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5th Annual Pre-Filled Syringes & Injectables Summit

  • 18th – 19th September 2019
  • Germany flag Germany Düsseldorf
  • Crowne Plaza Dusseldorf - Neuss Rheinallee 1, 41460 Neuss

The demand for efficient and convenient-to-use drug delivery devices and improving patient experience are key factors for the market growth advancing the technology.

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About

This event has been designed for industry leaders to disclose new horizons and developments in pre-filled syringes (PFS) and injectable devices. Attending this event will provide a broad overview of current and upcoming EU MDR regulatory requirements, innovative technologies, the impact of digitalisation, market trends and device needs. We will discuss the benefits of PFS and injection devices as the main factor for dosage accuracy, convenience and safe treatment for patients.

We are excited to be hosting the 5th edition of our Pre-Filled Syringes & Injectables Summit and look forward to meeting you in Düsseldorf in September!

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists, Chemists, and Engineers specialising in:

  • Bioprocess Research and Development
  • CMC
  • Container Development
  • Device Development & Manufacturing
  • Drug Delivery & Devices
  • Drug Packaging
  • Extractables & Leachables
  • Formulation Sciences
  • Injectables
  • Medical & Connected Devices
  • PFS
  • Regulatory Affairs
  • Risk Management
  • Standardisation science
  • Vaccines
  • Business Development
  • Combination Products
  • Controls and Robotics
  • Device Engineering & Design
  • Drug Development
  • External Supply
  • Fill/Finish
  • Human Factors
  • Materials Development
  • Parenterals
  • QA/QC
  • Research and Development
  • Stability
  • Sterile Products
  • Validation

Key Practical Learning Points

  • Overview of the upcoming EU MDR regulation, the role of notified bodies
  • The Impact of 21 CFR 4 on design control
  • Patient-Centric dosage form design
  • Digitalization
  • Integrating Quality Requirements
  • Implementation of novel technologies
  • Manufacturing of sterile injectable drugs
  • Analytical studies and chemical safety assessment

Bastiaan De Leeuw, NL

Head of Business Development

Cambridge Design Partnership

Bastiaan De Leeuw has been active in the field of drug delivery for the last 20 years. He has led projects covering dry-powder formulation development, inhaler design and development, and auto-injector design and development, as well as the associated stages of clinical and regulatory evaluations. In addition, he led the initial clinical evaluation of urologic diagnostic tests at NovioGendix (now MDxHealth) and has worked at Focus Inhalation, Akela Pharma, Oval Medical, and Bespak. Bastiaan has a degree in biopharmaceutical sciences, focussing on polymeric drug delivery systems for the formulation of proteins and peptides. His research combined pharmaceutical technology and pharmacology in industry-sponsored projects. 

Jakob Lange, CH

Senior Director, Delivery Systems

Ypsomed AG

Jakob Lange is an engineer and materials scientist by training with a master’s degree in chemical engineering from the Royal Institute of Technology in Stockholm, Sweden, and a PhD in polymer science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 30 peer-reviewed papers on medical devices, packaging materials and polymers, and is a regular contributor to technical and scientific conferences. Jakob started his professional career as a research scientist in packaging R&D with Nestlé at the Nestlé Research Centre in Lausanne, Switzerland. He then worked in R&D management with GE Healthcare Biosciences in Uppsala, Sweden, before joining Ypsomed in Burgdorf in 2006. With Ypsomed he has held different positions within marketing and sales as well as in R&D project management. Currently he is a senior director of delivery systems, overseeing two teams of product managers, one managing Ypsomed’s autoinjector platforms and the other focussing on customer relationships for device development projects and marketed device products.

Tiffany Kay McIntire, DE

Principal Human Factors Engineer

Roche

Tiffany McIntire has been working as a human factors engineer for five years, developing delivery systems and labelling strategies in the pharmaceutical industry. After her studies in industrial/organisational psychology, she started her career at Lilly, where she worked on a range of combination products, including dial-and-dose injectors for insulin, autoinjectors, pre-filled syringes, digital products and an emergency inhalation device. After working at Lilly, she jumped across the pond to Germany, joining a recently established device group within Boehringer Ingelheim. While there, she worked to deepen the team's knowledge of HF and improve their quality management system and vendor management. At the beginning of August, she joined the Roche HF team in Basel, Switzerland, to work with the team there, generating external, scientific publications as well as guiding the team towards best practices in HF.

