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SAE Media Group’s 6th Annual Conference
Pre-Filled Syringes West Coast
June 13 - 14, 2022 | San Diego, CA, USA
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SAE Media Group is delighted to announce the 6th annual Pre-Filled Syringes West Coast conference, to be held in San Diego. As part of SAE Media Group’s leading series of drug delivery device conferences, the 2022 event will provide insights into the rapidly accelerating market of combination product development with industry, device developer and regulatory perspectives.


This upcoming conference will assess the industry movement towards enabling self-administration through advanced user centric device design with case studies from AstraZeneca, Genentech and AbbVie exploring human factors approaches for injectable drug delivery systems. Innovations in on body injectors for large volume delivery and the use of connected features to aid user experience will be explored as part of two interactive panel discussions. Furthermore, industry experts will assess evolving approaches to lifecycle management for enhanced device development and discuss guidance for understanding essential performance requirements for combination products. As we look to the future, this year's conference will also delve into the evolution towards sustainable approaches for injectable device development through industry case study examples.

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.

We look forward to welcoming you to the conference in June.

  • Discover the latest advances in innovative device design for user-centric drug delivery
  • Assess evolving approaches to platforms for advanced combination product portfolios
  • Uncover the key considerations to ensure optimal lifecycle management for drug delivery devices
  • Explore how the industry is evolving with global developments including case studies of sustainable practices for drug delivery devices and the industry’s role in mass vaccination campaigns
  • Engage in interactive sessions reviewing the landscape of on-body injectors for large volume delivery and the role of connectivity for wearable devices

 

• Drug-delivery developers
• Medical Device Engineers
• Primary Packaging material designers
• Secondary packagers
• Smart device developers
• Training device developers
• Device-safety solution providers
• Drug developers

Previous attendees include:


 

 

Abbott Laboratories; AbbVie; Advanced Molding Technologies; Aegerion Pharmaceuticals; Ajinomoto Althea, Inc.; Allergan; Allergen Inc; Almac Group; Amgen; Antares Pharma; Aptar Pharma; AstraZeneca; Baxter Healthcare; BCM Group LLC; BioMarin; Boehringer Ingelheim; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Execution Metrics, Inc; Ferring Pharmaceuticals; Fresenius-Kabi; Genentech; Genentech, Inc.; Gilead Sciences; Glenmark Pharmaceuticals; Harro Hofliger Verpackungsmaschinen GmbH; Inovio Pharmaceuticals; iO Lifesciences; Ionis Pharmaceuticals; Ionis Pharmaceuticals, Inc.; Matchstick; MedImmune; MedImmune LLC; Medizap; Medtronic; Merck & Co.; Mitsubishi Gas Chemical Company, Inc; Nemera; Nipro PharmaPackaging; NOVO Engineering, Inc.; Novo Nordisk; Novo Nordisk A/S; One World DMG; Owen Mumford; Pfenex; Pfenex Inc; Pfizer CentreOne; RAUMEDIC INC; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Shire; Smithers Rapra; Steri-Tek; Stevanato Group S.p.A; Subcuject ApS; Suttons Creek Inc; Terumo Corporation; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; UserWise, Inc.; W. L. Gore & Associates, Inc.; West Pharmaceutical Services; West Pharmaceutical Services,; West Pharmaceuticals Services Inc; Worrell; Xeris Pharmaceuticals; ZebraSCI; zebrasci inc; ZEON CORPORATION; Zeon Specialty Materials ; Zeon Specialty Materials Inc
 

Conference programme

8:00 Registration & Coffee

9:00 Chairs' Opening Remarks

Natalie Abts

Natalie Abts, Head of Human Factors Engineering, Genentech
View Bio

Tina Rees

Tina Rees, Associate Director, Regeneron Pharmaceuticals Inc.
View Bio

9:10 Postmarket safety reporting for combination products and injectable devices

Khaudeja Bano

Khaudeja Bano, Vice President, Combination Product Quality, Amgen Inc
View Bio

  • How have we seen industry adapting to meet evolving regulations through effective compliance strategies
  • Current guidance for industry on postmarket 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
  • 9:50 Post Commercial Launch Device Change Considerations and Management for Combination Products

