Karin Sartorius is Manager Life Sciences at the Economic Development of the Canton of Basel-Stadt. The Unit is committed to creating optimal framework conditions for companies in the canton and together with their partners, to ensuring that companies in Basel-Stadt and the region can continue to contribute to positive economic, social and ecological development in the future. A robust ecosystem provides the critical enablers for innovation and new technologies. Prior to joining the public sector, Karin worked for global pharmaceutical and medical device companies in different functions. She has a Master’s degree in marketing and business administration from the University of Basel and a Bachelor’s degree in biomedical engineering from Arizona State University.

Dr. Bernhard Spörri is head of unit-2 at the division quality assessment of the sector authorisation at Swissmedic. He is in the lead of the interdepartemental expert group for combination products at Swissmedic. He studied Pharmacy and received a PhD from the University of Bern. After spending a year as a postdoc at the National Institutes of Health, Bethesda USA, he held several positions in the pharmaceutical industry before joining Swissmedic in 2008.

Mr. Nguyen is the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration since January 2008. OCP is primarily responsible for making jurisdictional determinations, ensuring timely premarket reviews, ensuring consistent and appropriate postmarket regulations, and developing policy, guidance documents, and regulations. Mr. Nguyen joined the agency in 1993 as a scientific reviewer in the Division of Cardiovascular and Respiratory Devices in the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH). His primary responsibilities included the review of premarket notifications (510(k)s), investigation device exemptions (IDEs), and premarket approval (PMA) applications for circulatory support devices such as heart lung perfusion systems, left ventricular assist devices, and total artificial hearts. During this time, he was also a member of several CDRH and intra-Agency working groups and had a long history of developing consensus among various components of the Agency on specific issues such as interference with medical devices from wireless telemetry. From 2000 – 2007, Mr. Nguyen was the Chief of the Premarket Approval Program in CDRH where he was primarily responsible for ensuring the uniform and consistent application of the PMA regulations and policies across CDRH and CBER. In this capacity, he had established significant policies and written numerous guidance documents (e.g., expedited review, user fees, PMA actions). On June, 2007, he became the ODE Associate Director for Regulatory Review Programs. During his tenure as the PMA Chief and ODE Associate Director, Mr. Nguyen also played a key role in the negotiation, passage and implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. Mr. Nguyen received a bachelor degree with honor in Electrical Engineering degree from North Carolina State in 1986.

Mike is Global Head Novartis MDR Implementation & DD&C Compliance at Novartis Pharma AG since April 2019. In this role, Mike oversees all activities related to the EU MDR implementation for Medical Devices & Combination Products at Novartis globally. Mike leads the Medical Device and Combination Product Expert Network at Novartis, and is a member of several US and EU Expert Committees and Interest Groups on Combination Products Prior to this position Mike was Executive Director QA / Senior Compliance Officer (GCA) for four years, overseeing all compliance activities related to Medical Devices & Combination Products at Novartis globally. He joined Novartis in 2010 as Global Auditor in Group Compliance and Audit. Before joining Novartis, he was Director Global Audit Systems at Gambro Renal Care (today Baxter) and European Head Quality Systems & Audits at 3M. He studied Chemical Engineering and Plastic Technologies in Münster, Germany, and has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry.

Maria Dutarte is the Executive Director of the European Patients’ Academy (EUPATI) since 2020. Maria has previously worked for the European AIDS Treatment Group (EATG) coordinating patient involvement in a number of training initiatives and scientific projects. She has also worked for different scientific and international organisations, e.g. French National Research Center for Scientific Research (CNRS), International AIDS Society (IAS), The Global Fund to Fight AIDS, Tuberculosis and Malaria and The International Foundation for Science (IFS). Her educational background is in International Education and Communications.

Stephan Affolter is Board member of MPP and currently the Regulatory + Quality Intelligence Manager at Ypsomed, having started working in the Drug delivery Device / Diabetes care industry more than 20 years ago, and has held various positions in Quality Management and Regulatory Affairs, including several management functions. Stephan has also been involved in development of current standards and guidance documents in national and international standards committees (ISO) and working groups (i.e. PDA, MPP, Swiss Medtech). Stephan is a board member of the industry association the Medtech & Pharma Platform (MPP), which supports collaboration across the different industries with a focus on combined products. Stephan Affolter studied Chemical Engineering at the University of Applied Sciences in Burgdorf, Switzerland and also obtained a degree as a Chemist (dipl. FH, BS), before spending almost 10 years working in the Food, Drug and Biotech industries in different leading QC/QA/QM/RA and Production functions, including as a Qualified Person.

Dr. Paolo Decuzzi is a Senior Scientist and Professor of Biomedical Engineering at the Italian Institute of Technology (IIT) in Genoa – Italy where, in July 2015, he founded the Laboratory of Nanotechnology for Precision Medicine returning in Europe after 10 years of activities conducted in different Clinical Research Institutions in Houston, Texas – USA. Decuzzi is a board member of multiple scientific associations, institutions, and advisory panels, including the Controlled Release Society, IIT, ERC, and the biotech accelerator program SPARK at Stanford. His multidisciplinary research focuses on the rational design of nanoconstructs and implantable devices for the treatment and imaging of various diseases and the development of AI-based models for optimizing the therapeutic efficacy of drug delivery systems. In this context, Decuzzi has published 200+ scientific contributions and generated 10+ patents. His activities have been funded by multiple organizations, in the US and EU, and private companies totaling over $15 million.

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Lada Leyens has a background in human genetics, health economics and personalised medicine. She has worked at Health Authorities for over 8 years, mainly as a clinical trial assessor and GCP inspector at Swissmedic. At EMA she was in the specialised disciplines office working in the centralised procedure on clinical pharmacology and pharmacogenomics aspects. Lada joined Roche in 2019, where she works as Global Regulatory Lead on Clinical Trial Innovation and digital health programs. In this role she is working to increase the adoption of innovative methods in Roche’s drug development programs and to increase their acceptance externally. Lada represents Roche in the Clinical Research Expert Group at EFPIA, including its Innovative Clinical Trial pillar.