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2019 UPS

2019 The Universe of Pre-filled Syringes and Injection Devices

Oct 22 - Oct 23, 2019
Gothenburg, Sweden

Advancing Drug Delivery Systems to Improve Patients’ Lives

  • Conference
  • Europe

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Program Highlights

Dear Colleagues,

The Parenteral Drug Association warmly invites you to come and be part of this year’s Universe of Pre-filled Syringes and Injection Devices, for the first time in Sweden!

Since its first edition in 2004, the conference has become a fixture in the calendar for the pharmaceutical industry, and a must-attend event for everyone working in the fields related to biopharmaceutical and parenteral drug delivery and device development.

For its 16th year, the European event ventures out to the north of Europe to Gothenburg, Sweden. This amazing city is located at a key strategic location where river meets the sea. With its Dutch heritage, Gothenburg perfectly combines tradition and innovation, offering an overwhelming cultural diversity of the arts and the sciences.

Geographically situated in the center of Scandinavia with the largest port of that region, traditionally, trade, manufacturing, and industry have been the main contributors to the city’s wealth.

This signature PDA event will expose you to the vast net of the PDA family, a culturally and scientifically diverse melting pot. Coming to Gothenburg will offer you close to unlimited potential for identifying new business partners, meet fellow professionals, connect with international colleagues, and simply make new friends!

PDA has made every effort to create yet another impressive opportunity for you to gain access to key decision makers in the pharmaceutical industry. Meet government representatives, service providers, biopharmaceutical and device manufacturers from all over the world this fall!

Join us in Gothenburg and be part of the world’s largest event on this subject.

Sincerely,

the Co-Chairs,

Mathias Romacker, Pfizer, Chair
Thomas Schoenknecht, LONZA, Chair

Overview

Scientific Program Planning Committee

Thomas Schoenknecht, LONZA, Chair
Mathias Romacker,
Pfizer, Chair
Frank Bamberg,
CSL-Behring
Theresa Bankston,
BD
Markus Bauss,
SHL Group
Sherri Biondi,
AstraZeneca
Nicolas Brandes, West
William Dierick,
Terumo
Olivia Henderson,
Amgen
Laurent Jeanmart,
GSK
Philippe Lauwers,
Terumo
Hanns-Christian Mahler, 
LONZA
Manfred Maeder,
Novartis
Alessandro Morandotti,
OMPI Stevanato Group
Brigitte Reutter-Härle,
Vetter
Thomas Seiffer,
Bausch + Ströbel
Ian Thompson,
Ypsomed
Karthik Vaideeswaran,
Eli Lilly
Falk Klar,
PDA Europe
Sylvia Becker,
Senior Programs & Events PDA Europe

Agenda

  • Day 1
  • Day 2
  • Tuesday, 22 October 2019

    9:00 – 9:30
    Welcome and Introduction
    PDA Awards

    Falk Klar, PDA Europe
    Thomas Schoenknecht, LONZA, Conference Chair
    Mathias Romacker, Pfizer, Conference Chair

    9:30 - 13:00
    Opening Plenary
    Moderators:
    Thomas Schoenknecht,
    LONZA
    Mathias Romacker, Pfizer

    The opening session of this year’s conference will feature a line-up of five senior speakers coming from industry, an NGO, and the European Medicines Agency! They join this event to present diverse experiences on digital and combination devices as well as the recent regulation pertaining to these modalities.
    The perspective of an NGO operating in low-income countries as well as insights into device development and life cycle management will be covered before opening the floor to a panel discussion and Q&A.

    KEYNOTE PRESENTATIONS: Regulatory & Technology Highlights

    9:30 - 9:55
    Digital Health: Design for the Behavior You Would Like to See
    Julia Häring, Novo Nordisk

    9:55 - 10:20
    Drug-Device Combinations in the EU: An Update
    Pascal Venneugues, European Medicines Agency

    10:20 - 10:45
    Challenges and Opportunities of Developing a Self-Injectable Platform for Global Health Applications
    Dennis Lee, Gates Foundation
    Robin Hwang, ICP Consulting

    10:45 - 11:30
    Coffee Break, Poster Session & Exhibition

    11:30 - 11:55
    Delivery Device Development in Midst of an Evolving Landscape of Novel Drug Modalities, Patient Centered Design and Digital Health
    Andrew Ratz, Eli Lilly

    11:55 - 12:20
    Life-Cycle Management of Combination Products
    Juan C. Kuang, Amgen

    12:20 - 13:00
    Panel Discussion, Q&A

    13:00 - 14:30
    Lunch Break, Poster Session & Exhibition 

    Transition to Three Parallel Tracks

    14:30 - 16:00
    Session 1A: Human Factors
    Moderator: Sherri Biondi, AstraZeneca

    This year’s human factors session will showcase a diversity of topics that represent areas of development ambiguity for manufacturers. These will range from device design considerations to development strategies that help effectively meet regulatory expectations.

