Summary
The regulatory landscape has shifted. ICH M15 is finalized. The EMA’s MIDD initiative is live. And the sponsors who are moving fastest aren’t waiting; they’re building mechanistic models that regulators trust and using them to make decisions that were previously impossible.
The question is no longer whether mechanistic modeling works. It’s whether your organization is using it boldly enough.
Join Karen Rowland Yeo and Piet van der Graaf, two of the field’s most recognized voices in Physiologically Based Pharmacokinetics (PBPK) and Quantitative Systems Pharmacology (QSP) for a frank, case-study-driven conversation about what’s achievable today and what’s coming next.
You'll walk away knowing:
- How to build a modeling strategy that regulators trust – the collaboration, transparency, and credibility-building practices that turn models into accepted regulatory evidence.
- How to maximize patient benefit with first-in-human dosing for novel medicines while reducing unnecessary animal usage with comprehensive regulatory justification
- What’s working in special populations and rare disease today including building AI-enabled mechanistic Virtual Twins® for gene therapies and how new approaches are changing what’s possible for underserved patient populations
- Beyond CYP-mediated DDI – DDI examples continue to grow including emerging GLP-1 interactions and what they reveal about where mechanistic modeling is going
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Karen Rowland Yeo, PhD
Senior Vice President, Client & Regulatory StrategyKaren 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.
Piet van der Graaf
Senior Vice President and Head of Quantitative Systems PharmacologyPiet 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.
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