Emer Cooke is the Executive Director of the European Medicines Agency, based in Amsterdam. She also holds the role of Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA). Previously, she was the Director responsible for all medical product-related regulatory activities at the World Health Organization in Geneva between November 2016 and November 2020. Ms. Cooke is a pharmacist with Masters degrees in Science and Business Administration from Trinity College Dublin. She has over 30 years’ experience in international regulatory affairs and held management positions at the European Medicines Agency as Head of Inspections and Head of International Affairs respectively from 2002 until 2016. From September 1998 to July 2002, she worked in the Pharmaceuticals unit of the European Commission, where intra-alia, she was responsible for international collaboration, EU enlargement and the orphan medicines regulation.

Matthias Kretzler, MD, PhD, is the Warner-Lambert/Parke-Davis Professor of Medicine and Professor of Computational Medicine and Bioinformatics at the University of Michigan where he also is an attending physician. His special interest is in the diagnosis and management of glomerular diseases and diabetic kidney disease. Dr. Kretzler’s overarching goal is to define renal failure in mechanistic terms and use this knowledge for targeted therapeutic interventions. He has developed a translational research pipeline centered on integrated systems biology analysis of renal disease. He and his team have performed interdisciplinary data integration of large-scale data sets in international and multi-disciplinary research in the United States, Europe, and China, resulting in new disease predictors and the first successful phase II trial of a novel therapy in diabetic kidney disease in two decades. Dr. Kretzler received dual doctoral degrees, MD and PhD, from the University of Heidelberg, Germany. He completed post-doctoral training as a research fellow in nephrology at the University of Michigan, Ann Arbor, followed by a residency in internal medicine and a fellowship in nephrology at the University of Munich. He leads the Nephrotic Syndrome Research Network (NEPTUNE) in the Rare Disease Clinical Research Network II and is a Principal Investigator for the Coordinating Centers of the Kidney Precision Medicine Project and the CureGN Research Network. Dr. Kretzler is the Director of the Applied Systems Biology Core at the Michigan Kidney Center, and is a leader in the NIH Acceleration of Medicine Program (AMP) in autoimmunity. Dr. Kretzler has 25 years of experience in integration of bioinformatics, molecular, and clinical approaches and has more than 400 publications in prominent scientific journals.

Dr Gabriel Westman is the head of Artificial Intelligence på Swedish Medical Products Infectious disease specialist and associate professor (MD, PhD) with a clinical, scientific and regulatory interest in viral infections, antiviral therapies and clinical study design. Also have a MSc in Engineering (Chemistry/Pharmaceuticals) and expertise in bioinformatics, AI and big data applications. Currently building regulatory AI/data science capacity and competence at the Swedish Medical Products Agency, exploring use of real world data and hoping for a better and data-driven world.

Dr Jörg Schläpfer is the Chief of Staff & Head Sector External Relations at Swissmedic, the Swiss Agency for Therapeutic Products. Dr Schläpfer studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine, completing his PhD and undertaking 12 years of academic research, he was employed by a number of companies in various roles within the pharmaceutical industry from 2002 to 2015. From 2015 to 2019, Dr Jörg Schläpfer was Head of Division Process Development and Support in the Authorisation sector at Swissmedic as well as Deputy Head of the sector. In March 2019, Dr Schläpfer was appointed as Chief of Staff & Head Sector External Relations.