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek

Tino Otte joined Intertek (Switzerland) AG in 2016 as a senior scientific consultant specialising in extractables/leachables analysis and GMP testing. Before working at Intertek, he studied analytical and polymer chemistry in Leipzig and Halle (Germany). After earning his PhD at Darmstadt Technical University (Germany), he worked for different companies in the instrumental analysis and pharmaceutical services industry. Within Intertek Group, Tino is responsible mainly for projects related to trace analysis, drug and impurity characterisation, and polymer testing.

Francesco Malavasi, CH

Medical Device Quality Manager

Novartis 

Francesco Malavasi brings over 10 years of medical device and combination products industry experience and knowledge in different business areas for development and commercialisation. Currently, he is medical device quality risk manager at Novartis BTDM, covering product, processes and risk-related activities for combination product and medical devices. He has an aeronautical background but is currently pursuing a degree in management engineering.

Dr. Thomas Schoenknecht, CH

Head of Research & Development Drug Product Services

Lonza AG

Thomas Schoenknecht, PhD, is the current head of R&D and drug product services at Lonza. In this role, Thomas will provide ownership for the innovation strategy, overview and tracking for current and future Lonza DPS R&D activities, liaise with external collaborations for R&D related to parenteral drug delivery and support the development of intellectual property and commercialisation of DPS-related innovations. With more than 16 years of senior leadership experience across the pharmaceutical industry, Thomas has worked in both technical and commercial functions with a proven track-record of establishing new profitable business segments. Prior to Lonza, Thomas held positions at SHL Group AB (Sweden), Schott Pharmaceutical Packaging (Mainz, Germany), Amgen Inc (Thousand Oaks, CA USA), Gerresheimer Bünde GmbH (Bünde, Germany) and Evotec Biosystems AG (Hamburg, Germany). He is a frequent speaker, moderator and chairperson on global events featuring science, technology, innovation and application in parenteral drug development and drug delivery. Thomas studied chemistry and holds a diploma and PhD in biophysical chemistry from the Max-Planck-Institute (MPI) for biophysical chemistry (Göttingen, Germany), performed post-doctoral studies at Karolinska Institute (Stockholm, Sweden), Institute for Molecular Biotechnology (Jena, Germany) and the MPI (Göttingen, Germany).

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Mark A. Chipperfield spent 20 years working within large pharma (GSK, Sanofi Aventis, Novartis, Roche) in the field of drug delivery devices and special purpose packaging. Throughout his career, he has been heavily involved in the development of combination products in several forms: solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, pen-injectors, auto-injectors, dispensers and special purpose applicators. Since 2015, he has been an independent consultant supporting pharma companies, suppliers and device innovators across the globe to develop, launch, and maintain their products.

Dr. Silke Conrad, CH

Quality Expert for Medical Devices

Novartis Pharma AG

Silke Conrad is currently quality expert for medical devices at Novartis Pharma AG. In her current role, she mainly supports medical devices and combination products from a QA perspective, negotiates and approves QA agreements and establishes and maintains QA processes for medical device development. Silke joined Novartis in 2011 as regulatory CMC associate director for biologics from the medical devices company Ypsomed AG/Switzerland, where she was leading the regulatory affairs department. Prior to Ypsomed AG, Silke worked for Sanofi-Aventis in Frankfurt, Germany, and Holmes Chapel, UK, holding different positions in regulatory affairs and quality assurance with main focus on biotech/biological products and combination products. Silke is a food chemist/environmental toxicologist from education and holds a doctorate degree in molecular biology/cancer research from the Technical University of Kaiserslautern, Germany.

