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4th Annual Pre-Filled Syringes & Injectables Summit

  • 20th – 21st September 2018
  • Netherlands flag Netherlands Amsterdam
  • Hotel NH Amsterdam Centre Stadhouderskade, 7 1054ES

We would like to welcome you to the 4th Annual Pre-Filled Syringes & Injectables Summit on September 20 - 21, 2018 in Amsterdam, Netherlands.

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About

This event provides the appropriate platform for industry leaders to discuss best practices as well as new developments in Pre-Filled Syringes (PFS) and injectable devices. The Summit will provide a broad overview of market trends and device needs, technologies and innovations, delivery aspects of parenteral drugs, and regulatory updates.

We will discuss the benefits of PFS and injection devices as a main factor for dosage accuracy, convenience and safe treatment for patients.

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

  • Current market developments, trends, and needs for Pre-Filled Syringes (PFS) and injection devices
  • Latest technical, quality, and regulatory considerations for injection devices
  • Combination products and auto-injectors: challenges and opportunities
  • Patient centric design: precision, convenience, and dosing accuracy
  • Increasing requirements for human-factors engineering
  • Clinical case studies
  • Next generation design and materials for PFS
  • Risk management background and the development
  • Commercial success of injectable devices

Bastiaan De Leeuw, NL

Head of Business Development

Cambridge Design Partnership

About Speaker

Ian Thompson, CH

Vice President Business Development, Delivery Systems med AG

Ypsomed AG

About Speaker

Francesco Malavasi, CH

Medical Device Quality Manager

Novartis 

About Speaker

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

About Speaker

Dr. Thomas Schönknecht, DE

Executive Director Business Development

SHL Group AB

About Speaker

Cedric Gysel, CH

Device Engineer and Technical Product Owner

Janssen

About Speaker

Didier Pertuy, FR

VP, Global Head of Drug/Device Integrated Development & Device

Sanofi

About Speaker

Chris Muenzer, CH

Senior Device Technology Manager

Novartis

About Speaker

Chi Yuen Liu, CH

Process Scientist Sterility Assurance Janssen Global Quality & Technical Operations Parenterals

Janssen

About Speaker

Davide Mercadante, CH

Senior Device Quality Engineer, Device Development Quality

Biogen

About Speaker

Shruthi Vidyasagar, UK

Device Development Technologist

GSK

About Speaker

Dr. Robert Hormes, CH

Head Packaging Technology Device Development & Commercialization

Novartis

About Speaker

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek

About Speaker

Klaus Ullherr, DE

Senior Product Manager

Robert Bosch Packaging Technology GmbH

About Speaker

Amit Khanna, UK

Application Project Manager, Team Lead

STERIS Corporation

About Speaker

Stephen Gilmore, UK

Engineering Director

Crux Product Design

About Speaker

David Phasey, UK

Senior Project Manager

3P innovation Limited

About Speaker

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. 

Ian Thompson, CH

Vice President Business Development, Delivery Systems med AG

Ypsomed AG

Ian Thompson has been with Ypsomed AG, formerly Disetronic AG, since 1995 in a number of roles, including key account management and business development working with pharma companies to develop and bring to market innovative self-injection systems. He studied biochemistry and biotechnology in the UK from 1979-83, working initially in commercial roles for fermentation technology. He has worked in medical device companies since moving to Switzerland in 1990. Since 2003, his main focus has been business development and new product innovation leading to the successful development and launch of a range of new pen and autoinjector custom products for Ypsomed Delivery Systems. Ypsomed Delivery Systems continues to focus on the development and manufacturing of next-generation pen, autoinjector, and wearable injector technologies.

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.

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. Thomas Schönknecht, DE

Executive Director Business Development

SHL Group AB

Thomas Schoenknecht has over 20 years’ experience in the pharmaceutical industry in various leading roles such as project management, research & development, and business development. Before joining SHL in 2013, Thomas was head of the global Key Account Organization at Schott Pharmaceutical Packing Division with a specific focus on new product developments addressing customer needs. Prior to Schott, Thomas worked at Amgen Inc California as director of Drug Product and Device Development, where he oversaw and managed Amgen’s global drug delivery container projects and interfaced Amgen’s drug delivery device platforms. Finally, previous to Amgen, Thomas headed up the Research & Development activities at Gerresheimer’s Pharmaceutical Packing Division and was leading the Product Management and Business Develop­ment activities of this division for sterile drug delivery solutions. Thomas has a Ph.D. in biophysical chemistry from the Max-Planck-Society and the University Goettingen, Germany and a master’s degree in chemistry from the University of Goettingen. He is a frequent speaker, moderator, and committee member at conferences regarding drug delivery and packing material science; Thomas was heading the PDA interest group for prefilled syringes and took over leadership for the new formed PDA combination prod­uct interest group. He is active as task force member within PDA regarding packaging material science and was being active as member in various DIN ISO committees re­garding primary packaging materials and drug delivery devices. Thomas Schönknecht is currently the executive director, Business Development at SHL Group, responsible for global business development, key account management and new technology evalua­tion within SHL’s Medical division.

