Manger Life Sciences, Economic Development | Canton Basel-Stadt
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.
Dr. Sebastian Fuchs is inspector in the Medical Devices Surveillance Division at Swissmedic. With market control activities such as inspections of medical device manufacturers, he ensures that medical devices on the market comply with conformity and legal requirements. He currently leads the borderline & classification expert pool and is deputy head of the interdivisional group for combination products at Swissmedic. Until May 2021, he was a member of EU Medical Device Coordination Group (MDCG) task force and working groups. Prior to joining Swissmedic, he held positions in the medical device and pharmaceutical industry, focusing on product development and portfolio innovation. Sebastian Fuchs studied Biotechnology in Strasburg, France and holds a PhD from the Swiss Federal Institute of Technology Zurich.
Director of the Office of Combination Products | US FDA
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.
John Barlow Weiner is the Associate Director for Policy in FDA’s Office of Combination Products, which is tasked with ensuring the efficient, effective and consistent regulation of combination products and the classification and assignment of medical products. In addition to overseeing the policy program for OCP, his responsibilities include providing guidance and direction for FDA policy initiatives and precedential regulatory actions concerning combination products and other medical products intended for combined use.
Prior to joining OCP, Mr. Weiner was in private practice and then an Associate Chief Counsel for FDA, focusing on drug regulation and related innovation and competition issues, and on cross-cutting topics such as use of nanotechnology. He has served as FDA’s liaison to the United States Trade Representative and other USG components of USG on pharmaceutical trade and competition. He received a BA from Princeton University and a JD with honors from the Columbia University School of Law.
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.
Sabina Hoekstra-van den Bosch
Sabina is Regulatory Strategy Principal at Notified Body TÜV SÜD and represents of TÜV SÜD and Notified Bodies at European level. She is Chair of NBCG-Med, the EU Commission’s working group of Notified Bodies, and Vice-President of Team-NB, the EU Notified Bodies’ association.
Sabina has 20 years of experience as pharmaceutical and medical device regulator and legislator in the Dutch government, serving subsequently in the Medicines Evaluation Board, Ministry of Health and the governmental organization for clinical investigations CCMO.
She has worked as Lead for European Regulation in Philips, where she acted as leader and expert in European Medical Device and Pharmaceutical Regulations on corporate level and was involved in EU MDR/IVDR implementation.
Sabina has a long track record as volunteer in global professional organizations (DIA and RAPS). She is a regular speaker and faculty member in educational conferences on regulatory topics.
She is Fellow of RAPS and serves in the RAPS Global Board of Directors.
Sabina is trained as pharmacist and holds a PharmD from Leiden University.
Executive Director | EUPATI
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.
Rahel von Rohr
Senior Consultant | anteris helvetia
Rahel von Rohr is a PMP-certified project manager with an MSc in biomedical engineering from ETH Zurich and a strong track record in the medical device and combination-product fields. In her current position as Senior Consultant at anteris helvetia AG, she supports companies in developing and marketing drug-device combination products. As a project manager she leads projects from ideation to design transfer, both with small start-ups and global big pharma and has gained international experience within projects in the EU, the US, China and Japan. She is passionate about advancing medical technology in general and particularly connected injection systems; helping patients enjoy the benefits of technology.
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. Atalah Haun is a passionate clinical research professional in a journey to find how to quantify and reduce patients’ unmet medical needs, how to be patient-centric when designing clinical studies, how to improve patient’s experience, and how to translate insights into opportunities to better help them. He is the head of the Global Medical Affairs Department at Veritat, responsible for Medical Monitoring, Pharmacovigilance (Phase 1-4 trials), Site Selection / Site Feasibility, Patient Recruitment, Virtual Site Solutions, DMC/DSMB support, among other medical consulting work focused on helping companies to transition from pre-clinical to clinical drug-development stage. He is an MD with training in internal medicine and intensive care accumulating 10+ years of medical practice and 7 years in the clinical research industry.
Senior Scientist and Professor of Biomedical Engineering | Italian Institute of Technology
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.
San Pun, Ph.D. has broad experiences in life sciences, including in different areas of pharmaceutical and diagnostic industries. He is both an author with top notch publications and an inventor. He is a founder of a high-tech startup aiming to provide a novel diagnostic solution to address unmet healthcare need in managing disease areas of cardiovascular and autoimmune diseases. Additionally, he is aiming to alleviate these diseases through enabling technologies that will fulfill the megatrend of future healthcare in personalized medicine, digital and remote health.
European Medicines Agency
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Dr. Dollins currently heads the Global Regulatory Affairs team, Precision Medicine and Digital Health at Bristol-Myers Squibb. In her current role, she leads team that provides regulatory strategy support to the companion diagnostics and digital health elements of the BMS portfolio.
Before joining BMS, she was responsible for the development and implementation of global regulatory strategies of companion diagnostics, medical devices and digital health products in the Merck Healthcare KGaA pipeline.
She further served as a senior reviewer and acting chief of the hematology branch of the Office of In Vitro Diagnostics and Radiologic Health at the FDA.
Dr. Dollins holds a PhD in Genetics and Genomics from Duke University Medical Center and completed postdoctoral training in Developmental Biology at the University of North Carolina, Chapel Hill.
Quantum Industry Consultant & Computational Scientist – Life Sciences & Healthcare | IBM
Director, Front-End Innovation | Phillips Medisize
Iain is a Commercial Director at Phillips-Medisize, where he is part of a global team developing industry leading solutions and platforms for drug delivery, digital medicine and connected health. He has more than 30-years’ experience in multi-disciplinary technology and product development; the last 20 years have in healthcare and increasingly focused on the use of devices and digital technologies to create product differentiation, improve patient engagement and better measure clinical outcomes in real world settings. He has a degree and PhD in physics both from University College London and an MBE in Technology Management from the Open University. He has published and presented at conferences on drug delivery, digital biomarkers, healthcare technology and technology licensing. He is an associate lecturer at the University of Cambridge in Bioscience Enterprise.
Global Regulatory Lead, Clinical Trial Innovation | Roche
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.
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