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Pharma

2nd Annual Drug/Device Combination Products Summit

  • 19th – 20th April 2018
  • Austria flag Austria Vienna
  • Meliá Vienna Donau City Strasse 7, 1220

We would like to welcome you to the 2nd Annual Drug/Device Combination Products Summit on April 19th - 20th, 2018 in Vienna, Austria. Combination products are still relatively new delivery systems for the healthcare market. New approaches are crucial for precise administration without inducing any harm. New laws and regulations have led to the increase in technological requirements within this industry.

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About

This event provides the appropriate platform for industry leaders to discuss the best practices in Drug/Device Combination Products development. The Summit will provide a broad overview of guidelines and regulations, registration requirements, market trends and device needs, technologies and innovations, and delivery aspects.

We are looking forward to your participation in this engaging Summit in Vienna in April!

Who Should Attend

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

  • Combination Products
  • CMC
  • Parenteral Products
  • Device Design
  • Human Factors
  • Usability Engineering
  • Drug Delivery & Devices
  • Quality Assurance / Control
  • Compliance
  • Risk Management
  • Packaging
  • Controls and Robotics
  • Pre-Filled Syringes
  • Design Controls
  • Device Development & Manufacturing
  • Inhalation Products
  • Device Engineering & Design
  • Formulation Sciences
  • Product Quality
  • Regulatory Affairs
  • Research & Development
  • Validation

Key Practical Learning Points

  • Overview of guidelines and regulations, registration requirements
  • Risk assessment for faster product realisation
  • Technical challenges and correct specifications
  • Innovative drug delivery solutions
  • Human-factors engineering and usability
  • Achieving a smooth market access
  • Clinical case studies
  • Real examples of successful launch of combination product

Paul Johnson, UK

Director

Paul Johnson Consulting Limited

About Speaker

Mike Wallenstein, CH

Global Head MDR Implementation & DD&C Compliance

Novartis International AG

About Speaker

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

About Speaker

Philipp Richard, CH

Product & Account Manager Delivery Systems

Ypsomed AG

About Speaker

Didier Pertuy, FR

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

Sanofi

About Speaker

Gregor Anderson, UK

Managing Director

Pharmacentric Solutions Ltd

About Speaker

Davide Mercadante, CH

Senior Associate II, Supplier Quality

Biogen

About Speaker

Florian Moik, GE

Product Manager Pen & Autoinjector Solutions

Schreiner MediPharm

About Speaker

Dr. Remy Vomscheid, FR

Director, Devices Development & Technologies

Ipsen

About Speaker

Dr. Stefanie Funke, CH

Group Leader Verification Engineering, Device Development

Roche

About Speaker

Patrice Becker, FR

Global Director Scientific Communications | Medical Affairs

Medtronic

About Speaker

Dr. Felix Weiland, DE

Head of Combination Product Development

Boehringer Ingelheim microParts GmbH

About Speaker

Dr. Daniel Latham, CH

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

Novartis Pharma AG

About Speaker

Jussi Haikarainen, FI

Head of Inhalation Technology, Easyhaler Therapy Area, R&D

Orion Corporation - Orion Pharma

About Speaker

Daniel Kehl, CH

CEO

Swissfillon AG

About Speaker

Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

About Speaker

Paul Johnson, UK

Director

Paul Johnson Consulting Limited

Paul Johnson is a pharmaceutical development consultant, specialising in inhaled medicines with over 30 years’ experience in the industry at blue-chip companies. In the late 1990s, he was leading the pharmaceutical re-development of a pMDI asset switching from propellant CFC 11/12 to HFA-134a and led GSK’s novel pMDI tech­nology efforts (generating a number of patents). In the early 2000s, Paul’s focus shifted from line extensions to bringing forward many of GSKs early development respiratory projects. He had the unique experience of leading the development of a portfolio of GSK inhaled NCEs and the associated novel delivery platform (Ellipta) from pre-candidate selection through to launch and lifecycle management. After his work on Ellipta, Paul was able to seek and incubate several novel delivery systems to provide future platforms for GSKs respiratory products. He is a CMC expert with special expertise in inhaled delivery systems and products who regularly partners with clinical, regulatory and commercial leaders, to shape and execute the overall drug development, manufacture, and launch strategy.

