomes to optimize impact and accessibility
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    9:00

    Session Reserved for Gold Sponsor SHL Medical

    SHL Medical - Senior Representative

    SHL Medical - Senior Representative, , SHL Medical AG

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    9:30

    Rethinking Device Substitutability: Human Factors Innovation for Generics & Biosimilars

    Mark DeStefano

    Mark DeStefano, Global Technology Innovation, Combination Products and Device Research & Development, Teva Pharmaceuticals

  • Challenging the Status Quo: Why replicating reference devices may perpetuate usability flaws and hinder innovation
  • Human Factors Reimagined: How traditional usability testing and validation methods offer a more effective path than CUHF studies
  • Real-World Study Insights: Evidence from substitutable device testing showing safe, effective use without added training or errors
  • Path to Patient-Centric Design: Leveraging risk-based human factors to accelerate access to affordable, user-friendly therapies
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    10:00

    Session Reserved for Gold Sponsor Gerresheimer

    Gerresheimer - Senior Representative

    Gerresheimer - Senior Representative, , Gerresheimer

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    10:30

    Morning Networking Break

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    11:00

    Global Perspectives on Subcutaneous Injection: Patient Needs and Barriers Across Three Markets

  • Present findings from recent survey-based patient research conducted across three global market regions
  • Identify key subcutaneous injection factors that drive patient preferences and barriers to adoption and adherence
  • Provide insights into drivers for patient preferences and acceptance of product sustainability and take-back offerings
  • Share implications for product development and use of conjoint analysis to evaluate “what if” scenarios to understand how changes in features and key injection factors would alter patient preferences
  • Adrienne Fletcher

    Adrienne Fletcher, Director, Packaging and Device Strategy and Innovation, Johnson & Johnson

    Johanna Schoss

    Johanna Schoss, Principal Human Factors Engineer, Biogen

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    11:30

    Session Reserved for Gold Sponsor CCL Healthcare

    CCL Healthcare - Senior Representative

    CCL Healthcare - Senior Representative, , CCL Healthcare

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    12:00

    Navigating the Complexities of mRNA PFS Scale-up: Development, Timelines and Supply

    Christina Van Geen Hoven

    Christina Van Geen Hoven, Director and Portfolio Project Lead, Pfizer

  • Navigating development of PFS format selection for mRNA drug products
  • Aligning device strategy with clinical and commercial timelines
  • Sourcing and capacity planning challenges
  • clock

    12:30

    Session Reserved for Gold Sponsor West Pharma

    West Pharmaceutical Services - Senior Representative

    West Pharmaceutical Services - Senior Representative, , West Pharmaceutical Services

    clock

    13:00

    Closing the Loop: Smarter Complaint Handling for Auto-Injector Combination Products

    Edward Hatton

    Edward Hatton, Director Quality Assurance, External Manufacturing, Amneal Pharmaceuticals

  • Integrating Drug and Device Data Streams: Complaint investigations must go beyond isolated failure reports - combining mechanical, formulation, and human factors data to reveal the true failure story
  • Predictive Insights Through Trend Analysis: Moving from reactive tracking to proactive signal detection - using complaint trend analytics to predict emerging failure modes before they trigger recalls or field actions
  • Human Factors and Root Cause Rigor: Shifting investigations from “user error” to “use error” - applying human factors engineering to identify systemic design or labelling contributors often missed in device complaint reviews
  • The Quality-Regulatory Continuum: Strengthening the feedback loop linking complaint handling to CAPA, risk management, and post-market surveillance - aligning with both FDA 21 CFR 4 and EU MDR Article 83 expectations
  • clock

    13:30

    Networking Lunch

    clock

    14:30

    Chair's Opening Remarks

    Ning Yu

    Ning Yu, Vice President, Device and Combination Product Development, Astria Therapeutics

    clock

    14:40

    Silicone Aging in Glass Barrels - Risks and Mitigation Strategies

    Ning Yu

    Ning Yu, Vice President, Device and Combination Product Development, Astria Therapeutics

  • Mechanisms of silicone degradation and its impact on drug-device compatibility
  • Analytical methods for monitoring silicone aging and migration over time
  • Design and formulation strategies to mitigate risks in long-term storage and use
  • clock