    Kristina Li

    Kristina Li, Sr. Engineer II, Technical Development, Biogen
    View Bio

  • Understanding and Evaluating Device-Related Changes
  • Design Control and Change Assessment per ISO 20069 Guidance
  • Vendor Communication and Collaboration
  • Regulatory Considerations and Strategies
  • 10:30 Morning Coffee

    11:00 Silicone in medical application

    Simone Marquardt

    Simone Marquardt, Key account Manager Silicone Europe, Raumedic AG
    View Bio

  • We would like to talk about a silicone material which we have developed which can be used in injection systems for applications which are very sensitive.
  • The trend of oral administration of medicine is increasingly being replaced by injection. In particular, we find that biopharmaceuticals and personalized medicine are growing above average.
  • RAUMEDIC has dealt intensively with these trends in recent years and created innovations that contribute to improving a safe and easy administration of drugs.
  • In particular in the area of syringe systems and components, we support various companies in development and manufacture. One of our innovations are our silicone syringe stoppers. These enable easier application and better dosage of the medication due to improved breakaway and gliding properties. We would like to talk about these and other innovations and introduce the new silicone stopper concept
  • 11:40 Understanding the inconsistency in determining EPRs for injectable combination products

    Session Reserved For Biophorum

    Session Reserved For Biophorum, ,

  • The industry does not have a consensus view on how to apply EPRs guidance
  • BioPhorum collaboration has brought together experts to share their experiences on applying EPRs to injectable combination products
  • The team had created a set of matrices that highlight the differences in opinion for several injectable devices (including PFS)
  • 12:20 Tackling high-volume administration challenges with a smart, sustainable on-body injector platform

    Cecile Gross

    Cecile Gross, Global Category Manager for Parenteral Devices, Nemera
    View Bio

  • Challenges facing modern drug delivery devices
  • Delivering large volumes at home in sustainable and user-friendly way
  • A differentiated approach in the wearables’ landscape: Nemera Symbioze platform
  • 13:00 Networking Lunch

    14:00 An Introduction to emerging technologies for injectable drug delivery

    James P. Wabby

    James P. Wabby, Executive Director, Regulatory Affairs - Device/Combination Products, Allergan
    View Bio

  • Reviewing the current landscape of emerging technologies to support injectable drug delivery
  • Assessing industry challenges in the emerging technology space
  • The growing need for effective injectable subcutaneous devices and digital apps for large volume and high viscosity drug products
  • 14:40 On body delivery and LVIs device design and development

  • Challenges in administration: how are we adapting device design to allow for increased volume and viscosity delivery
  • Improving acceptance rates: As we strive for self-administration, are we designing on body devices with the user in mind and how can we increase acceptance?
  • Designing on body delivery devices through collaborative design and testing 
  • Developing platforms for parenteral wearable device portfolios

     

  • James P. Wabby

    James P. Wabby, Executive Director, Regulatory Affairs - Device/Combination Products, Allergan
    View Bio

    Candice Lee

    Candice Lee, Human Factors Engineering, Genentech
    View Bio

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

    Megan Heft

    Megan Heft, Associate Director, Device Development, AstraZeneca
    View Bio

    15:20 Afternoon Tea

    15:50 Next generation subcutaneous injectables - Digital Applications and connected care for injectable devices and wearables

    Amin Sedighiamiri

    Amin Sedighiamiri, Associate Director Device Development, AstraZeneca
    View Bio

  • How have we seen digital and connected features being used for injectable devices and on body injectors
  • What benefits have we seen for the user from the introduction of connected features and how can we look to enhance connected features for injectables?
  • Considerations for the addition of connected features
  • Looking forward how can industry and device developers work to get the most out of connectivity for on body injectors
  • 16:30 Exploring the evolving landscape of connected features for injectable delivery devices

