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.

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.

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.

Julia Frese is a biomedical engineer with a Master's degree in business administration. Julia gained experience in the development, regulatory approval of combination devices, and ATMP products. She was further involved in the development of standards for ATMP products. Currently, Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organization. She is further co-chair of the Team NB working group for article 117.

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, phar­maceuticals and combination products. She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

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.

Aurélie Rebuffet is a Staff Regulatory Affairs Specialist at BD Medical –Phar­maceutical Systems. She has 11 years of regulatory experience in pharma and container closure system environments. Dr Rebuffet has been with BD since 2016, with position on increasing responsibilities. She manages a team supporting major accounts as well as R&D projects. Previously, she had 8 years of experience in Regulatory Affairs for Vaccines. She is a Doctor of Pharmacy, from University Joseph Fourier (Grenoble, France) and held 2 Master’s degrees: one in Regulatory Affairs from Paris Sud University, France and one in Business Engineering from Ecole Nationale Supérieure des Mines de Saint Etienne, France.

Andrew Dundon is the founder and owner of Pharmechceutics Ltd. an independent consultancy specialising in supporting clients to design, develop, register and industrialise robust, differentiated patient centric drug delivery systems. Andrew was formerly the Head of Device Engineering in the Product Development & Supply, GSK Research and Development. During a 20 year career within the GSK Device Engineering function, Andrew assumed roles of increasing responsibility.

Andrew joined GSK in January 1989. Initially, within the Inhalation Analysis De­partment where his formative years were involved in the development of Sal­meterol and Fluticasone in the Diskhaler™ and subsequently the Diskus™ drug delivery systems. In 1999, Andrew took a secondment opportunity in what would now be described as Device Engineering, thinking it would be an interesting short term secondment to broaden his experience of the product development pro­cess. Andrew has never regretted the move and has had the opportunity to lead or assume accountability for key deliverables in the development of the pMDI counter, Veramyst/Mistrpo™, Ellipta™ inhaler and a number novel drug delivery devices which are still in development. Andrew assumed leadership of the Device Engineering Group in September 2013. Andrew was formerly the Co-Chairperson of the IPAC-RS Devices Working Sub-Group between 2013-2019. Andrew has a real passion for how drug delivery systems should be most effectively developed from concept through the product lifecycle using a risk based approach informed by the regulatory framework, which he has used IPAC-RS to influence, within which companies are required to operate.

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.

Krystin Meidell joined the Regulatory CMC Medical Devices and Combination Products group at Biogen in 2018 where she supports combination prod­uct and medical device regulatory strategy and policy. Krystin’s experience includes global regulatory and analytical roles in medical devices, diagnos­tics, drug delivery, and combination products, with a focus in software and companion diagnostics. She holds a bachelor of science degree in chemical engineering from Carnegie Mellon University and is an active member of the Combination Products Coalition.

David is responsible for BSI’s testing and certification business for digital and connected products, such as “Internet of Things” (IoT) devices and software applications. He is an expert on digital transformation and IoT, supporting BSI clients in developing trusted digital, connected and ‘smart’ solutions. David sits on the IoT Security Foundation ‘Testing & Certification’ Working Group, and has authored regulatory and technical guidance, written articles for a range of publications and is a successful global keynote speaker and pre­senter. Originally training as an electronics engineer with the BBC, then serv­ing as an engineering officer in the RAF, David has since managed a range of projects covering secure distributed IT, optical telecommunications and pre­cision micro-electronics manufacturing, before moving into management of smart product and general IoT-related businesses, joining BSI in June 2017.