    15:10

    Session Reserved for Zeon

    Zeon - Senior Representative

    Zeon - Senior Representative, , Zeon

    clock

    15:40

    Accelerating Device Integration for Safe, Stable Combination Products

    Senior Representative

    Senior Representative, , Immunovant

  • Driving early device planning aligned with clinical and commercial expectations to shorten timelines from selection to IND submission
  • Ensuring cross-functional coordination on development strategies, including DV, shipping studies, and E/L HF assessments
  • Streamlining design transfer by onboarding manufacturing CMOs with robust audits, assembly line qualification, and risk-based control strategies
  • clock

    16:10

    Afternoon Networking Break

    clock

    17:00

    Stability Considerations for Combination Products

    Sharmad Joshi

    Sharmad Joshi, Senior Engineer II Device Development, Alexion

  • 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

    Session Reserved for Mitsubishi Gas Chemical

    Mitsubishi Gas Chemical Company, Inc - Senior Representative

    Mitsubishi Gas Chemical Company, Inc - Senior Representative, , Mitsubishi Gas Chemical Company, Inc

    clock

    17:40

    Closing Panel Discussion: Challenges and Opportunities in Biocompatibility for Combination Products

  • Complexity of Evaluation: Combination drug-device products require rigorous biocompatibility assessments, aligning with global standards and cross-organizational collaboration. BioPhorum’s position paper outlines these challenges
  • Stakeholder Alignment: Evolving regulations make internal and external alignment difficult. Biopharma must optimize use of supplier data; BioPhorum is developing a collaborative supplier checklist
  • Data Standardization: Industry is moving toward reusable, platformable data to reduce redundant testing. Harmonizing global standards and defining use cases are key. BioPhorum is reviewing case studies and next steps
  • clock

    18:10

    Chair’s Closing Remarks and Close of Conference

    Ning Yu

    Ning Yu, Vice President, Device and Combination Product Development, Astria Therapeutics

    clock

    14:30

    Chair's Opening Remarks

    Shirish Ingawale

    Shirish Ingawale, Director, Device & Combination Product Development, Takeda Pharmaceutical Company Limited

    clock

    14:40

    Transitioning from Drug to Device and Incorporating Connectivity

    Prasad Peri

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

  • Addressing evolving cybersecurity expectations and challenges in connected drug delivery systems
  • Insights into basics of interacting with the FDA and pre-market regulations for medical devices
  • Connected Solutions and PDURS: Impact on connected devices and related systems
  • clock

    15:10

    Session Reserved for Scheiner Medical

    Schreiner MediPharm - Senior Representative

    Schreiner MediPharm - Senior Representative, , Schreiner MediPharm

    clock

    15:40

    Patient-Driven, Targeted Enhancements That Elevate the User Experience

    Javad Eshraghi

    Javad Eshraghi, Senior Advisor, Eli Lilly and Company

  • Bullet points to be confirmed
  • clock

    16:10

    Afternoon Networking Break

    clock

    16:40

    Choosing the right prefilled syringe design for your intended user population

    Brittany Conrad

    Brittany Conrad, Senior Human Factors Engineer, Pfizer Inc.

  • Identify user characteristics that may influence the user interface
  • Understanding the market landscape for your proposed product
  • Putting it together: The path to approval
  • clock

    17:10

    Session Reserved for Sponsor

    clock

    17:40

    Evaluating Usability of a Safety Syringe Device for Pediatric Indications for Clinical Readiness

    Merin Kalapurackal

    Merin Kalapurackal, Engineer, Device Development, Bristol Myers Squibb

  • Human Factors and regulatory requirements for clinical readiness (what is required for IND)
  • Case Study: Pediatric Patient SSD (risk management, IFU development, etc)
  • Utilization of study results and feedback from users for clinical readiness
  • Merin Kalapurackal, Engineer, Device Development, Bristol Myers Squibb
  • clock

    18:10

    Chair’s Closing Remarks and Close of Day Two

    Shirish Ingawale

    Shirish Ingawale, Director, Device & Combination Product Development, Takeda Pharmaceutical Company Limited

    Confirmed Speakers Include:

    Associate Director - GRA Device Lead - Specialty Care Devices and Combination products
    Sanofi
    Director, Packaging and Device Strategy and Innovation
    Johnson & Johnson
    Human Factors Lead, Principal Scientist
    Merck
    Althena Medical
    Director Device R&D Lead, Biocompatibility Group
    AbbVie
    Senior Director, Device Development and Technology
    Merck
    Associate Director, RA Emerging Technologies, Combination Products, and Devices
    AbbVie
    Senior Device Engineer
    AstraZeneca
    Senior Human Factors Engineer
    Pfizer Inc.
    Cambridge Design Partnership Ltd
    CCL Healthcare
    Director and Portfolio Project Lead
    Pfizer
    Chief Executive Officer
    Ventura Solutions
    Credence MedSystems, Inc.
    Crux Product Design
    Sr Director of Digital & Device Technical Operations
    Pfizer
    Chief Technology Officer
    Kailera Therapeutics
    Senior Director
    AstraZeneca
    EdgeOne Medical
    Director Quality Assurance, External Manufacturing
    Amneal Pharmaceuticals
    Usability Leader
    Sanofi
    Gerresheimer
    Haselmeier GmbH
    Senior Advisor
    Eli Lilly and Company
    Senior Device Engineer
    AstraZeneca
    Principal Human Factors Engineer
    Biogen
    Senior Director, Biologics Drug Product Development
    Biogen
    Vice President - Global Head of Device Quality
    Roche-Genentech
    Sr. AD Combination Product Steward
    Boehringer Ingelheim
    Executive Director Program Management - Delivery, Device & Connected Solutions
    Eli Lilly and Company
    Global Technology Innovation, Combination Products and Device Research & Development
    Teva Pharmaceuticals
    VP, Device Development & Commercialization
    Viridian Therapeutics
    Senior Principal Engineer
    Genentech, A Member of the Roche Group
    Engineer, Device Development
    Bristol Myers Squibb
    Mitsubishi Gas Chemical Company, Inc
    Sr. Director & Head, Drug Delivery Innovation & New Product Planning
    Gilead Sciences
    Vice President, Device and Combination Product Development
    Astria Therapeutics
    AVP Regualtory Affairs Connected Delivery, Devices and Digital Health
    Eli Lilly
    Device SRM/CDMO Lead
    Takeda Pharmaceuticals
    Associate Director, Device Development & Manufacturing
    Viridian Therapeutics
    Schreiner MediPharm
    Immunovant
    Senior Engineer II Device Development
    Alexion
    Director, Device & Combination Product Development
    Takeda Pharmaceutical Company Limited
    SHL Medical AG
    Director, Product Design
    Takeda
    Sr. Manager, Product Quality Management
    Johnson & Johnson
    Stevanato Group
    Associate Director - MDCP QA
    Gilead
    Vice President & Head, Pharmaceutical Development
    Ionis Pharmaceuticals
    Suttons Creek
    Director R&D Drug Delivery Systems
    Johnson & Johnson
    West Pharmaceutical Services

    Gold Sponsors

    Sponsors

    Exhibitors

    Official Media Partner

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    Sponsors and Exhibitors


    Althena Medical

    Gold Sponsors
    http://www.althenamedica.it/

    Althena Medical is an Italian company specialized in the development and production of medical devices in the pharmaceutical field (pre-fillable syringes, oral liquid dispensers, droppers, etc.). In our catalogue we currently have COP pre-fillable syringes in several volumes. We also offer filling service and turn-key products.

    We work for small, medium and big brands for which we have designed, created and produced patented products.

    We differ from our competitors because we are flexible, reliable and we develop medical devices on demand very quickly.

    100% Made in Italy!



    CCL Healthcare

    Gold Sponsors
    https://cclhealthcare.com/

    CCL Healthcare excels in pharmaceutical labeling for injectables for vials, syringes, prefilled syringes, and autoinjectors. Our expertise covers labels, cartons, patient instructions, and smart labeling solutions, enhancing patient experience and adherence. With our high-speed RFID packaging line management, we enable encoding with speeds of 700 injectable items per minute, ensuring peak performance for hard-to-tag items through custom RFID product design. Contact us to discuss how we can enhance your injectable solutions with smart labels and packaging.


    Gerresheimer

    Gold Sponsors
    http://www.gerresheimer.com

    Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical primary packaging, drug delivery systems and digital solutions. Gerresheimer ensures that medicines reach patients safely and can be administered reliably. With around 12,000 employees and 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets with a focus on the pharma industry.