  • Perceived benefits of connected devices and what additional value being “connected” brings
  • Barriers to widespread adoption and use of connected drug delivery devices
  • Identifying connected features that provide beneficial user guidance and patient adherence
  • Ensuring data is being used productively to aid the treatment process and improve outcome
  • The future of connected devices. what we can expect to see
  • Amin Sedighiamiri

    Amin Sedighiamiri, Associate Director Device Development, AstraZeneca
    View Bio

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

    Mark DeStefano

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

    17:10 Chairs' Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairs' Opening Remarks

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    Tina Rees

    Tina Rees, Associate Director, Regeneron Pharmaceuticals Inc.
    View Bio

    9:10 The role of Human Factors for new product introduction and on market products

    Rachel Poker

    Rachel Poker, Human Factors Engineering Manager, AstraZeneca
    View Bio

  • The value of having a seamless connection between the HF data and expertise from development, use-related risk assessment, defect categories, information collected from complaints call centers, assessment of complaints, and periodic risk review / annual product quality review processes, as well as feeding back information into development of future similar products.
  • How human factors can contribute to the success of patient support programs to help ensure safe and effective use of the product and set the product up for success on the market.
  • The role of human factors for post-validation design changes.
  • 9:50 Introducing the next generation safety syringe with maximum usability and operational efficiency

  • Overview of existing challenges with legacy safety systems including: assembly inefficiency and associated waste, usage restrictions, premature system activation, and overall environmental footprint.
  • Introduction of the Credence-SCHOTT collaboration on Credence Companion® integrated safety with SCHOTT glass and polymer prefillable syringes. 
  • The Companion® system provides optimal freedom, with options in both glass and polymer, enablement of novel syringe and needle forms, and new functionalities such as dual-chamber reconstitution. 
  • Discussion of the value delivered to pharma and its end-users including user preference and product robustness data as well as environmental sustainability considerations.
  • John Merhige

    John Merhige, Chief Commercial Officer, Credence Systems Corporation
    View Bio

    Patrick Gallagher

    Patrick Gallagher, Head of Business Development, Schott AG
    View Bio

    10:30 Morning Coffee

    11:00 Incorporating Patient Centricity into Product Design

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

  • Consider both risk-based usability and user experience research in the development lifecycle
  • Patient-centric activities that can enhance product design 
  • Balancing user needs and preferences 
  • The impact of patient engagement on final designs
  • 11:40 A Glass Alternative: ZEONEX® and ZEONOR® Cyclo Olefin Polymer (COP) for Pre-Filled syringes

    Larry Atupem

    Larry Atupem, Strategic Business Development Manager, Zeon Specialty Materials
    View Bio

  • Key Benefits of COP for Medical Devices 
  • Case Study on Delamination: COP Syringe vs Glass Syringe 
  • Case Study on Protein Adsorption/Aggregation and its effect on Immunogenicity
  • 12:20 Networking Lunch

    13:20 Assessing human factors testing and validation approaches for combination product platforms

    Tina Rees

    Tina Rees, Associate Director, Regeneron Pharmaceuticals Inc.
    View Bio

  • When can you use platform approaches?
  • Strategies to save time developing combination product platforms
  • Best practices on platform human factors validation protocol development
  • 14:00 Bridging Human Factors Data for Combination Products

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

  • What are some examples of successful bridging strategies for both new drugs and biosimilars/generics? 
  • What are Threshold Analyses and when are they sufficient?
  • Biosimilars and Generics: What happens if my drug delivery device has non-minor differences compared to its reference device?
  • 14:40 Afternoon Tea

    15:10 An overview of sustainability and recycling on devices

    Sriman Banerjee

    Sriman Banerjee, Head of Packaging Development & CDE, Takeda Pharmaceutical Company Limited
    View Bio

  • The current landscape and industry movement towards sustainable practices
  • Examples of current approaches and steps to introduce recycling to the device delivery industry
  • Challenges and barriers in recycling for drug delivery devices
  • An outlook to the coming years of sustainability in pharma and recycling for drug delivery devices
  • 15:50 A sustainable future for R&D, manufacturing, and operations in the life sciences