    14:30 - 14:50
    Larger Injection Volumes, Longer Injection Times – Where are the Users' Limits with Handheld Devices?
    Jakob Lange, Ypsomed

    14:50 - 15:10
    Human Factors Perspectives on Leveraging a Platform Technology
    Nicholas Stones,
    Novartis

    15:10 - 15:30 
    Bringing Patient Experience to Life: Building Patient Centricity Broadly
    Marty Coyne,
    Matchstick
    Sherri Biondi, AstraZeneca

    15:30 - 16:00
    Q&A, Discussion

    14:30 - 16:00
    Session 1B: Polymer Containers
    Moderator: William Dierick, Terumo

    The application of polymer containers for Parenterals is gaining more traction in the global market where the interest is growing, specifically for biotherapeutics.
    More insight will be presented during this session with case studies and commercial applications, material compatibility research and processing techniques in fill & finish operations.

    14:30 - 14:50
    Business Case and Journey of Launching a Biosimilar in a Polymer Prefilled Syringe in the International Market
    Yoshifumi Torii, Fujifilm Kyowa Kirin Biologics Co.

    14:50 - 15:10
    Polymer Prefilled Syringes and Cartridges - Process Technology Development and Handling Aspects for Successful Fill-And-Finish
    Philipp Hoerner, Bausch+Stroebel

    15:10 - 15:30
    Excipients Effects on Functionality of Glass and Polymer Based Pre-filled Syringes
    Liang Fang, WEST

    15:30 - 16:00
    Q&A, Discussion

    14:30 - 16:00
    Session 1C: Regulatory Perspectives
    Moderator: Olivia Henderson, Amgen

    Article 117 an its impact on marketing authorization applications for drug-device-combinations has left many areas of uncertainty for the applicant. Who are the notifies bodies? How are their opinions communicated?
    How are changes to the combination products to be evaluated? All these questions will be addressed in this session.

    14:30 - 14:50
    An Opportunity to Leverage the Medical Devices Regulation (MDR) Whilst Supporting a Broad Innovative Portfolio in Pharma
    Daniel Latham, Novartis
    Mark Chipperfield, Corvus Device

    14:50 - 15:10
    Impact of MDR Article 117 on Marketing Authorization Applications for Pre-filled Syringes
    Stephanie Horn, F. Hoffmann-La Roche

    15:10 - 15:30
    MDR Article 117: Notified Body Opinion Interpretation and Implementation
    Blake Green, Amgen

    15:30 - 16:00
    Q&A, Discussion

    16:00 - 16:45
    Coffee Break, Poster Session & Exhibition

    Transition to Three Parallel Tracks

    16:45 - 18:00
    Session 2A: Large Volume Injection
    Moderator: Ian Thompson, Ypsomed

    The large number of injectable biologics and therapies, particularly for subcutaneous delivery, is driving the demand for injection volumes above 2ml requiring the use of large volume patch-injectors. The session focuses on the challenges of performing large volume subcutaneous injections, and the demands that are put on the drug container and delivery devices that are key to the success of this new combination product category.

    16:45 - 17:05
    MRI Clinical Imaging of Human Subcutaneous Injections Up to 10ml in the Abdomen, Thigh and Arm
    Wendy D. Woodley, Becton Dickinson

    17:05 - 17:25
    Evaluating Formulation and Device Factors on Subcutaneous Administration
    Rhea Sirkar, Eli Lilly

    17:25 - 17:45
    Evolving Component Technologies to Meet the Needs of Cartridge Delivery Applications
    Simon Côté, WEST

    17:45 - 18:00
    Q&A, Discussion

    16:45 - 18:00
    Session 2B: Manufacturing and Processing Technologies
    Moderators:
    Laurent Jeanmart,
    GSK
    Hanns-Christian Mahler,
    LONZA

    As we see an increasing trend towards personalization and customization of therapies and devices, we face a distinct set of challenges in the design, validation, and operation of manufacturing technologies and assets.
    In this session, our speakers will describe how novel technologies lead the way in tackling some of these challenges.

