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 is Senior Vice-President, Client & Regulatory Strategy at Certara UK Limited’s Simcyp Division. Prior to this, she was the Head of PBPK Consultancy Services at Simcyp where she led a team of scientists engaged in Consultancy projects relating to the application of physiologically based pharmacokinetic (PBPK) modelling in drug development. Her work has focused on the use of PBPK models for assessment of drug-drug interactions and dosing of special populations and she is the author/co-author of more than 100 peer reviewed articles in these areas.