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Pharma

3rd Annual Pre-Filled Syringes Summit

  • 28th – 29th September 2017
  • Spain flag Spain Barcelona
  • Hotel SB Diagonal Zero Plaça Llevant, s/n, 08019

This event provides the appropriate platform for industry leaders to discuss best practices as well as new developments in Pre-Filled Syringes (PFS).

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About

The Summit will provide a broad overview of market trends and device needs; technologies and innovations; delivery aspects of parenteral drugs; as well as regulatory updates.

We will discuss the benefits of PFS and injection devices as the main factor for convenient dosage 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)
  • Regulatory challenges and market approval
  • Next generation design and materials for PFS
  • Combination products and auto injectors
  • Sterile manufacturing
  • Ensuring efficient drug development
  • Human-factors engineering and usability
  • Patient-centric design

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. 

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.

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.

Nick Stones, CH

Senior Device Manager - Human Factors, Biologics Technical Development & Manufacturing

Novartis Pharma AG

Nick holds bachelor’s and master’s degrees in engineering from the University of Oxford. For nearly 20 years, he has worked in research, development and commercialisation of drug delivery systems for various medical device and specialty pharma companies in the UK, US and Switzerland. Nick has been with Novartis since 2009 and was responsible for human-factors during the development of several marketed products including the LUCENTIS® pre-filled syringe for intravitreal injection as well as the COSENTYX® Sensoready Pen for home use. He currently supports human-factors activities on several projects in development and is also responsible for Novartis processes for human-factors engineering on medical device and combination products.

Andreas Kerschbaumer, AT

Deputy Head of Manufacturing

Sandoz

Andreas Kerschbaumer gained a diploma in chemistry and a BSc in inno­vation management. He started his professional career at Fresenius Kabi Austria in 1995 and was responsible for development and validation of ana­lytical procedures and head of the laboratory “Spectroscopy”. Starting in 2007, he was involved in the implementation of pre-filled syringes within the Fresenius Group in a leading position. In February 2010 he became the global project manager and responsible person for the center of competence for pre-filled syringes. In September 2014, Andreas changed to Novartis as deputy head of manufacturing for compounding, filling and visual inspec­tion. In this function he was responsible for the implementation and quali­fication of compounding, filling and inspection processes and going live of the manufacturing area. Since October 2018, Andreas has been focussed on visual inspection and especially on automated visual inspection.

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.

Dr. Daniel Latham, CH

Head of Device Development Operations, Device Development & Commercialisation – BTDM

Novartis Pharma AG

Daniel Latham is the head of device development operations in Global Drug De­velopment, Novartis where he leads an organisation responsible for developing delivery systems for combination products for new biologic entities, biosimilars, and small molecules. Over the past 10 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and combination products within the organisation. Prior to Novartis, he worked in a variety of roles in consumer health­care, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, Uni­versity of London and a bachelor’s degree and master’s degree in engineering from the University of Sheffield.

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

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.

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.

Daniela Janek, GE

Associate Director Primary Packaging & Process Development Parenterals

Boehringer Ingelheim Pharma GmbH & Co. KG

Daniela Janek studied biochemistry and biology at the University of Tübingen. After that, she recieved a doctoral degree from the Department of Medical Microbiology in Tübingen followed by a period as a post doc at the Interfaculty Institute of Microbiology and Infection Medicine Tübingen. Since February 2016, she is working as a labhead in primary packaging and process development for parenterals at Boehringer Ingelheim in Biberach.

Dr. Nicolas Brandes, GE

Director Market Development, EU/Asia

West Pharmaceutical

Dr. Nicolas Brandes is responsible for market development of West’s self-injection portfolio in Europe and Asia-Pacific. In this role, he is working closely with customers to understand their delivery device needs and to develop these opportunities together with West’s device/container R&D and commercial organisation. Before working in business development, Dr. Brandes was in charge of product management for West’s proprietary COP container portfolio made from Daikyo Crystal Zenith®, working hand in hand with the strategic partner Daikyo Seiko in Japan. Dr. Brandes received his Ph.D. in biology from the University of Wuerzburg, Germany, after performing his research studies at the University of Michigan, USA.

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.

Daniel Kehl, CH

CEO

Swissfillon AG

Daniel Kehl holds a master’s degree in process engineering. After university, he worked for several years as a project manager with Lonza AG and Lonza Biotech s.r.o. before he founded the pixon Engineering AG. Pixon specialises in planning, re­alising, qualification, and validation of pharma manufacturing facilities. Since 2014, he is the president of strategic issues at pixon. 4 years ago, he set up a new com­pany, Swissfillon AG. Swissfillon is positioning itself as an agile fill & finish CDMO for high value, high potent injectables. As the CEO, his main function is the setting up of the CDMO fill & finish business for fully automatic GMP sterile filling of biophar­maceuticals and high-potent products for clinical material and for the commercial launch of vials, syringes, and cartridges.

Jordi Net, LU

Business Development Manager

STERISYS Sàrl

Jordi Net’s academic education and degrees include: licentiate degree – biology (biochemistry) at University Autònoma de Barcelona (UAB), Barcelona, 1985 -1990; Master of Business Administration (MBA) at ESADE, Barcelona, 1995- 1998. Jordi has more than 20 years’ experience in technical sales, marketing and business development of solution for the aseptic manufacturing and other related technologies in the global pharmaceutical market.

Bastiaan De Leeuw, NL

Head of Business Development

Cambridge Design Partnership

Didier Pertuy, FR

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

Sanofi

Ian Thompson, CH

Vice President Business Development, Delivery Systems med AG

Ypsomed AG

Nick Stones, CH

Senior Device Manager - Human Factors, Biologics Technical Development & Manufacturing

Novartis Pharma AG

Andreas Kerschbaumer, AT

Deputy Head of Manufacturing

Sandoz

Chris Muenzer, CH

Senior Device Technology Manager

Novartis

Dr. Daniel Latham, CH

Head of Device Development Operations, Device Development & Commercialisation – BTDM

Novartis Pharma AG

Klaus Ullherr, DE

Senior Product Manager

Robert Bosch Packaging Technology GmbH

Cedric Gysel, CH

Device Engineer and Technical Product Owner

Janssen

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Daniela Janek, GE

Associate Director Primary Packaging & Process Development Parenterals

Boehringer Ingelheim Pharma GmbH & Co. KG

Dr. Nicolas Brandes, GE

Director Market Development, EU/Asia

West Pharmaceutical

Lothar Habel, BE

Study Director, Extractables & Leachables

Nelson Labs Europe

Daniel Kehl, CH

CEO

Swissfillon AG

Jordi Net, LU

Business Development Manager

STERISYS Sàrl