    Christina Greever

    Christina Greever, Sustainability Program Manager, My Green Lab
    View Bio

  • The scope of the laboratory sustainability movement and possibly entry points
  • Sustainability considerations and touch-points for development operations and R&D
  • The benefits of going green – cost savings, reduced environmental impact, case studies
  • How to transform sustainability engagement at your organization – teams, discussions, behavior change
  • 16:30 Chairs' Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Amin Sedighiamiri

    Amin Sedighiamiri

    Associate Director Device Development, AstraZeneca
    Candice Lee

    Candice Lee

    Human Factors Engineering, Genentech
    Cecile Gross

    Cecile Gross

    Global Category Manager for Parenteral Devices, Nemera
    Christina Greever

    Christina Greever

    Sustainability Program Manager, My Green Lab
    James P. Wabby

    James P. Wabby

    Executive Director, Regulatory Affairs - Device/Combination Products, Allergan
    John Merhige

    John Merhige

    Chief Commercial Officer, Credence Systems Corporation
    Khaudeja Bano

    Khaudeja Bano

    Vice President, Combination Product Quality, Amgen Inc
    Kristina Li

    Kristina Li

    Sr. Engineer II, Technical Development, Biogen
    Larry Atupem

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Mark DeStefano

    Mark DeStefano

    Director, Combination Products and Device R&D, Teva Pharmaceuticals
    Megan Heft

    Megan Heft

    Associate Director, Device Development, AstraZeneca
    Natalie Abts

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Patrick Gallagher

    Patrick Gallagher

    Head of Business Development, Schott AG
    Rachel Poker

    Rachel Poker

    Human Factors Engineering Manager, AstraZeneca
    Shannon Clark

    Shannon Clark

    CEO, UserWise, Inc.
    Simone Marquardt

    Simone Marquardt

    Key account Manager Silicone Europe, Raumedic AG
    Sriman Banerjee

    Sriman Banerjee

    Head of Packaging Development & CDE, Takeda Pharmaceutical Company Limited
    Tina Rees

    Tina Rees

    Associate Director, Regeneron Pharmaceuticals Inc.

    Amin Sedighiamiri

    Associate Director Device Development, AstraZeneca
    Amin Sedighiamiri

    Amin Sedighiamiri has a PhD in Mechanical Engineering with more than 12 years of technical leadership experience, including product innovation and commercialization across multiple industry segments, like medical device, combination product, automotive and water management in Europe and the US. Currently, he is Device Development Engineering Manager in Dosage Form Design and Development organization of AstraZeneca where he is leading combination product development as well as smart drug delivery device technology development projects.

    Before joining AstraZeneca, Amin worked as Sr. Engineer in Delivery, Device and Connected Solutions Organization of Eli Lilly and Company, where he led cross-functional teams of engineers to develop connected solutions for drug delivery devices.

    He is also Board Member and Technical Programming Committee Chair at Medical Plastics Division in Society of Plastics Engineers.
     

    Candice Lee

    Human Factors Engineering, Genentech
    Candice Lee

    Candice is a Human Factors Engineer at Genentech supporting medical and combination device development. Prior to Genentech, she worked at UserWise as a Human Factors specialist and at NASA Ames as a human factors researcher where her research focus was on human performance in spaceflight operations and digital tools. Candice has a background in architecture and industrial design which inspired her to pursue human factors.

    Candice holds a Master’s degree in Human Factors and a Bachelor’s degree in Psychology from San Jose State University.

    Cecile Gross

    Global Category Manager for Parenteral Devices, Nemera
    Cecile Gross

    Cécile Gross is Marketing Global Category Manager at Nemera, focusing on Parenteral Devices. She oversees the product portfolio strategy, development and life-cycle for safety system, pen injector and on-body injector platforms. She has an experience of more than two decades in the Medical Device Industry, marketing BtoB technological products and implementing product lifecycle management for various kinds of devices. Graduated in International Business, she completed her initial training with a master’s degree in Marketing and Management in the Healthcare Industry at IMIS Institute, Lyon France.

