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SAE Media Group’s 11th Annual Conference
Pre-Filled Syringes East Coast
April 22- 24, 2024 | Boston, USA
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NEW FOR 2023:

Pre-Conference Focus Day: Advances in PFS Design for Enhanced Delivery


Main Conference Afternoon Streams
DAY 1: A)
Developing devices for challenging to delivery drugs B) Sustainability initiatives in the medical device industry
DAY 2: A) Primary packaging development B) Incorporating digital technologies for connected devices

SAE Media Group's 11th Annual Pre-Filled Syringes East Coast Conference will return to Boston in April 2024 to bring you the latest advances in the combination product drug delivery space. As part of SAE’s leading Injectable Drug Delivery Series, the 2024 conference will be bigger and better than ever, bringing you 3 days of expertise, comprising of a pre-conference focus day exploring the advances in PFS design for enhanced drug delivery proceeded by a two-day main conference with morning keynote plenaries and parallel afternoon topic streams addressing the industry’s hottest topics through case studies and industry insights.

This event will not only bring you key insights needed to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in April 2024!

This year's agenda has been validated by our 2024 advisory board:

  • John Schalago, Executive Director, Senior Global Program Director, Novartis
  • Khaudeja Bano, Vice President, Combination Product Quality, Amgen
  • James P. Wabby, Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products, AbbVie
  • Mark DeStefano, Director, Combination Products and Devices R&D, Teva
  • Michael Song, Director, Drug Product Development, Moderna


 

Why attend:

  • 3 full days of networking opportunities
  • 40+ presentations with 75% of speakers from the top 20 big pharma companies
  • The agenda has been curated by an advisory board of big pharma and biotech opinion leaders providing expertise focused on device development, regulatory affairs and quality
  • Access a focus day and 4 dedicated streams addressing the hottest topics in the industry

What you will gain:

  • Collaborate with pharma, biotech and device developers across 3 full days on the latest trends, advancements and challenges within the pre-filled syringe and injectable device market
  • Hear about new technological advances for challenging to delivery drugs such as large volume, highly viscous and lyophilised formulations with case studies on wearable injectors and more
  • Understand the latest regulatory requirements from experts surrounding combination products and engage in opportunities for collaboration and needs for advancing innovation in the field with an advisory board fireside chat
  • Gain insight into how big pharma is incorporating sustainable approaches into drug device design and lifecycle management
  • Delve into the growing potential of digital health to improve patient experience and treatment, and the challenges facing its implementation
  • Examine how container and packaging development can support the ever-evolving innovations drug development, including case studies on CCIT in deep-cold storage and formulator perspectives
     

 

 

 

Directors, Heads of Departments and Managers for the following areas:

  • Device Development
  • Device Engineering
  • Combination Product Development
  • Drug Delivery Devices
  • Primary Packaging Development
  • Digital Health
  • Sustainability and Circular Economy
  • Large Volume Drug Delivery
  • Novel Drug Product Formulation
  • Regulatory Affairs

Previous attendees include:

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

Conference agenda

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8:00

Registration & Coffee

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8:50

Chair's Opening Remarks

John Schalago, Executive Director of Regulatory Affairs, Novartis

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9:00

Opportunities for advancing your injectable device portfolio

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

  • Review of the current PFS and injectables landscape and emerging technologies
  • Recent developments in drug delivery platforms and device design or enhanced drug delivery
  • Opportunities for development processes to become more streamlined
     
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    9:30

    Collaboration for a Strategic Combination Product Development: A Case Study (Subject to Final Confirmation)

    Nicholas Mandala

    Nicholas Mandala, VP Medical Devices & Combination Products, Pfizer

  • Insights into developing a combination product portfolio using advanced technologies
  • Considerations for a collaborative development process across teams
  • Meeting essential performance requirements: challenges to define and identify essential performance requirement (EPR) during the development of a combination product
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    10:00

    Session reserved for lead sponsor

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    10:30

    Morning Break

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    11:00

    Strategic Combination Product Test Method Development and Validation

    Leonel Vanegas

    Leonel Vanegas, Director, Medical Device and Combination Product Quality, Alexion Pharmaceuticals

  • Applying statistical techniques to Method Validation of PFS following ISO11040
  • A paradigm shift integrating a Device vs Drug Quality Risk Management Process in Combination Products
  • Successful implementation of Data Science in lifecycle approach of Combination Products
     
