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.

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.

With over a decade of experience in regulatory and quality strategy for medical devices, drug-device combination products, and clinical research, a strong record of contributing to successful global product approvals (FDA, EMA, TGA, PMDA, and others) has been established through collaborative and innovative approaches. Successful support of high-stakes submissions—including NDA, BLA, MAA, JNDA, STED, MAF, and NBoP—has been achieved alongside cross-functional teams, enabling the development and commercialization of complex products. Experience includes building effective partnerships with CROs, CMOs, and global stakeholders, as well as active participation in industry discussions that help shape best practices and regulatory policy. Excellence is pursued through teamwork, shared success, and a commitment to advancing the regulatory field.

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).

Pieter Van Wouwe received his Master’s degree and PhD in Bioscience Engineering at the University of Leuven in 2016. Afterwards, he started working at Nelson Labs as a project manager, initially mainly involved in scientific interpretations and the reporting of analytical results. Over the years, he has expanded his role and became responsible for designing pharma-related extractable and leachable studies for both packaging materials and process materials, as well as for medical devices and combination devices. Providing support for extractables and leachables studies to both biopharmaceutical and medical device companies is currently one of his main day-to-day activities

Soumen Das is an experienced product development professional in the medical device industry, with a track record spanning over 10 years. For the past 6 years, Soumen has dedicated his efforts to ensuring the biocompatibility of medical devices for regulatory submissions to the FDA, EU, and PMDA. His expertise ranges from in-vitro diagnostics to implantable medical devices. His Ph.D. and postdoctoral work focused on the compatibility of materials and nanoparticles with biological systems, including systemic and organ toxicity. His extensive research has resulted in over 50 peer-reviewed publications in international journals, showcasing his commitment to advancing the field. He holds eight patents alongside his publications, demonstrating his innovative and creative problem-solving abilities. Recognized for his achievements, Soumen has been honored with several prestigious awards, including the Young Investigator Award 2016 and the 2014 Gordon Conference Award in Radiation Chemistry. Additionally, he received the University of Central Florida Innovator Award in 2014.

Amir Fakhari, PhD, is the Combination Products and Packaging Director within Global Technical Operations at AstraZeneca. With more than sixteen years of experience in developing and supporting drug delivery systems and combination products, he leads life‑cycle management and design transfer for biologics‑based combination products, as well as commercial packaging design and life‑cycle management. He also supports commercialization activities and manufacturing site readiness for AstraZeneca’s combination products and product packaging. Previously, Amir held roles at Teva Pharmaceuticals, AstraZeneca, Emergent BioSolutions, and Lonza. An innovative leader, he is the author of thirteen journal publications and four patent applications. He earned his PhD in Bioengineering from the University of Kansas.

Dr. Vrijens holds a PhD from the Department of Applied Mathematics and Informatics at Ghent University, Belgium. He has pioneered a research program focused on a simple but robust taxonomy of common dosing errors, along with exploring optimal measurement-guided medication management that can drive adherence and maintain long-term persistence. With over 100 peer-reviewed scientific papers and six patents to his name, Dr. Vrijens is also a founding member of the International Society for Medication Adherence (ESPACOMP) and an active member of several EU- and US-funded collaborative projects around the theme of adherence to medications. Dr. Vrijens is a highly-accomplished public speaker, having presented lectures at over 200 industry events and scientific conferences around the world over the past 20 years. Public speaking experience includes the NIH Adherence Network Distinguished Speaker Webinar Series, CDER Drug Packaging Summit at the FDA, European Society of Cardiology Congress, American Society on Pharmacometrics, WHO Global Forum on Innovation for Aging Populations, among many others.

Nélio Drumond is a PharmD by training with a PhD in Patient Centric Drug Product Design. He shares several years of experience in the Pharmaceutical Industry, providing expertise in strategic development, CMC strategy, commercial launch, and technical operations. Dr. Drumond is a strong advocate for Patient Centric Drug Product Design and is also the Founder of "The Pharma xCentric," an online community dedicated to advancing this subject within the Pharmaceutical Sciences.

Sebastian is Regulatory Strategy Principal at the Medical & Health Services business of TÜV SÜD Product Service GmbH, a German notified body. His key responsibilities are communication and collaboration with European authorities (e.g. EMA, MDCG-NET) and associations (e.g. NBCG-Med & Team-NB). His focus is on digital medical devices, Artificial Intelligence and combination products. Before joining the notified body, he acted in similar function in pharmaceutical industry, where he additionally covered paediatric medicine development and the Japanese regulatory environment.

Before switching to industry, he had research positions at the Max-Planck-Institutes for Intelligent Systems (Stuttgart) and Medical Research (Heidelberg). He studied in Bonn and Heidelberg, where he earned a Bachelor's degree in Biomedical Sciences and Master's degrees in Molecular and Cellular Biology (M.Sc.) as well as Drug Regulatory Affairs (MDRA).

Tieming Ruan is the Vice President and Head of Device & Packaging at Parabilis Medicines, where he leads the strategic development of next-generation drug delivery platforms. With over 20 years of industry experience, Tieming is a recognized expert in the end-to-end commercialization of combination products, including Auto-Injectors, Prefilled Syringes (PFS), and Large Volume Wearable Injectors.

Before joining Parabilis, Tieming served as Senior Director of Device Development at AstraZeneca Alexion, overseeing complex portfolios for biologics. His career is defined by a unique blend of technical rigor and business strategy, underpinned by a PhD in Mechanical Engineering from The Ohio State University and an MBA from New York University.