    Christina Greever

    Sustainability Program Manager, My Green Lab
    Christina Greever

    Christina is the Sustainability Program Manager for the nonprofit organization My Green Lab where she supports the My Green Lab Certification program, manages the International Laboratory Freezer Challenge, and provides subject matter expertise to the team.
    She has been in the laboratory sustainability movement for six years – first as part of the green labs program at the UC Boulder. Now she works to motivate behavior change for greater sustainability at the lab bench.
    Christina has held research positions in the fields of molecular biology, behavioral neuroscience, and wildlife conservation, and earned a bachelor’s degree in biology from Lewis & Clark College in Portland, Oregon.

    James P. Wabby

    Executive Director, Regulatory Affairs - Device/Combination Products, Allergan
    James P. Wabby

    Over 15 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas.

    Regularly provides Allergan therapeutic franchise units regulatory counsel to all aspects within the quality management system arena pertaining to medical devices and combination products regarding:

    • Regulatory Affairs – CMC Global Dossiers and Device Regulatory Strategy Registrations
    • MDR/IVDR – Person Responsible for Regulatory Compliance 
    • ISO 13485:2016/MDSAP
    • Product Development – Design Controls 
    • Risk Management
    • Human Factors Engineering
    • Acquisitions/Divestitures
    • Import/Export – U.S. Agent
    • CAPA
    • Production Controls
    • Regulatory Inspection Management
    • Materiovigilance 
    • Health-Care Related Laws and International Regulations

    John Merhige

    Chief Commercial Officer, Credence Systems Corporation
    John Merhige

    John A. Merhige is Chief Commercial Officer at Credence MedSystems, leading the Company's commercial activities and external collaborations. Previously, John was Vice President, Market Development at Sanofi. He came to Sanofi upon its acquisition of Pluromed, which John joined in its early stages and where he was a member of the executive management team leading the Company’s sales and marketing efforts. Prior to Pluromed, John founded Prelude Devices to target early-stage medical device technologies for development and commercialization.

    Khaudeja Bano

    Vice President, Combination Product Quality, Amgen Inc
    Khaudeja Bano

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

    She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

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

    Kristina Li

    Sr. Engineer II, Technical Development, Biogen
    Kristina Li

    Technical lead for life cycle management products at Biogen with 8+ years of medical device design and development experience

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Larry Atupem

    Larry Atupem is the Business Development Manager at Zeon Specialty materials with responsibility of Cyclic Olefin Polymer business in North America. He also assists with ZEON’s strategic interests in the region looking for new opportunities in the diagnostic space. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a Bachelor of Science degree in Chemical & Biological Engineering from Tufts University.

    Mark DeStefano

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

    Mr. Mark DeStefano is Director, Combination Products and Devices Research and Development for Teva Pharmaceuticals focusing on advanced technology identification and development for Teva pipeline combination products. He is an experienced Device Development Professional with a demonstrated 32 yr. history of product innovation, design, development, and launch in many areas of the medical device industry from surgical devices to drug delivery devices and is the inventor / co-inventor on many medical device patents. Mr. DeStefano has spent the last 23 years in drug delivery device development, including 12 years in the development of insulin pumps and infusion sets. Mr. DeStefano holds a Bachelor of Science in Mechanical Engineering from Drexel University.

    Megan Heft

    Associate Director, Device Development, AstraZeneca
    Megan Heft

    Megan Heft is Associate Director of Device Development at AstraZeneca, where she leads device teams in development of parenteral combination products for assets ranging from early to late stage, specializing in wearable injectors for large volume delivery. Megan has over twelve years of industry experience, with prior roles as device team lead in Combination Products R&D at Teva Pharmaceuticals and technical lead in Primary Container R&D at West Pharmaceutical Services. Megan holds a Master of Engineering in Biomedical Engineering from Cornell University and a Bachelor of Science in Biomedical Engineering from Bucknell University.