    16:45 - 17:05
    Innovations in Manufacturing of Elastomeric Components for Parenteral Packaging Applications
    Rahul Thakar, Datwyler Sealing Solutions

    17:05 - 17:25
    Augmented Reality for Preventive Maintenance
    Michael Pratz, Bausch & Stroebel

    17:25 - 17:45
    Vision Robot Unit (VRU)
    Michael Betz, F. Hoffmann-La Roche
    Andrea Sardella, Stevanato Group

    17:45 - 18:00
    Q&A, Discussion

    16:45 - 18:00
    Session 2C: Novel Therapeutics
    Moderator: Manfred Maeder, Novartis

    During this session, we will gain insight into processes, new materials, and modified primary containers, which become necessary for new modalities such as biologics, new ophthalmic treatments, and cell and gene therapy.

    16:45 - 17:05
    Design Considerations Pertaining to Primary Container Used for Cell Therapy Products
    Min Wei, AstraZeneca

    17:05 - 17:25
    A Science-Based Recommendation of Elastomer Components for Biologic Drugs
    Cathy Zhao, WEST

    Challenges & Device Opportunities with Microliter Dose Delivery Using Standard Pre-fillable Syringes: A Case Study
    Gautam Shetty, Congruence Medical
    Kedar Datar, Boehringer Ingelheim

    17:45 - 18:00
    Q&A, Discussion

    18:00
    End of Day 1 & Networking Event





  • Wednesday, 23 October 2019

    9:00 - 10:45
    Morning Plenary
    Moderator: Mathias Romacker, Pfizer

    The plenary session will kick-off with a patient sharing his experience of entering into the digital age of self-therapy. The following two presentations will then discuss the value proposition of device technology and the evolving payers’ perspective. Industry will share the benefits of injection device innovation before we delve deeper into discussing partnership opportunities to enhance digital innovation in the device space.

    KEYNOTE PRESENTATIONS: Patient & Payers Perspectives

    9:00 - 9:25
    Patient Perspective of Managing Type 1 Diabetes in the Digital Age
    Johan Ahström, Patient Speaker

    9:25 - 9:50
    The Evolving Payer Perspective on Injection Treatment Devices: Balancing Costs, Convenience, Outcomes and More
    Robert S. Epstein, Epstein Health

    9:50 - 10:15
    Unsolved Mystery:
    How to Get Payers to Reward Injection Device Innovation Every Time

    John Alter, Pfizer

    10:15 - 10:45
    Panel Discussion:
    Partnering with Payers and Health Systems to Support Digital Innovation in Drug Delivery Devices

    Moderator: Max Cambras, LEK

    10:45 - 11:30
    Coffee Break, Poster Session & Exhibition

    Transition to Three Parallel Tracks

    11:30 - 13:00
    Session 3A: Digital Health & Connected Devices
    Moderator: Markus Bauss, SHL-Connect

    The presentations in this session will provide insights into the development of connected medical device systems comprised of hardware & software.
    To meet the patients’ expectations, behavior design will be introduced as a method to support the development of digital solutions that improve patient engagement & medication adherence.

    11:30 - 11:50
    Digital Health Application Development Within a Pharmaceutical Culture
    Gareth Hilton, AstraZeneca

    11:50 - 12:10
    A Behavioural Design Approach to Digital Health Solutions
    Geraint Davies, F. Hoffmann-La Roche

    12:10 - 12:30
    To Connect or Not to Connect: When Should A Parenteral Device Go Connected?
    Paul Greenhalgh, TeamConsulting

    12:30 - 13:00
    Q&A, Discussion

    11:30 - 13:00 
    Session 3B: Manufacturing and Processing Technologies
    Moderators:
    Theresa Bankston,
    BD
    Philippe Lauwers Terumo

    The healthcare industry continues to balance bringing innovative therapies to the patient with reducing or controlling the total cost of care.
    In this session, we will discover how deploying new, more modular, flexible, and technologically advanced manufacturing approaches may help achieve this balance.

