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.

Ying Wang is an Associate Research Fellow and the Head of Device Development Science (DDS) in DCoE at Pfizer Cambridge UK.  Ying holds a PhD in Pharmaceutical and Biomedical Analysis and a BSc in Analytical Chemistry. 

Ying joined Pfizer, Cambridge UK after completed her PhD in 2006. Ying has over 25 years of analytical, statistical, and engineering experience in small molecule, large molecule, inhalation, and injectable drug delivery device development. 

As the head of DDS, she has steered the directions of the testing and control strategy development for several now marketed or to be marketed products.  Ying is a technical expert on combination product development with extensive focus on testing and control strategy, she is an expert on statistical sampling, Quality by Design and data analysis. 

Ying is a member of ISO/ TC 84: Devices for administration of medicinal products and catheters, presenting on behalf of the BSI.  She is also a C.Chemist, MRSC.

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.

Mehul Desai, PharmD, MBA, has vast experience in medical and clinical affairs across the pharmaceutical space. At Enable Injections, he leads medical and clinical programming to support publication, new partnerships, and regulatory approvals. Prior to Enable Injections, Mehul served as Associate Medical Director for argenx, driving the strategic direction, supporting clinical trial execution, and contributing to business development activities across various therapeutic areas. Previous experience includes field medical assignments in rare disease, nephrology, and neurology for Mallinckrodt Pharmaceuticals, nephrology and hematology for Alexion Pharmaceuticals, and post-doctoral fellowship work in Medical Affairs for Johnson & Johnson. Mehul also served as a clinical instructor of Pharmacy Practice and Pharmacy Administration at the University of the Sciences in Philadelphia.

Mehul is a published author in peer-reviewed journals, focusing on drug formulation and on-body delivery systems. He regularly delivers podium presentations at industry conferences, contributing to scientific discussions on novel drug delivery technologies.

Mehul holds a bachelor’s degree in Biochemistry and Business Foundations from Indiana University, Bloomington, a Doctor of Pharmacy from Purdue University, and a Master of Business Administration in Pharmaceutical and Healthcare Business from the University of the Sciences in Philadelphia.

Anja Wiersma, is a medical biologist by training with a PhD in the NeuroPharmacological –Behavioural - Physiology field. After working for 8 years at a multinational Pharmaceutical company (Organon), first as scientific researcher and later as a Strategist in Strategy and BusinessDevelopment department, she started to work for a Notified Body in the field of Medical Devices and In Vitro Diagnostic Medical Devices. She was working for this notified body for 6.5 years.

She is fully qualified as a notified body auditor for the Medical Device Directive (MDD 93/42/EEC), Medical Device Regulation (MDR EU 2017/745) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) and for the In Vitro Diagnostic Device Regulation (IVDR EU 2017/746). Since 2010 she is a RA/QA consultant for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossie reviews and CE and ISO 13485 audits as well as for executing inspections for independent organisations.

Furthermore, as of Jan 2013 until Aug 2015 she was a part time QA/RA director and part of management team of an IVD company in the Netherlands. Since March 2015 she is member in the board of the RAPS Netherlands Chapter. From March 2017, until 31 December 2024 she was the chair of the board of the RAPS Netherlands Chapter. And as of September 2017 until September 2020, she was a member of the REC as well (RAPS European Council).

As Managing Director at KAHLITY, Mélodie Kahl has two decades of hands-on experience in quality management, regulatory affairs, and project leadership for pharmaceutical and medical device organizations.

Mélodie has led global compliance programs, guiding clients through technical file development and remediation, designing and implementing quality management systems, and managing successful product launches.

With an Executive MBA in Sustainable Business, Mélodie combines thorough regulatory expertise with forward-looking strategies for drug-device combinations, AI-driven healthcare, and connected device solutions.

Her proven track record includes auditing multinational supply chains, consolidating post-acquisition operations into unified QMS frameworks, resolving critical issues from warning letters, and providing Swiss/EU Authorized Representative services. With KAHLITY’s ISO 13485 certification, Mélodie takes a flexible, tailored approach to align each client’s goals with robust compliance standards, consistently delivering transformative results in competitive markets.

Dr. Daniel Latham is the Strategic Advisor at KAHLITY, bringing over 25 years of experience in drug-device combination product development, connected health solutions, and life cycle management (LCM).

Formerly Head of Device Development & LCM at Novartis, he led large-scale teams and led multiple approvals for biologics, biosimilars, and cell & gene therapies.

