Bjarne Sørensen is a director of front-end innovation at Phillips-Medisize, based in the company’s development centre in Denmark. With more than 35 years of experience within product, strategy, and business development, Bjarne has a very visible track record within different business areas. At Phillips-Medisize, he participates in customer projects, typically involving electronic injectors and connected health systems. He is also deeply involved in new electronic platform programs, especially on conceptual, technical, and sustainability aspects.

Dr. René Dathe, MBA is a Biopharma professional with 15+ years’ experience in Drug Device Combination products, BD&L, CMC, Portfolio and Quality. Currently, he is Head Quality Advanced Therapy Medicinal Products at Novartis to support xRNA, Radioligand and Gene & Cell Therapy device development and commercial portfolios. Prior to this, René was establishing a Quality Connected Health organization and transforming a Quality shared function to a portfolio organization and expanding its footprint to China. At Sanofi, he was a PMO Project Manager in Cardiovascular & Metabolic, Immunology & Inflammation and Oncology Franchises. His career started René at a Start-up venture at Samsung. He obtained a degree in chemistry, followed by an MBA and was awarded with a doctor degree by the University of Gloucestershire.

Anne-Sofie Madsen Staples is a biomedical engineer with a PhD from the University of Copenhagen. She works as an innovation lead at Novo Nordisk  A/S, leading innovation projects focusing on combination products/injection devices. Anne-Sofie's work is motivated by a deep understanding of device-tissue interactions, as demonstrated by her Industrial PhD project on shield-triggered autoinjectors. With a solid academic background and extensive industry experience, she brings a unique combination of technical, clinical, and user-focused expertise to medical device R&D.

Will Denny, PhD has over 11 years’ experience in the medical device & combination products sector. He has worked with a number of companies on a broad range of product developments that include combination products, Class IIa, Class IIb, Class III and AMIDs. He holds a degree and PhD in Biomedical Engineering and is still active in publishing academic literature in the areas of device development concepts and in-silico modelling of drug delivery in-vivo.
Prior to his current role Will has worked for a number of other medical device and pharma companies in technical leadership roles.

Bernard spent the last 25 years to manage digital projects in a lot of different industries and role but always in pioneer field such as GSM, multichannel CRM, eBusiness, Disease management, PSP and lastly SaMD with telemedicine and connected medical device. In 2013 he started an international MBA to go beyond these technical & operational knowledge with skills in business administration, marketing and entrepreneurship.
Bernard moved in the Digital HealthCare space in 2015 : here with his skills he can have an positive impact on people's lives wihtout being a doctor ... and he feels personally concerned by helping people with diabetes.
His key words are involvement, deliver, innovate, team spirit and sharing, pugnacity, imagine new solution, benevolent, curious and build strong and honest relationships.

Paul Johnson is an independent consultant to the pharmaceutical industry who has specialised in the CMC aspects of NCE and generic inhaled product development since 2018 serving clients in large/small pharma companies, pharmaceutical component suppliers, and pharmaceutical service providers.

Paul gained 20 years of experience leading teams and projects involved for the development of inhaled products at Glaxo Smith Kline in a range of delivery systems, including dry powder inhalers, pressurised metered dose inhalers, and nebulisers. He is most proud to have led the CMC teams from early development, through clinical stages, registration, launch and lifecycle management for Relvar/Breo Ellipta, and provided leadership for the CMC aspects for the entire GSK inhaled franchise.  

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device and pharmaceutical industries. Yvonne leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations. Yvonne holds a BSc in industrial design and an MSc in human technology interaction, both from Eindhoven University of Technology (NL).

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan leads Global Pharma clients in complex compliance projects to meet the latest regulatory requirements. In his role as Managing Director at Beyond Conception, Juan has pioneered efforts in Combination Products in Europe by leading clients to obtain Notified Body Opinions as well as achieving compliance with the EU MDR and EU IVDR and other global regulations. His insights of the EU framework on medical devices and combination products and experience in Notified Body interactions and submissions have made Juan a constant speaker at leading conferences. His focus is on creating value beyond compliance and understanding thoroughly business needs to the deliver the highest value to his clients.