    Instron

    Gold Sponsors
    https://www.instron.com/en-gb/

    Instron® brings a wealth of knowledge to the biomedical industry, serving as a strategic partner to companies of all sizes. Our equipment and services are primed to help you investigate new technologies and ensure product quality, all while maintaining the highest levels of data integrity and security. Instron has been embedded in the biomedical industry for more than 75 years, and the technological, regulatory, and manufacturing challenges facing our customers have driven us to develop products and services to address their needs. These developments include specialized fixturing, compliant software, and automation capabilities. Our most valuable asset is our extensive customer network, which represents a wide range of medical device and pharmaceutical manufacturers, CDMOs, universities, test houses, and startups.



    SHL Medical

    Gold Sponsors
    http://www.shl-medical.com

    SHL Medical is a pioneering leader in self-injection solutions, such as autoinjectors. Driven by our purpose of “enabling patients’ independence”, we partner with leading pharma and biotech companies to develop self-injection systems and digital solutions that enhance patients’ treatment experience and quality of life. Our customers benefit from our proven track record and scalable, global manufacturing excellence, with locations in Switzerland, USA, Sweden, and Taiwan. By focusing on innovation, we challenge the status quo and shape the future of state-of-the-art drug delivery. We cover the entire drug delivery value chain, providing piece of mind through our end-to-end services, from design, development, to final assembly, labeling, and packaging.


    Suttons Creek

    Gold Sponsors
    http://www.suttonscreek.com

    Suttons Creek is pharma’s device team. Any company adopting combination product technology needs an experienced combination products team working alongside their drug team, including specialists in areas like quality, regulatory, vendor selection and management, systems engineering, risk management, clinical development, and commercialization. Suttons Creek has over 650 years of combined experience and 120+ combination product projects under its belt, with a talent pool of subject matter experts that specialize in all aspects of combination product development from strategic planning through device development to launch and postmarket activities. We can be any or all things combination product to a client, consulting hour by hour or engaging in strategic partnerships to achieve milestones, lift roadblocks, fill knowledge gaps, and drive program success.



    West Pharmaceutical Services

    Gold Sponsors
    https://www.westpharma.com/

    West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With over 10,000 team members across 50 sites including 25 manufacturing facilities worldwide, West helps support our customers by delivering over 41 billion components and devices each year.

    Sponsors


    Cambridge Design Partnership

    Sponsors
    https://www.cambridge-design.com/

    Cambridge Design Partnership is an end-to-end innovation partner. We build breakthrough products and services – from insight to ideas, prototypes to production. Our Drug Delivery sector focus on injection systems including auto injectors, pen injectors, wearable (OBDS) devices and infusion pumps, as well as Digital Health applications including connected drug delivery devices, diagnostics/biomarker devices, app development and cloud services.


    Credence MedSystems

    Sponsors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    EdgeOne Medical

    Sponsors
    http://www.edgeonemedical.com/

    EdgeOne Medical is a leading global Contract Device Development Organization, serving as the trusted testing and device development partner for more than half of the top 20 global pharmaceutical companies. As experts in compliant device development from benchtop to commercialization, we leverage our extensive industry knowledge, advanced in-house laboratory, and ISO 13485 certified Quality Management System to accelerate and derisk the development journey for our clients. EdgeOne Medical’s ability to get it “Right First Time” has made us the preferred partner for many key players in emerging pharma and big pharma. Our track record also includes supporting the combination product device development for several newly acquired emerging pharmaceutical companies representing the largest deals in the last year.


    Haselmeier

    Sponsors
    https://haselmeier.com/en/

    o Haselmeier, the drug delivery device business of medmix, designs, develops and manufactures advanced drug delivery systems such as pen injection systems and autoinjectors. Patient comfort and customers’ needs are always at the heart of the company’s practices. With its broad portfolio of technologies and services, Haselmeier delivers user-friendly injection systems that enable patients to self-administer their medication reliably and accurately. Haselmeier is known for its excellent and long-standing track record in providing these innovative drug delivery devices based on its proprietary IP business model. The company collaborates closely with its customers in the pharmaceutical and biopharmaceutical industries. Medmix, with its precision injection molding capabilities and expertise in liquid micro-dosing plus financial strength and global footprint, helps Haselmeier accelerate innovation in healthcare. With more than 100 years of expertise in the development and manufacture of drug delivery devices, our global footprint, nearly 250 distinguished and motivated experts, more than 200 patents granted, and numerous patents pending, Haselmeier remains committed to developing innovative solutions that support our customers and help improve the health of millions of people worldwide.