Daniel earned his Ph.D. in controlled drug delivery from Queen Mary, University of London. He pairs advanced R&D expertise with an entrepreneurial mindset to drive patient-focused innovation, spanning AI-driven device connectivity, strategic portfolio management, and global regulatory requirements. His flexible, results-oriented approach ensures solutions are both commercially viable and future-ready.

With a proven track record of bridging scientific rigor and business needs, Daniel excels at forging cross-functional partnerships to streamline product development, accelerate time-to-market, and enable sustainable growth in competitive markets.

Dr. Troels Keldmann has spent 25 years in the DDS devices and medical devices industry, working cross-functionally covering development, sourcing, innovation, IPR strategy, business development, partnering, and commercialisation. As interim technical lead on injection devices at LEO Pharma A/S, he headed identification, evaluation, and selection of SC injection devices. His prior DDS experience includes co-founding and heading innovative DDS startups, and consulting in DDS devices for pulmonary, nasal, SC (needle/needle-free), and IM delivery. He is an appointed business coach by the European Innovation Council and an industry fellow at Technical University of Denmark. He holds a BSc, MSc and PhD in mechanical engineering and innovation, as well as an MBA.

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).

Kewei has 13 years industry experience in Novartis, Roche and WuXi biologics in Switzerland, specializing in parenteral formulation& process development, high concentration formulations, long-acting delivery formulations, as well as combination products such as pre-filled syringe, and extending to CMC management for biologics.

Kewei obtained his Bachelor and Master degrees from School of Pharmaceutical Sciences in Peking University, PhD degree from University of Jena in Germany, focusing on pharmaceutical technology and drug delivery. He has published many research papers during his study and work.

John Mulcahy is the VP of Product Management at S3 Connected Health. He has 18 years of digital health platform and product leadership, working with Pharma, Medtech, health providers and medical societies to define their strategy, create digital health and medical device products and deploy services at scale in multiple Therapeutic Areas. He was formerly Global Head of eHealth and Patient Care at Merck KGaA He has an MBA from Imperial College London, MIT certificate in Strategy & Innovation, and BEng in Computer Engineering.

Educational background in design with an engineering Master's degree within design and innovation from the Technical University of Denmark working on designing a user-centred exoskeleton for rehabilitation of stroke patients.

3 years of experience within hearing aids industry with a design patent focusing on usability of future hearing aid technologies.

Currently 3 years in working as an advanced usability engineer within Novo Nordisk focusing on the next generation of platform projects.

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.

Miriam Schulze is the CEO and Co-Founder of BAYOOMED, bringing more than 15 years of expertise in (medical) software and apps for Health Insurances, Medical Technology, Life Science, and Pharma. With a strong foundation in computers, she has built a career focused on the development and delivery of compliant, user-centered digital health solutions.

Her know-how spans medical software engineering, quality and risk management, and regulatory affairs, making her a trusted expert in navigating complex development and approval pathways. Miriam is particularly passionate about reimbursable digital health applications (DiGA), clinical decision support systems, digital health technologies for clinical trials and investigations, as well as ensuring security and connectivity in healthcare IT. She champions agile methods and forward-looking strategies, leading with a commitment to innovation that enhances patient outcomes and strives to redefine the possibilities of modern healthcare technology.

Ortzi Olasolo is a seasoned regulatory affairs professional with extensive experience in the strategic challenges of drug-device combination products (iDDCs). His expertise centers on the practical implementation of the EU MDR, guiding companies through the entire Notified Body Opinion process from initial submission to post-approval lifecycle management. He has a keen focus on addressing critical industry issues, such as Notified Body inconsistencies, and creating efficient pathways for global regulatory approvals. He leads the Medical Devices and Combination Products of Beyond Conception, a Swiss-based consulting firm.

Francesca Bastaroli is Chief Marketing Officer at Haemopharm Healthcare and holds a PhD in Translational Medicine from the University of Pavia. She graduated in Biology and earned a Master’s Degree in Molecular Biology and Genetics with honors. During her PhD, and later as a researcher, she conducted advanced research on human induced pluripotent stem cells (hiPSCs) in the field of cardiology at Policlinico San Matteo (Italy). Currently, she combines her scientific expertise with strategic and operational responsibilities in the medical device sector, managing marketing, R&D coordination, product development, and intellectual property. She is

also involved in the organization of national and international tradeshows and supports business development activities. Francesca is currently pursuing a second-level Master’s in Clinical Research and Medical Affairs for Drugs and Medical Devices, with a thesis focused on drug-device combination products, further strengthening the connection between her academic background and industry experience.