Mechanistic MIDD: Achieving Regulatory Success Through Strong Scientific Foundations

Piet van der Graaf, PharmD, PhD is Senior Vice President Applied BioSimulation at Certara, Professor of Systems Pharmacology at Leiden University, and Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center. Previously, he was the Director of the Leiden Academic Centre for Drug Research and held leadership positions at Pfizer in Discovery Biology, DMPK and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet received his doctorate training in clinical medicine with Nobel prize laureate Sir James Black at King’s College London. He was awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet is an elected Fellow of the British Pharmacological Society and has published >250 articles in the area of quantitative pharmacology and drug development.

Karen Rowland-Yeo is Senior Vice President of Client & Regulatory Strategy at Certara UK Ltd. She has over two decades of experience applying PBPK models in both global health and drug development and is currently focused on driving advancement of PBPK modeling in child and maternal health. Prior to her current role, Karen was Head of PBPK Consultancy Services at Certara UK Ltd, where she led a core team of scientists engaged in consultancy projects relating to the application of PBPK modeling in drug development and drove development of best practices while working directly with global regulators to gain acceptance of PBPK models. Karen has authored or co-authored more than 100 publications in peer-reviewed journals spanning clinical pharmacology, drug metabolism, and drug-drug interactions, and is frequently invited to speak at international meetings in the field. In 2023, Karen was awarded the Roger Jelliffe Individualized Therapy Award by the American College of Clinical Pharmacology (ACCP), in recognition of her contributions to personalized medicine through model-informed precision dosing. In 2024, she chaired the Scientific Program Committee for the ASCPT Annual Meeting and served as Deputy Editor-in-Chief of CPT:PSP; in October 2025, she took over the helm as Editor-in-Chief of Clinical Pharmacology & Therapeutics.