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    11:30

    Session reserved for sponsor

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    12:00

    Panel Discussion: Ways to streamline development, accelerate product to customer

  • Promotion of collaboration between internal stakeholders
  • Learnings from COVID and recent programs to apply for fast to clinic and future success
  • How can we better leverage platforms for enhanced development
  • Reviewing current barriers and potential opportunities to overcome
     
  • Michael Song

    Michael Song, Director, Moderna

    E Guan

    E Guan, Head of Injection Systems, Takeda

    Dany Doucet

    Dany Doucet, Director Early Engagement and Deviceability, GSK

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

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    12:30

    Networking Lunch

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    12:30

    Reserved sponsor session

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    13:30

    Building an Ecosystem for Development and Supply of Combination Products

    Mark Howansky

    Mark Howansky, Vice President of Device Development and Commercialization, Viridian Therapeutics

  • Exploring key regulatory and QMS requirements for a robust and successful combination product portfolio
  • Key considerations for dealing with functional “Upgrades”
  • Exploring supply chain considerations and potential implications on product development
  • Implementing a design control framework
  • Case study on use of device platforms

     

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    14:00

    Session reserved for sponsor

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    14:30

    Digital Transformation’s Impact on Quality Engineering and Combination Products

    Alie Jahangir

    Alie Jahangir, Director, Digital Health & Medical Device Lifecycle Management, Pfizer

  • Quality 4.0 provides an effective framework to transition from a compliance-based, reactive, error-prone, and siloed Quality Management System (QMS) to the one that is proactive, integrated, efficient, and most importantly patient centric, thanks to current digital tools.
  • Adoption of Quality Management System would result in process and systems agility, efficiency, and flexibility, while breaking the silos in product development and validation.
  • Digital transformation will Improve efficiency and productivity of Combination Product’s Development and Qualification
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    15:00

    Afternoon Break

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    15:30

    Maximising Patient Centricity in PFS Design

    Shruti Parikh, Director, Product Design, Takeda Pharmaceuticals

  • Critical considerations for Patient Preference Study (PPS) creation
  • Executing human factors and usability studies to understand patient needs and preference and successfully implementing this in PFS design
  • Strategies and factors to consider for balancing requirements (e.g. technical, commercial, user needs)
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    16:00

    Optimising Lyophilized Drug Delivery

    Dany Doucet

    Dany Doucet, Director Early Engagement and Deviceability, GSK

  • Case study on reconstitution device development
  • Reflecting on major challenges faced during development with perspectives on future improvements
  • Impact of fill/finish on patient usability
  • Opportunities and approaches for enhancing patient usability
     
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    16:30

    Navigating the Complexities of Combination Product Risk: A System-Level Approach

    Benjamin Whitenack, Director, Quality, Combination Products, Gilead Sciences, Inc

  • Integrating ICH Q9(R1) and ISO 14971 risk analyses
  • Evaluating combination product residual risks
  • Enhancing traceability
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    17:00

    Chair’s Closing Remarks and Close of Focus Day

    John Schalago, Executive Director of Regulatory Affairs, Novartis

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    7:45

    Registration & Coffee

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    8:20

    Chair's Opening Remarks

    Mark DeStefano

    Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

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    8:30

    Post market safety reporting for combination products and injectable devices

    Khaudeja Bano, Vice President, Combination Product Quality, Amgen

  • How have we seen industry adapting to meet evolving regulations through effective compliance strategies
  • Current guidance for industry on post market safety reporting for combination products
  • Case study examples for effective approaches to efficiently maintain reporting for combination products and injectable devices
  • Looking to the future how can we expect the global regulatory landscape to evolve for combination product reporting and advice to be best prepared
     
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    9:00

    Advisory Board Fireside Chat: Encouraging Innovation and Addressing Potential Barriers and Pitfalls

  • How can industry keep up with emerging innovations in drug products such as cell and gene therapy
  • As we look to advance technology, how can we ensure stakeholder buy-in and truly aid the patient experience
  • Exchanging regulatory submission challenges and experiences
  • Assessing solutions for the future: considering sustainability and connected health
     
  • James P. Wabby

    James P. Wabby, Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products, AbbVie