    11:30 - 11:50
    Case Study:
    Modular Scalability & Flexibility in Device Assembly - From Early Stage to Full Scale Production

    Jens Schou Christensen, Stevanato Group

    11:50 - 12:10
    Modularizing Assembly and Testing Equipment for Auto and Pen Injectors
    Gilbert Fluetsch & Lucy Chung, SHL Group

    12:10 - 12:30
    Seeing the Hidden: Detection and Mechanistic Tests of Leakage in Pre-filled Syringe During Storage by Neutron Radiography
    Jonas Fransson, Swedish Orphan Biovitrum

    12:30 - 13:00
    Q&A, Discussion

    11:30 - 13:00 
    Session 3C: Development Strategies
    Moderator: Brigitte Reutter-Haerle, Vetter Pharma

    Evolving markets demand new and improved delivery systems that limit risk and enhance speed to market while offering compelling disease management solutions. This session offers attendees the opportunity to see how device teams are rethinking designs for delivery systems that meet numerous end user and market needs while effectively managing time and resource constraints. Additionally, participants will learn how a new pen-injector designed for developing markets overcame numerous challenges with interesting consequences.

    11:30 - 11:50
    Collaboration to Enable a Simple, Reliable Device Suitable for Self-Administration in Early Clinical Studies Through to Commercialization
    Nicolas Bralet, Becton Dickinson
    Peter Krulevitch, Janssen J&J

    11:50 - 12:10
    Creating a Parenteral Drug Delivery Device for Developing Markets – The Story of Allstar®
    Rob Veasey, DCA Design International
    Stefan Bohling, Sanofi Aventis

    12:10 - 12:30
    Connected Therapeutics Combine Smart Devices, Software and Services to Transform Drugs Into Disease Management Solutions
    Alexander Dahmani, QuiO Technologies

    12:30 - 13:00
    Q&A, Discussion

    13:00 - 14:20
    Lunch Break, Poster Session & Exhibition

    14:20 - 16:30
    Closing Plenary - Keynotes
    Moderators:
    Thomas Schoenknecht, LONZA
    Mathias Romacker, Pfizer

    The conference will be closed by keynote presentations featuring the importance of the delivery device for patient accessibility of a given drug formulation. The significance of reliable and robust test methods to ensure patient safety and regulatory compliance of the selected drug delivery device will also be covered. The session will include a conference summary provided by the conference chairs.

    14:20 - 14:45
    Formulation and Device Lifecycle Management – The Role of Drug Delivery Devices in Improving Access to Medicines
    Beate Bittner, F. Hoffmann-La Roche

    14:45 - 15:10
    Holistic Integration of Device Development: Key Interfaces
    Roman Mathaes
    , LONZA

    15:10 - 15:40
    Coffee Break, Poster Session & Exhibition

    15:40 - 16:10
    Closing Panel Discussion, Q&A
    Advancing Drug Delivery Systems to Improve Patients’ Lives

    16:10 - 16:30
    Conference Summary by the 2019 Co-Chairs
    Thomas Schoenknecht, LONZA
    Mathias Romacker, Pfizer

    16:30
    Closing Comments & Farewell
    Falk Klar, PDA Europe





Highlighted Speakers

Johan Ahstrom
Johan Ahstrom
Patient Speaker
John Alter
John Alter
Pfizer
Beate Bittner
Beate Bittner
F. Hoffmann - La Roche
Robert S. Epstein
Robert S. Epstein
Epstein Health
Julia Häring
Julia Häring
Novo Nordisk
Roman Mathaes
Roman Mathaes
LONZA
Andrew Ratz
Andrew Ratz
Eli Lilly & Co.
Yoshifumi Torii
Yoshifumi Torii
Fujifilm Kyowa Kirin Biologics Co., Ltd.

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

Got a Question? We have answers

Contact Us

Travel

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The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
  • Accommodations

    The Swedish Exhibition & Congress Centre Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg, Sweden


    Hotel Accommodation

    optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting the conference hotel.

    You can book your Hotel Accomodation here!

  • Amenities

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport – GOT
Airport Phone:
+46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.

Directions

Registration Fees

Early Registration
Registration Type Price by 25 August
Member €1.795
Non-member €2.095
Govern./Health Authority/Academic €800
Young Professional (Member) €800

All fees given in Euro, excluding VAT (25%)




































Regular Registration
Registration Type Price after 25 August
Member €1.995
Non-member €2.295
Govern./Health Authority/Academic €1.000
Young Professional (Member) €1.000

All fees given in Euro, excluding VAT (25%)




































* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

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