Summary
Unlock New Possibilities with Mechanistic Modeling: With ICH M15 finalized and EMA’s MIDD initiative active, forward-thinking sponsors are already leveraging trusted PBPK and QSP models to enable groundbreaking decisions.
Join Karen Rowland Yeo and Piet van der Graaf, leading voices in PBPK and QSP, for a practical webinar. Through real case studies, they’ll reveal what’s achievable now and what the future holds.
Move beyond asking if modeling works. Ask instead: Is your organization bold enough? Discover how mechanistic modeling drives real-world decisions, submissions, and the development of tomorrow’s novel medicines.
You’ll walk away knowing
- Building regulator-trusted modeling strategies — discover how collaboration, transparency, and credibility-focused practices transform models into accepted regulatory evidence
- Optimizing first-in-human dosing for novel medicines — maximize patient benefit while minimizing unnecessary animal use through robust regulatory justification
- Advancing care for special populations and rare diseases — explore AI-enabled mechanistic Virtual Twins® for gene therapies and emerging approaches expanding possibilities for underserved patients
- The future of drug-drug interaction (DDI) modeling — move beyond CYP-mediated interactions to examine emerging GLP-1 pathways and what they signal for the next generation of mechanistic modeling
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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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