    Mark DeStefano

    Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

    Khaudeja Bano, Vice President, Combination Product Quality, Amgen

    Michael Song

    Michael Song, Director, Moderna

    John Schalago, Executive Director of Regulatory Affairs, Novartis

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    9:30

    Disruptive Medicine Innovation – Next Generation of Combination Products

    James P. Wabby

    James P. Wabby, Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products, AbbVie

  • Analyze latest regulatory expectations and challenges
  • Understand potential future innovation platforms
  • Acknowledge potential and future Global Convergence/Harmonization initiatives for combination products
     
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    10:00

    Session reserved for gold sponsor CCL

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    10:30

    Morning Break

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    11:00

    Integrating Digital Technologies into Combination Product Lifecycle Management

    Joyce Zhao, Director, Combination Product Development, Takeda Pharmaceuticals

  • Digital Database Strategy: Exploring effective strategies for integrating digital databases into combination product lifecycle management, highlighting their significance and potential benefits
  • Challenges: Identifying and addressing the challenges that may arise when implementing digital technologies in combination product management, with a focus on practical solutions
  • Future Outlook: Offering insights into the future of combination product lifecycle management with the incorporation of digital technologies, including emerging trends and possibilities
     
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    11:30

    Reserved gold sponsor session

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    12:00

    Understanding pre-filled syringe human factors validation study results

    Alexandra Benbadis, Usability Leader, Sanofi

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    12:30

    Reserved gold sponsor session

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    13:00

    Practical and Patient Considerations for Large Volume and Highly Viscous Drug Delivery

    Anthony Coston, Principal Engineer, Biogen

  • Injection tolerability – effects of device technical attributes
  • Studies on user preferences and ensuring injection duration keeps pain low and facilitate safe use
  • Impact of drug formulation on robustness
  • Regulatory hurdles to overcome
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    13:30

    Networking Lunch

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    14:30

    Chair's Opening Remarks

    Manuel Sanchez-Felix, VP Drug Delivery Search & Evaluation, Halozyme

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    14:40

    Facilitating Rapid High Volume Subcutaneous (SC) Drug Delivery

    Manuel Sanchez-Felix, VP Drug Delivery Search & Evaluation, Halozyme

  • Case study on ENHANZE™: technology breaking through subcutaneous volume limitations to facilitate rapid high-dose, high-volume subcutaneous drug delivery
  • Converting long IV infusions to short SC injections
  • Enabling large volumes to be given SC at a single site
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    15:10

    Session reserved for Credence MedSystems, Inc

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    15:40

    Progressing Next Generation On-body/Wearable Device Development

    Peter Petrochenko, Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals

  • Market overview of on body delivery devices
  • Development of long-acting injections for wearable devices to allow for at home-delivery  
  • Maximising wearables potential through connectivity to allow for granular control of flow rate to improve patient comfort  
     
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    16:10

    Afternoon Break

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    16:40

    Navigating Regulatory Perspectives on Wearable Injectors

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

  • Optimizing CMC and bridging strategies during clinical development
  • Health authority interactions: when should they occur and what is expected?
  • Platform approaches to wearable injectors
  • Recommendations for improved guidance and harmonisation of global regulations
     
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    17:10

    Session reserved for Veryst Engineering, LLC

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    17:40

    Design Considerations for Wearable Injectors

    Sriram Natarjaan

    Sriram Natarjaan, Principal Engineer, Janssen Pharmaceuticals

  • Applicable Standards and Regulations
  • Design Considerations
  • Studies on user preferences
     
  • clock

    18:10

    Chair's Closing Remarks and Closing of Day One

    Manuel Sanchez-Felix, VP Drug Delivery Search & Evaluation, Halozyme

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    14:30

    Chair's Opening Remarks

    Ronald Forster

    Ronald Forster, Head of Manufacturing Sciences and Technologies for Combination Product Operations, Amgen

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    14:40

    Sustainability opportunities in PFS

    Sriman Banerjee

    Sriman Banerjee, Head of Packaging Development & CDE, Takeda Pharmaceuticals

  • Insight into recycling drug delivery devices after use and developing take-back schemes
  • Outlining strategies for product returns and building the environmental infrastructure
  • Waste reduction initiatives during manufacturing with consideration of plastic injection moulding
  • Opportunities for industry collaboration on recycling initiatives, optimization of processes and for promotion of sustainable material use
     
