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Prefilled Syringes West Coast

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.

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
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
Miles Buroker

Miles Buroker

Human Factors Engineer, UserWise, Inc.
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.
Shrikar Tatapudi

Shrikar Tatapudi

Human Factors Engineer, UserWise, Inc.
Shruti Parikh

Shruti Parikh

Associate Director Product Development, Takeda Pharmaceuticals
Simone Marquardt

Simone Marquardt

Key account Manager Silicone Europe, Raumedic AG
Sriman Banerjee

Sriman Banerjee

Head of Packaging Development & CDE, Takeda Pharmaceutical Company Limited
Stephanie Smith

Stephanie Smith

Human Factors Engineer, Genentech
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.

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.

Miles Buroker

Human Factors Engineer, UserWise, Inc.
Miles Buroker

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

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.

Rachael Relph

Chief Sustainability Officer, My Green Lab
Rachael Relph

Rachael is the Chief Sustainability Officer at My Green Lab, a non-profit organization dedicated to building a culture of sustainability in science. Rachael partners with organizations around the world to build tools and resources that support laboratory sustainability and help accelerate the adoption of best practices. Through education, engagement programs, and certifications, Rachael and My Green Lab are inspiring and supporting scientists as they advance sustainability at the bench. Rachael has a PhD in chemistry from Yale University and led Design for Environment and Sustainability initiatives for Life Technologies and Thermo Fisher Scientific.

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 Led by Biophorum

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Session Led by Biophorum

Since its inception in 2004, BioPhorum has become the open and trusted environment where senior leaders of the biopharmaceutical industry come together to openly share and discuss the emerging trends and challenges facing their industry.
Growing from an end-user group in 2008, BioPhorum now comprises over 135 manufacturers and suppliers deploying their top 6000 leaders and subject matter experts to work in nine focused Phorums, articulating the industry’s technology roadmap, defining the supply partner practices of the future, and developing and adopting best practices in drug substance, fill finish, process development and manufacturing IT.

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.
 

Shrikar Tatapudi

Human Factors Engineer, UserWise, Inc.
Shrikar Tatapudi

Shrikar is a Human Factors Engineer and a project lead at UserWise. He is involved in designing human factors/UX research studies, study protocols, moderating study sessions, and assisting with human factors strategy. He is experienced in working on a diverse set of research problems ranging from ergonomic capability assessments to designing smart human-machine interfaces (HMIs). As a UserWise consultant, Shrikar brings his out-of-the-box thinking and a strong work ethic to further human-centered design efforts, making medical products safe and easy to use.

Shruti Parikh

Associate Director Product Development, Takeda Pharmaceuticals
Shruti Parikh

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

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

Stephanie Smith

Human Factors Engineer, Genentech
Stephanie Smith

Stephanie has over 7 years of experience working in the Medical Device/Biotechnology space and over 4 years specializing in Human Factors. Stephanie has bachelors degrees in Biomedical and Electrical engineering from Marquette University and an MSc from Queen Mary University in London in Biomedical engineering. Stephanie has experience in conducting ethnography, formative and validation studies, and providing user requirements. Stephanie is also familiar with the Biodesign process and conducting ideation sessions.

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

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Michael Goehring

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

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9:10

Drug Delivery Device Overview

Michael Goehring

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

  • Applicable ISO standards and referenced UPS
  • Standard V Model from URS to PQ
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    9:50

    (Prefilled) Syringe Testing and Spring Simulation

    Michael Goehring

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

  • ISO 11040-4, -6, -8
  • “Live” performing a Break Loose / Glide Force Test
  • User influences and how to reduce or eliminate?
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    10:30

    Morning Coffee

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    11:00

    Autoinjector and Pen Injector Testing

    Michael Goehring

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

    • Pen Injectors – Manual Dose or Automated Dosing – ISO 11608-3
    • Autoinjectors - Full function tests – ISO 11608-5
    • Wearables – ISO 11608-6

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    11:40

    Regulatory Demands

    Michael Goehring

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

  • 21 CFR Part 11 – Traceability (When, Who, What, Why and Who is Responsible
  • Configuring Traceability and User Rights
  • DQ, IQ, OQ and PQ
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    12:20

    Closing Remarks

    Michael Goehring

    Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell

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    12:30

    Close of Workshop

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    8:00

    Registration & Coffee

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    9:00

    Chairs' Opening Remarks

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    9:10

    Postmarket safety reporting for combination products and injectable devices

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

  • 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
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    9:50

    Post Commercial Launch Device Change Considerations and Management for Combination Products

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

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

    Morning Coffee

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    11:00

    Silicone in medical application

    Simone Marquardt, Key account Manager Silicone Europe, Raumedic AG

  • 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
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    11:40

    Understanding the inconsistency in determining EPRs for injectable combination products

    Session Led by 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)
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    12:20

    Tackling high-volume administration challenges with a smart, sustainable on-body injector platform

    Cecile Gross, Global Category Manager for Parenteral Devices, Nemera

  • 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
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    13:00

    Networking Lunch

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    14:00

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

    Amin Sedighiamiri, Associate Director Device Development, AstraZeneca

  • 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
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    14:40

    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, Associate Director Device Development, AstraZeneca

    Natalie Abts, Head of Human Factors Engineering, Genentech

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

    Miles Buroker, Human Factors Engineer, UserWise, Inc.