Mike Wallenstein, CH

Global Head MDR Implementation & DD&C Compliance

Novartis International AG

Mike Wallenstein has over 25 years of experience in QA, R&D, and manufactur­ing within the medical device & pharmaceutical industry with positions as head of quality systems, global head of auditing, and compliance. His is currently director of QA & global head of device & combination product expert network at Novartis International, based in Basel, Switzerland.

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.

Philipp Richard, CH

Product & Account Manager Delivery Systems

Ypsomed AG

Philipp Richard has been with Ypsomed AG since 2009, managing existing products and working with pharma and biotech partners to bring innovative self-injection systems to market. Ever since joining the company, Philipp has been active in the area of human factors engineering. He studied electrical engineering (MSc ETH EE) and has worked in product development, project management, and international sales of technical products in other industries before joining Ypsomed and the world of medical devices.

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.

Gregor Anderson, UK

Managing Director

Pharmacentric Solutions Ltd

Gregor Anderson founded Pharmacentric Solutions Ltd in late 2017 to offer consul­tancy services for the pharma industry specialising in device and packaging strategies from early concept through to development. Prior to this, Gregor was senior device and packaging design director at GSK, based at Ware, UK. He has a bachelor’s in industrial design and a master’s in polymer science and engineering and after complet­ing a postgraduate in marketing from Heriot-Watt University in 1986, he worked for Smiths Industries Medical Systems as a device designer. In 1989, he joined the device development unit at GSK R&D. He worked on the design of various device platforms including injectors and respiratory devices. In 2009, Greg moved to GSK manufactur­ing to head up technical packaging. More recently, he has focussed on supporting the launches of the Ellipta inhaler, respiratory training devices and also researching and preparing GSK’s respiratory and packaging strategy for emerging markets. In 2016, he joined the Medicines Manufacturing Industry Partnership and the REMEDIES team. He holds over 40 patents and has presented widely on topics such as digital, patient-centric design and pharma road mapping.

Davide Mercadante, CH

Senior Associate II, Supplier Quality

Biogen

Davide Mercadante is a medical engineer with 10+ years of experience within mul­tiple areas of device and combination product development, including design & de­velopment, design quality assurance, verification & validation engineering, quality control, and supply chain quality. He received his bachelor’s and master’s degree 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 in the integration of software as a medical device into the existing quality management system.

Florian Moik, GE

Product Manager Pen & Autoinjector Solutions

Schreiner MediPharm

Florian Moik is product manager for pen & autoinjector solutions of Schreiner Medi­Pharm, a business unit of Schreiner Group based in Oberschleissheim near Munich in Germany. Schreiner MediPharm develops and produces innovative, multi-func­tional speciality labels with value-added benefits for the pharmaceutical industry. Florian is in charge of developing new markets and solutions for diverse applications in the field of drug delivery devices, with a special focus on pen and autoinjector so­lutions. Prior to joining Schreiner MediPharm, he worked in a strategic management consultancy, focusing on the conception and implementation of business transfor­mation programs. Florian holds a master’s degree in business administration.

Dr. Remy Vomscheid, FR

Director, Devices Development & Technologies

Ipsen

Remy Vomscheid, PhD has been working in the healthcare industry for the last 15 years. He coached biotech start-ups as a business developer for Genopole, the biggest French Incubator dedicated to Life Sciences. After this, he joined John­son & Johnson as business development manager, Medical Devices & Diagnostics, EMEA and later moved to a commercial position as regional business manager for LifeScan, the diabetes diagnostics franchise of J&J. Then, he led the technical de­velopment of automated medical devices at Eveon, as director of development. As director, devices development & technologies, he currently leads the development of innovative devices at Ipsen.

Dr. Stefanie Funke, CH

Group Leader Verification Engineering, Device Development

Roche

Stefanie Funke is a group leader in the Device Development Department at F. Hoffmann-La Roche. Together with her team, she is responsible for experimental and design verification activities as well as associated test methods to support the development and industrialisation of drug/device combination products. Stefanie is a pharmacist by training and holds a PhD in pharmaceutical technology from Ludwig-Maximilians-Universität (LMU) in Munich. Her scientific work at LMU Munich and previously at Abbott GmbH & Co. KG focused on siliconisation techniques, silicone-protein interactions, and protein aggregation.