  • clock

    15:10

    Session reserved for Haselmeier

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    15:40

    Tackling Eco-Design for Sustainability

    Speaker to be confirmed

    Speaker to be confirmed , , Amgen

  • Strategies for taking an eco-design approach and embedding sustainability into the medical device product life cycle
  • Successfully implementing lifecycle assessment driven problem solving and utilising life cycle assessment data for a more sustainable future
  • Case study on Amgen’s approach
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    16:10

    Afternoon Break

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    16:40

    Making a Move Towards Sustainable Packaging

    Cedric Gysel, Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson

  • Potential alternative materials that are recyclable and sourcing the right materials
  • Balancing cost, biocompatibility and sustainability when selecting materials
  • Reviewing secondary packaging and opportunities for reducing non-recyclable plastics
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    17:10

    Session reserved for ApiJect

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    17:40

    Sustainable drug delivery devices: A life cycle approach to embedding circularity and decarbonization across the value chain

    Speaker to be confirmed

    Speaker to be confirmed, , BioPhorum

  • Operating context for environmental sustainability in the healthcare sector
  • What this means for the biopharmaceutical industry and where the opportunities lie
  • Designing circular drug delivery devices -challenges and opportunities
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    18:10

    Chair's Closing Remarks and Close of Day One

    Ronald Forster

    Ronald Forster, Executive Director, Amgen

    clock

    7:45

    Registration & Coffee

    clock

    8:20

    Chair's Opening Remarks

    Lawton Laurence, Head of Device & Combination Product Development, Apellis

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    8:30

    Navigating Updates in Injection Device Regulatory Framework: Addressing Current Gaps in Knowledge

    Mike Wallenstein, Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine, Novartis Pharma AG

  • Important regulatory developments in US and EU over the past year
  • Recent challenges that have arisen in US and EU and how these can be overcome
  • Assessing the impact of new EU MDR regulation
  • Case study Notified Body Opinion under the EU MDR for a Prefilled Syringe
     
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    9:00

    Leveraging Bridging Principles for Innovative and Biosimilar/Gx Device Development: A Risk-Based Approach

    Carrie O'Donel, Principal Device Engineer, Teva Pharmaceuticals

  • Discussion of current guidance’s for Bridging and Comparative Use Human Factors Studies for commercialization of injection devices,
  • Comparison of requirements for US versus EU relative to device bridging
  • Effectively conducting a Threshold Analysis to define differences, using bridging data to justify a “minor” versus “other” difference, and defining Negative Transfer
     
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    9:30

    Producing Devices for the Future of Injectable Drugs

    Advait Badkar

    Advait Badkar, Executive Director, Pfizer

  • Key packaging considerations for emerging drugs such as mRNA/LNP and more
  • Satisfying needs of protein-based drug products and what is required for progression in drug product field for successful delivery
  • Delving into protein absorption and aggregation and its effect on immunogenicity
  • clock

    10:00

    Reserved gold sponsor session

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    10:30

    Morning Break

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    11:00

    Addressing Device Pain Points from a Formulation Perspective

    Serene Jabary

    Serene Jabary, Associate Scientist III, Biogen

  • Opportunities for formulation teams and device teams to align earlier in the process on injection needs and impact of formulation
  • Discussion of potential ways to alleviate pain points in the development process
  • Examples including high viscosity, large volumes and requirements for different types of administration
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    11:30

    Reserved gold sponsor session

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    12:00

    Harmonizing Innovation: Influencing Development by Integrating Device and Drug Requirements for Combo Product Functionality and Use

    Alicia Douglas, Human Factors Lead, Merck

  • The user of the combination product is the key to bringing Drug and Device together
  • How early collaboration with formulation/Human Factors/device can avoid costly late stage changes
  • How Device and Formulation partners can influence each other for development
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    13:00

    Cross roads between supplier management and purchasing controls and making supplier quality an asset for injectable drug devices

    Subhi Saadeh

    Subhi Saadeh, Senior Manager, Combination Products QA, Gilead

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    13:30

    Networking Lunch

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    14:30

    Chair's Opening Remarks

    Duncan Paterson, Senior Director, AstraZeneca

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    14:40

    Characterization of Pre-fi lled Syringe Container Closure Integrity in Deep-Cold Storage Conditions

