Jakob Lange recently started his position as head of account and business development with responsibility for Ypsomed delivery systems' customer relationships and marketing activities.

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 16 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.

Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA & RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.

Previously she worked in the medical affairs and pharmacovigilance department at Bayer as director of medical device safety global pharmacovigilance/medical device safety officer.

She has more than 15 years of experience in the quality management and regulatory affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training, and performance evaluation.

She studied biology with a focus on biochemistry, immunology, and pharmacology, and did her PhD in pharmacology and pharmacochemistry in Strasbourg, France. She started her professional life with more university-oriented areas doing research and development in France, Sweden, and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension, and development of immunoassays.

In her current position at Bayer AG, her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products, and eHealth components of the pharmaceuticals portfolio.

She is also responsible for ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, including accordance with medical device good clinical practice (GCP). She is also leading the project of the implementation of EU MDR for PH-Bayer AG.

She was nominated in 2019 by the European Commission as EFPIA observer for the post-market surveillance and vigilance subgroup (GROW.D4) responsible for the implementation of these process according to the medical device regulation. The period of nomination is of five years starting on March 1, 2019.

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.

Sahrah Parveen is a principal scientist within the development organisation with Lonza Drug Product Services (Basel, Switzerland). Sahrah is responsible for implementing device development strategies for customers. She has 15-plus years of experience in the medical device and combination product field and has worked for startups and large pharma.

Sahrah holds a PhD in inorganic chemistry from the University of New Mexico (USA).

Julia Frese holds an MBA and is a seasoned biomedical engineer. Her expertise lies in the field of development and regulatory approval of combination devices and ATMP products. She has also contributed to the development of standards for ATMP products. Currently, Julia serves as the head of the medical and health services division at TÜV SÜD Japan, and she is tasked with developing article 117 services within the organisation. Additionally, she serves as a co-chair of the Team NB working group for article 117.

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.

Lasse Staal is co-founder of Danish startup AddiFab, which was recently acquired by US AM pioneer Nexa3D. He is a passionate believer in the transformative potential of additive manufacturing (AM), and equally passionate about removing the key limitations that prevent AM from becoming a cornerstone in medical device manufacturing. The AddiFab key focus – to merge the most important benefits from AM and injection moulding to create the ultimate manufacturing platform – reflects this passion.

Gregor Anderson founded Pharmacentric Solutions Ltd in 2017 to deliver consultancy services for the pharma and device industries. Pharmacentric Solutions specialises in both device and packaging development and strategies from early concept through to commercial supply with a particular focus on sustainability. Previously, Gregor was senior design director at GSK working as a device and packaging specialist, he has over 30 years’ experience in pharma and medical device design, and he’s a named inventor on well over 50 patents. He has presented widely on topics such as digital, patient-centric design and pharma road-mapping. He has a BSc in industrial design and an MSc in polymer science and engineering. At GSK he led platform developments including injectable and respiratory devices, and in 2009 Greg moved to GSK Manufacturing as global head of technical packaging. In 2017, he authored the technology and innovation roadmap for the UK pharma industry. He is a board member of the packaging group at the Institute of Materials (IOM3).  

Davide Mercadante is a biomedical engineer with 15-plus years of experience within multiple areas of device and combination product development, including design and development, design quality engineering and assurance, verification and validation engineering, quality control, and supply chain quality. He received his bachelor’s and master’s degree from the University of Rome Tor Vergata, where his focus was on medical device design and development. Davide has a lean six sigma green belt certification and he currently works as principal quality engineer in the global device quality group providing oversight on different programs and being the quality project lead for the risk management process

Dr. Ronan MacLoughlin, PhD, MBS, is currently director of R&D, science, and emerging technologies in Aerogen Limited. Ronan has more than 20 years’ experience in respiratory drug delivery with several nebuliser and accessory product launches over that time. He has responsibility for new product development, establishing and exploiting the science underpinning respiratory drug delivery, and identifying new and potentially disruptive emerging technologies. To this end, he has developed multiple technologies and products with several patents granted and pending that cover the range of drug, device, drug/device combination products, patient interventions, and patient interfaces.  

Ronan currently serves as chair of the industry representative group in CURAM, the Science Foundation Ireland centre for developing the next generation of smart medical devices, and sits on the board, (previously chair) of the Medical and Engineering Technologies Center (MET), the Enterprise Ireland Technology Gateway. Additionally, he is currently chair of the Paediatric and Cystic Fibrosis working group within the International Society for Aerosols in Medicine (ISAM). He sits on the board of LEP Biomedical, a preclinical company focussed on the development of novel implantable drug delivery systems for the treatment of glaucoma and other ophthalmic conditions.

Finally, Ronan holds the position of adjunct associate professor in Trinity College Dublin (school of pharmacy and pharmaceutical sciences), and senior honourary lecturer in the Royal College of Surgeons, Ireland (school of pharmacy and biomolecular sciences).

Susanne Becker did her PhD at the University of Konstanz (DE) in analytical chemistry. After seven years’ experience in the pharmaceutical industry at Aeropharm and Baxter, in April 2016 she joined Intertek (Schweiz) AG, where she is working as project leader in E&L and since 2021 as head of extractables and leachables laboratories.

Pieter Van Wouwe received his master’s degree and PhD in bioscience engineering at the University of Leuven (Belgium) in 2011. In March 2016, he started to work at Nelson Labs NV (formerly Toxikon Europe) as a project manager. Since then he has been dealing with the design of extractable and leachable studies, as well as the scientific interpretation and reporting of analytical results. His main focus has been on extractable/leachable projects concerning large volume parenteral applications, single-use systems used in drug product manufacturing and infusion devices.