Patrice Becker, FR

Global Director Scientific Communications | Medical Affairs

Medtronic

Patrice is a medical device industry expert with 25 years of experience in clinical and medical affairs. He holds a master’s degree in pharmacology and a master’s degree in business administration for pharmaceutical and biomedical companies. After he joined Sofradim/Medtronic in 1998, he took the lead and established the clinical research department. Since 2012, he is the leader of scientific communication for abdominal and robotic surgery. Prior to joining Medtronic, he spent almost 5 years as a clinical research manager at Biomatech, a consulting and testing company focused on medical devices. In addition, Patrice is an expert in numerous standards including ISO 14155, EUCOMED, and is a member of several task forces.

Dr. Felix Weiland, DE

Head of Combination Product Development

Boehringer Ingelheim microParts GmbH

Felix is a pharmacist by training with a PhD in pharmacology. In 2006, he joined Boehringer Ingelheim as a trainee, focusing on launch and transfer activities of inhalative products. He then took over different roles at BI microParts in Dortmund at the development site of inhalation devices as development QA manager, senior project manager, and lab head of device development. In 2010, he joined the Ger­resheimer Group at Bünde as a QC head and later on as quality director. Buende is a large-scale manufacturing site of sterile primary packaging components, i.e.RTF®- syringes and insulin cartridges. In 2015, he returned to Boehringer Ingelheim to implement systems for systematic lifecycle management of the Respimat® Plat­form Technology, including ownership of the design history files. Currently, he is the director of product- & process-technology including responsibilities for project management, design verification laboratories, clinical trial supply, and design & process technology of devices.

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.

Jussi Haikarainen, FI

Head of Inhalation Technology, Easyhaler Therapy Area, R&D

Orion Corporation - Orion Pharma

Jussi Haikarainen has been involved in drug delivery device development since 1997. He has been responsible for current Easyhaler device development and indus­trialisation at Orion Corporation. Jussi worked for Sanofi 2004-2006 in Frankfurt am Main as project manager for SoloStar insulin pen for development, industrialisation, and regulatory approvals phases. Since 2007, he has worked at Orion as CMC leader on budesonide/formoterol Easyhaler development and salmeterol/fluticasone Easy­haler at Orion, where his team is responsible for device, formulation, and analytical method development. He has an M.Sc. in materials science. He participated in authoring the Aerosol drug delivery device design verification standard (ISO 20072) as an expert of Finland.

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.

Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the Universi­ty of Leuven (Belgium) in 2012. She started at Nelson Labs Europe (formerly Toxikon Europe) in 2013 as study director at the Extractables & Leachables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. In 2016, she became Department Head Pharma Services at Nelson Labs Europe. The main focus of this department is identifying organic impurities in drug products as well as in use stability of drug-device combination. In 2017, the scope expanded and includes now also all microbiological testing offered at Nelson Labs Europe.

Paul Johnson, UK

Director

Paul Johnson Consulting Limited

Mike Wallenstein, CH

Global Head MDR Implementation & DD&C Compliance

Novartis International AG

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Philipp Richard, CH

Product & Account Manager Delivery Systems

Ypsomed AG

Didier Pertuy, FR

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

Sanofi

Gregor Anderson, UK

Managing Director

Pharmacentric Solutions Ltd

Davide Mercadante, CH

Senior Associate II, Supplier Quality

Biogen

Florian Moik, GE

Product Manager Pen & Autoinjector Solutions

Schreiner MediPharm

Dr. Remy Vomscheid, FR

Director, Devices Development & Technologies

Ipsen

Dr. Stefanie Funke, CH

Group Leader Verification Engineering, Device Development

Roche

Patrice Becker, FR

Global Director Scientific Communications | Medical Affairs

Medtronic

Dr. Felix Weiland, DE

Head of Combination Product Development

Boehringer Ingelheim microParts GmbH

Dr. Daniel Latham, CH

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

Novartis Pharma AG

Jussi Haikarainen, FI

Head of Inhalation Technology, Easyhaler Therapy Area, R&D

Orion Corporation - Orion Pharma

Daniel Kehl, CH

CEO

Swissfillon AG

Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

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