Mark Guarraia, DK

Head of Design, User Experience & Prototypes; Device Research, Device R&D

Novo Nordisk

Mark Guarraia leads the design and user experience teams at Novo Nordisk, where the focus is on innovative drug delivery devices and connected systems. His team is committed to creating thoughtful and holistic user experiences that truly enhance patients’ lives. Prior to joining Novo Nordisk in 2018, Mark was creative director of digital health at Teva Pharmaceuticals in Cambridge, MA, and before that the design director at Ximedica, a full-service design and development consultancy. In addition to his role at Novo Nordisk, Mark is an adjunct professor at both the Rhode Island School of Design (RISD) and the Massachusetts College of Art and Design (MassArt), where his courses focus on the intersection of design and business. Originally from New England, Mark is now enjoying his time in Denmark and spending weekends exploring his new surroundings.

Tom Lawrie-Fussey, UK

Head of Digital Health

Cambridge Design Partnership

Tom Lawrie-Fussey is a digital services specialist at technology and product design firm Cambridge Design Partnership. He is a chartered engineer with a master’s degree and has more than 15 years’ product development experience. Tom works across multiple industry sectors, primarily focussed on drug delivery, consumer health and FMCG clients, where he drives various digital initiatives to help guide clients along their own digital roadmap. He specialises in digital implementation, linking device development with communications and data analytics platforms. Tom provides a technology-agnostic, pragmatic approach that is human-centred – unlocking benefits for all stakeholders and, ultimately, generating new revenue streams.

Cedric Gysel, CH

Manager, Health Care Solutions Design

Johnson & Johnson

Cedric Gysel is a healthcare solutions manager for Johnson  &Johnson Design, driving human-centred solutions for patients and customers of Janssen. He has more than 12 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science in Bern and Stanford University with a specialisation in human-centred design.

Lothar Habel, BE

Study Director, Extractables & Leachables

Nelson Labs Europe

Lothar Habel is working as a study director for extractables and leachables projects at Nelson Labs Europe with a strong focus on parenterals and injectable applica­tions. After his PhD graduation in organic chemistry at the University of Frankfurt am Main (Germany), he spent several years with research projects at universities and private companies in Germany and Belgium, where he gained experience in preparative and analytical organic chemistry. Lothar has a high reputation and expertise in the field of E&L.

Camilla Damgaard-Sørensen, DK

Senior Design Lead

Novo Nordisk

Camilla Damgaard-Sørensen is a senior design lead with Novo Nordisk Device R&D, where she leads the design of digital and physical user experiences for next genera­tion medical devices. Camilla worked for a number of years as a hands-on designer, design manager and usability engineer, and she has also been pivotal in bringing de­sign thinking to Novo Nordisk Device R&D. Camilla now plays a vital role in the digital transformation of the future device portfolio. She believes in the power of design and that while medical device projects by nature are wicked and complex – the solution can never be.

Thorben Hammerich, CH

Verification Engineer

Roche

Thorben joined Roche Device and Packaging Development in October 2012 as a Veri­fication Engineer. In his current role, he mainly works on the development and valida­tion of test methods for design verification activities of drug delivery device combina­tion products. He has more than 10 years of experience in different medical device industries mainly in R&D. Thorben holds a diploma degree in Biomedical Engineering from the University of Applied Sciences in Lübeck, Germany.

Bastiaan De Leeuw, NL

Head of Business Development

Cambridge Design Partnership

Jakob Lange, CH

Senior Director, Delivery Systems

Ypsomed AG

Tiffany Kay McIntire, DE

Principal Human Factors Engineer

Roche

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek

Francesco Malavasi, CH

Medical Device Quality Manager

Novartis 

Dr. Thomas Schoenknecht, CH

Head of Research & Development Drug Product Services

Lonza AG

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Dr. Silke Conrad, CH

Quality Expert for Medical Devices

Novartis Pharma AG

Mark Guarraia, DK

Head of Design, User Experience & Prototypes; Device Research, Device R&D

Novo Nordisk

Tom Lawrie-Fussey, UK

Head of Digital Health

Cambridge Design Partnership

Cedric Gysel, CH

Manager, Health Care Solutions Design

Johnson & Johnson

Lothar Habel, BE

Study Director, Extractables & Leachables

Nelson Labs Europe

Camilla Damgaard-Sørensen, DK

Senior Design Lead

Novo Nordisk

Thorben Hammerich, CH

Verification Engineer

Roche