  • CCI of pre-filled syringes is challenged at deep cold storage conditions due to plunger stopper shrinkage and material property changes
  • Theoretical modelling, in-situ imaging and empirical testing were combined to characterize pre-filled syringe CCI at deep cold storage conditions
  • The critical influence of the glass transition temperature plunger stopper elastomer is explored and discussed
  • Duncan Paterson, Senior Director, AstraZeneca

    Sonia Dragulin-Otto, Senior Scientist, AstraZeneca

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    15:10

    Session reserved for Mitsubishi Gas Chemical Company, Inc

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    15:40

    Formulator's perspective: Considerations of primary container closure selection

    Jamie Tsung, Director CMC Development, Alnylam

  • Selection criteria of containers from a formulation perspective
  • Evaluating container option to satisfy needs of protein-based drug products and what is required for progression in drug product field for successful delivery
  • Case study example of wrong container selection, consequences and learnings
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    16:10

    Afternoon Break

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    16:40

    Device Biocompatibility strategy and challenges

    Soumen Das, Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

  • Defining biocompatibility, key deliverables, and submission to health authorities
  • Strategically generating a toxicology risk assessment by unitizing a risk-based approach
  • Recent experiences with the global regulatory agencies

     

  • clock

    17:10

    Session reserved for Zeon

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    17:40

    A case study: Evaluation of Silicone Oil Free Pre-Filled Syringes

    Jacopo Michieli, Sr. Device Engineer, CSL Behring AG

  • Background and reason to choosing a SOF PFS system
  • Selection process of potential options: Glass and Polymer syringe PFS
  • Stability results with worst case molecule for drug container interaction
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    18:10

    Chair's Closing Remarks and Closing of Day Two

    Duncan Paterson, Senior Director, AstraZeneca

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    14:30

    Chair's Opening Remarks

    David Morra, Director, Devices and Digital Health, Merck, Sharpe, & Dohme

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    14:40

    The True Value of Connectivity: Opportunities and Challenges to be Overcome

    David Morra, Director, Devices and Digital Health, Merck, Sharpe, & Dohme

  • Striking a balance between a user-friendly device and a valuable asset
  • Achieving adequate benefits to the patient to offset problems with upgrades
  • Using connectivity broadly vs specific patient populations
  • Current barriers to advancing connectivity and potential ways to overcome this
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    15:10

    Session reserved for Suttons Creek, Inc.

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    15:40

    Taking a 3D Approach: Drug, Device and Digital

    Ravi Kaushik, Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals

  • Necessary steps to be taken to build a 3D ecosystem
  • Learnings to be taken from the established insulin pump ecosystem
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    16:10

    Afternoon Break

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    16:40

    Combination Product Aging Strategies: Key Considerations to Minimize Technical Risk and Support Program Milestones

    Alex Baker, Senior Engineer II, Product and Technology Development, Biogen

  • Real Time vs. Accelerated Aging: how to effectively define aging strategy while reducing technical risk and meeting stakeholder needs
  • Technical Considerations: how to define requirements to test and characterize aging conditions
  • Executing the Test Plan and Planning for Failure: how to prepare samples for testing and successfully create a Plan B
     
  • clock

    17:10

    Reserved sponsor session

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    17:40

    Integration of Human Factors into the Product Life Cycle of Connected Devices

    Speaker to be confirmed

    Speaker to be confirmed, , UserWise

  • What types of human factors practices are appropriate for each stage of product development?
  • Considerations for training and training decay
  • Navigating human factors as it relates to your devices in an ecosystem
  • What to expect for human factors timelines and workload
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    18:10

