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.

Torsten Kneuss studied business administration and engineering. Since 1999 he has been working with pharmaceutical packaging materials, medical devices and combi­nation products, including several years within the field of quality control, develop­ment, operations, and pharmacovigilance. Since November 2017 he is, as a quality manager of combination products, responsible for devices and combination products within Bayer 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 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.

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.

Dr. Herbert Wachtel is a senior principal scientist at Boehringer Ingelheim, Germany. Herbert joined the company in 1998 and since then he has been involved in basics of inhalation therapy, e.g. formulation development, novel methods for particle sizing, design of aerodynamic components in inhalers and aerosol therapy in children. In his spare time, Herbert serves as a lecturer on the subject of pharmaceutical technology at the Johannes Gutenberg-University in Mainz. Herbert studied physics at the Univer­sity of Stuttgart, where he investigated conducting molecular solid films and surfaces before switching to the field of aerosolised drug delivery. Apart from CAD tools, Herbert regularly applies computational fluid dynamics (CFD) and he investigates up-to-date ‘in vivo-in vitro correlations’ (IV-IVC) for the optimisation of medical devices in the industrial setting.

Dr. Bassil Akra is the vice president of the global focus teams (cardiovascular, ortho­paedic, active implantable, aesthetic devices and clinical) at TÜV SÜD Product Service. Bassil has a lot of experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products.

He is leading various consultation processes of medical devices incorporating an ancil­lary medicinal substance with the different competent authorities designated by the member states or the EMA. As a senior field expert, he is presenting worldwide the requirements in Europe and is involved in the development of several European guid­ance documents and standards.

Bassil is a member of the European Clinical Inves­tigation and Evaluation working group and is representing Team NB and NB MED in several European discussions regarding the clinical requirements such as MEDDEV and other guidance documents on innovative devices. He is a member of the German MDR Implementation Working Group (the NAKI) and also a member of new MDR European task forces such as the one on PSUR, SSCP, equivalence and sufficient clinical data.

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.

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.

Margaret Kelly is a biomedical engineer with eight years of combined experience in product development engineering and project management in orthopedics and combination products (drug delivery devices for pharmaceuticals). She has been with Novartis device development and commercialisation for nearly two years, and in that time she has led both product development projects and commercial product ac­tivities. Margaret is currently transitioning to a new role focussing on the processes and systems used to innovate, develop, transfer and maintain medical devices and combination products.

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.

Roman Mathaes is a group leader within the Lonza Drug Product Service organisa­tion. He is leading the Lonza particle lab and the container closure integrity testing. In this role, Roman is responsible for particle analytics in drug products and container closure integrity testing of vials and pre-filled syringes and process development of capping/crimping. Prior to this assignment, Roman was working within Roche/Ge­nentech network supporting process development of the commercial manufacturing. Roman is an active member of the European CCI industry focus group and part of the BPOG CCI workstream. Roman is a pharmacist by training and conducted his studies at the University of Marburg and King’s College London. He holds a PhD in pharmaceutical technology from the University of Munich for his work on subvisible particle characterisation.

Paul van den Biggelaar has studied the potential of thermotherapy for more than a decade and is co-founder of Sensius. He got his master’s degree in electrical en­gineering at Eindhoven University of Technology with the long-term ambition to be engaged with medical technology. Learning the essence of high-tech product devel­opment at Lucent Technologies, he broadened his experience as director of services at Peek Traffic. In 2005, he joined the executive team of Nucletron as business unit director and later he was responsible for all product development. During his time at Nucletron he got in touch with RF-based thermotherapy for the first time. At Sensius, Paul performs the role of CEO.

Mark Gordon has over 35 years of experience in medical device and combination-prod­uct development, starting with initial design development and progressing through high volume product manufacturing. He has managed new products from early stage development to high volume manufacturing operations, both in the US and in low-cost manufacturing sites. Medical device fields that he has worked in include hemodynamic monitoring, surgical laser systems, implanted and catheter-based sensor products in­cluding fiber optic O2 sensors. Mark has been active in combination products manu­facturing process development for 10 years. He has led the pre-clinical development work on multiple women’s health drug delivery products, including cGMP manufactur­ing for late-stage clinical evaluation products. In his current role as product manager at Trelleborg Sealing Solutions, Tustin, Inc., a medical product contract manufacturing organisation (CMO), he is responsible for new business development, technology as­sessment, new product manufacturability assessment and project management for all phases of bringing new products to commercial manufacturing. Mark owns, or is listed as an inventor, on 14 US and international patents, primarily for medical device design and manufacturing technology.