Bastiaan De Leeuw has been active in the field of drug delivery for the last 20 years. He has led projects covering dry-powder formulation development, inhaler design and development, and auto-injector design and development, as well as the associated stages of clinical and regulatory evaluations. In addition, he led the initial clinical evaluation of urologic diagnostic tests at NovioGendix (now MDxHealth) and has worked at Focus Inhalation, Akela Pharma, Oval Medical, Bespak, and most recently at Cambridge Design Partnership. Bastiaan holds a degree in biopharmaceutical sciences from Leiden University in The Netherlands. As of November 2020, he has joined Corbion as Director - Business Development Biomaterials.

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.

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.

Tiffany McIntire has been working as a human factors engineer for five years, developing delivery systems and labelling strategies in the pharmaceutical industry. After her studies in industrial/organisational psychology, she started her career at Lilly, where she worked on a range of combination products including dial-and-dose injectors for insulin, autoinjectors, pre-filled syringes, digital products and an emergency inhalation device. After working at Lilly, she jumped across the pond to Germany, joining a recently established device group within Boehringer Ingelheim. While there she worked to deepen the team’s knowledge of HF and improve their quality management system and vendor management. At the beginning of August, she joined the Roche HF team in Basel, Switzerland, to work with the team there generating external, scientific publications as well as guiding the team towards best practices in HF.

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany. From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strat­egy including human DMPK for development and life cycle management projects. After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals. Meanwhile Dr. Clemens Günther has gained about 30 years of experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.

Katharina Golly started her professional career as a Development Engineer at Schott in 2010. She was responsible for the design development, verification, and industrialization of silicone-based coatings for both glass and COC pre-filled syringes. In 2015 she joined Novartis as a primary packaging expert and supported ophthalmic PFS projects prior to becoming the Delivery System's technical lead for Vials& kits. Katharina holds a Medical Engineering degree, Dipl. Ing (FH), of the University of Applied Sciences Ulm, Germany.

Eva Conraths has been working as a technical expert in the area of primary packaging and fluid path components for 3.5 years at Novartis supporting vial kit and pre-filled syringe projects for parenteral and ophthalmic applications. She graduated from the Karlsruhe Institute of Technology with a B.Sc. in Bioengineering and from the University of Stuttgart with a M.Sc. in Medical Engineering. During her studies, she already gained various industrial expertise in drug delivery device development.

Cedric Gysel is a healthcare solutions manager for Johnson  &Johnson Design, driving human-centred solutions for patients and customers of Janssen. He has more than 12 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science in Bern and Stanford University with a specialisation in human-centred design.

Dr. Bassil Akra is CEO and one of the owners of the QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

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.