Cedric Gysel, CH

Device Engineer and Technical Product Owner

Janssen

Cedric is a device engineer and technical product owner at Janssen (Pharmaceutical Companies of J&J). He holds a master’s in medical device technology with a specialisa­tion in human centred design from the University of Applied Science in Berne. After working for Novartis and Actelion in different research and development roles, he joined Janssen in 2005 where he has held different development and market support roles. He is also a guest lecturer at the Berne University of Applied Science and a member of the Human Centered Design Workgroup of Swiss Medtech.

Didier Pertuy, FR

VP, Global Head of Drug/Device Integrated Development & Device

Sanofi

Didier Pertuy is vice president of drug-device integrated development & device strategy at Sanofi. He joined Sanofi in 2007 as vice president of global pharmaceuti­cal sciences. Prior to joining Sanofi, he served in a number of senior management roles in new product development starting with 3 years at 3M Healthcare, then 10 years at E.MERCK, and finally 10 years at GSK. He has more than 30 years of experience in all aspects of pharmaceutical and biopharmaceutical drug product de­velopment activities including medical device development, ranging from research through development to final product commercialisation, and contributing to the development and launch of numerous new drugs including drug-device combina­tion products. He is an engineer and holds a master’s degree in biochemistry from the Applied Sciences Institute (INSA) of Lyon, France and an advanced degree in pharmacology-toxicology from the University of Sciences of Lyon, France.

Chris Muenzer, CH

Senior Device Technology Manager

Novartis

Chris Muenzer is a senior device technology manager at Novartis in Basel, Switzerland. He has almost 20 years of development experience focusing on drug delivery devices and has filed several patents in the field. At Novartis, he leads a team supporting in­jectable delivery systems for Novartis’ diverse portfolio of drugs. Mr. Muenzer holds a BSME from Carnegie Mellon University in Pittsburgh, Pennsylvania in the US.

Chi Yuen Liu, CH

Process Scientist Sterility Assurance Janssen Global Quality & Technical Operations Parenterals

Janssen

Chi Liu holds a degree in chemical engineering from the Rotterdam University of Ap­plied Sciences. In 2012, he started working for Janssen as a process scientist within the Technical Operations Parenterals Platform, Janssen Supply Chain and Global Qual­ity organization of Johnson & Johnson. Chi leads and supports cross regional and cross sector projects from a technology innovation perspective. Chi has provided technology support as subject matter expert for fill finish operations by setting up technology standards in the Parenterals Platform.

Davide Mercadante, CH

Senior Device Quality Engineer, Device Development Quality

Biogen

Davide Mercadante is a medical engineer with 10-plus years of experience within multiple areas of device and combination product development, including design and development, design quality assurance, verification and validation engineering, qual­ity control and supply chain quality. He received his bachelor’s and master’s degrees in medical engineering from the Second University of Rome, where his focus was on medical device design and development. Davide has a Lean Six Sigma Green Belt and he currently works at Biogen in the corporate quality device group where he is the quality project lead for both the risk management continuous improvements and combination product DHF 21 CFR Part 4 final rule enhancement projects. He has also been instrumental with the integration of software as a medical device into the exist­ing quality management system.

Shruthi Vidyasagar, UK

Device Development Technologist

GSK

Shruthi is a Device Lead at GSK (Ware, UK) managing late-stage parenteral projects. Prior to GSK, she worked at Pfizer in North Chicago on differentiated drug delivery systems. She has device development and regulatory experience across multiple platforms - combination products, electromechanical devices and consumable products.

Her recent focus has been on parenteral combination products- syringes, injectors, closed transfer devices, supporting all activities from development to launch.

Shruthi holds a BE in Electrical Engineering (VTU, India) and an MS in Biomedical Engineering (University of Michigan, Ann Arbor)

Dr. Robert Hormes, CH

Head Packaging Technology Device Development & Commercialization

Novartis

Robert is the group head packaging technology in device development and commer­cialization at Novartis Pharma. He holds a degree in biochemistry from the University of Bayreuth and a Ph.D. from the University Heidelberg, where he graduated in 1998. He joined Novartis in Basel in 2016. Prior to joining Novartis, he worked with SCHOTT Pharmaceutical Packaging where he served in several leading functions in product management and product development for sterile primary packaging products and technical customer support. He has 17 years of experience in packaging products and devices for pharmaceutical and biotech applications.