    Chair's Closing Remarks and Close of Day Two

    David Morra, Director, Devices and Digital Health, Merck, Sharpe, & Dohme


    Executive Director
    Pfizer
    Senior Engineer II, Product and Technology Development
    Biogen
    Usability Leader
    Sanofi
    Human Factors Lead
    Merck
    Director, Digital Health & Medical Device Lifecycle Management
    Pfizer
    Principal Engineer
    Biogen
    Director, Quality, Combination Products
    Gilead Sciences, Inc
    Principal Device Engineer
    Teva Pharmaceuticals
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Director, Devices and Digital Health
    Merck, Sharpe, & Dohme
    Senior Director
    AstraZeneca
    Head of Injection Systems
    Takeda
    Sr. Device Engineer
    CSL Behring AG
    Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products
    AbbVie
    Director CMC Development
    Alnylam
    Executive Director of Regulatory Affairs
    Novartis
    Director, Combination Product Development
    Takeda Pharmaceuticals
    Vice President, Combination Product Quality
    Amgen
    Head of Device & Combination Product Development
    Apellis
    Director, Medical Device and Combination Product Quality
    Alexion Pharmaceuticals
    VP Drug Delivery Search & Evaluation
    Halozyme
    Director, Combination Products and Device R&D
    Teva Pharmaceuticals
    Vice President of Device Development and Commercialization
    Viridian Therapeutics
    Director
    Moderna
    Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine
    Novartis Pharma AG
    Associate Director
    Janssen, Pharmaceutical Companies of Johnson and Johnson
    Associate Director, Regulatory Strategy
    Regeneron Pharmaceuticals
    Vice President, Patient Integrated Care Innovation Platform
    Takeda Pharmaceuticals
    Head of Manufacturing Sciences and Technologies for Combination Product Operations
    Amgen
    Associate Scientist III
    Biogen
    Director, Product Design
    Takeda Pharmaceuticals
    Senior Scientist
    AstraZeneca
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited
    UserWise
    BioPhorum
    Head of Packaging Development & CDE
    Takeda Pharmaceuticals
    Principal Engineer
    Janssen Pharmaceuticals
    Senior Manager, Combination Products QA
    Gilead
    Head of Design & Innovation
    Johnson & Johnson

    Gold Sponsor

    Sponsors

    Exhibitors

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

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

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

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

    Sponsors and Exhibitors


    CCL Healthcare

    Gold Sponsor
    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.

    Sponsors


    ApiJect™

    Sponsors
    https://info.apiject.com/industry-events

    ApiJect™ is a global medical technology company creating the future of pharmaceutical injections.

    Our mission is to provide products with superior convenience, quality, and safety of prefilled syringes at the manufacturing scale and cost-efficiency of multi-dose formats – regardless of manufacturing volume. 

    Our Platform brings together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high-precision plastic injection molding. Our supply chain is simple and compact, using widely available raw materials, ensuring reliability and resilience.  

    The promise of our platform can be seen in our first device, a single-dose prefilled injector is designed to enhance commercial markets and global healthcare accessibility, enabling a wider range of healthcare professionals to administer necessary medications and vaccines to patients.



    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.


    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.



    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.


    Suttons Creek

    Sponsors
    https://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.


    Veryst

    Sponsors
    https://www.veryst.com/

    Veryst Engineering, LLC provides premium engineering consulting services at the interface of technology and manufacturing. We aim to be the best in the world for multiphysics simulation, materials science, failure analysis, and material modeling and testing, often applied to nonlinear, coupled problems, so that our clients can deliver the best products to their customers. We help clients around the world optimize product design, improve manufacturing processes, and diagnose product problems. Our methods are based on technical fundamentals – employing grounded knowledge of mechanics, physics, chemistry, material science, electricity and magnetism, and manufacturing to produce practical, useful results. Our consultants' backgrounds encompass industrial experience, research, teaching for some of the world’s best engineering schools, and publishing.

    At Veryst, we work to understand your needs, uses, purposes, and goals before proposing a solution or embarking on a program. We won’t just answer your questions—we help you solve your problems.



    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


    Noble

    Exhibitors
    https://www.gonoble.com/

    Noble and Metaphase an Aptar pharma company, provide expertise and the “voice of the patient” in product design, user-experience research, human factors, along with tailored training & on-boarding solutions to help our clients Ideate, Validate, and Educate throughout the product development process. In addition, Noble manufactures and commercializes training devices. These devices mimic the exact feel, force, and function of drug delivery devices such as autoinjectors, prefilled syringes, onbody, nasal and pulmonary devices in order to increase patient adherence and confidence and decrease usage errors. Noble was founded in 1994 and is based in Orlando, Florida. For more information, visit www.gonoble.com.



    Owen Mumford

    Exhibitors
    http://www.owenmumford.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.

    For more information please visit https://www.ompharmaservices.com/


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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
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