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Natalie Abts

    Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

    Patrick Gallagher

    Head of Business Development, Schott AG
    Patrick Gallagher

    Patrick Gallagher has over 10 years of experience in the pharmaceutical packaging industry and has worked in both technical and commercial customer-facing roles. In his career Patrick has sought to provide primary container solutions for elastomeric, glass, and high performance polymer containers ranging from vials to syringes, cartridges, and innovative products. Prior to his experience in pharmaceutical packaging, Patrick worked in Quality Assurance and Project Management roles in the environmental chemistry industry. Patrick has a BS in Biochemistry from Grove City College and a MS in Science and Religion from Biola University. In his current role Patrick is responsible for Business Development of SCHOTT’s Polymer Solutions platform globally.

    Rachel Poker

    Human Factors Engineering Manager, AstraZeneca
    Rachel Poker

    Rachel Poker is an Associate Director, Human Factors, at AstraZeneca, where she has responsibilities leading the incorporation of human factors and a patient- and user-centric mindset from early stage technology development to support for on market products for the biologics and parenteral portfolio.
    With 15 years in both device and drug-led combination products across a range of roles in R&D, her experience includes parenteral, inhalation, and ocular drug delivery devices, connected device technologies, and vascular intervention products.
    Rachel has a bachelors in Biomedical Engineering from the University of Minnesota and PMP certification from the Project Management Institute

    Session Reserved For Biophorum

    ,
    Session Reserved For Biophorum

    Shannon Clark

    CEO, UserWise, Inc.
    Shannon Clark

    Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

    Before founding UserWise in 2014, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

    Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.
     

    Simone Marquardt

    Key account Manager Silicone Europe, Raumedic AG
    Simone Marquardt

    Over 28 years’ experience in technical fields in various industries and market segments.
    Experienced application engineer in the field of silicone chemistry.
    Simone joined RAUMEDIC in 2017 as Business development manager silicone for Europe.
    Since January 2021, she has worked as a Key account manager silicone Europe to promote silicone in medical application.
    The field of medical technology is an important and growing sector of industry.
    Looking at trends and new market requirements where silicone could be a beneficial solution, supporting the whole development process – from the initial idea through to the end medical-technology product.

    Sriman Banerjee

    Head of Packaging Development & CDE, Takeda Pharmaceutical Company Limited
    Sriman Banerjee

    Sriman Banerjee has over 15 years experience in the field of Plastics & Packaging having worked with Reliance Industries , Marico & Johnson & Johnson. Currently he is working as Head of Packaging Development and Commercial Device Engineering at Takeda and prior to this he was Head of Packaging Development - Respiratory category at Glaxo Smithkline - Consumer Healthcare & co-based out of Switzerland & USA. Sriman is a Mechanical Engineer with a Masters in Packaging from Indian Institute of Packaging and a Post Graduate in Plastic Technology from Indian Plastic Institute. He has also a Masters in Financial Management from Mumbai University. He is a Certified Packaging Professional from IOPP, USA. He is also a Fellow of Indian Plastic Institute. Sriman has presented papers on Plastics technology & Packaging technology in National & International conferences organized by PackExpo, Pharmapack, American Packaging, International Corrugated Conference, PACE, Indian Plastics Institute, AIPMA, Indian Institute of Packaging, India Packaging Show, etc... He has published papers and written articles in South Asia Packaging, IPI Journal, Packaging India, ET Polymers. Etc… He is instrumental in developing many new technologies & applications like PP thermoforming, PP – ISBM, Random co-polymers, Ter-polymers, Spouted pouches, Frenel’s Lens cartons, Unidose packs, etc..… Under his leadership, GSK has been awarded several IndiaStar, Asia Star, Ameristar, WorldStar over the last 6 years & PlastIndia Sustainability award for Excellence in packaging

    Tina Rees

    Associate Director, Regeneron Pharmaceuticals Inc.
    Tina Rees

    Tina Rees is the Associate Director of Human Factors at Regeneron, where she leads a team of human factors engineers that manage all aspects of human factors integration across the development and commercialized platforms. Prior to Regeneron, she also led Human Factors at Ferring Pharmaceuticals and was a Principal Research Scientist in Human Factors at Eli Lilly. She has experience with a wide variety of combination products and medical devices and has participated in a number of submissions resulting in approval of combination products and clearance of medical devices. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN and was a Midwesterner until her move to the East Coast 5 years ago.