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.

Klaus Ullherr, DE

Senior Product Manager

Robert Bosch Packaging Technology GmbH

Klaus Ullherr, Senior Product Manager, has a degree in electrical engineering. After university he worked as a project manager in the electrical industry for several years. In March 2000, he joined Robert Bosch GmbH, Packaging Technology, Product Divi­sion Pharma Liquid. During the first two years, he was project manager responsible for handling complex customer orders. Since 2002, he is product manager for the business fields syringes and filling systems with global product responsibility. His main functions are: market analysis, initiating new product developments, business devel­opment, and expert for syringe processing. He is a member of the “PDA Interest Group pre-filled syringes” and works as an expert in the DIN/ISO group for primary packaging. Klaus is also member of ISPE and co-track-leader of the yearly ISPE Aseptic Conference. He is a well-known speaker on conferences covering trends and solutions for fill/finish equipment especially for pre-filled syringes, other pre-sterilized contain­ers, and single-use-filling-systems

Amit Khanna, UK

Application Project Manager, Team Lead

STERIS Corporation

Amit Khanna is an application project manager and team lead for STERIS Life Sciences. He has a bachelor’s degree in aerospace engineering. He joined STERIS in 2004 and has 14 years of experience with pharmaceutical and research process equipment in wash­ing, sterilizing, WFI, PSG, and VHP applications. He has worked on several customer projects in Europe, Middle East, South Africa, and Asia.

Stephen Gilmore, UK

Engineering Director

Crux Product Design

Stephen has a proven history and wealth of experience in the consultancy environ­ment - focused on medical device design and analysis. As engineering director at Crux Product Design, he has a particular interest in the use of cutting edge technology to promote evidence-based design development. Specialising in advancing the use of In- Silico techniques, he has worked extensively on the development of ‘digital twin’ mod­els, applying state-of-the-art simulation tools to de-risk and accelerate medical device programs. Leading technical projects with a science-led, informed approach, Stephen has supported medical clients to progress a number of successful flagship products to market. In his current role he continues to promote use of engineering analysis at all stages of product development, supporting design, validation, and verification of next-generation drug-delivery systems.

David Phasey, UK

Senior Project Manager

3P innovation Limited

David Phasey is a Senior Development Manager at 3P innovation with a background in mechanical engineering and industrial design. David graduated from the University of Bath, attaining a degree in Innovation and Engineering design. His early career was at Xerox working in the design of plastic components, human factors and Six­Sigma methodologies. Since joining 3P innovation, he has utilised his experience to help develop novel manufacturing processes and equipment for a wide variety of cus­tomers in the medical device and drug delivery field. His broad experience has seen him generate multiple patents for clients across a broad spectrum of industries and technological fields. David has delivered many successful projects including equip­ment for needle-free injectors, IUDs, high-precision gravimetric filling systems and auto injector assembly equipment. Most recently David has been instrumental work­ing with SteadyMed, developing the manufacturing processes and equipment for the SteadyMed patch pump.

Bastiaan De Leeuw, NL

Head of Business Development

Cambridge Design Partnership

Ian Thompson, CH

Vice President Business Development, Delivery Systems med AG

Ypsomed AG

Francesco Malavasi, CH

Medical Device Quality Manager

Novartis 

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Dr. Thomas Schönknecht, DE

Executive Director Business Development

SHL Group AB

Cedric Gysel, CH

Device Engineer and Technical Product Owner

Janssen

Didier Pertuy, FR

VP, Global Head of Drug/Device Integrated Development & Device

Sanofi

Chris Muenzer, CH

Senior Device Technology Manager

Novartis

Chi Yuen Liu, CH

Process Scientist Sterility Assurance Janssen Global Quality & Technical Operations Parenterals

Janssen

Davide Mercadante, CH

Senior Device Quality Engineer, Device Development Quality

Biogen

Shruthi Vidyasagar, UK

Device Development Technologist

GSK

Dr. Robert Hormes, CH

Head Packaging Technology Device Development & Commercialization

Novartis

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek

Klaus Ullherr, DE

Senior Product Manager

Robert Bosch Packaging Technology GmbH

Amit Khanna, UK

Application Project Manager, Team Lead

STERIS Corporation

Stephen Gilmore, UK

Engineering Director

Crux Product Design

David Phasey, UK

Senior Project Manager

3P innovation Limited