    Kindeva

    Sponsors
    https://www.kindevadd.com/about-us/

    As a purpose-fueled drug delivery CDMO, we leverage our specialist injectable, inhalation and dermal expertise to accelerate your product’s journey and make tomorrow’s possibilities a reality.

    From development to commercial manufacturing and beyond, amplify your product’s impact with our exceptional-by-design CDMO solutions.

    Our Bridgeton facility has over 155,000 sq. ft. of dedicated aseptic operations space, including state-of-the-art laboratories and formulation suites, alongside almost 11,000 sq. ft. of fill suites to ensure the highest levels of quality and patient safety.

    Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.



    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    Schreiner MediPharm

    Sponsors
    http://www.schreiner-group.com/en/company/about-us/schreiner-medipharm

    Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the healthcare industry. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. The product portfolio includes e.g. syringe labels with integrated needle protection, functional autoinjector labels and smart labeling solutions with integrated RFID/NFC. Our unique, highly robust RFID-Labels ensure easy integration into pharma manufacturing while providing reliable functionality from production till final use.



    Stevanato

    Sponsors
    https://www.stevanatogroup.com/en/

    Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes, and services that address customer needs across the entire drug life cycle at each of the development, clinical, and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation, and its engineering excellence are central to its ability to offer value-added solutions to clients. To learn more, visit: www.stevanatogroup.com


    Ventura Solutions

    Sponsors
    http://www.ventura-solutions.com

    Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations.


    ZEON

    Sponsors
    https://www.zeon.eu/

    o ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    Aptar Pharma

    Exhibitors
    http://aptar.com/pharmaceutical/

    For Pharma injectables customers worldwide, Aptar Pharma supports drug developments from formulation to patient, including drug development services, best-in-class injectables components and patient services. Our offer includes a wide range of solutions for vial containment, and Pre-Filled syringe components such as PremiumCoat® ETFE-coated platform to protect sensitive drugs or Advanced Parenteral Closure solutions to support compliance with the Annex 1 revision. We enable the delivery of billions of doses that improve the lives of patients every day across numerous injectable application fields, including GLP-1 drugs, biologics, small molecules, vaccines, antithrombotic and animal health.



    BBS Automation Chicago,

    Exhibitors
    https://www.bbsautomation.com/en

    BBS Automation, a leading automation provider with 2,500 employees in 20 sites worldwide, offers a broad range of solutions, including assembly and test, winding, insertion and take-out technology, feeder and palletizing systems. Serving mobility, medtech, consumer goods, new energy and electronics industries, BBS delivers solutions from a single source. BBS has sites in Europe, North America and Asia. Since 2023, BBS has been part of the Dürr Group.



    BD Medical - Pharmaceutical Systems

    Exhibitors
    http://drugdeliverysystems.bd.com

    As a partner of choice for the pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of ready-to-use drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems, self-injection systems and connected solutions that ensure smooth delivery, regardless of drug complexity, viscosity and dosing volume. We offer our expertise and resources to support their product launch and life cycle management through consultative, analytical and clinical services to help ensure drug compatibility and seamless systems integration, while accelerating time-to-market and reducing risk.

    More information available @ drugdeliverysystems.bd.com

    Contact us @ drugdeliverysystems.bd.com/contact-us



    Ensera

    Exhibitors
    https://www.ensera.com/

    Ensera is a global contract design and manufacturing organization (CDMO) specializing in complex product design, manufacturing and supply chain solutions for pharmaceuticals, drug-device combination products and medical devices. With facilities in the United States, Europe and Southeast Asia, we support leading pharma and MedTech innovators on their route to market, with services including design, manufacturing, final assembly, secondary packing, supply chain management and regulatory support.