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    15:20

    Afternoon Tea

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    15:50

    An Introduction to emerging technologies for injectable drug delivery

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

  • 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
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    16:30

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

    Megan Heft, Associate Director, Device Development, AstraZeneca

    Miles Buroker, Human Factors Engineer, UserWise, Inc.

    Stephanie Smith, Human Factors Engineer, Genentech

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    17:10

    Chairs' Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairs' Opening Remarks

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    9:10

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

    Rachel Poker, Human Factors Engineering Manager, AstraZeneca

  • 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.
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    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, Chief Commercial Officer, Credence Systems Corporation

    Patrick Gallagher, Head of Business Development, Schott AG

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    10:30

    Morning Coffee

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    11:00

    Incorporating Patient Centricity into Product Design

    Natalie Abts, Head of Human Factors Engineering, Genentech

  • 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
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    11:40

    A Glass Alternative: ZEONEX® and ZEONOR® Cyclo Olefin Polymer (COP) for Pre-Filled syringes

    Larry Atupem, Strategic Business Development Manager, Zeon Specialty Materials

  • 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
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    12:20

    Networking Lunch

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    13:20

    Assessing human factors testing and validation approaches for combination product platforms

    Tina Rees, Associate Director, Regeneron Pharmaceuticals Inc.

  • When can you use platform approaches?
  • Strategies to save time developing combination product platforms
  • Best practices on platform human factors validation protocol development
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    14:00

    Bridging Human Factors Data for Combination Products

    Shrikar Tatapudi, Human Factors Engineer, UserWise, Inc.

  • 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?
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    14:40

    Afternoon Tea

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    15:10

    An overview of sustainability and recycling on devices

    Shruti Parikh, Associate Director Product Development, Takeda Pharmaceuticals

  • 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
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    15:50

    A sustainable future for R&D, manufacturing, and operations in the life sciences

  • 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
  • Rachael Relph, Chief Sustainability Officer, My Green Lab

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    16:30

    Chairs' Closing Remarks and Close of Day Two


    Associate Director Device Development
    AstraZeneca
    Human Factors Engineering
    Genentech
    Global Category Manager for Parenteral Devices
    Nemera
    Executive Director, Regulatory Affairs - Device/Combination Products
    Allergan
    Chief Commercial Officer
    Credence Systems Corporation
    Vice President, Combination Product Quality
    Amgen Inc
    Sr. Engineer II, Technical Development
    Biogen
    Strategic Business Development Manager
    Zeon Specialty Materials
    Director, Combination Products and Device R&D
    Teva Pharmaceuticals
    Associate Director, Device Development
    AstraZeneca
    Human Factors Engineer
    UserWise, Inc.
    Head of Human Factors Engineering
    Genentech
    Head of Business Development
    Schott AG
    Chief Sustainability Officer
    My Green Lab
    Human Factors Engineering Manager
    AstraZeneca
    CEO
    UserWise, Inc.
    Human Factors Engineer
    UserWise, Inc.
    Associate Director Product Development
    Takeda Pharmaceuticals
    Key account Manager Silicone Europe
    Raumedic AG
    Head of Packaging Development & CDE
    Takeda Pharmaceutical Company Limited
    Human Factors Engineer
    Genentech
    Associate Director
    Regeneron Pharmaceuticals Inc.

    Sponsors

    Exhibitors

    Official Media Partner

    Workshops

    Testing of Drug Delivery Devices

    Testing of Drug Delivery Devices

    Hyatt Regency Mission Bay
    15 June 2022
    San Diego, USA

    Attendees Information 2022

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    Survey Results Infographic - State of the Industry 2022

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    Speaker Biographies

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    Conference Co-Chair Letter

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    Workshop Agenda

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    Pre-Filled Syringes West Coast 2022 Brochure

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    Past Presentation - Tina Rees, Regeneron

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    Past Attendees

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    Past Presentation - Sarah Mollo, FDA

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    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.



    Raumedic

    Sponsors
    http://www.raumedic.com

    RAUMEDIC serves Pharma / Biopharma / Cell and Gene Therapy - with first class tubing for fluid transfer and fluid handling applications.

    Benefit from Raumedic's 70+ years of experience as a single source tubing supplier - with an in-house materials department, in-house product development and tried and trusted manufacturing expertise at five different production sites in three countries.

    With Raumedic as your supplier, you can count on:

    Standards compliance and validation

    Biocompatibility

    Low extractable values

    Increased flow rates / Cell Growth yield

    Discover innovative tubing from Raumedic - In stock and ready to ship!

    • Standards compliance and validation

    • Biocompatibility

    • Low extractable values

    • Increased flow rates / Cell Growth yield

    • Platinum cured Silicone Tubing

    • Platinum cured Braided Silicone Tubing (high pressure)

    • Thermoplastic Elastomer Tubing (TPE)

    • Tubing sets - bespoke customer design



    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


    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.


    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


    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.


    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.


    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


    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


    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.


    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


    World Pharma News

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



    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

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

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




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