The global pre-filled syringes market witnesses an exponential growth owing to the increasing prevalence of chronic diseases and the demand for self-administered drugs. Today's patient looks for simplicity, personalization and instant connectivity, when it comes to self-administered injections. In parallel, the evolution of biologic parenterals creates unique demands and challenges for the development of a custom drug delivery device. A fully integrated approach to drug device development, with its focus on patient needs in terms of ease of use and safety, becomes a strategic imperative.
The call for speakers is open now.
Please find below the tentative schedule. Speaking sessions will be grouped according to similar themes into blocks and published upon finalizing the agenda, so please check back!
08:30 Registration and Welcome Coffee
09:00 Opening Address from the Chairman
09:10 Understand what it really takes to bring a self-injection device to market.
Gemma Budd
Alliance Manager, Bespak Europe Ltd., Cambridge, United Kingdom
A first-hand look at how partnership plays a key role in successfully launching a combination product such as an auto injector. In addition, the speaker will highlight important trends as well as challenges such as:
09:50 Speed Networking
10:30 Pre-loaded / Pre-filled large volume injectors.
Harshal Shah
Vice President, Global Medical Technology Division, Cambridge Consultants, Boston, USA
11:10 Morning coffee and networking break
11:40 The impact of Medical Device Regulation (EU) 2017/745, Art.117.
Mark A. Chipperfield
Company Director and Principal Consultant, Corvus Device, Holmes Chapel, United Kingdom
12:20 Protein pharmaceuticals, handling challenges and the role of devices.
Dr. Reza Nejadnik
Laboratory Head – Formulation Development Biologics, Sanofi, Frankfurt Am Main, Germany
13:00 Business lunch
14:00 How to prevent needle clogging in PFS by selecting the right needle shield.
Dr. Kewei Yang
Scientist, Late-Stage Pharmaceutical and Process Development, Pharmaceutical Development & Supplies, PTD Biologics Europe (PTDE-P) F. Hoffmann-La Roche Ltd., Basel, Switzerland
14:40 Developing delivery systems comprising pre-filled syringes and injection devices.
Dr. Daniel Latham
Head of Device Development Operation, Global Drug Development, Novartis, Basel, Switzerland
15:20 Afternoon coffee and networking break
15:50 The benefit of using drug delivery device platform technology in modern biotechnology:
An effective way to shorten time to market
Dr. Thomas Schoenknecht
Executive Director Business Development, SHL Group, Berlin, Germany
16:30 Panel Discussion
17:00 Chairman’s closing remarks and end of day one
18:30 Business dinner
08:30 Registration and Welcome Coffee
09:00 Opening Address from the Chairman
09:10 Uncover User Needs that can Translate into Design Inputs.
Matthew Gottschalk
Director of Program Development EMEA, Research & Human Factors, Worrell, London, United Kingdom
Too often devices are developed with incomplete, biased or unvalidated user inputs—and fail to provide what was truly needed. Using various techniques, we can objectively generate user needs that could be translated into design inputs and get it right the first time. Throughout our talk, we will:
09:50 A human centered approach to delivery systems development.
Cedric Gysel
Senior Device Engineer Device Center of Excellence, Janssen, Zürich, Switzerland
10:30 Morning coffee and networking break
11:00 What is the best choice for your product? Glass or polymer PFS?
Anil Kumar Busimi
Senior Global Product Manager, SCHOTT Pharmaceutical Packaging, Winterthur, Switzerland
It’s a question we hear again and again. A question that has greater importance for pharmaceutical manufacturers as the popularity of prefilled syringes (PFSs) continues to rise and manufacturers must not only develop an effective drug, but a streamlined and safe drug delivery system. A question that shows how pharmaceutical packaging plays a significant role in drug success, even as choosing the “right” packaging material for a drug remains a hot area of debate.
The question is seemingly simple: Is glass or polymer the better material for PFSs? Each has its strengths and weaknesses after all. Ultimately, that is the wrong debate to be having. Before analyzing the benefits and drawbacks of each material, pharmaceutical manufacturers need to start by assessing the user need for each PFS application.
This presentation will discuss the following points:
11:40 Functional evaluation and characterization of polymer-based prefillable syringes designed for sensitive biopharmaceuticals.
Katsuyuki Takeuchi
Associate Product Manager, Terumo Pharmaceutical Solutions Terumo Europe, Belgium
12:20 Business lunch
13:20 Selection of rubber components for Pre-Filled Syringes
Dr. Simon Kervyn
Manager Materials and Surface Treatments, Datwyler, Namur, Belgium
14:00 Approaching the goal of zero particles in the production line: Daikyo’s D Sigma quality of elastomeric components.
Piotr K. Wagner
Senior Specialist, Product Management Daikyo Portfolio, West Pharmaceutical Services Deutschland GmbH & Co KG, Eschweiler, Germany
This presentation will provide a contribution to the topic of particles, which is one of today’s major challenges in the pharmaceutical industry. Goal of significantly reduced particulate contamination is achieved via:
The discussion will include various studies demonstrating vision inspection of major/critical dimensions leading to reduced variability; particle characterization of various lots; and effect of shipment on particle loads within the package. Additionally, the overall improvement and in-process control will be quantified and visualized on examples of enhanced CpK values of the elastomeric components.
14:40 Afternoon coffee and networking break
15:10 Characterization of Silicone Oil Distribution in Syringes & Correlation with critical Functional Parameters of a Pre-Filled Syringe.
15:50 Application of Quantitative 1H-NMR Spectroscopy for the determination of silicone oil and degradation products hereof.
Dr. Joan Malmstrøm
Principal Scientist, Novo Nordisk, Copenhagen, Denmark
16:30 Smart material selection for quiet, smooth-sliding medical devices including new color concept.
Dr. Kirsten Markgraf
Manager Product Development EM Europe, Celanese, Frankfurt Am Main, Germany
Wendy Johnson
Medical Marketing Manager, Celanese Engineered Materials, Celanese, Rotterdam, Netherlands
17:10 Chairman’s closing remarks and end of summit
To register to the summit as Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com
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Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.