    Fischer Söhne AG

    Exhibitors
    http://www.fischersoehne.ch



    IGS GeboJagema

    Exhibitors
    http://www.igsgebojagema.nl

    For over 80 years, we have been delivering high precision injection molds for some of the most successful metered dose inhalers, insulin pens, diagnostic products and other medical drug delivery devices around the world. Our problem-solving mindset, proven track record in the healthcare industry, considerable medical experience and meticulously methodical way of working ensures you the highest quality, process control and traceability needed for your medical products. To learn more, visit www.igsgebojagema.nl



    KORU

    Exhibitors
    https://www.korumedical.com/

    KORU is, first and foremost, a patient-centric organization that will go the extra mile for our customers, providers, and partners who depend on our devices. We are a world-class manufacturer of subcutaneous infusion devices that deliver life-saving immunoglobulin therapies to patients with chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).



    MGS

    Exhibitors
    http://mgsmfg.com

    A global provider of healthcare contract development and manufacturing solutions, MGS provides the right balance to drive vital innovations: robust, vertically integrated global capabilities combined with the strong customer focus and seamless collaboration of an agile partner. That’s why we’re the healthcare CDMO of choice for today’s leading Pharma, Diagnostic and MedTech companies.



    Noxilizer

    Exhibitors
    https://noxilizer.com/

    Noxilizer is the expert in the application of the NO2 process within the supply chain. Noxilizer sells sterilization equipment to pharmaceutical, biotech, and medical device manufacturers and also offers contract sterilization services.



    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.


    PIA Automation US Inc.

    Exhibitors
    http://www.piagroup.com

    Creating efficiency - achieving significantly more performance with smart and creative solutions. This is the guiding principle of the PIA Automation companies connected in the PIA Group, which also includes the Evansville (IN) site. There, the company develops and produces technically complex and economically sophisticated assembly systems for the medical industry, on which, for example, auto-injectors, syringes, pens and inhalers are automatically manufactured and tested. With meditec® system technology, even the highest standards of precision, quality, cleanliness and availability can be achieved effortlessly. With decades of continuously growing expertise and more than 8,700 completed projects, PIA Group is now one of the world's leading automation specialists. Over 1,850 employees in 12 networked locations in Europe, North America and Asia make PIA a partner that flexibly, reliably and sustainably innovates automation for the automotive, energy storage, life science, medical, commercial goods, electronics and components industry. With a global service portfolio and its own Industry 4.0 solutions, PIA offers its customers decisive advantages in the system operations, and in the digitalization and networking of production.



    SCHOTT

    Exhibitors
    http://www.schott.com/en-us/markets/health/pharma

    SCHOTT is a global manufacturer of high-tech materials for specialty glass. With more than 130 years of experience, and represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy, and Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. SCHOTT is one of the world’s leading experts for parenteral packaging and supplies the pharma industry with more than 12 billion syringes, vials, ampoules, and cartridges of tubing glass and polymer per year.



    SFM Medical Devices

    Exhibitors
    https://www.sfm-medical.com/en/

    High quality single-use medical devices.

    Development, production, and registration – everything from one source for the global medical technology and pharmaceutical industry.

    Since the foundation of sfm medical devices GmbH in 1953, we, as a company, feel a responsibility to our employees, customers, suppliers, the environment, and society. Our precision single-use medical devices are used in many areas of human medicine and by the pharmaceutical industry. Numerous controlled manufacturing techniques and close collaboration amongst the different departments and subsidiaries results in outstanding quality. Mastering these collaborative efforts makes sfm unique in the market!“



    Smithers

    Exhibitors
    https://www.smithers.com/en-gb/home

    Smithers Medical Device Testing supports medical device and pharmaceutical manufacturers in bringing innovative, compliant, and high-performing products to market through expert, independent testing services. Operating from accredited laboratories in the USA, UK, and Europe, Smithers offers a comprehensive range of services including extractables and leachables (E&L) studies, functional testing for medical and combination devices, packaging validation, and advanced materials testing. With deep technical expertise and a commitment to the highest quality standards, Smithers partners with clients at every stage of the product lifecycle—from early R&D through regulatory submission and beyond—to ensure performance, efficacy, and global market readiness.



    Terumo

    Exhibitors
    https://www.terumopharmaceuticalsolutions.com/en-EMEA

    As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.

    Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.

    We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.

    Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.

    We listen. We question. We deliver.



    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.

    Media Partners


    ONdrugDelivery

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery provides readers throughout global pharma/biopharma with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: ondrugdelivery.com/subscribe

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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.
     

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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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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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