Horacio Pace Bedetti is the Human Factors Specialist at Novo Nordisk, where he ensures compliance with global human factors regulations for medical devices and combination products. With over a decade of experience in human factors and a PhD in Healthcare Technologies, Horacio has led Human Factors and Risk Management efforts in the pharmaceutical industry for the past five years. He is an active member of the AAMI Human Factors Group, contributing to the review and update of the international standards, serves on the Combination Product Coalition’s HF working group, and is an editor for the Journal of Human Factors in Healthcare.

Patrice Becker is a medical device industry expert with more than 30 years of experience in clinical and medical affairs. He holds a masters degree in pharmacology and a masters degree in business administration for pharmaceutical and biomedical companies. After several years of experience in small medical devices companies, he joined Biomatech a consulting and testing company focused on medical devices testing  as a clinical research manager . Then he joined  Sofradim/Medtronic in 1998, building and taking the lead of the clinical research department for 13 years. then he was the leader of the scientific communication department for abdominal and robotic surgery until february 2023.  He is now leading activities for St Gilesmedical in France. St Gilesmedical is a scientific communication and medical writing independent company based in London and Berlin.

Jakob Lange is Head of Account and Business Development at Ypsomed with responsibility for all sales, customer relationships and marketing activities in the B2B Delivery Systems business.

Prior to his current role, he has held different positions within marketing and sales as well as in R&D project management. He has been with Ypsomed for more than 18 years.

Jakob holds an MSc 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 40 peer-reviewed papers on medical devices, packaging materials, and polymers, and is a regular contributor to conferences on these topics.

Results-oriented professional with a proven track record in developing, registering, and commercializing medical devices, drug-device combination products, and software. With over +10 years of experience in R&D, QA, and RA departments, I excel in implementing regulatory strategies, preparing documentation, and liaising with regulatory authorities. Adept at navigating regulatory audits and ensuring compliance with submission requirements.

Kevin Brunet is currently leading the Device Devlopment and Primary Packaging Quality group at UCB.
During the last 12 years, he has developed a strong expertise in the development and manufacturing of Medical Devices and Drug-device combination products with roles in R&D, Supply chain, Operations and Quality.
His main expertise lays within Design and Development, Risk Management, Supplier Audits and Management with track records of innovative products brought to approval and launch (including N.B. Audits and H.A. Inspections).

Heather Johnson is a senior consultant with over 20 years’ regulatory expertise in drug-device combinations, borderline products and companion diagnostic devices. With a PhD in chemistry, her initial regulatory experience was with oral pharmaceutical products, followed by over 10 years leading global submissions for implantable, resorbable and drug-eluting orthopaedic devices with DePuy Synthes companies of Johnson & Johnson. Her career continued developing strategies for implementation of the EU Medical Devices Regulation across Johnson & Johnson devices companies. She then contracted for QIAGEN GmbH, to support clinical performance studies and marketing submissions for oncology companion diagnostic devices in US, EU, China and Japan. Heather now supports clients with US and EU submissions for drug-device combination products, strategies for development of novel devices, and the use of devices and IVDs within medicinal product clinical trials.

Richard has over 12 years of experience in medical device manufacturing and analytical laboratory services, working with emerging and established pharma companies to bring multiple projects to market. Currently Richard is heading up West's Combination Products Solutions offering, which leverages our deep experience in device development, manufacturing, testing, drug handling and packaging to provide a comprehensive range of services to streamline our clients route to market with a Combination Product.

Richard has a BE in Mechanical Engineering along with an MSc in Pharmaceutical & Biopharmaceutical Technology.

Michael Stapleton, based in Berlin offers over 25 years of commercial experience in leadership functions across various industries.

Throughout the past decade Michael has worked in the healthcare industry gaining experience with DuPont Healthcare, amongst others, where he headed up the EMEA sales team and partnered with numerous medical wearable and drug delivery manufacturers.

In his current role Michael coordinates the European Sales force for Lohmann.

Headquartered in Neuwied Germany Lohmann are a leading manufacturer and converter of pressure-sensitive adhesives and component parts for wearable, ostomy, diagnostic, and other medical applications, Lohmann delivers comprehensive solutions and provides a complete value chain, minimising risk and accelerating your medical device innovations to market.