概述
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
高级副总裁，客户与监管战略部Karen 是 Certara UK Limited 旗下 Simcyp 事业部的客户与监管战略高级副总裁。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 现任 Certara 公司应用生物模拟高级副总裁，莱顿大学系统药理学教授，以及辛辛那提儿童医院医疗中心儿科教授。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. Piet 于Pharmacometrics & Systems Pharmacology before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet 曾在伦敦国王学院师从诺贝尔奖获得者 Sir James Black，接受了临床医学的博士培训。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 是英国药理学会的当选委员，在定量药理学和药物开发领域发表了超过 250 篇同行评议的论文。
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