    Sponsors

    Exhibitors

    Official Media Partner

    Workshops

    Testing of Drug Delivery Devices
    Workshop

    Testing of Drug Delivery Devices

    Hyatt Regency Mission Bay
    15th June 2022
    San Diego, USA

    VENUE

    Hyatt Regency Mission Bay

    1441 Quivira Road, San Diego, California, USA

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    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 SAE Media Group. SAE Media 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

    Attendees Information 2022

    Download

    Survey Results Infographic - State of the Industry 2022

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    Speaker Biographies

    Download

    Conference Co-Chair Letter

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    Workshop Agenda

    Download

    Pre-Filled Syringes West Coast 2022 Brochure

    Download

    Past Presentation - Tina Rees, Regeneron

    Download

    Past Attendees

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    Past Presentation - Sarah Mollo, FDA

    Download

    Past Presentation - Aly McDonald, Genentech

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    Sponsors


    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.


    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.


    Nemera

    Sponsors
    http://www.nemera.net

    As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.

    Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions.



    Raumedic

    Sponsors
    http://www.raumedic.com

    Together with its customers, the medical technology company is breaking new ground to improve the diagnosis and treatment of diseases. In doing so, Raumedic focuses on polymer-based solutions for medical and pharmaceutical applications, as well as on products for intensive care. Raumedic has a global presence and a headcount of approximately 1,000. In its core markets of Europe and North America, the company manufactures using its own clean room production facilities.


    Schott

    Sponsors
    https://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.



    Zeon

    Sponsors
    http://www.zeonex.com

    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


    Boston Analytical

    Exhibitors
    http://www.bostonanalytical.com

    Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to Pharmaceutical, Biopharmaceutical and Medical Device companies worldwide including Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, Nitrosamines Testing and Extractables & Leachables Studies.



    Haselmeier

    Exhibitors
    http://

    Haselmeier, the drug delivery device business division 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 of 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 moulding 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, the 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 customers and help improve the health of millions of people worldwide.


    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/



    PHC

    Exhibitors
    http://www.phchd.com/global/

    PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences. With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life science and biotechnology applications across industries



    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


    pharmaphorum

    Official Media Partner
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    ASD MEDIA

    Official Media Partner
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    On Drug Delivery

    Official Media Partner
    http://www.ondrugdelivery.com/subscribe

    ONdrugDelivery provides 30,000 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: www.ondrugdelivery.com/subscribe.


    Gene Therapy Net

    Official Media Partner
    http://www.genetherapynet.com/

    Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines


    evvnt Ltd

    Official Media Partner
    http://www.evvnt.com

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    Technology Networks

    Official Media Partner
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharma Journalist

    Official Media Partner
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    IBI - International Biopharmaceutical Industry

    Official Media Partner
    http://www.biopharmaceuticalmedia.com

    IBI - International Biopharmaceutical Industry, provides the biopharmaceutical industry with comprehensive coverage of key scientific, technology, regulatory and business topics. The editorial mix of peer-reviewed papers, practical advice on managing bioprocessing and technology, regulatory and business columns, and expert commentary provides comprehensive coverage of upstream and downstream processing, manufacturing operations, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. The insight and analysis covers biologic – based therapies including We will report on emerging trends, strategies and best practices in the key areas.


    World Pharma News

    Official Media Partner
    http://www.worldpharmanews.com/



    Drug Discovery Today

    Official Media Partner
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.

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    Hyatt Regency Mission Bay

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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
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